Lemsip Max All in One Breathe Easy

1. Name Of The Medicinal Product

Lemsip Max All in One Breathe Easy

Powder for Oral Solution

2. Qualitative And Quantitative Composition

Each sachet (4.8g) contains:

Paracetamol 1000mg

Guaifenesin 200mg

Phenylephrine Hydrochloride 12.2mg

Excipients:

Each sachet of this product contains:

61.5mg Aspartame – a source of phenylalanine

1973.3mg of sucrose

129.0mg (5.6mmol) of sodium

Also contains lactose and sulphite

For full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Powder for oral solution

Pale yellow powder.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of symptoms of colds and influenza, including the relief of aches and pains, sore throat, headache, nasal congestion, lowering of temperature and chesty coughs.

4.2 Posology And Method Of Administration

Oral administration after dissolution in water.

Adults and adolescents 12 years and over: One sachet dissolved by stirring in hot water and sweetened to taste.

Dose may be repeated in 4-6 hours. No more than four doses should be taken in 24 hours.

Not to be given to children under 12 years of age without medical advice.

4.3 Contraindications

Hypersensitivity to any of the ingredients

Severe coronary heart disease and cardiovascular disorders

Hypertension

Hyperthyroidism

Concurrent use of monamine oxidase inhibitors (MAOI)

4.4 Special Warnings And Precautions For Use

Use with caution in patients with Raynaud's phenomenon or diabetes mellitus. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Phenylephrine should be used with care in patients with hyperthyroidism, cardiovascular disease, diabetes mellitus, closed angle glaucoma, prostatic enlargement and hypertension.

This product contains 1973.3mg sucrose per dose (total sugars 2g). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This product contains 129.0mg (5.6mmol) sodium per dose - to be taken into consideration for patients on a controlled sodium diet.

The following warnings will appear on the package label and/or leaflet:

Contains a source of phenylalanine. May be harmful for people with phenylketonuria. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. DO NOT EXCEED THE STATED DOSE. CONTAINS PARACETAMOL. Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well. Keep out of the reach and sight of children. If symptoms persist, consult your doctor. DO NOT TAKE IF: allergic to any of the ingredients, if you have heart disease or high blood pressure. Do not store above 25oC Store in the original package. This medicinal product contains 129.0mg of sodium per dose. To be taken into consideration by patients on a controlled sodium diet. Contains sulphite; may rarely cause severe hypersensitivity reactions and bronchospasm. If you are pregnant or are being prescribed medicine by your doctor, seek his advice before taking this product. Also includes aspartame, sucrose, lactose, sulphite and sodium.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Paracetamol

The rate of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption may be reduced by cholestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Medicinal products which induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdose.

Phenylephrine hydrochloride

Monoamine oxidase inhibitors (including moclobemide): hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see section 4.3).

Sympathomimetic amines: concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects.

Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine, methyldopa): phenylephrine may reduce the efficacy of beta-blockers and antihypertensives. The risk of hypertension and other cardiovascular side effects may be increased (see section 4.3).

Tricyclic antidepressants (e.g. amitriptyline): may increase the risk of cardiovascular side effects with phenylephrine (see section 4.3).

Digoxin and cardiac glycosides: concomitant use of phenylephrine may increase the risk of irregular heartbeat or heart attack.

Guaifenesin

Guaifenesin may increase the rate of absorption of paracetamol. Guaifenesin may interfere with diagnostic measurements of urinary 5-hydroxyindoleactic acid or vanillylmandelic acid.

4.6 Pregnancy And Lactation

Paracetamol

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breast-feeding.

Phenylephrine hydrochloride

The safety of this medicine during pregnancy and lactation has not been established but in view of a possible association of foetal abnormalities with first trimester exposure to phenylephrine, the use of the product during pregnancy should be avoided. In addition, because phenylephrine may reduce placental perfusion, the product should not be used in patients with a history of pre-eclampsia. In view of the lack of data on the use of phenylephrine during lactation, this medicine should not be used during breast feeding.

Guaifenesin

Has been linked with an increased risk of neural tube defects in a small number of women with febrile illness in the first trimester of pregnancy. The product should be used in pregnancy only if the benefits outweigh this risk. There is no information on use in lactation.

4.7 Effects On Ability To Drive And Use Machines

Lemsip Max All in One Breathe Easy has no or negligible influence on ability to drive or use machinery.

4.8 Undesirable Effects

Paracetamol

Adverse effects of paracetamol are rare, but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Acute pancreatitis after ingestion of above normal amounts.

Phenylephrine hydrochloride

High blood pressure with headache and vomiting, probably only in overdose. Rarely, palpitations. Also, rare reports of allergic reactions and urinary retention in males.

Guaifenesin

Guaifenesin has occasionally been reported to cause gastro-intestinal discomfort, nausea and vomiting, particularly in very high doses. Also, hypersensitivity reactions may occur.

4.9 Overdose

Paracetamol

Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of five or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors

If the patient:

(a) Is on long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes,

or

(b) Regularly consumes ethanol in excess of recommended amounts,

or

(c) Is likely to be glutathione depleted, e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.

Phenylephrine hydrochloride

Features of severe overdose of phenylephrine include haemodynamic changes and cardiovascular collapse with respiratory depression. Treatment includes early gastric lavage and symptomatic and supportive measures. Hypertensive effects may be treated with an i.v. alpha-receptor-blocking agent.

Phenylephrine overdose is likely to result in: nervousness, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, mydriasis, acute angle closure glaucoma (most likely to occur in those with closed angle glaucoma), tachycardia, palpitations, allergic reactions (e.g. rash, urticaria, allergic dermatitis), dysuria, urinary retention (most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy).

Additional symptoms may include, hypertension, and possibly reflex bradycardia. In severe cases confusion, hallucinations, seizures and arrhythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than that required to cause paracetamol-related liver toxicity.

Treatment should be as clinically appropriate. Severe hypertension may need to be treated with alpha blocking medicinal products such as phentolamine.

Guaifenesin

Very large doses may cause nausea and vomiting. The active substance is, however, rapidly metabolised and excreted in the urine. Patients should be kept under observation and treated symptomatically.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code: N02B E51.

Paracetamol: Paracetamol has both analgesic and antipyretic activity, which is believed to be mediated principally through its inhibition of prostaglandin synthesis within the central nervous system.

Phenylephrine hydrochloride: Phenylephrine is a post-synaptic alpha-receptor agonist with low cardioselective beta-receptor affinity and minimal central stimulant activity. It is a recognised decongestant and acts by vasoconstriction to reduce oedema and nasal swelling.

Guaifenesin: Guaifenesin is an expectorant which reduces the viscosity of tenacious sputum.

The active ingredients are not known to cause sedation.

5.2 Pharmacokinetic Properties

Paracetamol: Paracetamol is absorbed rapidly and completely from the small intestine, producing peak plasma levels after 15-20 minutes following oral dosing. The systemic availability is subject to first-pass metabolism and varies with dose between 70% and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated from plasma with a T½ of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates (>80%) which are excreted in urine.

Phenylephrine hydrochloride: Phenylephrine is absorbed from the gastrointestinal tract, but has reduced bioavailability by the oral route due to first-pass metabolism. It retains activity as a nasal decongestant when given orally, the drug distributing through the systemic circulation to the vascular bed of the nasal mucosa. When taken by mouth as a nasal decongestant phenylephrine is usually given at intervals of 4-6 hours.

Guaifenesin: Guaifenesin is absorbed from the gastrointestinal tract. It is rapidly metabolised by oxidation to ί-(2 methoxy-phenoxy) lactic acid; which is excreted in the urine.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Ascorbic acid

Sucrose

Citric acid

Sodium citrate

Lemon flavour no. 1

Menthol flavour (contains sulphite)

Aspartame (E951)

Saccharin sodium

Curcumin WD (contains lactose)

6.2 Incompatibilities

None known.

6.3 Shelf Life

Two years.

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

Heat-sealed sachet of paper/polyethylene/aluminium foil/ polyethylene laminate in an outer cardboard carton.

Packs: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 sachets.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, East Yorkshire, United Kingdom.

8. Marketing Authorisation Number(S)

PL 00063/0538

9. Date Of First Authorisation/Renewal Of The Authorisation

02/09/2008

10. Date Of Revision Of The Text

27/07/2011

11 DOSIMETRY (IF APPLICABLE)

N/A

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

N/A

Tridesilon

Generic Name: desonide (Topical application route)

DES-oh-nide

Commonly used brand name(s)

In the U.S.

• Desonate


• Desowen


• LoKara


• Tridesilon


• Verdeso

In Canada

• Pms-Desonide

Available Dosage Forms:

• Gel/Jelly


• Ointment


• Cream


• Foam


• Lotion

Therapeutic Class: Corticosteroid, Strong

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Tridesilon

Desonide topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions (e.g., atopic dermatitis). This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available only with your doctor's prescription.

Before Using Tridesilon

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of desonide topical foam or gel in children 3 months of age and older. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. For the foam and gel forms, safety and efficacy have not been established in infants younger than 3 months of age. The safety and efficacy of desonide topical cream, lotion, and ointment have not been established in children and use is not recommended.

Geriatric

No information is available on the relationship of age to the effects of desonide topical cream, ointment, or lotion in geriatric patients.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of desonide topical foam or gel in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving desonide topical foam or gel.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or


• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of desonide

This section provides information on the proper use of a number of products that contain desonide. It may not be specific to Tridesilon. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

Do not use the topical gel on the groin or underarms unless directed to do so by your doctor, and do not use this form for more than 4 weeks.

To use cream, gel, lotion, or ointment:

• Wash your hands with soap and water before and after using this medicine.


• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.


• With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried. Also, shake the lotion well before using it.


• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.


• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.

To use the foam:

• Wash your hands with soap and water before and after using this medicine.


• Shake the foam well before using it.


• Do not put the foam directly on your face. Turn the can upside down and place a small amount of medicine in your hands. Massage it gently into the affected areas of the face until the medicine has dried. For areas other than the face, you may put it directly on the affected area.


• Do not wash or rinse the treated area right after applying the medicine.


• Do not use this medicine near heat, an open flame, or while smoking.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For atopic dermatitis:
  
  • For topical dosage forms (foam or gel):
    
    • Adults and teenagers—Apply to the affected area of the skin two times per day.
    
    
    • Children 3 months of age and older—Apply to the affected area of the skin two times per day.
    
    
    • Children younger than 3 months of age—Use and dose must be determined by your doctor.
    
    
  
  


• For redness, itching, and swelling of the skin:
  
  • For topical dosage forms (cream, ointment, or lotion):
    
    • Adults—Apply to the affected area of the skin two or three times per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the foam can at room temperature, away from heat and direct light. Do not keep this medicine inside a car where it could be exposed to extreme heat. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Precautions While Using Tridesilon

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Make sure your doctor knows that you are using desonide foam. You may need to stop using this medicine several days before having surgery.

Do not use cosmetics or other skin care products on the treated areas.

Tridesilon Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Blistering, burning, crusting, dryness, or flaking of the skin


• burning, itching, redness, skin rash, swelling, or soreness at the application site


• flushing or redness of the skin


• irritation


• itching, scaling, severe redness, soreness, or swelling of the skin


• peeling of the skin


• raised, dark red, wart-like spots on the skin, especially when used on the face


• stinging and burning


• unusually warm skin

Incidence not known

• Redness and scaling around the mouth


• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g., between the fingers)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Body aches or pain


• chills


• cough


• difficulty with breathing


• ear congestion


• fever


• headache


• loss of voice


• nasal congestion


• runny nose


• sneezing


• sore throat


• unusual tiredness or weakness

Less common

• Cold flu-like symptoms


• congestion


• cough


• hoarseness


• irritability


• noisy breathing


• shortness of breath


• tender, swollen glands in the neck


• tightness in the chest


• trouble with swallowing


• voice changes


• wheezing

Incidence not known

• Acne or pimples


• burning and itching of the skin with pinhead-sized red blisters


• burning, itching, and pain in hairy areas, or pus at the root of the hair


• lightening of normal skin color


• lightening of treated areas of dark skin


• reddish purple lines on the arms, face, legs, trunk, or groin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Tridesilon side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Tridesilon resources

• Tridesilon Side Effects (in more detail)
• Tridesilon Use in Pregnancy & Breastfeeding
• Tridesilon Drug Interactions
• Tridesilon Support Group
• 0 Reviews for Tridesilon - Add your own review/rating

• Tridesilon Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• DesOwen Cream Kit Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Desonate Prescribing Information (FDA)


• Desonate Consumer Overview


• Desonate Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Desowen Prescribing Information (FDA)


• LoKara Prescribing Information (FDA)


• LoKara Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Verdeso Prescribing Information (FDA)


• Verdeso Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Verdeso Consumer Overview

Compare Tridesilon with other medications

• Atopic Dermatitis
• Dermatitis
• Eczema
• Psoriasis

Alamast

Generic Name: pemirolast ophthalmic (pem IR oh last off THAL mik)

Brand Names: Alamast

What is Alamast (pemirolast ophthalmic)?

Pemirolast is an anti-allergic medication. It inhibits processes in the body that cause allergic symptoms after exposure to an allergen.

Pemirolast ophthalmic is used to treat ocular (eye) symptoms of allergic conditions, such as itching.

Pemirolast ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Alamast (pemirolast ophthalmic)?

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not wear contact lenses during treatment with pemirolast ophthalmic if your eyes are red. If you wear soft contact lenses, and your eyes are not red, wait at least 10 minutes after using pemirolast ophthalmic before inserting your contact lenses.

Who should not use Alamast (pemirolast ophthalmic)?

Do not use pemirolast ophthalmic if you have a bacterial, viral, or fungal infection in your eye unless you are also receiving proper anti-infective treatment. Pemirolast ophthalmic is in the FDA pregnancy category C. This means that it is not known whether pemirolast ophthalmic will harm an unborn baby. Do not use pemirolast ophthalmic without first talking to your doctor if you are pregnant. It is not known whether pemirolast passes into breast milk. Do not use pemirolast ophthalmic without first talking to your doctor if you are breast-feeding a baby. Pemirolast ophthalmic is not approved for use by children younger than 3 years of age.

How should I use Alamast (pemirolast ophthalmic)?

Use pemirolast eye drops exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before using your eye drops.

To apply the eye drops:

• 
  

  Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye, repeat the process with about 5 minutes between drops. Repeat the process in your other eye if directed to do so by your doctor.

  
  

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not wear contact lenses during treatment with pemirolast ophthalmic if your eyes are red, unless otherwise directed by your doctor. If you wear soft contact lenses, and your eyes are not red, wait at least 10 minutes after using pemirolast ophthalmic before inserting your contact lenses.

Do not use any eye drop that is discolored or has particles in it.

Store pemirolast ophthalmic at room temperature away from moisture and heat. Keep the bottle properly capped.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, call an emergency room or poison control center near you. If the drops have been ingested (taken by mouth), call an emergency center for advice.

What should I avoid while using Alamast (pemirolast ophthalmic)?

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not wear contact lenses during treatment with pemirolast ophthalmic if your eyes are red, unless otherwise directed by your doctor. If you wear soft contact lenses, and your eyes are not red, wait at least 10 minutes after using pemirolast ophthalmic before inserting your contact lenses.

Do not use other eye medications during treatment with pemirolast ophthalmic without first talking to your doctor.

Alamast (pemirolast ophthalmic) side effects

Serious side effects are not expected with pemirolast ophthalmic.

Commonly, some burning, irritation, itching, dry eyes, or other eye discomfort may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Alamast (pemirolast ophthalmic)?

Do not use other eye medications during treatment with pemirolast ophthalmic without first talking to your doctor.

Drugs other than those listed here may also interact with pemirolast ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Alamast resources

• Alamast Side Effects (in more detail)
• Alamast Dosage
• Alamast Use in Pregnancy & Breastfeeding
• Alamast Support Group
• 2 Reviews for Alamast - Add your own review/rating

• Alamast Prescribing Information (FDA)


• Alamast Monograph (AHFS DI)


• Alamast Advanced Consumer (Micromedex) - Includes Dosage Information


• Alamast MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Alamast with other medications

• Conjunctivitis, Allergic

Where can I get more information?

• Your pharmacist has additional information about pemirolast ophthalmic written for health professionals that you may read.

See also: Alamast side effects (in more detail)

Cenestin

Generic Name: conjugated estrogens (oral) (KON joo gay ted ES troe jenz)

Brand Names: Cenestin, Enjuvia, Premarin

What are conjugated estrogens?

Estrogen is a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Conjugated estrogens are a mixture of estrogen hormones used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Other uses include prevention of osteoporosis in postmenopausal women, and replacement of estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. Conjugated estrogens are sometimes used as part of cancer treatment in women and men.

Conjugated estrogens should not be used to prevent heart disease or dementia, because this medicine may actually increase your risk of developing these conditions.

Conjugated estrogens may also be used for purposes not listed in this medication guide.

What is the most important information I should know about conjugated estrogens?

Do not use this medicine if you have any of the following conditions: a history of heart attack, stroke, or blood clot (especially in your lung or your lower body), liver disease, abnormal vaginal bleeding, or a hormone-related cancer such as breast or uterine cancer. Conjugated estrogens can harm an unborn baby or cause birth defects. Do not use if you are pregnant. Long-term use of conjugated estrogens may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using conjugated estrogens long term, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using conjugated estrogens.

Conjugated estrogens should not be used to prevent heart disease, strokes, or dementia, because this medicine may actually increase your risk of developing these conditions.

What should I discuss with my healthcare provider before taking conjugated estrogens?

Do not use conjugated estrogens if you have:

• 
  

  a history of heart attack, stroke, or blood clot (especially in your lung or your lower body);

  
  


• 
  

  abnormal vaginal bleeding that a doctor has not checked;

  
  


• 
  

  a bleeding or blood-clotting disorder;

  
  


• 
  

  liver disease; or

  
  


• 
  

  any type of breast, uterine, or hormone-dependent cancer.

  
  

To make sure you can safely take conjugated estrogens, tell your doctor if you have any of these other conditions:

• 
  

  high blood pressure, heart disease, or circulation problems;

  
  


• 
  

  a personal or family history of stroke;

  
  


• 
  

  endometriosis;

  
  


• 
  

  kidney disease;

  
  


• 
  

  asthma;

  
  


• 
  

  hereditary angioedema;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  migraines;

  
  


• 
  

  diabetes;

  
  


• 
  

  underactive thyroid;

  
  


• 
  

  high cholesterol or triglycerides;

  
  


• 
  

  high or low levels of calcium in your blood;

  
  


• 
  

  porphyria;

  
  


• 
  

  systemic lupus erythematosus (SLE);

  
  


• 
  

  gallbladder disease; or

  
  


• 
  

  if you have had your uterus removed (hysterectomy).

  
  

Conjugated estrogens increase your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using conjugated estrogens may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using conjugated estrogens. Long-term conjugated estrogens treatment may increase your risk of stroke or blood clots. Talk with your doctor about your individual risks before using conjugated estrogens long term, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use conjugated estrogens if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication. Conjugated estrogens can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use if you are breast-feeding a baby. Do not give this medication to anyone under 18 years old without the advice of a doctor.

How should I take conjugated estrogens?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Conjugated estrogens are sometimes taken on a daily basis. For certain conditions, the medication is given in a cycle, such as 3 weeks on followed by 1 week off. Follow your doctor's instructions.

If you see what looks like part of a conjugated estrogen tablet in your stool, talk with your doctor.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using conjugated estrogens.

Use conjugated estrogens regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your thyroid function may also need to be tested. Visit your doctor regularly.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are taking conjugated estrogens. Store at room temperature away from moisture and heat. Keep the medicine container tightly closed.

See also: Cenestin dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, or vaginal bleeding.

What should I avoid while taking conjugated estrogens?

Do not smoke while using this medication. Smoking can increase your risk of blood clots, stroke, or heart attack caused by conjugated estrogens.

Conjugated estrogens side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using conjugated estrogens and call your doctor at once if you have a serious side effect such as:

• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden severe headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  pain, swelling, warmth, or redness in one or both legs;

  
  


• 
  

  abnormal vaginal bleeding;

  
  


• 
  

  migraine headache;

  
  


• 
  

  pain, swelling, or tenderness in your stomach;

  
  


• 
  

  confusion, problems with memory or concentration;

  
  


• 
  

  jaundice (yellowing of the skin or eyes);

  
  


• 
  

  swelling in your hands, ankles, or feet; or

  
  


• 
  

  a breast lump.

  
  

Less serious side effects may include:

• 
  

  mild nausea, vomiting, bloating, stomach cramps;

  
  


• 
  

  breast pain, tenderness, or swelling;

  
  


• 
  

  freckles or darkening of facial skin;

  
  


• 
  

  increased hair growth, loss of scalp hair;

  
  


• 
  

  changes in weight or appetite;

  
  


• 
  

  problems with contact lenses;

  
  


• 
  

  vaginal itching or discharge;

  
  


• 
  

  changes in your menstrual periods, decreased sex drive; or

  
  


• 
  

  mild headache, nervousness, dizziness, tired feeling.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect conjugated estrogens?

Tell your doctor about all other medicines you use, especially:

• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven);

  
  


• 
  

  a thyroid medication such as levothyroxine (Synthroid, Levoxyl, Levothroid and others);

  
  


• 
  

  insulin or diabetes medicine taken by mouth;

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  
  


• 
  

  ketoconazole (Nizoral) or itraconazole (Sporanox);

  
  


• 
  

  seizure medicines such as phenytoin (Dilantin), carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), or primidone (Mysoline);

  
  


• 
  

  a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

  
  


• 
  

  antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

  
  

This list is not complete and other drugs may interact with conjugated estrogens. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Cenestin resources

• Cenestin Side Effects (in more detail)
• Cenestin Dosage
• Cenestin Use in Pregnancy & Breastfeeding
• Drug Images
• Cenestin Drug Interactions
• Cenestin Support Group
• 2 Reviews for Cenestin - Add your own review/rating

• Cenestin Advanced Consumer (Micromedex) - Includes Dosage Information


• Cenestin Prescribing Information (FDA)


• Cenestin MedFacts Consumer Leaflet (Wolters Kluwer)


• Conjugated Estrogens MedFacts Consumer Leaflet (Wolters Kluwer)


• conjugated estrogens Advanced Consumer (Micromedex) - Includes Dosage Information


• Enjuvia Prescribing Information (FDA)


• Enjuvia MedFacts Consumer Leaflet (Wolters Kluwer)


• Enjuvia Consumer Overview


• Premarin Prescribing Information (FDA)


• Premarin Consumer Overview

Compare Cenestin with other medications

• Abnormal Uterine Bleeding
• Atrophic Urethritis
• Atrophic Vaginitis
• Breast Cancer, Palliative
• Hypoestrogenism
• Oophorectomy
• Osteoporosis
• Postmenopausal Symptoms
• Primary Ovarian Failure
• Prostate Cancer

Where can I get more information?

• Your pharmacist can provide more information about conjugated estrogens.

See also: Cenestin side effects (in more detail)

Trospium

Pronunciation: TROSE-pee-um
Generic Name: Trospium
Brand Name: Sanctura

Trospium is used for:

Treating overactive bladder symptoms, such as incontinence, urgency, and frequency. It may also be used for other conditions as determined by your doctor.

Trospium is an antispasmodic and antimuscarinic agent. It works by reducing muscle tone of the bladder which decreases urinary spasm and frequency.

Do NOT use Trospium if:

• you are allergic to any ingredient in Trospium


• you have delayed or slow emptying of the stomach or uncontrolled narrow-angle glaucoma, you are unable to urinate, or you are at risk of developing these conditions


• you are taking a solid oral potassium product (eg, tablet)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Trospium:

Some medical conditions may interact with Trospium. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have liver or kidney problems, or glaucoma or increased pressure in the eye


• if you have stomach or bowel problems (eg, inflammation, constipation, blockage, problems with the muscles in your intestines), myasthenia gravis, bladder blockage, or trouble urinating

Some MEDICINES MAY INTERACT with Trospium. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Solid oral potassium products (eg, tablets) because the risk of stomach or bowel irritation may be increased by Trospium


• Anticholinergic medicines (eg, scopolamine), metformin, morphine, procainamide, tenofovir, or vancomycin because they may increase the risk of Trospium's side effects


• Phenothiazines (eg, thioridazine) because their effectiveness may be decreased by Trospium

This may not be a complete list of all interactions that may occur. Ask your health care provider if Trospium may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Trospium:

Use Trospium as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Trospium by mouth on an empty stomach at least 1 hour before or 2 hours after eating.


• If you miss a dose of Trospium, take it 1 hour before your next meal. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Trospium.

Important safety information:

• Trospium may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Trospium with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Trospium; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Trospium may cause dry mouth. To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.


• Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Tell your doctor or dentist that you take Trospium before you receive any medical or dental care, emergency care, or surgery.


• A severe and sometimes life-threatening side effect called angioedema has been reported with Trospium. Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.


• Use Trospium with caution in the ELDERLY; they may be more sensitive to its effects, including dry mouth, constipation, stomach upset, and trouble urinating.


• Trospium should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Trospium while you are pregnant. It is not known if Trospium is found in breast milk. If you are or will be breast-feeding while you take Trospium, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Trospium:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; constipation; dizziness; drowsiness; dry mouth or eyes; headache; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; dark urine; difficulty urinating; fainting; fast or irregular heartbeat; hallucinations; mental or mood changes; muscle pain or weakness; red, swollen, peeling, or blistered skin; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Trospium side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dry eyes; fast heartbeat.

Proper storage of Trospium:

Store Trospium at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Trospium out of the reach of children and away from pets.

General information:

• If you have any questions about Trospium, please talk with your doctor, pharmacist, or other health care provider.


• Trospium is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Trospium. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Trospium resources

• Trospium Side Effects (in more detail)
• Trospium Use in Pregnancy & Breastfeeding
• Drug Images
• Trospium Drug Interactions
• Trospium Support Group
• 17 Reviews for Trospium - Add your own review/rating

• trospium Advanced Consumer (Micromedex) - Includes Dosage Information


• Sanctura Prescribing Information (FDA)


• Sanctura Monograph (AHFS DI)


• Sanctura Consumer Overview


• Sanctura XR Prescribing Information (FDA)

Compare Trospium with other medications

• Interstitial Cystitis
• Overactive Bladder
• Urinary Incontinence

Boots 98.66% w / w Styptic Pencil

1. Name Of The Medicinal Product

Styptic Pencil

Nix 98.66% w/w Styptic pencil

Boots 98.66 % w/w Styptic Pencil

Murrays 98.66% w/w Styptic Pencil

2. Qualitative And Quantitative Composition

Aluminium sulphate. (Active) 98.66% w/w

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Compressed solid cylinder mounted in a plastic base

4. Clinical Particulars

4.1 Therapeutic Indications

Used as a haemostatic for superficial wounds and abrasions

Relief of discomfort of insect bites and stings

4.2 Posology And Method Of Administration

Administered topically by direct application to the wound or sting.

For topical application only.

4.3 Contraindications

Hypersensitivity to aluminium sulphate or to any of the excipients

4.4 Special Warnings And Precautions For Use

For topical application to skin only. For use by one person only.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

None

4.7 Effects On Ability To Drive And Use Machines

Not relevant

4.8 Undesirable Effects

None known

4.9 Overdose

None known

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Aluminium agents ATC code: D08AB

Aluminium sulphate precipitates protein and is a powerful astringent

5.2 Pharmacokinetic Properties

None stated

5.3 Preclinical Safety Data

None

6. Pharmaceutical Particulars

6.1 List Of Excipients

Purified Talc 1.34% w/w

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

5 years

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Plastic holder and push-on cover.

Pack size 5g

6.6 Special Precautions For Disposal And Other Handling

Moisten end of the pencil with water. Apply topically by direct application to the wound or sting. Dry pencil after use.

7. Marketing Authorisation Holder

Bray Group Ltd, 1 Regal Way, Faringdon, Oxfordshire SN7 7BX.

8. Marketing Authorisation Number(S)

PL 04286/0002

9. Date Of First Authorisation/Renewal Of The Authorisation

29^th September 1982 / 3^rd February 1993

10. Date Of Revision Of The Text

March 2008

Voltarol Ophtha Multidose 0.1% Eye Drops

1. Name Of The Medicinal Product

Voltarol^® Ophtha Multidose 0.1% Eye Drops

2. Qualitative And Quantitative Composition

Contains diclofenac sodium 1mg/ml

3. Pharmaceutical Form

Eye drops solution

4. Clinical Particulars

4.1 Therapeutic Indications

i. Inhibition of peroperative miosis during cataract surgery (Voltarol Ophtha Multidose has no intrinsic mydriatic properties and does not replace standard mydriatic agents).

ii. Treatment of post-operative inflammation in cataract surgery.

iii. Control of ocular pain and discomfort associated with corneal epithelial defects after excimer PRK surgery or accidental non-penetrating trauma.

iv. Control of inflammation after Argon Laser Trabeculoplasty (ALT).

v. The relief of the ocular signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).

vi. Treatment of inflammation and discomfort after strabismus surgery

vii. Treatment of ocular pain and discomfort after radial keratotomy

4.2 Posology And Method Of Administration

Voltarol Ophtha eye drop solution is for instillation into the conjunctival sac only. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

Adults:

Prophylaxis of preoperative miosis	Apply 1 drop four times during the 2 hours before surgery.
Control of post-operative inflammation	Apply 1 drop 4 times daily for up to 28 days.
Control of post-PRK pain and discomfort	Apply 1 drop 2 times in the hour prior to surgery, 1 drop 2 times five minutes apart immediately after PRK surgery and then post-operatively 1 drop every 2-5 hours while awake for up to 24 hours.
Control of ocular pain associated with corneal epithelial defects after accidental non-penetrating trauma.	Apply 1 drop 4 times daily for up to 2 days.
Control of post-ALT inflammation	Apply one drop 4 times during the 2 hours before ALT, and then one drop 4 times daily for up to 7 days.
The relief of the ocular signs and symptoms of Seasonal Allergic Conjunctivitis.	Apply one drop 4 times daily for as long as required.
Treatment of inflammation and discomfort after strabismus surgery	one drop 4 times daily in the 1st week, thrice daily in the 2nd week, twice daily in the 3rd week and as required in the 4th week.
Treatment of ocular pain and discomfort after radial keratotomy	pre-operatively one drop before surgery, post-operatively one drop immediately after surgery, and then one drop 4 times daily for up to 2 days.

Paediatric use: Voltarol Ophtha and Voltarol Ophtha Multidose are not indicated for use in children. Paediatric experience is limited to a few published clinical studies in strabismus surgery.

4.3 Contraindications

Patients with known hypersensitivity to any of the ingredients.

Like other non-steroidal anti-inflammatory agents, Voltarol is also contraindicated in patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibiting activity. Intraocular use during surgical procedure is also contraindicated. There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents.

4.4 Special Warnings And Precautions For Use

This product contains benzalkonium chloride as a preservative, which may be deposited in soft contact lenses. Therefore this product should not be used while wearing soft contact lenses. The lenses must be removed before application of the drops and not reinserted earlier than 15 minutes after use.

The anti-inflammatory activity of ophthalmic non-steroidal anti-inflammatory agents (NSAIDs) may mask the onset and/or progression of ocular infections. In the presence of infection, or if there is a risk of infection, appropriate therapy (e.g. antibiotics) should be given concurrently with Voltarol Ophtha Multidose.

Although there have been no reported adverse events, there is a theoretical possibility that patients receiving other medications which may prolong bleeding time, or with known haemostatic defects may experience exacerbation with Voltarol Ophtha Multidose.

Caution should be exercised when topical NSAIDs such as diclofenac are used concomitantly with topical steroids (see section 4.5 Interaction with other medicinal products and other forms of interaction).

Following instillation of the eye drops, nasolacrimal occlusion or closing the eyes for 3 minutes may reduce the systemic absorption. This may result in a decrease in systemic side effects and an increase in local activity.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant use of topical NSAIDs such as diclofenac and topical steroids in patients with significant pre-existing corneal inflammation may increase the risk of developing corneal complications, therefore caution should be used.

An interval of at least five minutes between the application of the different medicinal products must be allowed.

4.6 Pregnancy And Lactation

Pregnancy

There are no data on the use of Voltarol Ophtha or Voltarol Ophtha Multidose 0.1% in pregnancy. Studies in animals with diclofenac have shown reproductive toxicity (see Section 5.3).

1^st and 2^nd trimester: Animal studies to date have shown no risk to the foetus but no controlled studies in pregnant women are available.

3^rd trimester: Voltarol Ophtha Multidose Eye Drops should not be used due to a possible risk of premature closure of the ductus arteriosus and possible inhibitions of contractions.

Lactation

Diclofenac is excreted in breast milk. However, at therapeutic doses of Voltarol Ophtha no effects on the suckling child are anticipated. Use of ocular diclofenac is not recommended during breast feeding unless the expected benefits outweigh the possible risks.

4.7 Effects On Ability To Drive And Use Machines

Patients with blurred vision should refrain from driving a vehicle or operating machines.

4.8 Undesirable Effects

The most frequently observed adverse reaction is a transient, mild to moderate eye irritation.

Other less frequently observed reactions are eye pain, eye pruritus, ocular hyperaemia and blurred vision immediately after instillation of the eye drops.

Punctate keratitis or corneal disorders have been observed, usually after frequent application.

In patients with risk factors of corneal disorders such as during the use of corticosteroids or with concomitant diseases such as infections or rheumatoid arthritis, diclofenac has been associated, in rare cases, with ulcerative keratitis, corneal thinning, punctuate keratitis, corneal epithelium defect and corneal oedema, which might become sight-threatening. Most patients were treated for a prolonged period of time.

Allergic conditions have been reported for ocular reactions such as conjunctival hyperaemia, allergic conjunctivitis, eyelid erythema, oedema, and pruritus, and systemic hypersensitivity reactions such as urticaria, rash, eczema, erythema, pruritus, cough and rhinitis.

In rare cases dyspnoea and exacerbation of asthma have been reported.

4.9 Overdose

There is practically no risk of adverse effects due to accidental oral ingestion, since a 5ml bottle of the eye drops contains only 5mg of diclofenac sodium, corresponding to about 3% of the recommended maximum daily adult dose of Voltarol after oral administration. By way of comparison, the maximum oral daily dose for diclofenac sodium recommended in children is 2mg/kg body weight.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Voltarol Ophtha Multidose contains diclofenac sodium, a non-steroidal compound with pronounced anti-inflammatory and analgesic properties. Inhibition of prostaglandin biosynthesis, which has been demonstrated experimentally, is regarded as having an important bearing on its mechanism of action. Prostaglandins play a major role in the causation of inflammation and pain.

In clinical trials, Voltarol Ophtha has been found to:

i. inhibit miosis during cataract surgery

ii. reduce inflammation following surgical interventions

iii. reduce ocular pain and discomfort associated with corneal epithelial defects after excimer PRK surgery or accidental trauma.

iv. reduce the incidence of angiographic cystoid macular oedema after cataract surgery but clinical significance remains to be established.

v. reduce ocular inflammation and discomfort more effectively than topical steroids after strabismus surgery whilst avoiding steroidal adverse effects such as delayed conjunctival wound healing and raised intraocular pressure

vi. reduce ocular inflammation, pain and discomfort (photophobia, burning/stinging, foreign body sensation, deep headache-like ocular pain and itching) more effectively than placebo eye drops after corneal incisional surgery such as radial keratotomy.

The effective daily dose after ocular application of Voltarol Ophtha Multidose (approximately 0.25 - 0.5 mg diclofenac sodium) corresponds to less than 1% of the daily dose recommended for Voltarol in rheumatic indications.

Voltarol Ophtha Multidose Eye Drops contain a cyclodextrin, hydroxypropyl γ-cyclodextrin (HPγ-CD). Cyclodextrins (CDs) increase the aqueous solubility of some lipophilic water-insoluble drugs. It is believed that CDs act as true carriers by keeping hydrophobic drug molecules in solution and delivering them to the surface of biological membranes.

5.2 Pharmacokinetic Properties

In rabbits, peak concentrations of ¹⁴C-labelled diclofenac could be demonstrated in the cornea and conjunctiva 30 minutes after application. The highest amounts are found in these two tissues and in the choroid and retina. Elimination was fast and almost complete after 6 hours.

Penetration of diclofenac into the anterior chamber has been confirmed in humans. No measurable levels of diclofenac could be found in humans after ocular application of diclofenac sodium eye drops.

5.3 Preclinical Safety Data

Preclinical data of systemically applied diclofenac from acute and repeated dose toxicity studies, as well as from genotoxicity and carcinogenicity studies revealed no specific hazard for humans at the intended therapeutic doses.

In reproductive and developmental toxicity studies systemic diclofenac has been shown to cross the placental barrier in mice and rats. Whilst no teratogenic effects have been demonstrated, maternally toxic doses were associated with dystocia, prolonged gestation, decreased foetal survival, and intrauterine growth retardation. The effects of diclofenac on fertility and delivery as well as the constriction of the ductus arteriosus in utero are pharmacological consequences of this class of prostaglandin synthesis inhibitors

Local ocular tolerance and toxicity of Voltarol Ophtha and Voltarol Ophtha Multidose 0.1% eye drops (containing hydroxypropyl-gamma cyclodextrin) were investigated and no evidence of toxicity and local adverse effects was found.

Concentrations of HP-gamma-CD in plasma and aqueous humor were below detection limits (1 nMol/mL) in rabbits after single or four times daily (q.i.d.) ocular administration of Voltarol Ophtha Multidose 0.1% eye drops.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Benzalkonium chloride

Disodium edetate

Hydroxypropyl γ-cyclodextrin

Hydrochloric acid

Propylene glycol

Trometamol

Tyloxapol

Water for injections

6.2 Incompatibilities

None known

6.3 Shelf Life

Unopened:	24 months
Opened:	4 weeks

6.4 Special Precautions For Storage

No special precautions for storage

6.5 Nature And Contents Of Container

5ml white LDPE bottle with LDPE dropper and HDPE closure.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

8. Marketing Authorisation Number(S)

PL 00101/0632

9. Date Of First Authorisation/Renewal Of The Authorisation

22 August 2002 / 26 February 2009

10. Date Of Revision Of The Text

30 November 2011

LEGAL CATEGORY

POM