Isodermal

Isodermal may be available in the countries listed below.

Ingredient matches for Isodermal

Isotretinoin

Isotretinoin is reported as an ingredient of Isodermal in the following countries:

• Greece

International Drug Name Search

Mixtard 30 InnoLet 100 IU / ml suspension for injection in a pre-filled pen

Mixtard 30 InnoLet

100 IU/ml suspension for injection in a pre-filled pen

Insulin human (rDNA)

Read all of this leaflet carefully before you start using your insulin.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor, diabetes nurse or your pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist.

This side of the leaflet:

• 
  1. What Mixtard is and what it is used for
  


• 
  2. Before you use Mixtard
  


• 
  3. How to use Mixtard
  


• 
  4. What to do in an emergency
  


• 
  5. Possible side effects
  


• 
  6. How to store Mixtard
  


• 
  7. Further information
  

Overleaf: How to use your InnoLet

What Mixtard

is and what it is used for

Mixtard is human insulin to treat diabetes. Mixtard is a mixture of fast-acting insulin and long-acting insulin. This means that it will start to lower your blood sugar about half an hour after you take it, and the effect will last for approximately 24 hours.

Before you use Mixtard

Do not use Mixtard

• 
  If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information). Look out for the signs of allergy in 5 Possible side effects


• 
  If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar). See 4 What to do in an emergency for more about hypos.

Take special care with Mixtard

• 
  If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands


• 
  If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach


• 
  If you are exercising more than usual or if you want to change your usual diet


• 
  If you are ill: carry on taking your insulin


• 
  If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.

Using other medicines

Many medicines affect the way glucose works in your body and they may influence your insulin dose. Listed below are the most common medicines which may affect your insulin treatment. Talk to your doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.

Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta-sympathomimetics; growth hormone; danazol; octreotide or lanreotide.

Pregnancy and breastfeeding

If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.

Driving and using machines

If you drive or use tools or machines: watch out for signs of a hypo. Your ability to concentrate or to react will be less during a hypo. Never drive or use machinery if you feel a hypo coming on. Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.

How to use Mixtard

Talk about your insulin needs with your doctor and diabetes nurse. Follow their advice carefully. This leaflet is a general guide.

If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Eat a meal or snack containing carbohydrates within 30 minutes of the injection.

It is recommended that you measure your blood glucose regularly.

Injecting insulin

See overleaf for detailed instructions.

Before using Mixtard

• 
  Check the label to make sure it is the right type of insulin


• 
  Always use a new needle for each injection to prevent contamination.

Do not use Mixtard

• 
  In insulin infusion pumps
  


• 
  If InnoLet is dropped, damaged or crushed there is a risk of leakage of insulin


• 
  If it hasn’t been stored correctly or been frozen (see 6 How to store Mixtard)


• 
  If it’s not uniformly white and cloudy when it’s resuspended.

Mixtard is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein or muscle. Always vary the sites you inject, to avoid lumps (see 5 Possible side effects). The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms. Your insulin will work more quickly if you inject it around the waist.

What to do in an emergency

If you get a hypo

A hypo means your blood sugar level is too low.

The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

If you get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.

Don’t take any insulin if you feel a hypo coming on.

Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.

Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away. They must not give you any food or drink as it could choke you.

• 
  If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death


• 
  If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

Using glucagon

You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more.

Causes of a hypo

You get a hypo if your blood sugar gets too low. This might happen:

• If you take too much insulin


• If you eat too little or miss a meal


• If you exercise more than usual.

If your blood sugar gets too high

Your blood sugar may get too high (this is called hyperglycaemia).

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.

If you get any of these signs, test your blood sugar level and test your urine for ketones if you can. Then seek medical advice straight away.

These may be signs of a very serious condition called diabetic ketoacidosis. If you don’t treat it, this could lead to diabetic coma and death.

Causes of hyperglycaemia

• Having forgotten to take your insulin


• Repeatedly taking less insulin than you need


• An infection or a fever


• Eating more than usual


• Less exercise than usual.

Possible side effects

Like all medicines, Mixtard can cause side effects, although not everybody gets them. Mixtard may cause hypoglycaemia (low blood sugar). See the advice in 4 What to do in an emergency.

Side effects reported uncommonly

(in less than 1 patient in 100)

Changes at the injection site (Lipodystrophy). If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to prevent such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.

Signs of allergy. Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions). These usually disappear after a few weeks of taking your insulin. If they do not disappear, see your doctor.

Seek medical advice immediately:

• if signs of allergy spread to other parts of the body, or


• if you suddenly feel unwell and you start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy; feel like fainting.

You may have a very rare serious allergic reaction to Mixtard or one of its ingredients (called a systemic allergic reaction). See also warning in 2 Before you use Mixtard.

Diabetic retinopathy (eye background changes). If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse. Ask your doctor about this.

Swollen joints. When you start taking insulin, water retention may cause swelling around your ankles and other joints. This soon disappears.

Painful neuropathy (nerve related pain). If your blood glucose levels improve very fast it may cause a burning, tingling or electric pain. This is called acute painful neuropathy and it usually disappears. If it does not disappear, see your doctor.

Side effects reported very rarely

(in less than 1 patient in 10,000)

Vision problems. When you first start your treatment, it may disturb your vision, but the reaction usually disappears.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or pharmacist.

How to store Mixtard

Keep out of the reach and sight of children.

Do not use Mixtard after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

The InnoLet
that is not being used is to be stored in a refrigerator (2°C - 8°C).

Do not store them in or too near the freezer section or cooling element.

Do not freeze.

The InnoLet that is being used, about to be used or carried as a spare is not to be kept in a refrigerator. After removing the InnoLet from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use. See 3 How to use Mixtard. You can carry it with you and keep it at room temperature (not above 30°C) for up to 6 weeks. Always keep the pen cap on your InnoLet when you’re not using it in order to protect it from light. Mixtard must be protected from
excessive heat and sunlight.

Mixtard should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Mixtard 30 contains

• 
  The active substance is insulin human made by recombinant biotechnology (30% as soluble insulin and 70% as isophane insulin). 1 ml contains 100 IU of insulin human. 1 pre-filled pen contains 3 ml equivalent to 300 IU


• 
  The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.

What Mixtard looks like and contents of the pack

The suspension for injection comes as a cloudy, white, aqueous suspension.

It is supplied in packs of 1, 5 or 10 pre-filled pens of 3 ml. Not all packs may be marketed.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

Now turn over for information on how to use your InnoLet.

This leaflet was last approved in 09/2007

Mixtard
, InnoLet
and NovoFine
S
are trademarks owned by Novo Nordisk A/S, Denmark

© 2000/2007

Novo Nordisk A/S

Information on how to use Mixtard

30 InnoLet

Please read the following instructions carefully before using your Mixtard
30 InnoLet
.

Introduction

Mixtard 30 InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit. Mixtard 30 InnoLet is designed to be used with NovoFine S needles of 8 mm or shorter in length. Look for an S on the needle box. The S stands for short cap.

As a precautionary measure, always carry a spare insulin delivery device in case your InnoLet is lost or damaged.

Preparing for injection

Check the label to make sure that your Mixtard 30 InnoLet contains the correct type of insulin. Take off the pen cap (as shown by the arrow).

Resuspending is easier when the insulin has reached room temperature.

Suspending the insulin

Before every injection:

• 
  Check there are at least 12 units of insulin left in the cartridge to allow even resuspending. If there are less than 12 units left, use a new Mixtard 30 InnoLet


• 
  Move the pen up and down between positions A and B and back so that the glass ball moves from one end of the cartridge to the other (picture 1A) at least 20 times. Repeat this movement at least 10 times before each injection. The movement must always be repeated until the liquid appears uniformly white and cloudy


• 
  After resuspending, complete all of the following stages of injection without delay.
  

Attaching the needle

• 
  Disinfect the rubber membrane with a medicinal swab


• 
  Always use a new needle for each injection to prevent contamination


• 
  Remove the protective tab from a NovoFine S needle


• 
  Screw the needle straight and tightly onto Mixtard 30 InnoLet (picture 1B)


• 
  Pull off the big outer needle cap and the inner needle cap. You may want to store the big outer needle cap in the compartment.

Priming to expel air

Small amounts of air may collect in the needle and cartridge during normal use.

To avoid injection of air and ensure proper dosing:

• 
  Dial 2 units by turning the dose selector clockwise


• 
  Hold Mixtard 30 InnoLet with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge (picture 1C).


• 
  Keeping the needle upwards, press the push-button and the dose selector returns to zero


• 
  A drop of insulin must appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.

If a drop of insulin still does not appear, the device is defective and must not be used.

Setting the dose

• 
  Always check that the push-button is fully depressed and the dose selector is set at zero
  


• 
  Dial the number of units required by turning the dose selector clockwise (picture 2). Do not use the residual scale to measure your dose of insulin


• 
  You will hear a click for every single unit dialled. The dose can be corrected by turning the dial either way.

You cannot set a dose larger than the number of units left in the cartridge.

Injecting the insulin

• 
  Insert the needle into your skin. Use the injection technique advised by your doctor


• 
  Deliver the dose by pressing the push-button fully down (picture 3). You will hear clicks as the dose selector returns to zero


• 
  After the injection, the needle must remain under the skin for at least 6 seconds to ensure that the full dose has been delivered


• 
  Make sure not to block the dose selector while injecting, as the dose selector must be allowed to return to zero when you press the push-button


• 
  Remove the needle after each injection.
  

Removing the needle

• 
  Replace the big outer needle cap and unscrew the needle (picture 4). Dispose of it carefully.

Use a new needle for each injection.

Remove the needle after each injection and store InnoLet without the needle attached. Otherwise, the liquid may leak out which can cause inaccurate
dosing.

Health care professionals, relatives and other carers must follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration.

Dispose of your used Mixtard 30 InnoLet carefully without the needle attached.

Maintenance

Your Mixtard 30 InnoLet is designed to work accurately and safely. It must be handled with care.

Do not refill Mixtard 30 InnoLet.

You can clean your Mixtard 30 InnoLet by wiping it with a medicinal swab. Do not soak it, wash or lubricate it. This may damage the mechanism.

8-9603-01-002-3

Inexium EuropharmaDK

Inexium EuropharmaDK may be available in the countries listed below.

Ingredient matches for Inexium EuropharmaDK

Esomeprazole

Esomeprazole magnesium, trihydrate (a derivative of Esomeprazole) is reported as an ingredient of Inexium EuropharmaDK in the following countries:

• Denmark

International Drug Name Search

Guna-Ischial

Dosage Form: injection, solution
GUNA®-ISCHIAL (Homeopathic complex preparation) INJECTION SC, ID, IM

1. INDICATIONS AND USAGE

1.1.    Sciatica pain

1.2.    Lumbar-sciatic pain (use with GUNA®-LUMBAR)

1.3.    Nerve pain in the lower lumbar spine

1.4.    Leg nerve pain due to post-surgery treatment of disc herniation L4-L5, L5-S1

1.5.    Mortons neuroma. The simultaneous administration of GUNA®- NEURAL gives wider therapeutic coverage

2. DOSAGE AND ADMINISTRATION

2.1.    Standard protocol for IM administration: 1 vial 1-3 times a week according to severity and clinical response.

2.2.    Standard protocol according to mesotherapy technique: 1 vial per treatment: 2 treatments for the first 2 weeks, 1 treatment a week till pain relief (average 8-10 sessions). For chronic pathologies: continue 1 treatment a week for 1 month till pain relief, then 1 treatment a month.

Select application site according to trigger points, tender points, referred pain zones, acupuncture points, key nerve points or “local pain points”. Using a 13 mm, 30G or a 4 mm, 27G needle, make the classic intradermal injection according to mesotherapyic technique.

Discard unused solution.

2.3.    Opening of Vials: Use sterile needles and sterile syringe. Do not reuse. Do not use if foreign particles are present. Draw 1 cc of air into syringe, insert needle into vial inject air and withdraw the solution.

3. DOSAGE FORMS AND STRENGTHS

3.1.    2 ml glass vials

Each ingredient is attenuated according to the procedures stated in the Homeopathic Pharmacopeia of the United States.

Active ingredients: Aconitum napellus 8X, Anti interleukin 1 alpha 4C, Anti interleukin 1 beta 4C, Arsenicum album 6X, Beta-Endorphin 4C, Cimicifuga racemosa 4X, Gnaphalium  polycephalum 4X, Lachesis mutus 8X, Rhododendron chrysanthum 6X, Rhus toxicodendron 4X.

Inactive ingredient: Sterile isotonic sodium chloride solution.

4. CONTRAINDICATIONS

4.1.    There is no history of hypersensitivity to GUNA®-ISCHIAL. However patients with a known hypersensitivity to any ingredient should be tested before  use. Make a spot injection (0.1ml) into the forearm and observe for any reactions for 1 hour.

5. WARNINGS AND PRECAUTIONS

5.1.    Sciatic pain requires differential diagnosis for disc injuries, herniated disk, primary or secondary cancer pain; classification according to simple spinal pain, projected and referred pain from internal organs.

5.2.    Skin cleansing/disinfection is required before application. Saprophytic bacteria may produce injection site abscesses with improper skin preparation.

6. ADVERSE REACTIONS

6.1.    The most common mild adverse reaction is slight reddening at the injection site due to the mechanical effect of the needle or a superficial skin reaction of mild erythema.

7. DRUG INTERACTIONS

7.1.    None Known.

8. USE IN SPECIFIC POPULATIONS

8.1    Pregnancy:  Pregnancy  category  C.  Animal  reproduction  studies  have  not  been conducted  with  GUNA®-ISCHIAL.  GUNA®- ISCHIAL should  not  be  given  to  a pregnant woman. 

8.2    Nursing mothers:    It is not known whether any of the ingredients in GUNA®- ISCHIAL  are  secreted  in  human milk.  However, since many drugs are secreted in human milk, caution should be exercised when GUNA®- ISCHIAL is administered to a nursing woman.

8.3    Pediatric use: No restrictions.

8.4    Geriatric use: No restrictions

9. DRUG ABUSE AND DEPENDENCE

9.1.    No Known.

10. OVERDOSAGE

10.1.    No Known.

11. DESCRIPTION

11.1.    GUNA®-ISCHIAL is a sterile solution made with isotonic sodium chloride solution.

It is a homeopathic complex medicine, whose active ingredients have been selected in order to promote 2 main activities:

•    Detoxification of the connective tissue matrix

•    Pain modulation through stimulation of the physiological mechanism of pain control.

Attenuation of the biological substrates acts to target the area of activity of the product

12. CLINICAL PHARMACOLOGY

12.1.    Mechanism of Action

Due to the homeopathic nature of the active ingredients, receptors may be activated by feedback regulation. Beta-endorphins at the 4C dose activate the membrane receptors for endogenous endorphins that play a key role in pain relief. Anti IL-1 induces a download regulation of IL-1 inflammatory activity.

12.2.    Pharmacodynamics

The physiological effects of GUNA®-ISCHIAL are due to the action of the ingredients, as described in the Homeopathic Materia Medica.

In Homeopathy there is no direct relationship between dose and effect, but rather there is a relationship between attenuation and balancing effect on biochemical pathways.

In GUNA®-ISCHIAL the attenuation of each ingredient has been selected according to the Arndt-Schulz Principle (inverted effect law). Attenuation of the physiological ingredients promotes membrane receptor feedback in order to normalize altered biological pathways. In Addition the attenuation technique activates the low dilutions and stabilizes clinical activity of the compound.

12.3.    Pharmacokinetics

Homeopathic attenuation provides complete bioavailability of the active ingredients.

13. NONCLINICAL TOXICOLOGY

13.1.    GUNA®-ISCHIAL has no level of toxicity due to the attenuation of the ingredients.

14. CLINICAL STUDIES

14.1.    GUNA®-ISCHIAL formulation is based on classical Homeopathy and each ingredient has been selected according to its description in the Homeopathic Materia Medica. The product is intended for application to target points such as acupuncture points, Weihe points, and key neurological points.

  Clinical indications of the key ingredients:

Anti interleukin 1 alpha 4C / Anti interleukin 1 beta 4C:

•    Biological classification: Interleukin 1 receptor antagonist (IL-1ra) belongs to the IL-1 family. Endogenous IL-1ra is produced in human autoimmune and chronic inflammatory diseases.

•    Etiopathogenesis: It binds to IL-1 receptors in competition with IL-1, but does not elicit intracellular response from this binding. Its key role  is counteracting the proinflammatory effects of IL-1.

•    Space-time localization: next to Arnica.  Reference group: Arnica-Mercurius.

•    Clinical: Immunological based diseases, autoimmune and chronic inflammatory diseases, acute and chronic pain, osteoarthritis, chronic arthritis, inflammatory psoriasis, wet eczema, localized inflammatory swelling.  Appropriate for local application.

•    Modalities: Worsens with cold and   movement. Improves with rest and warmth.

•    Association with other cell mediators: TNF 15C / IL8 4C /

NT4 4C / GCSF 4C.

 Beta-Endorphin 4C:

•    Biological classification: Neuropeptide  and neurotransmitter. It is produced by the  anterior lobe of the hypophysis  and by the hypothalamus.

•    Etiopathogenesis: It acts on the mechanism that enhances pain. It suppresses the memory of painful events and negative experiences.

•    Space-time localization: next to Arnica.

 Reference group: Mercurius.

•    Clinical: Pain management by enhancing the immune response. It acts on modulating pain, cardiac, gastric and vascular function as well as panic syndrome and satiation. Organic and functional pain. Remedy for somatization disorders. It enhances acupuncture sessions. Antidepressive activity. It may improve individual positive attitudes.

14.2.    Modalities: It worsens with fatigue and intensive exercise.

•    Association with other cell mediators: Sepia / Arnica / Aconitum / Bromum / Aurum / Iodium / IL-6 4C / Melatonin 15C, 30C, 12LM, 18LM, 30LM / NT4 4C / BDNF 4C.

15. REFERENCES

15.1.    I. Bianchi: Citochine e Interferoni. Farmacologia e Clinica. Nuova IPSA Editore.

15.2.    L. Milani: Weihe e altri Punti tra Agopuntura e Omeopatia. Guna Editore.

15.3.    J. Malzac: Materia Medica Immunologia. IPSA Editore.

15.4.    H.H.Reckeweg: Homeopathic Materia Medica. Aurelia Verlag.

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1.    NDC  17089-277-31  10 glass vials packed in carton box

16.2.    NDC  17089-277-32   50 glass vials packed in carton box

16.3.    Store at room temperature, 20-25°C (68-77° F). Avoid  freezing  and  excessive  heat.

17. PATIENT COUNSELING INFORMATION

17.1.    Patients should be informed about Homeopathy and Acupuncture and the main differences with conventional clinical approaches.

PACKAGE LABEL

Guna-Ischial  aconitum napellus - arsenic trioxide - black cohosh - canakinumab - lachesis muta venom - metenkefalin - pseudognaphalium obtusifolium - rhododendron aureum leaf - toxicodendron pubescens leaf - anti-interleukin-1.alpha. immunoglobulin g rabbit -   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 17089-277 Route of Administration INTRADERMAL, SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 8 [hp_X]  in 2 mL ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT (ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT) ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT 4 [hp_C]  in 2 mL CANAKINUMAB (CANAKINUMAB) CANAKINUMAB 4 [hp_C]  in 2 mL ARSENIC TRIOXIDE (ARSENIC TRIOXIDE) ARSENIC TRIOXIDE 6 [hp_X]  in 2 mL METENKEFALIN (METENKEFALIN) METENKEFALIN 4 [hp_C]  in 2 mL BLACK COHOSH (BLACK COHOSH) BLACK COHOSH 4 [hp_X]  in 2 mL PSEUDOGNAPHALIUM OBTUSIFOLIUM (PSEUDOGNAPHALIUM OBTUSIFOLIUM) PSEUDOGNAPHALIUM OBTUSIFOLIUM 4 [hp_X]  in 2 mL LACHESIS MUTA VENOM (LACHESIS MUTA VENOM) LACHESIS MUTA VENOM 8 [hp_X]  in 2 mL RHODODENDRON AUREUM LEAF (RHODODENDRON AUREUM LEAF) RHODODENDRON AUREUM LEAF 6 [hp_X]  in 2 mL TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 4 [hp_X]  in 2 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.018 mL  in 2 mL WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17089-277-31 10 VIAL In 1 BOX contains a VIAL, GLASS 1 2 mL In 1 VIAL, GLASS This package is contained within the BOX (17089-277-31) 2 17089-277-32 50 VIAL In 1 BOX contains a VIAL, GLASS 2 2 mL In 1 VIAL, GLASS This package is contained within the BOX (17089-277-32)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/29/2006

Labeler - Guna spa (430538264)

Establishment
Name	Address	ID/FEI	Operations
Guna spa		430538264	manufacture

Revised: 06/2010Guna spa

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)