Persantin 25mg tablets

1. Name Of The Medicinal Product

PERSANTIN Tablets 25 mg

2. Qualitative And Quantitative Composition

Dipyridamole 25 mg.

For excipients, see 6.1

3. Pharmaceutical Form

Coated tablets

Orange sugar-coated tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

An adjunct to oral anti-coagulation for prophylaxis of thrombo-embolism associated with prosthetic heart valves.

4.2 Posology And Method Of Administration

Adults:300-600 mg daily in three or four doses.

Children:PERSANTIN is not recommended for children.

PERSANTIN should usually be taken before meals.

4.3 Contraindications

Hypersensitivity to any of the components of the product.

4.4 Special Warnings And Precautions For Use

Among other properties, dipyridamole acts as a vasodilator. It should be used with caution in patients with severe coronary artery disease, including unstable angina and/or recent myocardial infarction, left ventricular outflow obstruction or haemodynamic instability (e.g. decompensated heart failure).

Patients being treated with regular oral doses of PERSANTIN should not receive additional intravenous dipyridamole. Clinical experience suggests that patients being treated with oral dipyridamole who also require pharmacological stress testing with intravenous dipyridamole, should discontinue drugs containing oral dipyridamole for twenty-four hours prior to stress testing.

In patients with myasthenia gravis, readjustment of therapy may be necessary after changes in dipyridamole dosage (see Drug Interactions).

PERSANTIN should be used with caution in patients with coagulation disorders.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Dipyridamole increases plasma levels and cardiovascular effects of adenosine. Adjustment of adenosine dosage should be considered if use with dipyridamole is unavoidable.

There is evidence that the effects of aspirin and dipyridamole on platelet behaviour are additive.

The administration of antacids may reduce the efficacy of PERSANTIN.

It is possible that PERSANTIN may enhance the effects of oral anti-coagulants. When dipyridamole is used in combination with anticoagulants and acetylsalicylic acid, the statements on intolerance and risks for these preparations must be observed. Addition of dipyridamole to acetylsalicylic acid does not increase the incidence of bleeding events. When dipyridamole was administered concomitantly with warfarin, bleeding was no greater in frequency or severity than that observed when warfarin was administered alone.

Dipyridamole may increase the hypotensive effect of drugs which reduce blood pressure and may counteract the anticholinesterase effect of cholinesterase inhibitors thereby potentially aggravating myasthenia gravis.

4.6 Pregnancy And Lactation

There is inadequate evidence of safety in human pregnancy, but PERSANTIN has been used for many years without apparent ill-consequence. Animal studies have shown no hazard. Medicines should not be used in pregnancy, especially the first trimester unless the expected benefit is thought to outweigh the possible risk to the foetus.

Dipyridamole is excreted in breast milk at levels approximately 6% of the plasma concentration. Therefore PERSANTIN should only be used during lactation if considered essential by the physician.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

If these occur, it is usually during the early part of treatment. The vasodilating properties of PERSANTIN may occasionally produce a vascular headache which normally disappears with long-term use. Vomiting, diarrhoea and symptoms such as dizziness, faintness, nausea, dyspepsia and myalgia have been observed.

As a result of its vasodilator properties, PERSANTIN may cause hypotension, hot flushes and tachycardia. Worsening of symptoms of coronary heart disease such as angina and arrhythmias.

Hypersensitivity reactions such as rash, urticaria, severe bronchospasm and angio-oedema have been reported.

In very rare cases, increased bleeding during or after surgery has been observed. Isolated cases of thrombocytopenia have been reported in conjunction with treatment with PERSANTIN.

Dipyridamole has been shown to be incorporated into gallstones.

4.9 Overdose

Symptoms

Due to the low number of observations, experience with dipyridamole overdose is limited. Symptoms such as a warm feeling, flushes, sweating, restlessness, feeling of weakness, dizziness and anginal complaints can be expected. A drop in blood pressure and tachycardia might be observed.

Therapy

Symptomatic therapy is recommended. Administration of xanthine derivatives (e.g. aminophylline) may reverse the haemodynamic effects of dipyridamole overdose. Due to its wide distribution to tissues and its predominantly hepatic elimination, dipyridamole is not likely to be accessible to enhanced removal procedures.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Dipyridamole has an antithrombotic action based on its ability to modify various aspects of platelet function, such as platelet aggregation, adhesion and survival, which have been shown to be factors associated with the initiation of thrombus formation. Dipyridamole also has coronary vasodilator properties.

5.2 Pharmacokinetic Properties

Oral administration of dipyridamole gives a peak plasma level 1-2 hours after dosing. The drug has an apparent bioavailability of 37-66%.

In man the volume of distribution is 2.43±1.1 l/kg. When given orally the elimination half life is 30-50 minutes. In man the major route of excretion of dipyridamole is in the bile.

5.3 Preclinical Safety Data

None

6. Pharmaceutical Particulars

6.1 List Of Excipients

Core:

Lactose monohydrate

Maize starch, dried

Soluble maize starch

Colloidal silica, anhydrous

Magnesium stearate

Sunset yellow, E110

Coating:

Sucrose

Talc

Acacia

Titanium dioxide, E171

Macrogol 6000

Wax, bleached

Carnauba wax

Sunset yellow, E110

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

Do not store above 30°C. Protect from light.

6.5 Nature And Contents Of Container

Marketed packs: Blister pack containing 84 orange sugar coated tablets

Non-marketed packs: Blister packs of 100, 112 and 840 orange sugar coated tablets.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom

8. Marketing Authorisation Number(S)

PL 00015/0052R

9. Date Of First Authorisation/Renewal Of The Authorisation

28 July 1988 /01 May 2007

10. Date Of Revision Of The Text

01/05/2007

11. Legal category

POM

P2c/25mg/UK/SPC/7