DIPYRIDAMOLE TABLETS BP 100mg

Each tablet contains 100mg Dipyridamole Ph.Eur.

White film-coated tablets.

1) As an adjunct to oral anticoagulation for prophylaxis of thromboembolism associated with prosthetic heart valves.

Dipyridamole should usually be taken before meals.

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

Children: The normal total oral daily dose is 5mg/kg bodyweight daily in divided doses.

Elderly: No specific information is available.

Route of administration

For oral administration.

Hypersensitivity to dipyridamole or any other ingredients in the formulation.

Dipyridamole should be administered with caution in patients with sub-valvular aortic stenosis, worsening angina or haemodynamic instability associated with a recently sustained myocardial infarction as it is a potent vasodilator. Dipyridamole should be used with caution in patients with coagulation disorders.

It is possible that dipyridamole may enhance the effects of oral anticoagulants. The concurrent administration of antacids may reduce the efficacy of dipyridamole. There is evidence that the effects of aspirin and dipyridamole on platelet behaviour may be synergistic.

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

None known.

If these occur it is usually during the early part of treatment and they are often dose-related. The vasodilating properties of dipyridamole may also occasionally produce a vascular headache which normally disappears with dosage reduction. Dizziness, faintness, dyspepsia, mild diarrhoea and rash have been occasionally reported.

Symptoms include headache, gastrointestinal disturbances and hypotension. Coronary vasodilatation may cause chest pain in patients with ischaemic heart disease. General supportive measures should be employed. Coronary vasodilatation may be reversed by administration of aminophylline by slow iv injection, whilst monitoring the ECG.

Dipyridamole is an antithrombotic agent with antiplatelet activity.

Dipyridamole has an antithrombotic action based on its ability to modify various aspects of platelet function, such as platelet aggregation, adhesion and survival, which are factors associated with the initiation of thrombus formation.

Dipyridamole is rapidly absorbed from the gastro-intestinal tract. Peak plasma concentrations occur about 75 minutes after oral administration. Dipyridamole is highly bound to plasma proteins. A terminal half-life of 10-12 hours has been reported. It is conjugated in the liver and is mainly excreted in the faeces as glucuronides. Excretion may be delayed by re-absorption. A small amount is excreted in the urine.

Dipyridamole is detectable in breast milk, but at only approximately one seventeenth the concentration present in plasma.

Not applicable.

Also contains: lactose, magnesium stearate, maize starch, polyvidone, propylene glycol, E171, E464, E553.

None known.

Shelf-life

We propose a shelf-life of two years from the date of manufacture, to be extended when further stability testing becomes available.

Shelf-life after dilution/reconstitution

Not applicable.

Shelf-life after first opening

Not applicable.

Store below 25°C in a dry place.

Protect from light.

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps and polyfoam wad or cotton wool. An alternative closure for polyethylene containers is a polypropylene, twist on, push down and twist off child-resistant, tamper-evident lid.

The product may also be supplied in blister packs in cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 25Om white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-8g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 28s, 30s, 56s, 60s, 84s, 90s, l00s, 112s, l20s, l68s, l80s, 250s, 500s, l000s.

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 50,000.

Not applicable.

Actavis UK Limited

(Trading style: Actavis)

Whiddon Valley

BARNSTAPLE

N Devon EX32 8NS

PL 0142/0309

24.8.90

03/04/2007