DIPYRIDAMOLE Film-coated tablet Ref.[7996] Active ingredients: Dipyridamole

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.

Due to the low number of observations, experience with dipyridamole overdose is limited.

Symptoms such as a headache, gastrointestinal disturbances, warm feeling, flushes, sweating, restlessness, feeling of weakness, dizziness, hypotension and angina complaints can be expected. Coronary vasodilation may cause chest pain in patients with ischaemic heart disease.

General supportive measures should be employed. Coronary vasodilation may be reversed by administering of xanthine derivatives (e.g. aminophylline) by slow iv injection, whilst monitoring the ECG.

Due to its wide distribution to tissues and its predominantly hepatic elimination, dipyridamole is not likely to be accessible to enhanced removal procedures.

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) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-6g/M2 PVC and PVdC compatible heat seal lacquer on the reverse side.

The product may be contained in blister packs which enhances security of the pack increasing resistance to deliberate contamination, pilfering, etc.

Pack sizes: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s.

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.