OFCRAM Prolonged release capsules, hard Ref.[7998] Active ingredients: Dipyridamole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Focus Pharmaceuticals Ltd, Capital House, 1st Floor, 85 King William Street, London EC4N 7BL, United Kingdom

Therapeutic indications

Secondary prevention of ischaemic stroke and transient ischaemia attacks either alone or in conjunction with aspirin.

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

Posology and method of administration

Posology

The recommended dose is one capsule twice daily, usually one in the morning and one in the evening.

The capsules should be taken with food. The capsules should be swallowed whole without chewing.

Paediatric population

Ofcram PR 200mg Prolonged Release Capsules, Hard is not recommended for children, due to lack of data on safety and efficacy.

Elderly

No dosage adjustment is needed.

Patients with renal impairment

No dosage adjustment is needed.

Patients with hepatic impairment

No dosage adjustment is needed.

Method of administration

For oral administration.

Overdose

Symptoms

Due to the low number of observations, experience with dipyridamole overdose is limited. Symptoms such as feeling warm, flushes, sweating, restlessness, feeling of weakness, dizziness and angina 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. ECG monitoring is advised in such a situation.

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

Shelf life

Unopened: 30 months.

In-use: Discard any capsules remaining 6 weeks after first opening.

Special precautions for storage

Do not store above 25°C.

Keep the container tightly closed in order to protect from moisture.

Nature and contents of container

HDPE bottle with polypropylene child resistant closure, containing a desiccant in a pillow pouch.

Packs contain 60 capsules.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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