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

Dipyridamole is a potent vasodilator. It should be used with caution in patients with sub-valvular aortic stenosis, hypotension, severe coronary artery disease including unstable angina or haemodynamic instability associated with recent myocardial infarction, left ventricular outflow obstruction such as aortic stenosis, and in patients with decompensated heart failure.

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

Oral dipyridamole should be stopped 24 hours before intravenous use for stress testing.

In patients with myasthenia gravis readjustment of therapy may be necessary after changes in dipyridamole dosage (see Section 4.5).

This product contains lactose and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

The tablets contain sunset yellow, E110 which can cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.

The absorption of dipyridamole may be reduced by drugs such as antacids that increase gastric pH.

Dipyridamole Tablets may enhance the effects of oral anticoagulants due to its antiplatelet effect. When dipyridamole is used in combination with anticoagulants and aspirin the statements on intolerance and risks for these preparations must be observed.

Addition of dipyridamole to aspirin does not appear to increase the incidence of bleeding. The combination of dipyridamole and coumarin anticoagulants does not alter the prothrombin time, but might cause an increased risk of serious bleeding when compared with anticoagulants alone

There is an increased risk of bleeding when Clopidogrel is given with dipyridamole.

Dipyridamole inhibits the reuptake of adenosine and may enhance its effects; the dose of adenosine must be reduced if both drugs are given concomitantly.

Dipyridamole may also inhibit the uptake of fludarabine and may reduce its efficacy.

Dipyridamole has some antimuscarinic effects. Additive antimuscarinic effects, both peripheral and central, can develop if two or more drugs with antimuscarinic properties are used together.

Dipyridamole may cause a minor increase in the absorption of digoxin.

Dipyridamole may increase the hypotensive effects of drugs which reduce blood pressure.

Dipyridamole may counteract the anticholinesterase effects of cholinesterase inhibitors thereby potentially aggravating myasthenia gravis.

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.

Adverse reactions at therapeutic doses are usually mild. If these occur it is usually in the beginning of treatment and they are often dose-related.

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

The vasodilating properties of Dipyridamole Tablets may occasionally produce a throbbing headache which normally disappears with dosage reduction.

ADVERSE REACTIONS REPORTED IN PATIENTS TAKING DIPYRIDAMOLE

The following adverse reactions have been reported in patients taking dipyridamole. The adverse reactions are classified according to frequencies determined from postmarketing experience and reference literature.

Very common ≥1/10 (≥10%)
Common ≥1/100 and <1/10 (≥1% and <10%)
Uncommon ≥1/1000 and <1/100 (≥0.1% and <1%)
Rare ≥1/10,000 and <1/1000 (≥0.01% and 0.1%)
Very rare < 1/10,000 (<0.1%)

Immune System Disorders

Uncommon: Hypersensitivity reaction

Nervous System Disorders

Common: Headache, dizziness

Uncommon: Fainting

Cardiac Disorders

Uncommon: Angina pectoris aggravated, cardiac arrhythmia

Vascular Disorders

Common: Hypotension, facial flushing

Gastrointestinal Disorders

Common: Nausea, diarrhoea

Uncommon: Vomiting

Skin and Subcutaneous Tissue Disorders

Uncommon: rash

General Disorders and Administration Site Conditions

Uncommon: Chest pain

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 dipyridamole.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

None known.