Persantin 100 mg Tablets Ref.[2750] Active ingredients: Dipyridamole

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.

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.

Pregnancy

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 (please refer to section 5.3).

Lactation

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.

Fertility

No studies on the effect on human fertility have been conducted with PERSANTIN. Non-clinical studies with dipyridamole did not indicate direct or indirect harmful effects with respect to fertility (please refer to section 5.3).

None stated.

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.

Not applicable.