DIPYRIDAMOLE

Administration:

For oral use only. Dipyridamole suspension should usually be taken before meals. Adults: 300mg to a maximum of 600mg daily in three or four doses.

Children:

Dipyridamole is not recommend for children.

Adverse effects at therapeutic doses are usually mild and transient. The following side effects have been reported, frequencies have been assigned based on a clinical trial (ESPS-2) in which 1654 patients received dipyridamole alone.

If side effects do occur, it is usually during the early part of treatment. 4 Special warnings and precautions for use). 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4. Special Warnings and Special Precautions for Use Among other properties, dipyridamole acts as a vasodilator. g. decompensated heart failure). Dipyridamole should be used with caution in patients with coagulation disorders. In patients with myasthenia gravis, readjustment of therapy may be necessary after changes in dipyridamole dosage (see Drug Interactions).

Patients treated with regular oral doses of dipyridamole should not receive additional intravenous dipyridamole. If pharmacological stress testing with intravenous dipyridamole for coronary artery disease is considered necessary, then oral dipyridamole should be discontinued 24 hours prior to testing.

A small number of cases have been reported in which unconjugated dipyridamole was shown to be incorporated into gallstones to a variable extent (up to 70% by dry weight of stone). These patients were all elderly, had evidence of ascending cholangitis and had been treated with oral dipyridamole for a number of years.

There is no evidence that dipyridamole was the initiating factor in causing gallstones to form in these patients. It is possible that bacterial deglucuronidation of conjugated dipyridamole in the bile may be the mechanism responsible for the presence of dipyridamole in gallstones.

Excipients in the formulation: • Liquid maltitol (E965) 2500mg in each 5 ml. Patients with a rare hereditary problem of fructose intolerance should not take this medicine. • Propylene glycol (E1520). 3mg in each 5 ml. Co- administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates.

• Ethanol. 4 mg of alcohol (ethanol) in each 5 ml. The amount in 5 ml of this medicine is equivalent to less than 3 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects. • The medicine also contains parahydroxybenzoates which are known to cause urticaria, generally delayed type reactions such as contact dermatitis and rarely, immediate reaction with urticaria and bronchospasm.

3. Contra-indications Hypersensitivity to any of the ingredients in the product.