Dipyridamole 25 mg, 30 film-coated tablets, Zentiva

Indications:
- vasodilator in the long-term management of chronic ischemic heart disease;
- adjuvant to oral anticoagulant treatment for the prevention of thromboembolic complications in patients with prosthetic valves;
- antiplatelet agent, associated with acetylsalicylic acid, in the treatment of various conditions with thromboembolic risk (heart disease, aorto-coronary bypass, thrombocythemia, peripheral vascular disease, Kawasaki disease, etc.);
- in the stress test for thallium scintigraphic diagnosis of myocardial ischemia, as an alternative to IV administration; it produces significant coronary vasodilation;
- in children: for the prophylaxis of arterial thrombosis in the case of polyglobulins secondary to cyanogenic congenital heart disease and for the prevention of thromboembolic accidents in children wearing mechanical valve prostheses.

Composition:
One film-coated tablet contains 25 mg dipyridamole and excipients: - core - corn starch, lactose monohydrate, microcrystalline cellulose, povidone K 30, talc, magnesium stearate; - film - hypromellose, polysorbate 80, titanium dioxide (E171), macrogol 6000, sunset yellow (E110).

Method of administration:
Adults
- the recommended dose as an antiplatelet agent and adjuvant to oral anticoagulant treatment is 75-100 mg dipyridamole four times a day (3-4 Dipyridamole 25 mg film-coated tablets of 4 per day). It can be increased to a maximum of 600 mg dipyridamole per day.
- the recommended dose as a vasodilator is 50 mg dipyridamole three times a day (2 film-coated tablets of Dipyridamole 25 mg 3 times a day).
- in the stress test for thallium scintigraphic diagnosis of myocardial ischemia, 300 mg of dipyridamole can be administered orally (12 film-coated tablets Dipyridamole 25 mg, alternatively to iv administration in the form of an injectable solution.
Children over 5 years of age: the recommended dose is 2-4 mg dipyridamole per kg per day.

Dipyridamole is administered approximately 1 hour before meals.

Contraindications:
Hypersensitivity to dipyridamole or to any of the excipients.

Precautions:
Angina pectoris, ischemic ECG changes and conduction disturbances have been reported. Concomitant administration of vasodilators may cause severe hypotension.

Adverse reactions:
Gastrointestinal disorders: nausea, vomiting, diarrhea, can be incorporated into gallstones (can accelerate gallstone formation).
Nervous system disorders: headache, dizziness, vertigo.
Cardiac disorders: hypotension, precordial pain or worsening of anginal pain; arrhythmias, tachycardia due to vasodilator properties.
Vascular disorders: hypotension, feeling of heat, facial flushing.
Immune system disorders: rash, urticaria, angioedema, bronchospasm.
Blood and lymphatic system disorders: Very rare cases of hemorrhagic accidents and isolated cases of thrombocytopenia have been reported.
Also reported were:
- rare cases of myalgia.

Storage method:
Do not use after the expiration date stated on the packaging.
Store below 25°C, in the original packaging.
Keep out of reach and sight of children.

Presentation:
30 film-coated tablets

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.