PROCARDIN Film-coated tablet (2015)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Procardin 75mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 75.0 mg dipyridamole. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet. Yellow, round, convex, film-coated tablets with diameter of nucleus 7mm.
4.1. Therapeutic indications
Procardin is indicated as an adjunct to oral anticoagulation for prophylaxis of thromboembolism associated with prosthetic heart valves.
4.2. Posology and method of administration
Posology Adults 300–600mg daily in three or four doses. Paediatric population Procardin in not recommended for children. Method of administration Procardin should usually be taken before meals.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
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, ...
4.5. Interaction with other medicinal products and other forms of interaction
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 ...
4.6. Pregnancy and lactation
Pregnancy There is inadequate evidence of safety in human pregnancy, but dipyridamol has been used for many years without apparent ill-consequence. Animal studies have shown no hazard. Medicines should ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as dizziness during treatment ...
4.8. Undesirable effects
Adverse effects at therapeutic doses are usually mild and transient. The following side effects have been reported, frequencies have been assigned based on aclinical trial (ESPS-2) in which 1654 patients ...
4.9. Overdose
Symptom Due to the low number of observations, experience with dipyridamole overdosage is limited.Symptoms such as a warm feeling, flushes, sweating, restlessness, feeling of weakness, dizziness and anginal ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Platelet aggregation inhibitors excl. heparin, Antithrombotic agents <b>ATC code:</b> B01AC07 Dipyridamole inhibits the uptake of adenosine into erythrocytes, platelets ...
5.2. Pharmacokinetic properties
After dosing with the sugar-coated tablets there is a lag time of 10-15 min associated with disintegration of the tablet and gastric emptying. Thereafter the drug is rapidly absorbed and peak plasma concentrations ...
5.3. Preclinical safety data
Dipyridamole has been extensively investigated in animal models and no clinically significant findings have been observed at doses equivalent to therapeutic doses in humans.
6.1. List of excipients
<u>Excipients of nucleus:</u> Croscarmellose sodium, povidone K25, microcrystalline cellulose, colloidal anhydrous silica, purified talc and magnesium stearate. <u>Excipients of coating:</u> Polyethylene ...
6.2. Incompatibilities
None.
6.3. Shelf life
60 months.
6.4. Special precautions for storage
Store below 30°C in the original package, in order to protect from light.
6.5. Nature and contents of container
Packs of 20, 50, 100, and 120 are available, in PVC/Alu blisters. Packs of 500 and 1000 tablets are available in securitainers. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
19890
9. Date of first authorization / renewal of the authorization
28.12.2005 / 16.05.2014
10. Date of revision of the text
April 2015
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