Persantin 100 mg Tablets (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Boehringer Ingelheim Limited |
|---|---|
| Διεύθυνση | Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS |
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Nature and contents of container
Marketed packs: Blister pack containing 84 white sugar coated tablets Non-marketed packs: Blister packs of 100 and 112 white sugar coated tablets.
Date of first authorization / renewal of the authorization
24 November 1988 / 01 May 2007
Contraindications
Hypersensitivity to any of the components of the product.
Marketing authorization holder
Boehringer Ingelheim Limited Ellesfield Avenue Bracknell Berkshire RG12 8YS United Kingdom
Date of revision of the text
November 2012
Pharmacodynamic properties
Dipyridamole inhibits the uptake of adenosine into erythrocytes, platelets and endothelial cells in vitro and in vivo; the inhibition amounts to 80% at its maximum and occurs dose-dependently at therapeutic ...
Fertility, pregnancy and lactation
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 ...
Qualitative and quantitative composition
Dipyridamole 100 mg. For excipients, see 6.1.
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 ...
Special precautions for storage
Do not store above 30°C. Protect from light.
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.
Effects on ability to drive and use machines
None stated.
Overdose
Symptoms Due to the low number of observations, experience with dipyridamole overdose is limited. Symptoms such as a warm feeling, flushes, sweating, restlessness, feeling of weakness, dizziness and anginal ...
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 ...
Name of the medicinal product
PERSANTIN Tablets 100 mg.
Therapeutic indications
An adjunct to oral anti-coagulation for prophylaxis of thrombo-embolism associated with prosthetic heart valves.
List of excipients
Core: Calcium hydrogen phosphate, anhydrous Maize starch, dried Maize starch, soluble Colloidal silica Magnesium stearate Coating: Sucrose Talc Acacia Titanium dioxide, E171 Macrogol 6000 Wax, bleached ...
Marketing authorization number(s)
PL 0015/5016R
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, ...
Shelf life
5 years.
Pharmaceutical form
Coated Tablets. Round, white, biconvex, shiny, sugar-coated tablets.
Undesirable effects
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, ...
Incompatibilities
Not applicable.
Special precautions for disposal and other handling
None.
Posology and method of administration
Adults 300-600 mg daily in three or four doses. Children PERSANTIN is not recommended for children. PERSANTIN should usually be taken before meals.