Dipyridamole Tablets 100mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dipyridamole Tablets 100mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100mg Dipyridamole BP.
For excipients - see section 6.1.
3 PHARMACEUTICAL FORM
Tablet for oral use.
White, sugar coated, biconvex tablets printed “G” in red.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
An adjunct to oral anticoagulation for prophylaxis of thromboembolism associated with prosthetic heart valves.
4.2. Posology and method of administration
Dipyridamole tablets are administered orally. Dipyridamole should usually be taken before meals
Adults : 300 - 600 mg daily in three or four doses.
Children : Dipyridamole tablets are not recommended for children.
Elderly : There is no suggestion that the dose needs to be altered for the elderly.
4.3 Contraindications
Hypersensitivity to any of the components of the product.
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, left ventricular outflow obstruction or haemodynamic instability (e.g. decompensated heart failure).
Patients being treated with regular oral doses of Dipyridamole 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 section 4.5).
Dipyridamole should be used with caution in patients with coagulation disorders.
Patients with rare hereditary problems of fructose intolerance, galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
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 of aspirin and Dipyridamole on platelet behaviour are additive.
The concurrent administration of antacids may reduce the efficacy of Dipyridamole. It is possible that Dipyridamole may enhance the effects of oral anticoagulants.
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.
4.6 Pregnancy and lactation
There is inadequate evidence of safety to recommend the use of Dipyridamole in human pregnancy. However, Dipyridamole has been used for many years without apparent ill-consequence. Animal studies have shown no hazards. Medicines should not be used in pregnancy especially during the first trimester or throughout lactation, unless the expected benefit is thought to outweigh any possible risk to the foetus.
Dipyridamole is excreted in breast milk at levels approximately 6% of the plasma concentration. Therefore Dipyridamole should only be used during lactation if considered essential by the physician.
4.7. Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
If these occur it is usually during the early part of treatment. The vasodilating properties of Dipyridamole 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, Dipyridamole 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 Dipyridamole.
Dipyridamole has been shown to be incorporated into gallstones.
4.9 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 complaints can be expected. A drop in blood pressure and tachycardia might be observed.
Therapy
Symptomatic therapy is recommended. Administration of xanthine derivatives (e.g. aminophylline) may reverse the haemodynamic effects of dipyridamole overdose. Due to its wide distribution to tissues and its predominantly hepatic elimination, Dipyridamole is not likely to be accessible to enhanced removal procedures.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Dipyridamole has an antithrombotic action based on its ability to modify various aspects of platelet function, such as platelet aggregation, adhesion and survival, which have been shown to be factors associated with initiation of thrombus formation.
Dipyridamole modifies platelet function by enhancing prostacyclin effects through a strong inhibition of phosphodiesterase and mild stimulation of
adenyl cyclase of thromboxane A2 which is known to cause platelet adhesion and aggregation.
5.2. Pharmacokinetic properties
Oral administration of Dipyridamole gives a peak plasma level 1-2 hours after dosing. The drug has an apparent bioavailability of 37-66%. In man the volume of distribution is 2.43 ± 1.1 l/kg. When given orally, the elimination half-life is 30-50 minutes. In man the major route of excretion of Dipyridamole is in the bile.
5.3. Preclinical safety data
None.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
The tablet contains : Lactose EP, Maize starch EP, Methyl cellulose EP, Magnesium stearate EP, Colloidal silicon dioxide EP, Pregelatinised maize starch BP and Purified Talc EP.
The sugar coating contains : Gelatin solution, Dusting powder (talc), Syrup solution, Opaglos clear and Titanium dioxide.
6.2 Incompatibilities
None Known
6.3 Shelf life
36 months
6.4 Special precautions for storage
Store in a dry place below 25°C ‘Store in the original package in order to protect from light’
6.5 Nature and contents of container
Dipyridamole tablets are available in three pack types namely polypropylene containers with polyethylene caps (with optional polyethylene ullage filler), polypropylene container with polyethylene push on tamper evident closures containing a general polyethylene ullage filler or PVC/ Aluminium foil blister packs in packs of 28, 30, 50, 60, 100, 84, 90 and 500 tablets.
6.6 Instructions for use/handling
None
ADMINISTRATION DETAILS
7 MARKETING AUTHORISATION HOLDER
Generics [UK] Ltd t/a Mylan
Station Close
Potters Bar
Herts
EN6 1TL
8. MARKETING AUTHORISATION NUMBER
PL 04569/0038
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08/07/2004
10 DATE OF REVISION OF THE TEXT
24/07/2009