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Alfa Wassermann S.P.A - Italy


Forms and presentation
Tablets: Box of 50.

Each tablet contains: Nifedipine: 20 mg.

Nifedipine is a calcium antagonist that prevents and reduces coronary artery spasms, reduces blood pressure to normal by dilating the peripheral arterioles and diminishes myocardial energy consumption. These properties have led to its use in the treatment of angina and hypertension.

Prevention and treatment of acute and chronic coronary insufficiency; angina pectoris; post-infarctual conditions; essential arterial hypertension.

Ascertained individual hypersensitivity towards the product. The product must not be administered during ascertained or presumed pregnancy.

Owing to the effects of Nifedipine on vascular resistance, the patient's blood pressure must be carefully checked, especially at the beginning of treatment and until the maintenance dose has been established. For the same reason, the drug must be used with caution in patients with congestive heart failure, aortic stenosis and those taking -blockers or hypotensive agents. The appearance of peripheral oedema in patients with congestive heart failure will require differentiation of oedemas attributable to Nifedipine from those due to deterioration of left ventricular function.
Blood glucose must be carefully checked. The treatment must be discontinued in the event of hyperglycemia.
Nifedicor may diminish the ability to react, especially if taken together with alcohol. This possibility must be taken in to account by drivers of vehicles and people performing operations demanding unimpaired vigilance.

Drug interactions
Concomitant administration of -blockers is usually well tolerated, though hypotension, exacerbation of angina, congestive heart failure and arrhythmia may occur. If digoxin is administered concomitantly with Nifedipine, the hematic level of digoxin may increase and should be checked during the first few days of treatment. Concomitant administration of hypotensive agents (methyl-dopa, hydralazine, captopril, etc.) may lead to severe hypotension.

Side effects
The side effects of Nifedipine are usually slight and transient. They are the result of a vasodilatation and rarely it is necessary to suspend the treatment or adjust the dose. Vertigo, hot flushes and headache are the most common unwanted effect. Less frequent are: Hypotension, tachycardia, reduction of myocardial perfusion with increased heart rate and exacerbation of angina crises, asthenia and peripheral oedema responding to diuretic therapy. The incidence and gravity of peripheral oedema and hypotension are generally dose-dependent and can be relieved by reducing the dose.
Other common side effects are nausea, heartburn, diarrhoea, constipation, flatulence; hyperglycemia; insomnia, nervousness, tremors, vision disturbances; nasal congestion, sore throat, coughing, dyspnoea; cramp, stiffness of the joints; itchiness, urticaria and other skin reactions; sweating, shivering, fever; sexual difficulties.
There have been occasional reports of slight or moderate increase in alkaline phosphatase, LDH, SGOT, SGPT and as well as case of hepatitis, thrombocytopenia, purpura, anaemia and leucopenia.

Dosage and administration
1 tablet twice a day. An interval of at least 4 hrs must be left between one dose and the next. Tablets should be swallowed whole with a little liquid, preferably far from meals.

Origin: Italy
Laboratories: Alfa Wassermann
Distributor: Droguerie Phenicia
Number & Year of Registration: 27071/1992