Coronary heart disease: Chronic stable angina pectoris. Hypertension.
According to patient's needs. Therapy should be initiated with one tablet 30mg or 60mg swallowed whole once daily (see full prescribing information*).
Hypersensitivity to nifedipine, pregnancy, breast-feeding, cardiovascular shock, combination with rifampicin.
Severe hypotension, overt heart failure, tight aortic stenosis, severe gastrointestinal narrowing, impaired liver function.
Combination therapy with alpha-blockers in heart failure may lead to deterioration. Bioavailability of nifedipine is substantially reduced by rifampicin and co-medication should therefore be avoided. Phenytoin may reduce the bioavailability of nifedipine and its effect of lowering blood pressure. Cimetidine, cisapride and ketoconazole, itraconazole, fluconazole and quinupristin/dalfopristin increase the bioavailability of nifedipine and may potentiate its blood-pressure-lowering effect. Grapefruit juice may also increase the bioavailability of nifedipine and may potentiate its blood-pressure-lowering effect. Diltiazem decreases the clearance of nifedipine. Plasma levels of digoxin or quinidine should be monitored.
1–10%: Asthenia, vasodilatation, palpitation, constipation, oedema, peripheral oedema, dizziness, headache.
0.1–1.0%: Malaise, pain, angina pectoris (excluding unstable), chest pain, hypotension, postural hypotension, tachycardia, syncope, abdominal pain, diarrhoea, dry mouth, dyspepsia, flatulence, nausea, myalgia, hypesthesia, insomnia, nervousness, paresthesia, somnolence, vertigo, dyspnoea, maculopapular rash, pruritus, rash, sweating, nocturia, polyuria.
0.01–0.10%: Allergic reaction, face oedema, anorexia, eructation, gastrointestinal disorder, gingivitis, gum hyperplasia, GGT increased, liver function test abnormal, vomiting, arthralgia, tremor, epistaxis, angio-oedema, skin disorder, urticaria, abnormal vision, urinary frequency increased.
<0.01%: Anaphylactic reaction, bezoar, dysphagia, oesophagitis, gum disorder, intestinal obstruction, intestinal ulcer, jaundice, SGPT increased, leucopenia, purpura, hyperglycaemia, weight loss, muscle cramps, exfoliative dermatitis, gynecomastia, photosensitive dermatitis, blurred vision.
In dialysis patients with malignant hypertension and hypovolaemia, a distinct fall in blood pressure can occur as a result of vasodilatation. Ability to drive or operate machinery may be impaired.
*Full prescribing information available from Bayer Schering Pharma AG, PrimaryCare GSM CV, Berlin, Germany. BSS 01/2000.
