Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Stable angina pectoris.
Hypertension.
Short-term treatment of Raynaud’s disease, primary as well as secondary.
The dose is adjusted individually. The tablets are swallowed whole with liquid, independently of meals. The tablets must not be crushed. Grapefruit juice should be avoided when taking these tablets (see 4.5 Interactions).
The recommended dosing interval for Nifelat is approximately 12 hours but no less than 4 hours.
The appropriate starting dose is 10 mg twice daily. Normal dosage is 1-2 tablets (10-20 mg) twice daily.
The appropriate starting dose and usual maintenance dose is 10 mg twice daily. The dose may be increased gradually up to 40 mg twice daily. If a satisfactory therapeutic response has not been achieved after about 4-6 weeks with the initial dose, a dose increase or addition of another blood pressure lowering agent is recommended.
Given mainly to patients with bothersome symptoms when they are expected to be exposed to triggers. The usual dose is 10-20 mg twice daily. Experimentally, the dose may be increased to 40 mg twice daily.
The efficacy and safety of nifedipine in children below 18 years of age has not been established. The information currently available on the use of nifedipine in hypertension is described in section 5.1.
The pharmacokinetics of Nifelat are altered in the elderly. Lower maintenance doses may be needed (see section 5.2).
Should be given with caution. In, patients with impaired liver function, blood pressure should be carefully monitored. A dose reduction may be required, where appropriate (see sections 4.4 and 5.2).
Based on pharmacokinetic data, no dosage adjustment is required in patients with renal impairment.
Oral use.
Toxicity: 60 mg in a 3-year-old caused mild to moderate intoxication after gastric emptying. 100 mg in a 12-year-old caused mild intoxication after gastric emptying. Three doses of 30 mg in an elderly patient caused moderate intoxication. 210 mg and 900 mg in adults caused very severe intoxication.
Symptoms: The following symptoms are observed in severe overdose with nifedipine: Decreased consciousness, coma, drop in blood pressure, tachycardia/bradycardia, hyperglycaemia, metabolic acidosis, hypoxia, cardiogenic shock with pulmonary oedema.
Treatment of overdose: The most important thing is to eliminate the active substance and restore a stable cardiovascular condition.
After oral administration, gastric emptying is indicated, if necessary in combination with small intestinal lavage.
In case of intoxication with sustained release nifedipine preparations such as Nifelat, it is important that the elimination is as complete as possible, including the small intestine, in order to prevent absorption of active substance that is otherwise unavoidable.
Nifedipine is not dialysable, so hemodialysis has no function, but plasmapheresis is recommended (high plasma protein binding, relatively small volume of distribution).
In brady arrhythmias, symptomatic treatment with ß-sympathomimetics may be given. In life-threatening bradycardia, temporary pacemakers should be considered.
In case of hypotension due to cardiogenic shock and arterial vasodilatation, calcium should be administered (10-20 ml 10% calcium gluconate slowly intravenously, repeated as needed). As a result, serum calcium may reach the upper limit of normal or slightly elevated levels. If supply of calcium results in insufficient increase in blood pressure, vasoconstrictive sympathomimetics such as dopamine or noradrenaline is given in addition. The dosage of these is determined exclusively by what effect is achieved. Additional fluid or volume must be administered with caution due to the risk of heart congestion.
3 years.
Store below 25°C. Protect from light and moisture.
PVC/Aluminium blisters. Pack sizes of 30, 100 and 1000 film-coated tablets.
PP/PE containers with PE closure. Pack sizes of 100 and 1000 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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