NIDEF Prolonged release tablet Ref.[7009] Active ingredients: Nifedipine

Posology

In mild to moderate hypertension, the recommended initial dose is one 20 mg tablet once daily. In severe hypertension, the recommended initial dose is one 30 mg tablet once daily. If necessary, the dosage can be increased according to individual requirements up to a maximum of 90 mg once-daily.

For the prophylaxis of angina pectoris, the recommended initial dose is one 30 mg tablet once-daily. The dosage can be increased according to individual requirements up to a maximum of 90 mg once-daily.

Patients in whom hypertension or anginal symptoms are controlled on Nifedipine capsules or Nifedipine modified release tablets may be safely switched to Nifedipine prolonged release tablets.

Prophylactic anti-anginal efficacy is maintained when patients are switched from other calcium antagonists such as diltiazem or verapamil to Nifedipine prolonged release tablets.

Patients switched from other calcium antagonists should initiate therapy at the recommended initial dose of 30 mg Nifedipine prolonged release tablets once-daily. Subsequent titration to a higher dose may be initiated as warranted clinically.

Co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers may result in the recommendation to adapt the nifedipine dose or not to use nifedipine at all (see Section 4.5).

Duration of treatment

Treatment may be continued indefinitely.

Additional information on special populations

Paediatric population

The safety and efficacy of Nidef/Nifedipine Prolonged Released Tablets in children below 18 years has not been established. Currently available data for the use of nifedipine in hypertension are described in section 5.1.

Elderly

Based on pharmacokinetics data for nifedipine no dose adaptation in elderly people above 65 years is necessary.

Renal impairment

Based on pharmacokinetic data, no dosage adjustment is required in patients with renal impairment (see Section 5.2).

Method of administration

Oral use.

The tablets should be swallowed whole with a glass of water, either with or without food. The tablets should be taken at approximately 24-hour intervals, i.e. at the same time each day, preferably during the morning. Nidef / Nifedipine Prolonged Released Tablets must be swallowed whole; under no circumstances should they be bitten, chewed or broken up.

Nidef/Nifedipine Prolonged Released Tablets should not be taken with grapefruit juice (see Section 4.5).

Symptoms

The following symptoms are observed in cases of severe nifedipine intoxication:

Disturbances of consciousness to the point of coma, a drop in blood pressure, tachycardia, bradycardia, heart rhythm disturbances, hyperglycaemia, metabolic acidosis, hypoxia, cardiogenic shock with pulmonary oedema.

Management of Overdose

As far as treatment is concerned, elimination of the active substance and the restoration of stable cardiovascular conditions have priority.

After oral ingestion thorough gastric lavage is indicated, if necessary in combination with irrigation of the small intestine.

Particularly in cases of intoxication with slow-release products like nifedipine CR elimination must be as complete as possible, including the small intestine, to prevent the otherwise inevitable subsequent absorption of the active substance.

The benefit of gastric decontamination is uncertain.

1. Consider activated charcoal (50 g for adults, 1 g/kg for children) if the patient presents within 1 hour of ingestion of a potentially toxic amount. Although it may seem reasonable to assume that late administration of activated charcoal may be beneficial for sustained release (SR, MR) preparations there is no evidence to support this.
2. Alternatively consider gastric lavage in adults within 1 hour of a potentially life-threatening overdose.
3. Consider further doses of activated charcoal every 4 hours if a clinically significant amount of a sustained release preparation has been ingested with a single dose of an osmotic laxative (e.g. sorbitol, lactulose or magnesium sulphate).
4. Asymptomatic patients should be observed for at least 4 hours after ingestion and for 12 hours if a sustained release preparation has been taken.

Haemodialysis serves no purpose, as nifedipine is not dialysable, but plasmapheresis is advisable (high plasma protein binding, relatively low volume of distribution).

Bradycardiac heart rhythm disturbances may be treated symptomatically with atropine β-sympathomimetics, and in life-threatening bradycardiac disturbances of heart rhythm temporary pacemaker therapy can be advisable.

Hypotension as a result of cardiogenic shock and arterial vasodilation can be treated with calcium (10-20 ml of a 10% calcium gluconate solution administered slowly i.v. and repeated if necessary over 5-10 minutes). If the effects are inadequate, the treatment can be continued, with ECG monitoring. As a result, the serum calcium can reach the upper normal range to slightly elevated levels. If an insufficient increase in blood pressure is achieved with calcium, vasoconstricting sympathomimetics such as dopamine or noradrenaline are additionally administered. The dosage of these drugs is determined solely by the effect obtained.

Additional liquid or volume must be administered with caution because of the danger of overloading the heart.

2 years.

Store in the original container.

PVC/PE/PVDC, Aluminium Blister. Blister packs of 10, 14, 15, 28, 30, 56, 60, 90 and 112 Prolonged Release Tablets.

Not all pack sizes may be marketed.

No special precautions.