Composition

Each capsule contains: Nifedipine.10 mg

Inactive ingredients: Glycerin, polyethylene glycol 400, saccharin sodium, peppermint oil, polysorbate 80, purified water.

Therapeutic Indications

For the prophylaxis of chronic stable angina pectoris, the treatment of Raynaud’s phenomenon and essential hypertension.

For patients suffering from essential hypertension or chronic stable angina pectoris, and treated with fast release forms of nifedipine (Epilat capsules), a dose dependent increase in the risk of cardiovascular complications (e.g. myocardial infarction) and mortality may occur. Due to this, Epilat capsules should only be used for treatment of patients with essential hypertension or chronic stable angina pectorfs if no other treatment is appropriate.

Posology and Method of Administration

Method of administration: Oral use.

Epilat capsules should be swallowed whole with a little liquid, either with or without food.

Epilat capsules should not be taken with grapefruit juice.

Dosage regimen: The maximum total daily dose is 60 mg. The recommended starting dose of nifedipine is 5 mg every eight hours with subsequent titration of dose according to response permitting an increase to a maximum of 20 mg every eight hours.

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.

Duration of treatment: Treatment may be continued indefinitely.

Additional information for special populations

Children and Adolescents: The safety and efficacy of Epilat capsules in children below 18 years of age has not been established.

Geriatric patients: The pharmacokinetics of Epilat capsules are altered in the elderly so that lower maintenance doses of Epilat may be required compared to younger patients.

Patients with hepatic impairment: Nifedipine is metabolised primarily by the liver and therefore patients with liver dysfunction should be carefully monitored, and in severe cases, a dose reduction may be necessary.

Patients with renal impairment: Based on pharmacokinetic data, no dosage adjustment is required in patients with renal impairment.

Special Warnings and Precautions for use

Epilat capsules are not beta-blockers and therefore give no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be a gradual reduction of the dose of beta-blocker, preferably over 8-10 days.

Epilat capsules may be used in combination with beta-blocking drugs and other antihypertensive agents but the possibility of an additive effect resulting in postural hypotension should be borne in mind.

Epilat capsules will not prevent possible rebound effects after cessation of other antihypertensive therapy.

Care must be exercised in patients with very low blood pressure (severe hypotension with systolic pressure less than 90 mm Hg).

Treatment with short-acting nifedipine may induce an exaggerated fall in blood pressure and reflex tachycardia, which can cause cardiovascular complications such as myocardial and cerebrovascular ischaemia.

As with other vasoactive substances, angina pectoris may very rarely occur (data from spontaneous reports) with immediate release nifedipine, especially at the start of the treatment.

Data from clinical studies confirm that the occurrence of angina pectoris attacks is uncommon.

In patients suffering from angina pectoris, an increase in frequency, duration and severity of angina pectoris attacks may occur, especially at the start of the treatment.

The occurrence of myocardial infarction has been described in isolated cases, although it was not possible to distinguish this from the natural course of the underlying disease.