NIMOTOP TABLET 30 mg

INDICATIONS

After a preceding infusion of Nimotop infusion solution, for prophylaxis and treatment of ischaemic neurological deficits caused by cerebral vasospasm following subarachnoid haemorrhage of aneurysmal origin.

CONTRAINDICATIONS

Nimotop tablets must not be used in cases of hypersensitivity to nimodipine or to any of the excipients.

The use of nimodipine in combination with rifampicin is contraindicated as efficacy of Nimotop tablets could be significantly reduced when concomitantly administered with rifampicin (see “Interactions with other medicinal products and other forms of interaction”– please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The concomitant use of oral nimodipine and the antiepileptic drugs phenobarbital, phenytoin or carbamazepine is contraindicated as efficacy of Nimotop tablets could be significantly reduced (see “Interactions with other medicinal products and other forms of interaction” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

POSOLOGY AND METHOD OF ADMINISTRATION

Posology

Unless otherwise prescribed, the following dosage is recommended:

The recommended procedure is administration of Nimotop infusion solution for 5–14 days, followed by a daily dose of 6 x 2 Nimotop tablets (6 x 60 mg nimodipine)

In patients who develop adverse reactions the dose should be reduced as necessary or the treatment discontinued.

Patients with hepatic impairment

Severely disturbed liver function, particularly liver cirrhosis, may result in an increased bioavailability of Nimodipine due to a decreased first-pass capacity and a reduced metabolic clearance. The effects and side-effects, e.g. reduction in blood-pressure, may be more pronounced.

In such cases the dose should be reduced, depending on the blood pressure; or, if necessary, discontinuation of the treatment should be considered.

Administration

Administration of Nimotop tablets is recommended for about 7 days after the end of 5–14 days infusion therapy with Nimotop infusion solution.

In general, the tablets should be swallowed in whole with a little liquid, independently of meal times. Grapefruit juice is to be avoided (see “Interactions with other medicinal products and other forms of interaction” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The interval between successive doses must not be less than 4 h.

Duration of use:

- Prophylactic Use:

After the end of the infusion therapy, it is advisable to continue with oral administration of 6 x 60 mg Nimotop tablets daily at four-hourly intervals for about further 7 days.

- Therapeutic Use:

After intravenous application, oral administration of 6 x 60 mg Nimotop tablet per day at four-hourly intervals for 7 days is recommended.