Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**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.
ORAL
Medical Information
**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_).
C08CA06
nimodipine
Manufacturer Information
BAYER (SOUTH EAST ASIA) PTE LTD
Bayer AG
HAUPT PHARMA MÜNSTER GMBH (Primary & Secondary Packaging)
Active Ingredients
Documents
Package Inserts
Nimotop Tablet PI.pdf
Approved: June 20, 2022