NIMOTOP

Posology Aneurysmal subarachnoid haemorrhage:

Prophylactic administration - Adults The recommended dose is two tablets at 4-hourly intervals (total daily dose 360 mg) to be taken with water. Prophylactic administration should commence within four days of onset of subarachnoid haemorrhage and should be continued for 21 days.

In the event of surgical intervention, administration of Nimotop tablets should be continued (dosage as above) to complete the 21 days treatment period. 4) Special populations: 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.

g. reduction in blood pressure, may be more pronounced in these patients. In such cases, the dose should be reduced (depending on the blood pressure) or, if necessary, discontinuation of the treatment should be considered. 5). Elderly There are no special dosage requirements for use in the elderly.

Paediatric population The safety and efficacy of Nimotop in patients under 18 years of age have not been established. Method of administration In general, the tablets should be swallowed whole with a little liquid, with or without food.

The interval between successive doses must not be less than 4 hours. 5).

The frequencies of ADRs reported with nimodipine summarized in the tables below are based on clinical trials with nimodipine in the indication aSAH sorted by CIOMS III categories of frequency (placebo-controlled studies: nimodipine N = 703; placebo N = 692; uncontrolled studies: nimodipine N = 2496; status: 31 Aug 2005.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Frequencies are defined as:

Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to ≤ 1/100), Rare (≥ 1/10,000 to ≤ 1/1,000), Very rare (< 1/10,000) Not known (cannot be estimated from the available data). System Organ Class (MedDRA) Uncommon Rare Not known Blood and the lymphatic system disorders Thrombocytopenia Immune system disorders Allergic reaction Rash Nervous system disorders Headache Cardiac disorders Tachycardia Bradycardia Vascular disorders Hypotension Vasodilatation Gastrointestinal disorders Nausea Ileus Hepatobiliary disorders Respiratory, thoracic and mediastinal disorders Transient increase in liver enzymes Hypoxia Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

Nimotop should not be used in patients with traumatic subarachnoid haemorrhage as a positive benefit to risk ratio has not been established and the specific patient groups that might benefit cannot be identified for this indication.

Nimotop tablets should be used with care when cerebral oedema or severely raised intracranial pressure is present. Although treatment with Nimotop has not been shown to be associated with increases in intracranial pressure, close monitoring is recommended in these cases or when the water content of the brain tissue is elevated (generalised cerebral oedema).

Caution is required in patients with hypotension (systolic blood pressure lower than 100 mm Hg). Decreased drug clearance may occur in cirrhotic patients receiving Nimotop and, therefore, close monitoring of blood pressure is recommended in these patients.

Nimodipine is metabolised via the cytochrome P450 3A4 system. 2 – “Patients with hepatic impairment”). g. g. g. ketoconazole), - the antidepressants nefazodone and fluoxetine, - quinupristin/dalfopristin, - cimetidine, - valproic acid. Upon co-administration with these drugs, the blood pressure should be monitored and, if necessary, a reduction in the nimodipine dose should be considered.

1. Nimodipine should not be administered to patients during or within one month of a myocardial infarction or an episode of unstable angina. The use of nimodipine in combination with rifampicin or the antiepileptic drugs, phenobarbital, phenytoin or carbamazepine is contraindicated as the efficacy of Nimotop tablets could be significantly reduced when concomitantly administered.

5).