NIMOTOP Film-coated tablet Ref.[7832] Active ingredients: Nimodipine

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.

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

Traumatic subarachnoid haemorrhage

Not recommended as a positive benefit to risk ratio has not been established (see section 4.4)

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. The effects and side-effects, e.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.

Upon co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers a dose adaption may be necessary (see section 4.5).

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.

Grapefruit juice is to be avoided (see section 4.5).

Symptoms of intoxication

Symptoms of acute overdosage to be anticipated are marked lowering of the blood pressure, tachycardia, bradycardia and (after oral administration) gastro-intestinal complaints and nausea.

Treatment of intoxication

In the event of acute overdosage, treatment with Nimotop must be discontinued immediately. Emergency measures should be governed by the symptoms. Gastric lavage with addition of charcoal should be considered as an emergency therapeutic measure. If there is a marked fall in blood pressure, dopamine or noradrenaline can be administered intravenously. As no specific antidote is known, subsequent treatment for other side effects should be aimed at the most prominent symptoms.

5 years.

Do not store above 30°C.

PP/aluminium blister packs contained in cardboard outer, containing 100 × 30mg tablets.

Not applicable.