NYZAMAC Prolonged-release capsule, hard Ref.[27778] Active ingredients: Isosorbide mononitrate

Posology

Adults

One capsule once daily given in the morning. The dose may be increased up to 120 mg.

The product must not be given in divided doses as a daily nitrate free period is required in order to prevent the development of tolerance. Thus, if more than one capsule is needed they must be taken simultaneously.

The dose can be titrated to minimise the possibility of headache by initiating treatment by a lower dose for the first two to four days.

Paediatric population

The safety and efficacy of Nyzamac SR Capsules in children have not been established.

Elderly

There is no need for routine dose adjustment in the elderly, but care may be needed in those patients with increased susceptibility to hypotension, and in those with marked hepatic or renal insufficiency.

The lowest effective dose should be used.

There is a risk of tolerance developing to prolonged-release preparations. In such patients, intermittent therapy may be more appropriate (see section 4.4).

As with other drugs for the treatment of angina pectoris, abrupt discontinuation of therapy may lead to exacerbation of symptoms. When discontinuing long-term treatment, the dosage should be reduced gradually over several days, and the patient carefully monitored (see section 4.4).

Method of administration

For oral administration.

The capsules may be taken with or without food.

The capsules should be swallowed whole with half a glass of fluid and they should not be chewed or crushed to avoid damage to the prolonged-release characteristics of the microgranules.

Symptoms and signs

Pulsing headache. More serious symptoms are excitation, flushing, cold perspiration, nausea, vomiting, vertigo, syncope, tachycardia and a fall in blood pressure. A rise in intracranial pressure with confusion and neurological deficits can sometimes occur.

Methaemoglobinaemia (cyanosis, hypoxaemia, change in mental status, respiratory depression, convulsions, cardiac arrhythmias, circulatory failure and raised intracranial pressure) occurs rarely.

Management

Induction of emesis, activated charcoal.

In case of pronounced hypotension the patient should first be placed in the supine position with legs raised. If necessary, fluids should be administrated intravenously.

Consider oral activated charcoal if ingestion of a potentially toxic amount has occurred within 1 hour. Observe for at least 12 hours after the overdose. Monitor blood pressure and pulse.

If methaemoglobinaemia occurs seek expert advice. Treat with supplemental oxygen and methylene blue. In cases not responding to methylene blue or where methylene blue is contraindicated consider exchange transfusion or red blood cell concentrates. In case of cerebral convulsions, consider diazepam or clonazepam IV or, if therapy fails, phenobarbital, phenytoin or propofol anaesthesia.

2 years.

Do not store above 25°C. Store in the original package.

The capsules are packed in in blister packs (20 μm aluminium/250 μm PVC) and boxed in cardboard cartons containing 28, 30, 56 or 60 capsules.

Sample blister pack of 8 capsules.

Not all pack sizes may be marketed.

No special requirements.