CARMIL XL Prolonged release tablet Ref.[27626] Active ingredients: Isosorbide mononitrate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip, HA4 6QD, United Kingdom

4.1. Therapeutic indications

Prophylactic treatment of angina pectoris.

4.2. Posology and method of administration

Posology

Adults

One tablet to be taken once daily in the morning. The dose may be increased to 120mg (two tablets) daily, both to be taken once daily in the morning. The dose can be titrated to minimise the possibility of headache, by initiating the treatment with 30mg (half tablet) for the first 2–4 days.

Paediatric population

The safety and efficacy of Monomil XL/Carmil XL tablets in children has not been established.

Elderly

No evidence of a need for routine dosage adjustment in the elderly has been found, but special care may be needed in those with increased susceptibility to hypotension or marked hepatic or renal insufficiency.

Method of administration

Monomil XL/Carmil XL tablets must not be chewed or crushed. They should be swallowed whole with a small amount of water.

4.9. Overdose

Symptoms

Pulsing headache. More serious symptoms are excitation, flushing, cold perspiration, nausea, vomiting, vertigo, syncope, tachycardia and a fall in blood pressure.

Treatment

Induction of emesis, activated charcoal. In case of pronounced hypotension the patient should first be placed in the supine position with the legs raised. If necessary fluids should be administered intravenously.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Do not store above 25°C. Store in original container.

6.5. Nature and contents of container

PVC/Aluminium blisters in a cardboard carton. Each strip of blister contains 14 tablets and there are two strips of blisters per carton.

6.6. Special precautions for disposal and other handling

Not applicable.

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