ACNAMINO MR Capsule, hard Ref.[7905] Active ingredients: Minocycline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2014  Publisher: Dexcel-Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK

Therapeutic indications

Minocycline 100 mg capsules are indicated for the treatment of acne.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Posology and method of administration

Posology

Adults

One 100 mg capsule every 24 hours.

Children over 12 years

One 100 mg capsule every 24 hours.

Children under 12 years

Minocycline is not recommended.

Elderly

Dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Renal insufficiency

Minocycline must not be given to persons in renal failure. In lesser degrees of renal insufficiency, reduction of dosage and monitoring of renal function may be required (see sections 4.3 and 4.4).

Hepatic insufficiency

Minocycline should be used with caution in patients with hepatic dysfunction (see section 4.4).

Treatment of acne should be continued for a minimum of 6 weeks. If, after six months, there is no satisfactory response, Minocycline should be discontinued and other therapies considered. If Minocycline is to be continued for longer than six months, patients should be monitored at least three monthly thereafter for signs and symptoms of hepatitis or SLE or unusual pigmentation (see section 4.4).

Method of Administration

To reduce the risk of oesophageal irritation and ulceration, the capsules should be swallowed whole with plenty of fluid, while sitting or standing. The absorption of minocycline is not significantly impaired by food or moderate amounts of milk.

Overdose

Dizziness, nausea and vomiting are the adverse effects most commonly seen with overdose. There is no specific antidote. In cases of overdose, discontinue medication; treat symptomatically with gastric lavage and appropriate supportive measures. Minocycline is not removed in significant quantities by haemodialysis or peritoneal dialysis.

Shelf life

4 years.

Special precautions for storage

Store in the original package.

Nature and contents of container

The capsules are presented in aluminium/aluminium blisters, strips of which are contained within a printed cardboard carton. Each carton contains 56 capsules.

Special precautions for disposal and other handling

No special requirements.

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