MINOCIN SA Modified release hard capsule Ref.[50816] Active ingredients: Minocycline

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

4.1. Therapeutic indications

Minocin SA capsules are indicated for the treatment of acne.

4.2. Posology and method of administration

Dosage

Adults: One 100mg capsule every 24 hours.

Children over 12 years: One 100mg capsule every 24 hours.

Children under 12 years: Minocin is not recommended.

Elderly: No special dosing requirements.

Administration

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

Treatment of acne should be continued for a minimum of 6 weeks and where possible limited to a maximum of six months. If, after six months, there is no satisfactory response Minocin SA should be discontinued and other therapies considered. If Minocin SA is to be continued for longer than six months, patients should be monitored (including laboratory investigations) at least three monthly thereafter for signs and symptoms of hepatitis or systemic lupus erythematosus (SLE) or unusual pigmentation (see Special warnings and precautions for use).

4.9. 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 supportive measures. Minocin is not removed in significant quantities by haemodialysis or peritoneal dialysis.

6.3. Shelf life

24 months.

6.4. Special precautions for storage

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

6.5. Nature and contents of container

PVC/PVDC aluminium blister packs containing 2, 7, 28, 49 and 56 capsules.
Polypropylene bottle with urea cap containing 100
capsules.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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