Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Minocycline hydrochloride
Almirall Ltd
J01AA08
Minocycline hydrochloride
50mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010300; GTIN: 5000167022988
1 PACKAGE LEAFLET: INFORMATION FOR THE USER AKNEMIN 50 CAPSULES Minocycline base 50 mg (as the hydrochloride Ph Eur) per capsule IN THIS LEAFLET : 1. What Aknemin 50 is and what it is used for 2. Before you take Aknemin 50 3. How to take Aknemin 50 4. Possible side effects 5. How to store Aknemin 50 6. Further information 1. WHAT AKNEMIN 50 IS AND WHAT IT IS USED FOR Aknemin 50 is one of a group of antibiotics called tetracyclines. These are used in the treatment of acne, and for other bacterial infections. Acne is a common condition caused by an over production of the skin's sebum. It blocks pores causing blackheads. These become infected with bacteria. Then the surrounding skin gets inflamed causing acne spots. Aknemin 50 reduces the inflammation and allows spots to heal. 2. BEFORE YOU TAKE AKNEMIN 50 DO NOT TAKE AKNEMIN 50 • if you are allergic (hypersensitive) to minocycline hydrochloride, any other antibiotic from a group called tetracyclines or any of the other ingredients of Aknemin 50 (see section 6). • if you have been told that you have a condition called Systemic Lupus Erythematosus (SLE). • if you have problems with your kidneys. • if you are pregnant or there is a possibility that you may be pregnant or if you are breast-feeding. AKNEMIN 50 SHOULD NOT BE GIVEN TO CHILDREN UNDER 12 YEARS OF AGE. TAKE SPECIAL CARE WITH AKNEMIN 50 • if you have problems with your liver, eg if you have a condition called acute porphyria. • if you have been told that you have a muscle disease called Myasthenia Gravis. TAKING OTHER MEDICINES Talk to your doctor or pharmacist if you are taking • a medicine to reduce clotting of blood (an anticoagulant such as warfarin). • a penicillin antibiotic. • indigestion products such as antacids. • any medicines which contain iron, calcium, aluminium, magnesium, bismuth or zinc salts. • diuretics (sometimes described as “water tablets”). If you are taking the contraceptive pill and experience diarrhoea or bleeding in between your periods, there is a possibil Read the complete document
OBJECT 1 AKNEMIN 50 Summary of Product Characteristics Updated 07-Jul-2015 | Almirall Limited 1. Name of the medicinal product Aknemin 50 2. Qualitative and quantitative composition Minocycline base 50 mg (as the hydrochloride Ph Eur) per capsule. 3. Pharmaceutical form Capsule. 4. Clinical particulars 4.1 Therapeutic indications Minocycline is an antibiotic with a spectrum of activity similar to other tetracyclines but more active against _Staphylococcus aureus _and _Nocardia _spp. It is indicated for the treatment of organisms sensitive to tetracyclines such as acne, respiratory infections, gonorrhoea, nocardiosis, staphylococcal infections; the chemoprophylaxis of meningococcal infections. 4.2 Posology and method of administration For oral administration. _Adults:_ 1) Routine antibiotic use: 200 mg daily in divided doses. 2) Acne: 50 mg twice daily or 100 mg once daily. 3) Gonorrhoea: In adult males, 200 mg initially followed by 100 mg every 12 hours for a minimum of 4 days with post-therapy cultures within 2-3 days. Adult females may require more prolonged therapy. 4) Prophylaxis of meningococcal infections: 100 mg twice daily for five days, usually followed by a course of rifampicin. _Children:_ Aknemin 50 is not recommended for children under 12 years old. For children above 12 years old the recommended dose is 50 mg every 12 hours or 100 mg once daily. _The Elderly:_ Aknemin 50 may be used at the normal recommended dosage in elderly patients but caution is advised in patients with renal impairment. Unlike earlier tetracyclines, absorption of Aknemin 50 is not impaired significantly by the intake of food or moderate amounts of milk. The treatment of acne should be continued for a minimum of 6 weeks. If after 6 months there is no satisfactory response, Aknemin 50 should be discontinued and other therapies considered. If Aknemin 50 is to be continued for more than 6 months, patients should be monitored at least 3 monthly thereafter for signs and symptoms of hepatitis or SLE (See 4.4). 4.3 Contraindications Hy Read the complete document