Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Minocycline hydrochloride
Dexcel-Pharma Ltd
J01AA08
Minocycline hydrochloride
100mg
Modified-release capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010300; GTIN: 5033847000693
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. IT IS AN IMPORTANT SOURCE OF INFORMATION ABOUT YOUR MEDICINE AND HOW TO TAKE IT SAFELY. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor or your pharmacist. • This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. WHAT ACNAMINO MR IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE ACNAMINO MR 3. HOW TO TAKE ACNAMINO MR 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ACNAMINO MR 6. FURTHER INFORMATION 1. WHAT ACNAMINO MR IS AND WHAT IT IS USED FOR THE NAME OF YOUR MEDICINE is Acnamino MR 100mg Capsules (referred to as Acnamino MR throughout this leaflet). THE ACTIVE INGREDIENT in your medicine is minocycline. Minocycline is one of a group of antibiotics called Tetracyclines. ACNAMINO MR IS USED for the treatment of acne. It is thought that acne is partly due to, or made worse by, infection with a type of bacteria called Propionibacterium Acnes. Treating acne with Acnamino MR is intended to reduce the infection with this bacterium and so help in the overall treatment of acne 2. BEFORE YOU TAKE ACNAMINO MR DO NOT TAKE ACNAMINO MR IF: • You are allergic (hypersensitive) to minocycline or any of the other ingredients of Acnamino MR (these are listed below in Section 6). • You are allergic to any medicines from the group of antibiotics called Tetracycline (e.g. oxytetracycline, tetracycline, doxycycline). • You have kidney failure • You are pregnant, think you might be pregnant or are trying to become pregnant. Acnamino MR may cause harm to the foetus • You are breastfeeding. Medicines from the Tetracycline group (as Acnamino MR) passes through the breast milk. • You are less than 12 years old. The use of Acnamino Read the complete document
OBJECT 1 ACNAMINO MR 100MG CAPSULES Summary of Product Characteristics Updated 07-Jul-2017 | Dexcel Pharma Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Acnamino™ MR 100mg Capsules 2. Qualitative and quantitative composition Each capsule contains 100mg minocycline (as minocycline hydrochloride). For excipients, see section 6.1. 3. Pharmaceutical form Capsules, hard. Minocycline 100 mg is a hard gelatin capsule, with an opaque-buff body and an opaque-brown cap, containing one pink film-coated tablet, and one peach enteric-coated tablet. 4. Clinical particulars 4.1 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. 4.2 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. Elde Read the complete document