Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Minocycline hydrochloride
Crescent Pharma Ltd
J01AA08
Minocycline hydrochloride
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010300; GTIN: 5017123494130
148x210 Leaflet Reel Fed Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Minocycline Film-coated Tablets 50, 100mg x 28’s (UK) 148x210 (Reel Fed) 50978963 Leaflet for Blisters 1953 T. Hull 19/09/19 * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@accord-healthcare.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. FMD info NA (not a carton) No Yes Details MINOCYCLINE ALL STRENGTHS FILM-COATED TABLET PIL - UK Black Profile BBBA6347 G. Worth 24/09/2019 148 x 210 7 pt Accord Barnstaple n/a n/a 1 Version 2 01.11.2017 MINOCYCLINE 50MG AND 100MG TABLETS _Continued top of next column_ _Continued over page_ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1 WHAT MINOCYCLINE TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE MINOCYCLINE TABLETS 3 HOW TO TAKE MINOCYCLINE TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE MINOCYCLINE TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT MINOCYCLINE TABLETS ARE AND WHAT THEY ARE USED FOR Minocycline belongs to a group of medicines called tetracycline antibiotics. It is also known as a b Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Minocycline Tablets BP 100 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 115.85 mg of minocycline hydrochloride (dihydrate) equivalent to 100 mg of minocycline. Excipients with known effect: Each 100mg tablet contains 35.75 mg lactose. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM The product is presented in the form of buff coloured, biconvex, film coated tablet, engraved with company logo on one side and A494 on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Minocycline is a broad spectrum antibiotic used for the treatment of infections caused by tetracycline-sensitive organisms. Some tetracycline-resistant strains of staphylococci are also sensitive. It is indicated for the treatment of the following infections: • Gonorrhoea • Non-gonococcal urethritis • Prostatitis • Moderate to severe acne; use in moderate acne only if topical treatment is ineffective, if acne is extensive or hard to reach and if there is a high risk of scarring. • Acute and chronic bronchitis • Bronchiectasis • Lung abscess • Pneumonia • Ear, nose and throat infections • Urinary tract infections • Pelvic inflammatory disease e.g. salpingitis, oophoritis. • Skin and soft tissue infections caused by minocycline sensitive organisms • Ophthalmological infections • Nocardiosis • Prophylactic treatment of asymptomatic meningococcal carriers • Pre and post-operative prophylaxis of infection. Minocycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _ADULTS: _ _ _ Routine antibiotic use: 200 mg daily in divided doses. Acne: 50 mg twice daily. Treatment should continue for a minimum of six weeks. Gonorrhoea: Adult males: 200 mg initially followed by 100 mg Lesen Sie das vollständige Dokument