Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Oxytetracycline dihydrate
Dalkeith Laboratories Ltd
J01AA06
Oxytetracycline dihydrate
250mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010300; GTIN: 5039290001089
PATIENT INFORMATION LEAFLET OXYTETRACYCLINE TABLETS BP 250 MG This medicine will be called Oxytetracycline Tablets in this leaflet. 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 or pharmacist. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Oxytetracycline Tablets are and what they are used for 2. What you need to know before you take Oxytetracycline Tablets 3. How to take Oxytetracycline Tablets 4. Possible side effects 5. How to store Oxytetracycline Tablets 6. Contents of the pack and other information 1. WHAT OXYTETRACYCLINE TABLETS ARE AND WHAT THEY ARE USED FOR These tablets contain the active ingredient, oxytetracycline. Oxytetracycline belongs to a group of medicines called broad spectrum antibiotics. This means that it is active against a large number of bacteria which cause infections. Oxytetracycline Tablets are used to treat a wide range of infections caused by bacteria. They are also used for preventing and treating chronic bronchitis, urinary tract (bladder and kidney) infections, pneumonia, brucellosis, pertussis and venereal diseases such as syphilis and gonorrhoea. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OXYTETRACYCLINE TABLETS DO NOT TAKE OXYTETRACYCLINE TABLETS: Some people MUST NOT take these tablets. Do not take these tablets if: You know you are allergic to Oxytetracycline (or any other medicine belonging to the tetracycline group of drugs) or you are allergic to any of the other ingredients of this medicine (listed in section 6) You have kidney problems You suffer from (SLE) systemic lupus erythematosus (an a Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxytetracycline Tablets BP 250 mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablets contains Oxytetracycline 250.0 mg (as dihydrate). Excipients with known effect: Lactose 13.44 mg Sucrose 180 mg Tartrazine (E102) approximately 0.24 mg. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Coated tablet. Round, yellow, sugar coated tablets. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of infections due to Chlamydia, Brucella, Mycoplasma, Rickettsia, and other sensitive organisms. May also be used for prophylaxis and treatment of chronic bronchitis, non-gonococcal urethritis, gonorrhoea, syphilis, other urinary tract infections and severe acne vulgaris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The tablets should preferably be taken on an empty stomach (1 hour before food or 2 hours after). Adults, the elderly and children over 12 years: Normal dose is 250 – 500 mg every 6 hours (4 times a day). This may be increased in severe infections. For acne the dose is usually 250 mg three times a day for 4 weeks, but this may be prolonged if necessary. Children under 12 years of age: Not to be given. Route of administration For oral administration. 4.3 CONTRAINDICATIONS Must not be given to children under 12 years. Known hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Chronic renal or hepatic dysfunction. Pregnancy or breastfeeding. Systemic lupus erythematosus (SLE). Patients receiving vitamin A or retinoid therapy. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Tetracycline drugs may cause permanent tooth discoloration (yellow-grey-brown), if administered during tooth development, in the last half of pregnancy and in infancy up to twelve years of age. Enamel hypoplasia has also been reported. This adverse reaction is more common during long-term use of the drug but has been observed following repeated short term courses The anti-anabolic action of tetracyclines Leggi il documento completo