מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Oxytetracycline dihydrate
Bristol Laboratories Ltd
J01AA06
Oxytetracycline dihydrate
250mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010300; GTIN: 5060013942372
Package Leaflet: Information for the user OXYTETRACYCLINE TABLETS BP 250MG (Oxytetracycline dihydrate) 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 this medicine and what it is used for 2. What you need to know before you take this medicine 3. How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. What this medicine is and what it is used for Oxytetracycline belongs to a group of medicines called tetracycline-antibiotics. It is also known as a broad spectrum antibiotic and may be used to treat a wide range of infections caused by bacteria. These include: • lung infections such as pneumonia, bronchitis whooping cough • urinary tract infections • sexually transmitted diseases such as chlamydia, gonorrhoea or syphilis • skin infections such as acne • infections of the eye such as conjunctivitis • rickettsial infections such as Q fever or tick fever (severe headache, rash, high fever) • other infections including brucellosis (headache, sickness, fever, swollen lymph nodes), psittacosis (headache, nose bleeds, shivering, fever), plague (painful swelling of the lymph nodes), cholera (severe sickness and diarrhoea) • leptospirosis (fever causing jaundice or meningitis), gas-gangrene and tetanus (lock jaw). 2. What you need to know before you take this medicine Do not take this medicine if: • You are allergic to the tetracycline group of drugs or to any of the other ingredients of this medicine (liste קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Oxytetracycline Tablets BP 250 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 269.57 mg of oxytetracycline dihydrate equivalent to 250mg of oxytetracyline. Excipients with known effect: Also contains sucrose, glucose and tartrazine aluminium lake (E102). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet A yellow sugar-coated tablet with a smooth polished surface 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oxytetracycline is a bacteriostatic broad-spectrum antibiotic, active against a wide variety of Gram-positive and Gram-negative organisms. Infections caused by oxytetracycline-sensitive organisms include: 1) _Respiratory tract infections_: Pneumonia, whooping cough and other lower respiratory tract infections due to susceptible strains of _Streptococcus _ _pneumoniae_, _Haemophilus influenzae, Klebsiella pneumoniae_ and other organisms. _Mycoplasma pneumoniae_ pneumonia. Treatment of chronic bronchitis (including the prophylaxis of acute exacerbations). 2) _Urinary tract infections_: caused by susceptible strains of the Klebsiella species. Enterobacter species, _Escherichia coli, Streptococcus faecalis_ and other organisms. 3) _Sexually transmitted diseases_: Infections due to _Chlamydia trachomatis_ including uncomplicated urethral, endocervical or rectal infections. Non- gonococcal urethritis caused by _Ureaplasma_ _urealyticum_. Oxytetracycline is also indicated in chancroid, granuloma inguinale and lymphogranuloma venereum. Oxytetracycline is an alternative drug in the treatment of gonorrhoea and syphilis. 4) _Skin Infections_: Acne vulgaris when antibiotic therapy is considered necessary and severe rosacea. 5) _Ophthalmic infections_: Trachoma, although the infectious agent, as judged by immunofluorescence, is not always eliminated. Inclusion conjunctivitis may be treated with oral oxytetracycline alone or in combination with topical agents. 6) _Rickettsial infections_: Rocky Mountai קרא את המסמך השלם