Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chloramphenicol
Sussex Pharmaceutical Ltd
J01BA01
Chloramphenicol
250mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010700
FRONT REVERSE 75/L/f/6b 75/L/f/6b _Continued over page_ Package leaflet: Information for the patient Chloramphenicol Capsules BP 250 mg WHAT IS IN THIS LEAFLET: 1. WHAT CHLORAMPHENICOL CAPSULES ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHLORAMPHENICOL CAPSULES 3. HOW TO TAKE CHLORAMPHENICOL CAPSULES 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CHLORAMPHENICOL CAPSULES 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT CHLORAMPHENICOL CAPSULES ARE AND WHAT THEY ARE USED FOR Chloramphenicol capsules contain chloramphenicol which is an antibiotic for specific uses. They are used for treatment of typhoid fever and other dangerous infections where other antibiotics are not effective. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHLORAMPHENICOL CAPSULES DO NOT TAKE CHLORAMPHENICOL CAPSULES: • if you are allergic to chloramphenicol or any of the other ingredients (listed in section 6) • if you have recently been vaccinated • if you have porphyria (a metabolism disorder which causes abdominal pains and mental disorder) • if you have a minor infection • if you are taking medicines that may suppress your bone marrow • if you are pregnant or breast-feeding. If any of the above apply to you, speak to your doctor or pharmacist. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Chloramphenicol capsules • if you have liver or kidney problems • if you are elderly • if you are taking any of the medicines listed in the next section “Other medicines and Chloramphenicol capsules”. CHILDREN Do not give this medicine to children because it is unlikely to be safe. OTHER MEDICINES AND CHLORAMPHENICOL CAPSULES Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines may be affected by chloramphenicol or they may affect how well chloramphenicol will work. Tell your doctor or pharmacist if you are taking: • paracetamol • medicines that thin the blood (e.g. warfarin) • antidiabetics (sulphonylureas such Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Chloramphenicol 250 mg Capsules Cafcol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 250 mg of Chloramphenicol BP For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule White, opaque gelatine capsules 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS To be reserved for the treatment of life-threatening infections, particularly those caused by Haemophilus influenza, and typhoid fever, where other antibiotics will not suffice. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: _Adults (including the elderly): _ The usual dose is 500 mg every 6 hours (50 mg/kg bodyweight daily in 4 divided doses) and treatment should be continued for 2 or 3 days after the patient's temperature has returned to normal. For severe infections (meningitis, septicaemia) this dose may be doubled initially, but it must be reduced as soon as clinically practical. _Children: _ Not recommended Method of administration : Oral 4.3 CONTRAINDICATIONS Chloramphenicol is contra-indicated in: • individuals with a history of hypersensitivity or toxic reaction to chloramphenicol or to any of the excipients listed in section 6.1 • prophylaxis or treatment of minor infections • active immunisation • porphyria patients • blood dyscrasias including aplastic anaemia • patients taking drugs liable to depress bone marrow function (see section 4.5) • breast-feeding mothers and during pregnancy or labour, due to a risk of foetal/infant damage (Grey Baby syndrome) 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Dose reduction and plasma level monitoring may be required in patients with hepatic or renal impairment; in the elderly; and in patients concurrently treated with interacting drugs, see section 4.5 Determine routine blood profile before therapy and repeat blood studies at appropriate intervals, especially during prolonged or repeated therapy. The drug should be withdrawn if evidence of a significant detrimental effect is seen or depr Đọc toàn bộ tài liệu