Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chloramphenicol
Kent Pharma (UK) 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 Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Chloramphenicol Capsules BP 250mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 250 mg of chloramphenicol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsules Off-white, hard gelatin capsules 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Typhoid fever and life-threatening infections, particularly those caused by Haemophilus influenzae where other antibiotics will not suffice. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and elderly The normal dose is 50 mg/kg body weight daily in 4 divided doses. For severe infections (meningitis, septicaemia) this dose may be doubled initially, but it must be reduced as soon as clinically practical. Paediatric population The safety and efficacy of Chloramphenicol 250 mg Capsules BP have not yet been established in children. Method of administration For oral administration. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Chloramphenicol is contra-indicated in prophylaxis or treatment of minor infections; during active immunisation; and in porphyria patients. Chloramphenicol is contra-indicated in patients taking drugs liable to depress bone marrow function (see section 4.5). Chloramphenicol must not be used in breast-feeding mothers and during pregnancy or labour, due to a risk of foetal/ infant damage (Gray Baby syndrome). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Chloramphenicol should only be used if other treatments are ineffective and its use should always be carefully monitored. 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)._ _ Periodic blood testing should be conducted during prolonged or repeated treatment. Chloramphenicol should be discontinued if a significant detrimental effect is seen. This medicine contains le Belgenin tamamını okuyun