Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clindamycin hydrochloride
Accord-UK Ltd
J01FF01
Clindamycin hydrochloride
300mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010600
CLINDAMYCIN 150MG AND 300MG HARD CAPSULES Clindamycin hydrochloride PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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. • The full name of this medicine is Clindamycin 150mg, 300mg Hard Capsules but within the leaflet it will be referred to as Clindamycin. WHAT IS IN THIS LEAFLET 1 WHAT CLINDAMYCIN IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLINDAMYCIN 3 HOW TO TAKE CLINDAMYCIN 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE CLINDAMYCIN 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT CLINDAMYCIN IS AND WHAT IT IS USED FOR Clindamycin_ _Capsules contain clindamycin which is an antibiotic used in the treatment of severe bacterial infections. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLINDAMYCIN DO NOT TAKE CLINDAMYCIN • if you are allergic to clindamycin, lincomycin or to any of the ingredients of this medicine (listed in section 6). • if you have diarrhoea. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Clindamycin Tell your doctor if: • you usually get diarrhoea when you take antibiotics or have ever suffered from problems with your stomach or intestines. If you develop severe or prolonged or bloody diarrhoea during or after using Clindamycin TELL YOUR DOCTOR IMMEDIATELY since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics. • you suffer from problems with your kidneys or liver. If you h Baca dokumen lengkap
OBJECT 1 CLINDAMYCIN 300MG HARD CAPSULES Summary of Product Characteristics Updated 04-Aug-2016 | Accord-UK Ltd 1. Name of the medicinal product Clindamycin 300mg Hard Capsules 2. Qualitative and quantitative composition Each capsule contains 325.78 mg clindamycin hydrochloride equivalent to 300 mg clindamycin. Excipient with known effect: Each capsule contains 67.82 mg anhydrous lactose (see section 4.4). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Hard capsule Size '0' hard gelatin capsule with opaque white cap and opaque white body imprinted with 'A718' on cap with black ink. 4. Clinical particulars 4.1 Therapeutic indications Clindamycin is indicated for the treatment of severe infections (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 Posology and method of administration Posology _Adults_ Moderately severe infection: 150 - 300 mg every six hours Severe infection: 1200 - 1800 mg daily in divided doses given every six to eight hours _Elderly_ The half-life, volume of distribution and clearance, and extent of absorption after administration of clindamycin hydrochloride are not altered by increased age. Analysis of data from clinical studies has not revealed any age-related increase in toxicity. Dosage requirements in elderly patients, therefore, should not be influenced by age alone. _Children:_ 3 - 6 mg/kg every six hours depending on the severity of the infection. Clindamycin capsules are not suitable for children who are unable to swallow them whole. The capsules do not provide exact mg/kg doses therefore it may be necessary to use an alternative formulation in some cases. _Renal impairment_ No dose adjustment is necessary in patients with mild to moderate impairment of renal function. In patients with severe renal impairment or anuria, plasma concentration should be monitored. Depending on the results, this measure can make a reduction in dosage or an increase in the dose interval of 8 or even 12 Baca dokumen lengkap