Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CLINDAMYCIN HYDROCHLORIDE
B & S Healthcare
CLINDAMYCIN HYDROCHLORIDE
150 Base Milligrams
Capsules Hard
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER DALACIN ® C 150MG HARD CAPSULES clindamycin (as clindamycin hydrochloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or your pharmacist. - This medicine has been prescribed for you. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist. The name of your medicine is Dalacin C 150mg Hard Capsules but it will be referred to as Dalacin throughout this leaflet. IN THIS LEAFLET: 1. What Dalacin is and what it is used for 2. Before you take Dalacin 3. How to take Dalacin 4. Possible side effects 5. How to store Dalacin 6. Further Information 1. WHAT DALACIN IS AND WHAT IT IS USED FOR Dalacin contains clindamycin hydrochloride which is an antibiotic used in the treatment of serious bacterial infections. 2. BEFORE YOU TAKE DALACIN DO NOT TAKE DALACIN IF: You are allergic (hypersensitive) to clindamycin, lincomycin or to any of the other ingredients in this medicine. You are experiencing diarrhoea or suffer from intestinal inflammatory disease. You are taking erythromycin to treat an infection. TAKE SPECIAL CARE WITH DALACIN Tell your doctor if you have any of the following conditions to help him or her decide if Dalacin is suitable for you: You have diarrhoea or usually get diarrhoea when you take antibiotics, or hav Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dalacin C 150 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains clindamycin hydrochloride equivalent to 150 mg of clindamycin base. Excipients: Lactose monohydrate For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard _Product Imported from France:_ Size 1, hard gelatin capsules with an opaque white body and an opaque white cap, containing a white to off-white powder. The capsule is imprinted with ‘CLIN 150’ and ‘Pfizer’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of serious infections due to gram-positive organism, including staphylococci (both penicillinase and non- penicillinase producing), streptococci (except _Streptococcus faecalis_) and pneumococci. It is also indicated in serious infections caused by susceptible anaerobic pathogens. Clindamycin does not penetrate the blood/brain barrier in therapeutically effective quantities. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION To be taken orally. Dalacin C Capsules should always be taken with a glass of water. Absorption of Dalacin C is not appreciably modified by the presence of food. ADULTS (INCLUDING THE ELDERLY): Moderately severe infection: 150 - 300 mg every six hours CHILDREN (OVER 1 MONTH OF AGE): The usual daily dosage is 12 - 24 mg/kg in 4 divided doses. In children under one year of age or weighing 10 kg or less, the minimum recommended dosage is 37.5 mg every eight hours. DOSAGE IN ELDERLY The dosage of clindamycin may require reduction in patients with renal impairment due to prolongation of the serum half-life of this drug. This is particularly important with parenteral dosage. DOSAGE IN RENAL IMPAIRMENT Clindamycin dosage modification is not necessary in pa Read the complete document