País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Clindamycin
PCO Manufacturing Ltd.
D10AF; D10AF01
Clindamycin
150 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Antiinfectives for treatment of acne; clindamycin
Authorised
2007-10-05
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DALACIN C ® 150 MG HARD CAPSULES clindamycin (as clindamycin hydrochloride) 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 your 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Dalacin is and what it is used for 2. What you need to know before you take Dalacin 3. How to take Dalacin 4. Possible side effects 5. How to store Dalacin 6. Contents of the pack and other information 1. WHAT DALACIN IS AND WHAT IT IS USED FOR This medicine contains clindamycin hydrochloride which is an antibiotic used in the treatment of serious bacterial infections. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DALACIN DO NOT TAKE DALACIN: if you are allergic (hypersensitive) to clindamycin, lincomycin, soya, peanuts or to any of the other ingredients of this medicine (listed in section 6). if you are experiencing diarrhoea or suffer from intestinal inflammatory disease. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Dalacin: if you have diarrhoea or usually get diarrhoea when you take antibiotics or have ever suffered from problems with your stomach or intestines. if you develop diarrhoea during or after using Dalacin stop taking the capsules and TELL YOUR DOCTOR IMMEDIATELY. This may be a sign of bowel inflammation (_pseudomembranous _ _colitis_) which can occur even after 2 to 3 weeks following treatment with antibiotics. if you suffer from problems with your kidneys or Llegiu el document complet
Health Products Regulatory Authority 29 July 2020 CRN009VYG Page 1 of 2 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. Excipient(s)with known effect: Lactose monohydrate Medicinal product contains soya oil. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Hard capsule _ _ _Product imported from Hungary, Poland, Czech Republic and Spain:_ 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 As per PA0822/120/001 5 PHARMACOLOGICAL PROPERTIES As per PA0822/120/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Product imported from Hungary_ Lactose Monohydrate Maize starch Talc Magnesium stearate Capsules: Gelatin Black iron oxide (E172) Titanium dioxide (E171) _Product imported from Poland and the Czech Republic_ Lactose Monohydrate Maize starch Talc Magnesium stearte Capsules: Gelatin Titanium dioxide (E171) _Product imported from Spain _ Lactose monohydrate Health Products Regulatory Authority 29 July 2020 CRN009VYG Page 2 of 2 Maize starch Talc Magnesium stearate Capsules: Gelatin Erythrosine (E127) Indigo carmine (E132) Titanium dioxide (E171) 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store below 25 °C. Store in the original package in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Dalacin C 150 mg Hard Capsules are available in blister packs of 16 or 24 capsules Not all pack sizes may be marketed. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 1 Llegiu el document complet