Maa: Ruotsi
Kieli: ruotsi
Lähde: Läkemedelsverket (Medical Products Agency)
klindamycinhydroklorid
EQL Pharma AB
J01FF01
clindamycin
150 mg
Kapsel, hård
klindamycinhydroklorid 162,88 mg Aktiv substans; laktosmonohydrat Hjälpämne
Receptbelagt
Förpacknings: Blister, 32 kapslar; Blister, 40 kapslar; Burk, 45 kapslar; Burk, 105 kapslar; Burk, 100 kapslar
Godkänd
2018-11-01
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CLINDAMYCIN EQL PHARMA 150 MG CAPSULES, HARD CLINDAMYCIN EQL PHARMA 300 MG CAPSULES, HARD clindamycin 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Clindamycin EQL Pharma is and what it is used for 2. What you need to know before you take Clindamycin EQL Pharma 3. How to take Clindamycin EQL Pharma 4. Possible side effects 5. How to store Clindamycin EQL Pharma 6. Contents of the pack and other information 1. WHAT CLINDAMYCIN EQL PHARMA IS AND WHAT IT IS USED FOR Clindamycin EQL Pharma is a bactericidal agent (antibiotic). Clindamycin EQL Pharma is used for the treatment of infections in the pharynx and in skin and soft tissues. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLINDAMYCIN EQL PHARMA DO NOT TAKE CLINDAMYCIN EQL PHARMA • if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6); • if you are allergic to lincomycin. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Clindamycin EQL Pharma: • if you have, or have previously had, a bowel disease. If you have, tell your doctor about this before you start treatment with Clindamycin EQL Pharma. • if you have impaired liver or kidney function In case of long-term treatment, liver and kidney function and blood should be examined regularly by the physician. Acute kidney disorders may occur. Please inform your doctor about any medication you currently take and if you have any existing problems with your kidneys. If y Lue koko asiakirja
1 1. NAME OF THE MEDICINAL PRODUCT Clindamycin EQL Pharma 150 mg capsules, hard Clindamycin EQL Pharma 300 mg capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One hard capsule contains: Clindamycin hydrochloride, equivalent to 150 mg or 300 mg clindamycin. Excipients with known effect: one hard capsule contains lactose monohydrate of 0.6 mg or 1 mg (see section 4.4). For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Capsules, hard 150 mg: hard cylindrical gelatin capsules, 17,5 mm with blue body and blue cap. 300 mg: hard cylindrical gelatin capsules, 21,7 mm with white body and blue cap. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the following indications, Clindamycin EQL Pharma should be reserved for patients who are hypersensitive to beta-lactam antibiotics or where they are unsuitable for other reasons: Pharyngotonicillitis. Skin and soft tissue infections, including recurrent hidroadenitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage _Adults:_ 300 mg 2 times daily or 150 mg 3-4 times daily. If necessary, the dose can be increased to 300 mg 3-4 times daily. _Pediatric population:_ The capsules should only be used for children who are able to swallow capsules.15 mg / kg and day divided into 3 doses. Children weighing 30 - 45 kg are given 150 mg 3 times a day. The maximum dose is 20 mg / kg / day. At this dose, dosing should be done 4 times daily. As capsules cannot always be used to give the exact dose in mg / kg as desired in the treatment of children, it may be necessary to use other products and formulations with clindamycin instead. _Treatment control:_ In long-term treatment, liver and renal function tests should be performed and the blood image monitored. If diarrhea occurs during treatment, the product should be discontinued. If rapid improvement does not occur, study on _Clostridium difficile_ should be performed. Method of administration The capsules should be taken whole with at least ½ glass of liquid and in upright position (not in the lying positio Lue koko asiakirja