Страна: Мальта
Язык: английский
Источник: Medicines Authority
SACCHAROMYCES BOULARDII
Biocodex 7 Avenue Gallieni- 94250 Gentilly, France
A07FA02
SACCHAROMYCES BOULARDII 500 mg
POWDER FOR ORAL SUSPENSION
SACCHAROMYCES BOULARDII 500 mg
OTC
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-01-05
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BIOFLOR FORTE 500MG POWDER FOR ORAL SUSPENSION IN SACHET _SACCHAROMYCES BOULARDII_ CNCM I-745 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or your pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 2 days. WHAT IS IN THIS LEAFLET 1. What BIOFLOR FORTE 500mg powder for oral suspension in sachet is and what it is used for 2. What you need to know before you take BIOFLOR FORTE 500mg powder for oral suspension in sachet 3. How to take BIOFLOR FORTE 500mg powder for oral suspension in sachet 4. Possible side effects 5. How to store BIOFLOR FORTE 500mg powder for oral suspension in sachet 6. Contents of the pack and other information 1. WHAT BIOFLOR FORTE 500MG POWDER FOR ORAL SUSPENSION IN SACHET IS AND WHAT IT IS USED FOR Pharmacotherapeutic group: Anti-diarrhea. Replacement flora. (A: Digestive system and metabolism). Therapeutic indications: • Treatment of acute infectious diarrhoea of adults and children. • Prevention and treatment of antibiotic-associated colitis and diarrhoea. • Addition to vancomycin/metronidazole-treatment to prevent recurrence of _Clostridium difficile_ diseases. • Prevention of tube-feeding associated diarrhoea. • Treatment of irritable bowel syndrome. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BIOFLOR FORTE 500MG POWDER FOR ORAL SUSPENSION IN SACHET DO NOT TAKE BIOFLOR FORTE 500MG POWDER FOR ORAL SUSPENSION IN SACHET: - If you are allergic to _Saccharomyces boulardii_ CNCM I-745 or any of the other ingredients of this medicine (listed in section 6). - If you have a cent Прочитать полный документ
- 1 - SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BIOFLOR FORTE 500MG, POWDER FOR ORAL SUSPENSION IN SACHET. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Saccharomyces boulardii_ CNCM I-745 ............................................................................ 500.00mg (lyophilized cells of _Saccharomyces boulardii _CNCM I-745) Excipients with known effect: lactose, fructose, sorbitol (contained in tutti frutti aroma) For the full list of excipients: see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral suspension in sachet. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS - Treatment of acute infectious (viral or bacterial) diarrhea. - Preventive and curative treatment of antibiotic-associated diarrhea and colitis. - Preventive treatment of recurrence of _Clostridium _ _difficile_ disease in addition to vancomycin/metronidazole. - Preventive treatment of tube-feeding associated diarrhea. - Treatment of irritable bowel syndrome. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY _ 1 or 2 sachets daily. _METHOD OF ADMINISTRATION _ Oral route. Pour the contents of the sachet in a little water or sweetened beverage, mix, and drink. The powder can also be mixed with food or poured into a baby’s feeding-bottle. Due to a risk of airborne contamination, sachets should not be opened in patient rooms. Healthcare providers should wear gloves during handling of probiotics for administration, then promptly discard the gloves and properly wash their hands (see section 4.4). 4.3. CONTRA-INDICATIONS - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Patient with central venous catheter - Critically ill patients or immunocompromised patients due to a risk of fungaemia (see section 4.4). 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms persist for more than 2 days of treatment at usual posology, the therapeutic approach will be re- evaluated. The treatment does not replace rehydration when this is necessary. The rehydration dose and its Прочитать полный документ