Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
METRONIDAZOLE, SPIRAMYCIN
Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy
J01RA04
METRONIDAZOLE 125 mg SPIRAMYCIN 750000 IU
FILM-COATED TABLET
METRONIDAZOLE 125 mg SPIRAMYCIN 750000 IU
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2008-01-16
_ _ PACKAGE LEAFLET: INFORMATION FOR THE USER NAME OF THE MEDICINE RODOGYL FILM-COATED TABLETS SPIRAMYCIN, METRONIDAZOLE BOXED TEXT 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 Rodogyl film-coated tablets are and what they are used for 2. What you need to know before you take Rodogyl film-coated tablets 3. How to take Rodogyl film-coated tablets 4. Possible side effects 5. How to store Rodogyl film-coated tablets 6. Contents of the pack and other information 1. WHAT RODOGYL FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR PHARMACOTHERAPEUTIC GROUP: COMBINATIONS OF ANTIBACTERIALS, SPIRAMYCIN AND METRONIDAZOLE, ATC CODE: J01RA04. This medicine is a combination of two antibiotics, one belonging to the group of macrolides and the other belonging to the group of imidazoles. The active substances are spiramycin and metronidazole, respectively. This medicine is for use in adults and children to treat oral and dental infections such as certain tooth abscesses. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RODOGYL FILM-COATED TABLETS If your doctor has told you that you are intolerant to certain sugars, contact your doctor before taking this medicine. DO NOT TAKE RODOGYL FILM-COATED TABLETS: if you are allergic to spiramycin and/or metronidazole and/or other antibiotics in the imidazole group (the group of antibiotics that includes metronidazole) or any of the other ingredients of this medicine (listed in section 6). if the patient is a child under 6 years of age, as these are tablets. IF YOU ARE NOT SURE, YOU M Đọc toàn bộ tài liệu
_ _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT RODOGYL FILM-COATED TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Spiramycin ................................................................................................................................... 0.75 MIU Metronidazole ................................................................................................................................ 125 mg For one film-coated tablet. Excipient with known effect: 8 mg of sorbitol (E420) per tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Rodogyl film-coated tablets are indicated for the curative treatment of oral-dental infections such as dental abscesses in adults and children, after weighing the benefit/risk ratio of treatment with the fixed dose combination containing spiramycin-metronidazole and when another antibiotic treatment cannot be used (see sections 4.2, 4.4 and 5.1). The official recommendations on the proper use of antibacterial agents must be taken into account. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Adults _ • 4 to 6 tablets per day as 2 or 3 divided doses (i.e. 3 to 4.5 MIU of spiramycin and 500 to 750 mg of metronidazole). • In severe cases, the dosage may be increased to 8 tablets daily. _Pediatric population _ • From 6 to 10 years of age: 2 tablets daily (i.e. 1.5 MIU of spiramycin and 250 mg of metronidazole). • From 10 to 15 years of age: 3 tablets daily (i.e. 2.25 MIU of spiramycin and 375 mg of metronidazole). The optimal dose for this fixed-drug combination remains uncertain (see section 5.1). METHOD OF ADMINISTRATION Oral use. The tablets must be swallowed with a large glass of water. The tablets should be taken with meals. 4.3. CONTRAINDICATIONS • Hypersensitivity to spiramycin and/or metronidazole and/or any other antibiotic of the imidazole group or to any of the excipients listed in section 6.1. • Children under 6 years Đọc toàn bộ tài liệu