Land: Armenien
Språk: engelska
Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
alverine (alverine citrate), simethicone
Laboratoires Mayoly Spindler
A03AX58
alverine (alverine citrate), simethicone
60mg+ 300mg
capsules
(30/3x10/) in blister
OTC
Registered
2018-02-23
MS-EN-APH-0001 – SPC – METEOSPASMYL, soft capsule of 19/12/2012 Page 1 /3 SUMMARY OF PRODUCT CHARACTERISTICS 1) NAME OF THE MEDICINAL PRODUCT METEOSPASMYL, soft capsule 2) QUALITATIVE AND QUANTITATIVE COMPOSITION Alverine citrate .................................................................. 60.00 mg Simeticone ........................................................................ 300.00 mg For 1 soft capsule. For the full list of excipients, see section 6.1. 3) PHARMACEUTICAL FORM Soft capsule. 4) CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of functional bowel disorders, especially those with bloating. abdominal pain, belching, nausea, constipation, diarrhea .Before radiological , ultrasound or instrumental examinations of the abdominal cavity 4.2 POSOLOGY AND METHOD OF ADMINISTRATION FOR ADULTS ONLY. One soft capsule 2 to 3 times a day at the beginning of meals. In preparation for instrumental examinations of the abdominal cavity, 1 capsule 2-3 times the day before the examination , and 1 capsule in the morning on the day of the examination. 4.3 CONTRAINDICATIONS History of allergic reaction or intolerance to alverine or to any of the other ingredients. Children till 14 years 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Not applicable. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Not applicable. 4.6 PREGNANCY AND LACTATION PREGNANCY There are no available data regarding teratogenicity in animals. Clinically, no particular malformative or fetotoxic effect has been reported to date. However, follow-up of pregnancies exposed to this medicinal product is insufficient to exclude any risk. Consequently, for safety reasons, administration of this medicinal product should be avoided during pregnancy. Anatomical-clinical- chemical code (ATC) ATC Code A03 AX 58 MS-EN-APH-0001 – SPC – METEOSPASMYL, soft capsule of 19/12/2012 Page 2 /3 LACTATION This medicinal product should be avoided during breast-feeding, since there is no data on its excretion in Läs hela dokumentet