Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Diosmectite
IMEKS PHARMA SDN. BHD.
Diosmectite
20 ml
DAEWON PHARM CO LTD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ FOTAGEL SUSPENSION 3G/20ML Dioctahedral smectite (3g/20ml) _ _ 1 WHAT IS IN THIS LEAFLET 1. What Fotagel is used for 2. How Fotagel works 3. Before you use Fotagel 4. How to use Fotagel 5. While you are using it 6. Side Effects 7. Storage and Disposal of Fotagel 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT FOTAGEL IS USED FOR Fotagel is used for: • Acute and chronic diarrhoea. • Pain related to inflammation in digestive system including oesophagitis and colic disease. HOW FOTAGEL WORKS Diosmectite works by binding toxin, bacteria and viruses and reinforces the intestinal mucus barrier to shorten duration and reduces frequency of diarrhoea in children and adults. Diosmectite is not absorbed and it is eliminated through the faeces. BEFORE YOU USE FOTAGEL _ _ - _When you must not use it_ • In infants and children below 2 years old. • When constipation is worsened. • If you are hypersensitive to diosmectite or any other excipients of Fotagel. - _Before you start to use it _ Tell your doctor if you: • Are taking any other medicine at the same time. • Are pregnant or breastfeeding. _If you are not sure whether you should start _ _taking this product, consult your doctor. _ - _Taking other medicines _ Inform your doctor or pharmacist if you are taking or if you have recently taken any other medicines, including medicines obtained without a prescription such as supplements or traditional medicines. The absorbent properties of Fotagel may affect the efficacy of other medicines. It is recommended not to take any other medicines at the same time. _Pregnancy and lactation_ Fotagel is not recommended to be used during pregnancy or breastfeeding. HOW TO USE FOTAGEL Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. - _How much to use_ _TREATMENT OF ACUTE DIARRHOEA: _ In children >2 years old: 4 pouches a day for 3 days, then 2 pou Läs hela dokumentet
디자인 사양(시방서) 제품명 포타겔 설명서-말레이시아 (진천) 작성자/ 신규 작성일 이규왕 / 2022.07.18 규격(장폭고)(mm) 120 x 230 (mm) 개정번호/개정일자 V.0000 / 2022.07.18 컬러 단면 1도 먹 개정내용 신규 재질/용지/원단 (단위) 모조지 70g 코팅/ 후가공 - 특이사항 코드번호 : 0099 [COMPOSITION] Each 20mL pouch contains 3g of dioctahedral smectite. Other ingredients : D-sorbitol solution, Concentrated glycerin, Melon Flavor SJ-AD (1501025), Vanilla flavor #V-21011, Potassium dihydrogen phosphate, Xanthan Gum, Purified water Preservatives : · Methylparaben ................................... 0.001 % w/v · Propylparaben .................................... 0.009 % w/v [DESCRIPTION] Vanilla and melon-flavored light-brown suspension contained in a Al-foil pouch. [PHARMACODYNAMICS] Diosmectite (dioctahedral smectite) is a natural aluminomagnesium silicate taking the form of layers of fine sheet. It possesses a powerful coating property on the gastrointestinal mucosa due to its leaflet structure and its high plastic viscosity. Diosmectite increases the resistance of the mucosal gel in response to aggressive agents, by interacting with glycoproteins of mucus. Due to its action on the gastrointestinal mucous barrier and its high- binding capacity, diosmectite protects the gastrointestinal mucosa. It is radiolucent and does not colour the stools. At usual doses, does not modify the physiological intestinal transit time. [PHARMACOKINETICS] Diosmectite is not absorbed and it is eliminated through the faeces. [INDICATIONS] · Acute and chronic diarrhoea. · Symptomatic treatment of pain associated with oesogastroduodenal and colic disease. [RECOMMENDED DOSAGE] Treatment of Acute Diarrhoea Children : · 2 year and older: 4 pouches a day for 3 days, then 2 pouches per day (up to total maximum of 7 days) Adults : · An average of 3 pouches per day. In practice the daily dosage can be doubled at the beginning of the treatment. Other Indications : Childre Läs hela dokumentet