Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
Mebeverine hydrochloride; Ispaghula husks
Reckitt Benckiser Ireland Ltd
A06AC; A06AC51
Mebeverine hydrochloride; Ispaghula husks
3.5 g/135 milligram(s)
Granules for oral suspension
Product not subject to medical prescription
Bulk-forming laxatives; ispaghula, combinations
Marketed
1986-03-14
PACKAGE LEAFLET: INFORMATION FOR THE USER FYBOGEL MEBEVERINE GRANULES FOR ORAL SUSPENSION ISPAGHULA HUSK 3.5G MEBEVERINE HYDROCHLORIDE 135MG READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve. 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. IN THIS LEAFLET: 1. What Fybogel Mebeverine is and what it is used for 2. What you need to know before you take Fybogel Mebeverine 3. How to take Fybogel Mebeverine 4. Possible side effects 5. How to store Fybogel Mebeverine 6. Contents of the pack and other information 1.WHAT FYBOGEL MEBEVERINE IS AND WHAT IT IS USED FOR Fybogel Mebeverine contains ispaghula husk, which is a natural plant material which is high in fibre. Ispaghula husk increases fibre in your diet helping your digestive system work more efficiently and gently relieve constipation in a natural way helping to restore and maintain regularity. Mebeverine is an antispasmodic drug which relieves spasms and cramps, which occur in the gut causing pain. This product is used to relieve symptoms of irritable bowel syndrome. If you have irritable bowel syndrome, you are likely to suffer from painful spasms of the gut and irregular bowel habits. Fybogel Mebeverine is effective in relaxing the spasms of the gut, relieving pain. At the same time Fybogel Mebeverine will help you to restore and maintain bowel regularity. 2.WHAT YOU NEED TO KNOW BEFORE YOU USE FYBOGEL MEBEVERINE DO NOT TAKE FYBOGEL MEBEVERINE IF YOU are suffering from a BLOCKAGE OF THE BOWEL (intestinal obstruction or faecal impaction) have MUSCLE WEAKNESS OF THE BOWEL WALL (colonic atony) are ALLERGIC to ispaghula husk or mebeverine (See section 2“Warnings and precautions) or any of the other ingredients of this medicine (see section 6) have chronic c Կարդացեք ամբողջական փաստաթուղթը
Health Products Regulatory Authority 14 March 2023 CRN00CPMY Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fybogel Mebeverine Granules for Oral Suspension Ispaghula Husk 3.5g Mebeverine Hydrochloride 135mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains: ACTIVE INGREDIENT G/SACHET Ispaghula husk Mebeverine hydrochloride 3.5 0.135 Excipient(s) with known effect: Aspartame: 16 mg per sachet Sodium: 58.65 mg (2.55 mmol) per sachet Total maximum daily dose (MDD) is 176.0mg (7.65mmol) Potassium: 97.6 mg (2.5 mmol) per sachet For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Granules for oral suspension in a unit dose sachet Buff-coloured granules and orange-coloured spheroids. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of irritable bowel syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children over 12: One sachet morning and evening, taken half an hour before meals. A third dose may be taken before the midday meal if necessary. ELDERLY: There is no indication that the dose needs to be modified for the elderly. Children below 12: The product is not recommended in children under 12 years of age (see Section 4.4). The product is intended for oral administration as a suspension in water (See section 4.4 Special Warnings and Precautions for Use). The product should be stirred into a glass of cold water (approx. 240 mls) and taken immediately. The doctor should be consulted if you develop new symptoms, or if your symptoms worsen, or if symptoms do not improve after 2 weeks treatment (See section 4.4). The product should be taken during the day at least ½ to 1 hour before or after intake of other medicines and the product should not be taken immediately before going to sleep. Effects may take several hours. When preparing the product for administration, it is important to try to avoid inhaling any of the powder in order to minimize the risk of sensitisation to the active ingredient. Health Products Regulatory Auth Կարդացեք ամբողջական փաստաթուղթը