Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
mebeverine hydrochloride
Alphapharm Pty Ltd
Registered
MEBEVERINE ALPHAPHARM _contains the active ingredient mebeverine hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about MEBEVERINE Alphapharm. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking MEBEVERINE Alphapharm against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. PLEASE READ THIS LEAFLET CAREFULLY AND KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT MEBEVERINE ALPHAPHARM IS USED FOR MEBEVERINE Alphapharm is used to relieve the symptoms of irritable bowel syndrome such as: • stomach cramps or pain • bowel spasms • diarrhoea, which may alternate with periods of constipation • flatulence (wind). MEBEVERINE Alphapharm contains the active ingredient mebeverine hydrochloride. It belongs to a group of medicines called antispasmodic agents. These medicines work by relaxing the muscles in the gut, thereby relieving the contractions or spasms. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY MEBEVERINE ALPHAPHARM HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed MEBEVERINE Alphapharm for another reason. MEBEVERINE Alphapharm is available only with a doctor's prescription. There is no evidence that MEBEVERINE Alphapharm is addictive. BEFORE YOU TAKE MEBEVERINE ALPHAPHARM _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE MEBEVERINE ALPHAPHARM IF YOU ARE ALLERGIC TO: • medicines containing mebeverine hydrochloride (eg. Colofac) • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching or hives; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; wheezing or shortness of breath. DO NOT TAKE MEBEVERINE ALPHAPHARM IF THE EXPIRY DATE (EXP) PRINTED ON THE PACK HAS PASSED. If you t Прочитајте комплетан документ
AUSTRALIAN PRODUCT INFORMATION MEBEVERINE ALPHAPHARM _mebeverine hydrochloride tablet _ 1 NAME OF THE MEDICINE . Mebeverine hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each MEBEVERINE Alphapharm tablet contains 135 mg of mebeverine hydrochloride as the active ingredient. Excipients with known effect: Contains lactose. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Oral. Tablets. MEBEVERINE Alphapharm: 135 mg tablet: white, film coated, marked "MV 135" on one side, and blank on the other 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MEBEVERINE Alphapharm tablets are indicated in the management of the irritable bowel syndrome (irritable colon, spastic colon, functional bowel disorders, spastic constipation, nervous diarrhoea). MEBEVERINE Alphapharm is used to treat the symptoms of this condition - ie. abdominal pain and cramps, persistent non- specific diarrhoea (with or without alternating constipation) and flatulence. 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended adult dose is 135 mg (1 tablet) three times daily, preferably taken before or with food. After a period of several weeks when the desired effect has been obtained, the dosage may be gradually reduced. 4.3 CONTRAINDICATIONS Hypersensitivity to any component of this product. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Although not reported, MEBEVERINE Alphapharm tablets should be used with caution in patients with the following conditions on the basis of potential clinical significance. PHARMACEUTICAL PRECAUTION. MEBEVERINE Alphapharm tablets contain lactose (100 mg/tablet) and consideration should be given to patients with a potential diagnosis of lactose intolerance simulating the irritable bowel syndrome. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. MEBEVERINE Alphapharm – AUSTRALIAN PRODUCT INFORMATION 2 CARDIAC DYSRHYTHMIA. In particular patients with partial or comp Прочитајте комплетан документ