Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Loperamide hydrochloride
DE Pharmaceuticals
A07DA03
Loperamide hydrochloride
2mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01040200
PACKAGE LEAFLET: INFORMATION FOR THE USER LOPERAMIDE 2 MG HARD CAPSULES loperamide hydrochloride 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 Loperamide is and what it is used for 2. What you need to know before you take Loperamide 3. How to take Loperamide 4. Possible side effects 5. How to store Loperamide 6. Contents of the pack and other information 1. WHAT LOPERAMIDE IS AND WHAT IT IS USED FOR This medicine contains Loperamide which helps to stop diarrhoea by making the stools more solid and less frequent. This medicine is used for the treatment of sudden short-lived (acute) attacks of diarrhoea in adults and children over 12 years of age. PLEASE NOTE THAT THIS MEDICINE ONLY RELIEVES THE SYMPTOMS OF DIARRHOEA AND IT IS IMPORTANT TO DRINK SUFFICIENT FLUID TO REPLACE THE WATER LOST IN THE LOOSE STOOLS. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOPERAMIDE DO NOT TAKE LOPERAMIDE: - You are allergic to loperamide or to any of the other ingredients in this medicine (listed in section 6). - You suffer from colitis (inflammation of the colon) or any other inflammatory bowel disease, such as ulcerative colitis. - You have severe diarrhoea after taking antibiotics. - You have a swollen stomach or tummy, and/or constipation. - You are suffering from acute dysentery the symptoms of which may include blood in your stools and a high temperature. - if it is for a child aged below 12 If any of these apply to you, get advice from a doctor or pharmacist. WARNINGS AND PRECAUTIONS Talk to your doctor or phar Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Loperamide 2mg Capsules Numark Diarrhoea Relief 2 mg Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Loperamide Hydrochloride 2mg 3 PHARMACEUTICAL FORM Capsules, hard Green and grey hard capsules marked with ‘Max’ on the green cap and ‘Lop’ on the grey body. For a full list of excipients, see section 6.1. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic treatment of acute diarrhoea in adults and children aged 12 years and over. For the symptomatic treatment of acute episodes of diarrhoea associated with Irritable Bowel Syndrome (IBS) in adults aged 18 years and over following initial diagnosis by a doctor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The capsules should be taken with liquid. For oral administration. A) ACUTE DIARRHOEA Adults and children over 12 years of age Two capsules (4mg) initially followed by 1 capsule (2mg) after every loose stool (motion). The usual dose is 3-4 capsules (6mg – 8mg) a day. The total daily dose should not exceed 6 capsules (12mg). B) SYMPTOMATIC TREATMENT OF ACUTE EPISODES OF DIARRHOEA ASSOCIATED WITH IRRITABLE BOWEL SYNDROME IN ADULTS AGED 18 YEARS AND OVER. Two capsules (4mg) to be taken initially, followed by 1 capsule (2mg) after ever loose stool (motion), or as previously advised by your doctor. The maximum daily dose should not exceed 6 capsules (12mg). USE IN ELDERLY No dose adjustment is required for the elderly. RENAL IMPAIRMENT. No dose adjustment is required for patients with renal impairment. HEPATIC IMPAIRMENT. Although no pharmacokinetic data are available in patients with hepatic impairment, Loperamide Hydrochloride should be used with caution in such patients because of reduced first pass metabolism. (see 4.4 Special warnings and special precautions for use). 4.3 CONTRAINDICATIONS This medicine is contraindicated: • In patients with known hypersensitivity to Loperamide hydrochloride or to any of the excipients. • In children less than 12 years of age Đọc toàn bộ tài liệu