Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Loperamide hydrochloride
Morningside Healthcare Ltd
A07DA03
Loperamide hydrochloride
2mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01040200; GTIN: 5055132712180
• This medicine is used for two different types of diarrhoea. They have different age limits._ See Section 1._ • Do not take this medicine: o There are some people who should not use this medicine. _To find out if you are one of then,_ _see section 2._ o If you have ever had a bad reaction to any of the ingredients. For the list of ingredients, see Section 6. • Speak to your doctor: o If you suffer from any of the conditions mentioned in Section 2. o If you are taking any other medicines. See Section 2. • If you have Irritable Bowel Syndrome (IBS) _See also Section 2_ Extra warnings for IBS patients. • Follow the dosage instructions carefully. See Section 3. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again. 1. WHAT LOPERAMIDE TABLETS ARE FOR Loperamide 2mg Tablets are used to treat two types of diarrhoea. The two types have different age limits. Short-term diarrhoea • For adults and children aged 12 and over. • To treat attacks that last up to 48 hours. • If your attack lasts longer than 48 hours, talk to your doctor. IBS diarrhoea • For adults and young people aged 18 and over who have been diagnosed with IBS (Irritable Bowel Syndrome). • To treat attacks that last up to 48 hours. • You can use this medicine for up to 2 weeks for repeated attacks, but if any one attack lasts continuously for longer than 48 hours, talk to your doctor. The tablets contain_ loperamide_ _hydrochloride_, a substance that helps reduce diarrhoea by slowing down an overactive bowel. This allows water and salts that are usually lost in diarrhoea to be absorbed by the body. 2. BEFORE YOU TAKE LOPERAMIDE TABLETS Warnings for everyone This medicine is suitable for most people, but a few people should not use it: Do not take this medicine: • If you have ever had a bad reaction to any of the ingredients. • If it is for a child aged under 12 (or under Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Loperamide 2mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2mg loperamide hydrochloride. Excipients with known effect: each tablet contains 100mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Light green coloured capsule shaped, biconvex uncoated tablets, plain on one side and score line on other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 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 in adults aged 18 years and over following initial diagnosis by a doctor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY: ACUTE DIARRHOEA Adults and children over 12: Two tablets (4 mg) initially, followed by one tablet (2 mg) after each loose stool. The usual dose is 3-4 tablets (6 mg – 8 mg) a day. The total daily dose should not exceed 6 tablets (12 mg). SYMPTOMATIC TREATMENT OF ACUTE EPISODES OF DIARRHOEA ASSOCIATED WITH IRRITABLE BOWEL SYNDROME IN ADULTS AGED 18 YEARS AND OVER Two tablets (4 mg) to be taken initially, followed by 1 tablet (2 mg) after every loose stool, or as previously advised by your doctor. The maximum daily dose should not exceed 6 tablets (12 mg). _Paediatric population_ Lopramide is contraindicated in children less than 12 years of age. _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, Lopramide should be used with caution in such patients because of reduced first pass metabolism. (see 4.4 Special warnings and special precautions for use). Method of administration Oral use. The tablets should be Przeczytaj cały dokument