Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Loperamide Hydrochloride
Tenshi Kaizen B.V.
A07DA03
Loperamide Hydrochloride
Oral lyophilisate
loperamide
2022-03-11
1 PACKAGE LEAFLET: INFORMATION FOR THE USER [NATIONALLY COMPLETED NAME] loperamide hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 2 days. WHAT IS IN THIS LEAFLET 1. What [Nationally completed name]is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME]IS AND WHAT IT IS USED FOR This medicine contains loperamide hydrochloride 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 adolescents over 12 years of age. THIS MEDICINE MUST NOT BE USED FOR MORE THAN 2 DAYS WITHOUT MEDICAL ADVICE AND SURVEILLANCE. You must talk to a doctor if you do not feel better or if you feel worse after 2 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] DO NOT TAKE [NATIONALLY COMPLETED NAME], IF: - patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients (listed in section 6); - children aged less than 2 years of age - patients with acute dysentery, which is characterised by blood in stools and elevated body temperature. - patients with acute ulcerative colitis - patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella and Cam Preberite celoten dokument
Health Products Regulatory Authority 02 August 2022 CRN00CY30 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Loperamide hydrochloride 2 mg Oral Lyophilisate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Loperamide hydrochloride 2 mg equivalent to loperamide 1.85 mg per oral lyophilisate Excipients with known effect: 1.0 mg aspartame (E951) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM oral lyophilisate. White to off-white, round, tablets, debossed with T on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of acute diarrhoea in adults and adolescents aged 12 years and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ Two oral lyophilisates (4 mg) initially followed by 1 oral lyophilisate (2 mg) after every loose stool, not earlier than 1 hour after the initial dose. The usual dose is 3-4 oral lyophilisates (6 mg-8 mg) daily; the maximum daily dose should not exceed 6 oral lyophilisates (12 mg). _Adolescents aged 12 years and older _ One oral lyophilisate (2 mg) initially followed by 1 oral lyophilisate (2 mg) after every loose stool, not earlier than 1 hour after the initial dose. The maximum daily dose should not exceed 4 oral lyophilisates (8 mg). The maximum duration of treatment without consultation with a doctor is 2 days. _Children_ This medicinal product is not intended for children between 2 and 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, this medicine should be used with caution in such patients because of reduced first pass metabolism (see section 4.4). Method of administration: Health Products Regulatory Authority 02 August 2022 CRN00CY30 Page 2 of 7 The oral lyophilisate should be placed on your tongue, where it dissolves and can be swallowed with the saliva. No liquid inta Preberite celoten dokument