Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Loperamide hydrochloride
JNTL Consumer Health I (Ireland) Limited
A07DA; A07DA03
Loperamide hydrochloride
Capsule, hard
Antipropulsives; loperamide
Marketed
1977-04-14
® 2 mg Capsules Loperamide Hydrochloride – 1 – READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. ■ IMODIUM ® 2mg Capsules is used to treat sudden, shortlived (acute) attacks of diarrhoea in adults and children 4 years and over and long-lasting (chronic) diarrhoea in adults. ■ DO NOT TAKE THIS MEDICINE: ■ There are some people who should not use this medicine. _To find out if you are one of _ _them. See Section 2 _ _▶_ ■ If you are allergic to loperamide or any of the other ingredients of this medicine. _For _ _the list of ingredients. See Section 6 _ ▶ ■ SPEAK TO YOUR DOCTOR: ■ If you suffer from any of the conditions mentioned in _Section 2 _ _▶_ ■ If you are taking any OTHER MEDICINES. _See _ _Section 2 _ _▶_ ■ FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. These are shown in the dosage table. _See _ _Section 3 _ _▶_ NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. ■ Keep this leaflet. You may need to read it again. ■ If you have any further questions, ask your doctor, pharmacist or nurse. ■ 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. _See Section 4 _ _▶_ WHAT IS IN THIS LEAFLET 1. What IMODIUM ® 2mg Capsules are, and what they are used for. 2. What you need to know before you take IMODIUM ® 2mg Capsules. 3. How to take IMODIUM ® 2mg Capsules. 4. Possible side effects. 5. How to store IMODIUM ® 2mg Capsules. 6. Contents of the pack and other information. 1 WHAT IMODIUM 2MG CAPSULES ARE AND WHAT THEY ARE USED FOR IMODIUM ® 2mg Capsules is used to treat sudden, shortlived (acute) attacks of diarrhoea in adults and children 4 years and over and long-lasting (chronic) diarrhoea in adults, such as diarrhoea associated with Crohn's disease Read the complete document
Health Products Regulatory Authority 01 March 2024 CRN00F4T9 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imodium 2 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 2 mg of loperamide hydrochloride. Excipient with known effect - Each capsule contains 127 mg lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. (capsule) Gelatin capsules with an opaque green cap and an opaque dark grey body, containing white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults As an adjunct in the management of acute diarrhoea, together with appropriate fluid and electrolyte replacement. In the symptomatic control of diarrhoea associated with chronic inflammatory bowel disease, eg., Crohn’s disease and ulcerative colitis, as an adjunct to specific measures such as corticosteroids and sulphasalazine. Use in these conditions should be under specialist supervision. In the adjunctive short-term, control of post-surgical diarrhoea, including ileostomy. Children For the occasional use in the control of intractable diarrhoea under specialist supervision. Since persistent diarrhoea can be an indicator of potentially serious conditions, the underlying cause must always be investigated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. The capsules should be taken with water. i) As an adjunct in the management of acute diarrhoea Adults and children 9-12 years 1 to 2 capsules (2 to 4 mg) is the usual initial dose, followed by 1 capsule (2 mg) three times daily. The maximum daily dose should not exceed 10 mg. Children 4-8 years A total maximum daily dose of 4 mg in divided doses (see 4.4 Special warnings and precautions for use). Health Products Regulatory Authority 01 March 2024 CRN00F4T9 Page 2 of 7 Under 4 years Not recommended. 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 phar Read the complete document