Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Loperamide hydrochloride
Janssen-Cilag Ltd
A07DA03
Loperamide hydrochloride
200microgram/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01040200; GTIN: 5012674040485
- 1 - PACKAGE LEAFLET: INFORMATION FOR THE USER IMODIUM ® 1 MG/5 ML ORAL SOLUTION Loperamide hydrochloride Imodium is a registered trademark READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. 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 Imodium oral solution is and what it is used for 2 What you need to know before you use Imodium oral solution 3 How to use Imodium oral solution 4 Possible side effects 5 How to store Imodium oral solution 6 Contents of the pack and other information 1 WHAT IMODIUM ORAL SOLUTION IS AND WHAT IT IS USED FOR The name of your medicine is Imodium 1mg/5ml oral solution. It is called Imodium oral solution in this leaflet. WHAT IMODIUM ORAL SOLUTION IS USED FOR Imodium oral solution is used: • To treat sudden short-lived (acute) attacks of diarrhoea in adults and children over 4 years of age • To treat long-lasting (chronic) diarrhoea in adults If your child is using Imodium oral solution, the ‘you’ stated everywhere below should be read as ‘your child’. HOW IMODIUM ORAL SOLUTION WORKS Imodium oral solution contains a medicine called loperamide hydrochloride. It belongs to a group of medicines which helps reduce diarrhoea by slowing down an overactive bowel. It also helps the body to absorb more water and salts from the bowel. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE IMODIUM ORAL SOLUTION DO NOT USE IMODIUM ORAL SOLUTION: • If you are allergic to anything in Imodium oral solution (listed in section 6 below) - 2 - • If you have severe diarrhoea after taking antibiotics • If you are having a flare up of ul Lire le document complet
OBJECT 1 IMODIUM 1 MG/5 ML ORAL SOLUTION Summary of Product Characteristics Updated 05-Apr-2018 | Janssen-Cilag Ltd 1. Name of the medicinal product Imodium 1 mg/5 ml oral solution 2. Qualitative and quantitative composition Each 5 ml of oral solution contains 1 mg loperamide hydrochloride. Excipients with known effect: Each 5 ml of oral solution contains 3.78g of Glycerol 0.365 mg of Ethanol 3.6 mg of Methyl parahydroxybenzoate (E218) 0.4 mg of Propyl parahydroxybenzoate (E216) 0. 5 mg Cochineal Red A (E124) 4.85 mg Sodium For the full list of excipients, see section 6.1 3. Pharmaceutical form Oral solution for oral administration. A clear, red, slightly viscous fruit-flavoured oral solution. 4. Clinical particulars 4.1 Therapeutic indications For the symptomatic treatment of acute diarrhoea of any aetiology including acute exacerbations of chronic diarrhoea for periods of up to 5 days in adults and children over 4 years. For the symptomatic treatment of chronic diarrhoea in adults. 4.2 Posology and method of administration Acute diarrhoea Adults: Four 5 ml doses initially, followed by two 5 ml doses after each loose stool. The total daily dose should not exceed sixteen 5 ml doses. Children: The following doses should not be exceeded. Children over 8 years: Two 5 ml doses four times daily with the duration limited to 5 days. Children 4 - 8 years: One 5 ml dose three or four times daily with the duration limited to 3 days. Not recommended for children under 4 years of age. There is limited data available regarding use in children below 12 years of age. Please refer to Section 4.8 Undesirable effects. Further investigation into the cause of the diarrhoea should be considered if there is no improvement within two days of starting treatment with Imodium. Chronic diarrhoea Adults: Patients may need widely differing amounts of Imodium. The starting dose should be between four and eight 5 ml doses per day in divided doses, depending on severity. If required this dose can be adjusted up to a maximum of sixteen 5 ml dose Lire le document complet