Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Loperamide hydrochloride
Janssen-Cilag Ltd
A07DA03
Loperamide hydrochloride
2mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01040200; GTIN: 5012674040256 5012674040348
FACE 1 NOW READ THIS WHOLE LEAFL ET CAREFULLY BEFORE YOU USE THIS MEDICINE. Keep the leafl et: you might need it again. 1 WHAT THE MEDICINE IS FOR IMODIUM ® Classic 2mg Capsules is used to treat TWO TYPES OF DIARRHOEA. The two types have diff erent 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 capsules 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. This medicine is used for two diff erent types of diarrhoea. They have DIFFERENT AGE LIMITS. _See Section 1_ c DO NOT TAKE THIS MEDICINE: There are some PEOPLE WHO SHOULD NOT USE this medicine. _To fi nd out if you are one of them, _ _see Section 2_ c If you have ever had a BAD REACTION to any of the ingredients. _For the list of ingredients, _ _see Section 6_ c SPEAK TO YOUR DOCTOR: If you suff er from any of the conditions mentioned in _Section 2_ c If you are taking any OTHER MEDICINES. _See Section 2_ c IF YOU HAVE IRRITABLE BOWEL SYNDROME (IBS) _see also Section 2_ Extra warnings for IBS patients c FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. _See Section 3_ c Always take this medicine exactly as described in this leafl et or as your doctor or pharmacist has told you. 2 BEFORE TAKING THIS MEDICINE 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 ag Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imodium Original 2mg Capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 2 mg Loperamide hydrochloride. Excipient with known effect: lactose For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard Opaque green cap and grey body, hard gelatin capsule imprinted with ‘Imodium’ on cap and ‘Janssen’ on body containing white powder. 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: 2 capsules (4 mg) initially followed by 1 capsule (2 mg) after every loose stool. The maximum daily dose should not exceed 6 capsules (12 mg). SYMPTOMATIC TREATMENT OF ACUTE EPISODES OF DIARRHOEA ASSOCIATED WITH IRRITABLE BOWEL SYNDROME IN ADULTS AGED 18 YEARS AND OVER Two capsules (4 mg) to be taken initially, followed by 1 capsule (2 mg) after every loose stool, or as previously advised by your doctor. The maximum daily dose should not exceed 6 capsules (12 mg). _Paediatric population_ Imodium 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, Imodium 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 capsules should be taken with liquid. 4.3 CONTRAINDICATIONS This medicine is contraindicated: • hypersensitivity to the active substance or to any of the excipients l Lees het volledige document