البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Loperamide hydrochloride
McNeil Products Ltd
A07DA03
Loperamide hydrochloride
2mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01040200; GTIN: 3574661187709
TOP i i If your doctor has confi rmed that you have IRRITABLE BOWEL SYNDROME (IBS), this product can help you treat attacks of IBS diarrhoea associated with this condition. _See also _ _Section 2 _Extra Warnings for IBS patients. This medicine can also be used to treat short- term diarrhoea. The AGE LIMIT and TREATMENT PERIOD for this is different. _See Section 1 _ 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 have ever had a BAD REACTION to any of the ingredients. _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. See Section 3 NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. Keep the leafl et: you might need it again. 1 WHAT THE MEDICINE IS FOR IMODIUM ® IBS Relief 2 mg Soft Capsules is used to treat TWO TYPES OF DIARRHOEA. The two types have different age limits. 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. 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. 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. 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 ingred اقرأ الوثيقة كاملة
OBJECT 1 IMODIUM IBS RELIEF 2MG SOFT CAPSULES Summary of Product Characteristics Updated 09-Apr-2018 | McNeil Products Ltd 1. Name of the medicinal product Imodium IBS Relief 2 mg Capsules, soft 2. Qualitative and quantitative composition Each capsule contains 2 mg Loperamide hydrochloride. Excipient with known effect: Each capsule contains 115.31 mg Propylene Glycol which is equivalent to 0.65 mg/mg, also contains 0.06 micrograms of soya lecithin. For a full list of excipients, see Section 6.1. 3. Pharmaceutical form Capsule, soft (soft capsule). A clear blue oval soft gelatin capsule. 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 THE CAPSULES SHOULD BE SWALLOWED WHOLE WITH WATER. ACUTE DIARRHOEA Adults and children aged 12 years and over: 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). 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 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. 4.3 Contraindications This medicine is contraindicated: • in patie اقرأ الوثيقة كاملة