Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Loperamide hydrochloride; Simeticone
McNeil Products Ltd
Loperamide hydrochloride; Simeticone
2mg ; 125mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01040200; GTIN: 5027097909967 5027097376516
_PLUS _ CAPLETS_ _ _Loperamide hydrochloride & Simeticone_ PLEASE READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to take IMODIUM ® Plus Caplets carefully to get the best results. ■ Keep this leaflet. You may need to read it again. ■ Ask your pharmacist if you need more information or advice. ■ You must contact a doctor if your symptoms worsen or do not improve after two days. ■ If any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What the medicine is for. 2. Before taking this medicine. 3. How to take this medicine. 4. Possible side-effects. 5. Storing this medicine. 6. Further information. 1 WHAT THE MEDICINE IS FOR The caplets are used to treat a short-lived attack of diarrhoea when it occurs with stomach cramps, bloating and wind. The caplets contain loperamide hydrochloride, which helps reduce diarrhoea by slowing down an overactive bowel. It also helps the body to absorb more water and salts from the bowel. The caplets also contain simeticone, which breaks up the trapped wind in the bowel that causes cramps and bloating. This medicine is for use in adults and children aged 12 years and over. 2 BEFORE TAKING THIS MEDICINE This medicine is suitable for most adults and children aged 12 years and over, but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist. DO NOT TAKE THIS MEDICINE… ■ In children less THAN 12 YEARS OLD. ■ If you are allergic (hypersensitive) to loperamide hydrochloride, simeticone or any of the other ingredients of the caplets (see section 6). ■ If you have a HIGH TEMPERATURE (e.g. above 38° C) or BLOOD IN YOUR STOOLS. ■ If you are having a flare up of an INFLAMMATORY BOWEL condition like ULCERATIVE COLITIS. ■ If you have SEVERE DIARRHOEA after taking antibiotics. ■ If you are CONSTIPATED or your STOMACH APPEARS SWO Read the complete document
OBJECT 1 IMODIUM PLUS CAPLETS (P) Summary of Product Characteristics Updated 15-Jun-2017 | McNeil Products Ltd 1. Name of the medicinal product Imodium Plus Caplets 2. Qualitative and quantitative composition Each tablet contains loperamide hydrochloride 2 mg and simeticone equivalent to 125 mg dimeticone. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet, uncoated White, capsule-shaped tablets debossed with IMO on one side, the other side is debossed with a line between 2__and __125__. 4. Clinical particulars 4.1 Therapeutic indications Imodium Plus Caplets are indicated for the symptomatic treatment of acute diarrhoea in adults and adolescents over 12 years when acute diarrhoea is associated with gas-related abdominal discomfort including bloating, cramping or flatulence. 4.2 Posology and method of administration Posology _Adults over 18 years_ Take two caplets initially, followed by one caplet after every loose stool. Not more than 4 caplets should be taken in a day, limited to no more than 2 days. _Adolescents between 12 and 18 years_ Take one caplet initially, followed by one caplet after every loose stool. Not more than 4 caplets should be taken in a day, limited to no more than 2 days. _Paediatric population_ Imodium Plus is contraindicated in children under12 years (see section 4.3). _Use in the elderly_ No dosage adjustments are required for the elderly. _Use in renal impairment_ No dosage adjustment is necessary in patients with renal impairment. _Use in hepatic impairment_ Although no pharmacokinetic data are available in patients with hepatic insufficiency, Imodium Plus should be used with caution in such patients because of reduced first pass metabolism (see section 4.4). Method of administration Swallow the correct number of caplets whole with a drink of water. 4.3 Contraindications - Children less than 12 years of age - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 - Patients with acute dysentery, which is charact Read the complete document