Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Peppermint oil
Imbat Limited
A03A
Peppermint oil
0.2 millilitre(s)
Gastro-resistant capsule
Product not subject to medical prescription
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
Authorised
2009-03-06
_Page 1 of 2 _ PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER COLPERMIN ® IBS RELIEF CAPSULES (peppermint oil) 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 Colpermin carefully to get the best results from it. • 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 2 weeks. • If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please contact your doctor or pharmacist. IN THIS LEAFLET 1. WHAT COLPERMIN IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE COLPERMIN 3. HOW TO TAKE COLPERMIN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE COLPERMIN 6. FURTHER INFORMATION 1. WHAT COLPERMIN IS AND WHAT IT IS USED FOR Colpermin is an antispasmodic which is used to relieve the bloating, painful spasms and cramps which occur in the large bowel in Irritable Bowel Syndrome (IBS). The capsules contain peppermint oil, which relaxes the spasm of the bowel wall. This relieves pain and allows pockets of gas, which may have made you feel bloated, to pass along the bowel and out of the body. Irritable Bowel Syndrome is a condition in which there is pain, spasm and bloating at almost any point between the groin, the navel and the sides, sometimes accompanied by diarrhoea and constipation. The symptoms may be more noticeable when you are feeling stressed and anxious. 2. BEFORE YOU TAKE COLPERMIN This medicine is suitable for most people 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 • If you are allergic to peppermint oil, or any of the other ingredients of this medicine (listed in section 6). • If you are ALLERGIC TO PEANUTS OR SOYA. If any of these apply to you, GET ADVICE FROM YOUR DOCTOR OR PHARMACIST WITHOUT USING COLPERMIN. WARNINGS AND PRECAUTIONS Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Colpermin IBS Relief Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 0.2ml of Peppermint oil. Excipient: contains refined arachis oil (peanut oil). For a full list of excipients, see section see 6.1 3 PHARMACEUTICAL FORM Gastro-resistant capsules, hard _Product imported from the UK_ Enteric coated hard gelatin capsule coloured light blue/dark blue, with a blue band between cap and body, containing an oily mixture with an odour of peppermint. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of symptoms of discomfort and of abdominal colic and distension experienced by patients with irritable bowel syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS AND CHILDREN 15 YEARS AND OVER:_ One capsule three times a day, taken 30-60 minutes before food with a small quantity of water. The capsules should not be taken immediately after food. The dose may be increased to two capsules, three times a day when discomfort is more severe. _CHILDREN UNDER 15 YEARS:_ There is no experience of Colpermin Capsules in children under the age of 15 years. The capsules should be taken until symptoms resolve, usually within one or two weeks. At times when symptoms are more persistent, the capsules can be continued for longer periods of not longer than 2 to 3 months per course. 4.3 CONTRAINDICATIONS This product should not be used in patients who are hypersensitive to any of its ingredients, including menthol and arachis oil (peanut oil). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients who already suffer from heartburn, sometimes experience an exacerbation of these symptoms when taking the capsule. Treatment should be discontinued in these patients. The capsules should not be broken or chewed because this would release the peppermint oil prematurely, possible causing local irritation of the mouth and oesophagus. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Прочитать полный документ