国家: 马耳他
语言: 英文
来源: Medicines Authority
ISPAGHULA HUSKS
Boston Healthcare Limited Unit 6, Navigation Court, Calder Park, Wakefield, West Yorkshire WF2 7JB, United Kingdom
A06AC01
ISPAGHULA HUSKS 3.5 g
EFFERVESCENT GRANULES
ISPAGHULA HUSKS 3.5 g
OTC
DRUGS FOR CONSTIPATION
Withdrawn
2006-04-19
Package Leaflet: Information for the user ISPAGEL ORANGE ISPAGHULA HUSK GRANULES READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. • You must talk to a doctor if you do not feel better or if you feel worse. IN THIS LEAFLET: 1. What Ispagel Orange is and what it is used for 2. What you need to know before you take Ispagel Orange 3. How to take Ispagel Orange 4. Possible side effects 5. How to store Ispagel Orange 6. Contents of the pack and other information 1. WHAT ISPAGEL ORANGE IS AND WHAT IT IS USED FOR The name of your medicine is Ispagel Orange. It contains the active ingredient ispaghula husk in the form of granules which, when dispersed in water, make an orange flavoured drink. Ispaghula husk is a type of natural fibre that belongs to a group of medicines known as bulk-forming laxatives. It works by increasing the bulk of your stools so encouraging your bowels to move them through your digestive system and also helping to regulate their passage. Ispagel Orange is for the treatment of constipation and to help maintain normal bowel function in people with a colostomy or ileostomy, diarrhoea associated with diverticular disease, irritable bowel syndrome (IBS) or ulcerative colitis. It is also for use by people with haemorrhoids (piles) or anal fissures to make bowel movements more regular and easier to pass, and so avoid straining. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISPAGEL ORANGE DO NOT TAKE ISPAGEL ORANGE IF YOU: • are allergic (hypersensitive) to ispaghula husk or any of the other ingredients of Ispagel Orange (see 阅读完整的文件
Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ispagel Orange 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ispaghula Husk granules 3.5g For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Effervescent Granules for Oral Suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of constipation, for use in patients with colostomy, ileostomy, haemorroids, anal fissure, chronic diarrhoea associated with diverticular disease, irritable bowel syndrome, and as adunctants in ulcerative colitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION FOR CONSTIPATION. Adults: One sachet one to three times daily, mixed in at least 150 ml of liquid, followed by additional liquid. Children 6 – 12 years half the adult dose; children under 6 years consult a physician. Ispagel Orange should be taken with an adequate intake of fluid and not before bedtime. 4.3 CONTRAINDICATIONS Ispagel Orange should not be given to patients with intestinal obstruction or conditions likely to lead to this, abdominal pain, nausea or vomiting, colonic atony such as senile megacolon, difficulty in swallowing, faecal impaction, or known hypersensitivity to ispaghula. Patients suffering from phenylketonurea should not take this product. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms persist consult your doctor. Due to its aspartame content Ispagel Orange should not be given to patients with phenylketonuria. Ispaghula should not be given to patients with natural or drug induced failure of gut motility. Taking this product without adequate fluid may cause it to swell and block the throat or oesophagus and may cause choking. This product should not be taken if there is difficulty in swallowing. If chest pain, vomiting, or difficulty in swallowing or breathing is experienced 阅读完整的文件