Riik: Malta
keel: inglise
Allikas: Medicines Authority
ITOPRIDE
Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus
A03FA07
ITOPRIDE 50 mg
FILM-COATED TABLET
ITOPRIDE 50 mg
POM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
Authorised
2016-05-23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TOPRISAN, 50 MG FILM-COATED TABLETS Itopride hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Toprisan is and what it is used for 2. What you need to know before you take Toprisan 3. How to take Toprisan 4. Possible side effects 5. How to store Toprisan 6. Contents of the pack and other information 1. WHAT TOPRISAN IS AND WHAT IT IS USED FOR Toprisan belongs to a group of drugs called prokinetic agents. Prokinetic agents are drugs which normalise or enhance and accelerate bowel movement (motility). Their administration results in accelerated gastric emptying, accelerated rate of passage of digested food through the small intestine and increased tonus of the lower oesophageal sphincter. In addition Toprisan suppresses vomiting. Toprisan is indicated for the treatment of symptoms resulting from the slow gastric emptying, such as feeling of gastric fullness, upper abdominal pain, lack of appetite, heartburn, nausea and vomiting in gastrointestinal disorders, which are not caused by ulcer disease or organic disease affecting the rate of passage of digested food through the gastrointestinal tract. Toprisan is intended for adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPRISAN DO NOT TAKE TOPRISAN: -if you are allergic to itopride or any of the other ingredients of this medicine (listed in section 6) -if accelerated gastric emptying can be harmful for you, e.g. if you suffer from gastrointestinal bleeding, obstruction or perforation. Toprisan Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Toprisan, 50 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains itopride hydrochloride 50 mg. Excipient with known effect: lactose. Each film-coated tablet contains 58.7 mg of lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, round, biconvex, film- coated tablets with diameter 7mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Toprisan is indicated in adults as atreatment of gastrointestinal symptoms in functional, non-ulcer dyspepsia (chronic gastritis), such as: flatulence, gastric fullness, upper abdominal pain, anorexia, heartburn, nausea and vomiting. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ The recommended daily dose for adults is 150 mg daily, i.e. 1 tablet 3 times a day before meals. This dose may be reduced depending on the patient's age and symptoms (see section 4.4). _Elderly _ It was shown in clinical studies that the incidence of adverse effects in patients aged 65 years and older was not higher than in younger patients. Itopride should be administered in elderly patients with adequate precaution because of increased incidence of hepatic and renal function disorders, other diseases or treatment with additional drugs. _Paediatric population _ The safety and efficacy of itopride in paediatric population has not been established. _Patients with hepatic or renal impairment _ Itopride is metabolised in liver. Itopride and its metabolites are excreted mainly via kidneys. Patients with reduced hepatic or renal functions should be carefully monitored and in case of adverse reactions it is necessary to take appropriate measures, as e.g. to reduce the dosage or to discontinue the therapy. Duration of treatment The duration of administration of itopride during clinical studies was of maximum 8 weeks. If there is no improvement in gastrointestinal symptoms, Toprisan should not be used more Lugege kogu dokumenti