Država: Malta
Jezik: engleski
Izvor: Medicines Authority
METOCLOPRAMIDE HYDROCHLORIDE
Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta
A03FA01
METOCLOPRAMIDE HYDROCHLORIDE 10.5 mg
TABLET
METOCLOPRAMIDE HYDROCHLORIDE 10.5 mg
POM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
Authorised
2019-08-30
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT METOCLOPRAMIDE 10MG TABLETS metoclopramide 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. The name of your medicine is Metoclopramide 10mg Tablets but will be referred to as ‘Metoclopramide Tablets’ throughout this leaflet. WHAT IS IN THIS LEAFLET 1. What Metoclopramide Tablets are and what they are used for 2. What you need to know before you take Metoclopramide Tablets 3. How to take Metoclopramide Tablets 4. Possible side effects 5. How to store Metoclopramide Tablets 6. Contents of the pack and other information 1. WHAT METOCLOPRAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR Metoclopramide Tablets are an antiemetic. They contain a medicine called "metoclopramide" . It works on a part of your brain that prevents you from feeling sick (nausea) or being sick (vomiting). Adults Metoclopramide Tablets are used in adults: • to prevent delayed nausea and vomiting that may occur after chemotherapy • to prevent nausea and vomiting caused by radiotherapy • to treat nausea and vomiting including nausea and vomiting which may occur with a migraine. Metoclopramide can be taken with oral painkillers in case of migraine to help painkillers work more effectively. Children and adolescents Metoclopramide Tablets are used in children (aged 1-18 years) if other treatment does not work or cannot be used to prevent delayed nausea and vomiting that may occur after chemotherapy . 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METOCLOPRAMIDE TABLETS DO NOT TAKE THESE TABLETS Pročitajte cijeli dokument
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Metoclopramide 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains metoclopramide hydrochloride 10.50 mg equivalent to 10mg of the anhydrous substance. Excipients with known effect: lactose and sodium. Each tablet contains 80 mg lactose and 5 mg of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White, normal convex tablets, engraved with the company logo on one side and scored on the other, engraved with “A” above and “306” below the score. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Metoclopramide is indicated in adults for: Prevention of delayed chemotherapy induced nausea and vomiting (CINV). Prevention of radiotherapy induced nausea and vomiting (RINV). Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting. Metoclopramide can be used in combination with oral analgesics to improve the absorption of analgesics in acute migraine. Metoclopramide is indicated in children (aged 1 to 18 years) for: Prevention of delayed chemotherapy induced nausea and vomiting (CINV) as a second line option. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adult The recommended single dose is 10 mg, repeated up to three times daily. The maximum recommended daily dose is 30 mg or 0.5mg/kg body weight. The maximum recommended treatment duration is 5 days. _ _ _ _ _ _ Page 2 of 9 _Special populations _ _Elderly_ In elderly patients a dose reduction should be considered, based on renal and hepatic function and overall frailty. _Renal impairment_ In patients with end stage renal disease (Creatinine clearance ≤ 15 mL/min), the daily dose should be reduced by 75%. In patients with moderate to severe renal impairment (Creatinine clearance 15-60 mL/min), the dose should be reduced by 50% (see section 5.2). _Hepatic impairment_ In patients with severe hepatic impairment, the dose should be reduced by 50% (see section 5.2). Other pharmaceutical Pročitajte cijeli dokument