País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
METOCLOPRAMIDE HYDROCHLORIDE
Accord Healthcare Limited
A03FA01
METOCLOPRAMIDE HYDROCHLORIDE
10 Milligram
Tablets
Product subject to prescription which may not be renewed (A)
metoclopramide
Authorised
2016-03-11
PACKAGE LEAFLET: INFORMATION FOR THE USER METOCLOPRAMIDE HYDROCHLORIDE 10 MG 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. WHAT IS IN THIS LEAFLET 1. What Metoclopramide Hydrochloride tablets is and what it is used for 2. What you need to know before you take Metoclopramide Hydrochloride tablets 3. How to take Metoclopramide Hydrochloride tablets 4. Possible side effects 5. How to store Metoclopramide Hydrochloride tablets 6. Contents of the pack and other information 1. WHAT METOCLOPRAMIDE HYDROCHLORIDE TABLETS IS AND WHAT IT IS USED FOR Metoclopramide Hydrochlride is an antiemetic. It contains a medicine called “metoclopramide”. It works on a part of your brain that prevents you from feeling sick (nausea) or being sick (vomiting). Adult population: Metoclopramide Hydrochloride is 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. Paediatric population Metoclopramide Hydrochloride is indicated 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 HYDROCHLORIDE TABLETS DO NOT TAKE METOCLOPRAMIDE HYDROCHLORIDE TABLETS: Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Metoclopramide hydrochloride 10 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Metoclopramide Hydrochloride equivalent to 10 mg anhydrous Metoclopramide Hydrochloride Excipients: 101.24 mg lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off-white, round, biconvex tablets with the inscription ‘BD’ on one side and a scoreline on the other side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adult population 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. Paediatric population Metoclopramide is indicated in children (aged 1-18 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 population 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. Prevention of delayed chemotherapy induced nausea and vomiting (CINV) (paediatric patients aged 1-18 years) The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times daily by oral route. The maximum dose in 24 hours is 0.5 mg/kg body weight. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Llegiu el document complet