Country: Մալթա
language: անգլերեն
source: Medicines Authority
LORATADINE
Galpharm Healthcare Limited Wrafton, Braunton, North Devon, EX33 2DL, United Kingdom
R06AX13
LORATADINE
TABLET
LORATADINE 10 milligram(s)
OTC
ANTIHISTAMINES FOR SYSTEMIC USE
Authorised
2012-11-27
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER LORATADINE GALPHARM, 10 MG TABLETS 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 after 3 days. WHAT IS IN THIS LEAFLET 1. WHAT LORATADINE GALPHARM IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORATADINE GALPHARM 3. HOW TO TAKE LORATADINE GALPHARM 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE LORATADINE GALPHARM 6. CONTENTS OF THE PACK AND OTHER INFORMATION. 1. WHAT LORATADINE GALPHARM IS AND WHAT IT IS USED FOR Loratadine Galpharm contain loratadine, which belongs to a group of drugs called antihistamines. These medicines help to relieve the symptoms of some allergies. Loratadine Galpharm is used to relieve: • symptoms of hayfever and other allergies such as sneezing, runny nose and burning, itchy eyes. • Symptoms of chronic urticaria of unknown origin (itching and redness) which is often known as hives or nettle rash. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORATADINE GALPHARM Loratadine Galpharm can be taken by adults, and children aged 2 years and over PROVIDED THEY WEIGH OVER 30 KG . Some people should not take this medicine or should talk to their pharmacist or doctor first. DO NOT TAKE LORATADINE GALPHARM: If you are allergic (hypersensitive) to loratadine or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your pharmacist or doctor before taking if you: • Have liver problems. You may need to take a lower dose. Page 2 of 4 OTHER MEDICINES AND LORATADINE GALPHARM read_full_document
1/13 _CMDh/305/2013 _ _July 2013 _ SUMMARY PUBLIC ASSESSMENT REPORT GENERICS LORATADINE GALPHARM 10MG TABLETS LORATADINE 10MG MT/H/0155/001/DC _ _ DATE: MARCH 2014 2/13 SUMMARY PUBLIC ASSESSMENT REPORT GENERICS Loratadine Galpharm 10mg tablets Active ingredient - Loratadine This is a summary of the public assessment report (PAR) for Loratadine Galpharm . It explains how Loratadine Galpharm was assessed and its authorisation recommended as well as its conditions of use. It is not intended to provide practical advice on how to use Loratadine Galpharm. For practical information about using Loratadine Galpharm. Patients should read the package leaflet or contact their doctor or pharmacist. WHAT IS LORATADINE GALPHARM.AND WHAT IS IT USED FOR? Loratadine Galpharm.is a ‘generic medicine’. This means that Loratadine Galpharm.is similar to a ‘reference medicine’ already authorised in the European Union (EU) called CLARITYN ALLERGY 10MG TABLETS HOW IS LORATADINE GALPHARM USED? The medicine can be obtained without a prescription. HOW DOES LORATADINE GALPHARM WORK? Loratadine Galpharm contains loratadine, which belongs to a group of drugs called antihistamines. These medicines help to relieve the symptoms of some allergies. Loratadine Galpharm is used to relieve: • symptoms of hayfever and other allergies such as sneezing, runny nose and burning, itchy eyes. • Symptoms of chronic urticaria of unknown origin (itching and redness) which is often known as hives or nettle rash. _ _ HOW HAS LORATADINE GALPHARM BEEN STUDIED? Because Loratadine Galpharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Clarityn Allergy 10mg tablets . Two medicines are bioequivalent when they produce the same levels of the active substance in the body. WHAT ARE THE BENEFITS AND RISKS OF LORATADINE GALPHARM? Because Loratadine Galpharm is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same read_full_document