Loratadine Galpharm 10mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LORATADINE

Available from:

Galpharm Healthcare Limited Wrafton, Braunton, North Devon, EX33 2DL, United Kingdom

ATC code:

R06AX13

INN (International Name):

LORATADINE

Pharmaceutical form:

TABLET

Composition:

LORATADINE 10 milligram(s)

Prescription type:

OTC

Therapeutic area:

ANTIHISTAMINES FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2012-11-27

Patient Information leaflet

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

Summary of Product characteristics

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