Loratadine Chefaro 10mg Tablets

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Verfügbar ab:

Chefaro Ireland DAC The Sharp Building, Hogan Place, Dublin 2,, Ireland

ATC-Code:

R06AX13

INN (Internationale Bezeichnung):

LORATADINE 10 mg

Darreichungsform:

TABLET

Zusammensetzung:

LORATADINE 10 mg

Verschreibungstyp:

OTC

Therapiebereich:

ANTIHISTAMINES FOR SYSTEMIC USE

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2012-11-27

Gebrauchsinformation

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
LORATADINE CHEFARO, 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 CHEFARO IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORATADINE CHEFARO
3.
HOW TO TAKE LORATADINE CHEFARO
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE LORATADINE CHEFARO
6.
CONTENTS OF THE PACK AND OTHER INFORMATION.
1.
WHAT LORATADINE CHEFARO IS AND WHAT IT IS USED FOR
Loratadine Chefaro contain loratadine, which belongs to a group of
drugs called antihistamines. These
medicines help to relieve the symptoms of some allergies.
Loratadine Chefaro 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 CHEFARO
Loratadine Chefaro 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.
Suitable for people with coeliac disease.
DO NOT TAKE LORATADINE CHEFARO:
•
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 ME

Fachinformation

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Loratadine Chefaro, 10 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of loratadine.
Excipients with known effect:
The quantity of lactose monohydrate in the loratadine 10 mg tablet
composition is 62.50 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, oval tablets, scored on one side and plain on the other side,
debossed “L” on one side of the
scoreline and “10” on the other side of the scoreline.
The score line is not intended for breaking the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Loratadine tablets are indicated for the symptomatic treatment of
allergic rhinitis and chronic idiopathic
urticaria.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults and children 12 years of age and over: _
10mg daily (one tablet once daily).
The tablets may be taken without regard to mealtime.
_Children aged 2 to under 12 years with:_
Body weight more than 30 kg: 10mg daily (one tablet once daily).
Body weight 30 kg or less: The 10mg strength tablet is not appropriate
in children with a body weight
less than 30 kg.
Page 2 of 6
Efficacy and safety of Loratadine tablets in children under 2 years of
age have not been established.
Patients with severe liver impairment should be administered a lower
initial dose because they may
have reduced clearance of loratadine. An initial dose of one tablet
every other day is recommended for
adults and children weighing more than 30 kg.
No dosage adjustments are required in the elderly or in patients with
renal insufficiency.
Suitable for people with coeliac disease.
4.3
CONTRAINDICATIONS
Loratadine tablets are contraindicated in patients who are
hypersensitive to loratadine or to any of the
excipients listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Loratadine should be administered with caution in the treatment of
patients with severe liver impairment
(see Section 5.2).
This medicinal product conta