Cetirizine Fair-Med 10mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CETIRIZINE HYDROCHLORIDE

Available from:

FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany

ATC code:

R06AE07

INN (International Name):

CETIRIZINE HYDROCHLORIDE 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CETIRIZINE HYDROCHLORIDE 10 mg

Prescription type:

OTC

Therapeutic area:

ANTIHISTAMINES FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2013-09-13

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
CETIRIZINE FAIR-MED 10 MG FILM-COATED TABLETS
Cetirizine dihydrochloride
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, pharmacist or nurse
have 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
-
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 Cetirizine Fair-Med is and what it is used for
2. What you need to know before you take Cetirizine Fair-Med
3. How to take Cetirizine Fair-Med
4. Possible side effects
5. How to store Cetirizine Fair-Med
6. Contents of the pack and other information
1. WHAT CETIRIZINE FAIR-MED IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Cetirizine
Fair-Med. Cetirizine Fair-Med is an
antiallergic medication (antihistamine).
In adults and children aged 6 year and above, Cetirizine Fair-Med is
indicated
- for the relief of nasal and ocular symptoms of seasonal and
perennial allergic rhinitis.
- for the relief of chronic nettle rash (chronic idiopathic
urticaria).
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINE FAIR-MED
DO NOT TAKE CETIRIZINE FAIR-MED
-
if you are allergic to cetirizine or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are allergic to hydroxyzine or to piperazine derivatives
(closely related active
substances of other medicines).
-
if you have serious kidney problems
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Cetirizine
Fair-Med if;

you have kidney problems. You may need to t

Summary of Product characteristics

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Cetirizine Fair-Med 10 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 10 mg cetirizine dihydrochloride
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Film-coated tablets
White to off white, oval, rectangular film-coated tablets with
‘10’ on one side and break line on
other side.
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adults and children 6 years and above:
- Cetirizine is indicated for the relief of nasal and ocular symptoms
of seasonal and perennial
allergic rhinitis.
- Cetirizine is indicated for the relief of symptoms of chronic
idiopathic urticaria.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents over 12 years of age:_
10 mg once daily (1 tablet).
_Paediatric population _
_Children aged from 6 to 12 years:_
5 mg twice daily (a half tablet twice daily).
The safety and efficacy of cetirizine in children under the age of 6
years have not been established.
_Older people:_ Data do not suggest that the dose needs to be reduced
in elderly subjects provided
that the renal function is normal.
_Patients _
_with _
_moderate _
_to _
_severe _
_renal _
_impairment:_
There
are
no
data
to
document
the
efficacy/safety ration in patients with renal impairment. Since
cetirizine is mainly excreted via renal
route (see section 5.2), in cases no alternative treatment can be
used, the dosing intervals must be
Page 2 of 9
individualized according to renal function. Refer to the following
table and adjust the dose as
indicated. To use this dosing table, an estimate of the patient’s
creatinine clearance (CL
cr
) in ml/min
is needed. The CL
cr
(ml/min) may be estimated from serum creatinine (mg/dl) determination
using
the following formula:
CL
cr
=
[140-age (years)] x weight (_kg_) (x 0.85 for women)
72 x serum creatinine (_mg/dl_)
Dosing adjustments for adult patients with impaired renal f