Cetirizine GP 10 mg film-coated tablets

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

CETIRIZINE DIHYDROCHLORIDE

Dostopno od:

GP - Genericos Portugueses Lda. Rua Henrique de Paiva Couceiro no 29, Venda Nova, 2700-451, Amadora, Portugal

Koda artikla:

R06AE07

INN (mednarodno ime):

CETIRIZINE DIHYDROCHLORIDE 10 mg

Farmacevtska oblika:

FILM-COATED TABLET

Sestava:

CETIRIZINE DIHYDROCHLORIDE 10 mg

Tip zastaranja:

OTC

Terapevtsko območje:

ANTIHISTAMINES FOR SYSTEMIC USE

Povzetek izdelek:

Licence number in the source country: NOT APPLICAPABLE

Status dovoljenje:

Authorised

Datum dovoljenje:

2021-04-13

Navodilo za uporabo

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Cetirizine GP
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 or pharmacist
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 or pharmacist. 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 GP
is and what it is used for
2. What you need to know before you take Cetirizine GP
3. How to take Cetirizine GP
4. Possible side effects
5. How to store Cetirizine GP
6. Contents of the pack and other information
1. WHAT
Cetirizine GP
IS AND WHAT IT IS USED FOR
Cetirizine GP
is an anti-allergic medicinal product.
Cetirizine dihydrochloride is the active ingredient of Cetirizine GP.
In adults and children with or over 6 years, Cetirizine GP
10 mg is indicated:
- for the relief of nasal and ocular symptoms of seasonal and
perennial allergic rhinitis;
- for the relief of chronic idiopathic urticaria.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINE GP
DO NOT TAKE CETIRIZINE GP:
- if you have a severe renal disease (severe renal failure with
creatinine clearance below 10
ml/min); - if you are allergic to cetirizine dihydrochloride, or to
any of the other ingredients of
this medicine (listed in section 6), to hydroxyzine or to piperazine
derivatives (closely related
active substances of other medicines).
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WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Cetirizine GP.
If you are a patient with renal insufficiency, please ask your doctor
for advice; if necessary, you
will take a lower dose. The new dose will be determined by your
doctor.
If you

Lastnosti izdelka

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Cetirizine GP 10 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg cetirizine dihydrochloride.
Excipients with known effect:
One film-coated tablet contains 65.30 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Film-coated tablets, white, oblong, scored on one side.
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
The film-coated tablets containing 10 mg of Cetirizine dihydrochloride
are indicated in adults
and paediatric patients aged 6 years or more:
- for the relief of nasal and ocular symptoms of seasonal and
perennial allergic rhinitis.
- for the relief of symptoms of chronic idiopathic urticaria.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
10 mg once daily (1 tablet).
ELDERLY
The data available does not suggest that the dose needs to be reduced,
in elderly subjects,
provided that the renal function is normal.
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PATIENTS WITH MODERATE TO SEVERE RENAL IMPAIRMENT
There are no data to document the efficacy/safety ratio 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 individualized
according to renal function.
Adjust the dose as indicated in the table below. To use this dosing
table, an estimate of the
patient’s creatinine clearance (CLcr), in ml/min, is needed. The
CLcr (ml/min) may be
estimated from serum creatinine (mg/dl) determination using the
following formula:
_[140 - age (years)] x weight (kg) _
CL
cr
=
⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯
_(x 0.85 for women) _
72
_ x serum creatinine (mg/dl) _
DOSING ADJUSTMENTS FOR ADULT PATIENTS WITH IMPAIRED RENAL FUNCTION
GROUP
CREATININE CLEARANCE
(ML/MIN.)
DOSAGE AND FREQUENCY
Normal

80
10 mg, once daily
Mild
50 - 79
10 mg, once daily
Moderate
30 - 49