Cetirizine Aurobindo 10mg film-coated Tablets

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

CETIRIZINE HYDROCHLORIDE

可用日期:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC代码:

R06AE07

INN（国际名称）:

CETIRIZINE HYDROCHLORIDE 10 mg

药物剂型:

FILM-COATED TABLET

组成:

CETIRIZINE HYDROCHLORIDE 10 mg

处方类型:

POM

治疗领域:

ANTIHISTAMINES FOR SYSTEMIC USE

授权状态:

Authorised

授权日期:

2013-12-19

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
CETIRIZINE AUROBINDO 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 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.

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
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.
WHAT IS IN THIS LEAFLET
:
1.
What Cetirizine Aurobindo is and what it is used for
2.
What you need to know before you take Cetirizine Aurobindo
3.
How to take Cetirizine Aurobindo
4.
Possible side effects
5.
How to store Cetirizine Aurobindo
6.
Contents of the pack and other information
1.
WHAT CETIRIZINE AUROBINDO IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Cetirizine
Aurobindo.
Cetirizine Aurobindo is an antiallergic medication.
In adults and children aged 6 years and above, Cetirizine Aurobindo is
indicated
-
for the relief of nasal and ocular symptoms of seasonal and perennial
allergic rhinitis.
-
for the relief of urticaria.
2.
WHAT YOU NEED TO KNOW BEFO

产品特点

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1
of
9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cetirizine Aurobindo 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg cetirizine dihydrochloride.
Excipient with known effect: Each film-coated tablet contains 107.020
mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, film-coated, off-rectangular tablets, debossed
with "10" on one side and plain on
the other side. Score line between '1' and ‘0’. The tablet can be
divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In adults and paediatric patients 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
10 mg once daily (1 tablet).
Special population
Elderly: Data do not suggest that the dose needs to be reduced in
elderly subjects provided that the
renal function is normal.
_ _
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. Refer
to the following table and adjust the dose as indicated.
Dosing adjustments for adult patients with impaired renal function
GROUP
ESTIMATED GLOMERULAR
FILTRATION RATE(EGFR) (ML/MIN)
DOSAGE AND FREQUENCY
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9
NORMAL RENAL FUNCTION

90
10 mg once daily
MILDLY DECREASED RENAL
FUNCTION
60 - < 90
10 mg once daily
MODERATELY DECREASED RENAL
FUNCTION
30 – < 60
5 mg once daily
SEVERELY DECREASED RENAL
FUNCTION
15 - <30 not requiring dialysis
treatment
5 mg once every 2 days
END-STAGE RENAL DISEASE
< 15 requiring dialysis treatment
Contra-indicated
Hepatic impairment: N