Cetirizine 10mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Cetirizine hydrochloride

Tilgjengelig fra:

Dr Reddy's Laboratories (UK) Ltd

ATC-kode:

R06AE07

INN (International Name):

Cetirizine hydrochloride

Dosering :

10mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 03040100; GTIN: 05036072001305

Informasjon til brukeren

150057025
PACKAGE LEAFLET INFORMATION FOR THE USER
CETIRIZINE HYDROCHLORIDE 10MG TABLETS
READ ALL 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. See section 4.
-
You must talk to your doctor if you do not feel better or if you feel
worse after
3 days.
WHAT IS IN THIS LEAFLET:
1. What Cetirizine Hydrochloride Tablets are and what they are
used for
2. What you need to know before you take Cetirizine Hydrochloride
Tablets
3. How to take Cetirizine Hydrochloride Tablets
4. Possible side effects
5. How to store Cetirizine Hydrochloride Tablets
6. Contents of the pack and other information
1. WHAT CETIRIZINE HYDROCHLORIDE TABLETS ARE AND WHAT THEY ARE
USED FOR
The
active
ingredient
(which
makes
this
medicine
work)
is
called
cetirizine
hydrochloride, which belongs to a family of medicines called
antihistamines.
Cetirizine Hydrochloride 10mg Tablets are used for the relief of
symptoms of
hayfever and other allergic conditions (e.g. sneezing, runny or itchy
nose) or for
skin rashes (chronic nettle rash, idiopathic urticaria) in adults and
children over 6
years of age.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINE
HYDROCHLORIDE TABLETS
DO NOT TAKE CETIRIZINE HYDROCHLORIDE TABLETS IF YOU:
•
Are ALLERGIC to cetirizine hydrochloride, or any of the ingredients of
this
medicine (listed in section 6), to hydroxyzine or to any piperazine
derivatives
(closely related active substances of other medicines)
•
Suffer from SEVERE KIDNEY DISEASE (severe renal failure with
creatinine
clearance below 10 ml/min)
•
Have problems of urinary retention
•
If you have rare hereditary problems of galactose intolerance,

Preparatomtale

OBJECT 1
CETIRIZINE HYDROCHLORIDE 10MG TABLETS
Summary of Product Characteristics Updated 14-Mar-2017 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Cetirizine Hydrochloride 10mg Tablets
Tesco Allergy and Hayfever Relief 10mg Tablets
EM Pharma Allergy & Hayfever Relief 10mg Tablets
Pollenase Allergy & Hayfever Relief 10mg Tablets
Lloyds Pharmacy Antihistamine Hayfever Relief 10mg Tablets
Careway Antihistamine Hayfever Relief 10mg Tablets
2. Qualitative and quantitative composition
Each tablet contains Cetirizine hydrochloride 10mg.
For excipients, see 6.1.
3. Pharmaceutical form
Film-coated tablet.
White circular biconvex film-coated tablets, embossed 'C' on one side
and a deep score on the other.
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
Children aged from 6 to 12 years: 5mg twice daily (a half tablet twice
daily).
Adults and adolescents over 12 years of age: 10mg once daily (1
tablet)
The tablets need to be swallowed with a glass of liquid.
Elderly subjects: 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 ratio
patients with renal impairment. Since cetirizine is mainly excreted
via renal route (see section 5.2), in
cases where 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. To use the 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:
Dosing adjustm