Pollenshield Hayfever 10mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Cetirizine hydrochloride

Tilgjengelig fra:

Accord-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: 5012617015808

Informasjon til brukeren

148x210 Leaflet Reel Fed Profile (BST)
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. 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 POLLENSHIELD HAYFEVER IS AND WHAT IT
IS USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
POLLENSHIELD HAYFEVER
3 HOW TO TAKE POLLENSHIELD HAYFEVER
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE POLLENSHIELD HAYFEVER
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT POLLENSHIELD HAYFEVER IS AND WHAT IT IS
USED FOR
Pollenshield Hayfever contains cetirizine hydrochloride which
belongs to a group of medicines called antihistamines.
Pollenshield Hayfever may be used to relieve:
•
long-term runny nose and watery eyes
•
hayfever (runny and blocked-up nose, sneezing, watery
eyes)
•
a skin reaction with pale or red irregular raised patches and
severe itching.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
POLLENSHIELD HAYFEVER
DO NOT TAKE POLLENSHIELD HAYFEVER IF YOU:
•
are ALLERGIC to cetirizine, hydroxyzine, any piperazine
derivatives or any of the other ingredients of this medicine
(listed in section 6).
•
have SEVERE KIDNEY problems.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Pollenshield
Hayfever if you:
•
have EPILEPSY.
•
have DIFFICULTY IN PASSING WATER or any risk factors
associated with this.
If you are scheduled for allergy testing, ask your doctor if
you should stop taking Pollenshield Hayfever for several
days before testing. This medicine may affect your allergy
test results.
CHILDREN
NOT RECOMMENDED FOR CHILDREN UNDER 6 YEARS O

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cetirizine Hydrochloride 10mg Tablets
Pollenshield Hayfever
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg Cetirizine hydrochloride.
Excipient with known effect: Each tablet contains 117.00mg lactose
monohydrate
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet.
Film-coated, white or almost white convex, elliptical, tablets. 5.7 x
11.4 mm.
The letter “C” on one side and the letters “J” and “E” on
either side of a
central division line on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In adults and paediatric patients 6 year 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_: 10mg once daily (1
tablet).
_ _
_CHILDREN AGED FROM 6 TO 12 YEARS_: 5mg twice daily (a half tablet
twice daily).
_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 in patients
with renal
impairement. 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. 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:
CL
cr
= [140 − _age(years_)] _x weight(kg_)

(_x0.85 for women_)
(72 _x serum creatinine (mg_/_dl_)
Dosing adjustments for adult patients with impaired renal function
Group
Creatini