Pollenshield Hayfever Relief 10mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Cetirizine hydrochloride

Prieinama:

Accord-UK Ltd

ATC kodas:

R06AE07

INN (Tarptautinis Pavadinimas):

Cetirizine hydrochloride

Dozė:

10mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 03040100; GTIN: 5012617015815

Pakuotės lapelis

148x210 Leaflet Reel Fed Profile (BST)
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Cetirizine hydrochloride
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 RELIEF IS AND
WHAT IT IS USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
POLLENSHIELD HAYFEVER RELIEF
3 HOW TO TAKE POLLENSHIELD HAYFEVER RELIEF
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE POLLENSHIELD HAYFEVER
RELIEF
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT POLLENSHIELD HAYFEVER RELIEF IS AND
WHAT IT IS USED FOR
Pollenshield Hayfever Relief contains cetirizine
hydrochloride which belongs to a group of medicines
called antihistamines.
Pollenshield Hayfever Relief 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 RELIEF
DO NOT TAKE Pollenshield Hayfever Relief if you:
• are ALLERGIC to cetirizine, hydroxyzine, any piperazine
derivatives or any of the other ingredients in this
medicine (listed in section 6).
•
have SEVERE KIDNEY problems.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST before taking
Pollenshield Hayfever Relief 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

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
POLLENSHIELD HAYFEVER RELIEF
Cetirizine hydrochloride 10mg Film-coated Tablets
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 (Tablets).
Film-coated, white or almost white convex, elliptical, tablets. 5.7 x
11.4mm. 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