Zirtek Allergy Relief 10mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Cetirizine hydrochloride

제공처:

UCB Pharma Ltd

ATC 코드:

R06AE07

INN (국제 이름):

Cetirizine hydrochloride

복용량:

10mg

약제 형태:

Oral tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 03040100; GTIN: 5024091747021 05413787220885

환자 정보 전단

Font size body text: 8pt
Pharma code: TBC
Colours: Tech Colours:
Product name: CIA70971I_MU1 GB
Creation date: 27/09/2019
DCMF No: N/A
Operator: TC
Commodity: UCB10100
Ref no: CIA70971I_MU1
CMO Code: N/A
Core spec size: TI006PIL-024-06 305x148
Revision: 2019_SEP_0031_1
Page no: 1 of 2
Amended by: N/A
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Aesica Queenborough Ltd.
North Road, Queenborough,
Kent ME11 5EL UK
Zirtek
®
ALLERGY RELIEF 10 MG
FILM COATED TABLETS
Cetirizine dihydrochloride
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Zirtek Allergy Relief is and what it is used for
2. What you need to know before you take Zirtek Allergy Relief
3. How to take Zirtek Allergy Relief
4. Possible side effects
5. How to store Zirtek Allergy Relief
6. Content of the pack and other information. 1. WHAT ZIRTEK ALLERGY RELIEF IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride, the active ingredient of the tablets is an
antihistamine. It blocks the effects of a substance called histamine
which occurs naturally in the body. Histamine is involved in allergic
reactions.
In adults and children aged 6 years and above, Zirtek Allergy Relief
is used to treat people who have hay fever (seasonal allergic
rhinitis),
yea

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zirtek allergy relief 10 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablets contains 10 mg cetirizine dihydrochloride
Excipients with known effects: one film-coated tablet contains 66.40
mg
lactose-monohydrate
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablets
White, oblong, film-coated tablet, with breakline and Y-Y logo
The tablet can be divided into 2 equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cetirizine dihydrochloride 10 mg film-coated tablets are indicated in
adults and
paediatric patients 6 years and above:
-
for the relief of nasal and ocular symptoms of seasonal and perennial
allergic
rhinitis.
-
for the relief of symptoms of 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. To use this 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 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
5 mg once daily
Severe
<30
5 mg once every 2 days
End-stage renal
disease -
Patients undergoing
dialysis
<10
Contra-indicated
_Hepatic impairment _
No dose adjustment is needed in patients with solely hepatic