Zirtek 10mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Cetirizine hydrochloride

可用日期:

Waymade Healthcare Plc

ATC代码:

R06AE07

INN（国际名称）:

Cetirizine hydrochloride

剂量:

10mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 03040100

资料单张

ZIRTEK
® ALLERGY 10MG TABLETS
(cetirizine dihydrochloride)
PATIENT INFORMATION LEAFLET
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.
Your medicine will be referred to as Zirtek throughout the following
leaflet.
WHAT IS IN THIS LEAFLET:
1. What Zirtek is and what it is used for
2. What you need to know before you take Zirtek
3. How to take Zirtek
4. Possible side effects
5. How to store Zirtek
6. Content of the pack and further information.
1. WHAT ZIRTEK IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Zirtek.
Zirtek is an antiallergic medication
In adults and children aged 6 years and above, Zirtek 10 mg
film-coated
tablets are 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 BEFORE YOU TAKE ZIRTEK
DO NOT TAKE ZIRTEK
-
if you have a severe kidney disease (severe renal failure with
creatinine
clearance below 10 ml/min);
-
if you are allergic to cetirizine dihydrochloride, to any of the other
ingredients (listed in Section 6), to hydroxyzine or to piperazine
derivatives (closely related active ingredients of other medicines).
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Zirtek.
If you are a patient with renal insufficiency, please ask your doctor
for
advice; if necessary, you will take a lower dose. The new dose will be
determined by your doctor.
If you have problems passing urine (like spinal cord problems or
prostate or
bladder

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zirtek 10 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg cetirizine dihydrochloride.
Excipients with known effect: 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
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 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. 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
Contraindicated
_Hepatic impairment_
No dose adjustment is needed in patients with solely hepatic
impairment. In patients
with hepatic impair