HISTAZINE

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

CETIRIZINE DIHYDROCHLORIDE

متاح من:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD

ATC رمز:

R06AE07

الشكل الصيدلاني:

TABLETS

تركيب:

CETIRIZINE DIHYDROCHLORIDE 10 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL

المجموعة العلاجية:

CETIRIZINE

المجال العلاجي:

CETIRIZINE

الخصائص العلاجية:

Antihistaminic drug for the treatment of allergies. For the treatment of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria in children aged 6 years and over and adults.

تاريخ الترخيص:

2022-03-31

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed without a doctor’s prescription
HISTAZINE
SYRUP
ACTIVE INGREDIENT
Each 5 ml contain: cetirizine dihydrochloride 5 mg
Inactive ingredients and allergens: See section 2 under ‘Important
information about some of this medicine’s ingredients’ and section
6
‘Additional information’.
READ
THE
ENTIRE
LEAFLET
CAREFULLY
BEFORE
YOU
START
USING
THIS
MEDICINE. This leaflet contains concise information about this
medicine.
If you have any further questions, consult your doctor or pharmacist.
Take this medicine according to the instructions in the section about
dosage in this leaflet. Consult your pharmacist if you need further
information. Talk to a doctor if your symptoms of illness get worse or
do not improve after 3 days.
1. WHAT IS THIS MEDICINE INTENDED FOR?
This medicine is used to treat seasonal and perennial allergic
rhinitis
(hay fever) and chronic idiopathic uriticaria (hives) characterized by
skin irritation (such as itching, rash). For adults and for children
over
the age of 2 years.
THERAPEUTIC GROUP: antihistamines . BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
You have a severe kidney disease (severe renal failure with
creatinine clearance below 10 ml/min);
You are sensitive (allergic) to cetirizine dihydrochloride or to any
of the other ingredients in this medicine (listed in section 6), to
hydroxyzine or to any piperazine derivatives (similar piperazine-
group active ingredients of other medicines).
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE YOU START USING HISTAZINE, TELL YOUR DOCTOR IF:
You have kidney failure. If necessary, you will take a lower dose of
this medicine. Your doctor will determine your new dose.
You have problems passing urine (like spinal cord problems or
prostate or bladder problems).
You have epilepsy or are at risk of getting convulsions.
You are scheduled for allergy testing. Ask your doctor if you should
stop taking Histazine for several days b

خصائص المنتج

HISTAZINE TABLETS
Summary of Product Characteristics
1.
NAME OF THE MEDICINAL PRODUCT
Histazine Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg cetirizine dihydrochloride.
Excipients with known effects: one tablet contains 35 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
Round, biconvex, white film coated tablet with break line on one side.
The tablet can be divided into 2 equal doses.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Antihistaminic drug for the treatment of allergies.
For the treatment of seasonal and perennial allergic rhinitis and
chronic idiopathic urticaria in
children aged 6 years and over and adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children aged 12 years and over: maximum one tablet (10 mg)
per day.
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
impairment. In patients with hepatic
impairment and renal impai