ATARAX FILM-COATED TABLET 25MG

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Viambatanisho vya kazi:

HYDROXYZINE HYDROCHLORIDE

Inapatikana kutoka:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Jina la Kimataifa):

HYDROXYZINE HYDROCHLORIDE

Vitengo katika mfuko:

500Tablet Tablets

Viwandani na:

UCB S.A. SECTOR PHARMA

Taarifa za kipeperushi

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
ATARAX FILM-COATED TABLET/SYRUP
Hydroxyzine Hydrochloride (25 mg, 2 mg/ml)
1
WHAT IS IN THIS LEAFLET
1.
What ATARAX is used for
2.
How ATARAX works
3.
Before you use ATARAX
4.
How to use ATARAX
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of ATARAX
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT ATARAX IS USED FOR
•
Symptomatic relief of anxiety and
tension associated with psychoneurosis
and as an adjunct in organic disease
states in which anxiety is manifested.
•
a sedative used as premedication and
following general anaesthesia.
•
symptomatic treatment in atopic
pruritus.
HOW ATARAX WORKS
Atarax belongs to the group of medicines
called sedating antihistamines. It is
thought to work by inhibiting some
activity in the brain.
BEFORE YOU USE ATARAX
-
_When you must not use it _
Do not take Atarax if:
•
You are allergic to hydroxyzine
hydrochloride or any of the other
ingredients of Atarax (see section
PRODUCT DESCRIPTION
)
•
You are allergic to cetirizine, other
piperazine derivatives, aminophylline
or ethylenediamine
•
You are pregnant or breastfeeding
•
You have liver or kidney disease
•
You have prostate problems and you
are unable to pass urine
•
You have increased pressure in the eye
(glaucoma)
•
You have a condition called porphyria.
(A blood disease that can cause
stomach pain, vomiting and mental
disturbances such as depression.)
•
Your child is under 12 months
•
You are taking medicines for
depression called monoamine oxidase
inhibitors
•
You have a heart condition known as
prolonged QT interval causing
irregular heart beat and/or palpitations
•
You have a known risk factor to QT
interval prolongation including a
known heart disease, significantly low
potassium or magnesium ions in your
blood, family history of sudden cardiac
death, significant slow heart rate,
concomitant use with drugs known to
prolong the QT interval and/or ind

Tabia za bidhaa

ATARAX
Hydroxyzine hydrochloride
NAME OF THE MEDICINAL PRODUCT
Hydroxyzine hydrochloride, 25 mg, film -coated tablet
Hydroxyzine hydrochloride, 10 mg/5 ml, syrup
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydroxyzine hydrochloride, 25 mg, film -coated tablet
Each film -coated tablet contains 25 mg of hydroxyzine hydrochloride.
Hydroxyzine hydrochloride, 10 mg/5 ml, syrup
Each ml of syrup contains 2 mg of hydroxyzine hydrochloride.
Excipients
Hydroxyzine hydrochloride, 25 mg, film -coated tablet
Lactose monohydrate, Microcrystalline cellulose, Magnesium stearate, Colloidal anhydrous
silica, Titanium dioxide (E171), H.P.M.C. 2910 (645), Macrogol 400
Hydroxyzine hydrochloride, 10 mg/5 ml, syrup
Ethanol, Sucrose, Sodium benzoate, Levomenthol, Hazelnut flavour (containing a.o. propylene
glycol, vanillin, ethyl vanillin, fenugreek seed extract, lovage oil), Purified water
PHARMACEUTICAL FORM
Hydroxyzine hydrochloride, 25 mg, film -coated tablet