ZADIPRO SYRUP

Страна: Малайзія

мова: англійська

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

Активний інгредієнт:

KETOTIFEN FUMARATE

Доступна з:

SUNWARD PHARMACEUTICAL SDN. BHD.

ІПН (Міжнародна Ім'я):

KETOTIFEN FUMARATE

Одиниць в упаковці:

250 ml; 200 ml; 250 ml; 200 ml; 1000 ml; 100 ml mL; 100 ml mL; 120 ml mL; 120 ml mL

Виробник:

SUNWARD PHARMACEUTICAL SDN. BHD.

інформаційний буклет

ZADIPRO SYRUP
_Consumer Medication Information Leaflet (RiMUP)_
Ketotifen Fumarate (1mg/5ml)
WHAT IS IN THIS LEAFLET:
1. What Zadipro Syrup is used for
2. How Zadipro Syrup works
3. Before you use Zadipro Syrup
4. How to use Zadipro Syrup
5. While you are using it
6. Side effects
7. Storage & disposal of Zadipro
Syrup
8. Product description
9. Manufacturer and Product Registration Holder
10.Date of revision
WHAT ZADIPRO SYRUP IS USED FOR
It is used as a p r e v e n t i o n treatment
of asthma
associated with allergy.
It
i s
also used for t h e
prevention
and
relief
of
allergic
sympto ms
associated
with
conditions
such
as
allergic
rhinitis (an allergic inflammation of the inside of
the nose), allergic bronchitis (inflammation of the
windpipe
and
airways
within the
lungs)
skin
rashes and hay fever.
HOW ZADIPRO SYRUP WORKS
The active ingredients in the medicine is ketotifen.
Ketotifen is an antihistamine and is able to relieve
the
allergic
conditions
through
the
blockade
of
allergic reactions caused by chemicals in the body
which are realsed upon sensitization by allergens.
BEFORE YOU USE ZADIPRO SYRUP
_When you must not use it_
• If you are allergic to ketotifen or any other
ingredients in the product
_Before you start to use it_
You should check with your doctor:-

If you are or think you may be pregnant

If you are planning to become pregnant

If you are breastfeeding
Is should not be used to treat acute asthma attacks.
_Taking other medicines_
There are a few medicines which may not
mix
with Zadipro. It
is important to tell
your doctor
HOW TO USE ZADIPRO
_How much to use_
You
should
take
Zadipro
Syrup
exactly as advised by your doctor or
pharmacist.
The amount
you take
each day will depend on your
condition. Do not take more or less
than what your doctor prescribes.
The normal dosage for adults ranges
from 1mg (5ml) - 2mg (10ml) 2
times daily. If you are susceptible
to sedation, a progressive regimen is
recommended during the 1st week
of treatment commencing with
0.5mg ( 2.5ml ) twice daily or 1mg
(5m

Характеристики продукта

DRUG INTERACTIONS:
Ketotifen may potentiate the effects of CNS depressant, alcohol and
other antihistamines.
Concomitant administration of ketotifen with oral antidiabetic drug
can lead to a reversible fall in
thrombocyte count.
USE IN PREGNANCY & LACTATION:
Although there is no evidence of any teratogenic effect, ketotifen
like all drugs, should be given to pregnant
and nursing women only under compelling circumstances.
DOSAGE:
Oral administration.
Adult : 1mg (5ml) - 2mg (10ml) 2 times daily. In patients susceptible
to sedation, a progressive regimen is
recommended during the 1st week of treatment commencing with 0.5mg
(2.5ml) twice daily or 1mg (5ml) in
the evening only and increasing to the full therapeutic dose. If
necessary, the dosage may be increased up
to 4mg (20ml) a day in 2 divided doses.
Syrup : Children above 3 years - 1mg (5ml) twice daily.
6 months to 3 years - 0.5mg (2.5ml) twice daily.
SYMPTOMS AND TREATMENT FOR OVERDOSAGE AND ANTIDOTE(S):
The main symptoms of acute overdosage include: drowsiness to severe
sedation, confusion and
disorientation; tachycardia and hypotension; especially in children,
hyperexcitability or convulsions;
reversible coma.
Treatment should be symptomatic. If the drug has been taken recently,
the stomach should be emptied. If
necessary, symptomatic treatment and monitoring of the cardiovascular
system; if excitation or convulsions
are present: short-acting barbiturates, benzodiazepines.
PACK SIZE:
Syrup : A bottle of 100ml and 120ml.
PACK SIZE (EXPORT ONLY):
Syrup : A bottle of 200ml, 250ml and 1 litre.
SHELF LIFE: Bottle HDPE : 1.5 years
Bottle PET : 2 years
PRODUCT DESCRIPTION :
Syrup : Clear, colourless syrup with peach flavour.
STORAGE CONDITIONS:
Store at or below 30ºC. Protect from light.
PACKAGE INSERT
SL344A-R4
Revision Date : 19/07/2023
PROPERTIES
Ketotifen
is
a
non-bronchodilator
anti-asthmatic
drug
with
anti-anaphylactic
and
antihistaminic
properties. Studies on the mode of action of ketotifen have shown the
following properties of ketotifen
which may contribu