ASMAFEN SYRUP

מדינה: מלזיה

שפה: אנגלית

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

מרכיב פעיל:

KETOTIFEN FUMARATE

זמין מ:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

INN (שם בינלאומי):

KETOTIFEN FUMARATE

יחידות באריזה:

120 ml

תוצרת:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

עלון מידע

_Consumer Medication Information Leaflet (RiMUP)_
ASMAFEN SYRUP
Ketotifen fumarate (1mg/5ml)
1
WHAT IS IN THIS LEAFLET:
1.
What is Asmafen Syrup used for
2.
How Asmafen Syrup works
3.
Before you use Asmafen Syrup
4.
How to use Asmafen Syrup
5.
While you are using Asmafen Syrup
6.
Side effects
7.
Storage and disposal of Asmafen Syrup
8.
Product description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT IS ASMAFEN SYRUP USED FOR
Asmafen Syrup is used:

For the long term prevention of asthma,
inflammation of bronchial tube (airway)
in the lung, and asthmatic symptoms
associated with allergy.

For
the
prevention
and
treatment
of
other
allergic
conditions
such
as
allergic
rhinitis
(inflammation
of
the
mucous
membrane
in
the
nose),
inflammation of the outer layer of the
eyeball and the inner eyelid and allergic
skin disorders.
HOW ASMAFEN SYRUP WORKS
Ketotifen is an antihistamine and works by
blocking
a
certain
natural
substances
(histamine) that your body makes during
an allergic reaction.
BEFORE YOU USE ASMAFEN SYRUP_ _
_When you must not use it_
Do
not
use
Asmafen
Syrup
if
you
are
allergic to any ingredients in this medicine.
_ _
_ _
_Before you start to use it_
Tell your doctor or pharmacist before using
Asmafen Syrup if you:

are pregnant or plan to get pregnant.

are
breast-feeding
or
plan
to
start
breast-feeding.

have acute asthma.

taking oral antidiabetic treatment that
helps to control blood sugar levels.
Do not discontinue treatment abruptly as
this
may
lead
to
recurrence
of
the
symptoms of asthma. Should withdrawal
be
necessary,
reduce
the
dose
gradually
over a period of one week.
_Taking other medicines_
Tell your doctor or pharmacist if you are
taking or having recently taken any other
medicines.
This
includes
any
medicines
which
you
have
bought
without
a
prescription.
Ketotifen may increase the sedative effects
of other central nervous depressant (CNS),
antihistamine and alcohol.
HOW TO USE ASMAFEN SYRUP_ _
_How much to use _

_Adults and children above 12

מאפייני מוצר

•
:
• XCP.1 '
XEP'?I-SOUL PATTINSON (MALAYSIA) SDN. BHD.
1-5, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA.
Important information. Please read carefully.
ASMAFEN
™
Ketotifen 1 mg
COMPOSITION
Each 5ml contains Ketotifen (as hydrogen fumarate) 1 mg. Parabens
0.15%
_W/V _
as preservative.
PHARMACODYNAMICS
Ketotifen is a sedating antihistamine that also has a stabilizing
action on mast cells analogous to that of sodium c
r
omoglicate.
PHARMACOKINETICS
Ketotifen fuma
r
ate is almos
t
completely abso
r
bed from gast
r
ointestinal tract after oral doses, but bioavailability is reported to
be only about 50% due to hepatic first-pass
metabolism. Peak plasma concentrations occur 2 to 4 hours after an
oral dose. It is mainly excreted in the urine as inactive metabolites
with a small amount of unchanged
drug. The terminal elimination half-life is about 21 hours.
INDICATIONS
Asmafen is indicated for long-term prevention of bronchial asthma,
allergic bronchitis, asthmatic symptoms associated with hay fever.
It
is also indicated for the prevention and treatment of other allergic
conditions such as allergic rhinitis, conjunctivitis and allergic skin
disorders.
DOSAGE AND ADMINISTRATION
Unless otherwise prescribed by the physician.
Adults and children above 12 years
Children 2 to 12 years
Children 6 months to 2 years
5 to 10ml (twice a day)
5ml (twice a day)
2.5ml (twice a day)
CONTRAINDICATIONS
Asmafen is contraindicated for use during acute attacks of asthma and
in patients who are on oral
antidiabetic treatment
PRECAUTIONS
Do not discontinue treatment abruptly as this may lead to recurrence
of the symptoms
of asthma. Should withdrawal be necessary, reduce the dose gradually
over a period
of one week. Avoid alcoholic drinks. Use in pregnancy is best avoided.
When necessary, close medical supervision is required.
DRUG INTERACTIONS
Ketotifen may potentiate the sedative effects of other CNS
depressants,
antihistamines and alcohol.
SIDE EFFECTS
This preparation may cause drowsiness. Patients should be advised
against
drivi