U-KEFEN TABLETS 1MG

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

KETOTIFEN FUMARATE

Tillgänglig från:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (International namn):

KETOTIFEN FUMARATE

Enheter i paketet:

500 Tablets

Tillverkad av:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

Bipacksedel

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
__________________________________________________________________________________________________________
1
U-KEFEN TABLETS 1MG
Ketotifen Fumarate (1mg)
WHAT IS IN THIS LEAFLET:
1.
What U-Kefen Tablets is used for
2.
How U-Kefen Tablets works
3.
Before you use U-Kefen Tablets
4.
How to use U-Kefen Tablets
5.
While you are using it
6.
Side Effects
7.
Storage
and
Disposal
U-Kefen
Tablets
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT U-KEFEN TABLETS IS USED FOR
It
is
indicated
for
the
prevention
of
asthma and has also been given in the
treatment of allergic conditions such as
rhinitis (inflammation of the inside of
the
nose)
and
conjunctivitis
(inflammation of the membrane lining
the eyelids).
HOW U-KEFEN TABLETS WORKS
Ketotifen is the active ingredient of U-
Kefen
Tablets.
Ketotifen
is
an
antihistamine
with
anti-allergy
properties.
Histamine
is
a
chemical
released into the body during an allergic
condition. U-Kefen Tablets works by
blocking
the
effects
of
the
naturally
occuring
chemical
histamine
in
your
body.
BEFORE YOU USE U-KEFEN TABLETS
- _ When you must not use it _

If you are allergic to ketotifen or
other ingredients of the tablet.

If you are taking oral anti-diabetic
agents.

If you are breastfeeding.
- _ Before you start to use it _
You must tell your doctor if:

you have allergies to any medicine
which you have taken previously to
treat your current condition.

you
are
pregnant,
trying
to
get
pregnant,
think
you
may
be
pregnant or breast-feeding._ _
_ _
- _ Taking other medicines _
The
following
medicines
may
interact with U-Kefen Tablets:

Sedatives
(chemical
substances
used to reduce tension and anxiety
and to induce calm).

Hypnotics (chemical substances to
induce sleep).

Antihistamines.

Alcohol.
Tell your doctor and pharmacist if you
are
taking
any
other
medicines,
including any that you buy without a
prescription
from
a
pharmacy,
supermarket or health food shop.
HOW TO

Produktens egenskaper

7073-04
U-KEFEN TABLETS 1 MG
U-KEFEN SYRUP 1MG/5ML
NAME AND STRENGTH OF ACTIVE INGREDIENT:
(i)
U-KEFEN TABLETS 1MG
Each tablet contains Ketotifen Fumarate equivalent to
Ketotifen...…………….…………………1mg
(ii)
U-KEFEN SYRUP 1MG/5ML
Each 5ml syrup contains Ketotifen Fumarate equivalent to
Ketotifen……………………….……1mg
PRODUCT DESCRIPTION:
(i)
U-KEFEN TABLETS 1MG
A white, scored, flat of diameter 7mm round tablet with ‘MPI’
marking.
(ii)
U-KEFEN SYRUP 1MG/5ML
A clear liquid with tutti frutti flavour and sweet taste.
PHARMACODYNAMICS
:
Ketotifen has the properties of the antihistamines in addition to
action on mast cells analogous to those of sodium cromoglycate. In
addition to its antihistaminic action, inhibition of
phosphodiesterases, blockade of calcium channels, inhibition of the
release of
mixture of leukotrienes known as slow-reacting substance of
anaphylaxis (SRS-A) and functional antagonism of the effects of
SRS-A have been demonstrated, and there is now some evidence for an
effect on

2-receptor or mediated reactions.
PHARMACOKINETICS:
Ketotifen fumarate is absorbed from the gastrointestinal tract and
together with metabolites, is excreted in the urine and faeces. It
has a very slow onset of action, it must be administered on a regular
basis for 6-12 weeks before any beneficial effect is seen.
INDICATION:
Ketotifen is used in the prophylactic treatment of asthma and has also
been given in the treatment of allergic conditions such as
rhinitis and conjunctivitis.
RECOMMENDED DOSAGE:
Adults: 1mg of ketotifen (1 tablet or 5ml syrup) twice daily with
food, increased if necessary to 2mg (2 tablets or 10ml syrup)
twice daily.
Children over 2 years may be given 1mg (1 tablet or 5ml syrup) twice
daily.
It must be administered on a regular basis for 6–12 weeks before any
beneficial effects is seen. Patients known to be easily sedated
should begin treatment with 0.5–1mg (½ to 1 tablet or 2.5 to 5ml
syrup) at night for the first few days.
ROUTE OF ADMINISTRATION:
Oral
CONT