OROXINE 100mcg Tablet

Valsts: Malaizija

Valoda: angļu

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

Aktīvā sastāvdaļa:

LEVOTHYROXINE SODIUM

Pieejams no:

Aspen Medical Products Malaysia Sdn Bhd

SNN (starptautisko nepatentēto nosaukumu):

LEVOTHYROXINE SODIUM

Vienības iepakojumā:

100Tablet Tablets

Ražojis:

Aspen Bad Oldesloe GmbH

Lietošanas instrukcija

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
OROXINE TABLET
Levothyroxine Sodium (50mcg, 100mcg)
WHAT IS IN THE LEAFLET
1.
What Oroxine is used for
2.
How Oroxine works
3.
Before you use Oroxine
4.
How to use Oroxine
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Oroxine
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT OROXINE IS USED FOR
Oroxine is used to treat thyroid
hormone deficiency also known
as hypothyroidism.
HOW OROXINE WORKS
Oroxine
contains
Levothyroxine
Sodium. Levothyroxine Sodium is
a thyroid hormone. It is used as
replacement
therapy
in
the
treatment
of
thyroid
hormone
deficiency.
Thyroxine
(T
4
)
is
a
naturally
occurring hormone produced by the
thyroid gland and converted to the
more
active
hormone
tri-
iodothyronine
(T
3
).
The
thyroid
hormone are required for normal
growth
and
development,
particularly of the nervous system.
Thyroid
hormones
enhance
lipolysis
and
the
utilization
of
carbohydrate.
Ask your doctor if you have any
questions
about
why
this
medicine has been prescribed
for you. Your doctor may have
prescribed it for another reason.
BEFORE YOU USE OROXINE
-
_When you must not use it _
Do not take this medicine if you
have an allergy to:
•
levothyroxine sodium
•
any other thyroid hormone
•
any of the other ingredients
listed
at
the
end
of
this
leaflet
Do not take this medicine if you
have:
•
overactive
thyroid
gland,
which is resulting in a rapid
heartbeat and an increased
rate of metabolism.
•
heart
disease
and
inflammation
of
the
cardiac muscle
Do not take this medicine after
the expiry date printed on the
pack or if the packaging is torn
or shows signs of tampering. If
it has expired or is damaged,
return it to your pharmacist for
disposal.
If you are not sure whether you
should
start
taking
this
medicine, talk to your doctor.
-
_Before you start to use it _
Tell your doctor if you have
allergies to any other medicines,
foods, preservatives or dyes.
Tell your doctor if you have or
have had any o

Produkta apraksts

OROXINE
LEVOTHYROXINE SODIUM
NAME OF THE MEDICINAL PRODUCT
_OROXINE_ Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets containing anhydrous levothyroxine sodium, which is the
monosodium salt of the
levorotary isomer of thyroxine.
50 or 100 microgram non-scored tablets.
PHARMACEUTICAL FORM
_OROXINE_ Tablets 50mcg: White to off-white, round, bi-convex tablets
imprinted GS 11E on
one face and 50 on the other.
_OROXINE_ Tablets 100mcg: White to off-white, round, bi-convex tablets
imprinted GS 21C on
one face and 100 on the other.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Hypothyroidism.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_General _
If
the
dose
of
levothyroxine
is
increased
too
rapidly,
symptoms
such
as
diarrhoea,
nervousness, rapid pulse, insomnia, tremors and sometimes anginal pain
where there is latent
myocardial ischemia may occur, and the dosage must be reduced or
withheld for a day or two,
then restarted at a lower level. A pre-therapy ECG is valuable, as
changes induced by
hypothyroidism may be confused with ECG evidence of ischemia.
Due to a lack of data it is not appropriate to crush levothyroxine
tablets and levothyroxine
tablets without a score-line must not be halved.
Levothyroxine tablets should preferably be taken on an empty stomach.
_Missed Dosage _
If a scheduled daily dose is missed, the dose should be taken as soon
as the patient
remembers, unless it is almost time for the patient’s next dose. Two
doses should not be taken
together.
_Interactions _
In
patients
whose
medications
include
levothyroxine
and
known
interfering
agents,
administration should be separated by at least 4 hours.
Populations
_ _
_Adults _
Initially 50 to 100 micrograms daily, and adjusted at 4 to 6 week
intervals by 50 micrograms
until attainment of clinical and biochemical euthyroidism. This may
require doses of 100 to 200
micrograms daily.
With patients aged over 50 years, it is not advisable to exceed 50
micrograms a day initially.
Where there is cardiac disease, 50 micrograms on alternate days is
more