EUTHYROX 25MCG TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LEVOTHYROXINE SODIUM

Boleh didapati daripada:

MERCK SDN. BHD.

INN (Nama Antarabangsa):

LEVOTHYROXINE SODIUM

Unit dalam pakej:

100 Tablet Tablets; 100 Tablet Tablets; 100Tablet Tablets

Dikeluarkan oleh:

Merck Healthcare KGaA

Risalah maklumat

1
EUTHYROX
®
TABLET
Levothyroxine Sodium (25mcg, 50mcg, 100mcg)
Consumer Medication Information Leaflet (RiMUP)
What is in this leaflet
1.
What Euthyrox is used for
2.
How Euthyrox works
3.
Before you use Euthyrox
4.
How to take Euthyrox
5.
While you are using Euthyrox
6.
Side Effects
7.
Storage and Disposal of Euthyrox
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
What Euthyrox is used for
Euthyrox 25 - 100 microgram is used
for:
-
Treatment of benign euthyroid goiter
(condition present which
is
causing
the thyroid to grow abnormally when
there is correct amount of hormone
produced), mainly in adults when
iodine is not indicated.
-
Prophylaxis of relapse after surgery
for euthyroid goitre, depending on the
post-operative hormone status
-
Substitution therapy in underactive
thyroid gland
-
Suppression therapy in thyroid
cancer
-
Concomitant supplementation during
anti-thyroid medicine treatment of
overactive thyroid gland
Euthyrox 100 microgram:
-
Diagnostic use for thyroid
suppression tes
t
ing
How Euthyrox works
Euthyrox contains levothyroxine
sodium, which is a synthetic thyroid
hormone.
The levothyroxine sodium in Euthyrox
is intended to replace a hormone that
is normally produced by your thyroid
gland. Euthyrox, when taken correctly,
reverses the symptoms of underactive
thyroid gland.
Before you use Euthyrox
-
When you must not take it
Do not use this medication if:
you have had an allergic reaction
before to any of the ingredients in
Euthyrox

you have had uncorrected adrenal
insufficiency (lack of hormone)


you have had uncorrected pituitary
insufficiency

you have untreated thyrotoxicosis, a
disease in which the thyroid gland is
overactive and produces too much
thyroxine


you have had an acute myocardial
infarction (heart attack)

-
Before you start to take it
Tell your doctor before or while you
are using Euthyrox if you are allergic
to any foods, medicines or are lactose
intolerant.
Inform your doctor if you have,

Ciri produk

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EUTHYROX
® 25 MICROGRAM TABLETS
EUTHYROX
® 50 MICROGRAM TABLETS
EUTHYROX
® 100 MICROGRAM TABLETS
NAME OF THE MEDICINAL PRODUCT
Euthyrox 25 microgram tablets
Euthyrox 50 microgram tablets
Euthyrox 100 microgram tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet Euthyrox 25 microgram contains 25 microgram levothyroxine
sodium.
1 tablet Euthyrox 50 microgram contains 50 microgram levothyroxine
sodium.
1
tablet
Euthyrox
100
microgram
contains
100
microgram
levothyroxine sodium.
For a full list of excipients, see List of excipients.
PHARMACEUTICAL FORM
Tablet.
Off white, round, flat on both sides, with a bevelled edge, a dividing
score and an inscription on top:
Euthyrox 25 microgram
EM 25
Euthyrox 50 microgram
EM 50
Euthyrox 100 microgram
EM 100
The tablet can be divided into equal doses.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Euthyrox 25 - 100 microgram:
−
Treatment of benign euthyroid goitre, mainly in adults when iodine
is not indicated.
−
Prophylaxis of relapse after surgery for euthyroid goitre, depending
on the post-operative hormone status
−
Substitution therapy in hypothyroidism
−
Suppression therapy in thyroid cancer
−
Concomitant supplementation during anti-thyroid drug treatment
of hyperthyroidism
Euthyrox 100 microgram:
−
Diagnostic use for thyroid suppression tesTing
POSOLOGY AND METHOD OF ADMINISTRATION
In order to treat each patient according to his/her individual needs,
tablets are available with a levothyroxine sodium content ranging
from 25 to 200 microgram. Patients therefore usually need to take
only one tablet per day.
The dosage recommendations given are only for guidance.
The individual daily dose should be determined on the basis of
laboratory tests and clinical examinations. As a number of patients
show elevated concentrations of T
4
and fT
4
, basal serum concentration
of thyroid-stimulating hormone provides a more reliable basis for
following treatment course.
Thyroid hormone therapy should be started at low dose and increased
graduall