Thyrofix 25 microgram tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. 14th Km National Road Athens - Lamia 1, GR-145 64 Kifissia, Greece

ATC code:

H03AA01

INN (International Name):

LEVOTHYROXINE SODIUM 25 µg

Pharmaceutical form:

TABLET

Composition:

LEVOTHYROXINE SODIUM 25 µg

Prescription type:

POM

Therapeutic area:

THYROID THERAPY

Authorization status:

Authorised

Authorization date:

2024-02-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE
USER
THYROFIX 25 MICROGRAM
TABLETS
THYROFIX 50 MICROGRAM
TABLETS
THYROFIX 75 MICROGRAM
TABLETS
THYROFIX 100 MICROGRAM
TABLETS
THYROFIX 150 MICROGRAM
TABLETS
Levothyroxine sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Thyrofix is and what it is used for
2.
What you need to know before you take Thyrofix
3.
How to take Thyrofix
4.
Possible side effects
5.
How to store Thyrofix
6.
Content of the pack and other information
1.
WHAT THYROFIX IS AND WHAT IT IS USED FOR
Levothyroxine Sodium, the active substance in Thyrofix, is a synthetic
thyroid hormone for the
treatment of diseases and dysfunctions of the thyroid gland. It has
the same effect as the naturally
occurring thyroid hormones.
THYROFIX
is used
-
to treat goitre in patients (mainly adults) with normal thyroid
function,
-
to prevent recurrence of goitre after surgery,
-
to replace natural thyroid hormones, when your thyroid gland does not
produce enough,
-
to suppress tumour growth in patients with thyroid cancer,
Thyrofix 25 microgram, 50 microgram, 75 microgram and 100 microgram
tablets are also used to
balance thyroid hormone levels, when overproduction of hormones is
treated with antithyroid
medicines.
Thyrofix 75 microgram, 100 microgram and 150 microgram tablets may
also be used in the
testing of your thyroid function.
_ _
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE THYROFIX
DO NOT TAKE THYROFIX IF YOU HAVE
•
allergy (hypersensitivity) to the active substance or to any of the
other ingredient

Summary of Product characteristics

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Thyrofix 25 micrograms tablets
Thyrofix 50 micrograms tablets
Thyrofix 75 micrograms tablets
Thyrofix 100 micrograms tablets
Thyrofix 150 micrograms tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet Thyrofix 25 micrograms contains 25 micrograms levothyroxine
sodium.
1 tablet Thyrofix 50 micrograms contains 50 micrograms levothyroxine
sodium.
1 tablet Thyrofix 75 micrograms contains 75 micrograms levothyroxine
sodium.
1 tablet Thyrofix 100 micrograms contains 100 micrograms levothyroxine
sodium.
1 tablet Thyrofix 150 micrograms contains 150 micrograms levothyroxine
sodium.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Thyrofix 25 microgram tablets are white, round, biconvex tablets with
a diameter of 6.5 mm
and an average thickness of 3.5 mm, debossed with “25” on one
side.
Thyrofix 50 microgram tablets are white, round, biconvex tablets with
a diameter of 6.5 mm
and an average thickness of 3.5 mm, debossed with “50” on one
side.
Thyrofix 75 microgram tablets are white, round, biconvex tablets with
a diameter of 6.5 mm
and an average thickness of 3.5 mm, debossed with “75” on one
side.
Thyrofix 100 microgram tablets are white, round, biconvex tablets with
a diameter of 6.5 mm
and an average thickness of 3.5 mm, debossed with “100” on one
side.
Thyrofix 150 microgram tablets are white, round, biconvex tablets with
a diameter of 6.5 mm
and an average thickness of 3.5 mm, debossed with “150” on one
side.
Page 2 of 14
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Treatment of benign euthyroid goitre, especially in adults where
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
-
Diagnostic use for thyroid suppression testing (d