Levothyroxine Teva 50 micrograms Tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Levothyroxine sodium

Disponible desde:

Teva Pharma B.V.

Código ATC:

H03AA; H03AA01

Designación común internacional (DCI):

Levothyroxine sodium

Dosis:

50 microgram(s)

formulario farmacéutico:

Tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Thyroid hormones; levothyroxine sodium

Estado de Autorización:

Marketed

Fecha de autorización:

2012-11-23

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOTHYROXINE TEVA 25 MICROGRAMS TABLETS
LEVOTHYROXINE TEVA 50 MICROGRAMS TABLETS
LEVOTHYROXINE TEVA 100 MICROGRAMS 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 Levothyroxine Teva is and what it is used for
2.
What you need to know before you take Levothyroxine Teva
3.
How to take Levothyroxine Teva
4.
Possible side effects
5.
How to store Levothyroxine Teva
6.
Contents of the pack and other information
1.
WHAT LEVOTHYROXINE TEVA IS AND WHAT IT IS USED FOR
Levothyroxine Teva contains thyroid hormone as its active substance.
The aim of treatment with Levothyroxine Teva is to replace missing
thyroid hormone and/or to relieve
stress on the thyroid gland.
Levothyroxine Teva is used:
–
to replace the missing hormone in all forms of underactive thyroid
function,
–
to prevent the return of new goitres after goitre surgery in patients
with normal thyroid function,
–
to treat non malignant goitre (benign struma) in patients with normal
thyroid function,
25 micrograms
–
as add on therapy in the antithyroid treatment of an overactive
thyroid, after normal metabolic
status has been reached,
–
for malignant thyroid tumours, particularly after surgery to suppress
new tumour growth and as
a supplement for missing thyroid hormone,
50 micrograms
–
as add on therapy in the antithyroid treatment of an overactive
thyroid, after normal metabolic
status has been reached,
–
for malignant thyroid tumours, particularly after surgery

Ficha técnica

Health Products Regulatory Authority
18 May 2023
CRN00D4QF
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levothyroxine Teva 50 micrograms Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Levothyroxine Teva 25 micrograms contains 25 micrograms
of levothyroxine sodium
Excipient(s) with known effect:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white, round, 8mm in diameter, plain tablets with a cross
break-line on one side and debossing L2 on the other
side
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Hypothyroidism,
- Prophylaxis against goitre recurrence following resection of
euthyroid goitre,
- Benign, euthyroid goitre.
- Co-therapy in the antithyroid treatment of hyperthyroidism, once
euthyroid status has been achieved.
- Suppression and replacement therapy in thyroid malignancy,
especially post thyroidectomy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Thyroid hormone therapy/replacement_
Posology
The dosing information serves as a guideline. The individual daily
dose should be determined by laboratory diagnostic tests
and clinical examinations.
If any residual thyroid function remains, a lower replacement dose may
be sufficient.
In elderly patients, patients with coronary heart disease and patients
with severe or chronic hypothyroidism, thyroid hormone
treatment must be initiated with particular caution, i.e. by selecting
a low initial dose and increasing it slowly and at longer
intervals, with frequent thyroid hormone monitoring.
Experience has shown that a lower dose is also sufficient in patients
with a low body weight and in patients with large goitres.
As the tablets can be divided into equal doses, starting dose of 12.5
micrograms can be used.
As T
4
or fT
4
levels may be increased in some patients, determination of the serum
TSH concentration is better suited for
monitoring the treatment regimen.
INDICATION
​
DOSE
(MICROGRAMS
OF
LEVOTHYROXINE
SODIUM/DA