Levothyroxine sodium Aristo 150 micrograms tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levothyroxine Sodium Anhydrous EP

Available from:

Aristo Pharma GmbH

ATC code:

H03AA01

INN (International Name):

Levothyroxine Sodium Anhydrous EP

Pharmaceutical form:

Tablet

Therapeutic area:

levothyroxine sodium

Authorization status:

Not marketed

Authorization date:

2022-08-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVOTHYROXINE SODIUM ARISTO 150 MICROGRAM TABLETS
LEVOTHYROXINE SODIUM ARISTO 200 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 Levothyroxine sodium Aristo is and what it is used for
2.
What you need to know before you take Levothyroxine sodium Aristo
3.
How to take Levothyroxine sodium Aristo
4.
Possible side effects
5.
How to store Levothyroxine sodium Aristo
6.
Contents of the pack and other information
1.
WHAT LEVOTHYROXINE SODIUM ARISTO IS AND WHAT IT IS USED FOR
Thyroxine is a hormone which is produced naturally in the body by the
thyroid gland. Levothyroxine
sodium is a synthetic version of this hormone.
Levothyroxine sodium Aristo is used to replace the missing thyroid
hormone and/or to relieve stress
on the thyroid gland.
Levothyroxine sodium Aristo is used
-
to replace the missing thyroid hormone in all forms of underactive
thyroid function
_(hypothyroidism)_
or after the removal of the thyroid gland,
-
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,
-
for malignant thyroid tumours, particularly after surgery to suppress
new tumour growth and as
a supplement for missing thyroid hormone,
-
in the thyroid suppression test.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOTHYROXINE SODIUM ARISTO
DO NOT TAKE LEVOTHYROXINE SODIUM ARISTO
•
if you are allergic

Summary of Product characteristics

Health Products Regulatory Authority
11 July 2023
CRN00D9L5
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levothyroxine sodium Aristo 150 micrograms tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 microgram anhydrous levothyroxine sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Levothyroxine sodium Aristo tablets are white, round uncoated vaulted
tablets (snap tab) with a break mark on one side and
the numeric strength (150) embossed on the other. The tablets have an
approximate diameter of 7 mm and approximate
height of 3 mm.
The tablets 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

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, in patients with coronary heart disease, and in
patients with severe or long-existing hypothyroidism, special
caution is required when initiating therapy with thyroid hormones,
that is, a low initial dose (for example 12.5 microgram/day)
should be given which should then be increased slowly and at lengthy
intervals (e.g. a gradual increment of
12.5 microgram/day fortnightly) with frequent monitoring of thyroid
hormones. Experience has shown that a lower dose is also
sufficient in patients with a low body weight and in patients with a
large goitre.
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.
_Paediatric population_
For children