ELTROXIN NEW FORMULATION 150 ug TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Pharmacare Limited û Woodmead

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS LEVOTHYROXINE SODIUM 150,0 ug

Authorization status:

Registered

Authorization date:

2018-06-09

Patient Information leaflet

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1.3.2 PATIENT INFORMATION LEAFLET
SCHEDULING STATUS S3
PROPRIETARY NAME AND DOSAGE FORM
ELTROXIN NEW FORMULATION 25 ΜG
ELTROXIN NEW FORMULATION 50 ΜG
ELTROXIN NEW FORMULATION 75 ΜG
ELTROXIN NEW FORMULATION 88 ΜG
ELTROXIN NEW FORMULATION 100 ΜG
ELTROXIN NEW FORMULATION 112 ΜG
ELTROXIN NEW FORMULATION 125 ΜG
ELTROXIN NEW FORMULATION 137 ΜG
ELTROXIN NEW FORMULATION 150 ΜG
ELTROXIN NEW FORMULATION 175 ΜG
ELTROXIN NEW FORMULATION 200 ΜG
Tablet
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ELTROXIN
NEW
FORMULATION

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

ELTROXIN NEW FORMULATION has been prescribed for you personally and
you
should not share ELTROXIN NEW FORMULATION with other people. It may
harm
them, even if their symptoms are the same as yours.
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WHAT ELTROXIN NEW FORMULATION CONTAINS
The active substance is levothyroxine sodium.
Each tablet of ELTROXIN NEW FORMULATION contains 25 µg, 50 µg, 75
µg, 88 µg,
100 µg, 112 µg, 125 µg, 137 µg, 150 µg, 175 µg, or 200 µg of
levothyroxine sodium.
The inactive ingredients include:
Colloidal silica dioxide, magnesium stearate, microcrystalline
cellulose, pregelatinised maize
starch, talc.
Sugar free.
WHAT ELTROXIN NEW FORMULATION IS USED FOR
ELTROXIN NEW FORMULATION is used to treat hypothyroidism, a disease in
which the
thyroid gland is underactive and does not produce enough thyroxine, a
hormone, which is
important for controlling your metabolism.
BEFORE YOU TAKE ELTROXIN NEW FORMULATION
DO NOT TAKE ELTROXIN NEW FORMULATION IF:

You have had an allergic reaction before, to the active ingredient or
any of the other
ingredients in ELTROXIN NEW FORMULATION listed above.

You have untreated hyperthyroidism, a disease in which the thyroid
gland is overactive
and produces too much thyroxine (this can lead to a life- th

Summary of Product characteristics

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1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS
S3
PROPRIETARY NAME AND DOSAGE FORM
ELTROXIN NEW FORMULATION 25 ΜG (tablet)
ELTROXIN NEW FORMULATION 50 ΜG (tablet)
ELTROXIN NEW FORMULATION 75 ΜG (tablet)
ELTROXIN NEW FORMULATION 88 ΜG (tablet)
ELTROXIN NEW FORMULATION 100 ΜG (tablet)
ELTROXIN NEW FORMULATION 112 ΜG (tablet)
ELTROXIN NEW FORMULATION 125 ΜG (tablet)
ELTROXIN NEW FORMULATION 137 ΜG (tablet)
ELTROXIN NEW FORMULATION 150 ΜG (tablet)
ELTROXIN NEW FORMULATION 175 ΜG (tablet)
ELTROXIN NEW FORMULATION 200 ΜG (tablet)
COMPOSITION
Each tablet of ELTROXIN NEW FORMULATION contains 25 µg, 50 µg, 75
µg, 88 µg,
100 µg, 112 µg, 125 µg, 137 µg, 150 µg, 175 µg, or 200 µg of
levothyroxine sodium.
_Excipients: _
Colloidal silica dioxide, magnesium stearate, microcrystalline
cellulose, pregelatinised maize
starch, talc.
Sugar free.
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CATEGORY AND CLASS
A 21.3 Thyroid preparations
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Thyroxine (T
4
) is a naturally occurring hormone produced by the thyroid gland and
converted
to the more active hormone tri-iodothyronine (T
3
) in peripheral tissues. The precise signals
controlling the conversion of T
4
to T
3
within the cell are not known. The thyroid hormones are
required for normal growth and development, particularly of the
nervous system. They
increase the resting or basal metabolic rate of the whole organism and
have stimulatory
effects on the heart, skeletal muscle, liver and kidney. Thyroid
hormones enhance lipolysis
and the utilisation of carbohydrate. 100 µg thyroxine is equivalent
in activity to 20 µg to 30 µg
liothyronine/tri-iodothyronine or 60 mg thyroid BP.
PHARMACOKINETIC PROPERTIES
ABSORPTION
Following oral administration the absorption of thyroxine is
incomplete and variable
especially when taken