ELTROXIN levothyroxine sodium 125 microgram tablet bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
20-05-2019
Active ingredient:
levothyroxine sodium, Quantity: 125 microgram
Available from:
Aspen Pharmacare Australia Pty Ltd
INN (International Name):
levothyroxine sodium
Pharmaceutical form:
Tablet
Composition:
Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; purified talc; maize starch; microcrystalline cellulose
Administration route:
Oral
Units in package:
100, 200
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
ELTROXIN is indicated for the management of demonstrated thyroid hormone deficiency.,ELTROXIN is also used to suppress thyrotropin (TSH) for the management of TSH-responsive tumours of the thyroid.
Product summary:
Visual Identification: Round, white coloured, flat, bevelled tablets debossed with "125" on one side and "L12" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Authorization status:
Licence status A
Authorization date:
2014-05-19
Patient Information leaflet
ELTROXIN- Consumer Medicine Information
Page 1 of 4
ELTROXIN
®
_levothyroxine sodium _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Eltroxin tablets.
It does not contain all the
available information about the
medicine.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Eltroxin against the benefits he
or she expects it will have.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
The name of your medicine is
Eltroxin. It is available in
tablets of six different
strengths: 25 micrograms
(scored), 50 micrograms, 75
micrograms, 100 micrograms,
125 micrograms and 200
micrograms.
The active ingredient is called
_levothyroxine sodium._
WHAT IS IT USED FOR
_ _
_Levothyroxine sodium_ is a
thyroid hormone. It is used as
replacement therapy in the
treatment of thyroid hormone
deficiency.
Eltroxin is used to treat:
1. Thyroid hormone deficiency
also known as Hypothyroidism.
Hypothyroidism is a disease in
which the thyroid gland is
underactive and does not
produce enough levothyroxine,
a hormone, which is important
for controlling your
metabolism. Symptoms of
hypothyroidism include
tiredness, muscle weakness,
and cramps, feeling the cold, a
slow heart rate, dry and flaky
skin, hair loss, a deep husky
voice and weight gain.
2. TSH-responsive tumours
(certain tumours of the thyroid
gland) of the thyroid
For these conditions to be
treated, patients need a supply
of thyroid hormones in their
body. Eltroxin replaces the
shortage of thyroid hormones.
USE ELTROXIN ONLY AS
DIRECTED.
Your doctor may have
prescribed Eltroxin for another
condition.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THE
MEDICINE HAS BEEN
PRESCRIBED FOR YOU.
Ask your doctor if you have
any concerns about taking it.
Eltroxin tablets are only
available with a doctor’s
prescription.
BEFOR
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION
ELTROXIN (LEVOTHYROXINE SODIUM)
TABLET
1
NAME OF THE MEDICINE
Levothyroxine sodium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains levothyroxine sodium as the active ingredient.
For the full list of
excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
25 MICROGRAM: round, white coloured, flat, bevelled tablets debossed
with ‘25’ on one side
and bisected on the other side.
50 MICROGRAM: round, white coloured, flat, bevelled tablets debossed
with ‘50’ on one side
and ‘L01’ on the other side.
75 MICROGRAM: round, white coloured, flat, bevelled tablets debossed
with ‘75’ on one side
and ‘L02’ on the other side.
88 MICROGRAM: round, white coloured, flat, bevelled tablets debossed
with ‘88’ on one side
and ‘L07’ on the other side.
100 MICROGRAM: round, white coloured, flat, bevelled tablets debossed
with ‘100’ on one side
and ‘L10’ on the other side.
112 MICROGRAM: round, white coloured, flat, bevelled tablets debossed
with ‘112’ on one side
and ‘L11’ on the other side.
125 MICROGRAM: round, white coloured, flat, bevelled tablets debossed
with ‘125’ on one side
and ‘L12’ on the other side.
137 MICROGRAM: round, white coloured, flat, bevelled tablets debossed
with ‘137’ on one side
and ‘L15’ on the other side.
150 MICROGRAM: round, white coloured, flat, bevelled tablets debossed
with ‘150’ on one side
and ‘L17’ on the other side.
175 MICROGRAM: round, white coloured, flat, bevelled tablets debossed
with ‘175’ on one side
and ‘L20’ on the other side.
200 MICROGRAM: round, white coloured, flat, bevelled tablets debossed
with “200” on one side
and ‘L21’ on the other side.
ELTROXIN is not bioequivalent on a same-dose basis with
EUTROXSIG/OROXINE. If a
decision is made to switch a patient from EUTROXSIG/OROXINE to
ELTROXIN, then
prescribers should have a plan for monitoring TSH. Prescribers should
be aware that dose
adjustment may be required.
Prescribers should tell their pat
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