Eltroxin 25mcg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LEVOTHYROXINE SODIUM

Available from:

Mercury Pharmaceuticals Limited

ATC code:

H03AA01

INN (International Name):

LEVOTHYROXINE SODIUM

Pharmaceutical form:

TABLET

Composition:

LEVOTHYROXINE SODIUM 25 µg

Prescription type:

POM

Therapeutic area:

THYROID THERAPY

Authorization status:

Authorised

Authorization date:

2015-03-04

Patient Information leaflet

Please read this leaflet carefully before you
start to take your medicine. This leaflet
does not contain all the information about
your medicine. If you have any questions
or you are not sure about anything ask
your doctor or pharmacist.
THE NAME OF YOUR MEDICINE IS:
Eltroxin Tablets. Either 25, 50 or 100
micrograms.
THE ACTIVE INGREDIENT IS:
Each white tablet contains respectively
Anhydrous Levothyroxine Sodium 25 micrograms,
50 micrograms and 100 micrograms.
Each tablet is scored on one side and is
engraved on the other side with either
25mcg
- FW41
50mcg
- Eltroxin 50
100mcg - Eltroxin 100.
Eltroxin 25, 50 and 100 microgram tablets
are available in blister packs of 28, 56 or 112
tablets and polypropylene containers of 100
or 1000 tablets. Eltroxin 25 microgram
tablets are also available in polypropylene
containers of 28, 56 and 112 tablets. Not all
pack sizes may be marketed.
The active medicine is Levothyroxine
Sodium. This is the new name for
Thyroxine Sodium. The ingredient itself
has not changed.
WHAT ELSE IS IN YOUR MEDICINE:
As well as Levothyroxine Sodium, the
tablets also contain Sodium Citrate, Lactose
monohydrate, Maize Starch, Acacia Powder
and Magnesium Stearate.
The active ingredient, Levothyroxine
Sodium, although synthetic, is similar to
the natural thyroid hormone (chemical
messenger) in your body. Thyroid hormone
is produced by the thyroid gland in your
neck and regulates metabolism.
Eltroxin Tablets are made for the below
PA holder,
Eltroxin 25mcg PA 899/20/1
Mercury Pharmaceuticals Ltd.,
Capital House, 85 King William Street,
London EC4N 7BL, UK
Eltroxin 50mcg PA 701/1/1
Eltroxin 100mcg PA 701/1/2
Mercury Pharma Group Limited,
Capital House, 85 King William Street,
London EC4N 7BL, UK
Manufacturer: Custom Pharmaceuticals Ltd,
Tecore House, Conway Street,
Hove, East Sussex, BN3 3LW, UK.
WHAT IS YOUR MEDICINE USED FOR?
Eltroxin Tablets are given to you by your
doctor because you have low levels of
thyroid hormone (hypothyroidism) and
your metabolism is lower than normal.
Thyroid hormone is vit

Summary of Product characteristics

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Eltroxin 25 microgram Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 micrograms levothyroxine sodium anhydrous.
Excipients: contains Lactose
30.49mg
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet. White uncoated biconvex tablets engraved on one face
“FW41” and a score line on the
other. The scoreline is to allow breaking for ease of swallowing.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Recommended clinical indications: Control of hypothyroidism,
congenital hypothyroidism and
juvenile myxoedema.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults: Initially 50 to 100 micrograms daily (2 to 4 tablets daily),
preferably taken before breakfast.
Adjust at three to four week intervals by 50 micrograms until normal
metabolism is steadily
maintained: this may require doses of 100 to 200 micrograms daily.
For patients over 50 years, it is not advisable to exceed 50
micrograms daily initially and where
there is cardiac disease, 25 micrograms daily or 50 micrograms on
alternate days is more suitable
initially. In this condition the daily dose may be increased by 25
micrograms at intervals of perhaps
4 weeks.
For patients younger than 50 years, and in the absence of heart
disease, a serum thyroxine (T4) level
of 70 to 160 nanomols per litre, or a serum thyrotrophin level of less
than 5 milliunits per litre
should be targeted.
For patients aged over 50 years, with or without cardiac disease,
clinical response is probably a
more acceptable criterion of dosage, rather that serum levels.
A pre-therapy ECG is valuable because ECG changes due to
hypothyroidism may be confused with
ECG evidence of cardiac ischaemia. If too rapid an increase in
metabolism is produced (causing
diarrhoea, nervousness, rapid pulse, insomnia, tremors, and sometimes
anginal pain where there is
latent cardiac ischaemia,) dosage must be reduced, or withheld, for a
day or two, and then re-started
at a lower dose