Eltroxin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Levothyroxine sodium, hydrate 55.63ug (pentahydrate equivalent to 50 mcg of anhydrous substance)

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Levothyroxine sodium, hydrate 55.63 µg (pentahydrate equivalent to 50 mcg of anhydrous substance)

Dosage:

50 mcg

Pharmaceutical form:

Tablet

Composition:

Active: Levothyroxine sodium, hydrate 55.63ug (pentahydrate equivalent to 50 mcg of anhydrous substance) Excipient: Colloidal silicon dioxide Magnesium stearate Microcrystalline cellulose Pregelatinised maize starch Purified talc

Units in package:

Bottle, plastic, Polypropylene bottles; LDPE closures, 1000 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sandoz GmbH

Therapeutic indications:

Levothyroxine is indicated for the treatment of hypothyroidism.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with PP cap - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE with PP cap - 200 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, Polypropylene bottles with LDPE closures - 1000 tablets - 24 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2004-03-23

Patient Information leaflet

ELTROXIN® NZ – Consumer Medicine Information
Page 2 of 5
ELTROXIN
®
_LEVOTHYROXINE SODIUM 50 MICROGRAMS AND 100 MICROGRAMS TABLETS _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ELTROXIN tablets. It
does not contain all of the
available information. It does not take the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
expected benefits of you taking ELTROXIN
against the risks this medicine could have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR MEDICINE.
You may need to read it again.
WHAT ELTROXIN IS USED FOR
ELTROXIN contains the active ingredient levothyroxine sodium. It
belongs to a small group of medicines
called thyroid hormones, which work by replacing the body’s low
levels of thyroxine.
ELTROXIN 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. Symptoms of
hypothyroidism include tiredness, muscle weakness, cramps, feeling the
cold, a slow heart rate, dry and flaky
skin, hair loss, a deep husky voice and weight gain.
ELTROXIN is also used to treat children born with hypothyroidism
(congenital), those who develop
hypothyroidism in the first year of life (neonatal) and children who
have hypothyroidism as part of juvenile
myxoedema, a condition in which the amount of thyroxine produced by
the body is low.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ELTROXIN HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed ELTROXIN for another purpose. ELTROXIN
is available only with a
doctor’s prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE ELTROXIN IF:
•
you have or have had an allergic reaction to any of the ingredients in
ELTROXIN listed at the end of
this leaflet.
•
the packaging is torn or shows signs of interference, or

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1
PRODUCT NAME
ELTROXIN
®
(50 mcg, 100 mcg tablets)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets containing 50 micrograms (0.05 mg) or 100 micrograms (0.1 mg)
anhydrous
levothyroxine sodium, which is the monosodium salt of the levorotary
isomer of thyroxine.
100 mcg levothyroxine is equivalent in activity to 20 to 30 mcg
liothyronine or 60 mg thyroid
BP.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Eltroxin 50 microgram (0.05 mg) tablets are white to off-white, round,
biconvex tablets,
imprinted with GS 11E on one face and 50 on the other.
Eltroxin 100 microgram (0.1 mg) tablets are white to off-white, round,
biconvex tablets,
imprinted with GS 21C on one face and 100 on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levothyroxine is indicated for the treatment of hypothyroidism.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
Thyroxine has a narrow therapeutic index. Appropriate thyroxine dosage
is based upon
clinical assessment and laboratory monitoring of thyroid function
tests. During the initial
titration
period,
careful
dosage
titration
and
monitoring
is
necessary
to
avoid
the
consequences of under- or over-treatment. The symptoms of excessive
thyroxine dosage
are the same as many features of endogenous thyrotoxicosis.
If the dose of thyroxine is increased too rapidly, symptoms such as
diarrhoea, nervousness,
rapid pulse, insomnia, tremors and sometimes anginal pain where there
is latent myocardial
ischaemia may occur, and the dosage must be reduced or withheld for a
day or two, then
restarted at a lower level. A pre-therapy ECG is valuable, as changes
induced by
hypothyroidism may be confused with ECG evidence of ischaemia.
Thyroxine tablets should preferably be taken on an empty stomach.
Missed dosage – If a scheduled daily dose is missed, the dose should
be taken as soon as
the patient remembers, unless it is almost time for the patient’s
next dose. Two doses
should not be taken together.
In
patients
whose
medications
include
levothyro