Eltroxin 50mcg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LEVOTHYROXINE SODIUM

Available from:

Amdipharm Limited Temple Chambers, 3 Burlington Road, Dublin 4, Ireland

ATC code:

H03AA01

INN (International Name):

LEVOTHYROXINE SODIUM 50 µg

Pharmaceutical form:

TABLET

Composition:

LEVOTHYROXINE SODIUM 50 µg

Prescription type:

POM

Therapeutic area:

THYROID THERAPY

Authorization status:

Authorised

Authorization date:

2007-05-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ELTROXIN™ 25, 50, 100 MICROGRAMS 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4
• Thyroxine is a hormone produced by the thyroid gland.
Levothyroxine is used to replace
thyroxine in people whose thyroid gland does not work properly. You
will usually need to
take this medicine for the rest of your life and must not stop taking
it, or change the dose,
without speaking to your doctor first.
• This medicine can affect the way other medicines work
(See Section 2 ‘Taking other
medicines’). If you take medicines to control diabetes or warfarin
to prevent blood clots, the dose
may need to be adjusted by your doctor when you start taking Eltroxin
tablets.
• You will start off taking a low dose of this medicine (See Section
3 ‘How to take’). Your
doctor will then increase the dose gradually at 3 – 4 week intervals
until your thyroxine levels
are corrected. This will help to reduce the chance of side effects.
• You will need regular blood tests whilst you are taking this
medicine.
• These tablets can be taken by both adults and children. If you are
giving this medicine to your
child make sure you know how many and when to give the tablets (See
Section 3 ‘How to take’)
and what side effects to look out for (See Section 4 ‘Possible side
effects’).
WHAT IS IN THIS LEAFLET
1. What Eltroxin Tablets are and what they are used for
2. What you need to know before you take Eltroxin Tablets
3. How to take Eltroxin Tablets
4. Possible

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eltroxin 50 microgram Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 micrograms anhydrous levothyroxine sodium.
Excipient with known effect:
Lactose monohydrate 31.879 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Each white tablet is scored on one side and is engraved with
‘Eltroxin 50’ on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Recommended clinical indications: Control of hypothyroidism,
congenital hypothyroidism in
infants, acquired hypothyroidism in children and juvenile myxoedema.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 level.
Initial monitoring and dose adjustments.
It is especially necessary when starting Eltroxin to establish a
maintenance dose. The timing of
this blood test depends on patients symptoms. If their symptoms have
improved after starting
Eltroxin, patients should have their TSH level measured at around 6
weeks after starting Eltroxin.
If a patient still has symptoms 2-3 weeks after starting Eltroxin,
they will need a TSH level taken
earlier.
_Adults (under 50 years age)_
:
Initially 50 to 100 micrograms daily, preferably taken before
breakfast or the first meal of the day.
Adjust at three to four week intervals by 50 micrograms until normal
metabolism is steadily
maintained: The final daily dose may be up to 100 to 200 microgram. In
younger patients and in
the absence of heart disease, a serum thyroxine (T4) level of
appro