Eltroxin 100mcg Tablets

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

LEVOTHYROXINE SODIUM

Disponible des:

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

Codi ATC:

H03AA01

Designació comuna internacional (DCI):

LEVOTHYROXINE SODIUM 100 µg

formulario farmacéutico:

TABLET

Composición:

LEVOTHYROXINE SODIUM 100 µg

tipo de receta:

POM

Área terapéutica:

THYROID THERAPY

Estat d'Autorització:

Authorised

Data d'autorització:

2007-04-11

Informació per a l'usuari

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

Fitxa tècnica

SUMMARY OF
PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eltroxin 100 microgram Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 micrograms anhydrous levothyroxine sodium.
Excipients with known effect: lactose monohydrate 48.86mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A white uncoated biconvex tablet with the words ‘Eltroxin 100’
engraved on one face and with a
breakline on the other face.
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 micrograms.
In younger patients and in
the absence of heart disease, a serum