Eltroxin 25 microgram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levothyroxine sodium

Available from:

Mercury Pharmaceuticals Ltd

ATC code:

H03AA; H03AA01

INN (International Name):

Levothyroxine sodium

Dosage:

25 microgram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Thyroid hormones; levothyroxine sodium

Authorization status:

Marketed

Authorization date:

2004-07-02

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 side eff

Summary of Product characteristics

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 with known effect: Lactose 30.49mg
For the 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 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 ischemia.
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 ischemia) 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 (2 to 4 tablets 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 thyroxine
(T4) level of approximately 70 to 160 nanomoles per litre, or