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ELTROXIN 25 MICROGRAMS TABLETS

Active substance: LEVOTHYROXINE SODIUM ANHYDROUS

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Ref: 1336/110814/1/F

Eltroxin 25 micrograms Tablets
®

(levothyroxine sodium)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again. If you have any further
questions, ask your doctor or pharmacist. This medicine has been
prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
Your medicine is called Eltroxin 25 micrograms Tablets but will be referred to
as Eltroxin Tablets throughout the leaflet.

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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’).

In this leaflet:
1 What Eltroxin Tablets are and what they are used for
2 Before you take Eltroxin Tablets
3 How to take Eltroxin Tablets
4 Possible side effects
5 How to store Eltroxin Tablets
6 Further information

1

What Eltroxin Tablets are and what they are used for

Thyroxine is a hormone which is produced naturally in the body by the
thyroid gland. Levothyroxine is a synthetic version of this hormone.
Thyroxine controls how much energy your body uses.
When the thyroid gland does not produce enough thyroxine (a condition
known as hypothyroidism), many of the body’s functions slow down. Some
of the most common symptoms of hypothyroidism are:
* tiredness
* weight gain
* feeling depressed
Eltroxin tablets are used to replace the thyroxine that your thyroid gland
cannot produce and prevent the symptoms of hypothyroidism. Before
starting your treatment your doctor will carry out a blood test to work out how
much levothyroxine you need.

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Before you take Eltroxin Tablets

Do not take this medicine if you:
* are allergic to levothyroxine or to any of the other ingredients (see section
6)
suffer from an overactive thyroid gland that produces too much thyroid
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hormone (thyrotoxicosis)
* have any condition that affects your adrenal glands (your doctor will be
able to advise you if you are not sure).
If any of these apply to you, do not take this medicine and go back to your
doctor to discuss your treatment.
Check with your doctor or pharmacist before taking these tablets if
you:
* have suffered with an under active thyroid gland for a long time
from heart problems including angina, coronary artery disease or
* sufferblood pressure
high
for diabetes. The dose of your anti-diabetic medicine
* are being treatedchanged as levothyroxine can raise blood sugar levels
may need to be
are over 50 years of age.

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Blood tests:
Before you start taking levothyroxine your doctor will do a blood test to see
how much thyroxine your thyroid gland is making and what dose of the
medicine you will need. Once you start taking the medicine your doctor will
want you to have regular blood tests to see how well the medicine is
working.
Taking other medicines:
Many medicines affect the way levothyroxine works. The effects of other
drugs may also be affected by levothyroxine. You must tell your doctor if
you are taking or start taking any other medicines including over the
counter medicines, herbal remedies and vitamin supplements.
The following may affect the way that levothyroxine works:
* medicines for epilepsy such as carbamazepine, phenytoin, primidone
and barbiturates
* sertraline – used to treat depression and anxiety disorders
* antacids – used to treat indigestion
* medicines containing calcium salts
* cimetidine – used to reduce excess stomach acid
* proton pump inhibitors such as omeprazole, lansoprazole and
pantoprazole - used to reduce the amount of acid produced by the
stomach
* sucralfate – used to treat and prevent stomach and duodenal ulcers
* cholestyramine and colestipol – used to treat high level of fat in the
blood
* polystyrene sulphone resin – used to reduce high levels of potassium in
the blood
* medicines containing iron that are taken by mouth
* rifampicin – used to treat infections
* imatinib – used to treat certain types of cancer
* beta blockers such as atenolol and sotalol – used to treat high blood
pressure and heart problems
* oestrogen containing medicines for hormone replacement therapy
(HRT) and contraception (the ‘pill’)
* androgen containing medicines for male hormone replacement therapy
* corticosteroids such as hydrocortisone and prednisolone – used to
treat inflammation
* amiodarone – used to treat an irregular heart beat
The following may be affected by levothyroxine:
* anticoagulant medicines to prevent blood clots such as warfarin
* medicines to treat diabetes such as insulin and metformin
* tricyclic antidepressants such as amitriptyline, imipramine and
dosulepin
* medicines that stimulate the sympathetic nervous system such as
adrenaline (used to treat sever allergic reactions) or phenylephrine (a
decongestant found in many cold and flu treatments)
* digoxin – used to treat heart problems
* anti-inflammatory medicines such as phenylbutazone or aspirin
* propanolol – used to treat high blood pressure and heart problems
* ketamine – used as an anaesthetic. If you need to have an operation,
please tell your doctor or anaesthetist that you are taking levothyroxine
Pregnancy and breastfeeding:
If you are pregnant, particularly in the first three months of your pregnancy,
planning to become pregnant or are breastfeeding tell your doctor or
pharmacist before taking this medicine. Your doctor will decide if you should
continue treatment with levothyroxine whilst you are pregnant.
Important information about some of the ingredients of Eltroxin
Tablets:
This medicine also contains lactose, a sugar. If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicine.

3

How to take Eltroxin Tablets

You may be taking this medicine for the rest of your life. Always take Eltroxin
tablets exactly as your doctor has told you. If you are not sure, check with
your doctor or pharmacist.
Your dose will be decided by your doctor and will depend on the results of
your blood tests. The dose you should take will be on the label attached by
your pharmacist. Swallow the tablets with plenty of water. You should usually
take your tablets before breakfast or your first meal of the day
Adults:
The usual starting dose is 50 – 100 micrograms every day. Your doctor may
increase the dose you take every 3 – 4 weeks by 50 micrograms until your
thyroxine levels are correct. Your final daily dose may be up to 100 – 200
micrograms daily.

Ref: 1336/110814/1/B

Eltroxin 25 micrograms Tablets
®

(levothyroxine sodium)
Patient Information Leaflet (continued)
Patients over 50 years of age:
The usual starting dose will be no more than 50 micrograms every day. The
dose may then be increased by 50 micrograms every 3 – 4 weeks until your
thyroxine levels are correct. Your final daily dose will be between 50 – 200
micrograms daily.
Patients over 50 years of age with heart problems:
The starting dose will be 25 micrograms every day or 50 micrograms every
other day. The dose may be increased by 25 micrograms every 4 weeks
until your thyroxine levels are correct. Your final daily dose will usually be
between 50 – 200 micrograms daily.
Giving these tablets to children:
The dose for children depends on their age, weight and the condition being
treated. Your child will be monitored to make sure that they get the right
dose. You should give them their medicine at least half an hour before
breakfast or their first meal of the day. If necessary, the tablets can be
dissolved in 10 - 15ml of water and given with some more liquid (5 - 10ml).
The dissolved tablets should be taken straight away. Do not keep the
solution to give to your child later.
Congenital hypothyroidism in infants:
This is a condition where your baby has been born with a thyroid gland that
does not produce enough thyroxine. The starting dose is 10 -15
micrograms/kg bodyweight per day for the first three months. The dose will
then be adjusted depending on how your baby responds to the treatment.
Acquired hypothyroidism in children:
This is a condition where your child’s thyroid gland stops working properly
because it has been attacked by their immune system, e.g. in children with
an autoimmune disease or following a viral infection. The starting dose is
12.5 – 50 micrograms per day. The dose will then be increased every 2 - 4
weeks depending on how your child responds to the medicine.
Juvenile myxoedema:
This is a condition where children and adolescents develop severe
hypothyroidism (produce very low levels of thyroid hormones). The starting
dose is 25 micrograms every day. The dose will then be increased by 25
micrograms every 2 – 4 weeks until your child shows mild symptoms of
hyperthyroidism (a condition where the thyroid gland produces too much
thyroxine). The dose will then be reduced slightly.
If you take more Levothyroxine than you should:
If you (or someone else) swallow a lot of the tablets at the same time, or you
think a child may have swallowed some, contact your nearest hospital
casualty department or tell your doctor immediately. Signs of an overdose
may include: fever, chest pain (angina), racing or irregular heartbeat, muscle
cramps, headache, restlessness, flushing, sweating and diarrhoea. These
signs can take up to 5 days to appear. Take any remaining tablets and this
leaflet with you so that the medical staff knows exactly what you have taken.
If you forget to take Levothyroxine:
If you forget to take a dose take it as soon as you remember unless it is
nearly time for your next dose. Do not take a double dose. If you forget to
give your child their dose, contact your doctor or pharmacist for further
advice.
Stopping the tablets:
These tablets are for long term use. You may need to take them for the rest
of your life. Do not stop taking the tablets unless your doctor has told you to
do so

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Possible side effects

Some people may have side-effects when taking this medicine.
Stop taking the tablets and go to hospital at once if you have:
* a rare allergic reaction such as swelling of the face, tongue, lips and
throat, difficulty breathing, severe itching of your skin with raised lumps,
joint pain, sensitivity to the sun, general feeling of being unwell. You may
need urgent medical attention.
Some patients may experience a severe reaction to high levels of
thyroid hormone. This is called a “thyroid crisis” and you should
contact your doctor immediately if you have any of the following
symptoms:
* very high temperature; fast heart rate; irregular heartbeat; low blood
pressure; heart failure; jaundice; confusion; fits and coma.
Tell your doctor or pharmacist if any of the following side effects
continue, get worse or if you notice any other side effects not listed.
Most of the side effects are similar to the symptoms of hyperthyroidism
(where the thyroid gland makes too much thyroxine) and are due to your
dose of the medicine being too high. They will usually disappear after
reducing the dose or stopping the tablets. However, you must not change
the dose or stop the tablets without talking to your doctor first.
* headache
* flushing
* high temperature, sweating
* weight loss
* tremor, restlessness, excitability, difficulty sleeping (insomnia)

* increased pressure around the brain in children that is not cause by a
tumour or other diseases (benign intracranial hypertension)

* chest pain (angina), pounding, irregular or fast heartbeat
* diarrhoea, vomiting
* muscle cramps, muscle weakness,
* deformity of the skull in infants caused by the early closure of joins in the
skull bone (craniostenosis)

* growth in children may slow or stop due to changes in bone growth
* irregular periods
* intolerance to heat
* temporary hair loss in children.
Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.

5

How to store Eltroxin Tablets

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Store in the original package.
Protect from light. Protect from moisture.
Do not take this medicine after the expiry date shown on the carton or blister
label. If your doctor tells you to stop taking the medicine, take any remaining
medicine back to the pharmacist for safe disposal. Only keep this medicine if
your doctor tells you to.
If your medicine becomes discoloured or shows any signs of deterioration,
ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via waterwaste or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6

Further information

What this medicine contains:
Each tablet contains 25 micrograms of anhydrous levothyroxine sodium.
The other ingredients are sodium citrate, lactose, maize starch,
acacia powder and magnesium stearate.
What this medicine looks like and contents of the pack
Each tablets is white and round it is scored on one side and engraved FW41
on the other side.
They are packed in a blister pack of 28.
Manufacturer and Licence Holder
This medicine is manufactured by Custom Pharmaceuticals Ltd, Tecore
House, Conway Street, Hove, East Sussex, BN3 3LW, UK and is procured
from within the EU and repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1336

Eltroxin 25 micrograms tablets

Eltroxin is a registered trademark of Mercury Pharma Group Limited.
Revision date: 11/08/14

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Phone Lexon (UK) Limited, Tel: 01527 505414
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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