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Ref: 1336/180313/1/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.
* If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Eltroxin 25 micrograms Tablets but will be referred to
as Eltroxin Tablets throughout the leaflet.
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


What Eltroxin Tablets are and what they are used for

Eltroxin contains levothyroxine sodium which is a synthetic form of the
hormone thyroxine.
Thyroxine is normally in the body produced by the thyroid gland in the neck.
It controls many bodily functions, mainly to do with growth and energy.
Eltroxin is used to treat an under active thyroid which is not producing
enough thyroxine.


Before you take Eltroxin Tablets

DO NOT take Eltroxin Tablets if:
* you know that you are allergic to levothyroxine sodium or any of the other
ingredients of Eltroxin (see section 6 of this leaflet)
* you have been told that your thyroid is overactive (where your thyroid
gland produces too much thyroxine).
Please tell your doctor if any of the above applies to you.
Take special care with Eltroxin Tablets if you:
suffer from diabetes. The dosage of your diabetic treatment may need to
be altered.
* suffer from high blood pressure, heart failure or a heart attack
* suffer from any condition which affects your adrenal glands (your doctor
will be able to advise you)
* you are over 50 years of age
* have a long standing history of low thyroxine levels.


colestyramine and colestipol, used to reduce the level of cholesterol in the
calcium supplements, used to treat low levels of calcium in your blood
antacids, used to treat indigestion
rifampicin, used to treat infections
iron preparations, used to treat anaemia
cimetidine, used to treat excess acid in the stomach
beta-blockers (e.g. propranolol) used to treat high blood pressure
drugs used to treat epilepsy (e.g. phenytoin, carbamazepine, primidone,
anticoagulants (e.g. warfarin) used to thin the blood and treat blood clots
drugs used to treat depression and other conditions, including
amitriptyline, imipramine and sertraline
oral contraceptives (“the pill”)
steroids and other hormone treatments such as male hormone
replacement therapies
anti-inflammatory drugs e.g. phenylbutazone and aspirin
decongestant medicines such as phenylephrine, or adrenaline (for
treatment of severe allergies)
imatinib, used for the treatment of cancer
sodium polystyrene sulfonate, used in the treatment of kidney failure
sucralfate, used for the treatment of gut ulcers
ketamine, used as an anaesthetic.

Pregnancy and breast feeding:
If you are pregnant particularly in the first three months or planning to
become pregnant or are breast-feeding discuss your medication with your
doctor. The decision on whether it is best to take Eltroxin tablets during
pregnancy or breast feeding will be made by your doctor.
Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines:
Eltroxin tablets should not interfere with your ability to drive or use
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.


How to take Eltroxin Tablets

Always take Eltroxin Tablets exactly as your doctor has told you. Do NOT
take more than your doctor tells you to. You should check with your doctor or
pharmacist if you are not sure.


It is important that your doctor is aware if any of the above apply to you.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription,
especially if you are taking:
* digoxin, used to treat heart problems including an irregular heart beat
* insulin and other treatments for diabetes

Swallow the tablets with a glass of water, preferably before breakfast.
The usual starting dose for adults is 50 to 100 micrograms daily. This may
be adjusted after a few weeks depending on the response to your treatment
which will be monitored by blood tests.
For patients over 50 years the starting dose will not usually exceed 50
Children under 12 years:
The dose for children depends on their age, weight and the condition being
Your child will be monitored to make sure he/she gets the right dose.
Give your child this medicine at least half an hour before the first meal of the

Ref: 1336/180313/1/B

Eltroxin 25 micrograms Tablets

(rosuvastatin calcium)
Patient Information Leaflet (continued)
Congenital hypothyroidism in infants:
Initially 10 to 15 micrograms/kg body weight a day for the first 3 months. The
dose will then be adjusted depending on response to treatment.
Acquired hypothyroidism in children:
Initially 12.5 to 50 micrograms a day. The dose should be increased
gradually every 2 to 4 weeks depending on response to treatment. If
required the tablets can be dissolved in 10 to 15ml of drinkable water and
given freshly prepared with some more liquid (5 to 10ml).
In the event of stopping treatment, Eltroxin tablets should be withdrawn
gradually under the supervision of your doctor.
If you take more Eltroxin Tablets than you should:
If you think that you, or any other person, have taken too many tablets,
contact your doctor or hospital casualty department immediately. 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 your Eltroxin Tablets:
If you miss a dose but remember within two or three hours you can still take
that dose. If you miss a dose for longer then do not catch up. Wait until your
next dose is due and take the normal amount.


Possible side effects

Like all medicines, Eltroxin tablets can sometimes cause side effects,
although not everybody gets them.


How to store Eltroxin Tablets

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.


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.

The following effects can occur if your initial dose of the medicine is too high:
All medicines can cause allergic reactions although serious allergic
reactions are rare. Any sudden wheeziness, difficulty in breathing,
swelling of the eyelids, face or lips, rash or itching (especially affecting
your whole body) should be reported to a doctor immediately.
* fever
* intolerance to heat
* mild hair-loss is seen in children
* loose stools
* tremor (shaking), restlessness, excitability
* difficulty sleeping
* rapid heart beat or angina (pain in the chest on exercise).

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.

You should consult your doctor if any of the above effects occur. The effects
usually go away when the dose has been changed.

Eltroxin is a registered trademark of Mercury Pharma Group Limited.

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.


PL 15184/1336

Eltroxin 25 micrograms tablets

Revision date: 18/03/13
Other side effects you could experience are:
* irregular heart beats, palpitations (thumping heart beats)
* muscle cramps or weakness
* vomiting
* headaches, flushing, sweating
* loss of weight
* in women – changes to your periods.
If any of the side effects become serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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.