Skip to Content

UK Edition. Click here for US version.

ELTROXIN TABLETS 100MCG

Active substance(s): LEVOTHYROXINE SODIUM ANHYDROUS / LEVOTHYROXINE SODIUM ANHYDROUS / LEVOTHYROXINE SODIUM ANHYDROUS

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user
®

Eltroxin 50 and 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.

taken or might take any other medicines. This includes over the
counter medicines, herbal remedies and vitamin supplements.
Many medicines affect the way levothyroxine works. The effects
of other drugs may also be affected by levothyroxine.

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
Your medicine is called either Eltroxin 50 micrograms or 100
produced by the stomach
micrograms tablets depending on what your doctor has • sucralfate – used to treat and prevent stomach and
prescribed. It will be known as Eltroxin Tablets for ease hereafter.
duodenal ulcers
What is in this leaflet
• cholestyramine and colestipol – used to treat high level of
fat in the blood
1. What Eltroxin Tablets are and what they are used for
2. What you need to know before you take Eltroxin Tablets • polystyrene sulphone resin – used to reduce high levels of
potassium in the blood
3. How to take Eltroxin Tablets
• medicines containing iron that are taken by mouth
4. Possible side effects
• rifampicin – used to treat infections
5. How to store Eltroxin Tablets
• imatinib – used to treat certain types of cancer
6. Contents of the pack and other information
• beta blockers such as atenolol and sotalol – used to treat
1. WHAT ELTROXIN TABLETS ARE AND
high blood pressure and heart problems
WHAT THEY ARE USED FOR
• oestrogen containing medicines for hormone replacement
therapy (HRT) and contraception (the ‘pill’)
Thyroxine is a hormone which is produced naturally in the body
by the thyroid gland. Levothyroxine is a synthetic version of this • androgen containing medicines for male hormone
replacement therapy
hormone. Thyroxine controls how much energy your body uses.
When the thyroid gland does not produce enough thyroxine (a • corticosteroids such as hydrocortisone and prednisolone
condition known as hypothyroidism), many of the body’s
– used to treat inflammation
functions slow down.
• amiodarone – used to treat an irregular heart beat
Some of the most common symptoms of hypothyroidism are: • orlistat – used to treat obesity.
• tiredness
The following may be affected by levothyroxine:
• weight gain
• anticoagulant medicines to prevent blood clots such as
• feeling depressed
warfarin
Eltroxin tablets are used to replace the thyroxine that your
thyroid gland cannot produce and prevent the symptoms of • medicines to treat diabetes such as insulin and metformin
hypothyroidism. Before starting your treatment your doctor will • tricyclic antidepressants such as amitriptyline,
imipramine and dosulepin
carry out a blood test to work out how much levothyroxine you
• medicines that stimulate the sympathetic nervous system
need.
such as adrenaline (used to treat severe allergic reactions)
or phenylephrine (a decongestant found in many cold and
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
flu treatments)
ELTROXIN TABLETS
• digoxin – used to treat heart problems
Do not take Eltroxin tablets:
• anti-inflammatory medicines such as phenylbutazone or
• if you are allergic to levothyroxine or any of the other
aspirin
ingredients of this medicine (listed in section 6)
• propanolol – used to treat high blood pressure and heart
• if you suffer from an overactive thyroid gland that produces
problems
too much thyroid hormone (thyrotoxicosis)
• ketamine – used as an anaesthetic. If you need to have an
• if you have any condition that affects your adrenal glands
operation, please tell your doctor or anaesthetist that you
(your doctor will be able to advise you if you are not sure).
are taking levothyroxine.
If any of these apply to you, do not take this medicine and go
Pregnancy and breast-feeding:
back to your doctor to discuss your treatment.
If you are pregnant or breast-feeding, think you may be
Warnings and precautions
pregnant or are planning to have a baby, ask your doctor or
Talk to your doctor, pharmacist or nurse before taking Eltroxin pharmacist for advice before taking this medicine. Your doctor
Tablets:
will decide if you should continue treatment with levothyroxine
• if you have suffered with an under active thyroid gland for a whilst you are pregnant, particularly in the first three months of
your pregnancy.
long time
• if you suffer from heart problems including angina,
Driving and using machines:
coronary artery disease or high blood pressure
This medicine should not affect your ability to drive and use
• if you are being treated for diabetes. The dose of your anti- machines.
diabetic medicine may need to be changed as
Eltroxin Tablets contain lactose:
levothyroxine can raise blood sugar levels
This medicine also contains lactose, a sugar. If you have been
• if you are over 50 years of age.
told by your doctor that you have an intolerance to some
Blood tests:
sugars, contact your doctor before taking this medicine.
Before you start taking levothyroxine your doctor will do a blood
test to see how much thyroxine your thyroid gland is making
3. HOW TO TAKE ELTROXIN TABLETS
and what dose of the medicine you will need. Once you start
Always
take
this medicine exactly as your doctor or pharmacist
taking the medicine your doctor will want you to have regular
has told you. Check with your doctor or pharmacist if you are
blood tests to see how well the medicine is working.
not sure. You may be taking this medicine for the rest of your
Other medicines and Eltroxin Tablets
life. Your dose will be decided by your doctor and will depend
Tell your doctor or pharmacist if you are taking, have recently 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 recommended 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.
Patients over 50 years of age:
The recommended 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 recommended 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.
Use in children:
For young children, your doctor is likely to prescribe
Levothyroxine Oral Solution instead of tablets.
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 Eltroxin Tablets 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 Eltroxin Tablets:
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 to make up for a forgotten dose. If you forget to give your
child their dose, contact your doctor or pharmacist for further
advice.
If you stop taking Eltroxin 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.
If you have any further questions on the use of this medicine,
ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
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.
Not known (frequency cannot be estimated from the available
data)
• headache
• flushing
• high temperature, sweating
• weight loss
• tremor, restlessness, excitability, difficulty sleeping
(insomnia)
• increased pressure around the brain in children that is not
caused 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 joints 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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the carton after EXP.
Do not store above 25°C. Store in the original package in order
to protect from light and moisture.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the
environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Eltroxin Tablets contain
- The active substance is anhydrous levothyroxine sodium.
Each tablet contains 50 and 100 micrograms of anhydrous
levothyroxine sodium respectively.
- The other ingredients are sodium citrate, lactose, maize
starch, acacia powder and magnesium stearate.
What Eltroxin Tablets look like and contents of the pack
Each tablet is engraved on one side with LT and engraved on
the other with either
50mcg - 50
100mcg - 100.
They are packed in a blister pack of 28, 56 or 112 tablets and
polypropylene containers of 28, 56, 100, 112 or 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mercury Pharma Group Ltd., Capital House, 85 King William
Street, London, EC4N 7BL, UK
Manufacturer:
Custom Pharmaceuticals Ltd., Tecore House, Conway Street,
Hove, East Sussex, BN3 3LW, UK
This leaflet was last revised in September 2016.
Eltroxin is a registered trademark of Mercury Pharma Group
Limited.
100055-056-335-336/ LF/034/07

Expand Transcript

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.

Hide