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LEVOTHYROXINE TABLETS B.P. 25MCG.

Active substance(s): LEVOTHYROXINE SODIUM ANHYDROUS

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Package Leaflet: Information for the user
Levothyroxine 25 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 further questions, please
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.
The name of your medicine is
Levothyroxine 25 Micrograms Tablets.
In the rest of this leaflet it is called
Levothyroxine Tablets.
What is in this leaflet:
1. What Levothyroxine Tablets are and what they are used for
2. What you need to know before you take Levothyroxine Tablets
3. How to take Levothyroxine Tablets
4. Possible side effects
5. How to store Levothyroxine Tablets
6. Contents of the pack and other information

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1. What Levothyroxine Tablets are and what they
are used for
The active ingredient in Levothyroxine Tablets is levothyroxine sodium
which is the same as thyroxine, a hormone produced by the thyroid
gland.
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
Levothyroxine 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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2. What you need to know before you take
Levothyroxine Tablets
Do not take Levothyroxine Tablets:
• if you are allergic to levothyroxine sodium or any of the other
ingredients of this medicine (listed in section 6)
• if you suffer from an overactive thyroid gland that produces too
much thyroid hormone (thyrotoxicosis)
• if you 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.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Levothyroxine
Tablets:
• if you have suffered with an underactive thyroid gland for a long time
• if you suffer from heart problems including angina, coronary artery
disease, or high blood pressure
• if you are being treated for diabetes. The dose of your antidiabetic
medicine may need to be changed as levothyroxine can raise blood
sugar levels
• if you are over 50 years of age.
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.

Other medicines and Levothyroxine Tablets
Tell your doctor or pharmacist if you are taking, have recently 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 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
• orlistat – used to treat obesity.
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 severe 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.
If you have any doubts about whether you should take this medicine
then discuss matters with your doctor before taking it.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine. Your doctor will decide if you should
continue treatment with levothyroxine whilst you are pregnant,
particularly in the first three months of your pregnancy.
Driving and using machines
This medicine should not affect your ability to drive and use machines.
Levothyroxine Tablets contain lactose and sucrose
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal product,
as it contains lactose and sucrose. You should not take Levothyroxine
Tablets if you have hereditary problems such as galactose intolerance,
the Lapp lactose deficiency or glucose-galactose malabsorption.

3. How to take Levothyroxine Tablets
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
You may be taking this medicine for the rest of your life.
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 recommended starting dose is 50 – 100 micrograms daily.
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.

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Levothyroxine 25mcg - 28 Tablets
Wockhardt UK
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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
label. The expiry date refers to the last day of that month.
Do not use this medicine if you notice signs of deterioration such as
discoloration.
Do not store above 25°C.
Store in the original container or package in order to protect from light
and moisture. Do not transfer the tablets to another container.
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.

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What Levothyroxine Tablets contain
The active substance is levothyroxine sodium.
Each tablet contains 27.8 micrograms of levothyroxine sodium
equivalent to 25 micrograms of anhydrous levothyroxine sodium.
The other ingredients are lactose, sucrose (fine powder), maize starch,
magnesium stearate.
What Levothyroxine Tablets look like and contents of the pack
Levothyroxine 25 micrograms Tablets are white, circular, curved tablets
marked TX25 on one face and CP on the reverse.
Levothyroxine 25 micrograms Tablets are available in polypropylene or
polyethylene (plastic) containers or blister strip packs of 28 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham,
LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or
audio please call, free of charge: 0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Reference number
Levothyroxine 25 Micrograms Tablets
29831/0130
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in 06/2017

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6. Contents of the pack and other information

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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.

5. How to store Levothyroxine Tablets

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4. Possible side effects

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
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.

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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 body weight 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 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 Levothyroxine Tablets
If you forget to take a dose, take another 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 Levothyroxine 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.

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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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