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LEVOTHYROXINE SODIUM MPT PHARMA 25 MICROGRAMS/5 ML ORAL SOLUTION

Active substance(s): LEVOTHYROXINE SODIUM / LEVOTHYROXINE SODIUM

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Package Leaflet: Information for the User

Levothyroxine sodium Teva® 25 micrograms/5 ml oral solution
(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 or pharmacist.
 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 or pharmacist. This
includes any possible side effects not listed in this leaflet.
See section 4.
 The name of this medicine is Levothyroxine sodium Teva
25 micrograms/5ml oral solution but will be referred to as
Levothyroxine sodium Teva throughout the remainder of this leaflet.
 This medicine is also available in other strengths.

Levothyroxine sodium Teva with food and drink
Soy-containing products can decrease absorption of levothyroxine.

In this leaflet:
1. What Levothyroxine sodium Teva is and what it is used for
2. What you need to know before you take Levothyroxine sodium Teva
3. How to take Levothyroxine sodium Teva
4. Possible side effects
5. How to store Levothyroxine sodium Teva
6. Contents of the pack and other information

Levothyroxine sodium Teva contains sodium methyl
parahydroxybenzoate and glycerol
Sodium methyl parahydroxybenzoate (E219) which may cause allergic
reactions (possibly delayed). Glycerol may cause headache, stomach
upset and diarrhoea.

1. What Levothyroxine sodium Teva is and what it is used for
Levothyroxine sodium Teva is used to treat hypothyroidism, a condition
in which the thyroid gland is underactive and so does not make enough
thyroxine for the body’s needs.
Levothyroxine sodium Teva is also used to treat thyroid cancer and
diffuse non-toxic goitre or Hashimoto’s thyroiditis, conditions in which the
thyroid gland becomes enlarged causing a swelling in the front of the
neck.
2. What you need to know before you take Levothyroxine sodium
Teva
Do NOT take Levothyroxine sodium Teva:
 If you are allergic to levothyroxine, sodium methyl
parahydroxybenzoate or any of the other ingredients of this medicine
(listed in section 6)
 If you suffer from adrenal insufficiency and you do not have adequate
corticosteroid cover
 If you have a heart attack (acute myocardial infarction), inflammation of
the heart muscle (acute myocarditis) or inflammation of the sac
surrounding the heart (acute pancarditis)
 If you are pregnant do not take this medicine in combination with other
medicines to treat hyperthyroidism (see the section on Pregnancy and
breast-feeding).
Warnings and precautions
Talk to your doctor or pharmacist before taking Levothyroxine sodium
Teva:
 If you have heart disease, problems with your circulation or high blood
pressure
 If you are suffering from an overactive thyroid gland (hyperthyroidism),
an underactive adrenal gland, diabetes, or have had an underactive
thyroid gland for some time.
Other medicines and Levothyroxine sodium Teva
Tell your doctor or pharmacist if you are taking/using, have recently
taken/used or might take/use any other medicines.
Levothyroxine can interfere with the action of some other drugs and
some drugs can have an effect on Levothyroxine.
In particular inform your doctor or pharmacist about the use of the
following drugs:
 medication to stop your blood clotting (for example Warfarin)
 medication for depression (for example Sertraline, Imipramine,
Amitriptyline)
 medication for epilepsy (for example Phenytoin, Phenobarbital,
Carbamazepine)
 medication for diabetes
 Rifampicin (for infections, particularly tuberculosis)
 Digoxin or Amiodarone (for your heart)
 Propranolol (for high blood pressure), Lovastatin (for high cholesterol
levels) or Phenylbutazone or Aspirin (anti-inflammatory drugs)
 Oestrogen, oestrogen containing products and oral contraceptives,
androgens or corticosteroids
 Sucralfate, Cimetidine or aluminium hydroxide for a stomach ulcer,
Colestyramine or Colesevelam to lower your cholesterol levels, sodium
polystyrene sulphonate or calcium carbonate or iron supplements.
Levothyroxine can be taken with these medicines but not at the same
time
 Chloroquine or Proguanil for the prevention of malaria
 Protease inhibitors (for example Ritonavir, Indinavir and Lopinavir)
used to treat HIV
 Sevelamer (used to treat high levels of phosphate in the blood in
patients with renal failure)
 Tyrosine kinase inhibitors (for example Imatinib and Sunitinib) used to
treat cancer
 Propylthiouracil (used to treat hyperthyroidism)
 Beta blockers (used to treat high blood pressure and heart problems)
 Sympathomimetic agents (medicines that work by stimulating the
sympathetic nervous system)
 Glucocorticoids (steroid hormones used to treat adrenal insufficiency
and other diseases)
 Iodine containing contrast media (used to enhance the visibility of
vascular structures and organs during radiographic procedures)
 Orlistat (medicine to treat obesity)
If you go into hospital to have an operation, tell the anaesthetist or the
medical staff that you are taking Levothyroxine sodium Teva. It may react
with an anaesthetic (Ketamine) which you may be given before an
operation.

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.
If you are pregnant while taking this medicine your doctor will monitor you
closely.
Driving and using machines
Your medicine is unlikely to affect your ability to drive or to operate
machinery.

3. How to take Levothyroxine sodium Teva
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Levothyroxine sodium Teva should be swallowed.
Your doctor will have decided what dose you should take each day
depending on your condition. Your doctor will take blood samples at
regular intervals to monitor your response to treatment.
If you are switching from the oral solution to the tablet version of
levothyroxine or from the tablet version to the oral solution of
levothyroxine your doctor will monitor you more closely.
For hypothyroidism the usual daily dosages are:
Adults and children over 12 years:
The starting dose is 50 to 100 micrograms a day, increasing by 25 to
50 micrograms every 3-4 weeks, until you are taking the right amount for
your condition. The usual maintenance dose is 100 to 200 micrograms
daily.
For diffuse non toxic goitre or Hashimoto’s thyroiditis the
recommended dose is 50 to 200 micrograms per day.
For the treatment of thyroid cancer the recommended dose is 150 to
300 micrograms per day.
Elderly (over 50 years of age):
The starting dose is 12.5 micrograms a day, increasing by
12.5 micrograms every 2 weeks until the correct dose is obtained. The
usual final dose is between 50 and 200 micrograms daily. This dose also
applies to patients with severe hypothyroidism, and to those with heart
disease.
Children under 12 years:
The dose for children depends on their age, weight and the condition
being treated. 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 day.
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.
Method of administration
You should take your Levothyroxine on an empty stomach, usually
before breakfast.
Duration of treatment
The duration of treatment is usually for life if you are being treated for
hypothyroidism, non toxic diffuse goitre or Hashimoto’s thyroiditis.
Please use the oral syringe provided to deliver your specific dose - see
instructions below. The syringe can be used to measure your dose by
drawing the liquid to the correct mark on the syringe. For example if your
dose is 50 micrograms daily then the corresponding volume would be:
For the 25 microgram/5 ml strength – 2 x 5 ml (10 ml in total)
For the 50 microgram/5 ml strength – 5 ml
For the 100 microgram/5 ml strength – 2.5 ml
How to use the oral syringe:
1. Shake the bottle well, making sure the cap is firmly on the bottle.
2. Remove the cap. Note: Keep the cap nearby to close the bottle after
each use.
3. Push the plastic adapter into the neck of the bottle. Note: The
adapter must always stay in the bottle.
4. Take the syringe and check the plunger is fully down.
5. Keep the bottle upright and insert the oral syringe firmly into the
plastic adapter.
6. Turn the whole bottle with the syringe upside down.
7. Slowly pull the plunger down fully so that the syringe fills with
medicine. Push the plunger back up completely to expel any large air
bubbles that may be trapped inside the oral syringe.
8. Then pull the plunger slowly back to the volume you need for your
dose.
9. Turn the whole bottle with the syringe the right way up and take the
syringe out of the bottle.
10. The dose of medicine can now be swallowed directly from the oral
syringe. Please ensure that you are sitting upright and the plunger
must be pushed slowly to allow you to swallow the dose.
11. Replace the child resistant cap after use, leaving the adapter in
place.
12. Cleaning: After use, wipe the outside of the syringe with a dry, clean
tissue.

If you take more Levothyroxine sodium Teva than you should
If you accidentally take an overdose of your medicine, either call your
doctor straight away, or go to your nearest hospital casualty
department. Symptoms of overdose include fever, irregular heart beat,
muscle cramps, headache, restlessness, flushing, sweating or diarrhoea.
Always take any remaining medicine, the container and the label with
you, so that the medicine can be identified.
If you forget to take Levothyroxine sodium Teva
If you forget to take your medicine, take your dose when you remember
and then take your next dose at the usual time. Do not take a double
dose to make up for a forgotten dose. If you have forgotten several doses
tell your doctor when you have your next check-up or blood test. It can be
dangerous to stop taking your medicine without your doctor’s advice.
If you are worried, ask your doctor or pharmacist for advice.

6. Contents of the pack and other information
What Levothyroxine sodium Teva contains
The active substance is levothyroxine sodium.
Each 5 ml of oral solution contains 25 micrograms levothyroxine sodium.
Also contains: glycerol, citric acid, sodium methyl parahydroxybenzoate
(E219), sodium hydroxide and purified water.
What Levothyroxine sodium Teva looks like and contents of the
pack
Levothyroxine sodium Teva is a clear colourless solution. Each bottle
contains 100 ml of oral solution. A plastic dosing syringe (pipette) is also
included to help measure the dose.

If you stop taking Levothyroxine sodium Teva
For your treatment to be successful, you must take Levothyroxine
regularly at the dosage prescribed by your doctor. On no account should
you change, suspend or stop the prescribed treatment without talking to
your doctor. Symptoms of disease may return if you suspend or stop
treatment before you should. The nature of these symptoms depends on
the underlying disease.

Manufactured by
Pharmachemie BV, Swensweg 5, 2031 GA Haarlem, The Netherlands.

If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
These usually only happen if the dose you are taking is too high.
If any of the following happen, stop taking Levothyroxine sodium
Teva and tell your doctor immediately or go to the casualty
department at your nearest hospital
 Swelling of the hands, feet, ankles, face, lips, mouth, or throat which
may cause difficulty in swallowing or breathing
 Hives
 Fainting
 Yellowing of the skin and eyes also called jaundice.
These are all very serious side effects. If you have them, you may have a
serious allergic reaction to Levothyroxine sodium Teva. You may need
urgent medical attention or hospitalisation. All of these very serious side
effects are very rare.
Tell your doctor if you notice any of the following:
Fast or irregular heart beats, palpitations, chest pain, muscle cramps or
weakness, headache, restlessness, excitability, flushing, sweating,
diarrhoea, vomiting, fever, menstruation problems, high blood pressure in
the cranium, tremor, sleeplessness, heat intolerance and excessive
weight loss. Rash, itching and puffiness may also occur.
Very rarely, if far too much Levothyroxine sodium Teva has been taken in
one go or over many years, the heart may fail and coma and death have
been reported.
If you feel unwell in any other way, tell your doctor as soon as you can.
Children may have some hair loss at the beginning of treatment, however
this is usually temporary and the hair returns.
Do not be alarmed by this list of possible events. You may not have any
of them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Levothyroxine sodium Teva






Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original package in order to protect from light.
Dispose of any remaining medicine 8 weeks after opening.
Do not use this medicine after the expiry date which is stated on the
label and carton after EXP (month, year). The expiry date refers to the
last day of that month.
 Levothyroxine sodium Teva is odourless. Do not use this medicine if
you notice that the solution has an odour. Talk to your pharmacist.
 If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

Teva Pharma BV, Swensweg 5, 2031 GA Haarlem, The Netherlands.
Famar Netherlands BV, Industrieweg 1, 5531 AD Bladel,
The Netherlands.

Repackaged by MPT Pharma Ltd.
PL: 33532/0748

POM

Leaflet dated 25th May 2017
Leaflet coded XXXXXXXXXX
Teva® is a registered trademark.

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

Package Leaflet: Information for the User

Levothyroxine sodium MPT Pharma 25 micrograms/5 ml oral solution
(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 or pharmacist.
 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 or pharmacist. This
includes any possible side effects not listed in this leaflet.
See section 4.
 The name of this medicine is Levothyroxine sodium MPT Pharma
25 micrograms/5ml oral solution but will be referred to as
Levothyroxine sodium MPT Pharma throughout the remainder of this
leaflet.
 This medicine is also available in other strengths.
In this leaflet:
1. What Levothyroxine sodium MPT Pharma is and what it is used for
2. What you need to know before you take Levothyroxine sodium MPT
Pharma
3. How to take Levothyroxine sodium MPT Pharma
4. Possible side effects
5. How to store Levothyroxine sodium MPT Pharma
6. Contents of the pack and other information
1. What Levothyroxine sodium MPT Pharma is and what it is
used for

Levothyroxine sodium MPT Pharma with food and drink
Soy-containing products can decrease absorption of levothyroxine.
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.
If you are pregnant while taking this medicine your doctor will monitor you
closely.
Driving and using machines
Your medicine is unlikely to affect your ability to drive or to operate
machinery.
Levothyroxine sodium MPT Pharma contains sodium methyl
parahydroxybenzoate and glycerol
Sodium methyl parahydroxybenzoate (E219) which may cause allergic
reactions (possibly delayed). Glycerol may cause headache, stomach
upset and diarrhoea.
3. How to take Levothyroxine sodium MPT Pharma
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Levothyroxine sodium MPT Pharma should be swallowed.

Levothyroxine sodium MPT Pharma is used to treat hypothyroidism, a
condition in which the thyroid gland is underactive and so does not make
enough thyroxine for the body’s needs.

Your doctor will have decided what dose you should take each day
depending on your condition. Your doctor will take blood samples at
regular intervals to monitor your response to treatment.

Levothyroxine sodium MPT Pharma is also used to treat thyroid cancer
and diffuse non-toxic goitre or Hashimoto’s thyroiditis, conditions in which
the thyroid gland becomes enlarged causing a swelling in the front of the
neck.

If you are switching from the oral solution to the tablet version of
levothyroxine or from the tablet version to the oral solution of
levothyroxine your doctor will monitor you more closely.

2. What you need to know before you take Levothyroxine sodium
MPT Pharma
Do NOT take Levothyroxine sodium MPT Pharma:
 If you are allergic to levothyroxine, sodium methyl
parahydroxybenzoate or any of the other ingredients of this medicine
(listed in section 6)
 If you suffer from adrenal insufficiency and you do not have adequate
corticosteroid cover
 If you have a heart attack (acute myocardial infarction), inflammation of
the heart muscle (acute myocarditis) or inflammation of the sac
surrounding the heart (acute pancarditis)
 If you are pregnant do not take this medicine in combination with other
medicines to treat hyperthyroidism (see the section on Pregnancy and
breast-feeding).
Warnings and precautions
Talk to your doctor or pharmacist before taking Levothyroxine sodium
MPT Pharma:
 If you have heart disease, problems with your circulation or high blood
pressure
 If you are suffering from an overactive thyroid gland (hyperthyroidism),
an underactive adrenal gland, diabetes, or have had an underactive
thyroid gland for some time.
Other medicines and Levothyroxine sodium MPT Pharma
Tell your doctor or pharmacist if you are taking/using, have recently
taken/used or might take/use any other medicines.
Levothyroxine can interfere with the action of some other drugs and
some drugs can have an effect on Levothyroxine.
In particular inform your doctor or pharmacist about the use of the
following drugs:
 medication to stop your blood clotting (for example Warfarin)
 medication for depression (for example Sertraline, Imipramine,
Amitriptyline)
 medication for epilepsy (for example Phenytoin, Phenobarbital,
Carbamazepine)
 medication for diabetes
 Rifampicin (for infections, particularly tuberculosis)
 Digoxin or Amiodarone (for your heart)
 Propranolol (for high blood pressure), Lovastatin (for high cholesterol
levels) or Phenylbutazone or Aspirin (anti-inflammatory drugs)
 Oestrogen, oestrogen containing products and oral contraceptives,
androgens or corticosteroids
 Sucralfate, Cimetidine or aluminium hydroxide for a stomach ulcer,
Colestyramine or Colesevelam to lower your cholesterol levels, sodium
polystyrene sulphonate or calcium carbonate or iron supplements.
Levothyroxine can be taken with these medicines but not at the same
time
 Chloroquine or Proguanil for the prevention of malaria
 Protease inhibitors (for example Ritonavir, Indinavir and Lopinavir)
used to treat HIV
 Sevelamer (used to treat high levels of phosphate in the blood in
patients with renal failure)
 Tyrosine kinase inhibitors (for example Imatinib and Sunitinib) used to
treat cancer
 Propylthiouracil (used to treat hyperthyroidism)
 Beta blockers (used to treat high blood pressure and heart problems)
 Sympathomimetic agents (medicines that work by stimulating the
sympathetic nervous system)
 Glucocorticoids (steroid hormones used to treat adrenal insufficiency
and other diseases)
 Iodine containing contrast media (used to enhance the visibility of
vascular structures and organs during radiographic procedures)
 Orlistat (medicine to treat obesity)
If you go into hospital to have an operation, tell the anaesthetist or the
medical staff that you are taking Levothyroxine sodium MPT Pharma. It
may react with an anaesthetic (Ketamine) which you may be given before
an operation.

For hypothyroidism the usual daily dosages are:
Adults and children over 12 years:
The starting dose is 50 to 100 micrograms a day, increasing by 25 to
50 micrograms every 3-4 weeks, until you are taking the right amount for
your condition. The usual maintenance dose is 100 to 200 micrograms
daily.
For diffuse non toxic goitre or Hashimoto’s thyroiditis the
recommended dose is 50 to 200 micrograms per day.
For the treatment of thyroid cancer the recommended dose is 150 to
300 micrograms per day.
Elderly (over 50 years of age):
The starting dose is 12.5 micrograms a day, increasing by
12.5 micrograms every 2 weeks until the correct dose is obtained. The
usual final dose is between 50 and 200 micrograms daily. This dose also
applies to patients with severe hypothyroidism, and to those with heart
disease.
Children under 12 years:
The dose for children depends on their age, weight and the condition
being treated. 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 day.
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.
Method of administration
You should take your Levothyroxine on an empty stomach, usually
before breakfast.
Duration of treatment
The duration of treatment is usually for life if you are being treated for
hypothyroidism, non toxic diffuse goitre or Hashimoto’s thyroiditis.
Please use the oral syringe provided to deliver your specific dose - see
instructions below. The syringe can be used to measure your dose by
drawing the liquid to the correct mark on the syringe. For example if your
dose is 50 micrograms daily then the corresponding volume would be:
For the 25 microgram/5 ml strength – 2 x 5 ml (10 ml in total)
For the 50 microgram/5 ml strength – 5 ml
For the 100 microgram/5 ml strength – 2.5 ml
How to use the oral syringe:
1. Shake the bottle well, making sure the cap is firmly on the bottle.
2. Remove the cap. Note: Keep the cap nearby to close the bottle after
each use.
3. Push the plastic adapter into the neck of the bottle. Note: The
adapter must always stay in the bottle.
4. Take the syringe and check the plunger is fully down.
5. Keep the bottle upright and insert the oral syringe firmly into the
plastic adapter.
6. Turn the whole bottle with the syringe upside down.
7. Slowly pull the plunger down fully so that the syringe fills with
medicine. Push the plunger back up completely to expel any large air
bubbles that may be trapped inside the oral syringe.
8. Then pull the plunger slowly back to the volume you need for your
dose.
9. Turn the whole bottle with the syringe the right way up and take the
syringe out of the bottle.
10. The dose of medicine can now be swallowed directly from the oral
syringe. Please ensure that you are sitting upright and the plunger
must be pushed slowly to allow you to swallow the dose.
11. Replace the child resistant cap after use, leaving the adapter in
place.
12. Cleaning: After use, wipe the outside of the syringe with a dry, clean
tissue.

If you take more Levothyroxine sodium MPT Pharma than you
should
If you accidentally take an overdose of your medicine, either call your
doctor straight away, or go to your nearest hospital casualty
department. Symptoms of overdose include fever, irregular heart beat,
muscle cramps, headache, restlessness, flushing, sweating or diarrhoea.
Always take any remaining medicine, the container and the label with
you, so that the medicine can be identified.
If you forget to take Levothyroxine sodium MPT Pharma
If you forget to take your medicine, take your dose when you remember
and then take your next dose at the usual time. Do not take a double
dose to make up for a forgotten dose. If you have forgotten several doses
tell your doctor when you have your next check-up or blood test. It can be
dangerous to stop taking your medicine without your doctor’s advice.
If you are worried, ask your doctor or pharmacist for advice.
If you stop taking Levothyroxine sodium MPT Pharma
For your treatment to be successful, you must take Levothyroxine
regularly at the dosage prescribed by your doctor. On no account should
you change, suspend or stop the prescribed treatment without talking to
your doctor. Symptoms of disease may return if you suspend or stop
treatment before you should. The nature of these symptoms depends on
the underlying disease.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4. Possible side effects

6. Contents of the pack and other information
What Levothyroxine sodium MPT Pharma contains
The active substance is levothyroxine sodium.
Each 5 ml of oral solution contains 25 micrograms levothyroxine sodium.
Also contains: glycerol, citric acid, sodium methyl parahydroxybenzoate
(E219), sodium hydroxide and purified water.
What Levothyroxine sodium MPT Pharma looks like and contents of
the pack
Levothyroxine sodium MPT Pharma is a clear colourless solution. Each
bottle contains 100 ml of oral solution. A plastic dosing syringe (pipette)
is also included to help measure the dose.
Manufactured by
Pharmachemie BV, Swensweg 5, 2031 GA Haarlem, The Netherlands.
Teva Pharma BV, Swensweg 5, 2031 GA Haarlem, The Netherlands.
Famar Netherlands BV, Industrieweg 1, 5531 AD Bladel,
The Netherlands.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0748

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
These usually only happen if the dose you are taking is too high.
If any of the following happen, stop taking Levothyroxine sodium
MPT Pharma and tell your doctor immediately or go to the casualty
department at your nearest hospital
 Swelling of the hands, feet, ankles, face, lips, mouth, or throat which
may cause difficulty in swallowing or breathing
 Hives
 Fainting
 Yellowing of the skin and eyes also called jaundice.
These are all very serious side effects. If you have them, you may have a
serious allergic reaction to Levothyroxine sodium MPT Pharma. You may
need urgent medical attention or hospitalisation. All of these very serious
side effects are very rare.
Tell your doctor if you notice any of the following:
Fast or irregular heart beats, palpitations, chest pain, muscle cramps or
weakness, headache, restlessness, excitability, flushing, sweating,
diarrhoea, vomiting, fever, menstruation problems, high blood pressure in
the cranium, tremor, sleeplessness, heat intolerance and excessive
weight loss. Rash, itching and puffiness may also occur.
Very rarely, if far too much Levothyroxine sodium MPT Pharma has been
taken in one go or over many years, the heart may fail and coma and
death have been reported.
If you feel unwell in any other way, tell your doctor as soon as you can.
Children may have some hair loss at the beginning of treatment, however
this is usually temporary and the hair returns.
Do not be alarmed by this list of possible events. You may not have any
of them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Levothyroxine sodium MPT Pharma






Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original package in order to protect from light.
Dispose of any remaining medicine 8 weeks after opening.
Do not use this medicine after the expiry date which is stated on the
label and carton after EXP (month, year). The expiry date refers to the
last day of that month.
 Levothyroxine sodium MPT Pharma is odourless. Do not use this
medicine if you notice that the solution has an odour. Talk to your
pharmacist.
 If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

POM

Leaflet dated 25th May 2017
Leaflet coded XXXXXXXXXX
Teva® is a registered trademark.

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

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.

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