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LEVOTHYROXINE SODIUM PRIMECROWN 25 MICROGRAMS/5ML ORAL SOLUTION

Active substance(s): LEVOTHYROXINE SODIUM

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Levothyroxine sodium Teva 25 micrograms/5ml Oral Solution
Your medicine is known by the above name but will be referred to as
Levothyroxine Oral Solution throughout this leaflet. This medicine is also
available in other strengths - 50 micrograms/5ml and 100 micrograms/5ml
and this leaflet also refers to them.
Patient Information Leaflet
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.
In this leaflet:
1) What Levothyroxine Oral Solution is and what it is used for
2) What you need to know before you take Levothyroxine Oral Solution
3) How to take Levothyroxine Oral Solution
4) Possible side effects
5) How to store Levothyroxine Oral Solution
6) Contents of the pack and other information

1) What Levothyroxine Oral Solution is and what it is used for
Levothyroxine Oral Solution 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 Oral Solution 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 Oral
Solution
Do NOT take Levothyroxine Oral Solution:
• If you are allergic to levothyroxine 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 before taking Levothyroxine Oral Solution:
• 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 Oral Solution
Please tell your doctor or pharmacist if you are taking, have recently taken
or might 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 tell your doctor or pharmacist if you take 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 to lower your cholesterol levels, or calcium carbonate or
iron supplements
• 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-sympatholytics (used to treat cardiac arrest and low blood
pressure)

• Glucocorticoids (steroid hormones used to treat adrenal insufficiency
and other diseases)
• Soy-containing products (these can decrease absorption of
levothyroxine).
Let your doctor or pharmacist know. Levothyroxine Oral Solution can be
taken with these medicines but not at the same time.
If you go into hospital to have an operation, tell the anaesthetist or the
medical staff that you are taking Levothyroxine Oral Solution. It may react
with an anaesthetic (Ketamine) which you may be given before an
operation.
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Levothyroxine Oral Solution with food, drink and alcohol
You should take your Levothyroxine Oral Solution on an empty stomach,
usually before breakfast.
Pregnancy and Breast-Feeding
Ask your doctor or pharmacist for advice before taking any medicine.
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 Oral Solution contains methyl parahydroxybenzoate
and glycerol
Levothyroxine
Oral
solution
contains
sodium
methyl
parahydroxybenzoate (E219) which may cause allergic reactions
(possibly delayed). Also contains glycerol which may cause headache,
stomach upset and diarrhoea.

3) How to take Levothyroxine Oral Solution
Always take this medicine exactly as your doctor has told you. Check with
your doctor if you are not sure.
Levothyroxine Oral Solution 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.
Administration
You should take your Levothyroxine Oral Solution on an empty stomach,
usually before breakfast.
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.
Older patients (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.
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 Oral Solution 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 Oral Solution
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 two doses at
the same time. 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 Oral Solution
If you have any further questions on the use of this medicine, ask your
doctor.

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 Oral
Solution 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 Oral Solution. 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 Oral Solution 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.

If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.
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 Levothyroxine Oral Solution






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 the outer carton after EXP. The expiry date refers to the last
day of that month.
• Levothyroxine oral solution is odourless. Do not use this medicine if you
notice that the solution has an odour. Talk to your pharmacist.
• If your medicine shows any visible signs of deterioration, consult your
pharmacist who will advise you what to do.
• 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 Levothyroxine Oral Solution contains:
The active substance is levothyroxine sodium. Each 5ml of oral solution
contains 25 micrograms levothyroxine sodium.
The other ingredients are: glycerol, citric acid monohydrate, sodium methyl
parahydroxybenzoate (E219), sodium hydroxide and purified water.
What Levothyroxine Oral Solution looks like and the contents of the
pack
Levothyroxine Oral solution is a clear colourless liquid. Each bottle
contains 100ml of oral solution. Each pack contains 1 bottle. A 5ml
graduated plastic dosing syringe (pipette) and the corresponding neck
fitted syringe adaptor for the bottle is also included.
PL 10383/2210 Levothyroxine sodium Teva 25 micrograms/5ml Oral
Solution
POM
Who makes and repackages your medicine?
Your medicine is manufactured by Pharmachemie BV, Swensweg 5, 2031
GA, Haarlem, The Netherlands, or
Teva Pharma BV, Swensweg 5, 2031 GA, Haarlem, The Netherlands, or
Famar Netherlands BV, Industrieweg 1, 5531 AD Bladel,
The Netherlands.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex UB5 5QS.
Leaflet date: 27.04.2017

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8839 3000 to obtain the
leaflet in a format suitable for you.

Levothyroxine sodium Primecrown 25 micrograms/5ml Oral Solution
Your medicine is known by the above name but will be referred to as
Levothyroxine Oral Solution throughout this leaflet. This medicine is also
available in other strengths - 50 micrograms/5ml and 100 micrograms/5ml
and this leaflet also refers to them.
Patient Information Leaflet
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.
In this leaflet:
1) What Levothyroxine Oral Solution is and what it is used for
2) What you need to know before you take Levothyroxine Oral Solution
3) How to take Levothyroxine Oral Solution
4) Possible side effects
5) How to store Levothyroxine Oral Solution
6) Contents of the pack and other information

1) What Levothyroxine Oral Solution is and what it is used for
Levothyroxine Oral Solution 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 Oral Solution 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 Oral
Solution
Do NOT take Levothyroxine Oral Solution:
• If you are allergic to levothyroxine 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 before taking Levothyroxine Oral Solution:
• 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 Oral Solution
Please tell your doctor or pharmacist if you are taking, have recently taken
or might 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 tell your doctor or pharmacist if you take 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 to lower your cholesterol levels, or calcium carbonate or
iron supplements
• 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-sympatholytics (used to treat cardiac arrest and low blood
pressure)

• Glucocorticoids (steroid hormones used to treat adrenal insufficiency
and other diseases)
• Soy-containing products (these can decrease absorption of
levothyroxine).
Let your doctor or pharmacist know. Levothyroxine Oral Solution can be
taken with these medicines but not at the same time.
If you go into hospital to have an operation, tell the anaesthetist or the
medical staff that you are taking Levothyroxine Oral Solution. It may react
with an anaesthetic (Ketamine) which you may be given before an
operation.
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Levothyroxine Oral Solution with food, drink and alcohol
You should take your Levothyroxine Oral Solution on an empty stomach,
usually before breakfast.
Pregnancy and Breast-Feeding
Ask your doctor or pharmacist for advice before taking any medicine.
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 Oral Solution contains methyl parahydroxybenzoate
and glycerol
Levothyroxine
Oral
solution
contains
sodium
methyl
parahydroxybenzoate (E219) which may cause allergic reactions
(possibly delayed). Also contains glycerol which may cause headache,
stomach upset and diarrhoea.

3) How to take Levothyroxine Oral Solution
Always take this medicine exactly as your doctor has told you. Check with
your doctor if you are not sure.
Levothyroxine Oral Solution 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.
Administration
You should take your Levothyroxine Oral Solution on an empty stomach,
usually before breakfast.
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.
Older patients (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.
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 Oral Solution 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 Oral Solution
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 two doses at
the same time. 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 Oral Solution
If you have any further questions on the use of this medicine, ask your
doctor.

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 Oral
Solution 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 Oral Solution. 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 Oral Solution 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.

If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.
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 Levothyroxine Oral Solution






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 the outer carton after EXP. The expiry date refers to the last
day of that month.
• Levothyroxine oral solution is odourless. Do not use this medicine if you
notice that the solution has an odour. Talk to your pharmacist.
• If your medicine shows any visible signs of deterioration, consult your
pharmacist who will advise you what to do.
• 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 Levothyroxine Oral Solution contains:
The active substance is levothyroxine sodium. Each 5ml of oral solution
contains 25 micrograms levothyroxine sodium.
The other ingredients are: glycerol, citric acid monohydrate, sodium methyl
parahydroxybenzoate (E219), sodium hydroxide and purified water.
What Levothyroxine Oral Solution looks like and the contents of the
pack
Levothyroxine Oral solution is a clear colourless liquid. Each bottle
contains 100ml of oral solution. Each pack contains 1 bottle. A 5ml
graduated plastic dosing syringe (pipette) and the corresponding neck
fitted syringe adaptor for the bottle is also included.
PL 10383/2210 Levothyroxine sodium Primecrown 25 micrograms/5ml
Oral Solution
POM
Who makes and repackages your medicine?
Your medicine is manufactured by Pharmachemie BV, Swensweg 5, 2031
GA, Haarlem, The Netherlands, or
Teva Pharma BV, Swensweg 5, 2031 GA, Haarlem, The Netherlands, or
Famar Netherlands BV, Industrieweg 1, 5531 AD Bladel,
The Netherlands.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex UB5 5QS.
Leaflet date: 27.04.2017

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8839 3000 to obtain the
leaflet in a format suitable for you.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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