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Active substance(s): LEVOTHYROXINE SODIUM

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Date of Approval:



To be implemented by:
Product Description:

Originated by

Levothyroxine 25mcg, 50mcg, 100mcg/5ml Oral Soln. ADD



Tech Approved






Revised by




101910/LF/2, 101911/LF/2, 101912/LF/2


File Name:

CRF No.:

Famar Netherlands BV

101910 11 12LF LevothyroxineOralSoln v2_1 AMCo.CRF.133.2013


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Quark Xpress 9


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Pharma Code:

8pt Swiss 721 CN BT

165 x 320mm


Key Line:



165 mm


Levothyroxine 25 micrograms / 50 micrograms and
100 micrograms per 5ml Oral Solution
Levothyroxine sodium


What is 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

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.

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 medicines to treat hyperthyroidism
(see the section on Pregnancy and breast-feeding).
Warnings and precautions
Talk to your doctor before taking Levothyroxine Oral
• 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
• 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 ulcerColestyramine to lower your
cholesterol levels, or calcium carbonate or iron
• 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
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
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

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.
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
(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 50-200 micrograms
(micrograms) per day.
For the treatment of thyroid cancer the recommended
dose is 150-300 micrograms (micrograms) per day.
continued overleaf

320 mm


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.

165 mm

• 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
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.
Also you can help to make sure that medicines remain
safe as possible by reporting any unwanted side
effects via the internet at
Alternatively you can call freephone 0808 100 3352
(available from 10 a.m. to 2 p.m. Mondays to Fridays)
or fill in a paper form available from your local

Older patients (over 50 years of age):
The starting dose is 12.5 micrograms (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 dally. 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 or weight.
They will be monitored to make sure they get the right
dose. The following is a guide:
Micrograms per kg bodyweight
Up to 1 month 5-10 micrograms
Over 1 month 5 micrograms
The duration of treatment is usually for life if you are
being treated for hypothyroidism, non toxic diffuse
goitre or Hashitmoto’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 micgrogram/5ml strength – 2 x 5ml (10ml in
For the 50 microgram/5ml strength – 5ml
For the 100 micgrogram/5ml 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
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.

Keep this medicine out of the sight and reach of
Do not store above 25˚C.
Store in the original package in order to protect from
Dispose of any remaining medicine 8 weeks after
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 Oral Solution is odourless. Do not use
this medicine if you notice that the solution has an
odour. Talk to your pharmacist.
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.

If you take more Eltoxin Oral Solution than you
If you accidentally take an overdose of your medicine,
either call your doctor straight away, or go to your
nearest hospital casualty department. Symtoms of
overdose include fever, iregular 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.

What Levothyroxine Oral Solution contains:
The active substance is levothyroxine sodium. Each 5
ml of oral solution contains levothyroxine equivalent to
levothyroxine sodium anhydrous 25micrograms,
50micrograms or 100micrograms.
It also contains the following inactive ingredients:
glycerol, citric acid monohydrate, sodium methyl
parahydroxybenzoate (E219), sodium hydroxide and
purified water.

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

What Levothyroxine Oral Solution looks like and
contents of the pack
Levothyroxine Oral Solution is a clear colourless liquid.
Each bottle contains 100ml of oral solution. A plastic
dosing syringe (pipette) is also included to help
measure the dose.
Marketing Authorisation Holder
Mercury Pharmaceuticals Ltd., Capital House,
85 King William Street, London EC4N 7BL, UK

If you stop taking Levothyroxine Oral Solution
If you have any further questions on the use of this
medicine, ask your doctor

Bladel Production Site, Industrieweg 1, 5531 AD
BLADEL, The Netherlands

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
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 inswallowing or

This leaflet was last revised in December 2013.
101910/LF/2, 101911/LF/2, 101912/LF/2


320 mm


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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.