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LEVOTHYROXINE 100 MICROGRAMS PER 5ML ORAL SOLUTION

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

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165 mm

Package leaflet: Information for the user

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

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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

• 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)
• Orlistat (used to treat obesity).
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.

1. WHAT LEVOTHYROXINE ORAL SOLUTION
IS AND WHAT IT IS USED FOR
Levothyroxine Oral Solution contains the active
ingredient levothyroxine sodium. It 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.

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.

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 medicines to treat hyperthyroidism
(see the section on Pregnancy and breast-feeding).

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.

Warnings and precautions
Talk to your doctor, pharmacist or nurse 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.

3. HOW TO TAKE LEVOTHYROXINE ORAL
SOLUTION
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 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.

Other medicines and Levothyroxine Oral Solution
Tell your doctor or pharmacist if you are taking, have
recently taken or might take 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)

Administration
You should take your Levothyroxine Oral Solution on
an empty stomach, usually before breakfast.
For hypothyroidism:
Adults and children over 12 years:
The recommended 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 50-200 micrograms per day.
For the treatment of thyroid cancer the recommended
dose is 150-300 micrograms per day.
Older patients (over 50 years of age):
The recommended 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.
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Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. See section 4.

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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:

medical attention or hospitalisation. All of these very
serious side effects are very rare.
Tell your doctor if you notice any of the following side
effects:

Age
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 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/5ml strength – 2 x 5ml (10ml in
total)
For the 50 microgram/5ml strength – 5ml
For the 100 microgram/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
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.

Not known (frequency cannot be estimated from the
available data)
• fast or irregular heartbeats
• palpitations
• chest pain
• muscle cramps or weakness
• headache
• restlessness
• excitability
• flushing
• sweating
• diarrhoea
• vomiting
• fever
• menstruation problems
• tremor
• sleeplessness
• excessive weight loss
• rash
• itching
• puffiness.
Additional side effects in children and adolescents
• heat intolerance
• high blood pressure in the cranium
• hair loss at beginning of the treatment (temporary).
If you feel unwell in any other way, tell your doctor as
soon as you can.
Do not be alarmed by this list of possible events. You
may not have any of them.

5. HOW TO STORE LEVOTHYROXINE ORAL
SOLUTION
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 and carton after EXP. The expiry
date refers to the last day of that month.
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.
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 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 a double dose to make up
for a forgotten dose. If you have forgotten several
doses tell your doctor when you have your next checkup or blood test.
If you are worried, ask your doctor or pharmacist for
advice.
If you stop taking Levothyroxine Oral Solution
It can be dangerous to stop taking your medicine
without your doctor's advice.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
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.
- The other ingredients are glycerol, citric acid
monohydrate, sodium methyl parahydroxybenzoate
(E219), sodium hydroxide and purified water.

4. POSSIBLE SIDE EFFECTS

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.

Like all medicines, this medicine can cause side
effects, although not everybody gets them. These
usually only happens 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

Marketing Authorisation Holder
Mercury Pharmaceuticals Ltd., Capital House,
85 King William Street, London EC4N 7BL, UK
Manufacturer
FAMAR NETHERLANDS BV,
Bladel Production Site, Industrieweg 1, 5531 AD
BLADEL, The Netherlands
This leaflet was last revised in February 2017.
101910/LF/040/03, 101911/LF/040/03,
101912/LF/040/03
31029010.03
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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.

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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