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LEVOTHYROXINE 25 MICROGRAMS/5ML ORAL SOLUTION

Active substance(s): LEVOTHYROXINE SODIUM

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Package leaflet: Information for the user

Levothyroxine 25 micrograms/5ml Oral Solution
Levothyroxine 50 micrograms/5ml Oral Solution
Levothyroxine 100 micrograms/5ml Oral Solution
Levothyroxine 125 micrograms/5ml 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.

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.

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 contains
sodium methyl parahydroxybenzoate
and glycerol
Levothyroxine Oral Solution contains
sodium methyl parahydroxybenzoate (E219)
which may cause allergic reactions
(possibly delayed). It also contains glycerol
which may cause headache, stomach upset
and diarrhoea.

1. What Levothyroxine Oral Solution
is and what it is used for
Levothyroxine Oral Solution contains
levothyroxine which 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 underactive adrenal
glands and you do not have adequate
corticosteroid cover
■ if you have a history of heart attack
(acute myocardial infarction),
inflammation of the heart muscle (acute
myocarditis) or inflammation of the sac
surrounding the heart (acute pericarditis)
■ 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 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
take any other medicines, including
medicines without a prescription.
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 (antiinflammatory 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-sympathomimetics (used to treat
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.
Levothyroxine Oral Solution with food,
drink and alcohol
You should take your Levothyroxine Oral
Solution on an empty stomach, usually
before breakfast.

Driving and using machines
Levothyroxine Oral Solution is unlikely to
affect your ability to drive or to operate
machinery.

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
(mcg) 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
(mcg) per day.
For the treatment of thyroid cancer the
recommended dose is 150-300 micrograms
(mcg) per day.
Older patients (over 50 years of age):
The starting dose is 12.5 micrograms (mcg) 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
or weight. They will be monitored to make
sure they get the right dose. The following
is a guide:
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 micrograms/5ml strength –
2 x 5ml (10ml in total)
For the 50 micrograms/5ml strength – 5ml
For the 100 micrograms/5ml strength – 2.5 ml
For the 125 micrograms/5ml strength – 2 ml
Levothyroxine can be taken using an oral
syringe.
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 adaptor into the neck of
the bottle. Note: The adaptor 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
adaptor.
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 adaptor in place.
12. Cleaning: After use, wipe the outside of
the syringe with a dry, clean tissue.
Note: If necessary, Levothyroxine Oral
Solution can be administered via a
nasogastric feeding tube that should be
rinsed twice with 10 ml of water
immediately after administration.
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 heartbeat, 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 check-up or blood test.
If you stop taking Levothyroxine Oral
Solution
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 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 happen if the dose you
are taking is too high.
Tell your doctor if you have any of the
following side effects while you are taking
this medicine.
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 heartbeats,
palpitations, chest pain, muscle cramps or
weakness, headache, restlessness,
excitability, flushing, sweating, diarrhoea,
vomiting, fever, menstruation problems,
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.

5. How to store Levothyroxine
Oral Solution
Keep this medicine 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 2
months 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 Oral Solution is colourless
and odourless. Do not use this medicine if
you notice that the solution has a colour
and/or 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.

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 25 micrograms, 50
micrograms, 100 micrograms or 125
micrograms.
■ It also contains the following inactive
ingredients: glycerol, citric acid
anhydrous, sodium methyl
parahydroxybenzoate (E219), sodium
hydroxide 1N or citric acid 10% and
purified water.
What Levothyroxine Oral Solution looks
like and contents of the pack
Levothyroxine Oral Solution is a clear,
colourless and odourless liquid. Each bottle
contains 100ml of oral solution.
Levothyroxine Oral Solution is packed in an
amber glass bottle, with a child-resistant,
tamper-evident screw cap. A 5ml graduated
oral dosing syringe and a “press-in” syringe/
bottle adaptor are also provided.
Marketing Authorisation Holder
Colonis Pharma Limited
Quantum House
Hobson Industrial Estate
Burnopfield
County Durham
NE16 6EA
Manufacturer
Anfarm Hellas SA
61st km Nat. Rd. Athens-Lamia, Schimatari
32009, Greece
This leaflet was last revised in
September 2016

Additional side effects in children
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 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:
Website: www.yellowcard.mhra.gov.uk
By reporting side effects you can help
provide more information on the safety of
this medicine.

K0000

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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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