LEVOTHYROXINE 25 MICROGRAMS/5ML ORAL SOLUTION

Active substance: LEVOTHYROXINE SODIUM

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210 mm

LEVOTHYROXINE
25 micrograms/5 ml, 50 micrograms/5 ml AND
100 micrograms/5 ml ORAL SOLUTION
levothyroxine sodium

• 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)
PACKAGE LEAFLET: INFORMATION FOR THE USER
• Tyrosine kinase inhibitors (for example imatinib and
sunitinib) used to treat cancer
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you. • Propylthiouracil (used to treat hyperthyroidism)
• Beta-sympatholytics (used to treat cardiac arrest and low
• Keep this leaflet. You may need to read it again.
blood pressure)
• If you have any further questions, ask your doctor or
• Glucocorticoids (steroid hormones used to treat adrenal
pharmacist.
insufficiency and other diseases)
• This medicine has been prescribed for you only. Do not
• Soy-containing products (these can decrease absorption of
pass it on to others. It may harm them, even if their signs of
levothyroxine).
illness are the same as yours.
Let your doctor or pharmacist know. Levothyroxine Oral
• If you get any side effects, talk to your doctor or
Solution can be taken with these medicines but not at the
pharmacist. This includes any possible side effects not
same time.
listed in this leaflet.
If you go into hospital to have an operation, tell the
IN THIS LEAFLET:
anaesthetist or the medical staff that you are taking
1. What Levothyroxine Oral Solution is and what it is used for Levothyroxine Oral Solution. It may react with an anaesthetic
2. What you need to know before you take Levothyroxine
(Ketamine) which you may be given before an operation.
Oral Solution
Please tell your doctor if you are taking or have recently taken
3. How to take Levothyroxine Oral Solution
any other medicines, including medicines obtained without a
4. Possible side effects
prescription.
5. How to store Levothyroxine Oral Solution
6. Contents of the pack and other information
Levothyroxine Oral Solution with food, drink and alcohol
You should take your Levothyroxine Oral Solution on an
WHAT LEVOTHYROXINE ORAL SOLUTION IS AND
empty stomach, usually before breakfast.
1
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).

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.
Warnings and precautions
Your doctor will have decided what dose you should take
Talk to your doctor before taking Levothyroxine Oral Solution: each day depending on your condition. Your doctor will take
• If you have heart disease, problems with your circulation or blood samples at regular intervals to monitor your response
high blood pressure
to treatment.
• If you are suffering from an overactive thyroid gland
(hyperthyroidism), an underactive adrenal gland, diabetes, If you are switching from the oral solution to the tablet version
of levothyroxine or from the tablet version to the oral solution
or have had an underactive thyroid gland for some time.
of levothyroxine your doctor will monitor you more closely.
Other medicines and Levothyroxine Oral Solution
Administration
Please tell your doctor or pharmacist if you are taking, have
You should take your Levothyroxine Oral Solution on an
recently taken or might use any other medicines.
empty stomach, usually before breakfast.
Levothyroxine can interfere with the action of some other
drugs and some drugs can have an effect on Levothyroxine. For hypothyroidism the usual daily dosages are:
In particular tell your doctor or pharmacist if you take the
Adults and children over 12 years:
following drugs:
The starting dose is 50 to 100 micrograms a day, increasing
• medication to stop your blood clotting (for example
by 25 to 50 micrograms every 3-4 weeks, until you are taking
Warfarin)
the right amount for your condition. The usual maintenance
• medication for depression (for example Sertraline,
dose is 100 to 200 micrograms daily.
Imipramine, Amitriptyline)
For diffuse non toxic goitre or Hashimoto’s thyroiditis the
• medication for epilepsy (for example Phenytoin,
recommended dose is 50 to 200 micrograms per day.
Phenobarbital, Carbamazepine)
• medication for diabetes
For the treatment of thyroid cancer the recommended dose
• Rifampicin (for infections, particularly tuberculosis)
is 150 to 300 micrograms per day.
• Digoxin or Amiodarone (for your heart)
• Propranolol (for high blood pressure), Lovastatin (for high Older patients (over 50 years of age):
The starting dose is 12.5 micrograms a day, increasing by
cholesterol levels) or Phenylbutazone or Aspirin
12.5 micrograms every 2 weeks until the correct dose is
(anti-inflammatory drugs)
obtained. The usual final dose is between 50 and 200
• oestrogen, oestrogen containing products and oral
micrograms daily. This dose also applies to patients with
contraceptives, androgens or corticosteroids
severe hypothyroidism, and to those with heart disease.
• sucralfate, Cimetidine or aluminium hydroxide for a
stomach ulcer, Colestyramine to lower your cholesterol
levels, or calcium carbonate or iron supplements

320 mm

WHAT IT IS USED FOR

Ref:

231-30-80085-A LEA LEVOTHYROXINE A/S SOL TUK
Version:

7

30 May 2012

PL Number(s),
PL 00289/1593-5. TEVA UK Limited Licence (Responsible Regulatory Officer = Victoria Palmer),
MA Holder & Packer: Packed at PharmaMatch BV, Amsterdam.
Reason for revision: New item for product launch. V2: Day 210 text update. V3: Text corrections throughout, added packing site sap code. V4: Text update to dosage
information (oral syringe instructions added), larger template applied. V4 TECHNICALLY APPROVED. V5: Correction to bullets in Other medicines
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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.

• 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.

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 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 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.

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Levothyroxine Oral Solution contains:
The active substance is Levothyroxine sodium. Each 5 ml of
If you take more Levothyroxine Oral Solution than you should oral solution contains Levothyroxine equivalent to
If you accidentally take an overdose of your medicine, either Levothyroxine sodium anhydrous 25 micrograms,
call your doctor straight away, or go to your nearest hospital 50 micrograms or 100 micrograms.
casualty department. Symptoms of overdose include fever,
It also contains the following inactive ingredients: Glycerol,
irregular heart beat, muscle cramps, headache, restlessness, citric acid monohydrate, sodium methyl
flushing, sweating or diarrhoea. Always take any remaining
parahydroxybenzoate (E219), sodium hydroxide and purified
medicine, the container and the label with you, so that the
water.
medicine can be identified.
What Levothyroxine Oral Solution looks like and contents of
If you forget to take Levothyroxine Oral Solution
the pack
If you forget to take your medicine, take your dose when you Levothyroxine Oral solution is a clear colourless liquid. Each
remember and then take your next dose at the usual time. Do bottle contains 100 ml of oral solution. A double ended 5 ml
not take two doses at the same time. If you have forgotten
and 2.5 ml polypropylene spoon or a plastic dosing syringe
several doses tell your doctor when you have your next
(pipette) is also included to help measure the dose.
check-up or blood test. It can be dangerous to stop taking
Marketing Authorisation Holder
your medicine without your doctor’s advice.
If you are worried, ask your doctor or pharmacist for advice. TEVA UK Limited, Eastbourne, BN22 9AG, UK.
Manufacturer
If you stop taking Levothyroxine Oral Solution
Famar Netherlands BV, 5531 AD Bladel, The Netherlands.
If you have any further questions on the use of this medicine,
This leaflet was last revised in 05/2012
ask your doctor.
PL 00289/1593
PL 00289/1594
4 POSSIBLE SIDE EFFECTS
PL 00289/1595
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
80085-A
• Swelling of the hands, feet, ankles, face, lips, mouth, or
210115.01-GB
throat which may cause difficulty in swallowing or
31024646.01-GB
breathing

320 mm

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3rd Party Codes: 210115.01-GB
31024646.01-GB

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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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