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LEVOTHYROXINE 50 MICROGRAMS/5ML ORAL SOLUTION

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

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TEVA UK Ref:

Version:

EBNUK1730a LEA LEVOTHYROXINE A/S SOL TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
320 mm
210 mm
N/A
N/A

1

03 May 2017

Colours Used:

BLACK
PANTONE® GREEN C
Template

210 mm

Levothyroxine
25 micrograms/5ml, 50 micrograms/5ml and
100 micrograms/5ml Oral Solution
levothyroxine sodium
PACKAGE LEAFLET: INFORMATION FOR THE USER

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.











IN THIS LEAFLET:

1. What Levothyroxine is and what it is used for
2. What you need to know before you take Levothyroxine
3. How to take Levothyroxine
4. Possible side effects
5. How to store Levothyroxine
6. Contents of the pack and other information

1



calcium carbonate or iron supplements. Levothyroxine can
be taken with these medicines but not at the same time.
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 blockers (used to treat high blood pressure and
heart problems)
Sympathomimetic agents (medicines that work by
stimulating the sympathetic nervous system)
Glucocorticoids (steroid hormones used to treat adrenal
insufficiency and other diseases)
Iodine containing contrast media (used to enhance the
visibility of vascular structures and organs during
radiographic procedures)
Orlistat (medicine to treat obesity)

If you go into hospital to have an operation, tell the
anaesthetist or the medical staff that you are taking
Levothyroxine. It may react with an anaesthetic (Ketamine)
which you may be given before an operation.

WHAT LEVOTHYROXINE IS AND WHAT IT IS USED Levothyroxine with food, and drink
Soy-containing products can decrease absorption of
FOR
levothyroxine.

2

WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LEVOTHYROXINE

Do NOT take Levothyroxine:
• If you are allergic to levothyroxine, sodium methyl
parahydroxybenzoate 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
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 contains sodium methyl parahydroxybenzoate
and glycerol.
Sodium methyl parahydroxybenzoate (E219) which may
cause allergic reactions (possibly delayed). Glycerol may
cause headache, stomach upset and diarrhoea.

3

HOW TO TAKE LEVOTHYROXINE

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 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
Warnings and precautions
Talk to your doctor or pharmacist before taking Levothyroxine: to treatment.
• If you have heart disease, problems with your
If you are switching from the oral solution to the tablet version
circulation or high blood pressure
of levothyroxine or from the tablet version to the oral solution
• If you are suffering from an overactive thyroid gland
of levothyroxine your doctor will monitor you more closely.
(hyperthyroidism), an underactive adrenal gland, diabetes, For hypothyroidism the usual daily dosages are:
or have had an underactive thyroid gland for some time. Adults and children over 12 years:
Other medicines and Levothyroxine
Tell your doctor or pharmacist if you are taking/using, have
recently taken/used or might take/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 inform your doctor or pharmacist about the use
of 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 or Colesevelam to lower
your cholesterol levels, sodium polystyrene sulphonate or

Teva Pharmaceuticals Europe B.V
Effective Date: TBD

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.
Elderly (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.

REG0091487
Valid For 7 Days from 03-May-2017

Version 2.2

Approved
Page 1 of 4

320 mm

Levothyroxine 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 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.

TEVA UK Ref:

Version:

EBNUK1730a LEA LEVOTHYROXINE A/S SOL TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
320 mm
210 mm
N/A
N/A

1

03 May 2017

Colours Used:

BLACK
PANTONE® GREEN C
Template

210 mm



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.

Duration of treatment
The duration of treatment is usually for life if you are being
treated for hypothyroidism, non toxic diffuse goitre or
Hashimoto’s thyroiditis.

50mm

Original Artwork Scale = 1:1 (100%)

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 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.

These are all very serious side effects. If you have them, you
may have a serious allergic reaction to Levothyroxine. 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 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.
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 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

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.
Levothyroxine Oral solution is odourless. Do not use this
medicine if you notice that the solution has an odour. Talk to
your pharmacist.
Dispose of any remaining medicine 8 weeks after opening.
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

If you forget to take Levothyroxine
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. 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.

What Levothyroxine contains:
The active substance is Levothyroxine sodium. Each 5 ml of
oral solution contains Levothyroxine equivalent to
Levothyroxine sodium anhydrous 25 micrograms,
50 micrograms or 100 micrograms.

If you stop taking Levothyroxine
For your treatment to be successful, you must take
Levothyroxine regularly at the dosage prescribed by your
doctor. On no account should you change, suspend or stop
the prescribed treatment without talking to your doctor.
Symptoms of disease may return if you suspend or stop
treatment before you should. The nature of these symptoms
depends on the underlying disease.

What Levothyroxine looks like and contents of the pack
Levothyroxine Oral solution is a clear colourless liquid. Each
bottle contains 100 ml of oral solution. A double ended 5 ml
and 2.5 ml polypropylene spoon or a plastic dosing syringe
(pipette) is also included to help measure the dose.

The other ingredients are: Glycerol, citric acid monohydrate,
sodium methyl parahydroxybenzoate (E219), sodium
hydroxide and purified water.

Marketing Authorisation Holder
If you have any further questions on the use of this medicine, TEVA UK Limited, Eastbourne, BN22 9AG, UK.
ask your doctor or pharmacist..
Manufacturer
Famar Netherlands BV, 5531 AD Bladel, The Netherlands.

4

POSSIBLE SIDE EFFECTS

This leaflet was last revised in 12/2016
Like all medicines, this medicine can cause side effects,
PL 00289/1593
although not everybody gets them.
PL 00289/1594
These usually only happen if the dose you are taking is too high. PL 00289/1595
If any of the following happen, stop taking Levothyroxine
and tell your doctor immediately or go to the casualty
department at your nearest hospital

Teva Pharmaceuticals Europe B.V
Effective Date: TBD

REG0091487
Valid For 7 Days from 03-May-2017

EBNUK1730a
210115.03-GB
31024646.03

Version 2.2

Approved
Page 2 of 4

320 mm

Method of administration
You should take your Levothyroxine on an empty stomach,
usually before breakfast..





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.

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2
pil-uk-pl-00289-1593-5-levothyroxine-25micrograms-5ml-50micrograms-5ml
-100micrograms-5ml-oral-solution

APPROVALS
Signed by
Yifan Li

Meaning of Signature
Regulatory Affairs Approval

Teva Pharmaceuticals Europe B.V
Effective Date: TBD

Server Date

REG0091487

03-May-2017 03:25:39 PM

Version 2.2

Valid For 7 Days from 03-May-2017

Approved
Page 4 of 4

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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