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LEVOTHYROXINE 12.5 MICROGRAM TABLETS

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

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TEVA UK Ref:

231-30-30201-C LEVOTHYROXINE 12.5, 25, 50, 75, 100mcg TAB TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
200 mm
N/A
N/A

Version:

1

Colours Used:

13 December 2016
BLACK
PANTONE® GREEN C
Template

Pharma code 90
First bar is 105mm from the top edge of the leaflet.

• have diabetes as the dose of your insulin or oral
anti-diabetic medication, e.g. gliclazide, may need to be
altered
• suffer from diabetes insipidus, which is due to a low
level of antidiuretic hormone (ADH)
PACKAGE LEAFLET: INFORMATION FOR THE USER
• have suffered from an under-active thyroid for a long
Read all of this leaflet carefully before you start taking this
time, symptoms include swelling of the nose and lips
medicine because it contains important information for you.
(myxoedema)
• Keep this leaflet. You may need to read it again.
• are over 50 years of age
• If you have any further questions, ask your doctor or
• suffer from an under-active pituitary gland or other causes
pharmacist or nurse.
leading to adrenal insufficiency, as you may need to start
• This medicine has been prescribed for you only. Do not
corticosteroid therapy before taking levothyroxine.
pass it on to others. It may harm them, even if their signs
Other
medicines and Levothyroxine
of illness are the same as yours.
Tell your doctor or pharmacist if you are taking, have
• If you get any side effects, talk to your doctor or
recently taken or might take any other medicines:
pharmacist or nurse. This includes any possible side
• anticoagulants, used to prevent blood from clotting, such
effects not listed in this leaflet. See section 4.
as warfarin, dicoumarol and phenindione
• Thyroxine is a hormone produced by the thyroid gland.
• colestyramine and colestipol used to lower cholesterol
Levothyroxine is used to replace thyroxine in people
levels in the blood
whose thyroid gland does not work properly. You will
• beta blockers such as atenolol and sotalol – used to treat
usually need to take this medicine for the rest of your life
high blood pressure and heart problems
and must not stop taking it, or change the dose, without • medicines used to treat heart problems, such as digoxin,
speaking to your doctor first.
digitoxin, amiodarone or propranolol
• tricyclic antidepressants such as imipramine, amitriptyline
• This medicine can affect the way other medicines work
and dosulepin
(See Section 2 ‘Other medicines and Levothyroxine’). If
• sertraline – used to treat depression and anxiety disorders
you take medicines to control diabetes or warfarin to
prevent blood clots, the dose may need to be adjusted by • antacids – used to treat indigestion
• cimetidine and sucralfate, used to treat heartburn and
your doctor when you start taking levothyroxine tablets.
stomach ulcers
• You will start off taking a low dose of this medicine (See • proton pump inhibitors such as omeprazole, lansoprazole
Section 3 ’How to take Levothyroxine’). Your doctor will
and pantoprazole – used to reduce the amount of acid
then increase the dose gradually at 3-4 week intervals
produced by the stomach
until your thyroxine levels are corrected. This will help to • anticonvulsants, used to treat epilepsy, such as
reduce the chance of side effects.
phenytoin, primidone, carbamazepine and barbiturates
• barbiturates such as phenobarbital, used as sedatives
• You will need regular blood tests whilst you are taking
• ketamine – used as an anaesthetic. If you need to have
this medicine.
an operation, please tell your doctor or anaesthetist that
• These tablets can be taken by both adults and children. If
you are taking levothyroxine
you are giving this medicine to your child make sure you • oestrogen containing medicines for hormonal replacement
know how many and when to give the tablets (See
therapy (HRT) and oral contraceptives (“the pill”)
Section 3 ’How to take Levothyroxine’) and what side
• androgen containing medicines for male hormone
effects to look out for (See Section 4 ‘Possible side effects’).
replacement therapy
• corticosteroids such as hydrocortisone and prednisolone
What is in this leaflet:
– used to treat inflammation
1. What Levothyroxine is and what it is used for
• anti-inflammatory medicines such as phenylbutazone or
2. What you need to know before you take Levothyroxine
aspirin
3. How to take Levothyroxine
• imatinib – used to treat certain types of cancer
4. Possible side effects
• rifampicin, used to treat tuberculosis
5. How to store Levothyroxine
• insulin and medicines to treat diabetes
6. Contents of the pack and other information
• sodium polystyrene sulphonate (resin) used to treat high
levels of potassium
What
Levothyroxine
is
and
what
it
is
used
for

calcium salt supplements
1
• iron supplements (see section 3, How to take, Taking
Levothyroxine in combination with iron supplements)
Thyroxine is a hormone which is produced naturally in the
• sympathomimetic drugs such as dopamine, terbutaline,
body by the thyroid gland.
salmeterol, salbutamol, ephedrine, adrenaline or
Levothyroxine is a synthetic version of this hormone.
phenylpropanolamine. Phenylpropanolamine and
Thyroxine controls how much energy your body uses.
ephedrine may be in medicines for colds and nasal
When the thyroid gland does not produce enough
stuffiness. Tell your pharmacist you are taking
thyroxine (a condition known as hypothyroidism), many of
levothyroxine before buying such products.
the body’s functions slow down. Some of the most
• Colesevelam – used to lower cholesterol
common symptoms of hypothyroidism are:
• Orlistat – used to help with weight loss
• tiredness
Pregnancy, breast-feeding and fertility
• weight gain
If you are pregnant or breast-feeding, think you may be
• feeling depressed
pregnant or planning to have a baby, ask your doctor or
Levothyroxine tablets are used to replace the thyroxine
pharmacist for advice before taking this medicine.
that your thyroid gland cannot produce and prevent the
Driving and using machines
symptoms of hypothyroidism. Before starting your
Levothyroxine is not expected to affect your ability to drive
treatment your doctor will carry out a blood test to work
or operate machinery. However, if you are affected by any
out how much levothyroxine you need.
of the adverse events such as muscle weakness, cramps or
shaking, please refrain from driving or using machines and
What
you
need
to
know
before
you
take
2 Levothyroxine
speak to your doctor or pharmacist for further advice.
Do not take Levothyroxine if you:
3 How to take Levothyroxine
• are allergic to levothyroxine or any of the other
ingredients of this medicine (listed in section 6)
Always take this medicine exactly as your doctor has told you.
• suffer from an over-active thyroid gland (thyrotoxicosis) Check with your doctor or pharmacist if you are not sure.
• have any condition that affects your adrenal glands (your
The tablets should be swallowed, with a drink of water, in
doctor will be able to advise you if you are not sure).
the morning at least 30 minutes and preferably one hour
Warnings and precautions
before breakfast.
Talk to your doctor or pharmacist or nurse before taking
The usual dosage is:
Levothyroxine if you:
• have had a heart attack or any other heart problems, e.g. Adults up to 50 years old
• the usual starting dose for adults is 50 to 100 micrograms
chest pain (angina), thickening and hardening of artery
daily, preferably taken before breakfast.
walls (arteriosclerosis), coronary artery disease, high
blood pressure (hypertension), irregular or fast heart rate

PAGE 1: FRONT FACE (INSIDE OF REEL)

REG0067447

Version 3.4

Approved

Page 1 of 3

Top of page cut-off to middle of registration mark: 44 mm.

LEVOTHYROXINE 12.5, 25, 50, 75 and
100 microgram TABLETS
levothyroxine sodium

TEVA UK Ref:

231-30-30201-C LEVOTHYROXINE 12.5, 25, 50, 75, 100mcg TAB TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
200 mm
N/A
N/A

Version:

1

Colours Used:

13 December 2016
BLACK
PANTONE® GREEN C
Template

Your doctor may gradually increase your dose by
50 micrograms every three to four weeks until thyroid
deficiency is corrected, usually at a dosage of
100 - 200 micrograms daily.
Adults over 50 years old, or patients with heart disease
• for patients aged over 50 years, the starting dose should
be no more than 50 micrograms per day
• for patients with heart disease, the starting dose should
be no more than 25 micrograms per day or 50 micrograms
on alternate days.
Your doctor may gradually increase your dose by
25 micrograms every four weeks until thyroid deficiency is
corrected.

Some patients may experience a severe reaction to high
levels of thyroid hormone. This is called a “thyroid
crisis”and you should contact your doctor immediately if
you have any of the following symptoms:
• very high temperature; fast heart rate; irregular
heartbeat; low blood pressure; heart failure; jaundice;
confusion; fits and coma.

Tell your doctor as soon as possible if you suffer from any
of the following side effects, as they are usually due to
your dose being too high:
• fast heart beat, palpitations, irregular heart beat, chest
pain (angina), pounding, heart attack
• headache, tremor, excitability, restlessness, difficulty in
sleeping (insomnia)
Use in children:

increased pressure around the brain in children that is
The dose for children depends on their age, weight and the
not caused by a tumour or other disease, with symptoms
condition being treated. The child will be monitored to make
such as nausea, vomiting, increased blood pressure,
sure he/she gets the right dose. Give your child this medicine
decreased mental abilities, confusion, double vision,
at least half an hour before the first meal of the day.
pupils that don’t respond to changes in light, shallow
For young children, your doctor is likely to prescribe a
breathing, seizures, loss of consciousness, coma (benign
levothyroxine product in a liquid formulation.
intracranial hypertension)
• muscle cramps or weakness, shaking
Congenital hypothyroidism in infants:
• deformity of the skull in infants caused by the early
This is a condition where your baby has been born with a
closure of joins in the skull bone (carniostenosis)
thyroid gland that does not produce enough thyroxine.

growth in children may slow or stop due to changes in
The starting dose is 10 to 15 micrograms/kg body weight a
bone growth
day for the first 3 months. The dose will then be adjusted
• irregular periods
depending on response to treatment.
• high temperature, fever, sweating, flushing, intolerance
Acquired hypothyroidism in children:
to heat
This is a condition where your child’s thyroid gland stops
• vomiting, diarrhoea
working properly because it has been attacked by their
• weight loss
immune system, e.g. in children with an autoimmune
• temporary hair loss in children.
disease or following a viral infection.
The starting dose is 12.5 to 50 micrograms a day. The dose Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
will then be increased gradually every 2 to 4 weeks
or nurse. This includes any possible side effects not listed
depending on response to treatment.
in this leaflet. You can also report side effects directly via
Juvenile myxoedema:
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
This is a condition where children and adolescents develop By reporting side effects you can help provide more
severe hypothyroidism (produce very low levels of thyroid information on the safety of this medicine.
hormones).
The starting dose is 25 micrograms every day. The dose
5 How to store Levothyroxine
will then be increased by 25 micrograms every 2-4 weeks
until your child shows mild symptoms of hyperthyroidism Keep this medicine out of the sight and reach of children.
(a condition where the thyroid gland produces too much
Do not store above 25°C. Store in the original package.
thyroxine). The dose will then be reduced slightly.
Taking Levothyroxine in combination with iron supplements: Do not use this medicine after the expiry date which is
stated on the carton. The expiry date refers to the last day
• if you take iron supplements, you should take
of that month. Do not throw away any medicines via
levothyroxine and your iron supplement at least 4-5
wastewater or household waste. Ask your pharmacist how
hours apart.
to throw away medicines you no longer use. These
If you take more Levothyroxine than you should
measures will help protect the environment.
If you (or someone else) swallow a lot of the tablets all
together, or if you think a child has accidentally swallowed
6 Contents of the pack and other information
any of the tablets, contact your nearest hospital casualty
department or your doctor immediately. An overdose is
What Levothyroxine tablets contain:
likely to cause agitation, confusion, hyperactivity,
• The active ingredient is levothyroxine sodium, 12.5, 25,
irritability, sweating, very dilated pupils, fast or irregular
50, 75 or 100 micrograms.
heart beat, rapid breathing, fever, fits and increased bowel
• The other ingredients are maize starch, mannitol (E421),
movements. Please take this leaflet, any remaining tablets
microcrystalline cellulose, sodium citrate, acacia and
and the container with you to the hospital or doctor so that
magnesium stearate.
they know which tablets were consumed.
What Levothyroxine tablets look like and contents of the
If you forget to take Levothyroxine
pack:
If you forget to take a dose take one as soon as you
• The 12.5 microgram tablets are white, round, biconvex
remember, unless it is nearly time to take the next one. Do
tablets with marking 12.5 on one side of the tablet
not take a double dose to make up for a forgotten dose.
• The 25 microgram tablets are white, round biconvex
If you stop taking Levothyroxine
tablets with scoreline on one side and marking 25 on the
Do not stop taking your medicine without talking to your
other side of the tablet
doctor first even if you feel better.
• The 50 microgram tablets are white, round biconvex
tablets with scoreline on one side and marking 50 on the
If you have any further questions on the use of this
other side of the tablet
medicine, ask your doctor, pharmacist or nurse.
• The 75 microgram tablets are white, round biconvex
tablets with scoreline on one side and marking 75 on the
4 Possible side effects
other side of the tablet
• The 100 microgram tablets are white, round biconvex
Like all medicines, this medicine can cause side effects,
tablets with scoreline on one side and marking 100 on
although not everybody gets them.
the other side of the tablet
If the following happens, stop taking the tablets and tell
The product is available in packs of 28, 56 and 112 tablets.
your doctor immediately or go to the casualty department Not all pack sizes may be marketed.
at your nearest hospital:
Marketing Authorisation Holder and Manufacturer
• an allergic reaction (swelling of the lips, face or neck
TEVA UK Limited, Eastbourne, BN22 9AG.
leading to severe difficulty in breathing; skin rash or
hives; joint pain and general feeling of being unwell).
This leaflet was last revised in 12/2016
This is a very serious but rare side effect. You may need
PL 00289/1971-3 and PL 00289/0038-9
urgent medical attention or hospitalisation.
30201-C
323 x 200

PAGE 2: REAR FACE (OUTSIDE OF REEL)

REG0067447

Version 3.4

Approved

Page 2 of 3

TEVA UK Ref:

231-30-51057-C LEVOTHYROXINE 12.5, 25, 50, 75, 100mcg TAB TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
500 mm
155 mm
N/A
N/A

Version:

1

13 December 2016

Colours Used:

BLACK
PANTONE® GREEN C
Template

LEVOTHYROXINE 12.5, 25, 50,
75 and 100 microgram
TABLETS
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 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 or pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
• Thyroxine is a hormone produced by
the thyroid gland. Levothyroxine is
used to replace thyroxine in people
whose thyroid gland does not work
properly. You will usually need to take
this medicine for the rest of your life
and must not stop taking it, or change
the dose, without speaking to your
doctor first.
• This medicine can affect the way
other medicines work (See Section 2
‘Other medicines and Levothyroxine’).
If you take medicines to control
diabetes or warfarin to prevent blood
clots, the dose may need to be
adjusted by your doctor when you
start taking levothyroxine tablets.
• You will start off taking a low dose of
this medicine (See Section 3 ’How to
take Levothyroxine’). Your doctor will
then increase the dose gradually at
3-4 week intervals until your thyroxine
levels are corrected. This will help to
reduce the chance of side effects.
• You will need regular blood tests
whilst you are taking this medicine.
• These tablets can be taken by both
adults and children. If you are giving
this medicine to your child make sure
you know how many and when to
give the tablets (See Section 3 ’How
to take Levothyroxine’) and what side
effects to look out for (See Section 4
‘Possible side effects’).
What is 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 What Levothyroxine is and
what it is used for

Thyroxine is a hormone which is
produced naturally in the body by the
thyroid gland.
Levothyroxine is a synthetic version of
this hormone. Thyroxine controls how
much energy your body uses. When the
thyroid gland does not produce enough
thyroxine (a condition known as
hypothyroidism), many of the body’s
functions slow down. Some of the most
common symptoms of hypothyroidism
are:
• tiredness
• weight gain
• feeling depressed
Levothyroxine tablets are used to
replace the thyroxine that your thyroid
gland cannot produce and prevent the
symptoms of hypothyroidism. Before
starting your treatment your doctor will
carry out a blood test to work out how
much levothyroxine you need.







medication, e.g. gliclazide, may need
to be altered
suffer from diabetes insipidus, which
is due to a low level of antidiuretic
hormone (ADH)
have suffered from an under-active
thyroid for a long time, symptoms
include swelling of the nose and lips
(myxoedema)
are over 50 years of age
suffer from an under-active pituitary
gland or other causes leading to
adrenal insufficiency, as you may
need to start corticosteroid therapy
before taking levothyroxine.

Other medicines and Levothyroxine
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines:
• anticoagulants, used to prevent blood
from clotting, such as warfarin,
dicoumarol and phenindione
• colestyramine and colestipol used to
lower cholesterol levels in the blood
• beta blockers such as atenolol and
sotalol – used to treat high blood
pressure and heart problems
• medicines used to treat heart
problems, such as digoxin, digitoxin,
amiodarone or propranolol
• tricyclic antidepressants such as
imipramine, amitriptyline and
dosulepin
• sertraline – used to treat depression
and anxiety disorders
• antacids – used to treat indigestion
• cimetidine and sucralfate, used to
treat heartburn and stomach ulcers
• proton pump inhibitors such as
omeprazole, lansoprazole and
pantoprazole – used to reduce the
amount of acid produced by the
stomach
• anticonvulsants, used to treat
epilepsy, such as phenytoin,
primidone, carbamazepine and
barbiturates
• barbiturates such as phenobarbital,
used as sedatives
• ketamine – used as an anaesthetic. If
you need to have an operation,
please tell your doctor or anaesthetist
that you are taking levothyroxine
• oestrogen containing medicines for
hormonal replacement therapy (HRT)
and oral contraceptives (“the pill”)
• androgen containing medicines for
male hormone replacement therapy
• corticosteroids such as hydrocortisone
and prednisolone – used to treat
inflammation
• anti-inflammatory medicines such as
phenylbutazone or aspirin
• imatinib – used to treat certain types
of cancer
• rifampicin, used to treat tuberculosis
• insulin and medicines to treat diabetes
• sodium polystyrene sulphonate (resin)
used to treat high levels of potassium
• calcium salt supplements
• iron supplements (see section 3, How
to take, Taking Levothyroxine in
combination with iron supplements)
• sympathomimetic drugs such as
dopamine, terbutaline, salmeterol,
salbutamol, ephedrine, adrenaline or
phenylpropanolamine.
Phenylpropanolamine and ephedrine
may be in medicines for colds and
nasal stuffiness. Tell your pharmacist
you are taking levothyroxine before
buying such products.
• Colesevelam – used to lower
cholesterol
• Orlistat – used to help with weight loss
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding,
think you may be pregnant or planning
to have a baby, ask your doctor or
pharmacist for advice before taking this
medicine.

Driving and using machines
Levothyroxine is not expected to affect
your ability to drive or operate
machinery. However, if you are affected
by any of the adverse events such as
muscle weakness, cramps or shaking,
refrain from driving or using
2 What you need to know before please
machines
and speak to your doctor or
you take Levothyroxine
pharmacist for further advice.
Do not take Levothyroxine if you:
• are allergic to levothyroxine or any of
3 How to take Levothyroxine
the other ingredients of this medicine
(listed in section 6)
Always take this medicine exactly as your
• suffer from an over-active thyroid
doctor has told you. Check with your
gland (thyrotoxicosis)
doctor or pharmacist if you are not sure.
• have any condition that affects your
The tablets should be swallowed, with
adrenal glands (your doctor will be
able to advise you if you are not sure). a drink of water, in the morning at least
30 minutes and preferably one hour
Warnings and precautions
before breakfast.
Talk to your doctor or pharmacist or
nurse before taking Levothyroxine if you: The usual dosage is:
Adults up to 50 years old
• have had a heart attack or any other
• the usual starting dose for adults is
heart problems, e.g. chest pain
50 to 100 micrograms daily,
(angina), thickening and hardening of
preferably taken before breakfast.
artery walls (arteriosclerosis),
Your doctor may gradually increase
coronary artery disease, high blood
pressure (hypertension), irregular or your dose by 50 micrograms every
three to four weeks until thyroid
fast heart rate
deficiency is corrected, usually at a
• have diabetes as the dose of your
dosage of 100 - 200 micrograms daily.
insulin or oral anti-diabetic

REG0155070

Version 2.4

Approved

Page 1 of 3

TEVA UK Ref:

231-30-51057-C LEVOTHYROXINE 12.5, 25, 50, 75, 100mcg TAB TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
500 mm
155 mm
N/A
N/A

Version:

1

13 December 2016

Colours Used:

BLACK
PANTONE® GREEN C
Template

Adults over 50 years old, or patients
with heart disease
• for patients aged over 50 years, the
starting dose should be no more than
50 micrograms per day
• for patients with heart disease, the
starting dose should be no more than
25 micrograms per day or
50 micrograms on alternate days.
Your doctor may gradually increase your
dose by 25 micrograms every four weeks
until thyroid deficiency is corrected.
Use in children:
The dose for children depends on their
age, weight and the condition being
treated. The 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.
For young children, your doctor is likely
to prescribe a levothyroxine product in
a liquid formulation.
Congenital hypothyroidism in infants:
This is a condition where your baby has
been born with a thyroid gland that
does not produce enough thyroxine.
The starting dose is 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:
This is a condition where your child’s
thyroid gland stops working properly
because it has been attacked by their
immune system, e.g. in children with
an autoimmune disease or following a
viral infection.
The starting dose is 12.5 to 50 micrograms
a day. The dose will then be increased
gradually every 2 to 4 weeks depending
on response to treatment.
Juvenile myxoedema:
This is a condition where children and
adolescents develop severe
hypothyroidism (produce very low
levels of thyroid hormones).
The starting dose is 25 micrograms every
day. The dose will then be increased by
25 micrograms every 2-4 weeks until
your child shows mild symptoms of
hyperthyroidism (a condition where the
thyroid gland produces too much
thyroxine). The dose will then be
reduced slightly.

• very high temperature; fast heart rate;
irregular heartbeat; low blood
pressure; heart failure; jaundice;
confusion; fits and coma.
Tell your doctor as soon as possible if
you suffer from any of the following
side effects, as they are usually due to
your dose being too high:
• fast heart beat, palpitations, irregular
heart beat, chest pain (angina),
pounding, heart attack
• headache, tremor, excitability,
restlessness, difficulty in sleeping
(insomnia)
• increased pressure around the brain
in children that is not caused by a
tumour or other disease, with
symptoms such as nausea, vomiting,
increased blood pressure, decreased
mental abilities, confusion, double
vision, pupils that don’t respond to
changes in light, shallow breathing,
seizures, loss of consciousness, coma
(benign intracranial hypertension)
• muscle cramps or weakness, shaking
• deformity of the skull in infants
caused by the early closure of joins in
the skull bone (carniostenosis)
• growth in children may slow or stop
due to changes in bone growth
• irregular periods
• high temperature, fever, sweating,
flushing, intolerance to heat
• vomiting, diarrhoea
• weight loss
• temporary hair loss in children.
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.

5 How to store Levothyroxine
Keep this medicine out of the sight and
reach of children.
Do not store above 25°C. Store in the
original package.

Do not use this medicine after the
expiry date which is stated on the
carton. The expiry date refers to the last
Taking Levothyroxine in combination
day of that month. Do not throw away
with iron supplements:
any medicines via wastewater or
• if you take iron supplements, you
should take levothyroxine and your iron household waste. Ask your pharmacist
how to throw away medicines you no
supplement at least 4-5 hours apart.
longer use. These measures will help
protect the environment.
If you take more Levothyroxine than
you should
If you (or someone else) swallow a lot
6 Contents of the pack and other
of the tablets all together, or if you
information
think a child has accidentally swallowed
any of the tablets, contact your nearest What Levothyroxine tablets contain:
• The active ingredient is levothyroxine
hospital casualty department or your
sodium, 12.5, 25, 50, 75 or 100
doctor immediately. An overdose is
micrograms.
likely to cause agitation, confusion,
hyperactivity, irritability, sweating, very • The other ingredients are maize starch,
mannitol (E421), microcrystalline
dilated pupils, fast or irregular heart
cellulose, sodium citrate, acacia and
beat, rapid breathing, fever, fits and
magnesium stearate.
increased bowel movements. Please
take this leaflet, any remaining tablets
What Levothyroxine tablets look like
and the container with you to the
and contents of the pack:
hospital or doctor so that they know
• The 12.5 microgram tablets are white,
which tablets were consumed.
round, biconvex tablets with marking
12.5 on one side of the tablet
If you forget to take Levothyroxine
If you forget to take a dose take one as • The 25 microgram tablets are white,
round biconvex tablets with scoreline
soon as you remember, unless it is
on one side and marking 25 on the
nearly time to take the next one. Do not
other side of the tablet
take a double dose to make up for a
• The 50 microgram tablets are white,
forgotten dose.
round biconvex tablets with scoreline
If you stop taking Levothyroxine
on one side and marking 50 on the
Do not stop taking your medicine
other side of the tablet
without talking to your doctor first even • The 75 microgram tablets are white,
if you feel better.
round biconvex tablets with scoreline
on one side and marking 75 on the
If you have any further questions on the
other side of the tablet
use of this medicine, ask your doctor,
• The 100 microgram tablets are white,
pharmacist or nurse.
round biconvex tablets with scoreline
on one side and marking 100 on the
4 Possible side effects
other side of the tablet
Like all medicines, this medicine can
cause side effects, although not
everybody gets them.

The product is available in packs of 28,
56 and 112 tablets. Not all pack sizes
may be marketed.

If the following happens, stop taking
the tablets and tell your doctor
immediately or go to the casualty
department at your nearest hospital:
• an allergic reaction (swelling of the
lips, face or neck leading to severe
difficulty in breathing; skin rash or
hives; joint pain and general feeling
of being unwell).
This is a very serious but rare side
effect. You may need urgent medical
attention or hospitalisation.

Marketing Authorisation Holder
TEVA UK Limited, Eastbourne,
BN22 9AG.
Manufacturer
PLIVA Croatia Ltd, Prilaz baruna
Filipovića 25, 10000 Zagreb, CROATIA
This leaflet was last revised in 12/2016
PL 00289/1971-3 and PL 00289/0038-9

Some patients may experience a severe
reaction to high levels of thyroid
hormone. This is called a “thyroid
crisis”and you should contact your
doctor immediately if you have any of
the following symptoms:

51057-C

155 x 500

REG0155070

Version 2.4

Approved

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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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