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LEVOTHYROXINE TABLETS BP 100 MICROGRAMS

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

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Levothyroxine 50micrograms and 100micrograms tablets
Read all of this leaflet carefully before
you start taking this medicine.
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.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
• 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‘Taking
other medicines’). 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’).
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
2 Before you take
adults and children. If you are giving
Levothyroxine
this medicine to your child make sure
Do not take this medicine if you:
you know how many and when to give
• are allergic to levothyroxine or to any of
the tablets (See Section 3 ’How to take’)
the other ingredients (see section 6).
and what side effects to look out for (See • suffer from an overactive thyroid
Section 4 ’Possible side effects).
gland that produces too much thyroid
hormone (thyrotoxicosis)
In this leaflet
• have any condition that affects your
1 What Levothyroxine is and what
adrenal glands (your doctor will be able
it is used for
to advise you if you are not sure)
2 Before you take
• If any of these apply to you, do not take
this medicine and go back to your doctor
3 How to take
to discuss your treatment.
4 Possible side effects
Check with your doctor or pharmacist
5 How to store
before taking Levothyroxine tablets if you:
6 Further information
• have suffered with an under active
thyroid gland for a long time
1 What Levothyroxine is and what it
• suffer from heart problems including
is used for
angina, coronary artery disease or high
Thyroxine is a hormone which is
blood pressure.
produced naturally in the body by the
• are being treated for diabetes. The dose
thyroid gland. Levothyroxine is a synthetic
of your anti-diabetic medicine may need
version of this hormone. Thyroxine
to be changed as levothyroxine can raise
controls how much energy your body
blood sugar levels.
uses. When the thyroid gland does not
• are over 50 years of age.
produce enough thyroxine (a condition
Blood tests
known as hypothyroidism), many of
Before you start taking levothyroxine
the body’s functions slow down. Some
your doctor will do a blood test to see
of the most common symptoms of
how much thyroxine your thyroid gland
hypothyroidism are:
is making and what dose of the medicine
• tiredness
you will need. Once you start taking the
• weight gain
medicine your doctor will want you to
• feeling depressed
have regular blood tests to see how well
Levothyroxine tablets are used to
the medicine is working.
replace the thyroxine that your thyroid
Taking other medicines
gland cannot produce and prevent the
Many medicines affect the way
symptoms of hypothyroidism. Before
levothyroxine works. The effects of
starting your treatment your doctor will
other drugs may also be affected by
carry out a blood test to work out how
levothyroxine.
much levothyroxine you need.

You must tell your doctor if you
are taking or start taking any other
medicines, including over the counter
medicines, herbal remedies and vitamin
supplements.
The following may affect the way that
levothyroxine works:
• medicines for epilepsy such as
carbamazepine, phenytoin,
primidone and barbiturates
• sertraline - used to treat depression and
anxiety disorders
• antacids – used to treat indigestion
• medicines containing calcium salts
• cimetidine – used to reduce excess
stomach acid
• proton pump inhibitors such as
omeprazole, lansoprazole and
pantoprazole – used to reduce the
amount of acid produced by the
stomach
• sucralfate – used to treat and prevent
stomach and duodenal ulcers
• colestyramine and colestipol – used to
treat high level of fat in the blood
• polystyrene sulphone resin – used to
reduce high levels of potassium in the
blood
• medicines containing iron that are taken
by mouth
• rifampicin – used to treat infections
• imatinib – used to treat certain types of
cancer
• beta blockers such as atenolol and
sotalol – used to treat high blood
pressure and heart problems
• oestrogen containing medicines for
hormone replacement therapy (HRT)
and contraception (the ’pill’)
• androgen containing medicines for
male hormone replacement therapy

• corticosteroids such as hydrocortisone
and prednisolone – used to treat
inflammation
• amiodarone – used to treat an irregular
heart beat
The following may be affected by
levothyroxine:
• anticoagulant medicines to prevent
blood clots such as warfarin
• medicines to treat diabetes such as
insulin and metformin
• tricyclic antidepressants such as
amitriptyline, imipramine and
dosulepin
• medicines that stimulate the
sympathetic nervous system such
as adrenaline (epinephrine - used
to treat severe allergic reactions) or
phenylephrine (a decongestant found
in many cold and flu treatments)
• digoxin – used to treat heart problems
• anti-inflammatory medicines such as
phenylbutazone or aspirin
• propranolol – used to treat high blood
pressure and heart problems
• ketamine – used as an anaesthetic. If
you need to have an operation, please
tell your doctor or anaesthetist that you
are taking levothyroxine.
Pregnancy and breast-feeding
If you are pregnant particularly in the
first three months of your pregnancy,
planning to become pregnant or are
breast-feeding, tell your doctor or
pharmacist before taking this medicine.
Your doctor will decide if you should
continue treatment with levothyroxine
whilst you are pregnant.

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Important information about some of
the ingredients
If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicine, as it contains lactose.
3

How to take

You may be taking this medicine for the
rest of your life. Always take Levothyroxine
tablets exactly as your doctor has told you.
If you are not sure, check with your doctor
or pharmacist. Your dose will be decided
by your doctor and will depend on the
results of your blood tests. The dose you
should take will be on the label attached
by your pharmacist. Swallow the tablets
with plenty of water. You should usually
take your tablets before breakfast or your
first meal of the day.
Adults:
The usual starting dose is 50-100
micrograms every day. Your doctor
may increase the dose you take every
3-4 weeks by 50 micrograms until your
thyroxine levels are correct. Your final daily
dose may be up to 100-200 micrograms
daily.
Patients over 50 years of age:
The usual starting dose will be no more
than 50 micrograms every day. The dose
may then be increased by 50 micrograms
every 3-4 weeks until your thyroxine levels
are correct. Your final daily dose will be
between 50-200 micrograms daily.
Patients over 50 years with heart
problems:
The starting dose will be 25 micrograms
every day or 50 micrograms every other
day. The dose may be increased by 25
micrograms every 4 weeks until your
thyroxine levels are correct. Your final
daily dose will usually be between 50-200
micrograms daily.

Giving these tablets to children:
In children over 1 year, initially 2.5-5
The dose for children depends on their
micrograms per kg of bodyweight a day
age, weight and the condition being
should be taken.
treated. Your child will be monitored to
If you take more Levothyroxine than
make sure he/she gets the right dose.
you should
You should give them their medicine at
If you (or someone else) swallow a lot of
least half an hour before breakfast or
the tablets at the same time, or you think
their first meal of the day. If necessary, the
a child may have swallowed any, contact
tablets can be dissolved in 10-15ml of
your nearest hospital casualty department
water and given with some more liquid
or tell your doctor immediately. Signs of
(5-10ml). The dissolved tablets should
an overdose may include: fever, chest pain
be taken straight away. Do not keep the
(angina), racing or irregular heartbeat,
solution to give to your child later.
muscle cramps, headache, restlessness,
Congenital hypothyroidism in infants:
flushing, sweating and diarrhoea. These
This is a condition where your baby has
signs can take up to 5 days to appear.
been born with a thyroid gland that does
If you forget to take Levothyroxine
not produce enough thyroxine. The starting
If you forget to take a dose take it as soon
dose is 10 -15 micrograms/kg bodyweight as you remember unless it is nearly time
per day for the first three months. The
for your next dose. Do not take a double
dose will then be adjusted depending
dose. If you forget to give your child their
on how your baby responds to the
dose, contact your doctor or pharmacist
treatment.
for further advice.
Acquired hypothyroidism in children:
Stopping the tablets:
This is a condition where your child’s thyroid
These tablets are for long term use. You
gland stops working properly because it has
may need to take them for the rest of your
been attacked by their immune system, e.g.
life. Do not stop taking the tablets unless
in children with an autoimmune disease or
your doctor has told you to do so.
following a viral infection. The starting dose 4
Possible side effects
is 12.5 to 50 micrograms a day. The dose
Some people may have side-effects when
should be increased gradually every 2 to
taking this medicine.
4 weeks depending on how your child
Stop taking the tablets and go to
responds to the medicine.
hospital at once if you have:
Juvenile myxoedema:
• a rare allergic reaction such as swelling
This is a condition where children and
of the face, tongue, lips and throat,
adolescents develop severe hypothyroidism
difficulty breathing, severe itching of
(produce very low levels of thyroid
your skin with raised lumps, joint pain,
hormones). The starting dose is 25
sensitivity to the sun, general feeling
micrograms every day. The dose will
of being unwell. You may need urgent
then be increased by 25 micrograms
medical attention.
every 2-4 weeks until your child shows
Some patients may experience a
mild symptoms of hyperthyroidism
severe reaction to high levels of thyroid
(a condition where the thyroid gland
hormone. This is called a“thyroid crisis”
produces too much thyroxine). The dose
and you should contact your doctor
will then be reduced slightly.
immediately if you have any of the
following symptoms:
50920526 BBBA0535

• very high temperature; fast heart rate;
5 How to store
irregular heartbeat; low blood pressure;
• Keep out of the sight and reach of
heart failure; jaundice; confusion; fits and
children.
coma
• Do not store above 25ºC. Store in the
Tell your doctor or pharmacist if any
original package. Keep container in the
of the following side effects continue,
outer carton.
get worse or if you notice any other
• Do not use Levothyroxine tablets after
side effects not listed.
the expiry date stated on the label/
Most of the side effects are similar to the
carton/bottle. The expiry date refers to
symptoms of hyperthyroidism (where the
the last day of that month.
thyroid gland makes too much throxine)
• Medicines should not be disposed of
and are due to your dose of the medicine
via wastewater or household waste.
being too high. They will usually disappear
Ask your pharmacist how to dispose
after reducing the dose or stopping the
of medicines no longer required. These
tablets. However, you must not change
measures will help to protect the
the dose or stop the tablets without
environment.
talking to your doctor first.
6 Further information
• headache
What Levothyroxine tablets contain
• flushing
• The active substance (the ingredient that
• high temperature, sweating
makes the tablets work) is anhydrous
• weight loss
levothyroxine sodium. Each tablet
• tremor, restlessness, excitability, difficulty
contains either 50 micrograms or 100
sleeping (insomnia)
micrograms of the active substance.
• increased pressure around the brain in
• The other ingredients are lactose,
children that is not caused by a tumour
magnesium stearate, maize starch,
or other diseases (benign intracranial
stearic acid and pregelatinised maize
hypertension)
• chest pain (angina), pounding, irregular
starch.
or fast heartbeat
What Levothyroxine tablets look like
• diarrhoea, vomiting
and contents of the pack
• muscle cramps, muscle weakness,
50 microgram tablets are white, circular,
• deformity of the skull in infants caused
biconvex, uncoated tablets.
by the early closure of joins in the skull
100 microgram tablets are white, circular,
bone (craniostenosis)
shallow convex, uncoated tablets.
• growth in children may slow or stop due
Pack size is 28 and 1000 tablets.
to changes in bone growth
• irregular periods
Marketing Authorisation Holder and
• intolerance to heat
Manufacturer
• temporary hair loss in children
Actavis, Barnstaple, EX32 8NS, UK.
Reporting of side effects
This leaflet was last revised in
If you get any side effects, talk to your
February 2017
doctor, pharmacist or nurse. This includes
If
you would like a leaflet with
any possible side effects not listed in this
leaflet. You can also report side effects
larger text, please contact
directly via the Yellow Card Scheme at:
01271 385257.
www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety of
this medicine.

148x210 Leaflet Reel Fed Profile (BST)

Levothyroxine Tablets
50 & 100’s x 28’s (UK)

Levothyroxine Tablets 50mcg & 1000mcg x 28 & 100’s PIL -UK
approved for print/date

Proof Round

01

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0535

Originator:
C.Grant
Origination Date: 20/02/17
Revision Date:
Revised By:

Dimensions:
148x210
Min Body Text Size: 7.75 pt
Supplier:
Actavis UK

Date sent:
N/A
Date received:

50920526

Non Printing Colours

1. Black

1. Profile

2.

2.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

3.

3.

Pharmacode: 7203

4.
5.

Technical
Approval

JDE No.:

Colours

6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Date Sent:
17/02/17
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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