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TERTROXIN TABLETS 20MCG

Active substance(s): LIOTHYRONINE SODIUM

PDF Transcript

Peel here to read leaflet

CRF No.:

Barcode:

5021691 108528

The score line is not intended for
breaking the tablet.
If you take more Liothyronine
Sodium Tablets than you should:
This may cause agitation,
confusion, headache, sweating and
a rapid pulse. If you take too many
tablets contact your doctor or
nearest hospital casualty
department as soon as possible.
Take any remaining tablets and this
leaflet with you so the medical staff
will know what you have taken.

If you forget to take your
Liothyronine Sodium Tablets:
Take the next dose at the correct
time and then go on as before. It is
important, in order for your medicine
to work, that doses are not forgotten.
Do not take a double dose to make
up for a forgotten tablet.
If you stop taking Liothyronine
Sodium Tablets:
Do not stop taking Liothyronine
Sodium Tablets unless your doctor
tells you to.

4. Possible side effects
Like all medicines, Liothyronine
Sodium Tablets can cause side
effects, although not everybody
gets them. Side effects you could
experience are:
• Vomiting (being sick)
• Insomnia (sleeplessness)
• Fever
• Intolerance to heat
• Tremor (involuntary, rhythmic
muscle movements)
• Temporary loss of hair in children

• Allergic reactions such as rash,
itching, oedema (abnormal
accumulation of body fluid)
• Angina pain (pain in the chest
when exercising)
• Irregular, thumping or fast heart
beats
• Muscle cramps or weakness
• Diarrhoea
• Restlessness or excitability
• Headache, face and neck
redness, sweating
• Loss of weight.

These effects normally mean the
dose of the medicine needs
changing. You should consult your
doctor if they occur. The effects
usually go away when the dose has
been changed.
If any of the side effects become
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.

5. How to store Liothyronine
Sodium Tablets
Keep this medicine out of the sight
and reach of children.
Do not use Liothyronine Sodium
Tablets after the expiry date which is
stated on the bottle. The expiry date
refers to the last day of that month.
Keep your tablets out of direct
sunlight. Do not use your tablets if
you notice that the container or the
tablets are damaged. Medicines
should not be disposed of via

wastewater or household waste.
Ask your pharmacist how to
dispose of medicines no longer
required. These measures will help
to protect the environment.
Remember:
This medicine is for you. Only a
doctor can prescribe it for you.
Never give this medicine to
someone else; it could harm
them, even if their symptoms
seem the same as yours.

6. Further information
What Liothyronine Sodium Tablets
contain:
The active substance is liothyronine
sodium 20 micrograms.
The other ingredients are lactose,
maize starch, powdered acacia,
sodium chloride, magnesium
stearate, industrial methylated
spirit, and purified water.

What Liothyronine Sodium Tablets
look like and contents of the pack:
Liothyronine Sodium Tablets are
supplied in container packs of 28
tablets.
Marketing Authorisation Holder:
Mercury Pharma Group Ltd.,
Capital House,
85 King William Street,
London EC4N 7BL, UK

Manufacturer:
Custom Pharmaceuticals Ltd.
Conway Street, Hove, East Sussex,
BN3 3LW
This leaflet was last revised in
February 2018.
LL-103803-01

28 Tablets Each tablet contains

Liothyronine
Sodium

20 micrograms
Tablets

20

micrograms

20 micrograms liothyronine
sodium.
Also contains lactose.
See leaflet for further
information.
To be taken by mouth.

Marketing Authorization Holder:
Mercury Pharma Group Ltd.,
Capital House, 85 King William
Street, London EC4N 7BL, UK

Use as directed by your
doctor.
Keep out of the sight and
reach of children.
Do not store above 25˚C.
Store in the original container
in order to protect from light.
PL10972/0033

POM

LL-103803-01

Date:

Adults:
The dose will depend upon your
condition, ranging from
10 micrograms to 60 micrograms
daily in divided doses.
Children and elderly:
The dose may be started at
5 micrograms a day.
Please note that your doctor will
monitor your thyroid function
regularly to make sure that you
are given the right dose for your
condition.

Tech Approved

• You should then swirl the
solution for a few seconds prior
to using a suitable oral syringe
to withdraw the amount of
liquid corresponding to the
dose prescribed (5mL for a
5mcg dose; 10 mL for a 10mcg
dose) and squirt the liquid
directly into your mouth by
gently pressing the plunger.
• Any remaining liquid should be
discarded.

Liothyronine sodium
tablets
Date:

Pharma Code:

Originated by

Dimensions:

5

L

M

Version:

U

100201/LB/4, 100201/LF/4

Software Package:

File Name:

AMCo.CRF.260.2014

M

L

LL-103803-01

CRF No.:

C

M

POM

M

Barcode:

PL10972/0033

100201/LB/4, 100201/LF/4

C

Marketing Authorization Holder:
Mercury Pharma Group Ltd.,
Capital House, 85 King William
Street, London EC4N 7BL, UK

Version:

L

5021691 108528

20

micrograms

Pharma Code:

20 micrograms
Tablets

Revised by:

Use as directed by your
doctor.
Keep out of the sight and
reach of children.
Do not store above 25˚C.
Store in the original container
in order to protect from light.

U

Liothyronine
Sodium

Each tablet contains
20 micrograms liothyronine
sodium.
Also contains lactose.
See leaflet for further
information.
To be taken by mouth.

M

28 Tablets

AMS Component No.:
Proof Number:
Revision Date:
Product Description:

Component:
Product Code:
Country:
Vendor Name:
CRF(s):
Revised by:
Dimension:

PATIENT INFORMATION LEAFLET

Liothyronine Sodium 20 micrograms 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.
If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What are Liothyronine Sodium
Tablets and what they are used
for
2. Before you take Liothyronine
Sodium Tablets
3. How to take Liothyronine Sodium
Tablets
4. Possible side effects
5. How to store Liothyronine
Sodium Tablets
6. Further information

1. What are Liothyronine
Sodium Tablets and
what are they used for
Liothyronine Sodium Tablets are a
form of thyroxine which is quick
acting and long lasting. Thyroxine is
a hormone produced by the thyroid
gland in the neck which controls
many body functions.
Liothyronine Sodium Tablets are
used to:
• treat some of the more severe
conditions in which the thyroid

does not produce enough
thyroxine.
• balance the effect of medicines
used to treat an overactive thyroid.
2. Before you take Liothyronine
Sodium Tablets
DO NOT take Liothyronine Sodium
Tablets if:
• You know that you are allergic to
liothyronine sodium or any of the
other ingredients (listed in
Section 6 at the end of this
leaflet)

• You have angina (chest pain
when exercising) or conditions
affecting your heart or circulation
• If you are suffering from
thyrotoxicosis (condition due to
over activity of the thyroid
gland).
Speak to your doctor before you
take this medicine if any of the
above applies to you.
Take special care with
Liothyronine Sodium Tablets if:
• You are suffering from diabetes.

Liothyronine sodium tablets may
raise blood sugar levels
• You are suffering from a condition
called myxoedema (which can
happen when you have a
problem with your thyroid gland)
which makes your skin look
swollen and dry
• You are elderly
• You have suffered from low levels
of thyroid hormone in your body
for a long time, as this may affect
how your adrenal glands work.

You may be given additional
medication (corticosteriods) if
this is the case
• You are suffering from any heart
problems
• You are having increased blood
Pressure
• You suffer from increased heart
rate sleeplessness, loose watery
stools (suggesting increased
metabolism) on initiation of
treatment, dose reduction would
be required

• You are initiating treatment, as an
ECG test done at the time would
be valuable
• If you are pregnant or breast
feeding. Speak to your doctor
before you take this medicine if
any of the above applies to you.
Taking other medicines:
Please tell your doctor or
pharmacist if you are taking or have
recently taken any other medicines,
including medicines obtained
without a prescription. Liothyronine

Sodium Tablets may affect or be
affected by the following medicines:
• Anticoagulants (e.g. warfarin)
used to thin the blood and
prevent blood clots
• Anticonvulsants (e.g. carbamazepine
or phenytoin) used to prevent fits
• Insulin and other treatments for
diabetes
• Medicines called cardiac
glycosides (e.g. digoxin) used to
treat heart conditions such as
heart failure

• Tricyclic antidepressants
(e.g. amitriptyline / imipramine)
used to treat depression
• Colestyramine / colestipol which
reduces the level of cholesterol
(fats) in the blood
• Oral contraceptives (‘the pill’)
• Amiodarone, used to treat
irregular heart beats
• Barbiturates, used to induce
sleep and decrease anxiety
• Primidone, used for seizures or
fits.

Pregnancy and breast feeding:
If you are pregnant or planning to
become pregnant or breast feeding
discuss your medication with your
doctor. The decision on whether it
is best to take Liothyronine Sodium
Tablets during pregnancy or breast
feeding will be made by your
doctor. Ask your doctor or
pharmacist for advice before taking
any medicines.
Important information about some
of the ingredients of Liothyronine

Sodium Tablets:
This medicine contains Lactose,
which is a sugar. If you have
been told by your doctor that you
have an intolerance to some
sugars, contact your doctor
before taking this medicine.
3. How to take Liothyronine
Sodium Tablets
Always take Liothyronine Sodium
Tablets exactly as your doctor has
told you. You should check with your

doctor or pharmacist if you are not
sure. Liothyronine Sodium Tablets
are taken by mouth. They should be
swallowed with a glass of water.
• If you have been prescribed a
dose lower than 20
micrograms, you should allow
a tablet to dissolve/disperse in
20 mL of water for 10 minutes,
in a small measuring cup.
• You should gently swirl the
solution occasionally to aid the
dissolution/dispersion.

Commodity No.:
Pharma Code:
Core Spec Ref.:
Print Colours:
Non-Print Colours:
Min. Font Size:

LL-103803-01

3
07-Nov-2017
Liothyronine
Sodium 20mcg
Tablets 28
Label-Leaflet
100201
UK
Custom Pharma
PR 14278
PAT
35 x 69 mm Carrier
466 x 35 mm LF
35 x 110 mm LB
N/A
N/A
N/A
196 C, 368 C &
Black
Cutter & Varnish
5 pt

PAGE 1 OF 2

20

micrograms

• You should then swirl the
solution for a few seconds prior
to using a suitable oral syringe
to withdraw the amount of
liquid corresponding to the
dose prescribed (5mL for a
5mcg dose; 10 mL for a 10mcg
dose) and squirt the liquid
directly into your mouth by
gently pressing the plunger.
• Any remaining liquid should be
discarded.

Marketing Authorization Holder:
Mercury Pharma Group Ltd.,
Capital House, 85 King William
Street, London EC4N 7BL, UK

PL10972/0033

Adults:
The dose will depend upon your
condition, ranging from
10 micrograms to 60 micrograms
daily in divided doses.
Children and elderly:
The dose may be started at
5 micrograms a day.
Please note that your doctor will
monitor your thyroid function
regularly to make sure that you
are given the right dose for your
condition.

POM

The score line is not intended for
breaking the tablet.
If you take more Liothyronine
Sodium Tablets than you should:
This may cause agitation,
confusion, headache, sweating and
a rapid pulse. If you take too many
tablets contact your doctor or
nearest hospital casualty
department as soon as possible.
Take any remaining tablets and this
leaflet with you so the medical staff
will know what you have taken.

Liothyronine sodium
tablets
If you forget to take your
Liothyronine Sodium Tablets:
Take the next dose at the correct
time and then go on as before. It is
important, in order for your medicine
to work, that doses are not forgotten.
Do not take a double dose to make
up for a forgotten tablet.
If you stop taking Liothyronine
Sodium Tablets:
Do not stop taking Liothyronine
Sodium Tablets unless your doctor
tells you to.

4. Possible side effects
Like all medicines, Liothyronine
Sodium Tablets can cause side
effects, although not everybody
gets them. Side effects you could
experience are:
• Vomiting (being sick)
• Insomnia (sleeplessness)
• Fever
• Intolerance to heat
• Tremor (involuntary, rhythmic
muscle movements)
• Temporary loss of hair in children

• Allergic reactions such as rash,
itching, oedema (abnormal
accumulation of body fluid)
• Angina pain (pain in the chest
when exercising)
• Irregular, thumping or fast heart
beats
• Muscle cramps or weakness
• Diarrhoea
• Restlessness or excitability
• Headache, face and neck
redness, sweating
• Loss of weight.

These effects normally mean the
dose of the medicine needs
changing. You should consult your
doctor if they occur. The effects
usually go away when the dose has
been changed.
If any of the side effects become
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.

5. How to store Liothyronine
Sodium Tablets
Keep this medicine out of the sight
and reach of children.
Do not use Liothyronine Sodium
Tablets after the expiry date which is
stated on the bottle. The expiry date
refers to the last day of that month.
Keep your tablets out of direct
sunlight. Do not use your tablets if
you notice that the container or the
tablets are damaged. Medicines
should not be disposed of via

wastewater or household waste.
Ask your pharmacist how to
dispose of medicines no longer
required. These measures will help
to protect the environment.
Remember:
This medicine is for you. Only a
doctor can prescribe it for you.
Never give this medicine to
someone else; it could harm
them, even if their symptoms
seem the same as yours.

6. Further information
What Liothyronine Sodium Tablets
contain:
The active substance is liothyronine
sodium 20 micrograms.
The other ingredients are lactose,
maize starch, powdered acacia,
sodium chloride, magnesium
stearate, industrial methylated
spirit, and purified water.

What Liothyronine Sodium Tablets
look like and contents of the pack:
Liothyronine Sodium Tablets are
supplied in container packs of 28
tablets.
Marketing Authorisation Holder:
Mercury Pharma Group Ltd.,
Capital House,
85 King William Street,
London EC4N 7BL, UK

Manufacturer:
Custom Pharmaceuticals Ltd.
Conway Street, Hove, East Sussex,
BN3 3LW
This leaflet was last revised in
February 2018.
LL-103803-01

28 Tablets Each tablet contains

20 micrograms liothyronine
sodium.
Also contains lactose.
See leaflet for further
information.
To be taken by mouth.

Use as directed by your
doctor.
Keep out of the sight and
reach of children.
Do not store above 25˚C.
Store in the original container
in order to protect from light.

Liothyronine sodium
tablets

Liothyronine
Sodium

20 micrograms
Tablets

20

micrograms

Marketing Authorization Holder:
Mercury Pharma Group Ltd.,
Capital House, 85 King William
Street, London EC4N 7BL, UK

PL10972/0033

POM

LL-103803-01

20 micrograms
Tablets

Use as directed by your
doctor.
Keep out of the sight and
reach of children.
Do not store above 25˚C.
Store in the original container
in order to protect from light.

Peel here to read leaflet

Liothyronine
Sodium

Each tablet contains
20 micrograms liothyronine
sodium.
Also contains lactose.
See leaflet for further
information.
To be taken by mouth.

LL-103803-01

28 Tablets

AMS Component No.:
Proof Number:
Revision Date:
Product Description:

Component:
Product Code:
Country:
Vendor Name:
CRF(s):
Revised by:
Dimension:

PATIENT INFORMATION LEAFLET

Liothyronine Sodium 20 micrograms 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.
If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What are Liothyronine Sodium
Tablets and what they are used
for
2. Before you take Liothyronine
Sodium Tablets
3. How to take Liothyronine Sodium
Tablets
4. Possible side effects
5. How to store Liothyronine
Sodium Tablets
6. Further information

1. What are Liothyronine
Sodium Tablets and
what are they used for
Liothyronine Sodium Tablets are a
form of thyroxine which is quick
acting and long lasting. Thyroxine is
a hormone produced by the thyroid
gland in the neck which controls
many body functions.
Liothyronine Sodium Tablets are
used to:
• treat some of the more severe
conditions in which the thyroid

does not produce enough
thyroxine.
• balance the effect of medicines
used to treat an overactive thyroid.
2. Before you take Liothyronine
Sodium Tablets
DO NOT take Liothyronine Sodium
Tablets if:
• You know that you are allergic to
liothyronine sodium or any of the
other ingredients (listed in
Section 6 at the end of this
leaflet)

• You have angina (chest pain
when exercising) or conditions
affecting your heart or circulation
• If you are suffering from
thyrotoxicosis (condition due to
over activity of the thyroid
gland).
Speak to your doctor before you
take this medicine if any of the
above applies to you.
Take special care with
Liothyronine Sodium Tablets if:
• You are suffering from diabetes.

Liothyronine sodium tablets may
raise blood sugar levels
• You are suffering from a condition
called myxoedema (which can
happen when you have a
problem with your thyroid gland)
which makes your skin look
swollen and dry
• You are elderly
• You have suffered from low levels
of thyroid hormone in your body
for a long time, as this may affect
how your adrenal glands work.

You may be given additional
medication (corticosteriods) if
this is the case
• You are suffering from any heart
problems
• You are having increased blood
Pressure
• You suffer from increased heart
rate sleeplessness, loose watery
stools (suggesting increased
metabolism) on initiation of
treatment, dose reduction would
be required

• You are initiating treatment, as an
ECG test done at the time would
be valuable
• If you are pregnant or breast
feeding. Speak to your doctor
before you take this medicine if
any of the above applies to you.
Taking other medicines:
Please tell your doctor or
pharmacist if you are taking or have
recently taken any other medicines,
including medicines obtained
without a prescription. Liothyronine

Sodium Tablets may affect or be
affected by the following medicines:
• Anticoagulants (e.g. warfarin)
used to thin the blood and
prevent blood clots
• Anticonvulsants (e.g. carbamazepine
or phenytoin) used to prevent fits
• Insulin and other treatments for
diabetes
• Medicines called cardiac
glycosides (e.g. digoxin) used to
treat heart conditions such as
heart failure

• Tricyclic antidepressants
(e.g. amitriptyline / imipramine)
used to treat depression
• Colestyramine / colestipol which
reduces the level of cholesterol
(fats) in the blood
• Oral contraceptives (‘the pill’)
• Amiodarone, used to treat
irregular heart beats
• Barbiturates, used to induce
sleep and decrease anxiety
• Primidone, used for seizures or
fits.

Pregnancy and breast feeding:
If you are pregnant or planning to
become pregnant or breast feeding
discuss your medication with your
doctor. The decision on whether it
is best to take Liothyronine Sodium
Tablets during pregnancy or breast
feeding will be made by your
doctor. Ask your doctor or
pharmacist for advice before taking
any medicines.
Important information about some
of the ingredients of Liothyronine

Sodium Tablets:
This medicine contains Lactose,
which is a sugar. If you have
been told by your doctor that you
have an intolerance to some
sugars, contact your doctor
before taking this medicine.
3. How to take Liothyronine
Sodium Tablets
Always take Liothyronine Sodium
Tablets exactly as your doctor has
told you. You should check with your

doctor or pharmacist if you are not
sure. Liothyronine Sodium Tablets
are taken by mouth. They should be
swallowed with a glass of water.
• If you have been prescribed a
dose lower than 20
micrograms, you should allow
a tablet to dissolve/disperse in
20 mL of water for 10 minutes,
in a small measuring cup.
• You should gently swirl the
solution occasionally to aid the
dissolution/dispersion.

Commodity No.:
Pharma Code:
Core Spec Ref.:
Print Colours:
Non-Print Colours:
Min. Font Size:

LL-103803-01

3
07-Nov-2017
Liothyronine
Sodium 20mcg
Tablets 28
Label-Leaflet
100201
UK
Custom Pharma
PR 14278
PAT
35 x 69 mm Carrier
466 x 35 mm LF
35 x 110 mm LB
N/A
N/A
N/A
196 C, 368 C &
Black
Cutter & Varnish
5 pt

PAGE 2 OF 2

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.