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Liothyronine Sodium Bp 20micrograms Tablets

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LT1



28 Tablets Each tablet contains Use as directed by your 20 micrograms liothyronine doctor.

Liothyronine sodium. Keep out of the sight and Also contains lactose. reach of children. Sodium See leaflet for further Do not store above 255C.

20 micrograms information. Store in the original container Tablets To be taken by mouth. in order to protect from light.

20 Marketing Authorization Holder: PL10972/0033 ^^^^^^Biriici-ogi-aiTis Mercury Pharma Group Ltd., pOM Capital House, 85 King William LpOM Street, London EC4N 7BL, UK

I

Peel here to read leaflet


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.


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



MercuryPharma


Product Description:

Liothyronine Sodium 20mcg Tablets


Component:

Label & Leaflet


Manufacturer:

Custom


Market:

UK


Minimum Font Size & Typeface:

5pt. Swiss 721BT


•    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.


Date of Approval:

N/A


PROOF


To be implemented by:

N/A


03/07/2014


Originated by

KBR


Date:

31/1/2012


Tech Approved    Date:

No    N/A


Revised by:

PAT


Version:

100201/LB/4, 100201/LF/4


File Name:

100201LB LF Liothyronine v4_1


CRF No.:

AMCo.CRF.260.2014


• •

• •

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0

T

H

v

a

0

N

• ••

• •

• •

• •

• •

T

A

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L

E

T

S


Software Package:

Illustrator CS5


Barcode:

5021691 108528


Dimensions:

35 x 69mmCarrier | 466 x 35mmLF | 35 x 110mmLB


Colours: pmsTp

196


Black


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.


Pharma Code:

N/A


Key Line:


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 December 2013

100201/LF/4


28 Tablets

Liothyronine Sodium 20 micrograms Tablets



Each tablet contains 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


I


MercuryPharma

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.

They may be crushed for children and elderly patients.


LT1



28 Tablets Each tablet contains Use as directed by your 20 micrograms liothyronine doctor.

Liothyronine sodium. Keep out of the sight and Also contains lactose. reach of children. Sodium See leaflet for further Do not store above 2550.

20 micrograms information. Store in the original container Tablets To be taken by mouth. in order to protect from light.

20 Marketing Authorization Holder: PL10972/0033 ^^^^^^Biriici-ogi-aiTis Mercury Pharma Group Ltd., pOm Capital House, 85 King William LpOM Street, London E04N 7BL, UK

I

Peel here to read leaflet


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.


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



MercuryPharma


Product Description:

Liothyronine Sodium 20mcg Tablets


Component:

Label & Leaflet


Manufacturer:

Custom


Market:

UK


Minimum Font Size & Typeface:

5pt. Swiss 721BT


•    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.


Date of Approval:

N/A


PROOF


To be implemented by:

N/A


03/07/2014


Originated by

KBR


Date:

31/1/2012


Tech Approved    Date:

No    N/A


Revised by:

PAT


Version:

100201/LB/4, 100201/LF/4


File Name:

100201LB LF Liothyronine v4_1


CRF No.:

AMCo.CRF.260.2014


• •

• •

• •

• •

• •

L 1

0

T

H

v

a

0

N

• ••

• •

• •

• •

• •

T

A

E

L

E

T

S


Software Package:

Illustrator CS5


Barcode:

5021691 108528


Dimensions:

35 x 69mmCarrier | 466 x 35mmLF | 35 x 110mmLB


Colours: pmsTp

196


Black


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.


Pharma Code:

N/A


Key Line:


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 December 2013

100201/LF/4


28 Tablets Each tablet contains •    • • 20 miotgrafts liothyonUe

Liothyronine O^'lPO OO O SOdium • AlsOnts lactos»*

See leaflet for further 20 mlcrograms information.


To be taken


Use as directed by your doctor.

Keep out of the sight and reach of children.

Do not store above 25*0.

y mouth.


Tablets O

Marketing Authorization nolder: Mercury Pharma Group Ltd., Capital Hpjse05 King Wlliam Stre||, LHdon EC4N 7^ UK


PL1Q972/QQ33

[POM]

• • • • • •


MercuryPharma

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.

They may be crushed for children and elderly patients.