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Tyvera 100mg Tablets

Document: leaflet MAH BRAND_PL 17507-0057 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

TYVERA™ 50 mg and 100 mg Tablets Thiamine Hydrochloride


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Always take this medicine exactly as described in this

or as your doctor or pharmacist have told you.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    Ifyou get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

-    You must talk to a doctor if you do not feel better or if you feel worse.

Space for pharmacode

What is in this leaflet:

1.    What TYVERA Tablets is and what it is used for

2.    What you need to know before you take TYVERA Tablets

3.    How to take TYVERA Tablets

4.    Possible side effects

5.    How to store TYVERA Tablets

6.    Contents of the pack and other information

1. WHAT TYVERA TABLETS IS AND WHAT IT IS USED FOR


TYVERA Tablets are vitamin tablets and you have been given them because your body does not have enough thiamine (Vitamin B^. Although this vitamin occurs naturally in nearly all living tissues, and some is obtained from almost all foods - particularly yeast, wholegrain cereals, meat and beans - unpleasant physical symptoms can develop if you do not get enough thiamine in your diet. Taking TYVERA Tablets - a synthetic version of natural Vitamin B1 - helps to make up for any lack of thiamine in your diet.


2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TYVERA TABLETS

Do not take TYVERA Tablets

f you are allergic to thiamine hydrochloride or any of the other ingredients of TYVERA Tablets (see 6. 'What TYVERA Tablets contains'). An allergic reaction may be recognised as a rash, itching, swollen face or lips, shortness of breath.

Important information about one of the ingredients of TYVERA Tablets f you have been told by your doctor that you have an intolerance to lactose or some other sugars, contact your doctor before taking this product.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including those obtained without a prescription, such as vitamins or herbal preparations which you have bought yourself.

Certain medicines can reduce the effect of yourTYVERA tablets.

Tell your doctor if you are taking the following medicine because he/she may need to adjust your TYVERA dose:

• fluorouracil (used to treat certain cancers and viral infections)

Having blood tests or other medical tests:

High concentrations of thiamine in the blood can affect certain medical tests. If you are having a blood test, scan, or any other medical test, tell your doctor that you are taking TYVERA tablets.

Pregnancy and breast feeding

Do not take TYVERA tablets if you are pregnant or breast-feeding unless under the direction of your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

TYVERA is not known to affect the ability to drive or use machines.

However, if you feel you may be affected, do not drive or use machines and speak to your doctor.


3. HOW TO TAKE TYVERA TABLETS_

Take the tablets by mouth. Swallow whole with water. If you find a whole tablet too big to swallow, break it first along the score line.

The usual dose is as follows:

If you are taking TYVERA 50mg Tablets:

Adults. the Elderly and Children over 3 years.

Wild chronic deficiency: One tablet a day.

5evere thiamine deficiency: Two tablets three times a day.

Children: Not recommended for those under 3 years of age.


If you are taking TYVERA 100mg Tablets:

Adults. the Elderly and Children over 3 years.

Severe thiamine deficiency: One tablet three times a day.

Children: Not recommended for those under 3 years of age.

If you take more TYVERA Tablets than you should:

This is unlikely to be harmful but contact your doctor or pharmacist if you are worried or develop a reaction such as a skin rash.

If you forget to take TYVERA Tablets:

You can wait and take the next dose at the normal time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.


4. POSSIBLE SIDE EFFECTS_

These tablets are unlikely to cause side effects unless you are overly sensitive (hypersensitive) to thiamine or one of the other ingredients in the tablets. Hypersensitivity reactions to thiamine have been reported, but mostly when it has been given by injection.

Very few people may experience an allergic reaction after taking this medicine, symptoms of this could be: rash or skin irritation; swelling of face, lips, throat or tongue; stomach pain; difficulty in breathing or swallowing; rapid pulse; heart pain.

Some people may experience a mild stomach upset after taking this medicine, symptoms of this include: nausea; vomiting; stomach pain: diarrhoea.

If you notice any unusual feelings or symptoms, stop taking the tablets and contact your doctor or pharmacist as soon as you can.

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;

Website: 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 TYVERA TABLETS_

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Keep the container tightly closed and in the outer carton in order to protect from light.

Do not use this medicine after the expiry date which is stated on the carton and bottle after "EXP'. The expiry date refers to the last day of that month.

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_

What TYVERA Tablets contains

The active substance is thiamine hydrochloride.

The other ingredients are:

_actose monohydrate, Maize starch, Sucrose, Sodium starch glycolate, Talc, Magnesium stearate.

What TYVERA Tablets looks like and contents of the pack

TYVERA 50 mg Tablets are white uncoated tablets, 8mm in diameter, one side scored, the other marked T/50. Each tablet contains 50 mg thiamine hydrochloride.

TYVERA 100 mg Tablets are white uncoated tablets, 11 mm in diameter, one side scored, the other marked T/100. Each tablet contains 100 mg thiamine hydrochloride.

Each carton of TYVERA Tablets contains a bottle of 100 tablets.

Marketing Authorisation Holder

Auden Mckenzie (Pharma Division) Ltd,

Whiddon Valley, Barnstaple, North Devon, EX32 8NS, UK.

Manufacturer

Surepharm Services Ltd,

Bretby Business Park, Bretby, Burton on Trent, DE15 0YZ, UK This leaflet was last approved in 10/2015.

For information in large print, on tape, on CD or in Braille, phone +44 (0) 1271 385 257.


TYVERA 50mg Tablets PL 17507/0056 TYVERA 100mg Tablets PL 17507/0057

Auden Mckenzie



TYVERA™ 50 mg and 100 mg Tablets Thiamine Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    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.

-    You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet:

1.    What TYVERA T ablets is and what it is used for

2.    What you need to know before you take TYVERA Tablets

3.    How to take TYVERA T ablets

4.    Possible side effects

5.    How to store TYVERA Tablets

6.    Contents of the pack and other information

1.    WHAT TYVERA TABLETS IS AND WHAT IT IS USED FOR

TYVERA Tablets are vitamin tablets and you have been given them because your body does not have enough thiamine (Vitamin B1). Although this vitamin occurs naturally in nearly all living tissues, and some is obtained from almost all foods - particularly yeast, wholegrain cereals, meat and beans - unpleasant physical symptoms can develop if you do not get enough thiamine in your diet. Taking TYVERA Tablets - a synthetic version of natural Vitamin B1 - helps to make up for any lack of thiamine in your diet.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE TYVERA TABLETS Do not take TYVERA Tablets

If you are allergic to thiamine hydrochloride or any of the other ingredients of TYVERA Tablets (see 6. 'What TYVERA Tablets contains'). An allergic reaction may be recognised as a rash, itching, swollen face or lips, shortness of breath.

Important information about one of the ingredients of TYVERA Tablets

If you have been told by your doctor that you have intolerance to lactose or some other

sugars, contact your doctor before taking this product.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including those obtained without a prescription, such as vitamins or herbal preparations which you have bought yourself.

Certain medicines can reduce the effect of your TYVERA tablets.

• fluorouracil (used to treat certain cancers and viral infections Having blood tests or other medical tests:

High concentrations of thiamine in the blood can affect certain medical tests. If you are having a blood test, scan, or any other medical test, tell your doctor that you are taking TYVERA tablets.

Pregnancy and breast feeding

Do not take TYVERA tablets if you are pregnant or breast-feeding unless under the direction of your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

TYVERA is not known to affect the ability to drive or use machines.

However, if you feel you may be affected, do not drive or use machines and speak to your doctor.

3. HOW TO TAKE TYVERA TABLETS

Take the tablets by mouth. Swallow whole with water. If you find a whole tablet too big to swallow, break it first along the score line.

The usual dose is as follows:

If you are taking TYVERA 50mg Tablets:

Adults: the Elderly and Children over 3 years.

Mild chronic deficiency: One tablet a day.

Severe thiamine deficiency: Two tablets three times a day.

Children: Not recommended for those under 3 years of age.

If you are taking TYVERA 100mg Tablets:

Adults: the Elderly and Children over 3 years.

Severe thiamine deficiency: One tablet three times a day.

Children: Not recommended for those under 3 years of age.

If you take more TYVERA Tablets than you should:

This is unlikely to be harmful but contact your doctor or pharmacist if you are worried or develop a reaction such as a skin rash.

If you forget to take TYVERA Tablets:

You can wait and take the next dose at the normal time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

These tablets are unlikely to cause side effects unless you are overly sensitive (hypersensitive) to thiamine or one of the other ingredients in the tablets. Hypersensitivity reactions to thiamine have been reported, but mostly when it has been given by injection.

Very few people may experience an allergic reaction after taking this medicine, symptoms of this could be: rash or skin irritation; swelling of face, lips, throat or tongue; stomach pain; difficulty in breathing or swallowing; rapid pulse; heart pain.

Some people may experience a mild stomach upset after taking this medicine, symptoms of this include: nausea; vomiting; stomach pain: diarrhoea.

If you notice any unusual feelings or symptoms, stop taking the tablets and contact your doctor or pharmacist as soon as you can.

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; Website: 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 TYVERA TABLETS

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Keep the container tightly closed and in the outer carton in order to protect from light.

Do not use this medicine after the expiry date which is stated on the carton and bottle after "EXP". The expiry date refers to the last day of that month.

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

What TYVERA Tablets contains

The active substance is thiamine hydrochloride.

The other ingredients are:

Lactose monohydrate, Maize starch, Sucrose, Sodium starch glycolate, Talc, Magnesium stearate.

What TYVERA Tablets looks like and contents of the pack

TYVERA 50 mg Tablets are white uncoated tablets, 8mm in diameter, one side scored, the other marked T/50.

Each tablet contains 50 mg thiamine hydrochloride.

TYVERA 100 mg Tablets are white uncoated tablets, 11 mm in diameter, one side scored, the other marked T/100.

Each tablet contains 100 mg thiamine hydrochloride.

Each carton of TYVERA Tablets contains a bottle of 100 tablets.

Marketing Authorisation Holder

Auden Mckenzie (Pharma Division) Ltd

Whiddon Valley, Barnstaple, North Devon, EX32 8NS, UK.

Manufacturer

Auden Mckenzie (Pharma Division) Ltd, Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK

This leaflet was last approved in 10/2015.

For information in large print, on tape, on CD or in Braille, phone +44 (0) 1271 385 257.

TYVERA 50mg Tablets PL 17507/0056 TYVERA 100mg Tablets PL 17507/0057

TYVERA™ 50 mg and 100 mg Tablets Thiamine Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    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.

-    You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet:

1.    What TYVERA T ablets is and what it is used for

2.    What you need to know before you take TYVERA Tablets

3.    How to take TYVERA T ablets

4.    Possible side effects

5.    How to store TYVERA Tablets

6.    Contents of the pack and other information

1.    WHAT TYVERA TABLETS IS AND WHAT IT IS USED FOR

TYVERA Tablets are vitamin tablets and you have been given them because your body does not have enough thiamine (Vitamin B1). Although this vitamin occurs naturally in nearly all living tissues, and some is obtained from almost all foods - particularly yeast, wholegrain cereals, meat and beans - unpleasant physical symptoms can develop if you do not get enough thiamine in your diet. Taking TYVERA Tablets - a synthetic version of natural Vitamin B1 - helps to make up for any lack of thiamine in your diet.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE TYVERA TABLETS Do not take TYVERA Tablets

If you are allergic to thiamine hydrochloride or any of the other ingredients of TYVERA Tablets (see 6. 'What TYVERA Tablets contains'). An allergic reaction may be recognised as a rash, itching, swollen face or lips, shortness of breath.

Important information about one of the ingredients of TYVERA Tablets

If you have been told by your doctor that you have intolerance to lactose or some other

sugars, contact your doctor before taking this product.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including those obtained without a prescription, such as vitamins or herbal preparations which you have bought yourself.

Certain medicines can reduce the effect of your TYVERA tablets.

• fluorouracil (used to treat certain cancers and viral infections)

Having blood tests or other medical tests:

High concentrations of thiamine in the blood can affect certain medical tests. If you are having a blood test, scan, or any other medical test, tell your doctor that you are taking TYVERA tablets.

Pregnancy and breast feeding

Do not take TYVERA tablets if you are pregnant or breast-feeding unless under the direction of your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

TYVERA is not known to affect the ability to drive or use machines. However, if you feel you may be affected, do not drive or use machines and speak to your doctor.

3. HOW TO TAKE TYVERA TABLETS

Take the tablets by mouth. Swallow whole with water. If you find a whole tablet too big to swallow, break it first along the score line.

The usual dose is as follows:

If you are taking TYVERA 50mg Tablets:

Adults. the Elderly and Children over 3 years.

Mild chronic deficiency: One tablet a day.

Severe thiamine deficiency: Two tablets three times a day.

Children: Not recommended for those under 3 years of age.

If you are taking TYVERA 100mg Tablets:

Adults. the Elderly and Children over 3 years.

Severe thiamine deficiency: One tablet three times a day.

Children: Not recommended for those under 3 years of age.

If you take more TYVERA Tablets than you should:

This is unlikely to be harmful but contact your doctor or pharmacist if you are worried or develop a reaction such as a skin rash.

If you forget to take TYVERA Tablets:

You can wait and take the next dose at the normal time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

These tablets are unlikely to cause side effects unless you are overly sensitive (hypersensitive) to thiamine or one of the other ingredients in the tablets. Hypersensitivity reactions to thiamine have been reported, but mostly when it has been given by injection.

Very few people may experience an allergic reaction after taking this medicine, symptoms of

this could be: rash or skin irritation; swelling of face, lips, throat or tongue; stomach pain; difficulty in breathing or swallowing; rapid pulse; heart pain.

Some people may experience a mild stomach upset after taking this medicine, symptoms of this include: nausea; vomiting; stomach pain: diarrhoea.

If you notice any unusual feelings or symptoms, stop taking the tablets and contact your doctor or pharmacist as soon as you can.

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; Website: 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 TYVERA TABLETS

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Keep the container tightly closed and in the outer carton in order to protect from light.

Do not use this medicine after the expiry date which is stated on the carton and bottle after "EXP".

The expiry date refers to the last day of that month.

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

What TYVERA Tablets contains

The active substance is thiamine hydrochloride.

The other ingredients are:

Lactose monohydrate, Maize starch, Sucrose, Sodium starch glycolate, Talc, Magnesium stearate.

What TYVERA Tablets looks like and contents of the pack

TYVERA 50 mg Tablets are white uncoated tablets, 8mm in diameter, one side scored, the other marked T/50.

Each tablet contains 50 mg thiamine hydrochloride.

TYVERA 100 mg Tablets are white uncoated tablets, 11 mm in diameter, one side scored, the other marked T/100.

Each tablet contains 100 mg thiamine hydrochloride.

Each carton of TYVERA Tablets contains a bottle of 100 tablets.

Marketing Authorisation Holder

Auden Mckenzie (Pharma Division) Ltd, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, UK.

Manufacturer

Tiofarma B.V., Benjamin Franklinstraat 7-9, 3261 LW Oud-Beijerland, The Netherlands

This leaflet was last approved in 10/2015.

For information in large print, on tape, on CD or in Braille, phone +44 (0) 1271 385 257.

TYVERA 50mg Tablets PL 17507/0056 TYVERA 100mg Tablets PL 17507/0057