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THIAMINE HYDROCHLORIDE 50 MG TABLETS

Active substance(s): THIAMINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

TYVERATM 50 mg and 100 mg Tablets
Thiamine Hydrochloride

Space for pharmacode

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
You may need to read it again.
- Ask your pharmacist if you need more information or
advice.
listed in this
See section 4.
- You must talk to a doctor if you do not feel better or if
you feel worse.

1.
2.
3.
4.
5.
6.

What TYVERA Tablets is and what it is used for
What you need to know before you take TYVERA Tablets
How to take TYVERA Tablets
How to store TYVERA Tablets
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 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.

Tell your doctor if you are taking the following medicine because he/she may need to adjust your
TYVERA dose:
(used to treat certain cancers and viral infections)
Having blood tests or other medical tests:
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

3. HOW TO TAKE TYVERA TABLETS

The usual dose is as follows:
If you are taking TYVERA 50mg Tablets:
Adults. the Elderly and Children over 3 years.

Children: Not recommended for those under 3 years of age.
AAAI3587

Thiamine (Tyvera) 50mg & 100mg Tablets PIL - UK
item no: AAAI3587

dimensions: 110 x 250

print proof no: 4

pharmacode:

origination date: 12.10.15

min pt size: 7

originated by: S.Anson
approved for print/date

colours/plates
1. black
2.
3.
4.
5.
6.

revision date: 05.11.15

Technical Approval

revised by: S.Anson

date sent: 12.10.15

supplier: Surepharm

technically app. date: 03.11.15

Non Printing Colours
1. Profile
2.

3.

* Please note that only Actavis Global Artwork Studios are 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.

If you are taking TYVERA 100mg Tablets:
Adults. the Elderly and Children over 3 years.
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
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
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
This includes any possible side

not listed in this

Website: www.mhra.gov.uk/yellowcard.

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
Surepharm Services Ltd,
Bretby Business Park, Bretby, Burton on Trent, DE15 0YZ, UK
This

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

AAAI3587

Thiamine (Tyvera) 50mg & 100mg Tablets PIL - UK
item no: AAAI3587

dimensions: 110 x 250

print proof no: 4

pharmacode:

origination date: 12.10.15

min pt size: 7

originated by: S.Anson
approved for print/date

colours/plates
1. black
2.
3.
4.
5.
6.

revision date: 05.11.15

Technical Approval

revised by: S.Anson

date sent: 12.10.15

supplier: Surepharm

technically app. date: 03.11.15

Non Printing Colours
1. Profile
2.

3.

* Please note that only Actavis Global Artwork Studios are 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.

PACKAGE LEAFLET: INFORMATION FOR THE USER
PACKAGE LEAFLET: INFORMATION FOR THE USER
TYVERATM 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 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 1 ). 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 B 1 - 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.
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.
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

PACKAGE LEAFLET: INFORMATION FOR THE USER
PACKAGE LEAFLET: INFORMATION FOR THE USER
TYVERATM 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 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 1 ). 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 B 1 - 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.
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.
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

Expand view ⇕

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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