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1. WHAT THIAMINE HYDROCHLORIDE TABLETS IS AND WHAT IT IS USED FOR Thiamine Hydrochloride 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 Thiamine Hydrochloride 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 THIAMINE HYDROCHLORIDE TABLETS Do not take Thiamine Hydrochloride Tablets If you are allergic to thiamine hydrochloride or any of the other ingredients of Thiamine Hydrochloride Tablets (see 6. ‘What Thiamine Hydrochloride 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 Thiamine Hydrochloride 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 Thiamine Hydrochloride dose: (used to treat certain cancers and viral infections) Having blood tests or other medical tests: having a blood test, scan, or any other medical test, tell your doctor that you are taking Thiamine Hydrochloride Tablets. Pregnancy and breast feeding Do not take Thiamine Hydrochloride 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. Certain medicines can reduce the effect of your Thiamine Hydrochloride Tablets. Driving and using machines 3. HOW TO TAKE THIAMINE HYDROCHLORIDE TABLETS The usual dose is as follows: If you are taking Thiamine Hydrochloride 50 mg Tablets: Adults. the Elderly and Children over 3 years. 1. What Thiamine Hydrochloride Tablets is and what it is used for 2. What you need to know before you take Thiamine Hydrochloride Tablets 3. How to take Thiamine Hydrochloride Tablets 4. 5. How to store Thiamine Hydrochloride Tablets 6. Contents of the pack and other information 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. PACKAGE LEAFLET: INFORMATION FOR THE USER Thiamine Hydrochloride 50 mg and 100 mg Tablets BBBA1645 Space for pharmacode

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Page 1: PACKAGE LEAFLET: INFORMATION FOR THE USER Thiamine ... · reaction may be recognised as a rash, itching, swollen face or lips, shortness of breath. Important information about one

1. WHAT THIAMINE HYDROCHLORIDE TABLETS IS AND WHAT IT IS USED FOR

Thiamine Hydrochloride 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 Thiamine Hydrochloride 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 THIAMINE HYDROCHLORIDE TABLETS

Do not take Thiamine Hydrochloride TabletsIf you are allergic to thiamine hydrochloride or any of the other ingredients of Thiamine Hydrochloride Tablets (see 6. ‘What Thiamine Hydrochloride 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 Thiamine Hydrochloride TabletsIf 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 medicinesTell 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 Thiamine Hydrochloride dose:

(used to treat certain cancers and viral infections)

Having blood tests or other medical tests:

having a blood test, scan, or any other medical test, tell your doctor that you are taking Thiamine Hydrochloride Tablets.

Pregnancy and breast feedingDo not take Thiamine Hydrochloride 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.

Certain medicines can reduce the e�ect of your Thiamine Hydrochloride Tablets.

Driving and using machines

3. HOW TO TAKE THIAMINE HYDROCHLORIDE TABLETS

The usual dose is as follows:

If you are taking Thiamine Hydrochloride 50 mg Tablets:Adults. the Elderly and Children over 3 years.

1. What Thiamine Hydrochloride Tablets is and what it is used for2. What you need to know before you take Thiamine Hydrochloride Tablets3. How to take Thiamine Hydrochloride Tablets4. 5. How to store Thiamine Hydrochloride Tablets6. Contents of the pack and other information

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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Thiamine Hydrochloride 50 mg and 100 mg Tablets

BBBA1645

Space for pharmacode

* 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.

approved for print/date

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Date sent:Date received:

Item number:

Originator:Origination Date:Revision Date:Revised By:

Dimensions:Min Body Text Size:Supplier:

1.

2.

3.

4.

5.

6.

1.

2.

3.

FMD info NA (not a carton) No Yes Details ________________________________________________________________________________________

Version 201.11.2017

Thiamine Hydrochloride 50mg & 100mg Tablets PIL - UK

2

Black ProfileS.Anson08.01.1811.01.18S.Anson

BBBA1645110 x 2507ptSurepharm

08.01.18

09.01.18

Page 2: PACKAGE LEAFLET: INFORMATION FOR THE USER Thiamine ... · reaction may be recognised as a rash, itching, swollen face or lips, shortness of breath. Important information about one

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

If you are taking Thiamine Hydrochloride 100 mg Tablets:Adults. the Elderly and Children over 3 years.

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

If you take more Thiamine Hydrochloride 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 Thiamine Hydrochloride 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 You can also report side directly via the Yellow Card Scheme; Website: www.mhra.gov.uk/yellowcard

5. HOW TO STORE THIAMINE HYDROCHLORIDE TABLETSKeep 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 INFORMATIONWhat Thiamine Hydrochloride Tablets containsThe active substance is thiamine hydrochloride.

The other ingredients are:Lactose monohydrate, Maize starch, Sucrose, Sodium starch glycolate, Talc, Magnesium stearate.

What Thiamine Hydrochloride Tablets looks like and contents of the packThiamine Hydrochloride 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.

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

Each carton of Thiamine Hydrochloride Tablets contains a bottle of 100 tablets.

Marketing Authorisation HolderAccord Healthcare LimitedSage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

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

This leaflet was last approved in 01/2018.

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

BBBA1645

* 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.

approved for print/date

Proof Round

[email protected]

Technical Approval

Non Printing ColoursColours

Date sent:Date received:

Item number:

Originator:Origination Date:Revision Date:Revised By:

Dimensions:Min Body Text Size:Supplier:

1.

2.

3.

4.

5.

6.

1.

2.

3.

FMD info NA (not a carton) No Yes Details ________________________________________________________________________________________

Version 201.11.2017

Thiamine Hydrochloride 50mg & 100mg Tablets PIL - UK

2

Black ProfileS.Anson08.01.1811.01.18S.Anson

BBBA1645110 x 2507ptSurepharm

08.01.18

09.01.18