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Thiamine Hydrochloride 50mg Tablets

2.    STATEMENT OF ACTIVE SUBSTANCE(S)_

Each tablet contains 50mg of the active substance thiamine hydrochloride (vitamin Bi)

3.    LIST OF EXCIPIENTS_

Also contains lactose monohydrate

4.    PHARMACEUTICAL FORM AND CONTENTS_

i00 Tablets

5.    METHOD AND ROUTE(S) OF ADMINISTRATION_

For oral use

DOSAGE: (Adults and children over 12 years of age)

Mild thiamine deficiency: 1-2 tablets once a day.

Severe thiamine deficiency: 2 tablets 2-3 times a day.

The tablets should be swallowed with water. Do not chew the tablets.

6.    SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF

THE SIGHT AND REACH OF CHILDREN_

Keep out of the sight and reach of children.

7.    OTHER SPECIAL WARNING(S), IF NECESSARY_

If your condition does not improve, tell your doctor.

8.    EXPIRY DATE_

EXP:

Store below 25°C. Store in the original pack.

PATIENT INFORMATION LEAFLET

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.

•    You must contact a doctor if your symptoms worsen or do not improve.

•    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

1. WHAT THIAMINE HYDROCHLORIDE TABLETS ARE AND WHAT THEY _ARE USED FOR_

Thiamine Hydrochloride Tablets are vitamin tablets which contain thiamine (vitamin B1). They are used to treat thiamine deficiency (when your body does not have enough of the vitamin).

Even though thiamine is found naturally in many foods (especially in yeast, wholegrain cereals, meats and beans), sometimes your body requires a supplement. This may be because your diet does not contain enough thiamine or you may not be absorbing it from your diet effectively. You may also have a special need for extra thiamine, especially if you are excreting it quickly from your body (e.g. in your urine). By taking Thiamine Hydrochloride Tablets, you can make sure you have sufficient 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 (hypersensitive) to thiamine or any of the other ingredients in this medicine (see section 6, Contents of the pack and other information)

•    Under 12 years of age

Other medicines and Thiamine Hydrochloride Tablets:

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 thiamine tablets.

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

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

Pregnancy, breast-feeding and fertility

Do not take Thiamine Hydrochloride Tablets if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine 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.

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 thiamine tablets.

Thiamine Hydrochloride Tablets contains lactose

These tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults and children over 12 years of age

The tablets should be swallowed with water. Do not chew the tablets

50mg:

Mild deficiency:    1-2 tablets once a day

Severe deficiency:    2 tablets 2-3 times a day

100mg:

Mild deficiency:    1 tablet once a day

Severe deficiency:    1 tablet 2-3 times a day

The tablets can be taken as long as symptoms persist or a dietary supplement is required, follow the recommendation of your doctor or pharmacist.

If your condition does not improve, tell your doctor.

Children under 12 years of age: Not recommended

If you take more Thiamine Hydrochloride Tablets than you should

This is unlikely to be harmful, but if you have taken too many tablets tell your doctor or pharmacist immediately or contact your nearest emergency department.

If you forget to take Thiamine Hydrochloride tablets

Take your dose as soon as you remember, then carry on taking your tablets as usual. Do not take a double dose to make up for a forgotten dose.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines Thiamine Hydrochloride Tablets can cause side effects, although not everybody gets them. Side effects are unlikely at the recommended doses.

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 could be:

•    Nausea

•    Vomiting

•    Stomach pain

•    Diarrhoea

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 at 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 THIAMINE HYDROCHLORIDE TABLETS KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

Store below 25°C.

This product should be stored in its original pack.

Do not use Thiamine Hydrochloride Tablets after the expiry date which is stated on the carton and container pot. The expiry date refers to the last day of that month.

After first opening of the pot, Thiamine Hydrochloride Tablets should be used within 100 days.

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.

What Thiamine Hydrochloride Tablets contain

The active substance is thiamine hydrochloride (50mg or 100mg per tablet).

The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, stearic acid and magnesium stearate.

What Thiamine Hydrochloride Tablets look like and contents of the pack

Thiamine 50mg Hydrochloride Tablets are white or almost white biconvex round, embossed with “T50”

Thiamine 100mg Hydrochloride Tablets are white or almost white biconvex round, embossed with “T100”

They are available in blister packs containing 84 tablets or pots containing 100 tablets.

Not all pack sizes may be marketed

PL Holder

Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.

PL 30464/0136-0137

This leaflet was last revised in April 2015.