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Benerva 100mg Tablets

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Document: leaflet MAH BRAND_PL 00010-0611 change

Benerva

100mg tablets

Thiamine Hydrochloride 100mg

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Benerva 100mg tablets carefully to get the best results from it.

•    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 have any unusual effects after using this product, tell your doctor or pharmacist.

IN THIS LEAFLET

1.    What are Benerva 100mg tablets and what are they used for?

2.    Before you use Benerva 100mg tablets

3.    How to use Benerva 100mg tablets

4.    Possible side effects

5.    How to store Benerva 100mg tablets

6.    Further information

1. WHAT ARE BENERVA® 100mg TABLETS AND WHAT ARE THEY USED FOR?

Benerva 100mg 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 Benerva 100mg tablets, you can make sure you have sufficient thiamine in your diet.

2. BEFORE YOU TAKE BENERVA® 100mg TABLETS

DO NOT take Benerva 100mg tablets if you are:

•    Allergic (hypersensitive) to thiamine or any of the other ingredients in the product (see section 6, Further Information).

•    Under 12 years of age.

Important information about some of the ingredients:

These tablets contain lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, speak to your doctor before taking this medicine.

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 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).

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.

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.

Pregnancy and breast-feeding:

Do not take Benerva 100mg 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.

3.    HOW TO TAKE BENERVA® 100mg TABLETS

This product may have been prescribed for you by your doctor. If so, follow his/her directions carefully.

The usual dosage recommendations are as follows. Adults and children over 12 years of age:

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

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: Do not use.

If you take too many Benerva 100mg tablets:

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 your tablet:

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 product, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Benerva 100mg 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.

If you experience these or any other unusual side effect after taking these tablets you should seek the advice of a doctor or pharmacist.

5.    HOW TO STORE BENERVA® 100mg TABLETS
Keep out of the reach and sight of children.

Store below 25°C. This product should be stored in its original carton.

Do not use Benerva 100mg tablets after the expiry date which is stated on the carton and on the bottle. The expiry date refers to the last day of that month.

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.

6.    FURTHER INFORMATION
What Benerva 100mg tablets contain:

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

The other ingredients are lactose monohydrate, sucrose, pregelatinised maize starch, maize starch, purified talc and magnesium stearate.

See Section 2, ‘Important information about some of the ingredients’ for advice about lactose and sucrose.

What Benerva 100mg tablets look like and contents of the pack:

Benerva 100mg tablets are available in bottles containing 100 round white tablets marked with ‘100 Benerva’ on one side.

Marketing Authorisation Holder:

Bayer plc

Consumer Care Division Bayer House, Strawberry Hill Newbury, Berkshire RG14 1JA United Kingdom

Manufacturer:

Brunel Healthcare Manufacturing Ltd

William Nadin Way

Swadlincote

Derbyshire, DE11 0BB

United Kingdom

This leaflet was last approved in July 2008.

Remember: if you have any doubts about using Benerva 100mg tablets correctly, seek the advice of your doctor or pharmacist.

Bayer

Benerva is a Registered Trademark of Bayer AG, Germany.