Consumer medicine information

Betamin®

Thiamine hydrochloride

BRAND INFORMATION

Brand name

Betamin

Active ingredient

Thiamine hydrochloride

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Betamin®.

What is in this leaflet

This leaflet answers some common questions about Betamin.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Betamin is used for

Betamin is a type of medicine used to treat thiamine (Vitamin B1) deficiency.

Thiamine is an essential vitamin from the B group of vitamins involved in a number of important metabolic functions in the body.

Thiamine deficiency can be caused by:

  • restricted diets
  • gastrointestinal diseases
  • major burns
  • kidney or liver problems
  • thyroid problems
  • alcoholism
  • receiving injectable nutrition
  • diabetes
  • development of abnormal breast tissue

Your doctor or pharmacist, however, may recommend Betamin for another purpose.

Ask your doctor or pharmacist if you have any questions about why it has been recommended for you.

There is no evidence that this medicine is addictive.

Before you take it

When you must not take it

Do not take Betamin if you are allergic to it or any of the ingredients listed at the end of this leaflet.

Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.

Do not take it after the expiry date (EXP) printed on the pack.

If you take it after the expiry date has passed, it may not work as well.

Do not take it if the packaging is torn or shows signs of tampering.

Before you start to take it

Tell your doctor or pharmacist if you have allergies to:

  • any of the ingredients listed at the end of this leaflet
  • any other substances, such as foods, preservatives or dyes.

Tell your doctor or pharmacist if you are pregnant or intend to become pregnant.

Tell your doctor or pharmacist if you are breastfeeding or planning to breastfeed.

Tell your doctor or pharmacist if you plan to have surgery.

If you have not told your doctor or pharmacist about any of the above, tell them before you take Betamin.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food store.

Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking Betamin.

How to take it

How much to take

The standard dose for this medicine is 1/2 to 1 tablet daily.

Your doctor may have recommended a different dose.

Ask your doctor or pharmacist if you are unsure of the correct dose for you.

They will tell you exactly how much to take.

Follow the instructions they give you.

If you take the wrong dose, Betamin may not work as well and your problem may not improve.

How to take it

Swallow the tablet with a full glass of water or other liquid.

When to take it

Take Betamin during or immediately after a meal, at about the same time each day.

If you take it on an empty stomach, it may cause stomach upset.

Take Betamin at about the same time each day.

Taking your tablets at the same time each day will have the best effect. It will also help you remember when to take the tablets.

If you are not sure when to take it, ask your doctor or pharmacist.

How long to take it

Continue taking your medicine for as long as your doctor or pharmacist tells you.

Ask your doctor or pharmacist if you are not sure how long to take the medicine for.

If you forget to take it

Do not try to make up for missed doses by taking more than one dose at a time.

If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.

Do not take a double dose to make up for the dose you have missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for hints.

If you take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764766), or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much Betamin.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are taking it

Things you must do

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Betamin.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Betamin.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine.

Things you must not do

Do not take more than the recommended dose unless your doctor or pharmacist tells you to.

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not use this medicine to treat any other complaints unless your doctor or pharmacist tells you to.

Side effects

All medicines have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor or pharmacist has weighed the risks of using this medicine against the benefits they expect it will have for you.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Betamin.

It helps most people with thiamine deficiency, but it may have unwanted side effects in a few people.

If any of the following happen, stop taking this medicine and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:

  • swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
  • hives
  • fainting

These are very serious side effects. If you have them, you may have had a serious allergic reaction to Betamin. You may need urgent medical attention or hospitalisation.

These side effects are very rare

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

Other side effects not listed above may occur in some consumers.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

After taking it

If you have any queries about any aspect of your medicine, or any questions regarding the information in this leaflet, discuss them with your doctor or pharmacist.

Storage

Keep your tablets in the bottle until it is time to take them.

If you take the tablets out of the bottle they may not keep well.

Keep the medicine in a cool, dry place where the temperature stays below 30 °C.

Do not store it or any other medicine in the bathroom, near a sink, or on a windowsill.

Do not leave it in the car.

Heat and damp can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor or pharmacist tells you to stop taking Betamin, or the medicine has passed its expiry date, ask your pharmacist what to do with any that are left over.

Return any unused medicine to your pharmacist.

Product description

What it looks like

Betamin tablets are a white, scored tablet available in a bottle containing 100 tablets.

Ingredients

Active Ingredient:

100mg thiamine hydrochloride (Vitamin B1) per tablet

Inactive Ingredients:

The tablets also contain the following inactive ingredients:

  • starch - wheat
  • lactose
  • magnesium stearate

Manufacturer/Sponsor

Betamin is made in Australia.
Betamin is supplied in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113

This leaflet was prepared in July 2008

Australian Register Number:
AUST R 27460

® Registered Trademark

Published by MIMS October 2008

BRAND INFORMATION

Brand name

Betamin

Active ingredient

Thiamine hydrochloride

Schedule

Unscheduled

 

Name of the medicine

Thiamine hydrochloride (vitamin B1).

Description

Each Betamin tablet contains 100 mg thiamine hydrochloride. Inactive ingredients include starch-wheat, lactose and magnesium stearate.

Pharmacology

Thiamine is associated with carbohydrate metabolism. By combining with the pyrophosphoric acid in nucleated cells, particularly in the liver, kidneys and white blood cells, it is converted to its pyrophosphate which acts as a coenzyme in such reactions as the decarboxylation of α-keto acids, particularly of pyruvate and α-keto-glutarate.
Thiamine pyrophosphate also acts as a coenzyme in the direct oxidating pathway of glucose metabolism. Thiamine is utilised by the liver to detoxify oestrogen and in vitamin deficiency states has a dramatic effect in lowering serum oestrogen levels.

Pharmacokinetics

Thiamine is absorbed from the gastrointestinal tract and is distributed to most body tissues. It is not stored to any appreciable extent in the body and amounts in excess of the body's requirements are excreted in the urine as unchanged thiamine or as the metabolite, pyrimidine.

Indications

Thiamine deficiency in patients on restricted diets, with gastrointestinal diseases, extensive burns, diabetes, impaired kidney or liver function, hyperthyroidism, alcoholism, benign mammary dysplasia. Patients on total parenteral nutrition should be given a generous allowance of thiamine.
Chronic thiamine deficiency (beri-beri, alcoholism) manifests in such states as peripheral neuropathy, Wernicke's encephalopathy, Korsakoff's psychosis, cardiac failure, etc.
Acute thiamine deficiency causes weakness, fatigue, nausea, hypotension, loss of appetite, loss of sensation, loss of reflexes and paralysis in the legs.

Dosage and Administration

50 mg to 100 mg daily as a single or divided dose.

Overdosage

Contact the Poisons Information Centre for advice on management of overdosage.

Presentation

100 mg tablets (white, scored) 100's.

Storage

Store below 30°C. Protect from light.

Poison Schedule

Unscheduled.