Consumer Information for: AURO-BETAHISTINE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

AURO-BETAHISTINE is used for reducing the episodes of recurrent vertigo (dizziness) associated with Ménière’s disease.

What it does

AURO-BETAHISTINE is a type of medicine called a histamine-analogue. It is thought to work by helping the blood flow in your inner ear, which lowers the build up of pressure. It is this build up of pressure in the ear which is thought to cause feelings of dizziness (vertigo), feelings of being sick (nausea and vomiting), ringing in the ears (tinnitus), and hearing loss or hearing difficulty suffered by people with Ménière’s disease.

When it should not be used

Do not take AURO-BETAHISTINE if:

  • you are allergic (hypersensitive) to betahistine dihydrochloride or to any of the non-medicinal ingredients in the product.
  • you have a peptic (stomach) ulcer or have a history of this condition.
  • your doctor has told you that you have an adrenal gland tumour (called phaeochromocytoma).
What the medicinal ingredient is

Betahistine Dihydrochloride

What the non-medicinal ingredients are

Microcrystalline cellulose, mannitol, povidone, crospovidone, anhydrous citric acid, colloidal anhydrous silica, talc and stearic acid.

What dosage form it comes in

Tablets: 8 mg, 16 mg and 24 mg.

Warnings and precautions

BEFORE you use AURO-BETAHISTINE talk to your doctor, nurse or pharmacist if you:

  • have or have had health problems in the past.
  • you are taking medications, including ones you can take without a doctor’s prescription e.g. natural or herbal remedies.
  • suffer from bronchial asthma, since asthmatic patients should use AURO-BETAHISTINE with caution.
  • have liver problems.
  • are pregnant, plan to become pregnant, or are breastfeeding.
  • are less than 18 years old.

Driving and using machines: AURO-BETAHISTINE is not likely to affect your ability to drive or use tools or machinery. However, remember that the disease for which you are being treated (recurrent vertigo associated with Ménière’s disease) can make you feel dizzy or sick, and can affect your ability to drive and use machines. Do not drive or engage in hazardous activities if you are experiencing these symptoms.

Interactions with this medication

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

  • antihistamines - these may lower the effect of AURO-BETAHISTINE. In addition, AURO-BETAHISTINE may lower the effect of antihistamines.
  • monoamine-oxidase inhibitors (MAOIs) - used to treat depression or Parkinson’s Disease. These may increase the amount of AURO-BETAHISTINE available in your bloodstream and your doctor may have to change your dose of AURO-BETAHISTINE.
Proper use of this medication

It is very important to take AURO-BETAHISTINE exactly as your doctor has instructed. If you are not sure when or how many tablets to take each day, check with your doctor, nurse or pharmacist. It is recommended to take your dose at about the same time every day. AURO-BETAHISTINE is not recommended for use in children below 18 years of age.

AURO-BETAHISTINE can be taken with or without food. If AURO-BETAHISTINE causes upset stomach, take it with meals.

Usual Dose

Usual adult dose:

The usual daily dose is 24 – 48 mg daily in divided doses.

AURO-BETAHISTINE 8 mg tablets – one to two tablets three times a day.

AURO-BETAHISTINE 16 mg tablets - half to one tablet three times a day. or AURO-BETAHISTINE 24 mg tablets - one tablet twice a day.

Overdose

If you think you have taken too much AURO-BETAHISTINE contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you forget a dose, skip the missed dose. Take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose

Side effects and what to do about them

Like all medicines, AURO-BETAHISTINE can cause side effects in some people. Most people have few or no side effects from AURO-BETAHISTINE. Side effects that do occur tend to be generally mild and do not last a long time.

Side effects include:

  • skin rashes and itching
  • stomach pain
  • nausea, vomiting
  • bloating, indigestion
  • headache

After the release of AURO-BETAHISTINE on the market, there were few reports of patients experiencing drowsiness, heart palpitations or light-headedness, faintness or dizziness from a drop in blood pressure during treatment with AURO-BETAHISTINE. It is unclear whether they resulted from the use of AURO-BETAHISTINE or other unrelated factors.

If any of these affect you severely, tell your doctor, nurse or pharmacist.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Rare
Severe allergic reaction: rash, hives, itching, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing     ✔

This is not a complete list of side effects. For any unexpected effects while taking AURO-BETAHISTINE, contact your doctor, nurse or pharmacist.

How to store

Store at room temperature (15°C to 30°C). Keep out of reach and sight of children.

Reporting side effects

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

Please consult your doctor or pharmacist with any questions or concerns you may have regarding your individual condition.

If you want more information about AURO-BETAHISTINE:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/healthcanada/services/drugs-health-products/drugproducts/drug-product-database.html); the manufacturer’s website http:// www.auropharma.ca, or by calling 1-855-648-6681.

This leaflet was prepared by
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.

Date of Revision: December 1, 2017

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