NRA-Betahistine: Uses, Side Effects and Dosage

INTERACTIONS WITH THIS MEDICATION

IMPORTANT: PLEASE READ

PART III: CONSUMER INFORMATION

^PrNRA-BETAHISTINE

Betahistine Dihydrochloride Tablets BP

Read this carefully before you start taking NRA-BETAHISTINE and each time you get a refill. This leaflet is a summary and will not tell you everything about NRA-BETAHISTINE. Talk to your doctor, nurse, or pharmacist about your medical condition and treatment and ask if there is any new information about NRA-BETAHISTINE.

What the medication is used for:

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

What it does:

NRA-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 NRA-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:

Citric acid anhydrous, Colloidal silicon dioxide, Mannitol, Microcrystalline cellulose and Talc.

What dosage forms it comes in:

Tablets: 8 mg, 16 mg and 24 mg

WARNINGS AND PRECAUTIONS

BEFORE you use NRA-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 NRA-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: NRA-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.

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.

The following may interact with NRA-BETAHISTINE:

• antihistamines - these may lower the effect of NRA-BETAHISTINE. In addition, 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 betahistine dihydrochloride available in your bloodstream and your doctor may have to change your dose of NRA-BETAHISTINE.

PROPER USE OF THIS MEDIATION

It is very important to take NRA-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. NRA-BETAHISTINE is not recommended for use in children below 18 years of age.

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

ABOUT THIS MEDICATION

HOW TO STORE IT

IMPORTANT: PLEASE READ

Usual adult dose:

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

NRA-BETAHISTINE 8 mg tablets – one to two tablets three times a day,

NRA-BETAHISTINE 16 mg tablets – half to one tablet three times a day,

or

NRA-BETAHISTINE 24 mg tablets – one tablet twice a day.

Overdose:

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

Store at room temperature 15°C to 30°C. Keep in a tightly closed container to protect from moisture. Protect from light.

Missed Dose:

Keep out of reach and sight of children.

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, NRA-BETAHISTINE can cause side effects in some people. Most people have few or no side effects from betahistine dihydrochloride. 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 betahistine dihydrochloride 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 betahistine dihydrochloride. It is unclear whether they resulted from the use of betahistine dihydrochloride or other unrelated factors.

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

If you want more information about NRA-BETAHISTINE:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this consumer information by visiting the Health Canada website (https://www.canada.ca/en/health- canada/services/drugs- health-products/drug- products/drug-product- database.html); or by calling 1-877-726-2707.

Last revised: February 01, 2024

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

MORE INFORMATION

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

Symptom/effect Talk with Stop taking your doctor, drug and

nurse or seek pharmacist immediate

Reporting Side Effects

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

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs- health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

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.