SUMMARY CMI

BETASERT

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using BETASERT?

BETASERT contains the active ingredient betahistine dihydrochloride. BETASERT is used to treat a disorder of your inner ear. This disorder may include one or more of the following symptoms, in one or both ears: ringing in the ears (tinnitus), loss of clear hearing and problems with balance (vertigo). These symptoms may also be associated with nausea, vomiting and headache. Often these symptoms together are referred to as Meniere's Syndrome.

For more information, see Section 1. Why am I using BETASERT? in the full CMI.

2. What should I know before I use BETASERT?

Do not use if you have ever had an allergic reaction to betahistine dihydrochloride or any of the ingredients listed at the end of the CMI.

Do not take this medicine if you have peptic ulcer or a rare abnormality of the adrenal gland known as phaeochromocytoma.

Talk to your doctor if you have any other medical conditions (e.g. peptic ulcer, asthma or a history of skin conditions), take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use BETASERT? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with BETASERT and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use BETASERT?

• The usual adult starting dose is half to one tablet taken three times a day.
• Take BETASERT at about the same time each day during or immediately after a meal.

More instructions can be found in Section 4. How do I use BETASERT? in the full CMI.

5. What should I know while using BETASERT?

For more information, see Section 5. What should I know while using BETASERT? in the full CMI.

6. Are there any side effects?

Tell your doctor or pharmacist if you notice any of the following and they worry you: skin irritations, stomach upsets, dizziness, fast heartbeat, headache and difficulty sleeping (insomnia). Stomach upsets can be overcome by taking BETASERT during meals.

Tell your doctor as soon as possible if you notice any skin reactions or difficulty breathing.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

BETASERT

Active ingredient(s): betahistine dihydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using BETASERT. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using BETASERT.

Where to find information in this leaflet:

1. Why am I using BETASERT?
2. What should I know before I use BETASERT?
3. What if I am taking other medicines?
4. How do I use BETASERT?
5. What should I know while using BETASERT?
6. Are there any side effects?
7. Product details

1. Why am I using BETASERT?

BETASERT contains the active ingredient betahistine dihydrochloride.

BETASERT works by improving the blood flow of the inner ear and restoring it to normal. It also acts on the nerve endings in the inner ear to normalise the way in which the nerves respond to outside influences.

BETASERT is used to treat a disorder of your inner ear. This disorder may include one or more of the following symptoms, in one or both ears:

• ringing in the ears (tinnitus)
• loss of clear hearing
• problems with balance (vertigo)

These symptoms may also be associated with nausea, vomiting and headache. Often these symptoms together are referred to as Meniere's Syndrome.

2. What should I know before I use BETASERT?

Warnings

Do not use BETASERT if:

• you are allergic to betahistine dihydrochloride, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.
  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 give BETASERT to a child under the age of 18 years.
• Do not take BETASERT if you have a rare abnormality of the adrenal gland known as phaeochromocytoma.
• Do not take BETASERT if you have or have had a peptic ulcer.
  Do not take BETASERT if the packaging is damaged or shows signs of tampering.

Check with your doctor if you:

• have or have had any of the following medical conditions:
  - peptic ulcer
  - asthma
  - a history of allergic skin conditions

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Do not take this medicine if you are pregnant.

It may affect your developing baby if you take it during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Do not breastfeed if you are taking this medicine.

The active ingredient in BETASERT may pass into breast milk and therefore there is a possibility your baby may be affected.

This medicine is not addictive.

3. What if I am taking other medicines?

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

Some medicines and BETASERT may interfere with each other

These include:

• any anti-histamine medications, which are used to treat allergies and allergic reactions

These medicines may be affected by BETASERT, or may affect how well it works. You may need to use different mounts of your medicine, or take different medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect BETASERT.

4. How do I use BETASERT?

How much to take / use

• The usual adult starting dose is half to one tablet taken three times a day.
• However, your doctor may prescribe a different dose depending on the severity of your condition.
• Follow the instructions provided and continue taking BETASERT as long as the doctor tells you.
• If you follow your doctor's instructions, BETASERT should start working within a few days, although in some cases it may take a few weeks. The length of time that you should take BETASERT tablets varies from patient to patient. Some patients respond rapidly to treatment and others may take some time. Please be patient with your treatment and take your tablets regularly.

When to take BETASERT

• Take BETASERT at about the same time each day.
• Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
• Take BETASERT during or immediately after a meal.
• If you take BETASERT on an empty stomach, it may cause stomach upsets.

How to take BETASERT

• Swallow the tablet with a full glass of water.

If you forget to take BETASERT

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

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

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

This may increase the chance of getting an unwanted side effect.

If you use too much BETASERT

If you think that you have used too much BETASERT, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

Symptoms of an overdose may include nausea.

5. What should I know while using BETASERT?

Things you should do

If you are going to have surgery, tell the surgeon that you are taking this medicine.

Call your doctor straight away if you:

• if you become pregnant while you are taking this medicine.

Remind any doctor, dentist or pharmacist you visit that you are using BETASERT.

Things you should not do

• Do not stop taking this medicine suddenly, or change the dosage, without checking with your doctor.
• Do not use this medicine to treat any other complaints 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.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how BETASERT affects you.

BETASERT may cause dizziness in some people.

Drinking alcohol

BETASERT is indicated for Meniere's syndrome with symptoms of vertigo, hearing loss and tinnitus which can negatively affect the ability to drive and use machines.

BETASERT is shown to have no or negligible effects to affect the ability to drive.

Looking after your medicine

• Keep your tablets in the pack until it is time to take them.
• If you take the tablets out of the box or the blister pack they may not keep well.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place below 25°C away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

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

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

More common side effects

Serious side effects

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

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What BETASERT contains

Do not take this medicine if you are allergic to any of these ingredients.

What BETASERT looks like

16mg Tablet: Uncoated, round, biconvex, white to light creamy tablets, with a groove on one surface.

Available in blister packs of 25 tablets (AUST R 212080)

Who distributes BETASERT

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne, Victoria 3121
Australia
www.arrotex.com.au

This leaflet was prepared in August 2024.

Published by MIMS October 2024

1 Name of Medicine

Betahistine dihydrochloride.

2 Qualitative and Quantitative Composition

Betasert (betahistine dihydrochloride) tablets are available as uncoated tablets containing betahistine dihydrochloride 16 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Betasert (betahistine dihydrochloride) 16 mg tablets are uncoated, round, biconvex, white to light creamy tablets, with a groove on one surface.

4 Clinical Particulars

4.1 Therapeutic Indications

Meniere's syndrome as defined by the following core symptoms: vertigo (with nausea/vomiting), hearing loss (hardness of hearing), tinnitus.

4.2 Dose and Method of Administration

The recommended starting dose in adults is 8 to 16 mg three times a day. The maximum recommended daily dose is 48 mg.
The tablets may be taken with or without food. However, if gastrointestinal upset occurs, it is recommended that the tablets be taken with meals.
The dosage should be individually adapted according to the response. Improvement in symptoms may be observed in the first few days to weeks of treatment.

4.3 Contraindications

Betasert (betahistine dihydrochloride) tablets are contraindicated as follows:
during pregnancy and lactation;
in children less than 18 years;
in patients suffering from phaeochromocytoma;
in patients with active peptic ulcer or a history of this condition;
in patients with hypersensitivity to any component to the product (see Section 6.1 List of Excipients).

4.4 Special Warnings and Precautions for Use

Patients with bronchial asthma need to be carefully monitored during therapy.
Caution should be taken in the treatment of patients receiving antihistamines (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

In vitro data indicate an inhibition of betahistine metabolism by drugs that inhibit monoamine oxidase (MAO) including MAO subtype B (e.g. selegiline). Caution is recommended when using betahistine and MAO inhibitors (including MAO-B selective) concomitantly.
An antagonism between betahistine dihydrochloride and antihistamines could be expected on a theoretical basis. However, no such interactions have been reported.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Betahistine is indicated for Meniere's syndrome defined by the triad of core symptoms vertigo, hearing loss and tinnitus which can negatively affect the ability to drive and use machines. In a clinical study (12 healthy volunteers) specifically designed to investigate the ability to drive, betahistine had no or negligible effects compared to placebo.

4.8 Adverse Effects (Undesirable Effects)

Most of the reported adverse reactions pertain to the skin, gastrointestinal tract, body as a whole, nervous system, respiratory system and cardiovascular system. See Table 1.
Events are listed within body systems and categorised by frequency according to the following definitions: Very common (> 1/10), Common (frequency ≥ 1 and < 10%), Uncommon (frequency ≥ 0.1% and < 1%), Rare (frequency ≥ 0.01% and < 0.1%), Very rare (frequency < 0.01%).

Reporting suspected adverse effects.

4.9 Overdose

There have been a few cases of overdosage reported. Although in most cases no overdose symptoms were reported, some patients have experienced mild to moderate symptoms of overdosage including nausea, dry mouth, epigastric pain and sleepiness at doses above 200 mg. A case of convulsion was reported at a dose of 728 mg. In all cases recovery was complete. Treatment should include standard supportive measures.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

The inactive ingredients in Betasert 16 mg tablets are colloidal anhydrous silica, microcrystalline cellulose, mannitol, citric acid anhydrous, and purified talc.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf-life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C in original container to protect from light and moisture.

6.5 Nature and Contents of Container

OPA/Al/PVC/Al blister packs of 100*, 60*, 30*, 25 and 10*.
* Not currently marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Betahistine dihydrochloride is chemically identified as N-Methyl-2-(pyridine-2-yl) ethanamine dihydrochloride. Chemically, betahistine has a close resemblance to histamine.
Molecular formula of C₈H₁₄Cl₂N₂.
Molecular weight of 209.1.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

Summary Table of Changes