Consumer medicine information

Setear

Betahistine dihydrochloride

BRAND INFORMATION

Brand name

Setear

Active ingredient

Betahistine dihydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Setear.

SUMMARY CMI

Setear

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 Setear?

Setear contains 24 mg of the active ingredient betahistine dihydrochloride. Setear is used to treat an inner ear disorder called Meniere's syndrome, which may cause ringing in the ears, hearing loss or balance problems and sometimes nausea, vomiting and headache.

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

2. What should I know before I use Setear?

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

Talk to your doctor if you have any other medical 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 Setear? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Setear 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 Setear?

  • The usual adult starting dose is half to one 24 mg tablet taken twice a day. Your doctor may however prescribe a different dose. The maximum recommended daily dosage is 48 mg.
  • Swallow Setear with a glass of water following food, and at about the same time each day.

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

5. What should I know while using Setear?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Setear.
  • Tell your doctor if you have or have had a peptic ulcer, suffer from asthma, have a history of allergic skin conditions or tumours of the adrenal gland, have or have had any other medical conditions including pregnancy or breastfeeding, or have any allergies to any other medicines or substances.
Things you should not do
  • Do not give Setear to anyone else, even if they have the same condition as you.
  • Do not take Setear to treat any other complaints unless your doctor tells you to.
  • Do not stop taking Setear, or lower the dosage without checking with your doctor.
Driving or using machines
  • If you have dizziness from your condition or this medication, do not drive or use machines until you are sure that that the dizziness has eased.
Looking after your medicine
  • Keep your tablets in a cool, dry place where the temperature stays below 25°C.
  • Keep your tablets in the pack until it is time to take them.

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

6. Are there any side effects?

Common side effects include skin irritations, stomach upsets, dizziness, fast heart-beat, headache, difficulty sleeping, tiredness, nausea, vomiting, bloating, swollen stomach and diarrhoea.

Serious side effects include skin reactions, difficulty breathing, convulsions, hallucinations, confusion, allergic reaction, low blood pressure and slow heart-beat.

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

Setear

Active ingredient: betahistine dihydrochloride


Consumer Medicine Information (CMI)

This leaflet provides important information about using Setear. 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 Setear.

Where to find information in this leaflet:

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

1. Why am I using Setear?

Setear contains the active ingredient betahistine dihydrochloride.

Setear is used to treat a disorder of the working 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 Méniere's Syndrome.

Setear tablets contain the active ingredient betahistine dihydrochloride, which work 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 normalize the way in which the nerves respond to outside influences.

Your doctor may have prescribed Setear for another reason. Ask your doctor if you have any questions about why Setear has been prescribed for you.

There is no evidence that Setear is addictive.

2. What should I know before I use Setear?

Warnings

Do not use Setear if:

  • you are pregnant or intend to become pregnant.
    Setear may affect your developing baby if taken during pregnancy.
  • you are breast-feeding or plan to breast-feed. Setear may pass into breast milk and therefore there is possibility that the breast-fed baby may be affected.
  • you are allergic to betahistine dihydrochloride 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.
  • you have a rare abnormality of the adrenal gland known as phaeochromochytoma.
  • you have or have had a peptic ulcer.

Do not give Setear to children under 18 years of age.

Check with your doctor if you:

  • have any other medical conditions
  • take any medicines for any other condition

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.

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

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 Setear may interfere with each other.

These include:

  • any antihistamine medications, which are used to treat allergies and allergic reactions
  • monoamine oxidase inhibitors (MAOIs) (e.g. some antidepressants, selegiline)

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking Setear.

4. How do I use Setear?

How much to take

  • The usual adult starting dose is half to one 24mg Setear tablet, taken twice times a day. However your doctor may prescribe a different dose depending on the severity of your condition.
  • The maximum recommended daily dosage is 48 mg.
  • Swallow Setear with a glass of water.
  • Follow the instructions provided and use Setear until your doctor tells you to stop.
  • If you follow your doctor's instructions Setear 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 Setear tablets varies from patient to patient.

When to take Setear

  • Take Setear 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.
  • Take Setear during or immediately after a meal, at about the same time each day. If you take Setear on an empty stomach, it may cause stomach upsets.

If you forget to use Setear

Setear should be used regularly at the same time each day. If you miss your dose at the usual time, take it as soon as you remember.

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

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

If you use too much Setear

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

The most common symptom of overdosing is nausea.

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.

5. What should I know while using Setear?

Things you should do

Tell your doctor if you have allergies to any other medicines or any other substances, such as foods, preservatives or dyes.

Tell your doctor if:

  • you have or have had a peptic ulcer
  • you suffer from asthma
  • you have a history of allergic skin conditions or if you have or have had any other medical conditions.

Tell your doctor if you are pregnant or intend to become pregnant. Your doctor will discuss the possible risks and benefits of using Setear during pregnancy. If you become pregnant while taking Setear, tell your doctor immediately.

Tell your doctor if you are breastfeeding or plan to breast-feed. Your doctor will discuss the possible risks and benefits of using Setear during breastfeeding.

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

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking Setear.

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

Keep all of your doctor's appointments so that your progress can be checked.

Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things you should not do

  • Do not give Setear to anyone else, even if they have the same condition as you.
  • Do not take Setear to treat any other complaints unless your doctor tells you to.
  • Do not stop taking Setear, or lower the dosage without checking with your doctor.

Driving or using machines

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

Your condition or Setear may cause dizziness in some people.

Looking after your medicine

  • Keep your tablets in the pack until it is time to take them.
  • Keep your tablets in a cool, dry place where the temperature stays below 25°C.

Store it in a cool dry place 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?

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.

Less serious side effects

Less serious side effectsWhat to do
  • skin irritations
  • stomach upsets
  • dizziness
  • fast heart-beat
  • headache
  • difficulty sleeping (insomnia)
  • tiredness
  • nausea, vomiting, bloating, or swollen stomach
  • diarrhoea
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • skin reactions
  • difficulty breathing
  • convulsions
  • hallucinations
  • confusion
  • allergic reaction
  • low blood pressure, slow heart beat
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these 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.

Setear tablets contain 24 mg of the active ingredient betahistine dihydrochloride.

What Setear contains

Active ingredient
(main ingredient)
betahistine dihydrochloride
Other ingredients
(inactive ingredients)
lactose monohydrate
maize starch
microcrystalline cellulose
citric acid
povidone
crospovidone
hydrogenated vegetable oil
Potential allergenslactose monohydrate

Contains sugars as lactose.

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

What Setear looks like

Setear tablets are white and flat with bevelled edges. They have a breakline on one side. Available in blister packs of 60 tablets. (AUST R 261439)

Who distributes Setear

Southern XP Pty Ltd
Unit 5/118 Church Street
Hawthorn, 3122, Victoria
Australia

Sponsor:

Southern XP IP Pty Ltd
Unit 5/118 Church Street
Hawthorn, 3122, Victoria
Australia

This leaflet was prepared in December 2021.

Published by MIMS April 2022

BRAND INFORMATION

Brand name

Setear

Active ingredient

Betahistine dihydrochloride

Schedule

S4

 

Notes

Distributed by Southern XP Pty Ltd

1 Name of Medicine

Betahistine dihydrochloride.

2 Qualitative and Quantitative Composition

Setear tablets contain the active ingredient betahistine dihydrochloride.
Each Setear tablet contains 24 mg of betahistine dihydrochloride.

Excipient with known effect.

Sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Setear 24 mg tablets are white flat tablets with bevelled edges and a break line on one side.

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 one 24 mg taken two times a day.
The maximum recommended daily dosage is 48 mg, which may be taken as 16 mg three times daily or 24 mg twice daily. Refer to separate Product Information for betahistine 16 mg tablets.
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

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 the elderly.

No data available.

Paediatric use.

Due to lack of clinical experience, betahistine dihydrochloride should not be used in children less than 18 years (see Section 4.3 Contraindications).

Effects on laboratory tests.

Interactions with laboratory tests have not been established.

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.

Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of foetal damage.
(Category B2)
Betahistine dihydrochloride should not be used during pregnancy (see Section 4.3 Contraindications), since there are insufficient data on the use of this drug during pregnancy to evaluate possible harmful effects.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of foetal damage.
Betahistine dihydrochloride should not be used during lactation (see Section 4.3 Contraindications).

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 small clinical study of 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.
Events are listed within body systems and categorised by frequency according to the following definitions:
Common (frequency greater than or equal to 1 and < 10%); Uncommon (frequency greater than or equal to 0.1% and < 1%); Rare (frequency greater than or equal to 0.01% and < 0.1%); Very rare (frequency < 0.01%).

Skin and subcutaneous tissue disorders.

Rare: various types of rash, pruritus and urticaria/angioneurotic oedema. These reactions are probably related to the histamine-like structure of betahistine. There was a single case of Stevens-Johnson syndrome.

Body as a whole.

Rare: tiredness and malaise.

Gastrointestinal system.

Common: nausea and dyspepsia. Rare: vomiting, diarrhoea, abdominal distension, bloating and epigastric pain have been reported. These symptoms were usually mild. Gastrointestinal disturbances may be relieved by reducing the dose or by taking betahistine with meals.

Nervous system.

Common: headache. Rare: dizziness. Very rare: convulsions, somnolence, confusion and hallucinations.
Some of these symptoms may also be observed as part of the disease condition and are usually resolved without changes to the treatment schedule.
Patients with neurological events usually presented with confounding factors.

Cardiovascular system.

Very rare: vasodilation, postural hypotension and tachycardia.

Respiratory system.

Very rare: dyspnoea, asthma and bronchospasms (see Section 4.4 Special Warnings and Precautions for Use).

Immune system disorder.

Hypersensitivity reactions, e.g. anaphylaxis have been reported.

Reporting suspected adverse events.

Reporting suspected adverse reactions after registration of the medical product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms.

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.

Treatment should include standard supportive measures.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

The mechanism of action of betahistine is not known. Pharmacological testing in animals has shown that the blood circulation in the striae vascularis of the inner ear improves, probably by means of a relaxation of the precapillary sphincters of the microcirculation of the inner ear.
In further animal pharmacological studies, betahistine was found to have weak H1-receptor agonistic and considerable H3-antagonistic properties in the CNS and autonomic nervous system. Betahistine was also found to have a dose dependent inhibiting effect on spike generation of neurons in lateral and medial vestibular nuclei in cats. The importance of this observation in the action against Meniere's syndrome or vestibular vertigo, however, remains unclear.

Clinical trials.

Twice versus three times daily dosage administration.

Four published studies comparing the safety and efficacy of betahistine 48 mg daily, when administered in twice daily or three times daily regimens have been assessed.
Tran Ba Huy 1992 was a randomized, controlled, open label study comparing the safety and efficacy of betahistine administered as 24 mg twice daily or 16 mg three times daily for 3 months, in 24 patients with recurrent vertigo, with or without cochlear symptoms typical of Meniere's disease.
Gananca 2009 was a randomized, open label study comparing the efficacy and tolerability of betahistine, administered either as 16 mg three times daily (60 patients) or 24 mg twice daily (60 patients) for 24 weeks, when used to treat vertigo in patients with well-established Meniere's disease.
Benecke 2010 was a prospective, multicentre, open label comparative post-marketing surveillance study comparing the effect on quality of life and tolerability of betahistine, administered either as 16 mg three times daily (742 patients) or 24 mg twice daily (1226 patients) for 3 months, when used to treat vertigo of peripheral vestibular origin just 13.3% with a diagnosis of Meniere's. Treatment allocation to each treatment regimen was determined by the approved product information of each country contributing patients to the study, and therefore was not randomly assigned.
Jurkiewicz 2009 was a prospective, open-label, parallel group trial which compared the efficacy of betahistine, when administered in a twice daily (44 patients) or three times daily dosage (38 patients) regimen, to treat patients with balancing disorders or vertigo. The maximum daily dosing regimens were administered for 4 weeks only, prior to reducing the dosage regimens to 12 mg twice daily and 8 mg three times daily for the remaining 8 weeks' of the study. Assignment to either regimen was not strictly randomized, but rather based on a pre-treatment screening questionnaire and examination undertaken by an audiology specialist.
All studies were conducted in a patient population relevant to the approved indication. The efficacy of the two dosage regimens was evaluated using a range of primary and secondary outcome measures. Efficacy measures were assessed at baseline and at least twice during the course of the treatment period. Outcomes were assessed subjectively by investigator and/or the individual patient. Jurkiewicz 2009 also objectively assessed efficacy using videonystagmography and posturography.
The subjective measures ranged from changes in vertigo intensity, severity, frequency and duration of vertigo, dizziness handicap index to health related quality of life (QoL), global assessment of progression of vertigo. The objective measures assessed posture, movement and optokinetics.
In all studies both treatment arms produced significant improvements in the various efficacy parameters during the treatment periods.
With the small patient numbers no statistically significant difference between the twice daily and three times daily regimens was demonstrated in any study.
There was no difference in the incidence or range of adverse events reported in the 3 studies which evaluated safety, between the twice daily and three times daily dosage regimens.

5.2 Pharmacokinetic Properties

Absorption.

In humans, orally administered doses of betahistine dihydrochloride are rapidly and completely absorbed from the gastrointestinal tract.

Metabolism.

The drug is rapidly metabolised to one major metabolite, 2-pyridylacetic acid, and excreted in the urine. Studies with radiolabelled betahistine have demonstrated a plasma half-life of 3.4 hours and a urinary half-life of 3.5 hours for the radiolabel.

Excretion.

Urinary excretion of the label was about 90% complete within 24 hours of administration.

5.3 Preclinical Safety Data

Genotoxicity.

No nonclinical data are available on the genotoxic potential of betahistine.

Carcinogenicity.

No animal data are available on the carcinogenic potential of betahistine.

6 Pharmaceutical Particulars

6.1 List of Excipients

Setear 24 mg tablets contain the following inactive ingredients: lactose monohydrate, maize starch, microcrystalline cellulose, citric acid, crospovidone, povidone and hydrogenated vegetable oil.

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.

6.5 Nature and Contents of Container

Setear 24 mg tablets are available in PVC/PE/PVDC/Al blister packs of 25*, 60 tablets and a sample pack of 15 tablets.
*Not 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

Chemical structure.


Chemical name: 2-[2-methylamino)ethyl]pyridine dihydrochloride.
Molecular formula: C8H12N2.2HCl.
Molecular weight: 209.1.

CAS number.

5579-84-0.
Betahistine dihydrochloride is a white almost white crystalline powder which is very hygroscopic. The product is very soluble in water, freely soluble in methanol and 96% ethanol, and slightly soluble in isopropanol. The pKa values are 3.5 and 9.7.
Chemically, betahistine has a close resemblance to histamine.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes