Consumer medicine information

Betahistine Sandoz

Betahistine dihydrochloride

BRAND INFORMATION

Brand name

Betahistine Sandoz

Active ingredient

Betahistine dihydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Betahistine Sandoz.

SUMMARY CMI

Betahistine Sandoz

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 Betahistine Sandoz?

Betahistine Sandoz contains 16 mg of the active ingredient betahistine dihydrochloride. Betahistine Sandoz 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 Betahistine Sandoz? in the full CMI.

2. What should I know before I use Betahistine Sandoz?

Do not use if you have ever had an allergic reaction to Betahistine Sandoz 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 Betahistine Sandoz? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Betahistine Sandoz 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 Betahistine Sandoz?

  • The usual adult starting dose is half to one 16 mg tablet taken three times a day. Your doctor may however prescribe a different dose. The maximum recommended daily dosage is 48 mg.
  • Swallow Betahistine Sandoz 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 Betahistine Sandoz? in the full CMI.

5. What should I know while using Betahistine Sandoz?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Betahistine Sandoz.
  • 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 Betahistine Sandoz to anyone else, even if they have the same condition as you.
  • Do not take Betahistine Sandoz to treat any other complaints unless your doctor tells you to.
  • Do not stop taking Betahistine Sandoz, 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 Betahistine Sandoz? 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

Betahistine Sandoz

Active ingredient: betahistine dihydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Betahistine Sandoz. 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 Betahistine Sandoz.

Where to find information in this leaflet:

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

1. Why am I using Betahistine Sandoz?

Betahistine Sandoz contains the active ingredient betahistine dihydrochloride.

Betahistine Sandoz 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.

Betahistine Sandoz 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 Betahistine Sandoz for another reason. Ask your doctor if you have any questions about why Betahistine Sandoz has been prescribed for you.

There is no evidence that Betahistine Sandoz is addictive.

2. What should I know before I use Betahistine Sandoz?

Warnings

Do not use Betahistine Sandoz if:

  • you are pregnant or intend to become pregnant.
    Betahistine Sandoz may affect your developing baby if taken during pregnancy.
  • you are breast-feeding or plan to breast-feed.
    Betahistine Sandoz 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 Betahistine Sandoz 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 Betahistine Sandoz 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 Betahistine Sandoz.

4. How do I use Betahistine Sandoz?

How much to take

  • The usual adult starting dose is half to one 16mg Betahistine Sandoz tablet, taken three 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 Betahistine Sandoz with a glass of water.
  • Follow the instructions provided and use Betahistine Sandoz until your doctor tells you to stop.
  • If you follow your doctor's instructions Betahistine Sandoz 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 Betahistine Sandoz tablets varies from patient to patient.

When to take Betahistine Sandoz

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

If you forget to use Betahistine Sandoz

Betahistine Sandoz should be used regularly at the same time each day. If you miss your dose at the usual time,

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 Betahistine Sandoz

If you think that you have used too much Betahistine Sandoz, 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 Betahistine Sandoz?

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 Betahistine Sandoz during pregnancy. If you become pregnant while taking Betahistine Sandoz, 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 Betahistine Sandoz during breastfeeding.

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

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

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

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 Betahistine Sandoz to anyone else, even if they have the same condition as you.
  • Do not take Betahistine Sandoz to treat any other complaints unless your doctor tells you to.
  • Do not stop taking Betahistine Sandoz, 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 Betahistine Sandoz affects you.

Your condition or Betahistine Sandoz 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.

Betahistine Sandoz tablets contain 16 mg of the active ingredient betahistine dihydrochloride.

What Betahistine Sandoz 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 Betahistine Sandoz looks like

Betahistine Sandoz tablets are white and flat with beveled edges. They have a breakline on one side. Available in packs of 25 tablets. (AUST R 253732)

Who distributes Betahistine Sandoz

Sandoz Pty Ltd
54 Waterloo Road
Macquarie Park, NSW, 2113
Australia
Tel: 1800 726 369

This leaflet was prepared in March 2021.

Published by MIMS October 2022

BRAND INFORMATION

Brand name

Betahistine Sandoz

Active ingredient

Betahistine dihydrochloride

Schedule

S4

 

1 Name of Medicine

Betahistine dihydrochloride.

2 Qualitative and Quantitative Composition

Betahistine Sandoz tablets contain 16 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

Betahistine Sandoz tablets are white flat tablets with bevelled edges and a breakline 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

Dosage.

The recommended starting dose in adults is one-half to one tablet (8 to 16 mg) taken three times a day. The maximum recommended daily dosage is 48 mg. 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.
Improvement in symptoms may be observed in the first few days to weeks of treatment.

Method of administration.

The tablets may be taken with or without food. However, if gastrointestinal upset occurs, it is recommended that the tablets be taken with meals.

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.

No data available.

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

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

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/angioedema. 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.

Common: headache.
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.

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 effects.

Reporting suspected adverse reactions after registration of the medicinal 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 Poison 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.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

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

Distribution.

No data available.

Metabolism.

The drug is rapidly metabolised to one major metabolite, 2-pyridylacetic acid.

Excretion.

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

5.3 Preclinical Safety Data

Genotoxicity.

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

Carcinogenicity.

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

6 Pharmaceutical Particulars

6.1 List of Excipients

Lactose monohydrate, maize starch, microcrystalline cellulose, citric acid, povidone, crospovidone and hydrogenated vegetable oil.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
For information on interactions with other medicines and other forms of interactions, see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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

Tablets should be stored below 25°C.

6.5 Nature and Contents of Container

Betahistine Sandoz tablets are presented in PVC/PE/PVDC/Al blister packs of 25 tablets.

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 2-[2-ethylamino)ethyl]pyridine dihydrochloride. Its molecular formula is C8H14Cl2N2 (MW: 209.1).

Chemical structure.

Its chemical structure is:

CAS number.

5579-84-0.
Betahistine dihydrochloride is a white to 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.

Summary Table of Changes