Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Seniere tablets. It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given Seniere tablets against the benefits this medicine is expected to have for you.

Keep this leaflet with the medicine. You may need to read it again.

What Seniere is used for

Seniere 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.

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

There is no evidence that Seniere is addictive.

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

Before you take Seniere

When you must not take it

Do not take Seniere if:

• you are pregnant or intend to become pregnant. Seniere may affect your developing baby if taken during pregnancy.
• you are breast-feeding or plan to breast-feed. Seniere 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 Seniere to children under 18 years of age.

Do not take Seniere after the expiry date (EXP) printed on the pack.

Do not take Seniere if the packaging is torn or shows signs of tampering, or if the tablets do not look quite right. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking Seniere, talk to your doctor or pharmacist.

Before you start to take it

You must tell your doctor if you have allergies to:

• any other medicines
• 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 Seniere during pregnancy.

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

If you have not told your doctor about any of the above, tell them before you start taking Seniere.

Taking other medicines

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

Some medicines and Seniere 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)

These medicines may be affected by Seniere or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

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

How take Seniere

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

Your doctor or pharmacist will tell you how many tablets you will need to take each day. This depends on your condition and whether or not you are taking any other medicines.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

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.

The maximum recommended daily dosage is 48 mg.

How to take it

Swallow Seniere with a glass of water.

When to take it

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

How long to take it

If you follow your doctor's instructions Seniere 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 Seniere tablets varies from patient to patient. Some people respond rapidly to treatment and others may take some time. Please be patient with your treatment and take your tablets regularly. Do not stop taking your medicine unless your doctor tells you to - even if you feel better.

If you forget to take your tablets

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

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately contact your doctor or pharmacist or the Poisons Information Centre (In Australia, call 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Seniere. Do this even if there are no signs of discomfort or poisoning.

The most common symptom of overdosing is nausea.

While you are taking Seniere

Things you must do

Tell any other doctors, dentists, and pharmacists who are treating you that you are taking Seniere.

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

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

If you become pregnant while taking Seniere, tell your doctor immediately.

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 must not do

Do not give Seniere to anyone else, even if they have the same condition as you.

Do not take Seniere to treat any other complaints unless your doctor tells you to.

Do not stop taking Seniere, or lower the dosage without checking with your doctor.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Seniere. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side-effects.

Ask your doctor or pharmacist to answer any questions you may have.

Following is a list of possible side effects. Do not be alarmed by this list.

You may not experience any of them.

If you get any side effects, do not stop taking Seniere without first talking to your doctor.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

• skin irritations
• stomach upsets
• dizziness
• fast heart beat
• headache
• difficulty sleeping (insomnia)
• tiredness
• nausea, vomiting, bloating, or swollen stomach
• diarrhoea

These side effects are usually mild and often short-lived. Some symptoms may also be present as part of your disorder. Stomach upsets can be overcome by taking Seniere during meals.

Tell your doctor as soon as possible if you notice any of the following:

• skin reactions
• difficulty breathing
• convulsions
• hallucinations
• confusion
• allergic reaction
• low blood pressure, slow heart beat

These may be serious side effects. You may need medical attention. Serious side effects are very rare.

Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

After using Seniere

Storage

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they will not keep well.

Keep your tablets in a cool, dry place where the temperature stays below 25°C. Do not store Seniere or any other medicine in the bathroom or near a sink.

Do not leave it on a windowsill or in the car on hot days. Heat and dampness can destroy some medicines.

Keep Seniere tablets where children cannot reach them. A locked cupboard at least one-and- a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Seniere, or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets left over.

Product description

What the tablets look like

Seniere tablets are white and flat with beveled edges. They have a breakline on one side. Available in packs of 25 tablets.

Ingredients

Active ingredient:

Seniere 16 mg tablet - 16 mg betahistine dihydrochloride.

Inactive ingredients:

• lactose monohydrate
• maize starch
• microcrystalline cellulose
• citric acid
• povidone
• crospovidone
• hydrogenated vegetable oil.

Contains sugars as lactose.

Supplier/ Distributor

Distributor

Arrow Pharmaceuticals Pty Ltd
15–17 Chapel Street Cremorne
VIC 3121

Sponsor

Southern Cross Pharma Pty Ltd
Suite 5/118 Church Street
Hawthorn VIC 3122

This leaflet was prepared in February 2020.

Australian Register Number
16 mg tablet: AUST R 163022 (blisters)

Published by MIMS April 2020

1 Name of Medicine

Betahistine dihydrochloride.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

Chemical name.

Molecular formula.

Molecular weight.

2 Qualitative and Quantitative Composition

Seniere tablets contain 16 mg of the active ingredient 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

Seniere tablets are white flat tablets with bevelled edges and a break-line on one side.

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.

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.

4.3 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.

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.

4.8 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.

Body as a whole.

Gastrointestinal system.

Nervous system.

Cardiovascular system.

Respiratory system.

Immune system disorder.

Reporting suspected adverse effects.

4.2 Dose and Method of Administration

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 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.

4.7 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.

4.9 Overdose

Symptoms.

Treatment.

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Seniere tablets contain the inactive ingredients 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.

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

Seniere 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.

Summary Table of Changes