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SERC

Betahistine Dihydrochloride

Consumer Medicine Information

WHAT IS IN THIS LEAFLET

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

If you have any concerns about taking SERC, ask your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking SERC against the benefits they expect it will have for you.

Keep this leaflet with the medicine.

You may need to read it again.

WHAT SERC IS USED FOR

SERC 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 Meniere`s Syndrome.

Based on animal studies, the active ingredient of SERC tablets, betahistine dihydrochloride, 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.

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

There is no evidence that SERC is addictive.

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

BEFORE YOU TAKE SERC

When you must not take SERC

Do not take SERC tablets if:

you are pregnant or intend to become pregnant.

SERC may affect your developing baby if taken during pregnancy.

you are breast-feeding or plan to breast-feed.

SERC may pass into breast milk and therefore there is a 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.
you have a rare abnormality of the adrenal gland known as phaeochromochytoma.
you have or have had a peptic ulcer.

Do not give SERC to children under 12 years of age.

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

Do not take SERC 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 SERC, talk to your doctor or pharmacist.

Before you start to take SERC

Tell your doctor or pharmacist 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 SERC 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 SERC during breastfeeding.

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

Taking other medicines

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

Some medicines and SERC may interfere with each other. These include:

any antihistamine medications

These medicines may be affected by SERC 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 SERC.

HOW TO TAKE SERC

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/bottle, 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.

How to take it

Swallow SERC with a glass of water.

When to take it

Take SERC 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 SERC during or immediately after a meal, at about the same time each day.

If you take SERC on an empty stomach, it may cause stomach upsets.

How long to take it

If you follow your doctor`s instructions SERC 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 SERC 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. 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 telephone 13 11 26, in New Zealand telephone 03 474 7000), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much SERC. Do this even if there are no signs of discomfort or poisoning.

The most common symptom of overdosing is nausea.

WHILE YOU ARE TAKING SERC

Things you must do

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

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

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

If you become pregnant while taking SERC, tell your doctor.

Things you must not do

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

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

Do not stop taking SERC, 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 SERC.

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 SERC 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)

These side effects are usually mild and some may also be present as part of your disorder. Stomach upsets can be overcome by taking SERC during meals.

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

skin reactions
difficulty breathing

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 SERC

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 30 degrees C.

Do not store SERC 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 SERC 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 your SERC or the tablets have passed their expiry date, ask your pharmacist what you should do with any tablets that are left over.

PRODUCT DESCRIPTION

What the tablets look like

SERC tablets 16mg are white, round, scored, one side inscribed with “S”, the other with “267” on either side of the score. Available in packs of 25 and 10 tablets (sample pack).

Ingredients

Each SERC tablet contains 16 mg of the active ingredient betahistine dihydrochloride. The tablet also contains colloidal anhydrous silica, microcrystalline cellulose, mannitol, citric acid monohydrate, and talc.

SERC does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Manufacturer

SERC tablets are manufactured in The Netherlands for:

Solvay Pharmaceuticals
A division of Solvay Biosciences Pty. Ltd.
Level 1, Building 2, 20 Bridge St.
Pymble NSW 2066
Telephone: (02) 944 00 977
This leaflet was prepared in December 1996.
Revised August 2000.

Australian Registration Number: 61687

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Serc Tablets 16MG Pack Of 25