Consumer medicine information

Serc

Betahistine dihydrochloride

BRAND INFORMATION

Brand name

Serc

Active ingredient

Betahistine dihydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Serc.

SUMMARY CMI

SERC®

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 SERC?

SERC contains the active ingredient betahistine dihydrochloride. SERC 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 SERC? in the full CMI.

2. What should I know before I use SERC?

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 SERC? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with SERC 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 SERC?

  • The usual adult starting dose is half to one tablet taken three times a day.
  • Take SERC 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 SERC? in the full CMI.

5. What should I know while using SERC?

Things you should do
  • Remind any doctor or pharmacist you visit that you are using SERC.
  • If you are going to have surgery, tell the surgeon that you are taking this medicine.
Things you should not do
  • Do not stop taking SERC, 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.
Driving or using machines
  • SERC 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.
  • SERC 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.
  • Keep the medicine in a cool, dry place where the temperature stays below 30°C.
  • Keep it where children cannot reach it.

For more information, see Section 5. What should I know while using SERC? 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 SERC 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

SERC®

Active ingredient: betahistine dihydrochloride


Consumer Medicine Information (CMI)

This leaflet provides important information about using SERC. 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 SERC.

Where to find information in this leaflet:

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

1. Why am I using SERC?

SERC contains the active ingredient betahistine dihydrochloride. SERC 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.

SERC 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 SERC?

Warnings

Do not use SERC 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 SERC to a child under the age of 18 years.
  • Do not take SERC if you have a rare abnormality of the adrenal gland known as phaeochromocytoma.
  • Do not take SERC if you have or have had a peptic ulcer.
  • Do not take SERC 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:
    - a 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 SERC 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 SERC 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 SERC, or may affect how well it works. You may need to use different amounts 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 SERC.

4. How do I use SERC?

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.
  • Follow the instructions provided and continue taking SERC as long as your doctor tells you.
  • 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.

When to take SERC

  • Take SERC 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 SERC during or immediately after a meal.
  • If you take SERC on an empty stomach, it may cause stomach upsets.

How to take SERC

  • Swallow the tablet whole with a full glass of water.

If you forget to take SERC

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 SERC

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

You should immediately:

  • phone the Poisons Information Centre
    (Australia telephone 13 11 26) for advice, 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 SERC?

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 SERC.

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

SERC 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.

SERC 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 30°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.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

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 SERC.

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

More common side effectsWhat to do
  • skin irritations
  • stomach upsets (can be overcome by taking SERC during meals)
  • dizziness
  • fast heartbeat
  • headache
  • difficulty sleeping (insomnia)
Speak to your doctor or pharmacist if you notice any of these side effects and they worry you.
They are usually mild and short-lived.

Serious side effects

Serious side effects
  • skin reactions
  • difficulty breathing
Call your doctor as soon as possible if you notice these side effects.
They may require medical attention. Serious side effects are rare.

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 SERC contains

Active ingredient
(main ingredient)
betahistine dihydrochloride
Other ingredients
(inactive ingredients)
citric acid monohydrate
colloidal anhydrous silica
mannitol
microcrystalline cellulose
purified talc

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

What SERC looks like

SERC 16 mg tablets are uncoated round, biconvex, scored, white to almost white with bevelled edges, one side inscribed with "267" on either side of the score (AUST R 61687).

Who distributes SERC

Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in March 2022.

SERC® is a Viatris company trade mark

SERC_cmi\Mar22/00

Published by MIMS April 2022

BRAND INFORMATION

Brand name

Serc

Active ingredient

Betahistine dihydrochloride

Schedule

S4

 

1 Name of Medicine

Betahistine dihydrochloride.

2 Qualitative and Quantitative Composition

Active ingredient is betahistine dihydrochloride.
Each tablet contains 8 mg or 16 mg of betahistine dihydrochloride.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Serc (betahistine dihydrochloride) 16 mg tablets: round, biconvex, scored, white to almost white uncoated tablet, one side inscribed with '267' on either side of the score.
Serc (betahistine dihydrochloride) *8 mg tablets: round, flat, white to almost white uncoated tablet, one side inscribed with '256'.

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

Serc (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 2 Qualitative and Quantitative Composition; Section 6 Pharmaceutical Particulars; 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 Clinical Particulars; 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 Serc 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)
Category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
Betahistine dihydrochloride must 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 must 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 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.
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%).

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 disorders.

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 www.tga.gov.au/reporting-problems.

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 Poisons Information Centre on 13 11 26 (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 man, 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.

Excretion.

Urinary excretion of the label was about 90% complete within 24 hours of administration. Studies with radio-labelled betahistine have demonstrated a plasma half-life of 3.4 hours and a urinary half-life of 3.5 hours for the radio-label.

5.3 Preclinical Safety Data

Genotoxicity.

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

Carcinogenicity.

See Section 5.3 Preclinical Safety Data, Genotoxicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Serc (betahistine dihydrochloride) is available as 8 mg and 16 mg uncoated tablets. The inactive ingredients in Serc tablets are: colloidal anhydrous silica, microcrystalline cellulose, mannitol, citric acid monohydrate, and purified talc.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.4 Special Precautions for Storage

Storage.

Store below 30°C, protect from light.

6.5 Nature and Contents of Container

8 mg: PVC/PVDC/aluminium blister packs containing 10 tablets and 120 tablets.
16 mg: PVC/PVDC/aluminium blister packs containing 10 tablets (sample pack), 25 tablets and *100 tablets.
*Not currently distributed in Australia.

Australian Register of Therapeutic Goods (ARTG).

AUST R 61687 - Serc Betahistine dihydrochloride 16 mg tablet blister pack.
AUST R 61688 - Serc Betahistine dihydrochloride 8 mg tablet blister pack.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

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.

Chemical structure.


Chemical formula.

Betahistine dihydrochloride is chemically identified as 2-[2-(methylamino) ethyl] pyridine dihydrochloride. Chemically, betahistine has a close resemblance to histamine.

Molecular weight.

209.1.

CAS number.

(CAS) Registry Number: 5579-84-0.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes