Betaserc

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Betaserc
24 mg, tablets
Betahistini dihydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor, pharmacist, or nurse if you have any questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

1. What Betaserc is and what it is used for
2. Important information before taking Betaserc
3. How to take Betaserc
4. Possible side effects
5. How to store Betaserc
6. Contents of the pack and other information

What is Betaserc
Betaserc contains betahistine. Betaserc is a type of medicine known as a "histamine analogue".
Why Betaserc is used
Betaserc is used in the treatment of Ménière's disease, which is characterised by the following
symptoms:

• vertigo (with nausea, vomiting)
• progressive hearing loss
• tinnitus.

For symptomatic treatment of vestibular origin vertigo.
How Betaserc works
Betaserc works by improving blood flow in the inner ear. This leads to a reduction in increased
pressure.

2. Important information before taking Betaserc

When not to take Betaserc

• if the patient is allergic (hypersensitive) to betahistine or to any of the other ingredients of Betaserc (listed in section 6)
• if the doctor has diagnosed the patient with a tumour of the adrenal medulla (‘phaeochromocytoma’). Do not take Betaserc if any of the above apply. If in doubt, consult a doctor or pharmacist before taking Betaserc.

Warnings and precautions
Before taking Betaserc, consult a doctor or pharmacist if:

• the patient has ever had stomach ulcers
• the patient suffers from bronchial asthma. If any of the above apply (or if in doubt), consult a doctor or pharmacist before taking Betaserc. The doctor may wish to monitor the patient closely during treatment with Betaserc.

Children
Betaserc is not recommended for use in individuals under 18 years of age.
Other medicines and Betaserc
Tell your doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines, including those obtained without a prescription and herbal medicines.
In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• antihistamines – these may (theoretically) affect the action of Betaserc. Betaserc may also reduce the effectiveness of antihistamines.
• Monoamine oxidase inhibitors (MAOIs) – used in the treatment of depression or Parkinson’s disease. These may enhance the effect of Betaserc. If any of the above apply (or if in doubt), consult a doctor or pharmacist before taking Betaserc.

Betaserc with food and drink
Betaserc may be taken with or without food. However, Betaserc may cause mild gastrointestinal discomfort (listed in section 4). Taking Betaserc with food may help reduce gastrointestinal discomfort.
Pregnancy, breastfeeding and fertility
It is unknown whether Betaserc affects the unborn child:

• Discontinue taking Betaserc and inform your doctor if the patient is pregnant or suspects she may be pregnant.
• Do not take Betaserc during pregnancy unless the doctor decides it is necessary.

It is unknown whether Betaserc passes into breast milk:

• Do not breastfeed while taking Betaserc unless instructed otherwise by the doctor.

Driving and using machines
It is unlikely that Betaserc affects the ability to drive or operate tools and machinery.
However, bear in mind that the conditions treated with betahistine (Ménière’s disease and vertigo) may cause sensations of spinning and nausea, and may therefore affect the ability to drive and operate machinery.

3. How to take Betaserc

Betaserc should always be taken as prescribed by your doctor. If you have any doubts,
you should contact your doctor or pharmacist.

• Your doctor will adjust the dose according to your condition.
• You should continue taking the medicine. It may take some time for the medicine to start working.

How to take the medicine

• Swallow the tablet with water.
• The tablet can be taken with or without food. However, Betaserc may cause mild gastrointestinal discomfort (listed in section 4). Taking Betaserc with food may help reduce gastrointestinal symptoms.

How much medicine to take
Betaserc is available in two strengths: 8 mg and 24 mg. The usual dose is:

• Betaserc 24 mg – one tablet twice daily.

If more than one tablet per day is prescribed, the doses should be evenly spaced throughout the day, e.g. one tablet in the morning and one in the evening.
Try to take the tablets at the same times each day. This ensures a constant level of the medicine in the body. Taking the medicine at the same time each day will also help you remember to take it.

Taking more Betaserc than prescribed
If you take more Betaserc than recommended, you may experience nausea, drowsiness, or abdominal pain. If in doubt, contact your doctor.

If you miss a dose of Betaserc

• If you miss a dose of Betaserc, take the next dose at the scheduled time.
• Do not take a double dose to make up for a missed dose.

Stopping Betaserc
Do not stop taking Betaserc without consulting your doctor, even if you feel better.

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Betaserc may cause adverse reactions, although not everyone experiences them. The following unwanted effects may occur after taking this medicine:

Allergic reactions
If an allergic reaction occurs, stop taking Betaserc and consult a doctor immediately or go to the nearest hospital. Symptoms may include:

• red or bumpy skin rash or inflammatory skin condition with itching
• swelling of the face, lips, tongue or neck
• low blood pressure
• loss of consciousness
• breathing difficulties. If any of the above symptoms occur, stop taking Betaserc immediately and contact a doctor or go to hospital.

Other adverse reactions:
Common (affects less than 1 in 10 people):

• nausea
• digestive disturbances
• headaches.

Other adverse reactions reported during treatment with Betaserc:

• Mild gastrointestinal discomfort such as vomiting, stomach and intestinal pain, bloating and gas. Taking Betaserc with food may help reduce gastrointestinal discomfort.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301; Fax: +48 22 49 21 309; Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Betaserc

• Keep out of the sight and reach of children.
• No special temperature storage conditions required.
• Store in the original packaging to protect from moisture.
• Do not use Betaserc after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Betaserc contains

• The active substance is 24 mg of betahistine dihydrochloride.
• The other ingredients are: microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal anhydrous silica, talc.

What Betaserc looks like and contents of the pack
Betaserc 24 mg tablets are round, biconvex, divisible, white to almost white tablets with bevelled edges. They are 10 mm in diameter and are marked with "289" embossed on both sides of the breakline on one side of the tablet. The breakline on the tablet is intended only to facilitate breaking for ease of swallowing and does not guarantee equal dosing.

Betaserc 24 mg is available in packs of 20 or 60 tablets, packed in PVC/PVDC/Aluminium blisters.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in the Czech Republic, the country of export:
Viatris Healthcare Limited
Damastown Industrial Park, Mulhuddart
Dublin 15, Dublin
Ireland

Manufacturer:
Mylan Laboratories S.A.S.
Chatillon sur Chalaronne
France

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in the Czech Republic, the country of export: 83/368/03-C
Parallel Import Licence Number: 108/21