BETASERC

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Betaserc (Betahistine Viatris)
24 mg, tablets
Betahistini dihydrochloridum
Betaserc and Betahistine Viatris are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• Consult your doctor, pharmacist, or nurse if you have any doubts.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm someone else, even if their symptoms are the same.
• If any adverse reactions occur, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Betaserc is and what it is used for
2. What you need to know 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

1. What Betaserc is and what it is used for

What Betaserc is
Betaserc contains betahistine. Betaserc is a type of medicine known as a "histamine analogue".
What Betaserc is used for
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 dizziness.
How Betaserc works
Betaserc works by improving blood flow in the inner ear. This leads to a reduction in elevated pressure.

2. Important information before taking Betaserc

When not to take Betaserc

• if the patient is allergic (hypersensitive) to betahistine or 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 ("pheochromocytoma"). 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 there is any uncertainty), speak to 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
Inform the doctor or pharmacist about all medicines currently taken or recently taken, including those obtained without a prescription and herbal remedies.
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 there is any uncertainty), speak to 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 not known whether Betaserc affects the unborn child:

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

It is not known whether Betaserc passes into breast milk:

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

Driving and using machines
It is unlikely that Betaserc affects the ability to drive or operate machinery.
However, bear in mind that the conditions treated with betahistine (Meniere's disease and vertigo) may cause sensations of spinning and nausea, which may affect the ability to drive and operate machinery.
3. How to take Betaserc
3. How to take Betaserc
Always take Betaserc exactly as prescribed by the doctor. If in doubt, contact the doctor or pharmacist.

• The doctor will adjust the dose according to the patient's condition.
• 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 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.

How much 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 taken, 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 time each day. This ensures a constant level of medicine in the body. Taking the medicine at the same time each day will also help remember to take it.
Taking more Betaserc than prescribed
If more Betaserc has been taken than recommended, nausea, drowsiness or abdominal pain may occur. If in doubt, contact the doctor.
Missing a dose of Betaserc

• If a dose of Betaserc has been missed, take the next dose at the usual time.
• Do not take a double dose to make up for a missed dose.

Stopping Betaserc
Do not stop taking Betaserc without consulting the doctor, even if symptoms improve.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.
4. Possible side effects
4. Possible side effects
Like all medicines, Betaserc may cause side effects, although not everybody will experience them.
The following adverse effects may occur after taking this medicine:
Allergic reactions
If an allergic reaction occurs, stop taking Betaserc immediately and consult a doctor 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 throat
• low blood pressure
• loss of consciousness
• difficulty breathing. Stop taking Betaserc and seek immediate medical attention or go to hospital if any of the above symptoms occur.

Other side effects:
Common (affects less than 1 in 10 people):

• nausea
• digestive disturbances
• headache.

Other side effects 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 side effects
If any side effects occur, including any not listed in this leaflet, inform the doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 side effects helps to provide more information on the safety of the medicine.
5. How to store Betaserc
5. How to store Betaserc

• Keep out of sight and reach of children.
• Store below 25°C.
• Do not use Betaserc after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
• Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the pack and other information
6. Contents of the pack and other information
What Betaserc contains

• The active substance is 24 mg of betahistine dihydrochloride.
• The other ingredients are: microcrystalline cellulose, mannitol (E 421), citric acid monohydrate, colloidal anhydrous silica, talc.

What Betaserc looks like and contents of the pack
Betaserc 24 mg of betahistine dihydrochloride is a round, biconvex, white to almost white, scored tablet with bevelled edges. It is 10 mm in diameter and marked with "289" on one side of the tablet, on both sides of the break line. The break line is intended only to facilitate breaking the tablet for ease of swallowing and does not guarantee equal dosing.
Betaserc 24 mg is available in packs of 20, 60, 100 or 120 tablets, packed in PVC/PVDC/Al blisters.
For more detailed information, contact the marketing authorisation holder or parallel importer.
Marketing Authorisation Holder in Belgium, country of export:
Viatris GX BV
Terhulpsesteenweg 6A
B-1560 Hoeilaart
Belgium
Manufacturer:
Mylan Laboratories S.A.S.
Route de Belleville, Lieu-dit Maillard
01400 Châtillon-sur-Chalaronne
France
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Belgium, country of export: BE353245
Parallel Import Authorisation Number: 211/23