Betaserc

Leaflet attached to the packaging: patient information

Warning! Keep the 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.

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If any side effects occur, including any possible side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. See section 4.

Table of contents of the leaflet

• 1. What is Betaserc and what is it 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 packaging and other information

1. What is Betaserc and what is it used for

What is Betaserc

Betaserc contains betahistine. Betaserc is a type of medicine called a "histamine analog".

What is Betaserc used for

Betaserc is used to treat Meniere's disease, which is characterized by the following symptoms:

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

In the symptomatic treatment of dizziness of vestibular origin.

How Betaserc works

Betaserc works by improving blood flow in the inner ear. This reduces increased pressure.

2. Important information before taking Betaserc

When not to take Betaserc

Warnings and precautions

Before taking Betaserc, the doctor or pharmacist should be consulted if:

• the patient has ever had stomach ulcers
• the patient has asthma. If the patient has any of the above conditions (or doubts have arisen), the doctor or pharmacist should be consulted before taking Betaserc. The doctor may want to closely monitor the patient while taking Betaserc.

Children

Betaserc is not recommended for use in children under 18 years of age.

Other medicines and Betaserc

The doctor or pharmacist should be informed about all medicines currently being taken or recently taken, including those available without a prescription and herbal medicines.
In particular, the doctor or pharmacist should be informed if the patient is taking any of the following medicines:

• Antihistamines - they may (theoretically) affect the action of Betaserc. Betaserc may also reduce the effect of antihistamines.
• Monoamine oxidase inhibitors (MAOIs) - used to treat depression or Parkinson's disease. They may enhance the effect of Betaserc. If the patient has any of the above conditions (or doubts have arisen), the doctor or pharmacist should be consulted before taking Betaserc.

Betaserc with food and drink

Betaserc can be taken with or without food. However, Betaserc may cause mild stomach upset (listed in section 4). Taking Betaserc with food may help reduce stomach upset.

Pregnancy, breastfeeding, and fertility

It is not known whether Betaserc affects the fetus:

• Betaserc should be stopped and the doctor informed if the patient is pregnant or suspects pregnancy.
• Betaserc should not be taken during pregnancy, unless the doctor decides it is necessary.

It is not known whether Betaserc passes into breast milk:

• Breastfeeding should not be done while taking Betaserc, unless the doctor allows it.

Driving and using machines

It is unlikely that Betaserc will affect the ability to drive or use tools and machines.
However, it should be remembered that the diseases treated with betahistine (Meniere's disease and dizziness) can cause a feeling of spinning and nausea and may affect the ability to drive or use machines.

3. How to take Betaserc

3. How to take Betaserc

Betaserc should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.

• The doctor will adjust the dose according to the patient's condition.
• The medicine should be continued. It may take some time for the medicine to start working.

How to take the medicine

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

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 a day.

If more than one tablet is taken per day, the intake should be spread evenly throughout the day, e.g., one tablet should be taken in the morning and one in the evening.
The tablets should be taken at the same time of day. This will ensure a constant amount of medicine in the body. Taking the medicine at the same time will also help remember to take it.

Taking more Betaserc than prescribed

If more Betaserc is taken than prescribed, nausea, drowsiness, or stomach pain may occur. In case of doubts, the doctor should be consulted.

Missing a dose of Betaserc

• If a dose of Betaserc is missed, the next dose should be taken at the scheduled time.
• A double dose should not be taken to make up for the missed dose.

Stopping Betaserc

Betaserc should not be stopped without consulting the doctor, even if an improvement occurs.
In case of any further doubts about the use of the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

4. Possible side effects

Like all medicines, Betaserc can cause side effects, although not everybody gets them.
After taking this medicine, the following side effects may occur:

Allergic reactions

If an allergic reaction occurs, Betaserc should be stopped and the doctor or the nearest hospital should be consulted immediately. The symptoms may be:

• red or lumpy skin rash or skin inflammation with itching
• swelling of the face, lips, tongue, or throat
• low blood pressure
• loss of consciousness
• difficulty breathing.

Betaserc should be stopped, and the doctor or hospital should be consulted immediately if any of the above symptoms occur.

Other side effects:

Frequent(occurring in less than 1 in 10 people):

• nausea
• digestive disorders
• headaches.

Other side effects that have been reported during the use of Betaserc

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

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 side effects can help gather 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 at a temperature not exceeding 25°C.
• Do not use Betaserc after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
• Medicines should not be disposed of via wastewater or household waste containers. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

6. Contents of the packaging and other information

What Betaserc contains

• The active substance of Betaserc 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 what the pack contains

Betaserc 24 mg betahistine dihydrochloride is available in the form of round, biconvex, divisible, white to almost white tablets with beveled edges. They have a diameter of 10 mm and are engraved with "289" on one side of the tablet, on both sides of the break line. The break line on the tablet only facilitates breaking for swallowing and does not divide the tablet into equal doses.
Betaserc, 24 mg is available in packs of 20, 60, 100, or 120 tablets, packaged in PVC/PVDC/Al blisters.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Belgium, the 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Belgian marketing authorization number:BE353245

Parallel import authorization number: 211/23

Date of leaflet approval: 28.09.2023
[Information about the trademark]