Betaserc

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Betaserc (Bétaserc)

24 mg, tablets

Betahistini dihydrochloridum
Betaserc and Bétaserc are different trade names for the same medicine.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• Consult a doctor, pharmacist, or nurse if you have any doubts.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any side effects occur, including any possible side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse (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. Package contents 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 analogue".

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 (ringing in the ears).

For symptomatic treatment of dizziness of vestibular origin.

How Betaserc works

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

2. Important information before taking Betaserc

When not to take Betaserc

• if you are allergic (hypersensitive) to betahistine or any of the other ingredients of Betaserc (listed in section 6),
• if your doctor has diagnosed you with a pheochromocytoma (a tumor of the adrenal gland). Do not take Betaserc if any of the above applies to you. If in doubt, consult your doctor or pharmacist before taking Betaserc.

Warnings and precautions

Before taking Betaserc, consult your doctor or pharmacist if:

• you have ever had stomach ulcers,
• you have asthma. If any of the above applies to you (or if you have any doubts), consult your doctor or pharmacist before taking Betaserc. Your doctor may want to monitor you closely while you are taking Betaserc.

Children

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

Other medicines and Betaserc

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, including those obtained without a prescription and herbal medicines.
In particular, inform your doctor or pharmacist if you are 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 any of the above applies to you (or if you have any doubts), consult your doctor or pharmacist before taking Betaserc.

Betaserc with food and drink

You can take Betaserc 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:

• Stop taking Betaserc and inform your doctor if you are pregnant or think you may be pregnant.
• Do not take Betaserc during pregnancy, unless your doctor decides it is necessary.

It is not known whether Betaserc passes into breast milk:

• Do not breastfeed while taking Betaserc, unless your doctor allows it.

Driving and using machines

It is unlikely that Betaserc will affect your ability to drive or use machines.
However, remember that the diseases being treated with betahistine (Meniere's disease and dizziness)
can cause dizziness and nausea and may affect your ability to drive or use machines.

3. How to take Betaserc

Always take Betaserc exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

• Your doctor will adjust the dose according to your 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.
• You can take the tablet 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 you are taking more than one tablet a day, space out the doses evenly throughout the day, e.g., take one tablet in the morning and one in the evening.
Try to take the tablets at the same time each day. This will help keep a steady amount of medicine in your body.
Taking the medicine at the same time each day will also help you remember to take it.

If you take more Betaserc than you should

If you take more Betaserc than you should, you may experience nausea, drowsiness, or stomach pain. If you are unsure, consult your doctor.

If you forget to take Betaserc

• If you miss a dose, 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 questions about the use of this medicine, ask your doctor or pharmacist.

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 you experience an allergic reaction, stop taking Betaserc and consult your doctor or go to the nearest hospital 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.

Stop taking Betaserc and consult your doctor or go to the hospital immediately if you experience any of the above symptoms.

Other side effects:

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

• nausea,
• digestive disorders,
• headache.

Other side effects that have been reported with Betaserc

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

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Betaserc

• Keep out of the 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents 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 betahistine dihydrochloride is a round, biconvex, divisible, white to almost white tablet with a score line on one side. The tablet is 10 mm in diameter and has "289" engraved on one side of the tablet on either side of the score line. The score line is only to facilitate breaking the tablet for swallowing and not to divide it into equal doses.
Betaserc, 24 mg is available in packs of 20, 40, 60, 100, or 120 tablets, packaged in PVC/PVDC/Aluminum blisters.
For more detailed information, consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in France, the country of export:

Viatris Médical, 1 bis place de la Défense - Tour Trinity, 92400 Courbevoie, France

Manufacturer:

Mylan Laboratories SAS, Route de Belleville, Lieu-dit Maillard, F 01400 Châtillon-sur-Chalaronne, France

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
French, country of export marketing authorization number: 34009 355 646 5 8
34009 355 647 1 9
34009 563 248 9 7
34009 563 249 5 8

Parallel import authorization number: 196/23

Date of leaflet approval: 14.09.2023

[Information about the trademark]