Betaserc

Package Leaflet: Information for the Patient

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

Betaserc

24 mg, tablets
Betahistine dihydrochloride

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 patient should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for one 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 patient should inform the doctor, pharmacist, or nurse.

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 pack 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:

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

In the symptomatic treatment of vertigo 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 patient should consult a doctor or pharmacist if:

• they have ever had stomach ulcers,
• they have asthma. If the patient has any of the above conditions (or has doubts), they should consult a doctor or pharmacist 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 patient should tell the doctor or pharmacist about all medicines they are currently taking or have recently taken, including those obtained without a prescription and herbal medicines.
In particular, the patient should inform the doctor or pharmacist if they 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 the patient has any of the above conditions (or has doubts), they should consult a doctor or pharmacist 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:

• The patient should stop taking Betaserc and inform the doctor if they are pregnant or think they may be pregnant.
• 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 machines.
However, the patient should remember that the diseases being treated with betahistine (Meniere's disease and vertigo) can cause dizziness and nausea and may affect the ability to drive or use machines.

3. How to take Betaserc

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

• The doctor will adjust the dose according to the patient's condition.
• The patient should continue taking the medicine. 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 patient should space out the doses evenly throughout the day, e.g., take one tablet in the morning and one in the evening. The patient should try to take the tablets at the same time every day. This will help keep a steady amount of medicine in the body.
Taking the medicine at the same time every day will also help the patient remember to take it.

Taking more Betaserc than prescribed

If more Betaserc is taken than prescribed, the patient may experience nausea, drowsiness, or stomach pain. In case of doubts, the patient should consult a doctor.

Missing a dose of Betaserc

• If a dose of Betaserc is missed, the patient should take the next dose at the scheduled time.
• The patient should not take a double dose to make up for the missed dose.

Stopping Betaserc

The patient should not stop taking Betaserc without consulting a doctor, even if they feel better.
In case of any further doubts about the use of the medicine, the patient should consult a 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 an allergic reaction occurs, the patient should stop taking Betaserc and consult a 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.

The patient should stop taking Betaserc, consult a doctor, or go to the hospital immediately if any of the above symptoms occur.

Other side effects:

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

• nausea,
• digestive disorders,
• headache.

Other side effects that have been reported while taking 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 patient should inform the doctor, pharmacist, or nurse. 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
By reporting side effects, more information can be gathered on the safety of the medicine.

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. The patient should ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

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, citric acid monohydrate, colloidal anhydrous silica, talc.

What Betaserc looks like and contents of the pack

Betaserc 24 mg betahistine dihydrochloride is available in the form of round, biconvex, divisible, white to almost white tablets with a score line. They have a diameter of 10 mm and are engraved with "289" on one side of the tablet on either side of the score line. The score line on the tablet is only to facilitate breaking and not to divide into equal doses.
Betaserc, 24 mg is available in packs of 20, 60, or 100 tablets, packaged in PVC-PVDC/Al blisters in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15, Dublin, Ireland

Manufacturer:

Mylan Laboratories S.A.S.
Route de Belleville
Lieu-dit Maillard
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
Marketing authorization number in Romania, the country of export: 2717/2010/03

Parallel import authorization number: 40/19

Date of approval of the leaflet: 23.01.2024

[Information about the trademark]