Betaserc

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Betaserc

8 mg, tablets
Betahistini dihydrochloridum

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 specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your 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, 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, 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 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 the 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 if 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 if 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, 8 mg - one or two tablets three times a day.

If you are taking more than one tablet a day, spread 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 constant 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 in doubt, 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 forgotten dose.

If you stop taking Betaserc

Do not stop taking Betaserc without consulting your doctor, even if you feel better.
If you have any further questions on the use of this product, 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 during treatment with 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 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, 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, 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 in a temperature not exceeding 25°C, in a dry place.
• 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. Contents of the pack and other information

What Betaserc contains

• The active substance is 8 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 8 mg betahistine dihydrochloride is a round, flat, white to almost white tablet with beveled edges. It is 7 mm in size and has "256" engraved on one side.
Betaserc, 8 mg is available in packs of 100 tablets, packaged in PVC/PVDC/Al blisters.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Belgium, the country of export:

Mylan EPD bvba/sprl
Terhulpsesteenweg, 6A

• B - 1560 Hoeilaart Belgium

Manufacturer:

Mylan Laboratories SAS
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:BE071766
Parallel import authorization number:120/17
Date of leaflet approval: 07.03.2022
[Information about the trademark]