Betaserc

Package Leaflet: Information for the Patient

Betaserc

8 mg, tablets
Betahistini dihydrochloridum

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

• Keep this leaflet, you may need to read it again.
• Ask your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this 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, which is characterized by the following symptoms:

• vertigo (with nausea and vomiting)
• progressive hearing loss
• tinnitus

For the symptomatic treatment of vertigo of peripheral origin.

How Betaserc works

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

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 are in doubt), 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 the medicines you are taking, or have recently taken, including those obtained without a prescription and herbal medicines.
In particular, tell 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 increase the effect of Betaserc If any of the above applies to you (or if you are in doubt), consult your 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:

• stop taking Betaserc and tell your doctor if you are pregnant or think you may be pregnant.
• do not take Betaserc if you are pregnant, 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 tells you to.

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 vertigo) 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 in doubt, consult your doctor or pharmacist.

• Your doctor will adjust the dose according to your condition.
• continue taking Betaserc. 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 level of the 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 in doubt, consult your doctor.

If you forget to take Betaserc

• if you miss a dose, take the next dose at the usual time.
• do not take a double dose to make up for a forgotten dose.

Stopping Betaserc

do not stop taking Betaserc without talking to 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 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 not listed in this leaflet, tell your doctor, pharmacist, or nurse.
side effects can be reported directly to the Department of Medicinal Product Monitoring, 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
side effects can also be reported to the marketing authorization holder.
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.
• store in the original package to protect from light.
• do not use Betaserc after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
• 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 is a round, flat, white to almost white tablet with beveled edges, 7 mm in diameter, with "256" engraved on one side.
Betaserc 8 mg is available in packs of 30 or 100 tablets, packaged in Al/PVC/PVDC blisters.
not all pack sizes may be marketed.

Marketing authorization holder

Viatris Healthcare Sp. z o.o.
ul. Postępu 21B

Manufacturer

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

For more detailed information, please contact the marketing authorization holder:

Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
tel. 22 546 64 00
Date of last revision of the leaflet:02/2024