Betaserc Odt

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Betaserc ODT(Betaserc Odis)

24 mg, orally disintegrating tablets

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to. If you have any doubts, you should consult your doctor or pharmacist.
• 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Betaserc ODT and what is it used for
• 2. Important information before taking Betaserc ODT
• 3. How to take Betaserc ODT
• 4. Possible side effects
• 5. How to store Betaserc ODT
• 6. Contents of the package and other information

1. What is Betaserc ODT and what is it used for

What is Betaserc ODT

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

What is Betaserc ODT used for

Betaserc ODT is used:

• for Meniere's disease - the symptoms of this disease are:
• dizziness and nausea or vomiting
• ringing in the ears (tinnitus)
• hearing loss or difficulty hearing
• for dizziness caused by abnormal functioning of the inner ear, which controls balance (so-called "vestibular dizziness").

How Betaserc ODT works

Betaserc ODT works by improving blood flow in the inner ear. The inner ear is one of the organs responsible for balance.

2. Important information before taking Betaserc ODT

When not to take Betaserc ODT

• if the patient is allergic to betahistine or any of the other ingredients of this medicine (listed in section 6)
• if the doctor has diagnosed the patient with a tumor of the adrenal gland (so-called "pheochromocytoma")

Do not take this medicine if any of the above statements apply to you. If in doubt, consult your doctor or pharmacist before taking Betaserc ODT.

Warnings and precautions

Before starting to take Betaserc ODT, consult your doctor or pharmacist if:

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

Children and adolescents

Do not use Betaserc ODT in children and adolescents under 18 years of age.

Betaserc ODT and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• antihistamines - they may (theoretically) reduce the effect of Betaserc ODT. Betaserc ODT may also reduce the effect of antihistamines.
• monoamine oxidase inhibitors (MAOIs) - used to treat depression or Parkinson's disease. They may increase exposure to Betaserc ODT. If any of the above statements apply to you (or if you have any doubts), consult your doctor or pharmacist before taking Betaserc ODT.

Betaserc ODT with food and drink

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
It is not known whether Betaserc ODT affects the fetus:

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

It is not known whether Betaserc ODT passes into breast milk:

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

Driving and using machines

It is unlikely that Betaserc ODT will affect your ability to drive or use machines.
However, keep in mind that the diseases being treated with this medicine may cause dizziness and nausea and may affect your ability to drive or use machines.

Betaserc ODT contains

• This medicine contains 3.4 mg of aspartame in each tablet. Aspartame (E 951) is a source of phenylalanine. It may be harmful to patients with phenylketonuria (a rare genetic disorder characterized by the accumulation of phenylalanine in the body, which cannot be properly removed).
• Sucrose. If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Betaserc ODT

This medicine should always be taken exactly as directed by your doctor. If you are unsure, 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

• Place the tablet on your tongue and let it dissolve before swallowing, with or without water (depending on your preference).
• You can take the tablet with or without food. However, Betaserc ODT may cause mild stomach upset (listed in section 4). Taking Betaserc ODT with food may help reduce stomach upset.

How much to take

The recommended dose is one tablet twice a day.
Take the medicine 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 ensure 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.

Taking more Betaserc ODT than recommended

If you take more Betaserc ODT than recommended, you may experience nausea (vomiting), drowsiness, or stomach pain. If in doubt, contact your doctor.

Missing a dose of Betaserc ODT

• If you miss a dose, take the next dose at the scheduled time.
• Do not take a double dose to make up for the missed dose.

Stopping Betaserc ODT

Do not stop taking Betaserc ODT without consulting your doctor, even if you feel better.
If you have any further doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Allergic reactions

If an allergic reaction occurs, stop taking Betaserc ODT 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 ODT 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 (vomiting)
• digestive disorders
• headaches

Other side effects that have been reported while taking Betaserc ODT

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to: Department for Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje 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 ODT

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
• There are no special precautions for storage of the medicinal product.
• 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 package and other information

What Betaserc ODT contains

• The active substance of the medicine is betahistine dihydrochloride. Each tablet contains 24 mg of betahistine dihydrochloride.
• The other ingredients are: microcrystalline cellulose, crospovidone (type A), citric acid, anhydrous colloidal silica, talc, aspartame (E 951), acesulfame potassium (E 950), peppermint flavor, flavor corrective (sucrose, aspartame (E 951), acesulfame potassium (E 950)).

What Betaserc ODT looks like and what the package contains

• Betaserc ODT is a round, flat, white to yellowish, uncoated, with beveled edges, without engraving, orally disintegrating tablet. The diameter of the tablet is approximately 9 mm.
• Betaserc ODT is available in packages of 60 tablets, packed in soft blisters of PA/Aluminum/PVC/Aluminum in a cardboard box.

For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Viatris Healthcare, Lda.
Av. D. João II, Edifício Atlantis, N.º 44C - 7.3 e 7.4
1990-095 Lisbon
Portugal

Manufacturer:

Delpharm l’Aigle
Zone Industrielle n.º1
Route de Crulai
61300 L’aigle
France

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Portugal, the country of export:
5644760
5644752
Parallel import authorization number: 145/20

Date of approval of the leaflet: 12.05.2025

[Information about the trademark]