Betaserc Odt

Package Leaflet: Information for the User

Betaserc ODT

24 mg, orally disintegrating tablets
Betahistini dihydrochloridum

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

• Keep this package leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. See section 4.

Table of Contents of the Package 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 pack 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 does Betaserc ODT work

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

Warnings and precautions

Before taking Betaserc ODT, 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 unsure), 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 give Betaserc ODT to children and adolescents under 18 years of age.

Betaserc ODT and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
In particular, tell 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 applies to you (or if you are unsure), 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 are planning to have a baby, ask your doctor for advice before taking this medicine.
It is not known whether Betaserc ODT affects the fetus:

• Stop taking Betaserc ODT and tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant.
• Do not take Betaserc ODT if you are pregnant, 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 tells you to.

Driving and using machines

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

What Betaserc ODT contains

• This medicine contains 3.4 mg of aspartame in each tablet. Aspartame (E951) 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 been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

• Sucrose.

3. How to take Betaserc ODT

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.

• Your doctor will adjust the dose according to your condition.
• Continue to take 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 (according to 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 spaced 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 ODT than you should

If you take more Betaserc ODT than you should, you may experience nausea (vomiting), drowsiness, or stomach pain. If you are unsure, contact your doctor.

If you forget to take 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 a 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 questions on the use of this product, ask 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 during treatment with this medicine:

Allergic reactions

If you experience an allergic reaction, stop taking Betaserc ODT and consult your doctor or go to the nearest hospital immediately. Symptoms may include:

• 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
• headache

Other side effects that have been reported during treatment with 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 not listed in this leaflet, tell 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
Jerozolimskie Avenue 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 ODT

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP and on the blister after EXP. The expiry date refers to the last day of that month.
• There are no special storage instructions for this medicine.
• 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 ODT contains

• The active substance is betahistine dihydrochloride. Each tablet contains 24 mg of betahistine dihydrochloride.
• The other ingredients are: microcrystalline cellulose, crospovidone (type A), anhydrous citric acid, colloidal anhydrous silica, talc, aspartame (E951), acesulfame potassium (E950), peppermint flavor, flavor corrective (sucrose, aspartame (E951), acesulfame potassium (E950)).

What Betaserc ODT looks like and contents of the pack

• 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 packs of 20, 30, 50, 60, or 100 tablets, packaged in soft blisters of PA/Aluminum/PVC/Aluminum in a cardboard box.
• Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Ireland

Manufacturer

Delpharm l'Aigle
Zone Industrielle No 1
Route de Crulai
61300 L'Aigle
France
To obtain more detailed information, contact your local representative of the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00

Date of last revision of the package leaflet: