Betaserc odt

Package leaflet: Information for the user

Betaserc ODT
24 mg, orodispersible tablets
Betahistini dihydrochloridum
Read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for possible future reference. If in doubt, consult a doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

What Betaserc ODT is
Betaserc ODT contains betahistine. Betaserc ODT is a type of medicine known as a "histamine analogue".
What Betaserc ODT is used for
Betaserc ODT is used:

• in Ménière's disease – symptoms of this condition include:
  • vertigo and nausea or vomiting
  • ringing in the ears (tinnitus)
  • hearing loss or difficulty hearing
• in vertigo caused by dysfunction of the part of the inner ear that controls balance (so-called "vestibular vertigo")

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 patient has been diagnosed with a tumour of the adrenal gland (‘phaeochromocytoma’)

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

Warnings and precautions
Before taking Betaserc ODT, consult a doctor or pharmacist if:

• the patient has ever had stomach ulcers
• the patient suffers from bronchial asthma

If any of the above apply to the patient (or if there is any uncertainty), speak to a doctor or pharmacist before taking Betaserc ODT. The doctor may wish to monitor the patient particularly closely during treatment with Betaserc ODT.

Children and adolescents
Betaserc ODT must not be used in children and adolescents under 18 years of age.

Betaserc ODT and other medicines
Tell the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.

In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• antihistamines – these may (theoretically) reduce the effect of Betaserc ODT. Betaserc ODT may also reduce the effect of antihistamine medicines.
• monoamine oxidase inhibitors (MAOIs) – used to treat depression or Parkinson’s disease. These may increase exposure to Betaserc ODT.

If any of the above apply to the patient (or if there is any uncertainty), speak to a doctor or pharmacist before taking Betaserc ODT.

Betaserc ODT with food and drink
Betaserc ODT may be taken with or without food. However, Betaserc ODT may cause mild gastrointestinal discomfort (listed in section 4). Taking Betaserc ODT with food may help reduce gastrointestinal discomfort.

Pregnancy, breast-feeding and fertility
If the patient is pregnant or breast-feeding, suspects she may be pregnant or is planning to become pregnant, she should consult her doctor before using this medicine.

It is not known whether Betaserc ODT affects the unborn child:

• Discontinue taking Betaserc ODT and inform the doctor if the patient is pregnant, suspects she may be pregnant, or is planning a pregnancy.
• Do not take Betaserc ODT during pregnancy unless the doctor decides it is necessary.

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

• Do not breast-feed while taking Betaserc ODT unless instructed to do so by the doctor.

Driving and using machines
It is unlikely that Betaserc ODT will affect the ability to drive or operate tools and machines.
However, bear in mind that the conditions treated with this medicine may cause sensations of vertigo and nausea, which may affect the ability to drive and operate machinery.

Betaserc ODT contains

• This medicine contains 3.4 mg of aspartame per tablet. Aspartame (E951) is a source of phenylalanine. It may be harmful for patients with phenylketonuria (a rare genetic disorder characterised by the accumulation of phenylalanine in the body, which cannot be properly eliminated).

• Sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Betaserc ODT

This medicine should always be taken as prescribed by your doctor. If you have any doubts,
you should consult your doctor or pharmacist.

• Your doctor will adjust the dose according to your condition.
• You should continue taking the medicine. It may take some time for the medicine to start working.

How to take

• Place the tablet on the tongue and allow it to disintegrate before swallowing, with or without water (depending on patient preference).
• The tablet may be taken with or without food. However, Betaserc ODT may cause mild gastrointestinal discomfort (mentioned in section 4). Taking Betaserc ODT with food may help reduce gastrointestinal discomfort.

How much medicine to take
The recommended dose is one tablet twice daily.
The doses should be evenly spaced throughout the day; for example, take one tablet in the morning and one in the evening.
Try to take the tablets at the same times each day. This ensures a constant level of medicine in the 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 prescribed, you may experience nausea, drowsiness, or abdominal pain. If you are in any 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 treatment
Do not stop taking Betaserc ODT without consulting your doctor, even if you feel better.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur during treatment with this medicine:

Allergic reactions
If an allergic reaction occurs, stop taking Betaserc ODT and consult a doctor immediately or go to the nearest hospital. Symptoms may include:

• red or bumpy skin rash or inflamed skin with itching
• swelling of the face, lips, tongue, or neck
• low blood pressure
• loss of consciousness
• breathing difficulties
  Stop taking Betaserc ODT immediately and contact your doctor or go to hospital if any of the above symptoms occur.

Other adverse reactions:

Common (affects less than 1 in 10 people):

• nausea
• digestive disturbances
• headaches

Other adverse reactions reported during treatment with Betaserc ODT:

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department for Monitoring 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 4921301; Fax: +48 22 4921309; website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 carton after: Expiry date (EXP) and on the blister after: EXP. The expiry date refers to the last day of the specified month.
• No special storage instructions apply.
• 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 packaging and other information

What Betaserc ODT contains

• The active substance is betahistine dihydrochloride. Each tablet contains 24 mg of betahistine dihydrochloride.
• Other ingredients: microcrystalline cellulose, crospovidone (type A), anhydrous citric acid, anhydrous colloidal silicon dioxide, talc, aspartame (E951), acesulfame potassium (E950), peppermint flavour, taste-masking flavour (sucrose, aspartame (E951), acesulfame potassium (E950)).

What Betaserc ODT looks like and contents of the pack

• Betaserc ODT is a round, flat, white to slightly yellowish, uncoated tablet with bevelled edges, which disintegrates rapidly in the oral cavity. Tablet diameter: approximately 9 mm.
• Betaserc ODT is available in packs of 20, 30, 50, 60 or 100 tablets, packed in soft blisters made of PA/Aluminum/PVC/Aluminum foil, contained in a cardboard box.
• Not all pack sizes may be marketed.

Marketing Authorisation 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
For further information, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00