Betaserc odt

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Betaserc ODT (Betaserc Odis)
24 mg, orodispersible tablets
Betahistini dihydrochloridum
Betaserc ODT and Betaserc Odis are different brand names of the same medicine.
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary. If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

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
  • tinnitus (ringing in the ears)
  • hearing loss or difficulty hearing
• in vertigo caused by dysfunction of the inner ear component responsible for 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 (‘chromaffin tumour of the adrenal gland’)

Do not take this medicine if any of the above apply to the patient. In case of
doubt, speak to a doctor or pharmacist before taking Betaserc ODT.
Warnings and precautions
Before starting to take Betaserc ODT, consult a doctor or
pharmacist if:

• the patient has ever had stomach ulcers
• the patient has 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 antihistamines.
• monoamine oxidase inhibitors (MAOIs) – used in the treatment of 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, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to become pregnant, she should consult a doctor before taking 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 breastfeed while taking Betaserc ODT unless the doctor advises otherwise.

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 dizziness and nausea, which may affect the ability to drive and operate machinery.
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 characterised by 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 directed by the physician. In case of doubts, consult
your doctor or pharmacist.

• The doctor will adjust the dose according to the patient's 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 (listed in section 4). Taking Betaserc ODT with food may help reduce gastrointestinal discomfort.

How much 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 will ensure 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.
If you take more Betaserc ODT than recommended
If you take more Betaserc ODT than prescribed, you may experience nausea, drowsiness, or abdominal pain. In case of doubt, contact your doctor.
If you miss 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 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 doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects 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 Discontinue taking Betaserc ODT immediately and contact a doctor or go to the hospital if any of the above symptoms occur. Other adverse effects: Common (occurring in less than 1 in 10 people):
• nausea
• digestive disturbances
• headaches

Other adverse effects reported during treatment with Betaserc ODT

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to: Department for Monitoring Adverse Effects of 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
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Betaserc ODT

• Keep this medicine out of 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 stated month.
• No special storage conditions are required for this medicinal product.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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.
• Other ingredients: microcrystalline cellulose, crospovidone (type A), citric acid, colloidal anhydrous silica, talc, aspartame (E 951), potassium acesulfame (E 950), peppermint flavour, taste-masking flavour (sucrose, aspartame (E 951), potassium acesulfame (E 950)).

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 and no embossing, which disintegrates rapidly in the oral cavity. Tablet diameter: approximately 9 mm.
• Betaserc ODT is available in packs of 60 tablets, packed in soft blisters made of PA/Aluminium/PVC/Aluminium, contained in a cardboard box.

For more detailed information, please contact the responsible entity or parallel importer.
Marketing Authorisation Holder in Portugal, country of export:
Viatris Healthcare, Lda.
Av. D. João II, Edifício Atlantis, N.º 44C - 7.3 and 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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in Portugal, country of export:
Parallel import authorisation number: 145/20