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 trade names for the same medicinal product.
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Betaserc ODT is and what it is used for
2. What you need to know 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, which 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 doctor has diagnosed the patient with a tumour of the adrenal gland (‘chromaffin tumour’).

This medicine should not be taken if any of the above apply. In case of
doubt, talk 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 (or if there is any doubt), talk to a doctor or pharmacist before using 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 the patient is currently taking or has 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 in the treatment of depression or Parkinson’s disease. These may increase exposure to Betaserc ODT. If any of the above apply (or if there is any doubt), talk to a doctor or pharmacist before using 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 have a child, she should consult a doctor before using this medicine.
It is not known whether Betaserc ODT affects the unborn child:

• Betaserc ODT should be discontinued and the doctor informed if the patient is pregnant, suspects she may be pregnant, or is planning a pregnancy.
• Betaserc ODT should not be taken during pregnancy unless the doctor decides it is necessary.

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

• Breastfeeding should not be undertaken while taking Betaserc ODT unless advised by a doctor.

Driving and operating machinery
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 and may affect the ability to drive and operate machinery.
Betaserc ODT contains

• This medicine contains 3.4 mg of aspartame (E 951) in each tablet. Aspartame (E 951) is a source of phenylalanine. It may be harmful for patients with phenylketonuria (a rare genetic disorder involving 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 contact the doctor before taking this medicine.

3. How to take Betaserc ODT

This medicine should always be taken as directed by the doctor. If in doubt, consult the
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 medicine to take
The recommended dose is one tablet twice daily.
The doses should be evenly spaced throughout the day, e.g. 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 you should
If you take more Betaserc ODT than prescribed, you may experience nausea, drowsiness or abdominal pain. If in doubt, contact your doctor.
If you forget to take Betaserc ODT

• 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 ODT
Do not stop taking Betaserc ODT without consulting your doctor, even if you feel better.
If you have any further doubts about the use of 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 lumpy skin rash or inflamed skin with itching
• swelling of the face, lips, tongue, or throat
• low blood pressure
• loss of consciousness
• breathing difficulties. If any of the above symptoms occur, stop taking Betaserc ODT immediately and contact a doctor or go to a hospital.

Other adverse reactions:
Common (affects less than 1 in 10 people):

• nausea
• digestive disorders
• headache

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 not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps 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 mentioned month.
• No special storage instructions apply.
• Medicines must 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 are: 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 available as round, flat, white to yellowish, uncoated tablets with bevelled edges and no embossing, which disintegrate 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 blisters made of polyamide/Aluminium/PVC/Aluminium, contained in a cardboard box.

For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Portugal, country of export:
BGP Products, Unipessoal Lda.
Av. D. João II, Edifício Atlantis, N.° 44C – 7.3 and 7.4
1990-095 Lisbon
Portugal
Manufacturer:
Delpharm l’Aigle
Zone Industrielle n.°1 Route de Crulai, 61300 L’Aigle
France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Marketing Authorisation number in Portugal, country of export: 5644752
Parallel import authorisation number: 119/19