Apobetina

Leaflet included in the packaging: patient information

ApoBetina, 8 mg, tablets

ApoBetina, 16 mg, tablets

Betahistini dihydrochloridum
You should carefully read the contents of the leaflet before using 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.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific condition. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is ApoBetina and what is it used for

What is ApoBetina

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

What is ApoBetina used for

ApoBetina is used to treat Meniere's disease, which is characterized by the following symptoms:

• -vertigo of labyrinthine origin (with nausea and/or vomiting)
• -progressive hearing loss
• -tinnitus.

In the symptomatic treatment of vertigo of vestibular origin.

How ApoBetina works

ApoBetina works by improving blood flow in the inner ear. This leads to a reduction in increased pressure.

2. Important information before taking ApoBetina

When not to take ApoBetina

• if the patient is allergic (hypersensitive) to betahistine or any of the other ingredients of the medicine (listed in section 6),
• if the doctor has diagnosed the patient with a pheochromocytoma (a tumor of the adrenal gland). The patient should not take ApoBetina if they have any of the above conditions. In case of doubts, the patient should consult their doctor or pharmacist before taking ApoBetina.

Warnings and precautions

Before starting to take ApoBetina, the patient should discuss it with their doctor or pharmacist:

• if the patient currently has or has had a stomach ulcer (peptic ulcer),
• if the patient has asthma,
• if the patient has hives, skin rash, or allergic rhinitis, as these conditions may worsen,
• if the patient has low blood pressure.

If the patient has any of the above conditions, they should ask their doctor if they can take betahistine. These patient groups should be under medical supervision during treatment.

Children and adolescents

ApoBetina is not recommended for use in patients under 18 years of age.

ApoBetina and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. An interaction means that different medicines or substances taken at the same time may affect each other's action or undesirable effects. In particular, the patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• antihistamines - they may theoretically affect the action of ApoBetina. ApoBetina may also reduce the action of antihistamines.
• monoamine oxidase inhibitors (MAOIs) - used to treat depression or Parkinson's disease. They may enhance the action of ApoBetina. If the patient has any of the above conditions (or if doubts arise), they should consult their doctor or pharmacist before taking ApoBetina.

ApoBetina with food and drink

ApoBetina can be taken with or without food. However, ApoBetina may cause mild gastrointestinal disorders (listed in section 4). Taking ApoBetina with food may help reduce gastrointestinal disorders.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. It is not known whether ApoBetina affects the fetus:

• The patient should stop taking ApoBetina and inform their doctor if they are pregnant or suspect they are pregnant.
• ApoBetina should not be taken during pregnancy, unless the doctor decides it is necessary.

It is not known whether ApoBetina passes into breast milk:

• The patient should not breastfeed while taking ApoBetina, unless the doctor allows it.

Driving and using machines

Betahistine has no or negligible influence on the ability to drive and use machines. However, the patient should remember that the diseases being treated with betahistine (Meniere's disease and vertigo) may cause dizziness and nausea and may affect the ability to drive and use machines.

ApoBetina contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take ApoBetina

ApoBetina should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.

• The doctor will adjust the dose according to the patient's condition.
• The patient should continue taking the medicine. It may take some time for the medicine to start working.

How to take the medicine

• Swallow the tablet and drink water.
• The tablet can be taken with or without food. However, ApoBetina may cause mild gastrointestinal disorders (listed in section 4). Taking ApoBetina with food may help reduce gastrointestinal disorders.

How much medicine to take

Betaserc is available in three strengths: 8 mg, 16 mg, and 24 mg. The recommended dose is:

• ApoBetina, 8 mg - one or two tablets three times a day.
• ApoBetina, 16 mg - half a tablet or one tablet three times a day.

If the patient is taking more than one tablet a day, they should spread the doses evenly throughout the day, e.g., take one tablet in the morning and one in the evening. The patient should try to take the tablets at the same time every day. This will ensure a constant amount of medicine in the body. Taking the medicine at the same time will also help the patient remember to take it.

Taking more ApoBetina than recommended

If the patient takes more ApoBetina than recommended, they may experience nausea, drowsiness, or stomach pain. In case of doubts, the patient should consult their doctor.

Missing a dose of ApoBetina

• If the patient misses a dose of ApoBetina, they should take the next dose at the scheduled time.
• The patient should not take a double dose to make up for the missed tablet.

Stopping ApoBetina treatment

The patient should not stop taking ApoBetina without consulting their doctor, even if their symptoms improve. If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, ApoBetina can cause undesirable effects, although not everybody gets them.

Allergic reactions

If an allergic reaction occurs, the patient should stop taking ApoBetina and consult their 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.

The patient should stop taking ApoBetina and consult their doctor or go to the hospital immediately if they experience any of the above symptoms.

Other undesirable effects:

Common(occurring in less than 1 in 10 people):

• nausea
• digestive disorders
• headache.

Other undesirable effects reported during ApoBetina treatment

• Mild gastrointestinal disorders such as vomiting, stomach pain, and bloating. Taking ApoBetina with food may help reduce gastrointestinal disorders.

Reporting undesirable effects

If the patient experiences any undesirable effects, including any undesirable effects not mentioned in the leaflet, they should inform their doctor or pharmacist. Undesirable effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting undesirable effects, more information can be collected on the safety of the medicine.

5. How to store ApoBetina

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after "Expiry date" or "EXP". The expiry date refers to the last day of the given month. The medicine should be stored at a temperature below 25°C, in the original packaging. Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What ApoBetina contains

The active substance of the medicine is betahistine dihydrochloride. ApoBetina, 8 mg: each tablet contains 8 mg of betahistine dihydrochloride. ApoBetina, 16 mg: each tablet contains 16 mg of betahistine dihydrochloride. The other ingredients are: povidone K90, microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crospovidone (type A), and stearic acid.

What ApoBetina looks like and contents of the packaging

ApoBetina, 8 mg: round, white tablet with "B8" embossed on one side. Tablets are available in blisters of 30, 50, 100, and 120 tablets in a cardboard box. ApoBetina, 16 mg: round, white tablet with "B16" embossed on one side and a score line on the other side. The tablet can be divided into two halves. Tablets are available in blisters of 20, 30, 42, 50, 60, and 84 tablets in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok. 27
01-909 Warsaw
Poland

Manufacturer:

Catalent Germany Schorndorf GmbH
Steinbeisstrasse 2
D-73614 Schorndorf
Germany

Date of last revision of the leaflet: