Apobetina

Package Leaflet: Information for the Patient

ApoBetina, 24 mg, Tablets

Betahistini dihydrochloridum

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

• Keep this 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, please tell your 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 side effects
• 5. How to store ApoBetina
• 6. Contents of the pack 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 you are allergic (hypersensitive) to betahistine or any of the other ingredients of the medicine (listed in section 6),
• if your doctor has diagnosed you with a pheochromocytoma (a tumor of the adrenal gland). You should not take ApoBetina if any of the above applies to you. If you are in doubt, consult your doctor or pharmacist before taking ApoBetina.

Warnings and precautions

Before taking ApoBetina, discuss with your doctor or pharmacist:

• if you have currently or have had a stomach ulcer (peptic ulcer),
• if you have asthma,
• if you have urticaria, skin rash, allergic rhinitis, as these conditions may worsen,
• if you have low blood pressure.

If you have any of the above conditions, you should ask your doctor or pharmacist if you can take betahistine. These patient groups should be under medical supervision during treatment.

Children and adolescents

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

ApoBetina with other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take. Interaction means that different medicines or substances taken at the same time can affect each other's action or side effects. In particular, tell your doctor or pharmacist if you 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 any of the above applies to you (or if you are in doubt), consult your doctor or pharmacist before taking ApoBetina.

ApoBetina with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is not known whether ApoBetina affects the fetus:

• Stop taking ApoBetina and inform your doctor if you are pregnant or think you may be pregnant.
• Do not take ApoBetina during pregnancy, unless your doctor decides it is necessary.

It is not known whether ApoBetina passes into breast milk:

• Do not breastfeed while taking ApoBetina, unless your doctor allows it.

Driving and using machines

Betahistine has no or negligible influence on the ability to drive and use machines. However, 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 monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take ApoBetina

ApoBetina should always be taken exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

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

How to take the medicine

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

How much to take

The recommended dose is one tablet twice a day. If you are taking more than one tablet a day, spread the doses evenly 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 you remember to take them. Taking the tablets at the same time each day will also help keep a steady amount of medicine in your body.

If you take more ApoBetina than you should

If you take more ApoBetina than you should, you may experience nausea, drowsiness, or stomach pain. If you are unsure, consult your doctor.

If you forget to take ApoBetina

• If you miss a dose, take the next dose at the scheduled time.
• Do not take a double dose to make up for a forgotten tablet.

Stopping treatment with ApoBetina

Do not stop taking ApoBetina 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, ApoBetina can cause side effects, although not everybody gets them.

Allergic reactions

If you experience an allergic reaction, stop taking ApoBetina 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 ApoBetina 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
• digestive disorders
• headache.

Other side effects reported during treatment with ApoBetina

• Mild stomach upset such as vomiting, stomach and intestinal pain, bloating, and gas. Taking ApoBetina with food may help reduce stomach upset.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Pharmacovigilance, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. You can also report side effects 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 ApoBetina

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 packaging after "EXP". The expiry date refers to the last day of that month. Store in a temperature below 25°C, in the original packaging to protect from moisture. 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 ApoBetina contains

The active substance is betahistine dihydrochloride. Each tablet contains 24 mg of betahistine dihydrochloride. The other ingredients are: povidone, microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crospovidone (type A), stearic acid.

What ApoBetina looks like and contents of the pack

White or almost white, round, biconvex, scored tablets, approximately 11.3 mm in diameter, with a dividing line on one side. The tablet can be divided into equal doses. ApoBetina is available in packs of 20, 30, 40, 50, 60, or 100 tablets in blisters, in a cardboard box. Not all pack sizes may be marketed.

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 1-2
73614 Schorndorf
Germany

Date of last revision of the leaflet: 02/2024