Apobetina

Package leaflet: Information for the patient

ApoBetina, 24 mg, tablets
Betahistini dihydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What ApoBetina is and what it is 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 ApoBetina is and what it is used for

What ApoBetina is
ApoBetina contains betahistine. ApoBetina is a type of medicine known as a "histamine analogue".
What ApoBetina is used for
ApoBetina is used in the treatment of Ménière's disease, which is characterized by the following
symptoms:

• Vestibular vertigo (with nausea and/or vomiting)
• Progressive hearing loss
• Tinnitus.

For symptomatic treatment of vestibular vertigo.
How ApoBetina works
ApoBetina works by improving blood flow in the inner ear. This leads to a reduction in elevated
pressure.

2. Important information before using ApoBetina

When not to use 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 tumour of the adrenal gland (pheochromocytoma). Do not take ApoBetina if any of the above apply to the patient. If in doubt, speak to a doctor or pharmacist before taking ApoBetina.

Warnings and precautions
Before starting to take ApoBetina, discuss with a doctor or pharmacist:

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

If any of the above conditions apply, the patient should ask a doctor or pharmacist whether betahistine can be taken.
These patient groups should be under medical supervision during treatment.

Children and adolescents
The use of ApoBetina is not recommended in individuals under 18 years of age.

ApoBetina with 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.
An interaction means that different medicines or substances, when taken together, may affect each other's action or side effects.
In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• antihistamines – these may (theoretically) affect the action of ApoBetina. ApoBetina may also reduce the effect of antihistamine medicines.
• monoamine oxidase inhibitors (MAOIs) – used in the treatment of depression or Parkinson’s disease. These may enhance the effect of ApoBetina. If any of the above apply (or if there is any uncertainty), speak to a doctor or pharmacist before using ApoBetina.

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
It is not known whether ApoBetina affects the unborn child:

• ApoBetina should be discontinued and the doctor informed if the patient is pregnant or suspects pregnancy.
• ApoBetina should not be taken during pregnancy unless the doctor decides it is necessary.

It is not known whether ApoBetina passes into breast milk:

• Breastfeeding should not be undertaken while taking ApoBetina unless approved by the doctor.

Driving and operating machinery
Betahistine has no effect or a negligible effect on the ability to drive and operate machinery. However, it should be noted that the diseases treated with betahistine (Meniere’s disease and vertigo) may cause sensations of spinning and nausea, and may affect the ability to drive and operate machinery.

ApoBetina contains lactose monohydrate
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 ApoBetina

ApoBetina should always be taken as directed by the physician. In case of doubt,
consult a doctor or pharmacist.

• The physician will adjust the dose according to the patient's condition.
• Continue taking the medicine. It may take some time for the medicine to take effect.

How to take the medicine

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

How much medicine to take
The recommended dose is one tablet twice daily.
If more than one tablet per day is prescribed, 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 ensures a constant level of the medicine in the body. Taking the medicine at the same times each day will also help you remember to take it.

Taking more ApoBetina than recommended
If you take more ApoBetina than recommended, symptoms such as nausea, drowsiness, or abdominal pain may occur. In case of doubt, contact your doctor.

Missing a dose of ApoBetina

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

Stopping ApoBetina treatment
Do not stop taking ApoBetina without consulting your doctor, even if you feel better.

If you have any further doubts concerning 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.
Allergic reactions
If an allergic reaction occurs, stop taking ApoBetina and consult a doctor immediately or go to the nearest hospital. Symptoms may include:

• red or lumpy skin rash or inflammatory skin condition with itching
• swelling of the face, lips, tongue or neck
• low blood pressure
• loss of consciousness
• difficulty breathing. If any of the above symptoms occur, stop taking ApoBetina immediately and contact a doctor or go to hospital.

Other adverse reactions:
Common (occurring in fewer than 1 in 10 people):

• nausea
• digestive disturbances
• headache.

Other adverse reactions reported during treatment with ApoBetina

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

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 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 ApoBetina

Keep this medicine 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 stated month.
Store below 25°C, in the original packaging, to protect from moisture.
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 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 tablets, approximately 11.3 mm in diameter, with a division line on one side.
The tablet can be divided into equal doses.
The medicine is available in packs of 20, 30, 40, 50, 60 or 100 tablets in blister packs, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok. 27
01-909 Warszawa
Poland

Manufacturer:
Catalent Germany Schorndorf GmbH
Steinbeisstrasse 1-2
73614 Schorndorf
Germany