Apobetina

Package leaflet: Information for the patient

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person. 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 adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

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 package 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 Meniere's disease, which is characterized by the following symptoms:

• Vertigo of vestibular origin (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. Information before using ApoBetina

When not to use ApoBetina

• if the patient is allergic (hypersensitive) to betahistine or to 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 (‘chromaffin tumour’).
  Do not take ApoBetina if any of the above apply. If in doubt, talk to your doctor or pharmacist before taking ApoBetina.

Warnings and precautions
Before starting treatment with ApoBetina, discuss with your doctor or pharmacist:

• if the patient currently has or has had a stomach ulcer (peptic ulcer) in the past,
• 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 their doctor or pharmacist whether they can take betahistine.
These patient groups should be under medical supervision during treatment.

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

ApoBetina with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
An interaction means that different medicines or substances taken simultaneously may affect each other’s action or side effects.
In particular, inform your 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), talk to your 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 her doctor or pharmacist before using this medicine.
It is not known whether ApoBetina affects the unborn child:

• Discontinue taking ApoBetina and inform your doctor if the patient is pregnant or suspects pregnancy.
• 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 advises otherwise.

Driving and operating machinery
Betahistine has no effect or has a negligible effect on the ability to drive and operate machinery. However, remember 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 been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to take ApoBetina

ApoBetina should always be taken exactly as directed by your doctor. If you are unsure,
you should contact your doctor or pharmacist.

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

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 stomach discomfort.

How much medicine to take
The recommended dose is one tablet twice daily.
If more than one tablet per day is prescribed, 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
your body. Taking the medicine at the same time each day will also help you remember to take it.

Taking more ApoBetina than prescribed
If you take more ApoBetina than recommended, symptoms such as nausea,
drowsiness or abdominal pain may occur. If you are unsure, contact your doctor.

If you miss a dose of ApoBetina

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

Stopping ApoBetina
Do not stop taking ApoBetina without consulting your doctor, even if you feel better.
If you have any further doubts regarding 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 blotchy skin rash or inflamed skin with itching
• swelling of the face, lips, tongue or throat
• low blood pressure
• loss of consciousness
• difficulty breathing. You must stop taking ApoBetina and immediately contact a doctor or go to hospital if any of the above symptoms occur.

Other adverse reactions:
Common (occurring in less 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 symptoms.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 authorisation holder.
Reporting of adverse reactions allows further collection of information on the safety of the 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 stated on the packaging after "Expiry date" or "EXP". The expiry date refers to the last day of the stated month.
This medicine should be stored 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 you no longer use. 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, monohydrate lactose, anhydrous colloidal silicon dioxide, 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 blister packs containing 20, 30, 40, 50, 60 or 100 tablets, packed in a cardboard box.
Not all pack sizes may be marketed.

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

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