Aurobetina

Package Leaflet: Information for the User

AuroBetina, 8 mg, tablets

AuroBetina, 16 mg, tablets

AuroBetina, 24 mg, tablets

Betahistini dihydrochloridum

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

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects, including any side effects not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What is AuroBetina and what is it used for
• 2. Important information before taking AuroBetina
• 3. How to take AuroBetina
• 4. Possible side effects
• 5. How to store AuroBetina
• 6. Package contents and other information

1. What is AuroBetina and what is it used for

Betahistamine is a type of medicine called a "histamine analogue".
AuroBetina is a medicine used to treat:
Ménière's disease - the symptoms of this disease include:

• dizziness (of vestibular origin)
• ringing in the ears (tinnitus)
• hearing loss or hearing problems
  Symptomatic treatment of dizziness of labyrinthine origin (occurring when the part of the inner ear controlling balance does not function properly).

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

2. Important information before taking AuroBetina

When not to take AuroBetina

• if the patient is allergic to betahistamine or any of the other ingredients of this medicine (listed in section 6)
• if the patient has a pheochromocytoma, a rare tumor of the adrenal gland.

Warnings and precautions

Before taking AuroBetina, the patient should discuss it with their doctor or pharmacist:

• if the patient has a stomach ulcer (peptic ulcer)
• if the patient has asthma
• if the patient has hives, skin rash, or hay fever, as these conditions may worsen
• if the patient has low blood pressure. If the patient has any of the above conditions, they should consult their doctor to see if they can take AuroBetina tablets. These patient groups should be monitored by a doctor during treatment.

Children and adolescents

AuroBetina is not recommended for patients under 18 years of age.

AuroBetina and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
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 betahistamine. Betahistamine may also reduce the effect of antihistamines.
Monoamine oxidase inhibitors (MAOIs) - medicines used to treat depression or Parkinson's disease. They may enhance the effect of betahistamine.
If any of the above situations apply to the patient (or if they have any doubts), they should talk to their doctor or pharmacist before taking AuroBetina.

Taking AuroBetina with food and drink

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

Pregnancy, breastfeeding, and fertility

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.
AuroBetina tablets should not be taken during pregnancy, unless the doctor decides it is absolutely necessary. The patient should consult their doctor. AuroBetina tablets should not be taken during breastfeeding, unless the doctor allows it. It is not known whether betahistamine passes into breast milk.

Driving and using machines

It is unlikely that AuroBetina will affect the patient's ability to drive or use machines.
However, the patient should remember that the disease being treated with AuroBetina (Ménière's disease and dizziness of labyrinthine origin) may cause dizziness or nausea and may affect the ability to drive or use machines.

3. How to take AuroBetina

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. 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 AuroBetina

• Swallow the tablet with water.
• The patient should take the tablet with food or after food. AuroBetina may cause mild stomach upset (listed in section 4). Taking AuroBetina with food may help reduce stomach upset.

How much AuroBetina to take

The patient should always follow their doctor's advice, as the doctor may adjust the dose.
The recommended dose is:
Adults
24 mg to 48 mg per day. Tablets, 8 mg: one or two tablets, three times a day.
Tablets, 16 mg: half or one tablet, three times a day.
If the patient takes more than one tablet per day, they should spread the tablets evenly throughout the day. For example, they can take one tablet in the morning, one at noon, and one in the evening.
The patient should try to take the tablet at the same time every day. This will ensure that a steady amount of medicine is in the body. Taking the tablets at the same time will also help the patient remember to take them. AuroBetina is not recommended for children.

Taking more AuroBetina than prescribed

If the patient or someone else has taken too many AuroBetina tablets (overdose), they may experience nausea (vomiting), drowsiness, or stomach pain. The patient should contact their doctor or go to the hospital immediately. They should take the AuroBetina package with them.

Missing a dose of AuroBetina

The patient should wait until it is time for the next dose. They should not take a double dose to make up for the missed tablet.

Stopping AuroBetina treatment

The patient should keep taking the tablets until their doctor tells them to stop.
Even if the patient feels better, their doctor may recommend continuing to take the tablets for a while to make sure the medicine has worked completely.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, AuroBetina can cause side effects, although not everybody gets them.
Very few side effects have been reported during betahistamine treatment.
The following serious side effects may occur during betahistamine treatment:

Allergic reactions:

• 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
  If any of these side effects occur, the patient should stop treatment and consult their doctor immediately.

Other side effects include:

Frequent (may occur in up to 1 in 10 people):

• nausea (vomiting)
• indigestion
• headache.

Other side effects that have been reported during betahistamine treatment

Mild stomach problems, such as vomiting, stomach pain, stomach bloating, and gas.
Taking betahistamine with food may help reduce stomach problems.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store AuroBetina

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What AuroBetina contains

• The active substance is betahistamine dihydrochloride (Betahistini dihydrochloridum). Each tablet contains 8 mg of betahistamine dihydrochloride. Each tablet contains 16 mg of betahistamine dihydrochloride. Each tablet contains 24 mg of betahistamine dihydrochloride.

The other ingredients are: microcrystalline cellulose, mannitol, povidone (K-90), crospovidone (type B), citric acid, colloidal anhydrous silica, talc, and stearic acid.

What AuroBetina looks like and contents of the pack

Tablet.
AuroBetina, 8 mg, tablets
White or almost white, round, flat, uncoated tablets (approximately 7.0 mm in size) with the inscription "X" on one side and "87" on the other side.
AuroBetina, 16 mg, tablets
White or almost white, round, uncoated tablets (approximately 8.5 mm in size) with the inscription "X" and a dividing line on one side and "88" on the other side. The tablet can be divided into equal doses.
AuroBetina, 24 mg, tablets
White or almost white, round, uncoated tablets (approximately 10.0 mm in size) with the inscription "X" and a dividing line on one side and "89" on the other side. The tablet can be divided into equal doses.
AuroBetina tablets are available in cold-formed blisters of triple-layered PA/Aluminum/PVC/Aluminum foil, in a cardboard box.
Package sizes:
Blisters: 20, 30, 50, 60, and 100 tablets.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland:
AuroBetina
Portugal:
Beta-histina Labesfal

Date of last revision of the package leaflet: 05/2024