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.
• 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.

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

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

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

This medicine works by improving blood flow in the inner ear. This reduces increased pressure.

2. Important information before taking AuroBetina

When not to take AuroBetina

Warnings and precautions

Before taking AuroBetina, discuss with your doctor or pharmacist:

Children and adolescents

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

AuroBetina and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
Antihistamines - they may theoretically affect the action of betahistine. Also, betahistine may reduce the effect of antihistamines.
Monoamine oxidase inhibitors (MAOIs) - medicines used to treat depression or Parkinson's disease. They may enhance the effect of betahistine.
If any of the above situations apply to you (or you have any doubts), talk to your 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 betahistine with food may help reduce stomach upset.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take AuroBetina tablets if you are pregnant, unless your doctor decides it is absolutely necessary. Consult your doctor. Do not breastfeed while taking AuroBetina tablets, unless your doctor allows it. It is not known whether betahistine passes into breast milk.

Driving and using machines

It is unlikely that AuroBetina will affect your ability to drive or use machines.
However, remember that the disease for which you are being treated with AuroBetina (Ménière's disease and vertigo of vestibular origin) may cause dizziness or nausea and may affect your ability to drive or use machines.

3. How to take AuroBetina

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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

How to take AuroBetina

• Swallow the tablet with water.
• 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

Always follow your doctor's advice, as your doctor may adjust the dose.
The recommended dose is:
Adults
The recommended dose is 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 you take more than one tablet per day, take the tablets evenly spaced throughout the day. For example, you can take one tablet in the morning, one at noon, and one in the evening.
Try to take the tablet at the same time each day. This will ensure that a steady amount of medicine is in your body. Taking the tablets at the same time will also help you remember to take them. AuroBetina is not recommended for use in children.

Taking too much AuroBetina

If you or someone else has taken too many AuroBetina tablets (overdose), nausea (vomiting), drowsiness, or stomach pain may occur. Contact your doctor or go to the hospital immediately. Take the AuroBetina package with you.

Missing a dose of AuroBetina

Wait until it is time for your next dose. Do not take a double dose to make up for the missed tablet.

Stopping treatment with AuroBetina

Take the tablets for as long as your doctor recommends.
Even if you feel better, your doctor may recommend continuing to take the tablets for some time to make sure the medicine has worked completely.
If you have any further questions about taking this medicine, ask your 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 treatment with betahistine.
The following serious side effects may occur during treatment with betahistine:

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 you experience any of these side effects, stop treatment and consult your doctor immediately.

Other side effects include:

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

• nausea (vomiting)
• indigestion
• headache.

Other side effects that have been reported during treatment with betahistine

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, you can help provide more information on the safety of this medicine.

5. How to store AuroBetina

Keep the medicine out of the sight and reach of children.
There are no special storage instructions for this 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.
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. Package contents and other information

What AuroBetina contains

• The active substance is betahistine dihydrochloride (Betahistini dihydrochloridum). Each tablet contains 8 mg of betahistine dihydrochloride. Each tablet contains 16 mg of betahistine dihydrochloride. Each tablet contains 24 mg of betahistine 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 break 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 break 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.
Pack sizes:
Blisters: 20, 30, 50, 60, and 100 tablets.
Not all pack 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: [email protected]

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 leaflet: 05/2024