Aurobetina

Package Leaflet: Information for the User

AuroBetina, 8 mg, tablets

AuroBetina, 16 mg, tablets

AuroBetina, 24 mg, tablets

Betahistini dihydrochloridum

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

• 1. What AuroBetina is and what it is used for
• 2. Before you take AuroBetina
• 3. How to take AuroBetina
• 4. Possible side effects
• 5. How to store AuroBetina
• 6. Contents of the pack and other information

1. What AuroBetina is and what it is used for

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

• vertigo (of vestibular origin)
• tinnitus (ringing in the ears)
• hearing loss or hearing problems
  Symptomatic treatment of vertigo of peripheral 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 leads to a reduction in
increased pressure.

2. Before you take AuroBetina

Do not take AuroBetina

• if you are allergic to betahistine or any of the other ingredients of this medicine (listed in section 6)
• if you have a pheochromocytoma, a rare tumour of the adrenal gland.

Warnings and precautions

Before taking AuroBetina, talk to your doctor or pharmacist:

• if you have a peptic ulcer (stomach ulcer)
• if you have bronchial asthma
• if you have urticaria, skin rash or allergic rhinitis, as these conditions may worsen
• if you have low blood pressure. If you have any of these conditions, you should consult your doctor to see if you can take AuroBetina tablets. These patient groups should be monitored by a doctor during treatment.

Children and adolescents

AuroBetina is not recommended for use in patients below 18 years of age.

AuroBetina with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about 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 action of antihistamines.
Monoamine oxidase inhibitors (MAOIs) - medicines used to treat depression or Parkinson's disease. They may increase the action of betahistine.
If any of the above applies to you (or if you are unsure), 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 problems (listed in section 4). Taking betahistine with food may help reduce stomach problems.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning 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 has decided that it is absolutely necessary. Ask your doctor. Do not breast-feed if you are taking AuroBetina tablets unless your doctor has told you that you can. It is not known whether betahistine passes into breast milk.

Driving and using machines

AuroBetina is unlikely to 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 peripheral vestibular origin) may cause vertigo 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, check with 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 problems (listed in section 4). Taking AuroBetina with food may help reduce stomach problems.

How much AuroBetina to take

Always follow your doctor's instructions, as they 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 are taking more than one tablet per day, take the tablets at evenly spaced intervals 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 help you remember to take the tablets. AuroBetina is not recommended for use in children.

If you take more AuroBetina than you should

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

If you forget to take AuroBetina

Wait and take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking 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 a while to make sure the medicine has worked completely.
If you have any further questions on the use of this product, 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 bloating, and gas.
Taking betahistine with food may help reduce stomach problems.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact details for the reporting of side effects" section below.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AuroBetina

Keep this 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 which is stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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 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 made of triple-layered PA/Aluminium/PVC/Aluminium foil, in a cardboard box.
Pack sizes:
Blisters: 20, 30, 50, 60, and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer

Marketing Authorisation Holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
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 medicinal product is authorised 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