Aurobetina

Package leaflet: Information for the user

AuroBetina, 8 mg, tablets
AuroBetina, 16 mg, tablets
AuroBetina, 24 mg, tablets
Betahistini dihydrochloridum
Please 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 personally. 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, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What AuroBetina is and what it is used for
2. What you need to know 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 known as a "histamine analogue".
AuroBetina is a medicine used to treat:
Ménière's disease – symptoms of this condition include:

• vertigo (of labyrinthine origin)
• ringing in the ears (tinnitus)
• hearing loss or hearing problems

Symptomatic treatment of vestibular vertigo (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 reduction in elevated pressure.

2. Important information before using AuroBetina

When not to take AuroBetina

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

Warnings and precautions
Before starting to take AuroBetina, discuss this with your doctor or pharmacist:

• if the patient has peptic ulcer disease (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 the patient has any of the above conditions, consult a doctor whether AuroBetina tablets can be taken. These patient groups should be monitored by a doctor during treatment.

Children and adolescents
AuroBetina is not recommended for use in patients under 18 years of age.
AuroBetina and other medicines
Inform your doctor or pharmacist about any medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
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 betahistine. Betahistine may also reduce the effect of antihistamines.
Monoamine oxidase inhibitors (MAOIs) – medicines used in the treatment of depression or Parkinson’s disease. These may enhance the effect of betahistine.
If any of the above situations apply to the patient (or if there are any doubts), talk to a 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 gastrointestinal discomfort (listed in section 4). Taking betahistine with food may help reduce gastrointestinal discomfort.
Pregnancy, breastfeeding and fertility
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 taking this medicine.
Do not take AuroBetina tablets if the patient is pregnant unless the doctor decides it is absolutely necessary. Consult your doctor. Do not breastfeed while taking AuroBetina tablets unless your doctor advises otherwise. It is not known whether betahistine passes into breast milk.
Driving and using machines
It is unlikely that AuroBetina affects the ability to drive or operate tools and machinery.
However, remember that the condition for which the patient is being treated with AuroBetina (Ménière’s disease and vestibular vertigo) may cause dizziness or nausea and may affect the ability to drive and operate machinery.

3. How to take AuroBetina
This medicine should always be used according to the instructions given by the doctor or pharmacist. If in doubt, consult the 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.
• Take the tablet with food or after a meal. AuroBetina may cause mild gastrointestinal discomfort (listed in section 4). Taking AuroBetina with food may help reduce gastrointestinal discomfort.

How much AuroBetina to take
Always follow the doctor’s instructions, as the doctor may adjust the dose.
Recommended dose:
Adults
The recommended dose is 24 mg to 48 mg per day.
8 mg tablets: one or two tablets, three times a day.
16 mg tablets: half or one tablet, three times a day.
If the patient is taking more than one tablet per day, the doses should be evenly spaced throughout the day. For example, one tablet in the morning, one at midday and one in the evening.
Try to take the tablet at the same time each day. This will ensure a constant level of medicine in the body. Taking the tablets at the same time each day will also help remember to take them. AuroBetina is not recommended for use in children.
If more AuroBetina has been taken than recommended
If the patient or someone else has taken too many AuroBetina tablets (overdose), symptoms such as nausea (feeling sick), drowsiness or abdominal pain may occur. Contact a doctor or go to hospital immediately. Take the AuroBetina packaging with you.
If a dose of AuroBetina is missed
Wait until it is time to take the next dose. Do not take a double dose to make up for a missed tablet.
Stopping AuroBetina
Continue taking the tablets until the doctor advises stopping treatment.
Even if the patient feels better, the doctor may recommend continuing to take the tablets for some time to ensure the medicine has fully taken effect.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Very few adverse reactions have been reported during treatment with betahistine.
The following serious adverse reactions may occur during treatment with betahistine:

Allergic reactions:

• red or lumpy skin rash or inflammatory skin condition with itching
• swelling of the face, lips, tongue, or throat
• low blood pressure
• loss of consciousness
• breathing difficulties

If any of these adverse reactions occur, treatment must be stopped immediately and medical advice sought.

Other adverse reactions include:
Common (may occur in up to 1 in 10 people):

• nausea
• indigestion
• headache

Other adverse reactions reported during betahistine use
Mild gastrointestinal problems such as: vomiting, stomach pain, stomach swelling, and bloating.
Taking betahistine with food may help reduce gastrointestinal problems.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. 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 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 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 AuroBetina

Keep this medicine out of sight and reach of children.
No special storage conditions apply for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack after: EXP.
The expiry date refers to the last day of the stated 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 an embossed mark "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 an embossed mark "X" and a division 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 an embossed mark "X" and a division 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-laminated foil PA/Aluminium/PVC/Aluminium, packed in cardboard boxes.

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.
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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: AuroBetina
Portugal: Beta-histina Labesfal