Vestibo

Package Leaflet: Information for the Patient

Vestibo, 24 mg, Tablets

Betahistini Dihydrochloridum

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

• 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 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.

Table of Contents of the Leaflet

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

1. What is Vestibo and what is it used for

Vestibo contains betahistine, a type of medicine called a "histamine analogue".
Betahistine is used to treat symptoms of Meniere's disease, such as: dizziness and
nausea or vomiting, ringing in the ears (tinnitus) and hearing loss or difficulty hearing.
Betahistine can also be used to treat dizziness that occurs when the inner part of the ear that controls balance does not work properly (vestibular dizziness).
Betahistine works by improving blood flow in the inner ear. The inner ear is one of the organs responsible for the sense of balance.

2. Important information before taking Vestibo

When not to take Vestibo

• 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 tumor of the adrenal gland.

Warnings and precautions

Before taking Vestibo, discuss it with your doctor or pharmacist

• if you have or have had a stomach ulcer (peptic ulcer)
• if you have asthma
• if you have hives, rash or hay fever, as there is a possibility of worsening these symptoms
• if you have low blood pressure.

If you have any of the above conditions, you should consult your doctor before taking betahistine.
Your doctor may want to monitor your condition more closely while taking Vestibo.

Children and adolescents

Vestibo is not recommended for children and adolescents under 18 years of age due to lack of information on safety and efficacy in these age groups.

Vestibo and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, 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 (medicines used to treat allergies, such as hay fever and motion sickness). They may (theoretically) reduce the effect 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 increase the levels of betahistine in the body.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether betahistine affects the unborn child. Do not take Vestibo if you are pregnant, unless your doctor has decided that it is absolutely necessary.
It is not known whether betahistine passes into breast milk. Do not breastfeed while taking Vestibo, unless your doctor allows it.

Driving and using machines

Studies have shown that betahistine does not affect driving or operating machinery.
However, keep in mind that the diseases for which you are taking this medicine (Meniere's disease or dizziness) can cause dizziness or nausea and affect your ability to drive or operate machinery.

Vestibo contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Vestibo

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

Recommended dose:

From half a tablet to one tablet twice a day.
It may take a few weeks before you notice an improvement.

How to take the medicine

Swallow the tablets whole, with a sufficient amount of liquid, during or after a meal.

Taking a higher dose of Vestibo than recommended

If you have taken a higher dose than recommended, contact your doctor.
Symptoms of betahistine overdose are nausea, feeling tired, stomach pain, vomiting, indigestion, and after taking large doses, seizures and problems with lungs or heart.

Missing a dose of Vestibo

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

Stopping treatment with Vestibo

Do not stop taking Vestibo without consulting your doctor, even if you feel better. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, Vestibo can cause side effects, although not everybody gets them.
The following serious side effectsmay occur:
Allergic reactions(frequency not known) such as:

• swelling of the face, lips, tongue or throat.
• This may cause difficulty breathing.
• red skin rash or skin inflammation with itching
• sudden drop in blood pressure
• loss of consciousness. Stop taking Vestibo and immediatelycontact your doctor if you experience any of the above symptoms.

Other side effects include:

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

• nausea
• indigestion (digestive disorders)
• headache

Rare (may affect up to 1 in 1,000 people):

• palpitations (heart palpitations)

Frequency not known (frequency cannot be estimated from the available data):

• mild stomach disorders such as: vomiting, stomach pain and gas. These side effects can be alleviated by taking the dose during a meal or reducing the dose.
• drowsiness

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 Vestibo

Keep out of the sight and reach of children.
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.
Store in a temperature below 25°C in the original package, to protect from moisture.
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. Contents of the pack and other information

What Vestibo contains

The active substance is betahistine dihydrochloride.
One tablet contains 24 mg of betahistine dihydrochloride.
The other ingredients are: povidone K90, microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crospovidone and stearic acid.

What Vestibo looks like and contents of the pack

White or almost white, round, biconvex tablets, with a score line on one side.
The tablet can be divided into equal doses.
Blisters in a cardboard box containing: 20, 30, 50, 60 or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer:

Catalent Germany Schorndorf GmbH
Steinbeisstrasse 1- 2
D-73614 Schorndorf
Germany
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

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

Member State
Marketing authorization holder
Czech Republic:
Betahistin Actavis 24 mg
Estonia:
Betahistine Actavis
Netherlands
Betahistine diHCL Actavis 24 mg, tabletten
Latvia:
Betahistine Actavis 24 mg tabletes
Lithuania:
Betahistine Actavis 24 mg tabletės
Malta
Betahistin Actavis
Poland
Vestibo
Romania
Vestibo comprimate 24 mg
Slovakia:
Betahistin Actavis 24 mg
Hungary
Betahistin Actavis 24 mg tabletta
Italy
Betahistina Actavis PTC 24 mg compresse
To obtain more detailed information on this medicine, please contact the marketing authorization holder's representative:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.
Date of last revision of the leaflet: June 2024