Vestibo

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Vestibo(Betahistin Actavis 24 mg)

24 mg, Tablets

Betahistini dihydrochloridum
Vestibo and Betahistin Actavis 24 mg are different trade names for the same medicine.

Read the Leaflet Carefully Before Taking the Medicine, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• 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 you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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 is a medicine used to treat symptoms of Meniere's disease, such as: dizziness,
tinnitus, hearing loss, nausea, and dizziness of vestibular origin. Betahistine may also be used to treat dizziness caused by improper functioning of the inner ear responsible for balance (dizziness of labyrinthine origin).

2. Important information before taking Vestibo

When not to take Vestibo

Warnings and precautions

Before taking Vestibo, discuss it with your doctor, pharmacist, or nurse

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

Due to the lack of sufficient data on safety and efficacy, it is not recommended to use Vestibo in children and adolescents under 18 years of age.

Vestibo and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• antihistamines - they may (theoretically) weaken the effect of Vestibo. Vestibo may also reduce the effect of antihistamines.
• monoamine oxidase inhibitors (MAOIs) - used to treat depression or Parkinson's disease. They may increase the concentration of Vestibo in the body.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Do not take Vestibo if you are pregnant, unless your doctor decides it is absolutely necessary. It is not known whether betahistine is safe during pregnancy.
Do not breastfeed while taking Vestibo, unless your doctor allows it. It is not known whether betahistine passes into breast milk.

Driving and using machines

It is unlikely that Vestibo will affect your ability to drive or use tools and machines.
However, keep in mind that the diseases treated with betahistine (Meniere's disease and dizziness) can cause dizziness of vestibular origin and nausea, and may affect your ability to drive or use machines.

Vestibo contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, consult 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:

Adults
From half a tablet to one tablet twice a day.
It may take several 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.

Overdose of Vestibo

If you have taken more than the recommended dose, consult your doctor.
Symptoms of betahistine overdose are nausea, fatigue, abdominal pain, vomiting, indigestion, and after taking large doses, seizures, and respiratory or cardiac problems.

Missed dose of Vestibo

Wait until the next dose is due before taking the missed dose. Do not take a double dose to make up for the missed tablet.

Stopping Vestibo treatment

Do not stop taking Vestibo without consulting your doctor, even if you feel better. If you have any further doubts about taking this medicine, consult 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 during treatment with Vestibo:
Allergic reactionssuch as:

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

Other side effects include:

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

Nausea, indigestion, headache.

Uncommon side effects (may affect up to 1 in 1,000 people):

Palpitations.

Side effects with unknown frequency (frequency cannot be estimated from available data):

Drowsiness, itching, rash, hives, mild stomach disorders such as vomiting, stomach pain, and gas. Taking Vestibo with food may help reduce stomach disorders.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Vestibo

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Store in a temperature below 25°C. Store in the original packaging 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 K 90, microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crospovidone, 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.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Actavis Group PTC ehf.
Reykjavikurvegur 76-78
220 Hafnarfjördur
Iceland

Manufacturer:

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

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:83/348/08-C
Parallel import authorization number:393/13

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

Member State Medicinal product name
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
Date of leaflet approval: 26.05.2023
[Information about the trademark]