Vestibo

Package Leaflet: Information for the Patient

Vestibo, 8 mg, tablets

Vestibo, 16 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. 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.

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 (dizziness of vestibular origin).
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, tell 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 itching, as these symptoms may worsen
• 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 you are taking Vestibo.
Children and adolescents
Vestibo should not be used in 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. Betahistine may also 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 advises you to do so.

Driving and using machines

Studies have shown that betahistine does not affect driving or using machines.
However, remember that the diseases for which you are taking this medicine (Meniere's disease or dizziness) may cause dizziness or nausea and affect your ability to drive or use machines.

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 or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
8 mg tablets:
The recommended initial dose is 1 to 2 tablets of 8 mg three times a day. The maintenance dose is usually 24 mg to 48 mg per day.
16 mg tablets:
The recommended initial dose is 0.5 to 1 tablet of 16 mg three times a day. The maintenance dose is usually 24 mg to 48 mg per 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 meals.

Take more Vestibo than prescribed

If you have taken more than the prescribed dose, contact your doctor.
Symptoms of betahistine overdose are nausea, fatigue, stomach pain, vomiting, indigestion, and after taking large doses, seizures and respiratory or cardiac disorders.

Forget to take Vestibo

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

Stop taking 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 or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe side effectsmay occur:
Allergic reactions(frequency not known) such as:

• swelling of the face, lips, tongue or throat.
• This may cause difficulty breathing.
• red 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 meals or reducing the dose.
• drowsiness

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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
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 or blister after EXP.
The expiry date refers to the last day of that month.
Store in a temperature below 25°C, store in the original package.
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 8 mg of betahistine dihydrochloride.
One tablet contains 16 mg of betahistine dihydrochloride.
The other ingredients are: povidone K90, microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crospovidone, stearic acid.

What Vestibo looks like and contents of the pack

8 mg tablets:
White or almost white, round tablets, with the inscription B8 on one side.
PVDC/PVC/Aluminum blisters. Available packs: 30, 50, 100 or 120 tablets.
16 mg tablets:
White or almost white, round tablets, with the inscription B16 on one side and a score line on the other side. The tablet can be divided into equal doses.
PVDC/PVC/Aluminum blisters. Available packs: 20, 30, 42, 50, 60 or 84 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

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
Estonia
Betahistine Actavis
Lithuania
Betahistine Actavis 16 mg tablets
Latvia
Betahistin Actavis 16 mg tablets
Poland
Vestibo
Slovakia
Betahistin Actavis 8 mg
Betahistin Actavis 16 mg
Hungary
Elven 16 mg tablet
To obtain more detailed information on this medicine, contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw,
phone (22) 345 93 00.
Date of last revision of the leaflet:June 2024