VESTIBO

Package leaflet: Information for the patient

Warning! Keep this 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 brand names for the same medicine.
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Vestibo is and what it is 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 Vestibo is and what it is used for

Vestibo is a medicine used in the treatment of symptoms of Ménière’s disease, such as vertigo,
tinnitus, hearing loss, nausea, and vestibular vertigo. Betahistine may also be used in the symptomatic
treatment of vertigo caused by impaired function of the inner ear responsible for balance (vestibular vertigo).

2. Information before using Vestibo

When not to use Vestibo

• 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 taking Vestibo, talk to your doctor, pharmacist or
nurse

• if the patient has or has previously had peptic ulcer disease (peptic ulcer)
• if the patient suffers from bronchial asthma
• if the patient has urticaria, rash or allergic rhinitis, as these symptoms may worsen
• if the patient has low blood pressure.

If the patient has any of the conditions listed above, they should consult a doctor before taking betahistine.
The doctor may wish to monitor the patient's condition more closely during treatment with Vestibo.
Children and adolescents
Due to insufficient data on safety and efficacy, Vestibo is not recommended for use in children and adolescents under 18 years of age.
Vestibo with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take.
In particular, inform your doctor or pharmacist if the patient is taking any of the
following medicines:

• antihistamines – these may (theoretically) reduce the effect of Vestibo. Vestibo may also reduce the effect of antihistamines.
• monoamine oxidase inhibitors (MAOIs) – used in the treatment of depression or Parkinson's disease. These may increase the concentration of Vestibo in the body.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Vestibo should not be used during pregnancy unless the doctor has decided it is absolutely necessary. It is not known whether betahistine is safe to use during pregnancy.
Breastfeeding should not be carried out during treatment with Vestibo unless authorized by a doctor. It is not known whether betahistine passes into breast milk.
Driving and operating machinery
It is unlikely that Vestibo affects the ability to drive or operate tools and machines.
However, it should be remembered that the conditions treated with betahistine (Meniere's disease and vertigo) may cause vestibular vertigo and nausea, and may thus affect the ability to drive and operate machinery.
Vestibo contains monohydrate lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Vestibo

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Recommended dose:
Adults
From half a tablet to one tablet twice daily.
It may take several weeks before the patient notices improvement.
How to take the medicine
Tablets should be swallowed whole, with sufficient liquid, during or after a meal.
Taking more Vestibo than recommended
If the patient has taken more than the recommended dose, they should contact their doctor.
Symptoms of betahistine overdose include nausea, fatigue, abdominal pain, vomiting,
dyspepsia, and, after ingestion of large doses, seizures and problems with the lungs or heart.
Missed dose of Vestibo
If a dose 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 treatment with Vestibo
Do not stop taking Vestibo without consulting your doctor, even if symptoms improve.
If you have any further questions about the use of this medicine, consult your doctor,
pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following serious adverse reactions may occur during treatment with Vestibo:
Allergic reactions such as:

• swelling of the face, lips, tongue or throat, which may cause difficulty in breathing
• red skin rash, skin inflammation with itching
• sudden drop in blood pressure
• loss of consciousness

If any of the above symptoms occur, stop taking Vestibo and contact a doctor immediately.

Other adverse reactions include:
Common adverse reactions (may affect less than 1 in 10 people):
Nausea, digestive disturbances, headache.
Uncommon adverse reactions (may affect less than 1 in 1,000 people):
Palpitations.
Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):
Drowsiness, itching, rash, urticaria, mild gastrointestinal disturbances such as vomiting, stomach pain and flatulence. Taking Vestibo with food may help reduce gastrointestinal discomfort.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vestibo

Keep this medicine out of 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 stated month.
Store below 25°C. Keep in the original packaging to protect from moisture.
Medicines must 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 packaging and other information

What Vestibo contains

• The active substance is betahistine dihydrochloride. Each tablet contains 24 mg of betahistine dihydrochloride.
• Other ingredients are: povidone K 90, microcrystalline cellulose, monohydrate lactose, 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.
Blister packs in a cardboard box containing: 20, 30, 50, 60 or 100 tablets.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation 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., Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation Number in the Czech Republic, the country of export: 83/348/08-C
Parallel Import Authorisation Number: 393/13
This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Member country Name of the medicinal product
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