Patient Information Leaflet

Vestibo, 24 mg, tablets
Betahistini dihydrochloridum
Please read the following leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents

What Vestibo is and what it is used for
Important information before taking Vestibo
How to take Vestibo
Possible side effects
How to store Vestibo
Contents of the pack and other information

1. What Vestibo is and what it is used for

Vestibo contains betahistine, a type of medicine known as a "histamine analogue".
Betahistine is used to treat symptoms of Ménière's disease such as dizziness, nausea or vomiting, tinnitus (ringing in the ears), and hearing loss or difficulty hearing.
Betahistine may also be used for symptomatic treatment of dizziness caused by improper functioning of the inner ear responsible for balance (vestibular-origin 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 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 phaeochromocytoma, a rare tumour of the adrenal gland.

Warnings and precautions
Before starting to use Vestibo, discuss this with a doctor or pharmacist

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

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

antihistamines (medicines used particularly in the treatment of allergies, such as hay fever and motion sickness). These may (theoretically) reduce the effect of betahistine. Also, betahistine may reduce the effect of antihistamines.
monoamine oxidase inhibitors (MAOIs) (medicines used in the treatment of depression or Parkinson's disease). These may increase the concentration of betahistine in the body.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
It is not known whether betahistine affects the unborn child. Vestibo should not be taken during pregnancy unless the doctor decides it is absolutely necessary.
It is not known whether betahistine passes into breast milk. Breastfeeding should not be undertaken during treatment with Vestibo unless approved by a doctor.
Driving and operating machinery
Studies have shown that betahistine has no effect on the ability to drive or operate machinery.
However, it should be remembered that the conditions for which the patient is taking this medicine (Menière's disease or vertigo) may cause sensations of spinning or nausea and may affect the ability to drive or operate machinery.
Vestibo contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Vestibo

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
Recommended dose:
From half a tablet to one tablet twice daily.
It may take several weeks before the patient notices improvement.
How to use the medicine
Tablets should be swallowed whole, with sufficient liquid, during or after a meal.
Use of a higher than recommended dose of Vestibo
If the patient has taken more than the recommended dose, they should contact a doctor.
Symptoms of betahistine overdose include nausea, feeling of fatigue, abdominal pain, vomiting, indigestion, and after ingestion of large doses, seizures and problems with lungs or heart.
Missed dose of Vestibo
If a dose is missed, wait until the next scheduled dose. Do not use a double dose to make up for the missed tablet.
Stopping treatment with Vestibo
Do not stop taking Vestibo without consulting a doctor, even if symptoms improve. If you have any further questions regarding 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 will experience them.
The following serious adverse reactions may occur:
Allergic reactions (frequency unknown), such as:

swelling of the face, lips, tongue, or throat.
This may cause difficulty in breathing.
red skin rash or inflammatory skin condition with itching
sudden drop in blood pressure
loss of consciousness. You must stop taking Vestibo immediately and contact your doctor without delay if any of the above symptoms occur.

Other adverse reactions include:
Common (may affect less than 1 in 10 people):

nausea
indigestion (digestive disturbances)
headache

Rare (may affect less than 1 in 1,000 people):

palpitations (awareness of heartbeat)

Frequency unknown (frequency cannot be estimated from available data):

mild gastrointestinal disturbances such as: vomiting, stomach pain, and flatulence. These adverse reactions may be reduced by taking the dose with food or by reducing the dose.
drowsiness

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. 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,
Tel.: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported directly to the Marketing Authorisation Holder.
Reporting adverse reactions helps 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 pack following EXP.
The expiry date refers to the last day of the stated month.
Store below 25°C 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Vestibo contains
The active substance is betahistine dihydrochloride.
Each tablet contains 24 mg of betahistine dihydrochloride.
The other ingredients are: povidone K90, microcrystalline cellulose, lactose monohydrate,
anhydrous colloidal silicon dioxide, 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.
Blister packs in a cardboard box containing: 20, 30, 50, 60 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the member countries of the European Economic Area 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 |

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw,
tel. (22) 345 93 00.