Vertisan 24

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Vertisan 24, tablets, 24 mg

betahistine dihydrochloride

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Vertisan 24 and what is it used for
• 2. Important information before taking Vertisan 24
• 3. How to take Vertisan 24
• 4. Possible undesirable effects
• 5. How to store Vertisan 24
• 6. Contents of the packaging and other information

1. What is Vertisan 24 and what is it used for

Betahistine, the active substance of Vertisan 24, is similar to histamine - a substance naturally occurring in the human body.
Vertisan 24 is indicated for the treatment of Meniere's disease, characterized by the following symptoms: dizziness (often associated with nausea and/or vomiting), tinnitus, and hearing loss.

2. Important information before taking Vertisan 24

When not to take Vertisan 24

• if the patient is allergic to betahistine dihydrochloride or any of the other ingredients of this medicine (listed in section 6),
• if the patient has a pheochromocytoma (a tumor of the adrenal gland).

Warnings and precautions

Before starting to take Vertisan 24, the patient should discuss it with their doctor, pharmacist, or nurse,

• if the patient has a stomach or intestinal ulcer,
• if the patient has a chronic respiratory disease (asthma),
• if the patient has hives, skin rash, or nasal congestion due to an allergic reaction
• symptoms may worsen while taking Vertisan 24,
• if the patient has very low blood pressure,
• if the patient is taking other medicines for allergies or colds
• so-called antihistamines (see also section "Vertisan 24 and other medicines").

There is limited data on patients with liver or kidney function disorders, as well as in elderly patients. Therefore, betahistine should be used with caution in this group of patients.

Children and adolescents

Vertisan 24 should not be used in children and adolescents under 18 years of age due to insufficient information on safety and efficacy.

Vertisan 24 and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
If Vertisan 24 is taken at the same time as certain medicines for allergies or colds (antihistamines), the effect of both medicines may be reduced. If the patient is currently taking an antihistamine, the dose should be gradually reduced over 6 days before starting to take Vertisan 24.
Medicines used to treat depression or Parkinson's disease (e.g., monoamine oxidase inhibitors, IMAO) may enhance the effect of Vertisan 24.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before taking this medicine.
Vertisan 24 should not be taken during pregnancy, unless the doctor decides it is necessary.
It is not known whether Vertisan 24 passes into breast milk. Therefore, this medicine should not be taken during breastfeeding, unless it has been discussed with the doctor.

Driving and using machines

Meniere's disease symptoms may negatively affect the ability to drive and operate machines. In clinical trials, betahistine did not affect this ability or had a negligible effect.

Vertisan 24 contains lactose

This medicine contains lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Vertisan 24

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the doctor or pharmacist should be consulted.

Recommended dose

Unless the doctor recommends otherwise, the usual dose is:
1/2-1 tablet of Vertisan 24 mg 2 times a day (corresponding to 24-48 mg of betahistine dihydrochloride). The tablet can be divided into equal doses.
The tablet should be swallowed without chewing, washed down with water during or after a meal.
The doctor will inform the patient about the duration of treatment with Vertisan 24. The medicine is usually taken for a long time, and treatment lasts several months.

Taking a higher dose of Vertisan 24 than recommended

In case of taking a higher dose of Vertisan 24 than recommended, the following overdose-related symptoms may occur:
headache, facial flushing, decreased blood pressure, rapid heartbeat, difficulty breathing due to bronchospasm (asthma) and edema of the mucous membranes of the upper respiratory tract due to water retention (Quincke's edema).
If any of the above symptoms occur, the patient should immediately consult their doctor. The doctor will prescribe the appropriate procedure.

Missing a dose of Vertisan 24

If the patient forgets to take a tablet of Vertisan 24, they should take the next tablet at the usual time. A double dose should not be taken to make up for the missed tablet.

Stopping treatment with Vertisan 24

Treatment with Vertisan 24 should not be stopped without the doctor's recommendation.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible undesirable effects

Like all medicines, Vertisan 24 can cause undesirable effects, although not everybody gets them.
The patient should stop taking Vertisan 24 and immediately consult their doctor if they experience any of the following symptoms:

• facial, tongue, or throat edema
• difficulty swallowing
• hives and difficulty breathing.

Undesirable effects are listed below by frequency of occurrence.
Common(occurring in less than 1 in 10 people)

• headache.
• nausea
• gastrointestinal disturbances

Rare(occurring in less than 1 in 1,000 people)

• palpitations, feeling of chest tightness
• possible worsening of existing asthma
• vomiting, heartburn, stomach pain and discomfort, bloating
• feeling of warmth

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

• drowsiness
• vomiting
• allergic reactions
• skin and subcutaneous tissue reactions, including hives, rash, and itching

Special attention:

The patient should ask their doctor to take appropriate measures if any of the above symptoms occur.
Gastrointestinal disturbances can be avoided by taking Vertisan 24 with a meal or after a meal, or by reducing the dose.

Reporting undesirable effects

If the patient experiences any undesirable effects, including any undesirable effects not mentioned in the leaflet, they should inform their doctor, pharmacist, or nurse.
Undesirable effects can be reported directly to the Department of Post-Marketing Surveillance, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.
Undesirable effects can also be reported to the marketing authorization holder.
Reporting undesirable effects helps to gather more information on the safety of the medicine.

5. How to store Vertisan 24

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging and blister after: "Expiry date" or "EXP". The expiry date refers to the last day of the given month.
The medicine should not be stored at a temperature above 25°C.
Medicines should not be disposed of via wastewater. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Vertisan 24 contains

The active substance of the medicine is betahistine dihydrochloride.
One tablet contains 24 mg of betahistine dihydrochloride.
Other ingredients of the medicine are lactose monohydrate, corn starch, microcrystalline cellulose (type 102), citric acid, povidone K 25, crospovidone (type A), hydrogenated vegetable oil.

What Vertisan 24 looks like and contents of the packaging

White to cream-colored, flat, round tablets with beveled edges and a dividing line on both sides.
The tablet can be divided into equal doses.
Vertisan 24 is packaged in blisters containing 20, 24, 30, 48, 50, 60, 96, or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

HENNIG ARZNEIMITTEL GmbH & Co. KG
Liebigstrasse 1 – 2
65439 Flörsheim am Main
Germany
Tel.: +49 61 45 - 508 0
Fax: +49 61 45 - 508 140
e-mail: info@hennig-am.de

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

Austria
Betahistin Hennig 24 mg Tabletten
Bulgaria
Вертизан N 24 mg таблетки
Germany
Betavert N 24 mg Tabletten
Hungary
Vertisan 24 mg tabletta
Italy
Betigo 24 mg compresse
Poland
Vertisan 24
Romania
Vertisan 24 mg comprimate

Date of the last revision of the leaflet: 07.06.2018