Vertisan 24

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Vertisan 24, tablets, 24 mg
betahistine dihydrochloride
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Leaflet contents:

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

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

Betahistine, the active substance in Vertisan 24, is similar to histamine – a substance naturally present in the human body.
Vertisan 24 is indicated for the treatment of Ménière's disease, characterized by the following symptoms: vertigo (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 to any of the other ingredients of this medicine (listed in section 6),
• if the patient has an adrenal gland tumour (pheochromocytoma).

Warnings and precautions
Before starting treatment with Vertisan 24, consult your doctor, pharmacist,
or nurse if:

• the patient has a stomach or intestinal ulcer,
• the patient has chronic respiratory disease (bronchial asthma),
• the patient suffers from hives, skin rash or allergic rhinitis,
  • symptoms may worsen during treatment with Vertisan 24,
• the patient has very low blood pressure,
• the patient is concurrently taking other medicines used to treat allergies or colds,
  • so-called antihistamines (see also section "Vertisan 24 and other medicines").

Limited data are available in patients with hepatic impairment, renal impairment, and in elderly patients. Therefore, betahistine should be used with caution in these patient groups.

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

Vertisan 24 and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
If Vertisan 24 is taken concomitantly with certain medicines used to treat 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 treatment with Vertisan 24.
Medicines used to treat depression or Parkinson’s disease (e.g. monoamine oxidase inhibitors, MAOIs) may enhance the effect of Vertisan 24.

Pregnancy, breastfeeding and fertility
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.
Vertisan 24 should not be taken during pregnancy unless clearly necessary and advised by a doctor.
It is not known whether Vertisan 24 passes into breast milk. Therefore, this medicine should not be used during breastfeeding unless discussed with a doctor.

Driving and operating machinery
Symptoms of Ménière’s disease may negatively affect the ability to drive or operate machinery. In clinical studies assessing the effect on the ability to drive and operate machinery, betahistine had no effect or only a negligible effect.

Vertisan 24 contains lactose
This medicine contains lactose. If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Vertisan 24

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
Unless otherwise advised by your doctor, the usual recommended dose is:
1/2–1 tablet of Vertisan 24 mg twice daily (corresponding to 24–48 mg of betahistine dihydrochloride). The tablet may be divided into equal doses.
Swallow the tablet whole without chewing, with water during or after a meal.
Your doctor will inform you how long to take Vertisan 24. This medicine is usually taken long-term, and treatment typically lasts several months.
Taking more than the recommended dose of Vertisan 24
If more than the recommended dose of Vertisan 24 is taken, the following symptoms associated with overdose may occur:
Headache, facial flushing, decreased blood pressure, rapid heartbeat, breathing difficulties due to bronchiolar constriction (bronchial asthma), and swelling of the mucous membranes of the upper respiratory tract due to fluid retention (Quincke’s edema).
If any of the above symptoms occur, contact your doctor immediately. The doctor will advise appropriate management.
Missed dose of Vertisan 24
If a patient forgets to take a dose of Vertisan 24 tablet, take the next tablet at the usual scheduled time. Do not take a double dose to make up for the missed tablet.
Stopping treatment with Vertisan 24
Do not stop taking Vertisan 24 without consulting your doctor.
If you have any further questions regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, Vertisan 24 may cause adverse reactions, although not everyone experiences them.

You should stop taking Vertisan 24 and immediately consult a doctor if any of the following symptoms occur:

• swelling of the face, tongue or throat
• difficulty swallowing
• urticaria and breathing difficulties

Adverse reactions are listed below according to frequency.
Common (occurring in less than 1 in 10 people)

• headache
• nausea
• gastrointestinal disturbances

Rare adverse reactions (may affect up to 1 in 1,000 people)

• sensation of heartbeat, feeling of pressure in the chest
• possible worsening of pre-existing bronchial asthma
• vomiting reflex, heartburn, stomach pain and discomfort, bloating
• feeling of warmth

Frequency not known (cannot be estimated from available data)

• drowsiness
• vomiting
• allergic reactions
• skin and subcutaneous hypersensitivity reactions, particularly urticaria, rash and itching

Special note:
Please consult your doctor about using appropriate treatment if any of the above symptoms occur.
Gastrointestinal disturbances may be avoided by taking Vertisan 24 with food or after a meal, or by reducing the dose of the medicine.
Reporting adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-02-222 Warsaw, Tel.: +48 22 4921 301, Fax: +48 22 4921 309, e-mail: [email protected].
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Vertisan 24

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister
after: “Expiry date” or “EXP”. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. Such action helps protect the environment.

6. Contents of the package and other information

What Vertisan 24 contains
The active substance is betahistine dihydrochloride.
Each tablet contains 24 mg of betahistine dihydrochloride.
Other ingredients are monohydrate lactose, 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 pack
White to cream-coloured, flat, round tablets with bevelled edges, marked with outer notches and a division line on both sides.
The tablet can be divided into equal doses.
Vertisan 24 is packed in blisters containing 20, 24, 30, 48, 50, 60, 96 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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: [email protected]

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