Lavistina

Package Leaflet: Information for the Patient

Lavistina, 24 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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Lavistina and what is it used for
• 2. Important information before taking Lavistina
• 3. How to take Lavistina
• 4. Possible side effects
• 5. How to store Lavistina
• 6. Package contents and other information

1. What is Lavistina and what is it used for

Lavistina is a medicine used to treat symptoms of Meniere's disease, such as dizziness, ringing in the ears, hearing loss, nausea, and symptomatic treatment of dizziness of vestibular origin.

2. Important information before taking Lavistina

When not to take Lavistina:

• 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 pheochromocytoma (a rare tumor of the adrenal gland);
• in patients under 18 years of age;
• in breastfeeding women (see section: Pregnancy, breastfeeding, and fertility).

Warnings and precautions

Before starting treatment with Lavistina, the patient should discuss it with their doctor or pharmacist. The medicine should be used with caution:

• if the patient has active peptic ulcer disease or a history of peptic ulcer disease;
• if the patient has bronchial asthma;
• if the patient has urticaria, skin rash, allergic rhinitis, as these conditions may worsen;
• if the patient has low blood pressure.

If the patient has any of the above conditions, they should ask their doctor if they can take Lavistina. These patient groups should be under medical supervision during treatment.

Children and adolescents

Do not use in children under 18 years of age.

Lavistina and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those obtained without a prescription. This includes:

• antihistamines (medicines used to treat allergic diseases, e.g., hay fever, and motion sickness),
• monoamine oxidase inhibitors (MAOIs), including MAO-B subtype (e.g., selegiline) - medicines used to treat depression, which may inhibit the metabolism of betahistine.

No other interactions between betahistine and other medicines have been observed. The term "interaction" means that different medicines or substances taken at the same time may affect each other's action or side effects.

Lavistina with food and drink

The tablet is best taken during a meal.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. There are no adequate data on the safety of betahistine in pregnancy. Therefore, Lavistina should not be used during pregnancy unless absolutely necessary. It is not known whether betahistine passes into breast milk. The decision to breastfeed and take betahistine should be made after considering the benefits of breastfeeding and the potential risk to the child.

Driving and using machines

Lavistina is indicated for the treatment of Meniere's disease, characterized by the following symptoms: dizziness, ringing in the ears, hearing loss, and nausea. All these symptoms can negatively affect the ability to drive and operate machinery. If drowsiness occurs, the patient should not drive, operate machinery, or perform other activities that require concentration. If the patient is unsure whether betahistine affects their ability to drive, they should consult their doctor.

Lavistina 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 Lavistina

This medicine should always be taken exactly as directed by the doctor. In case of any doubts, the patient should consult their doctor or pharmacist. Method of administration: The medicine is for oral use. Recommended dose: Adults (including elderly patients): The usual initial dose is half to one tablet, twice a day. It may take several weeks before an improvement is observed.

Use in children and adolescents

Do not use in children under 18 years of age.

Use of Lavistina

The tablet is best taken during a meal.

Overdose of Lavistina

In case of overdose, the patient should contact their doctor. Symptoms of overdose may include: nausea, vomiting, digestive disorders, coordination disorders

• in case of large doses - seizures.

Missed dose of Lavistina

The patient should wait until it is time for the next dose. They should not take a double dose to make up for the missed tablet. In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Lavistina can cause side effects, although not everybody gets them.

The following side effects may occur:

Common (occurring in 1 to 10 people in 100):

• headache,
• nausea and indigestion.

Frequency not known (the frequency of these effects cannot be determined from the available data):

• hypersensitivity reactions, e.g., anaphylaxis,
• headaches, occasionally drowsiness,
• mild gastrointestinal disorders (e.g., vomiting, stomach and intestinal pain, bloating, and gas),
• skin and subcutaneous hypersensitivity reactions, especially angioedema, urticaria, rash, and itching.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, e-mail: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Lavistina

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C, in the original packaging. Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month. Batch: Batch number. EXP: Expiry date. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Lavistina contains

• The active substance is betahistine dihydrochloride in a dose of 24 mg.
• The other ingredients are: povidone K90, microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crospovidone (type A), stearic acid.

What Lavistina looks like and contents of the pack

White to off-white, round, biconvex tablet with a score line on one side, approximately 11.3 mm in diameter. The tablet can be divided into equal doses. The tablets are packaged in blisters, 20, 30, 40, 50, 60, or 100 tablets in a carton. Not all pack sizes may be marketed.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o., ul. Partyzancka 133/151, 95-200 Pabianice, Poland. Manufacturer: Catalent Germany Schorndorf GmbH, Steinbeisstrasse 2, D-73614 Schorndorf, Germany. Aflofarm Farmacja Polska Sp. z o.o., ul. Szkolna 31, 95-054 Ksawerów, Poland. Date of last revision of the leaflet:22.06.2020