Lavistina

Package Leaflet: Information for the Patient

Lavistina, 8 mg, tablets

Lavistina, 16 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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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. Contents of the pack and other information

1. What is Lavistina and what is it used for

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

2. Important information before taking Lavistina

When not to take Lavistina:

• if you are allergic to betahistine or any of the other ingredients of this medicine (listed in section 6);
• if you have 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 taking Lavistina, discuss it with your doctor or pharmacist. The medicine should be used with caution:

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

If you have any of the above conditions, you should ask your doctor if you 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

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, including those obtained without a prescription. This also applies to medicines that you plan to take.

• 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, may inhibit betahistine metabolism.

No other interactions between betahistine and other medicines have been observed so far. 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There are no adequate data on the safety of betahistine use during pregnancy. Therefore, do not take Lavistina 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 baby.

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 disease symptoms may negatively affect the ability to drive and operate machines. If drowsiness occurs, do not drive, operate machines, or perform other activities that require concentration. If you are unsure whether Lavistina affects your ability to drive, consult your doctor.

Lavistina contains lactose

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Lavistina

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Method of administration: The medicine is for oral use. Recommended dose: Adults (including the elderly): The usual initial dose is 1 to 2 tablets of 8 mg or half to 1 tablet of 16 mg, 3 times a day. The maintenance dose is usually 24 mg to 48 mg per 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, contact your doctor. Overdose symptoms may occur: nausea, vomiting, digestive disorders, coordination disorders

• in case of large doses - seizures.

Missed dose of Lavistina

Wait until it is time for the next dose. Do not take a double dose to make up for the missed tablet. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects may occur:

Frequent (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 you experience any side effects, including those not listed in this leaflet, please inform your 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, you can help provide more information on the safety of this medicine.

5. How to store Lavistina

Keep the medicine out of the 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. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lavistina contains

• The active substance is betahistine dihydrochloride in a dose of 8 mg or 16 mg.
• The other ingredients are: povidone K90, microcrystalline cellulose, lactose monohydrate, colloidal silica anhydrous, crospovidone (type A), stearic acid.

What Lavistina looks like and contents of the pack

Lavistina 8 mg tablets: round, white tablet with "B8" embossed on one side, approximately 7 mm in diameter. The tablets are packaged in blisters, 30, 50, or 100 tablets in a cardboard box. Lavistina 16 mg tablets: round, white tablet with "B16" embossed on one side and a dividing line on the other side, approximately 9 mm in diameter. The tablet can be divided into equal doses. The tablets are packaged in blisters, 30, 60, and 100 tablets in a cardboard box. 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