Lavistina

Package leaflet: Information for the patient

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• 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 the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Lavistina is and what it is 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 Lavistina is and what it is used for

Lavistina is a medicine used to treat symptoms of Ménière's disease, such as vertigo,
tinnitus, hearing loss, nausea, and for symptomatic treatment of vestibular-origin dizziness.

2. Important information before using Lavistina

When not to use 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 chromaffin tumour of the adrenal gland (a rare tumour 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, discuss this with your 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 any of the above conditions apply, the patient should consult a doctor before using 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription.
Inform your doctor if the patient is taking:

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

No other interactions of betahistine with other medicines have been observed so far.
The term "interaction" means that different medicines or substances, when taken simultaneously, may affect each other's actions or adverse effects.
Lavistina with food and drink
The tablet should preferably be taken with food.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
There are insufficient data on the safety of betahistine use during pregnancy.
Therefore, Lavistina should not be used during pregnancy unless absolutely necessary.
It is not known whether betahistine passes into breast milk. The decision on breastfeeding and treatment with betahistine should be made after considering the benefits of breastfeeding and the potential risk to the infant.
Driving and operating machinery
Lavistina is indicated for the treatment of Ménière's disease, which is characterised by symptoms such as vertigo, tinnitus, hearing loss, and nausea. All these symptoms may negatively affect the ability to drive or operate machinery.
If drowsiness occurs, the patient should not drive, operate machinery, or perform any other tasks requiring concentration.
If the patient is unsure whether betahistine affects his ability to drive, he should consult a doctor.
Lavistina contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Lavistina

This medicine should always be taken as directed by a physician. If you have any doubts,
consult your doctor or pharmacist.
Method of administration
Oral use medicine.
Recommended dose:
Adults (including elderly patients)
The usual initial dose is half to one tablet twice daily.
It may take several weeks before improvement is observed.
Use in children and adolescents
Do not use in children under 18 years of age.
Administration of Lavistina
The tablet is best taken with food.
Taking more Lavistina than recommended
If you take more than the recommended dose, contact your doctor immediately. Symptoms of overdose may include: nausea, vomiting, digestive disturbances, coordination disorders,

• and 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 a missed tablet.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicinal products, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur:
Common (occur in 1 to 10 people out of 100):

• headache,
• nausea and dyspepsia.

Frequency not known (frequency of these reactions cannot be estimated from the available data):

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Lavistina

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Lot: Batch number.
EXP: Expiry date.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use. 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 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.
Tablets are packed in blisters, 20, 30, 40, 50, 60 or 100 tablets per cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation 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