Lerivon

Package Leaflet: Information for the User

Lerivon, 10 mg, coated tablets

Lerivon, 30 mg, coated tablets

Lerivon, 60 mg, coated tablets

Mianserin hydrochloride

Read the 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 specifically for you. 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 tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Lerivon and what is it used for

Lerivon is an antidepressant that contains mianserin hydrochloride as the active substance.
Lerivon is an antidepressant that provides relief in the treatment of depressive moods,
which are the most common symptom of depression. Depression is a mental illness. During
depression, changes occur in the brain. Brain nerve cells communicate with each other
through chemical substances. In depression, the amount of these substances decreases. Antidepressants
increase the amount of these substances and restore normal brain function.
Improvement usually occurs after 2 to 4 weeks of treatment.

2. Important information before taking Lerivon

When not to take Lerivon

If the patient has:

• hypersensitivity to mianserin or any of the other ingredients of this medicine (listed in section 6);
• mania (a state of excitement and excessive activity);
• severe liver failure;
• if the patient is taking or has recently taken (within the last two weeks) monoamine oxidase inhibitors (MAOIs).

Taking Lerivon in children and adolescents under 18 years of age
Normally, Lerivon should not be used in children and adolescents under 18 years of age.
It should also be emphasized that in the case of taking medicines of this class, patients under 18 years of age are at increased risk of adverse reactions such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). Nevertheless, the doctor may prescribe Lerivon to patients under 18 years of age if they consider it necessary. If the doctor has prescribed Lerivon to a patient under 18 years of age, and you have any doubts, please consult the doctor. In the event of the development or intensification of the above-mentioned symptoms in patients under 18 years of age taking Lerivon, you should inform your doctor. Additionally, as of now, there is a lack of data on the long-term safety of using Lerivon in this age group regarding growth, maturation, and cognitive and behavioral development.

Suicidal thoughts and depression worsening

Patients with depression and/or anxiety disorders may sometimes have thoughts of self-harm or
suicidal thoughts. In patients with depression, there is an increased risk of self-harm or suicide,
especially at the beginning of treatment, before the medicine starts to work, which usually takes about two
weeks or sometimes longer.
This may occur:

• if the patient has previously had suicidal thoughts or self-harm.
• if the patient is a young adult. Information from clinical trials shows an increased risk of suicidal behavior in patients with mental disorders under 25 years of age taking antidepressants.

You should contact your doctor or go to the hospital immediately if you experience suicidal thoughts or thoughts of self-harm.
It may be helpful if you tell someone in your family or a close personthat you have depression or
anxiety disorders and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Special precautions when taking Lerivon

You should be particularly careful when taking Lerivon if you have or have had:

• epilepsy (seizures),
• diabetes,
• liver diseases, such as jaundice,
• kidney diseases,
• urination problems due to prostate enlargement,
• heart diseases, including rhythm disorders, recent myocardial infarction, heart failure, or if you are taking medicines that affect heart rhythm,
• high blood pressure,
• glaucoma (increased eye pressure),
• mental illnesses, such as: the occurrence of hypomania in patients with bipolar affective disorder (alternating elevated mood/depressed mood),
• decreased white blood cell count or their absence (see section 4 "Possible side effects").

You should consult your doctor if you experience any of the above situations.

Warnings and precautions

Before starting to take Lerivon, you should discuss it with your doctor or pharmacist.

Lerivon and other medicines

You should tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those that are available without a prescription.
Other medicines may affect the action of Lerivon, and Lerivon may affect other medicines.
Do not take Lerivonin combination with:

• monoamine oxidase inhibitors (MAOIs), or before two weeks have passed since their administration. If you stop taking Lerivon, you should not take MAOIs for two weeks. MAOIs include: moclobemide, tranylcypromine (antidepressants), selegiline (used in the treatment of Parkinson's disease), and linezolid (an antibiotic).

Be carefulwhen taking Lerivon in combination with:

• antiepileptic drugssuch as carbamazepine and phenytoin.
• anticoagulant drugssuch as warfarin. Lerivon may enhance the effect of warfarin. You should inform your doctor about taking these medicines. In the case of combined treatment with Lerivon, it is recommended to monitor blood tests.
• medicines that may affect heart rhythm, such as certain antibiotics and antipsychotic drugs.

Lerivon with food and drink

Do not drink alcohol while taking Lerivon, as it increases the effect of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Animal studies and limited human data indicate that mianserin does not have a harmful effect on the fetus or newborn. Mianserin passes into breast milk in very small amounts. The benefits of mianserin for the mother during pregnancy and breastfeeding should be weighed against the potential risk to the fetus or newborn.

Driving and using machines

Lerivon may cause drowsiness.
Do not drive vehicles, as Lerivon reduces psychomotor abilities.
Do not operate any machines or use tools.

3. How to take Lerivon

This medicine should always be taken according to the doctor's recommendations. In case of doubts, consult a doctor or pharmacist.
Recommended dose
Usually, treatment should be started with a lower dose (30 mg per day), and then the dose can be increased to achieve the desired patient response.
The dosage is from 60 to 90 mg, depending on the severity of depression. To ensure the effectiveness of treatment, the medicine should be taken every day. You should strictly follow the recommended doses and instructions for taking the medicine. Tablets should be taken every day at the same time, preferably in a single dose before bedtime.
If the doctor recommends, Lerivon can also be taken in divided doses (one in the morning and one in the evening before bedtime).
Tablets should be swallowed without chewing, washed down with a small amount of water or other fluids.
Do not stop treatment immediately after improvement. Too early or sudden discontinuation of the medicine may lead to worsening of the condition.
Consult your doctor, who will decide how to reduce the dosage and when treatment should be stopped.

Patients of advanced age:

The dosage should be adjusted individually for each patient. Initially, the dose should be 30 mg per day. The dose can be increased every few days.
Usually, a dose lower than for adults is sufficient to achieve a satisfactory clinical response.

Use in children and adolescents:

Lerivon should not be used to treat children and adolescents under 18 years of age.

Taking a higher dose of Lerivon than recommended

In case of taking a higher dose of Lerivon than recommended, consult a doctor or pharmacist immediately.
You should induce vomiting as soon as possible. Symptoms of Lerivon overdose include prolonged drowsiness or sleepiness. Overdose symptoms may include changes in heart rhythm (accelerated, irregular heartbeat) and/or fainting. These may be symptoms of life-threatening ventricular arrhythmias known as "torsade de pointes".

Missing a dose of Lerivon

Do not take a double dose to make up for a missed dose.
In case of missing a dose, if the medicine is taken once a daybefore bedtime, do not take the missed dose in the morning, as it may cause drowsiness and sleepiness during the day. Continue treatment, taking the medicine in the evening according to the previously established schedule.
In case of missing one or both doses, if the medicine is taken twice a day(one dose in the morning after breakfast and one before bedtime) you should:

• in case of missing the morning dose, take it together with the evening dose;
• in case of missing the evening dose, do not take it with the morning dose, but continue treatment, taking the medicine the next day according to the previously established schedule;
• in case of missing both doses, do not try to make them up; the next day, continue treatment, taking the usual doses: morning and evening.

Stopping Lerivon treatment

Although Lerivon is not addictive, sudden discontinuation of the medicine after long-term use may cause dizziness, agitation, anxiety, headache, and nausea. Therefore, the dose of the medicine should be gradually reduced.
In case of any further doubts related to the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following may occur temporarily:

• drowsiness or sleepiness,
• weight gain,
• thoughts of self-harm or suicidal thoughts.

You should contact your doctor or go to the hospital immediately.

In rare cases, Lerivon may cause a decrease in white blood cell count, which reduces the body's resistance to infections. If you experience fever, sore throat, mouth ulcers, or other signs of infection, you should consult your doctor immediately and have a blood test. These symptoms usually occur after 4-6 weeks of treatment

and disappear after discontinuation of the medicine.
Other side effects include:

• low blood pressure, manifested by dizziness, fainting, or fainting when changing body position;
• seizures;
• hypomania;
• increased liver enzyme levels;
• swelling of the ankles or feet due to fluid accumulation;
• yellowing of the eyes or skin, which may indicate liver function disorders;
• hepatitis;
• slow heart rate after initial administration;
• malignant neuroleptic syndrome (the most important symptoms are stiffness of the whole body, involuntary movements, increased body temperature);
• joint pain;
• restless legs syndrome (a feeling of burning, tingling in the legs, causing insomnia);
• rash;
• changes in heart rhythm (accelerated, irregular heartbeat) and/or fainting. These may be symptoms of life-threatening ventricular arrhythmias known as "torsade de pointes".

Suicidal thoughts, depression worsening, or anxiety disorders

Patients with depression or anxiety disorders may sometimes have thoughts of self-harm or
suicidal thoughts. Such thoughts may worsen at the beginning of therapy with antidepressants,
as these medicines usually start to work after 2 weeks, sometimes later.
The occurrence of suicidal thoughts, thoughts of self-harm, or suicidal attempts is more likely if:

• the patient has previously had suicidal thoughts or self-harm;
• the patient is a young adult; data from clinical trials indicate an increased risk of suicidal behavior in patients under 25 years of age with mental disorders who have been treated with antidepressants. If you experience suicidal thoughts or thoughts of self-harm, you should contact your doctor or go to the hospital immediately.

It may be helpful to inform your relatives or friends about your depression or anxiety disorders and ask them to read this leaflet. You can ask them to help you and tell you if they think your depression or anxiety has worsened or if they notice any worrying changes in your behavior.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Lerivon

The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
Store in a temperature below 30°C, protected from light and moisture.
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. Package contents and other information

What Lerivon contains

• The active substance of the medicine is mianserin hydrochloride. One tablet contains 10 mg or 30 mg or 60 mg of mianserin hydrochloride.
• The other ingredients are: potato starch, colloidal anhydrous silica, magnesium stearate, methylcellulose, calcium hydrogen phosphate dihydrate. Coating: Opadry OY-S-28914 White: hypromellose, macrogol 8000, titanium dioxide (E 171).

What Lerivon looks like and what the package contains

The coated tablets are round, convex (10 mg) or oval, divisible, and convex (30 and 60 mg).
All tablets are marked with the inscription "Organon" on one side and a code on the other side.
Packaging with 10 mg coated tablets (code CT/4):
Aluminum/PCW film blisters in a cardboard box – 30 pieces (1 blister of 30 pieces).
Packaging with 30 mg coated tablets (code CT/7):
Aluminum/PCW film blisters in a cardboard box – 30 pieces (3 blisters of 10 pieces).
Packaging with 60 mg coated tablets (code CT/9):
Aluminum/PCW film blisters in a cardboard box – 30 pieces (3 blisters of 10 pieces).

Marketing authorization holder

Organon Polska Sp. z o.o.
Marszałkowska Street 126/134
00-008 Warsaw
Phone: +48 22 105 50 01
organonpolska@organon.com

Lerivon 10 mg, 30 mg:

Manufacturer/Importer

Organon Heist bv, Industriepark 30, 2220 Heist-op-den-Berg, Belgium

Lerivon 60 mg:

Manufacturer

N.V. Organon, Kloosterstraat 6, 5349 AB Oss, Netherlands
Schering-Plough Labo NV, Industriepark 30, Heist-op-den-Berg, 2220, Belgium

Date of last revision of the leaflet: 11/2022