Lerivon

Leaflet attached to the packaging: information for the user

Lerivon, 10 mg, coated tablets

Lerivon, 30 mg, coated tablets

Lerivon, 60 mg, coated tablets

Mianserin hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should 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 the symptoms of their illness 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. Contents of the packaging 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:

• an allergy 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).

Use 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, so far, 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 worsening of depression

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 caution is required when taking Lerivon if the following conditions occur or have occurred:

• 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 the patient is taking medicines that affect heart rhythm,
• hypertension,
• glaucoma (increased eye pressure),
• mental illnesses, such as the occurrence of hypomania in patients with bipolar affective disorder (alternating elevated mood/depressive mood),
• decreased white blood cell count or their absence (see section 4 "Possible side effects").

You should consult a doctor in case 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 medicines you are currently taking or have recently taken, as well as 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.
You should not take Lerivonin combination with:

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

You should be cautiouswhen 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

You should 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, you should consult a doctor or pharmacist before taking this medicine.
Animal studies and limited human data on safety do not indicate any harmful effects of mianserin 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 operating machines

Lerivon may cause drowsiness.
You should not drive vehicles, as Lerivon reduces psychomotor abilities.
You should 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, you should 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 going to bed at night.
If the doctor recommends, Lerivon can also be taken in divided doses (one in the morning and one in the evening before going to bed at night).
Tablets should be swallowed without chewing, washed down with a small amount of water or other fluids.
You should not stop treatment immediately after improvement. Too early or sudden discontinuation of the medicine may lead to worsening of the condition.
You should consult a doctor who will decide how to reduce the dosage and when treatment should be stopped.

Elderly patients:

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 that for adults is sufficient to achieve a satisfactory clinical response in the patient.

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, you should immediately consult a doctor or pharmacist.
You should induce vomiting as soon as possible. Symptoms of Lerivon overdose include prolonged drowsiness or sleepiness. Other symptoms of overdose 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

You should 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 going to bed at night, you should not take the missed dose in the morning, as this may cause drowsiness and sleepiness during the day. You should 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 dose in the evening before going to bed at night), 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 treatment with Lerivon

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, you should 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 lack of white blood cells, which reduces the body's resistance to infections. If you experience fever, sore throat, mouth ulcers, or other signs of infection, you should immediately consult your doctor 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, darkening of the eyes, or fainting after sudden changes in 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, and 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, worsening of depression or anxiety disorders

Patients with depression or anxiety disorders may sometimes have thoughts of self-harm or suicidal thoughts. Such thoughts may intensify at the beginning of therapy with antidepressants, as these medicines usually start to work after two weeks, sometimes later.
The occurrence of suicidal thoughts, thoughts of self-harm, or suicidal thoughts 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 immediately contact your doctor or go to the hospital.

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, 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.
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 invisible and inaccessible to children.
You should not use this medicine after the expiration date stated on the box after the inscription: "Expiration date (EXP)". The expiration date means the last day of the specified month.
Store at a temperature below 30°C, protect from light and moisture.
Medicines should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging 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.
• 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 packaging 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
Tel.: +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