Lerivon

Package leaflet: Information for the user

Lerivon 10 mg, film-coated tablets
Lerivon 30 mg, film-coated tablets
Lerivon 60 mg, film-coated tablets
Mianserin hydrochloride
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, 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

1. What Lerivon is and what it is 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 pack and other information

1. What Lerivon is and what it is used for

Lerivon is an antidepressant medicine containing mianserin hydrochloride as the active substance.
Lerivon is an antidepressant medicine that helps relieve 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 levels of these substances are reduced. Antidepressant medicines increase the levels of these substances and restore normal brain function.
Improvement usually occurs after 2 to 4 weeks of treatment.

2. Important information before using Lerivon

When not to use Lerivon
Do not use Lerivon if the patient:

• is allergic to mianserin or any of the other ingredients of this medicine (listed in section 6);
• is experiencing mania (a state of excitement and excessive activity);
• has severe liver failure;
• is currently taking or has recently taken (within the last two weeks) medicines that are monoamine oxidase inhibitors (MAO inhibitors).

Use in children and adolescents under 18 years of age
Lerivon is normally not recommended for use in children and adolescents under 18 years of age.
It should also be emphasized that when medicines of this class are used, patients under 18 years of age may have an increased risk of experiencing adverse effects such as suicidal behaviour, suicidal thoughts, and hostility (particularly aggression, defiant behaviours, and manifestations of anger). Nevertheless, a doctor may prescribe Lerivon to patients under 18 years of age if they consider it necessary. If your doctor has prescribed Lerivon for a patient under 18 years of age and you have any doubts, please consult your doctor. If any of the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Lerivon, inform your doctor immediately. Furthermore, to date, there are no data on the long-term safety of Lerivon in this age group with regard to growth, maturation, cognitive development, and behavioural development.

Suicidal thoughts and worsening of depression
Patients with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicidal ideation. Patients with depression have an increased risk of self-harm or suicide, particularly at the beginning of treatment, before the medicine starts to take effect—this usually takes about two weeks or sometimes longer.

This may occur:

• if the patient has previously experienced thoughts of suicide or self-harm;
• if the patient is a young adult. Clinical trial data show an increased risk of suicidal behaviour in patients under 25 years of age with psychiatric disorders who are taking antidepressant medicines.

Seek immediate medical advice or go to hospital immediately if you experience suicidal thoughts or thoughts of self-harm.

It may be helpful to tell a family member or close friend that you have depression or anxiety disorders and ask them to read this leaflet. You may also ask them to inform you if they notice that your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.

Special caution is required when using Lerivon if any of the following conditions are present or have ever been present:

• epilepsy (seizures);
• diabetes;
• liver diseases, such as jaundice;
• kidney diseases;
• problems with urination due to benign prostatic hyperplasia;
• heart diseases, including arrhythmias, recent myocardial infarction, heart failure, or if the patient is taking medicines that affect heart rhythm;
• hypertension (high blood pressure);
• glaucoma (increased pressure in the eye);
• psychiatric disorders, such as occurrence of hypomania in patients with bipolar affective disorder (alternating episodes of elevated mood and depressive mood);
• reduced white blood cell count or absence of white blood cells (see section 4, "Possible side effects").

Consult your doctor if any of the above conditions apply.

Warnings and precautions

Before starting treatment with Lerivon, discuss this with your doctor or pharmacist.

Lerivon and other medicines

Inform your doctor about all medicines you are currently taking or have recently taken, including those obtained without a prescription, as well as any medicines you plan to take.

Other medicines may affect the action of Lerivon, and Lerivon may also affect the action of other medicines.

Do not use Lerivon in combination with:

• monoamine oxidase inhibitors (MAOIs), or within two weeks of stopping such treatment. After discontinuing Lerivon, MAO inhibitors should not be taken for at least two weeks. MAO inhibitors include: moclobemide, tranylcypromine (antidepressants), selegiline (used in the treatment of Parkinson's disease), and linezolid (an antibiotic).

Exercise caution when using Lerivon in combination with:

• antiepileptic medicines such as carbamazepine and phenytoin;
• anticoagulants such as warfarin. Lerivon may enhance the effect of warfarin. Inform your doctor if you are taking these medicines. When using Lerivon in combination with anticoagulants, blood monitoring is recommended;
• medicines that may affect heart rhythm, such as certain antibiotics and antipsychotics.

Lerivon with food and drink
Do not drink alcohol while taking Lerivon, as it may intensify the effects of alcohol.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Animal studies and limited human safety data suggest that mianserin does not have harmful effects on the fetus or newborn. Mianserin passes into breast milk only in very small amounts. The benefits of mianserin treatment for the mother during pregnancy and breastfeeding should be weighed against any potential risk to the fetus or newborn.

Driving and operating machinery
Lerivon may cause drowsiness.
Do not drive, as Lerivon may impair psychomotor performance.
Do not operate any machinery or use tools.

3. How to use Lerivon

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dose

Treatment should usually be started with a lower dose (30 mg once daily), which may then be increased until an appropriate patient response is achieved.

The usual dose ranges from 60 to 90 mg, depending on the severity of depression. To ensure effective treatment, the medicine must be taken every day. It is essential to strictly follow the recommended doses and instructions for use.

Tablets should be taken at the same time each day, preferably as a single dose before going to bed.

If your doctor advises, Lerivon may also be taken in divided doses (one in the morning and one in the evening before bedtime).

Tablets should be swallowed whole, without chewing, with a small amount of water or other liquid.

Do not stop treatment immediately after feeling better. Premature or sudden discontinuation of the medicine may worsen your health condition.

Consult your doctor, who will decide how to reduce the dose and when treatment should be stopped.

Elderly patients:

Dosage should be individually adjusted for each patient. Initially, the dose should be 30 mg once daily. The dose may be increased every few days.

Usually, a lower dose than that for adults is sufficient to achieve a satisfactory clinical response.

Use in children and adolescents:

Lerivon should not be used in the treatment of children and adolescents under 18 years of age.

Taking more than the recommended dose of Lerivon

If you take more than the recommended dose of Lerivon, seek immediate advice from your doctor or pharmacist.

Vomiting should be induced as quickly as possible. Symptoms of overdose include prolonged drowsiness or sleepiness. Other symptoms may include changes in heart rhythm (rapid, irregular heartbeat) and/or fainting. These may be signs of life-threatening ventricular arrhythmias known as "torsade de pointes".

Missed dose of Lerivon

Do not take a double dose to make up for a missed dose.

If you miss a dose and take the medicine once daily before bedtime:

• Do not take the missed dose in the morning, as this may cause drowsiness and sleepiness during the day. Continue treatment by taking the medicine in the evening according to the previously established schedule.

If you miss one or both doses and take the medicine twice daily (one dose in the morning after breakfast and one before bedtime):

• If you miss the morning dose, take it together with the evening dose.
• If you miss the evening dose, do not take it together with the morning dose; instead, continue treatment the next day according to the previously established schedule.
• If you miss both doses, do not try to make them up. The next day, continue treatment by taking the usual doses: one in the morning and one in the evening.

Stopping Lerivon

Although Lerivon is not addictive, sudden discontinuation after long-term use may cause dizziness, agitation, anxiety, headache, and nausea. Therefore, the dose should be gradually reduced.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following may occur transiently:

• drowsiness or sleepiness,
• weight gain,
• thoughts of self-harm or suicidal thoughts. In such case, contact a doctor immediately or go to hospital.

In rare cases, Lerivon may cause a deficiency of white blood cells, resulting in
reduced resistance of the body to infections. If fever, sore throat,
oral ulcers or other signs of infection occur, consult a doctor immediately
and have a blood test performed. These symptoms usually occur after 4-6 weeks of treatment
and resolve after discontinuation of the medicine.
Other adverse reactions include:

• low blood pressure, manifesting as dizziness, dimming of vision, or fainting upon sudden change in body position;
• seizures;
• hypomania;
• increased liver enzyme levels;
• swelling of the ankles or feet due to fluid accumulation;
• yellow discoloration of the eyes or skin, which may indicate liver function disturbances;
• hepatitis;
• reduced heart function after administration of the initial dose;
• neuroleptic malignant syndrome (key symptoms include whole-body stiffness, involuntary movements, increased body temperature);
• joint pain;
• restless legs syndrome (burning or tingling sensations in the legs, causing insomnia);
• rash;
• changes in heart rhythm (rapid, 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 suffering from depression or anxiety disorders may sometimes experience thoughts
of self-harm or suicide. Such thoughts may intensify at the beginning of treatment
with antidepressant medicines, as these medicines usually start to work after about 2 weeks,
sometimes later.
The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely if:

• the patient has previously experienced suicidal thoughts or self-harm;
• the patient is a young adult; clinical data indicate an increased risk of suicidal behaviour in individuals under 25 years of age with psychiatric disorders who are treated with antidepressant medicines. If a patient experiences suicidal thoughts or thoughts of self-harm, immediate contact should be made with a doctor or the patient should go to hospital.

It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask for help from family or friends and request them to report any information if they notice worsening of depression or anxiety, or concerning changes in behaviour.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lerivon

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Store below 30 °C, protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lerivon contains

• The active substance is mianserin hydrochloride. One tablet contains 10 mg, 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, polyethylene glycol 8000, titanium dioxide (E 171).

What Lerivon looks like and contents of the pack
The coated tablets are round, convex (10 mg) or oval, scored and convex (30 and 60 mg).
All tablets are marked with the word “Organon” on one side and a code on the other side.
Pack containing 10 mg coated tablets (code CT/4):
Aluminium/PCW foil blisters in a cardboard carton – 30 tablets (1 blister containing 30 tablets).
Pack containing 30 mg coated tablets (code CT/7):
Aluminium/PCW foil blisters in a cardboard carton – 30 tablets (3 blisters containing 10 tablets each).
Pack containing 60 mg coated tablets (code CT/9):
Aluminium/PCW foil blisters in a cardboard carton – 30 tablets (3 blisters containing 10 tablets each).
Marketing Authorisation Holder
Organon Polska Sp. z o.o.
ul. Marszałkowska 126/134
00-008 Warsaw
Tel.: + 48 22 105 50 01
[email protected]
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, The Netherlands
Schering-Plough Labo NV, Industriepark 30, Heist-op-den-Berg, 2220, Belgium