Miansegen

Leaflet attached to the packaging: patient information

Miansegen, 10 mg, coated tablets

Miansegen, 30 mg, coated tablets

Miansegen, 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 you can read it again if you need to.
• 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 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, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Miansegen and what is it used for
• 2. Important information before taking Miansegen
• 3. How to take Miansegen
• 4. Possible side effects
• 5. How to store Miansegen
• 6. Contents of the packaging and other information

1. What is Miansegen and what is it used for

Miansegen contains the active substance mianserin hydrochloride.
Miansegen is an antidepressant that is indicated for the treatment of symptoms of depressive disorders. 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. The antidepressant effect becomes apparent after a few days of treatment, and improvement is usually observed after 2 to 4 weeks of treatment.

2. Important information before taking Miansegen

When not to take Miansegen

• if the patient is allergic to mianserin hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• in diagnosed mania (a state of excitement and excessive activity)
• in case of severe liver failure
• if the patient is taking or has recently taken (within two weeks) monoamine oxidase inhibitor (MAOI) drugs.

Warnings and precautions

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

Special caution is required if the patient has or has had in the past:

• heart disease, including recent myocardial infarction and severe heart function disorders (heart block), rhythm disorders, heart failure
• epilepsy - if seizures occur, the medicine should be discontinued
• liver disease, such as jaundice - the medicine should be discontinued
• diabetes
• kidney disease
• urination problems due to prostate enlargement
• glaucoma with a narrow angle of filtration
• symptoms indicating prostate enlargement (urination problems)
• mental illnesses, such as the occurrence of hypomania in patients with bipolar affective disorder (alternating elevated mood/depressive mood) - mianserin, like other antidepressants, may cause hypomania. In such a case, the medicine should be discontinued and the doctor should be consulted.
• decreased white blood cell count or their absence (see section 4 "Possible side effects").

You should consult a doctor if any of the above situations occur.

Children and adolescents

Mianserin should not be used in children and adolescents under the age of 18. It should also be emphasized that in the case of taking drugs of this class, patients under the age of 18 are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). Nevertheless, the doctor may prescribe Miansegen to a patient under the age of 18 if they consider it necessary. The patient should be carefully observed for suicidal behavior. If the above-mentioned symptoms develop or worsen in patients under the age of 18 taking Miansegen, or if there are any doubts, you should consult a doctor.
Additionally, as of now, there is a lack of data on the long-term safety of using the medicine in children and adolescents in terms of its impact on 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 had suicidal thoughts or self-harm in the past
• if the patient is a young adult. Information from clinical trials shows an increased risk of suicidal behavior in patients with mental disorders under the age of 25 who are taking antidepressants. You should immediately contact a doctor or go to the hospital if you experience suicidal thoughts or thoughts of self-harm. It may be helpful if the patient tells someone in their family or a close personthat they have depression or anxiety disorders and asks them to read this leaflet. They may also ask them to tell the patient if they think their depression or anxiety has worsened or if they notice worrying changes in their behavior.

Miansegen 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.
Do not take mianserinat the same time as monoamine oxidase inhibitors (MAOIs)or within 2 weeks of stopping their use. If you stop taking Miansegen, you should not take MAOIs for 2 weeks. MAOIs include: moclobemide, tranylcypromine (antidepressants), selegiline (used in the treatment of Parkinson's disease), and linezolid (an antibiotic).
Be careful when taking Miansegen at the same time as:

• carbamazepine and phenytoin (antiepileptic drugs)
• anticoagulant drugsfrom the coumarin derivative group (e.g., warfarin) - you should constantly monitor coagulation parameters
• drugs that may affect heart rhythm, such as certain antibiotics and antipsychotic drugs.

Miansegen with food, drink, and alcohol

Mianserin enhances the effect of alcohol on the central nervous system. During treatment with mianserin, you should not drink 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 suggest that mianserin does not have a harmful effect on the fetus or newborn. Mianserin passes into breast milk in very small amounts. You should weigh the benefits of taking mianserin during pregnancy and breastfeeding against the possible risk to the fetus or newborn.

Driving and operating machines

Due to the fact that mianserin can cause drowsiness and impair psychomotor performance, you should not drive vehicles or operate machines.

3. How to take Miansegen

This medicine should always be taken as directed by your doctor. If you have any 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 30 mg 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, the medicine can be taken in divided doses (one in the morning and one in the evening before bedtime) or in a single daily dose before sleep (due to the beneficial effect on sleep).
Tablets should be swallowed whole 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.
You should consult a 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, sufficient therapeutic effect can be achieved using a lower dose than the typical maintenance dose in adults.

Use in children and adolescents

Mianserin should not be used in children and adolescents under the age of 18.

Taking a higher dose of Miansegen than recommended

In case of taking too high a dose of the medicine, you should immediately contact a doctor or call an ambulance.
You should induce vomiting as soon as possible. The main symptom of overdose is prolonged drowsiness or sleepiness. Other symptoms of overdose are: heart rhythm disorders (changes in heart rhythm, such as accelerated, irregular heartbeat) and/or fainting. These may be symptoms of life-threatening ventricular arrhythmias known as "torsade de pointes".

Missing a dose of Miansegen

You should not take a double dose to make up for a missed dose.
If you miss a dose, if you take the medicine once a daybefore bedtime, 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.
If you miss one or both doses, if you take the medicine twice a day(one dose in the morning after breakfast and one before bedtime) you should:

• in case of a missed morning dose, take it together with the evening dose;
• in case of a missed 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 Miansegen

Although Miansegen 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.
If you have any further doubts about 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 immediately contact a doctor or go to the hospital.

Miansegen can rarely 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 a 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, fainting, or fainting when changing body position
• joint pain
• tremors or seizures
• swelling of the ankles or feet due to fluid accumulation
• skin rash
• slow heart rate after initial administration
• malignant neuroleptic syndrome (the most important symptoms are stiffness of the whole body, involuntary movements, increased body temperature)
• restless legs syndrome (a feeling of burning, tingling in the legs, causing insomnia)
• yellowing of the skin and whites of the eyes, which may indicate liver function disorders
• increased liver enzyme activity (which can be detected in blood tests)
• liver inflammation
• hypomania
• heart rhythm disorders (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 who have depression or anxiety disorders may sometimes have thoughts of self-harm or suicidal thoughts. Such thoughts may worsen at the beginning of treatment 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 thoughts is more likely if:

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

It may be helpful to inform relatives or friends about depression or anxiety disorders and ask them to read this leaflet. The patient may ask relatives or friends for help and ask them to pass on information if they notice that their depression or anxiety has worsened or if they notice worrying changes in their behavior.
Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Miansegen

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 packaging after the phrase "Expiry date (EXP)". The expiry date refers to the last day of the given month.
Store in a temperature below 25°C. Protect from light.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Miansegen 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: cornstarch, colloidal anhydrous silica, microcrystalline cellulose, calcium hydrogen phosphate anhydrous, magnesium stearate. The composition of the coating: Opadry White 03B28796, talc.

What Miansegen looks like and what the packaging contains

Miansegen, 10 mg, coated tablets
The medicine is in the form of white, biconvex, coated tablets with a diameter of about 6 mm. On one side of the tablet, there is the inscription "MI 10", and on the other side, the letter "G".
Tablets are packaged in aluminum/PVC blisters with a transparent foil, in a cardboard box with an information leaflet. The packaging contains: 30, 90 tablets.
Not all pack sizes may be marketed.
Miansegen, 30 mg, coated tablets
The medicine is in the form of white, biconvex, coated tablets with a diameter of about 8 mm. On one side of the tablet, there is the inscription "MI 30", and on the other side, the letter "G".
Tablets are packaged in aluminum/PVC blisters with a transparent foil, in a cardboard box with an information leaflet.
The packaging contains: 20, 30, 60, 90 tablets.
Not all pack sizes may be marketed.
Miansegen, 60 mg, coated tablets
The medicine is in the form of white, oval, biconvex, coated tablets. On one side of the tablet, there is the inscription "MI", a dividing line, and the inscription "60", and on the other side, the letter "G".
Tablets are packaged in aluminum/PVC blisters with a transparent foil, in a cardboard box with an information leaflet.
The packaging contains: 30, 60 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer/Importer

Mylan Hungary Kft. / Mylan Hungary Ltd.
Mylan utca 1.
Komárom, 2900
Hungary
To obtain more detailed information, you should contact the representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

tel: +48 22 54 66 400

Date of last revision of the leaflet: