Miansegen

Package Leaflet: Information for the Patient

Miansegen, 10 mg, coated tablets

Miansegen, 30 mg, coated tablets

Miansegen, 60 mg, coated tablets

Mianserin hydrochloride

Read the package 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, 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 pack and other information

1. What is Miansegen and what is it used for

Miansegen contains the active substance mianserin hydrochloride.
Miansegen is an antidepressant medicine used to treat 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. Antidepressant medicines 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

Warnings and precautions

Before starting treatment with Miansegen, discuss it with your doctor or pharmacist.

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

• heart diseases, including recently suffered myocardial infarction and severe heart function disorders (heart block), rhythm disorders, heart failure
• epilepsy - in case of seizures, the medicine should be discontinued
• liver diseases, such as jaundice - the medicine should be discontinued
• diabetes
• kidney diseases
• 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 antidepressant medicines, 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").

In case of the above situations, consult a doctor.

Children and adolescents

Mianserin 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 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 18 years of age if they consider it necessary. The patient should be carefully monitored for suicidal behavior. If symptoms develop or worsen in patients under 18 years of age taking Miansegen, or if there are any doubts, consult a doctor.
Additionally, there is currently a lack of data on the long-term safety of the medicine in children and adolescents in terms of its impact on 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:

consult a doctor or go to the hospital immediately.

Miansegen with food, drinks, and alcohol

Mianserin enhances the effect of alcohol on the central nervous system. During treatment with mianserin, do not drink alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult a 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 treatment during pregnancy and breastfeeding should be weighed against the potential risk to the fetus or newborn.

Driving and using machines

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

3. How to take Miansegen

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your 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. Follow the recommended doses and instructions for taking the medicine. Take the tablets 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).
Swallow the tablets whole with a small amount of water or other liquids without chewing.
Do not stop treatment immediately after improvement. Too early or sudden discontinuation of the medicine may lead to worsening of the condition.
Consult a doctor who will decide how to reduce the dose and when treatment should be stopped.

Elderly patients

The dose 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 18 years of age.

Taking a higher dose of Miansegen than recommended

In case of taking too high a dose of the medicine, consult a doctor or call emergency services immediately.
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

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 Miansegen treatment

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.
In case of any further doubts about 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.

In this case, consult a doctor or go to the hospital immediately.

Miansegen can rarely cause a lack of white blood cells, which reduces the body's resistance to infections. If fever, sore throat, mouth ulcers, or other signs of infection occur, consult a 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, darkening of vision, or fainting after sudden changes in body position
• joint pain
• tremors or seizures
• swelling of the ankles or feet due to fluid accumulation
• skin rash
• slow heart rate after initial dose administration
• malignant neuroleptic syndrome (main symptoms are stiffness of the whole body, involuntary movements, increased body temperature)
• restless legs syndrome (feeling of burning, tingling of 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)
• hepatitis
• 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, depression worsening, or anxiety disorders
Patient with depression or anxiety disorders may sometimes have thoughts of self-harm or suicidal thoughts. Such thoughts may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually start to work after two weeks, sometimes later.
The occurrence of suicidal thoughts, self-harm thoughts, 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 with mental disorders under 25 years of age taking antidepressant medicines. If suicidal thoughts or self-harm thoughts occur, consult a doctor or go to the hospital immediately.

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 the depression or anxiety has worsened or if there are worrying changes in behavior.
Reporting side effects
If any side effects occur, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 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 provide more information on the safety of this medicine.

5. How to store Miansegen

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.
Store in a temperature below 25°C. Protect from light.
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. Contents of the pack 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.
• Other ingredients are: cornstarch, colloidal anhydrous silica, microcrystalline cellulose, calcium hydrogen phosphate anhydrous, magnesium stearate. Coating: Opadry White 03B28796, talc.

What Miansegen looks like and contents of the pack

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