Miansegen

Package leaflet: Information for the patient

Miansegen, 10 mg, coated tablets
Miansegen, 30 mg, coated tablets
Miansegen, 60 mg, coated tablets
Mianserini hydrochloridum
Please read the entire leaflet carefully before using the 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. The medicine may harm someone else, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Miansegen is and what it is 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 Miansegen is and what it is used for

Miansegen contains mianserin hydrochloride as the active substance.
Miansegen is an antidepressant medicine indicated for the treatment of symptoms of
depressive disorders. Depression is a mental illness. During depression, changes occur in the brain.
Nerve cells in the brain communicate with each other using chemical substances. In depression,
the levels of these substances are reduced. Antidepressant medicines increase the levels of these substances and restore normal brain function. The antidepressant effect becomes apparent after several days of treatment, and improvement is usually observed after 2 to 4 weeks of treatment.

2. Important information before using Miansegen

When not to use 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 severe liver failure
• if the patient is currently taking or has recently taken (within two weeks) medicines which are monoamine oxidase inhibitors (MAO inhibitors).

Warnings and precautions
Before starting treatment with Miansegen, discuss this with your doctor or pharmacist.
Special caution is necessary if the patient has or has previously had:

• heart diseases, including recent myocardial infarction and severe cardiac dysfunction (heart block), disorders causing changes in heart rhythm, heart failure
• epilepsy – if seizures occur, treatment must be discontinued
• liver diseases, such as jaundice – the medicine should be discontinued
• diabetes
• kidney diseases
• problems with urination due to benign prostatic hyperplasia
• narrow-angle glaucoma
• symptoms indicating benign prostatic hyperplasia (problems with urination)
• psychiatric disorders, such as occurrence of hypomania in patients with bipolar affective disorder (alternating elevated mood/depressed mood) – mianserin, like other antidepressants, may induce a hypomanic state. In such a case, the medicine should be discontinued and the doctor contacted.
• decreased 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 occur.
Children and adolescents
Mianserin should not be used in the treatment of children and adolescents under 18 years of age. It should also be emphasized that when patients under 18 years of age take medicines of this class, they are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, oppositional behaviors, and anger). Nevertheless, a doctor may prescribe Miansegen to a patient under 18 years of age if he or she considers it necessary. The patient should be carefully monitored for suicidal behavior. If development or worsening of the above-mentioned symptoms occurs in patients under 18 years of age taking Miansegen, or if there are any doubts, consult a doctor.
Moreover, to date, there are no data on the long-term safety of the medicine in children and adolescents regarding its impact on growth, maturation, cognitive development, 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. Patients with depression have 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 previously experienced thoughts of suicide or self-harm
• if the patient is a young adult. Clinical trial data show an increased risk of suicidal behavior in psychiatric patients under 25 years of age taking antidepressants. Contact your doctor immediately or go to hospital immediately if you experience suicidal thoughts or thoughts of self-harm. It may be helpful if the patient tells a family member or close person that he or she has depression or anxiety disorders and asks them to read this leaflet. The patient may also ask them to inform him or her if they notice that his or her depression or anxiety is worsening, or if they are concerned about changes in his or her behavior.

Miansegen and other medicines
Tell your doctor about all medicines currently or recently taken by the patient, as well as medicines the patient plans to take.
Do not take mianserin simultaneously with monoamine oxidase inhibitors (MAOIs) or within 2 weeks after stopping their use. After discontinuing Miansegen, do not take MAO inhibitors for 2 weeks. MAO inhibitors include: moclobemide, tranylcypromine (antidepressants), selegiline (used in the treatment of Parkinson's disease), and linezolid (an antibiotic).
Exercise caution when using Miansegen together with:

• carbamazepine and phenytoin (antiepileptic drugs)
• anticoagulant medicines of the coumarin derivatives group (e.g. warfarin) – coagulation parameters should be monitored regularly
• medicines that may affect heart rhythm, such as certain antibiotics and antipsychotic medicines.

Miansegen, food, drink, and alcohol
Mianserin enhances the effect of alcohol on the central nervous system. Alcohol should not be consumed during treatment with mianserin.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Animal studies and limited human safety data indicate that mianserin has no harmful effect on the fetus or newborn. Mianserin passes into breast milk only in very small amounts. The benefits to the mother from using mianserin during pregnancy and breastfeeding should be weighed against the potential risks to the fetus or newborn.
Driving and operating machinery
Due to the fact that mianserin may cause drowsiness and impair psychomotor performance, driving vehicles and operating machinery should be avoided.

3. How to take Miansegen

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

Recommended dose
Treatment should usually be started at a lower dose (30 mg daily), which may then be increased until the appropriate patient response is achieved.
The dosage ranges from 30 mg to 90 mg, depending on the severity of depression.
To ensure effective treatment, the medicine must be taken daily. It is essential to strictly follow the recommended dosage and instructions for use. Tablets should be taken every day at the same time, preferably as a single dose before going to bed.
If directed by your doctor, the medicine may be taken in divided doses (one in the morning and one in the evening before bedtime) or as a single daily dose before sleep (due to its beneficial effect on sleep).
Tablets should be swallowed whole, without chewing, with a small amount of water or other liquid.
Do not stop treatment immediately after improvement is observed. Premature or abrupt discontinuation of the medicine may lead to worsening of health condition.
Consult your doctor, who will decide how to reduce the dose and when treatment should be discontinued.

Elderly patients
Dosage should be individually adjusted for each patient. The initial dose should be 30 mg daily. The dose may be increased every few days. Therapeutic effect is usually achieved with a lower dose than the typical maintenance dose used in adults.

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

Taking more Miansegen than recommended
If you have taken too much medicine, contact your doctor immediately or call emergency services.
Vomiting should be induced as quickly as possible. The main symptom of overdose is prolonged drowsiness or sleepiness. Other symptoms of overdose include: heart rhythm disturbances (changes in heart rhythm such as rapid, irregular heartbeat) and/or fainting. These may be symptoms of life-threatening ventricular arrhythmias known as "torsade de pointes".

If you forget to take a dose of Miansegen
Do not take a double dose to make up for a missed dose.
If you take the medicine once daily before going to bed and miss a dose, do not take the missed dose in the morning, as this may cause daytime drowsiness and sleepiness. 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), then:

• if you miss the morning dose, take it together with the evening dose;
• if you miss the evening dose, do not take it with the morning dose; instead, continue treatment the next day according to the previously established schedule;
• if you miss both doses, do not attempt to compensate for them; continue treatment the next day by taking the usual morning and evening doses.

Stopping Miansegen
Although Miansegen is not addictive, abrupt discontinuation after long-term use may cause dizziness, restlessness, anxiety, headache, and nausea. Therefore, the dose should be gradually reduced.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine may 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 such cases, contact your doctor immediately or go to hospital.

Miansegen may rarely cause a low white blood cell count, which reduces the body's resistance to infections. If fever, sore throat, mouth ulcers, or other signs of infection occur, consult your doctor immediately and have a blood test. These symptoms usually appear after 4–6 weeks of treatment and resolve after stopping the medicine.

Other side effects include:

• low blood pressure causing dizziness, darkening of vision, or fainting upon sudden change in body position,
• joint pain,
• tremor or twitching,
• swelling of the ankles or feet due to fluid accumulation,
• skin rash,
• slowed heart function after initial dose administration,
• neuroleptic malignant syndrome (key symptoms include body stiffness, involuntary movements, increased body temperature),
• restless legs syndrome (burning or tingling sensation in legs causing insomnia),
• yellowing of the skin or whites of the eyes, which may indicate liver function disorders,
• increased liver enzyme activity (detectable in blood tests),
• hepatitis,
• hypomania,
• 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 with depression or anxiety disorders may sometimes experience thoughts of self-harm or suicide. These thoughts may increase at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, sometimes longer, to start working.
The occurrence of suicidal thoughts, thoughts of self-harm, or suicide attempts is more likely if:

• the patient has previously experienced suicidal thoughts or self-harm,
• the patient is a young adult; clinical trial data indicate an increased risk of suicidal behaviour in individuals under 25 years of age with psychiatric disorders treated with antidepressants. If the patient experiences suicidal thoughts or thoughts of self-harm, seek immediate medical attention or 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 family or friends for help and request them to inform you if they notice worsening of depression or anxiety, or concerning changes in behaviour.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. 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 responsible entity.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Miansegen

Keep this medicine out of the 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 stated month.
Store below 25 °C. Protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Miansegen contains

• The active substance is mianserin hydrochloride. One tablet contains 10 mg, 30 mg, or 60 mg of mianserin hydrochloride.
• The other ingredients are: pregelatinized starch, colloidal anhydrous silica, microcrystalline cellulose, anhydrous calcium hydrogen phosphate, magnesium stearate. Film-coating composition: Opadry White 03B28796, talc.

What Miansegen looks like and contents of the pack
Miansegen 10 mg, film-coated tablets
The medicine is in the form of white, biconvex, film-coated tablets with a diameter of approximately 6 mm. On one side of the tablet there is the imprint "MI 10", and on the other side the letter "G".
The tablets are packed in aluminium/PVC blisters with transparent foil, in a cardboard box with an instruction leaflet. The pack contains: 30, 90 tablets.
Not all pack sizes may be marketed.

Miansegen 30 mg, film-coated tablets
The medicine is in the form of white, biconvex, film-coated tablets with a diameter of approximately 8 mm. On one side of the tablet there is the imprint "MI 30", and on the other side the letter "G".
The tablets are packed in aluminium/PVC blisters with transparent foil, in a cardboard box with an instruction leaflet.
The pack contains: 20, 30, 60, 90 tablets.
Not all pack sizes may be marketed.

Miansegen 60 mg, film-coated tablets
The medicine is in the form of white, oval, biconvex, film-coated tablets. On one side of the tablet there is the imprint "MI", a score line, and the imprint "60", and on the other side the letter "G".
The tablets are packed in aluminium/PVC blisters with transparent foil, in a cardboard box with an instruction leaflet.
The pack contains: 30, 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information, please contact the representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
tel: +48 22 54 66 400