MIANSERIN

Package leaflet: Information for the patient

MIANSEC, 10 mg, coated tablets
Mianserini hydrochloridum
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 further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents of the leaflet

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

1. What is Miansec and what is it used for

Miansec is an antidepressant medicine containing mianserin hydrochloride as the active substance.
Miansec is an antidepressant that helps relieve depressive moods, which are the most common symptom of depression. Depression is a disorder characterized by symptoms such as sadness, sleep disturbances, or loss of interest and pleasure in life. 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.
Indications
Depressive symptoms of various origins, where pharmacological treatment is indicated.

2. Important information before using Miansec

When not to use Miansec

• if the patient is allergic (hypersensitive) to mianserin or any of the other ingredients of Miansec (listed in section 6),
• if the patient has severe liver impairment,
• if the patient is experiencing mania (a state of excitement and excessive activity),
• if the patient is currently using or has recently used (within the last two weeks) medicines that are monoamine oxidase inhibitors (MAO inhibitors).

Warnings and precautions
Before starting treatment with Miansec, discuss this with your doctor or pharmacist.
Suicidal thoughts and worsening depression
Patients with depression and/or anxiety disorders may sometimes experience thoughts of self-harm or suicidal ideation. 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 behaviour in patients with psychiatric disorders under 25 years of age taking antidepressant medicines. Immediately contact your doctor or go to hospital 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 believe your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.
Exercise particular caution when using mianserin if any of the following conditions are present or have ever occurred:

• epilepsy (seizures),
• diabetes,
• liver disorders, such as jaundice,
• kidney disorders,
• difficulty urinating due to benign prostatic hyperplasia,
• heart disorders, including arrhythmias, recent myocardial infarction, heart failure, or if the patient is taking medicines that affect heart rhythm,
• arterial hypertension,
• glaucoma (increased intraocular pressure),
• psychiatric disorders, such as episodes of hypomania in patients with bipolar affective disorder (alternating elevated mood/depressive episodes),
• 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.
Miansec and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Other medicines may affect the action of Miansec, and Miansec may also affect other medicines.
Mianserin must not be used in combination with:

• monoamine oxidase inhibitors (MAOIs) or within two weeks of stopping such treatment. After discontinuing Miansec, MAO inhibitors should not be taken for 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 mianserin in combination with:

• antiepileptic drugs such as carbamazepine and phenytoin,
• anticoagulants such as warfarin. Mianserin may enhance the effect of warfarin. Inform your doctor if you are taking these medicines. Blood monitoring is recommended when mianserin is used concomitantly.
• medicines that may affect heart rhythm, such as certain antibiotics and antipsychotics.

Use of Miansec with alcohol
Do not consume alcoholic beverages during treatment, as Miansec enhances the effects of alcohol.
Children and adolescents
Miansec must not be used in children and adolescents under 18 years of age. However, if the doctor considers it necessary, they may prescribe its use.
Patients in this age group taking Miansec are at higher risk of adverse effects such as suicide attempts, suicidal thoughts, hostility, aggression, defiant behaviour, and anger outbursts. There is insufficient data on the long-term use of Miansec and its effects on growth, maturation, cognitive development, and behaviour in children under 18 years of age.
If any of the above adverse effects occur or worsen, or if you have any concerns during treatment, contact your doctor or pharmacist immediately.
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 foetus or newborn. Mianserin passes into breast milk only in very small amounts. The doctor should weigh the benefits of mianserin for the mother against the potential risks to the foetus or newborn during pregnancy and breastfeeding.
Driving and operating machinery
Miansec may cause drowsiness.
Do not drive, as Miansec may impair psychomotor performance.
Do not operate machinery or use tools.

3. How to use Miansec
Always use this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Tablets should be taken orally without chewing, with liquid.
Adults
The doctor will individually adjust the dosage for each patient.
Treatment should usually start with a lower dose (30 mg per day), which may then be increased until the appropriate patient response is achieved.
The usual dosage ranges from 60 to 90 mg, depending on the severity of depression. To ensure effective treatment, the medicine should be taken daily. 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 prescribed by the doctor, mianserin may also be taken in divided doses (one in the morning and one in the evening before bedtime).
Tablets should be swallowed whole, taken with a small amount of water or other liquid. Do not stop treatment immediately after feeling better. Premature or abrupt discontinuation of the medicine may lead to worsening of health.
Consult your doctor, who will decide how to gradually reduce the dose and when treatment should be stopped.
Elderly patients
The doctor will individually adjust the dosage for each patient. Initially, the dose should not exceed 30 mg per day. The dose may be increased every few days. Usually, a lower dose than in adults is sufficient to achieve a satisfactory clinical response.
Use in children and adolescents
Miansec should not be used in the treatment of children and adolescents under 18 years of age – see section 2.
Taking more than the recommended dose of Miansec
If more than the recommended dose of Miansec is taken, seek immediate medical advice from a doctor or pharmacist.
Vomiting should be induced as soon as possible. Symptoms of mianserin overdose include prolonged drowsiness or sedation. 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 Miansec
Do not take a double dose to make up for a missed dose.
If a dose is missed and the medicine is taken once daily before bedtime, 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 one or both doses are missed and the medicine is taken twice daily (one dose in the morning after breakfast and one before bedtime), then:

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

Stopping treatment with Miansec
Although mianserin is not addictive, abrupt discontinuation after prolonged use may cause dizziness, agitation, anxiety, headache, and nausea. Therefore, the dose should be gradually reduced.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The following may occur transiently:

• drowsiness or somnolence,
• weight gain,
• thoughts of self-harm or suicidal thoughts.

In such cases, you should immediately contact your doctor or go to hospital.
Mianserine may cause a deficiency of white blood cells, which reduces the body's resistance to
infections. If fever, sore throat, mouth ulcers or other signs of infection occur, you should immediately
consult a doctor and have a blood test performed. These symptoms usually appear after 4–6 weeks
of treatment and resolve after discontinuation of the medicine.
Other adverse effects include:

• low blood pressure, causing dizziness, blurred vision, or fainting upon sudden change in body position;
• seizures;
• hypomania;
• increased levels of liver enzymes;
• swelling of the ankles or feet due to fluid retention;
• yellowing of the eyes or skin, which may indicate liver dysfunction;
• 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 (a burning or tingling sensation 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";
• sedation (occurring at the beginning of treatment and decreasing as therapy continues).

Suicidal thoughts, worsening of depression or anxiety disorders
Patients with depression or anxiety disorders may sometimes experience thoughts of self-harm or suicide.
Such thoughts may worsen 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-harming behaviour;
• 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 a patient experiences suicidal thoughts or thoughts of self-harm, you should immediately contact a doctor 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 to inform them if they notice worsening of depression or anxiety, or any worrying changes in behaviour.
The frequency and severity of symptoms associated with depression, such as dryness of the oral mucosa and constipation, usually do not increase during treatment with mianserine.
Adverse effects resulting from anticholinergic activity (such as dry mouth, blurred vision, increased heart rate, constipation, difficulty in urination) and cardiac disturbances occur less frequently and are milder compared to tricyclic antidepressants.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of 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,
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Miansec

Store below 25 °C. Keep in the outer packaging to protect from light.
Keep Miansec out of the sight and reach of children.
Do not use Miansec after the expiry date stated on the carton after: EXP.
The expiry date refers to the last day of the stated month.

6. Contents of the packaging and other information

What the medicine Miansec contains

• The active substance is mianserin hydrochloride. One tablet contains 10 mg of mianserin hydrochloride.
• Other ingredients are: calcium hydrogen phosphate dihydrate, potato starch, povidone K-25, colloidal anhydrous silica, magnesium stearate. The tablet coating consists of: ethylcellulose, hypromellose, macrogols, titanium dioxide.

What Miansec looks like and contents of the pack
Miansec is a round, biconvex, white coated tablet.
Medicine packaging available:
PVC/Aluminium foil blisters in a cardboard box
30 tablets (1 blister with 30 tablets)
90 tablets (3 blisters with 30 tablets each)
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic
Manufacturer
Jelfa Pharmaceutical Company SA
Wincentego Pola 21
58-500 Jelenia Góra
Poland
2025-05-12