Package leaflet: Information for the patient

MIANSEC 30, 30 mg, coated tablets
Mianserinum hydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, 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 another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Leaflet contents

What Miansec 30 is and what it is used for
Important information before taking Miansec 30
How to take Miansec 30
Possible side effects
How to store Miansec 30
Contents of the pack and other information

1. What Miansec 30 is and what it is used for

Miansec 30 is an antidepressant medicine containing mianserin hydrochloride as the active substance.
Miansec 30 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 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, in which pharmacological treatment is indicated.

2. Important information before using Miansec 30

When not to use Miansec 30

if the patient is allergic (hypersensitive) to mianserin or any of the other ingredients of Miansec 30 (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 taking or has recently taken (within the last two weeks) medicines that are monoamine oxidase inhibitors (MAO inhibitors).

Warnings and precautions
Before starting treatment with Miansec 30, discuss this with your doctor or pharmacist.
Suicidal thoughts and worsening of depression
Patients with depression and/or anxiety disorders may sometimes have thoughts about 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 has previously experienced suicidal thoughts 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. Contact your doctor immediately 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 person that you have depression or
anxiety disorders and ask them to read this leaflet. You may also ask them
to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.
Exercise particular caution when using mianserin if you have or have ever had:

epilepsy (seizures),
diabetes,
liver disorders, such as jaundice,
kidney disorders,
problems with urination 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 pressure in the eye),
psychiatric disorders, such as occurrence of hypomania in patients with bipolar affective disorder (alternating periods of elevated mood/depressed 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.
Miansec 30 and other medicines
Tell 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 30, and Miansec 30 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 30, 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 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. When used concomitantly with mianserin, blood monitoring is recommended.
medicines that may affect heart rhythm, such as certain antibiotics and antipsychotic medicines.

Use of Miansec 30 with alcohol
Do not drink alcoholic beverages during treatment, as Miansec 30 enhances the effects of alcohol.
Children and adolescents
Miansec 30 must not be used in children and adolescents under 18 years of age. However, if the doctor
considers it necessary, they may recommend its use.
Patients in this age group taking Miansec 30 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 30 and its effects on growth, maturation, cognitive development, and behaviour in children under 18 years of age.
If any of the above-mentioned adverse effects occur or worsen, or if you have any doubts during treatment, contact your doctor or
pharmacist.
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 suggest that
mianserin does not have harmful effects on the fetus or newborn. Mianserin passes into
breast milk only in very small amounts. The doctor should weigh the benefits to the mother of using mianserin during pregnancy and breastfeeding against the potential risks to the fetus or newborn.
Driving and operating machinery
Miansec 30 may cause drowsiness.
Do not drive, as Miansec 30 reduces psychomotor performance.
Do not operate any machinery or tools.
Miansec 30 contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.

3. How to use Miansec 30
This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
The tablets should be taken orally without chewing, with liquid.
Adults
The doctor will adjust the dosage individually for each patient.
Treatment should usually begin with a lower dose (30 mg per day), which may then be increased to achieve the appropriate patient response.
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 dosages and
instructions for use. Tablets should be taken every day at the same time, preferably as a single dose before bedtime.
If the doctor advises, mianserin may also be taken in divided doses (one in the morning and the second in the evening before bedtime).
Tablets should be swallowed whole with a small amount of water or other liquid. Do not stop treatment immediately after improvement occurs. Stopping treatment too early or abruptly may lead to worsening of health.
Consult your doctor, who will decide how to reduce the dosage and when treatment should end.
Elderly patients
Dosage should be individually adjusted 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 30 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 30
If more than the recommended dose of Miansec 30 is taken, seek immediate advice from a doctor or pharmacist.
Vomiting should be induced as soon as possible. Symptoms of mianserin overdose include prolonged drowsiness or sedation. Symptoms of overdose may also 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 30
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 the second 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 the next day, but continue treatment by taking the medicine the next day according to the previously established schedule;
if both doses are missed, do not attempt to make them up; continue treatment the next day by taking the usual morning and evening doses.

Stopping treatment with Miansec 30
Although mianserin is not addictive, abrupt discontinuation after long-term use may cause dizziness, restlessness, anxiety, headache, and nausea. Therefore, the dose should be reduced gradually.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

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

In such cases, contact a doctor immediately or go to hospital.
Mianserin may cause a deficiency of white blood cells, leading to 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 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 accumulation;
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 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 with continued therapy).

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 intensify at the beginning of treatment with antidepressant medicines, 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 data indicate an increased risk of suicidal behaviour in individuals under 25 years of age with psychiatric disorders treated with antidepressant medicines.

If a patient experiences suicidal thoughts or thoughts of self-harm, they 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 concerning 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 mianserin.
Adverse effects resulting from anticholinergic activity (such as dry mouth, blurred vision, increased heart rate, constipation, difficulty urinating) and cardiac disturbances occur less frequently and are milder than with tricyclic antidepressants.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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,
website: http://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Miansec 30

Store below 25 °C.
Keep the medicine out of sight and reach of children.
Do not use Miansec 30 after the expiry date stated on the carton after: EXP.
The expiry date refers to the last day of the specified month.

6. Contents of the pack and other information

What Miansec 30 contains

The active substance is mianserin hydrochloride. One tablet contains 30 mg of mianserin hydrochloride.
The other ingredients are: Ludipress (monohydrate lactose, povidone, crospovidone), magnesium stearate, colloidal anhydrous silica. The tablet coating consists of: SeleCoat 1248, which contains ethylcellulose, hypromellose, Macrogol 6000, titanium dioxide (E 171), indigo carmine, lacquer (E 132).

What Miansec 30 looks like and contents of the pack
Miansec 30 are light blue, round, biconvex coated tablets.
Available pack sizes are:
PVC/Aluminum blister in a cardboard box
20 tablets (1 blister with 20 tablets)
30 tablets (2 blisters with 15 tablets each)
90 tablets (6 blisters with 15 tablets each)

Marketing Authorisation Holder
PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic

Manufacturer
Jelfa SA Pharmaceutical Company
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland
2025-05-12