Miansec 30

Leaflet attached to the packaging: patient information

MIANSEC 30, 30 mg, coated tablets

Mianserin hydrochloride

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Miansec 30 and what is it used for
• 2. Important information before taking Miansec 30
• 3. How to take Miansec 30
• 4. Possible side effects
• 5. How to store Miansec 30
• 6. Contents of the pack and other information

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

Miansec 30 is an antidepressant that contains mianserin hydrochloride as the active substance.
Miansec 30 is an antidepressant that provides relief in the treatment of depressive moods,
which are the most common symptom of depression. Depression is a disorder whose symptoms
are: sadness, difficulty sleeping or lack of joy in life. 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. Improvement usually occurs after 2 to 4 weeks of treatment.

Indications for use

Depressive symptoms of various etiologies, in which pharmacological treatment is indicated.

2. Important information before taking Miansec 30

When not to take 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 failure;
• if the patient has mania (a state of excitement and excessive activity)
• if the patient is taking or has recently taken (within the last two weeks) monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Before starting treatment with Miansec 30, the patient should discuss it with their doctor or pharmacist.

Suicidal thoughts and depression

Patients with depression and/or anxiety disorders may sometimes have thoughts of self-harm or
suicidal thoughts. Patients with depression are at 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 had suicidal thoughts or self-harm.
• 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 taking antidepressants. You should immediately contact your doctor or go to the hospital if you experience suicidal thoughts or thoughts of self-harm.

It may be helpful if you tell someone in your family or a close personthat you have depression or
anxiety disorders and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Special caution should be exercised when taking mianserin if the following conditions occur or have occurred:

• epilepsy (seizures),
• diabetes,
• liver disease, such as jaundice,
• kidney disease,
• urination problems due to prostate enlargement,
• heart disease, including rhythm disorders, recent myocardial infarction, heart failure, or if the patient is taking medications that affect heart rhythm,
• hypertension,
• glaucoma (increased eye pressure),
• mental illness, such as: hypomania in patients with bipolar affective disorder (alternating elevated mood/depressive mood),
• decreased white blood cell count or their absence (see section 4 "Possible side effects").

The patient should consult their doctor in case of the above situations.

Miansec 30 and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or
have recently taken, as well as any medicines they plan to take .
Other medicines may affect the action of Miansec 30, and Miansec 30 may affect other medicines.
Mianserin should not be taken in combination with:

• - monoamine oxidase inhibitors (MAOIs)or within two weeks of stopping their use. If Miansec 30 treatment is stopped, MAOIs should not be taken for two weeks. MAOIs include: moclobemide, tranylcypromine (antidepressants), selegiline (used in the treatment of Parkinson's disease), and linezolid (an antibiotic).

Caution should be exercised when taking mianserin in combination with:

• antiepileptic drugs such as carbamazepine and phenytoin.
• anticoagulant medications such as warfarin. Mianserin may enhance the effect of warfarin. The patient should inform their doctor about taking these medications. In the case of combined treatment with mianserin, it is recommended to monitor blood tests.
• medications that may affect heart rhythm, such as certain antibiotics and antipsychotic medications.

Taking Miansec 30 with alcohol

The patient should not drink alcoholic beverages during treatment, as Miansec 30 enhances the effect of alcohol.

Children and adolescents

Miansec 30 should not be used in children and adolescents under the age of 18 - see section 2.
If the doctor considers it necessary, they may prescribe its use.
Patients in this age group taking Miansec 30 are more likely to experience side effects such as suicidal attempts, suicidal thoughts, hostility, aggression, rebellious behavior, and expressions of anger. There is a lack of data on the long-term use of Miansec 30 and its impact on growth, maturation, cognitive development, and behavior in children under 18 years of age.
In case of occurrence or worsening of the above side effects or any doubts during treatment, the patient should contact their doctor or pharmacist.

Pregnancy, breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Animal studies and limited human data suggest that mianserin does not have a harmful effect on the fetus or newborn. Mianserin passes into breast milk in very small amounts. The doctor should weigh the benefits of mianserin use during pregnancy and breastfeeding against the potential risk to the fetus or newborn.

Driving and operating machinery

Miansec 30 may cause drowsiness.
The patient should not drive vehicles, as Miansec 30 reduces psychomotor abilities.
The patient should not operate any machines or use tools.

Miansec 30 contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.

3. How to take Miansec 30

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The tablets should be taken orally without chewing, with a liquid.

Adults

The doctor will adjust the dosage individually for each patient.
Treatment should usually be started with a lower dose (30 mg per day), and then the dose can be increased to achieve the desired response from the patient.
The dosage is from 60 to 90 mg, depending on the severity of depression. To ensure the effectiveness of treatment, the medicine should be taken every day. The patient should strictly follow the recommended dosages and instructions for taking the medicine. The tablets should be taken every day at the same time, preferably in a single dose before bedtime.
If the doctor recommends, mianserin can also be taken in divided doses (one in the morning and one in the evening before bedtime).
The tablets should be swallowed without chewing, with a small amount of water or other liquids. The patient should not stop treatment immediately after improvement. Too early or sudden discontinuation of the medicine may lead to worsening of the patient's condition.
The patient should consult their doctor, who will decide how to reduce the dosage and when treatment should be stopped.

Elderly patients

The dosage should be adjusted individually for each patient. Initially, the dose should not be higher than 30 mg per day. The dose can be increased every few days. Usually, a dose lower than that for adults is sufficient to achieve a satisfactory clinical response from the patient.

Use in children and adolescents

Miansec 30 should not be used in the treatment of children and adolescents under the age of 18 - see section 2.

Taking a higher dose of Miansec 30 than recommended

In case of taking a higher dose of Miansec 30 than recommended, the patient should immediately consult their doctor or pharmacist.
The patient should induce vomiting as soon as possible. Symptoms of mianserin overdose include prolonged drowsiness or sleepiness. Other symptoms of overdose may include changes in heart rhythm (accelerated, irregular heartbeat) and/or fainting. These may be symptoms of life-threatening ventricular arrhythmias known as "torsade de pointes".

Missing a dose of Miansec 30

The patient should 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, the patient should not take the missed dose in the morning, as this may cause drowsiness and sleepiness during the day. The patient should 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) the patient should:

• in case of missing the morning dose, take it together with the evening dose;
• in case of missing the evening dose, 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, not try to make them up; the next day, the patient should continue treatment, taking the usual doses: morning and evening.

Stopping treatment with Miansec 30

Although mianserin 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 related to the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Miansec 30 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.

The patient should immediately contact their doctor or go to the hospital.

Mianserin may cause a decrease in white blood cell count, which reduces the body's immunity to infections. If the patient experiences fever, sore throat, mouth ulcers, or other signs of infection, they should immediately consult their 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 effectsinclude:

• low blood pressure, manifested by dizziness, fainting, or fainting when changing body position;
• seizures;
• hypomania;
• increased liver enzyme levels;
• swelling of the ankles or feet due to fluid accumulation;
• yellowing of the eyes or skin, which may indicate liver function disorders;
• hepatitis;
• slow heart rate after initial dose administration;
• malignant neuroleptic syndrome (the most important symptoms are stiffness of the whole body, involuntary movements, increased body temperature);
• joint pain;
• restless legs syndrome (a feeling of burning, tingling in the legs, causing insomnia);
• rash;
• changes in heart rhythm (accelerated, 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, decreasing with continued therapy).

Suicidal thoughts, depression, or anxiety

People with depression or anxiety disorders may sometimes have thoughts of self-harm or
suicidal thoughts. Such thoughts may worsen at the beginning of therapy with antidepressants, as these medicines usually start to work after 2 weeks, sometimes later.
The occurrence of suicidal thoughts, thoughts of self-harm, or suicide 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 under the age of 25 with mental disorders who have been treated with antidepressants.

If the patient experiences suicidal thoughts or thoughts of self-harm, they should immediately
contact their doctor or go to the hospital.
It may be helpful if the patient informs their relatives or friends about their depression or anxiety disorders and asks them to read this leaflet. The patient can also ask them to tell them if they think their depression or anxiety has worsened, or if they have noticed any worrying changes in their behavior.
The frequency and severity of symptoms occurring in depression, such as dry mouth and constipation, usually do not increase during treatment with mianserin.
Unwanted symptoms resulting from anticholinergic action (such as dry mouth, vision disturbances, accelerated heart rate, constipation, difficulty urinating) and heart disorders occur less frequently and are milder than with tricyclic antidepressants.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309,
website: http://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Miansec 30

Store in a temperature 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 given month.

6. Contents of the pack and other information

What Miansec 30 contains

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

What Miansec 30 looks like and what the pack contains

Miansec 30 is a light blue, round, biconvex, film-coated tablet.
The medicine is available in:
blister packs of 20, 30, or 90 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland
Bausch Health Poland sp. z o.o.
ul. Przemysłowa 2
35-959 Rzeszów
Poland

Date of last revision of the leaflet: