Miansec

Package Leaflet: Information for the Patient

MIANSEC, 10 mg, Film-Coated Tablets

Mianserin Hydrochloride

Read the Leaflet Carefully Before Taking the Medication, 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 medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those 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 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 medication that contains mianserin hydrochloride as the active substance.
Miansec is an antidepressant medication that provides relief in the treatment of depressive moods,
which are the most common symptoms of depression. Depression is a disorder whose symptoms
include: 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.
Antidepressant medications 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 origins, in which pharmacological treatment is indicated.

2. Important Information Before Taking Miansec

When Not to Take 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 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 inhibitor (MAOI) medications.

Warnings and Precautions

Before starting treatment with Miansec, discuss it with a doctor or pharmacist.

Suicidal Thoughts and Depression

Patient 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 medication starts to work, which usually takes about two
weeks or sometimes longer.
This may occur:

• if the patient has had suicidal thoughts or self-harm in the past.
• 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 antidepressant medications. You should immediately contact a doctor or go to the hospital if you experience suicidal thoughts or thoughts of self-harm.

It may be helpfulif you tell someone in your family or a close person that 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 has worsened, or if they are concerned about changes in your behavior.

Special Caution is Required When Taking Miansec 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 illnesses, 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").

Consult a doctor in case of the above situations.

Miansec and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Other medications may affect the action of Miansec, and Miansec may affect other medications.
Mianserin should not be used in combination with:

• - monoamine oxidase inhibitors (MAOIs)or within two weeks of stopping their administration. In case of stopping Miansec, 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 is advisedwhen taking mianserin in combination with:

• antiepileptic drugssuch as carbamazepine and phenytoin.
• anticoagulant medicationssuch as warfarin. Mianserin may enhance the effect of warfarin. Inform your doctor about taking these medications. In 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 with Alcohol

Do not drink alcoholic beverages during treatment, as Miansec enhances the effect of alcohol.

Children and Adolescents

Miansec 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 are more likely to experience side effects such as suicidal attempts, suicidal thoughts, hostility, aggression, rebellious behavior, and manifestations of anger. There is a lack of data on the long-term use of Miansec 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-mentioned side effects or any doubts during treatment, consult a doctor or pharmacist.

Pregnancy, Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medication.
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 doctor should weigh the benefits of mianserin for the mother against the potential risk to the fetus or newborn.

Driving and Operating Machines

Miansec may cause drowsiness.
Do not drive vehicles, as Miansec reduces psychomotor abilities.
Do not operate any machines or use tools.

3. How to Take Miansec

Always take this medication exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Take the tablets orally without chewing, with a liquid.

Adults

The doctor will adjust the dosage individually for each patient.
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 60 to 90 mg, depending on the severity of depression. To ensure the effectiveness of treatment, take the medication every day. Strictly follow the recommended dosages and instructions for taking the medication. Take the tablets 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).
Swallow the tablets without chewing, with a small amount of water or other liquids. Do not stop treatment immediately after improvement. Premature or sudden discontinuation of the medication may lead to worsening of the condition.
Consult a doctor who will decide how to reduce the dosage and when treatment should be stopped.

Elderly Patients

The doctor will adjust the dosage individually for each patient. Initially, the dose should not exceed 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.

Use in Children and Adolescents

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

Overdose of Miansec

In case of taking a higher dose of Miansec than recommended, immediately consult a doctor or pharmacist.
Induce vomiting as soon as possible. Symptoms of mianserin overdose include prolonged drowsiness or sleepiness. Overdose symptoms 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".

Missed Dose of Miansec

Do not take a double dose to make up for a missed dose.
In case of missing a dose, if the medication 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 medication in the evening according to the previously established schedule.
In case of missing one or both doses, if the medication is taken twice a day(one dose in the morning after breakfast and one before bedtime):

• 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 medication 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 Miansec Treatment

Although mianserin is not addictive, sudden discontinuation of the medication after long-term use may cause dizziness, agitation, anxiety, headache, and nausea. Therefore, the dose of the medication should be gradually reduced.
In case of any further doubts about taking the medication, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medications, Miansec 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.

Immediately Contact a Doctor or Go to the Hospital.

Mianserin May Cause a Decrease in White Blood Cell Count, Which Reduces the Body's Resistance to Infections. If You Experience Fever, Sore Throat, Mouth Ulcers, or Other Infection Symptoms, Immediately Consult a Doctor and Have a Blood Test.

These symptoms usually occur after 4-6 weeks of treatment and disappear after discontinuation of the medication.
Other side effectsinclude:

• low blood pressure, manifested by dizziness, darkening of vision, or fainting after sudden changes in 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 suicide. Such thoughts may worsen at the beginning of treatment with antidepressant medications, as these medications usually start to work after 2 weeks, sometimes later.
The occurrence of suicidal thoughts, self-harm, or suicide is more likely if:

• the patient has had suicidal thoughts or self-harm in the past.
• 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 treated with antidepressant medications.

If you experience suicidal thoughts or thoughts of self-harm, immediately contact a doctor or go to the hospital.
It may be helpful to inform your relatives or friends about your 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 has worsened, or if they are concerned about changes in your behavior.
The frequency and severity of symptoms occurring in depression, such as dry mouth and constipation, usually do not increase during treatment with mianserin.
Undesirable 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 antidepressant medications.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
Reporting side effects will help to gather more information on the safety of the medication.

5. How to Store Miansec

Store in a temperature below 25°C. Store in the outer packaging to protect from light.
Keep the medication out of 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 month stated.

6. Contents of the Pack and Other Information

What Miansec Contains

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

What Miansec Looks Like and Contents of the Pack

Miansec is a round, biconvex white film-coated tablet.
The medication is available in:
PVC/Aluminum blisters in a cardboard box
30 tablets (1 blister of 30 tablets)
90 tablets (3 blisters of 30 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
Wincentego Pola 21
58-500 Jelenia Góra
Poland
Bausch Health Poland sp. z o.o.
Przemysłowa 2
35-959 Rzeszów
Poland

Date of Last Revision of the Leaflet: