Package leaflet: Information for the user

Deprexolet, 60 mg, coated tablets
Mianserin hydrochloride
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet so that you can read it again if necessary.
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. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

What Deprexolet is and what it is used for
What you need to know before taking Deprexolet
How to take Deprexolet
Possible side effects
How to store Deprexolet
Contents of the pack and other information

1. What Deprexolet is and what it is used for

Deprexolet is an antidepressant medicine containing mianserin hydrochloride as the active substance.
Deprexolet is an antidepressant. It helps relieve depressive moods, which are the most common symptom of depression. Depression is a mental illness. During depression, changes occur in the brain. Brain nerve cells 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.
Improvement usually occurs after 2 to 4 weeks of treatment.

2. Important information before using Deprexolet

When not to use Deprexolet
If the patient is allergic to mianserin or any of the other ingredients of this medicine
(listed in section 6);

if the patient is experiencing mania (a state of excitement and excessive activity);
if the patient has severe liver failure;
if the patient is taking or has recently taken (within the last two weeks) medicines which are monoamine oxidase inhibitors (MAO inhibitors).

Warnings and precautions
Before starting to take Deprexolet, discuss this with your doctor or pharmacist.
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, particularly 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 thoughts;
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.

Seek immediate medical advice from your doctor or go to hospital if you experience
suicidal thoughts or thoughts of self-harm.
It may be helpful to inform family members or friends about your depression or anxiety disorders and ask them to read this leaflet. You may wish to ask for support from family or friends and request them to inform you if they notice worsening of depression or anxiety, or any disturbing changes in behaviour.
Exercise particular caution when using Deprexolet if you have or have ever had:

epilepsy (seizures);
diabetes;
liver diseases, such as jaundice;
kidney diseases;
problems with passing urine due to enlarged prostate;
heart diseases, including disorders causing changes in heart rhythm, recent heart attack, heart failure, or if the patient is taking medicines causing changes in heart rhythm;
high blood pressure;
glaucoma (increased pressure in the eye);
psychiatric disorders, such as occurrence of hypomania in patients with bipolar affective disorder (alternating episodes of elevated mood/depressed mood);
reduced number of white blood cells 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
Deprexolet is generally not recommended for use in children and adolescents under 18 years of age. When taking medicines of this class, patients under 18 years of age are at increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, oppositional behaviour and irritability). Nevertheless, your doctor may prescribe Deprexolet to patients under 18 years of age if he or she considers it necessary. If your doctor has prescribed Deprexolet to a patient under 18 years of age and you have any concerns, please consult your doctor. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Deprexolet, inform your doctor. Furthermore, there are currently no data on the long-term safety of Deprexolet with regard to growth, maturation, cognitive development and behavioural development in this age group.
Deprexolet and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without prescription.
Other medicines may affect the action of Deprexolet, and Deprexolet may also affect other medicines.
Do not use Deprexolet in combination with:

monoamine oxidase inhibitors (MAO inhibitors), or within two weeks after stopping such treatment. After discontinuing Deprexolet, 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 Deprexolet in combination with:
antiepileptic medicines such as carbamazepine and phenytoin;
anticoagulant medicines such as warfarin. Deprexolet may enhance the effect of warfarin. Inform your doctor if you are taking these medicines. When treating concomitantly with Deprexolet, monitoring of blood parameters is recommended;
medicines that may affect heart rhythm, such as certain antibiotics and antipsychotic medicines.

Food and alcohol
Do not drink alcohol while taking Deprexolet, as it may intensify the effects of alcohol.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Animal studies and limited human safety data suggest that mianserin has no harmful effect on the foetus or newborn. Mianserin passes into breast milk only in very small amounts. The benefits of mianserin treatment for the mother during pregnancy and breastfeeding should be weighed against the potential risks to the foetus or newborn.
Driving and operating machinery
Deprexolet may cause drowsiness.
Do not drive, as Deprexolet may impair psychomotor performance. Do not operate machinery or use tools.

3. How to use Deprexolet

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Recommended dose
Treatment should usually be started at a lower dose (30 mg per day), which may then be increased
until the appropriate patient response is achieved.
The usual dose ranges from 60 to 90 mg per day, depending on the severity of depression. To ensure
treatment effectiveness, the medicine should be taken daily. It is essential to strictly follow the
recommended dosing instructions and directions for use. Tablets should be taken every day at the
same time, preferably as a single dose before going to bed.
If your doctor advises, Deprexolet may also be taken in divided doses (one in the morning and the
second in the evening before going to bed).
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. Stopping the medicine too early
or abruptly 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 per day. The
dose may 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:
Deprexolet should not be used in the treatment of children and adolescents under 18 years of age.
Taking more than the recommended dose of Deprexolet
If more Deprexolet has been taken than prescribed, seek immediate advice from your doctor or
pharmacist.
Vomiting should be induced as quickly as possible. Symptoms of overdose include prolonged
drowsiness or sleepiness. 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 Deprexolet
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 going to bed, do not take the
missed dose in the morning, as this may cause drowsiness and sleepiness during the day. 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 going to bed), then:

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

Stopping Deprexolet
Although Deprexolet is not addictive, sudden 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 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 will experience them.
The following adverse effects have been reported during treatment with Deprexolet at an unknown frequency (frequency cannot be estimated from the available data):

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 following initial dose administration;
neuroleptic malignant syndrome (key symptoms include whole-body stiffness, involuntary movements, and increased body temperature);
joint pain;
restless legs syndrome (a burning or tingling sensation in the legs, leading to 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.

Additionally, the following transient effects may occur:

lethargy or drowsiness,
weight gain,
self-harming thoughts or suicidal thoughts.

If self-harming thoughts or suicidal thoughts occur, contact a doctor immediately
or go to a hospital.
In rare cases, Deprexolet may cause a deficiency of white blood cells, resulting in
reduced resistance to infections. If fever, sore throat, oral ulcers, or other signs of infection occur,
seek immediate medical advice and have a blood test performed. These symptoms usually appear 4–6 weeks after starting treatment and resolve upon discontinuation of the medicine.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a 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, phone: +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 Deprexolet

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What the medicinal product contains

The active substance is mianserin hydrochloride. One tablet contains 60 mg of mianserin hydrochloride.
The other ingredients are: calcium hydrogen phosphate dihydrate, pregelatinized corn starch, methylcellulose, colloidal anhydrous silica, magnesium stearate, hypromellose E5, hypromellose E15, macrogol 8000, hydroxypropylcellulose, titanium dioxide (E 171).

What Deprexolet looks like and contents of the pack
The tablets are white or almost white, oblong, measuring 18.08 mm/7.30 mm/5.50 mm, biconvex with a division line on one side. The tablets can be divided into two equal parts.
Packaging of 60 mg coated tablets: PVC/Aluminum or PVC/PVDC/Aluminum blisters in a cardboard box – 30 tablets (3 blisters with 10 tablets each).
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5,
95-200 Pabianice