Deprexolet

Leaflet attached to the packaging: patient information

Deprexolet, 10 mg, coated tablets

Deprexolet, 30 mg, coated tablets

Mianserin hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any further doubts, consult a doctor, pharmacist, or nurse.
• 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 any of the side effects worsen or if any side effects not mentioned in the leaflet occur, tell your doctor or pharmacist or nurse.

Table of contents of the leaflet

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

1. What is Deprexolet and what is it used for

Deprexolet is an antidepressant that contains mianserin as the active substance.
Mianserin is a tetracyclic antidepressant with a complex mechanism of action.
The medicine also has sedative properties. The antidepressant effect occurs after a few days of treatment, while clinical improvement is usually observed after a few weeks.
The sedative and sleep-inducing effects of the medicine may appear as early as the first day of treatment and are strongest in the first week of treatment.
Compared to tricyclic antidepressants, mianserin is better tolerated by patients and does not affect the circulatory system at therapeutic doses.
After oral administration, mianserin is rapidly absorbed, but its bioavailability is only about 30%. Mianserin binds to a large extent (90%) to plasma proteins. It easily penetrates tissues, including the central nervous system. It is metabolized in the liver and excreted mainly in the urine.

Indications

Treatment of depressive syndrome.

2. Important information before taking Deprexolet

When not to take Deprexolet

Do not take at the same time as MAO inhibitors and for 2 weeks after stopping their use.

Warnings and precautions

Before starting treatment with Deprexolet, discuss it with your doctor or pharmacist.
Below are situations in which you should be particularly cautious when taking Deprexolet.
Warnings about suicidal thoughts and behaviors
If you have suicidal thoughts or thoughts of self-harm, contact your doctor or go to the hospital immediately.
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 ask your relatives or friends for help and ask them to inform you if they notice that your depression or anxiety has worsened or if there are worrying changes in your behavior .
Be cautious if you:

• have recently had a heart attack or have a heart block;
• have bone marrow damage;
• have diabetes (you should have your blood glucose levels regularly checked);
• have high blood pressure (you should have your blood pressure regularly checked);
• have liver or kidney failure;
• have epilepsy;
• have narrow-angle glaucoma;
• have an enlarged prostate;
• have bipolar disorder (you may experience a state of hypomania; in such a case, treatment should be discontinued).

The medicine may enhance the inhibitory effect of alcohol on the central nervous system.
In case of planned surgery, inform the anesthesiologist about taking mianserin.
Treatment should be discontinued in case of jaundice or seizures.
During the first three months of treatment, especially in elderly patients, blood morphology should be checked every 4 weeks. Your doctor will also recommend periodic checks of liver and kidney function.
Due to the fact that improvement may occur only after 2-4 weeks of treatment, patients treated with mianserin should be under special supervision during this period.
In some cases, improvement in the clinical condition is achieved only after several months of treatment with mianserin.
Discuss this with your doctor, even if the above warnings concern situations that occurred in the past.

Children

Do not use the medicine in children.

Elderly patients

Be cautious, although mianserin is usually better tolerated than tricyclic antidepressants.
Dosage, see section 3.

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.
Mianserin should not be administered at the same time as or within 2 weeks after discontinuation of monoamine oxidase inhibitors (MAOIs).
The medicine does not show significant clinical interactions with blood pressure-lowering medicines, such as betanidine, clonidine, hydralazine, guanethidine, and propranolol. However, it is recommended to check blood pressure more frequently in these cases.
In patients treated with phenytoin, it is recommended to monitor the concentration of the medicine in the blood when mianserin is used at the same time.
Mianserin can be used in patients treated with oral anticoagulants derived from hydroxycoumarin. However, in this case, blood coagulation parameters should be checked more frequently.
No interactions have been found between mianserin and medicines stimulating the sympathetic nervous system.
Mianserin enhances the effect of alcohol, barbiturates, sedatives, and anxiolytics, as well as the antidepressant effect of fluoxetine.
Concomitant administration of mianserin with digitalis glycosides or antiarrhythmic medicines with a quinidine-like effect increases the risk of cardiac arrhythmias.
Mianserin reduces the concentration of 1,25-dihydroxycholecalciferol in the blood.
The medicine may enhance the effect of medicines blocking the parasympathetic nervous system.

Deprexolet with food and drink

No data available.
During treatment with mianserin, do not drink alcohol.

Pregnancy and breastfeeding

In pregnancy, during breastfeeding, or if you suspect you are pregnant, or if you plan to become pregnant, consult your doctor before taking this medicine.
Mianserin passes through the placenta to a small extent. The medicine can be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
Mianserin passes into breast milk to a small extent. The medicine should not be used in breastfeeding women. If antidepressant treatment with mianserin is necessary, breastfeeding should be discontinued.
Consult your doctor before taking the medicine.

Driving and using machines

Due to the possibility of side effects affecting the central nervous system, such as fatigue or drowsiness, do not drive vehicles or operate machines while taking mianserin.

Deprexolet contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means that the medicine is considered "sodium-free".

3. How to take Deprexolet

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Swallow the tablets whole, without chewing.
Initially, for the first few days, 30 mg (3 tablets of 10 mg or 1 tablet of 30 mg) should be administered per day in a single dose, in the evening or in divided doses. The usual maintenance dose is 30-90 mg (3-9 tablets of 10 mg or 1-3 tablets of 30 mg) per day. Some patients may require higher doses of the medicine.
The medicine is usually well tolerated in divided doses up to 200 mg per day. However, the maximum dose for the treatment of depression has been set at 120 mg (12 tablets of 10 mg or 4 tablets of 30 mg) per day.
Antidepressant treatment should be continued for at least several months (4-6 months) after the symptoms of depression have subsided.
In elderly patients, during the initial treatment period, do not exceed 30 mg (3 tablets of 10 mg) per day. The dose of the medicine should be increased cautiously.

Use in children

Do not use this medicine in children.

Elderly patients

Be cautious, although mianserin is usually better tolerated than tricyclic antidepressants.

Overdose of Deprexolet

In case of overdose, contact your doctor immediately.
The most common symptom of mianserin overdose is prolonged sedation and drowsiness.
Rarely, the following may occur: cardiac arrhythmias, severe hypotension, seizures, or respiratory disorders. There is no specific antidote for mianserin. Gastric lavage and symptomatic treatment are recommended.

Missed dose of Deprexolet

Take the missed dose as soon as possible. If it is almost time for the next dose, do not take a double dose to make up for the missed dose.
If you have any further doubts about taking this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effect of mianserin is drowsiness, especially in the first few days of treatment. This symptom may worsen after consuming alcohol.
During treatment with mianserin, bone marrow damage may occur, manifested by changes in the blood count, most often between the 4th and 6th week of treatment. This complication occurs more frequently in elderly patients, is reversible, and disappears completely after discontinuation of the medicine.
Jaundice, hypomania, or seizures may occur even at therapeutic doses and are indications for discontinuation of mianserin. The occurrence of infection symptoms (e.g., fever, sore throat, oral inflammation, or other inflammatory conditions) is an indication for discontinuation of the medicine and ordering a blood morphology test with a smear.
The frequency of possible side effects listed below is defined as follows:
Common (may affect up to 1 in 10 people): weight gain, sedation occurring at the beginning of treatment, decreasing with continued therapy (Note: reducing the dose usually does not lead to less sedation, but may jeopardize the efficacy of the antidepressant), drowsiness (especially in the first few days of treatment), increased liver enzyme levels, edema.
Uncommon (may affect up to 1 in 100 people): orthostatic hypotension, skin rash, joint pain.
Rare (may affect up to 1 in 1000 people): changes in blood count (usually granulocytopenia or agranulocytosis), hypomania (longer-lasting mood, drive, or activity disorders), seizures, hyperkinesia (restless legs syndrome), neuroleptic malignant syndrome, rare tachycardia after initial dose, jaundice.
Frequency not known (cannot be estimated from the available data): anemia, increased appetite, suicidal thoughts, suicidal behaviors, in patients with bipolar disorder, phase change, worsening of psychotic symptoms, dizziness, liver damage, excessive sweating, tremor, weakness, gynecomastia (breast enlargement in men), breast tenderness, galactorrhea.
Suicidal thoughts, worsening of depression or anxiety disorders
People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressants, as these medicines usually start working after 2 weeks, sometimes later.
The occurrence of suicidal thoughts, thoughts of self-harm, or suicide is more likely:

If you experience any side effects, including any possible side effects not listed in the leaflet, consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Deprexolet

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Deprexolet contains

• The active substance of the medicine is mianserin hydrochloride. One tablet contains 10 mg or 30 mg of mianserin hydrochloride.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, povidone, citric acid monohydrate, magnesium stearate, macrogol 8000, hypromellose (E5), hypromellose (E15), hydroxypropyl cellulose, titanium dioxide (E 171).

What Deprexolet looks like and contents of the pack

Deprexolet 10 mg: white or almost white, round, smooth, biconvex tablets with the imprint "10".
Deprexolet 30 mg: white or almost white, round, smooth, biconvex tablets with the imprint "30".
The pack contains 30, 60, or 90 coated tablets.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Date of last revision of the leaflet: