Deprexolet

Package Leaflet: Information for the Patient

Deprexolet, 10 mg, Coated Tablets

Deprexolet, 30 mg, 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.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others.
• It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, or if any side effects get worse, 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 drug also has sedative properties. The antidepressant effect occurs after several days of treatment, while clinical improvement is usually observed after several weeks.
The sedative and sleep-inducing effects of the drug 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 cardiovascular 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

• if you are allergic to mianserin or any other ingredients of this medicine (listed in section 6);
• if you have been diagnosed with manic excitement;
• if you have been diagnosed with severe liver damage.

Do not take at the same time as MAO inhibitors and up to 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 careful when taking Deprexolet.
Suicide warnings and suicidal thoughts
If you experience 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 careful 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;
• suffer from epilepsy;
• have narrow-angle glaucoma;
• have an enlarged prostate;
• suffer from bipolar disorder (you may experience a state of hypomania; in such a case, treatment should be discontinued).

The drug may enhance the inhibitory effect of alcohol on the central nervous system.
In the event 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, it is recommended to monitor the full blood count every 4 weeks. The doctor will also recommend periodic monitoring 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.
You should discuss this with your doctor, even if the above warnings concern situations that occurred in the past.

Children

Do not use this medicine in children.

Elderly patients

Caution should be exercised, although mianserin is usually better tolerated than tricyclic antidepressants.
Dosing, 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 given at the same time as or within 2 weeks after discontinuing monoamine oxidase inhibitors (MAOIs).
The drug does not show clinically significant interactions with blood pressure-lowering drugs, such as betanidine, clonidine, hydralazine, guanethidine, and propranolol. However, it is recommended to monitor blood pressure more frequently in these cases.
In patients treated with phenytoin, it is recommended to monitor the drug's blood levels when mianserin is used concomitantly.
Mianserin can be used in patients treated with oral anticoagulants derived from hydroxycoumarin. However, in this case, blood coagulation parameters should be more frequently monitored.
No interactions have been found between mianserin and drugs 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 drugs with a quinidine-like effect increases the risk of cardiac arrhythmias.
Mianserin reduces the level of 1,25-dihydroxycholecalciferol in the blood.
The drug may enhance the effect of drugs blocking the parasympathetic nervous system.

Deprexolet with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Mianserin passes through the placenta to a small extent. The drug can be used during pregnancy only when, 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 drug should not be used during breastfeeding. If antidepressant treatment with mianserin is necessary, breastfeeding should be discontinued.
Before taking the medicine, consult your doctor.

Driving and using machines

Due to the possibility of central nervous system side effects, such as fatigue or drowsiness, do not drive or operate machinery 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.
In case of doubt, consult 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) per day should be administered 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 drug.
The drug is usually well tolerated in divided doses up to 200 mg per day. However, the maximum dose in 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 disappeared.
In elderly patients, in the initial treatment period, do not exceed 30 mg (3 tablets of 10 mg) per day. The dose of the drug should be increased with caution.

Use in children

Do not use this medicine in children.

Elderly patients

Caution should be exercised, although mianserin is usually better tolerated than tricyclic antidepressants.

Overdose of Deprexolet

If you have taken more than the prescribed dose of the medicine, 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. However, 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 questions about the use of this medicine, ask 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 be exacerbated by alcohol consumption.
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 drug.
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 drug and ordering a blood count 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 1,000 people): changes in the 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 behavior, 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 drugs usually start working after 2 weeks, sometimes later.
The occurrence of suicidal thoughts, thoughts of self-harm, or suicide is more likely:

• if you have had suicidal thoughts or self-harm in the past;
• if you are a young adult; data from clinical trials indicate an increased risk of suicidal behavior in people under 25 years of age with mental disorders who were treated with antidepressants.

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

Reporting side effects

If you experience any side effects, including any side effects 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: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this 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 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 no longer required. 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 carmellose, 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 inscription "10".
Deprexolet 30 mg: white or almost white, round, smooth, biconvex tablets with the inscription "30".
The pack contains 30, 60, or 90 coated tablets.

Marketing Authorisation 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: