Deprexolet

Package Leaflet: Information for the User

Deprexolet, 60 mg, Coated Tablets

Mianserin Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medication 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, Including Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 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 Medication Containing the Active Substance Mianserin Hydrochloride.
Deprexolet is an Antidepressant. It Relieves 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 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.

2. Important Information Before Taking Deprexolet

When Not to Take Deprexolet

If You are Allergic to Mianserin or Any of the Other Ingredients of this Medication (Listed in Section 6);

• If You Have Mania (a State of Excitement and Excessive Activity);
• If You Have Severe Liver Failure;
• If You are Taking or Have Recently Taken (Within the Last Two Weeks) Monoamine Oxidase Inhibitor (MAOI) Medications.

Warnings and Precautions

Before Starting to Take Deprexolet, Discuss it with Your Doctor or Pharmacist.

Suicidal Thoughts and Depression Worsening

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 Happen:

• If You Have Had Suicidal Thoughts or Self-Harm in the Past.
• If You are 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 Contact Your Doctor or Go to the Hospital Immediately if You Experience Suicidal Thoughts or Self-Harm.
It May be Helpful to Inform Your Relatives or Friends About Your Depression or Anxiety Disorders and Ask Them to Read this Package Leaflet. You Can Ask Your Relatives or Friends for Help and Ask Them to Pass on the Information if They Notice that Your Depression or Anxiety has Worsened or if You Have Concerning Changes in Behavior.

Special Caution is Required When Taking Deprexolet if You Have or Have Had:

• Epilepsy (Seizures),
• Diabetes,
• Liver Diseases, Such as Jaundice,
• Kidney Diseases,
• Urination Problems Due to Prostate Enlargement,
• Heart Diseases, Including Those that Cause Changes in Heart Rhythm, Recent Myocardial Infarction, Heart Failure, or if You are 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/Depressed Mood),
• Decreased White Blood Cell Count or Absence of White Blood Cells (See Section 4 "Possible Side Effects").

You Should Consult Your Doctor if You Experience Any of the Above Situations.

Children and Adolescents

Deprexolet Should Not be Used in Children and Adolescents Under the Age of 18. In the Case of Taking Medications of this Class, Patients Under the Age of 18 are at Increased Risk of Side Effects, Such as Suicidal Attempts, Suicidal Thoughts, and Hostility (Especially Aggression, Rebellious Behavior, and Anger Outbursts). However, the Doctor May Prescribe Deprexolet to Patients Under the Age of 18 if They Consider it Necessary. If the Doctor Has Prescribed Deprexolet to a Patient Under the Age of 18, and You Have Any Doubts, Please Consult Your Doctor. If the Above Symptoms Develop or Worsen in Patients Under the Age of 18 Taking Deprexolet, You Should Inform Your Doctor. Additionally, There is Currently a Lack of Data on the Long-Term Safety of Deprexolet in this Age Group Regarding Growth, Maturation, and Cognitive and Behavioral Development.

Deprexolet and Other Medications

Tell Your Doctor About All Medications You are Currently Taking or Have Recently Taken, as Well as Medications You Plan to Take, Including Those Available Without a Prescription.
Other Medications May Affect the Action of Deprexolet, and Deprexolet May Affect Other Medications.
Do Not Take Deprexoletin Combination with:

• Monoamine Oxidase Inhibitors (MAOIs), or Within Two Weeks of Stopping Their Use. If You Stop Taking Deprexolet, You Should Not Take MAOIs for Two Weeks. MAOIs Include: Moclobemide, Tranylcypromine (Antidepressants), Selegiline (Used in the Treatment of Parkinson's Disease), and Linezolid (Antibiotic).
  Be CautiousWhen Taking Deprexolet in Combination with:
  • Antiepileptic Medications, Such as Carbamazepine and Phenytoin.
  • Anticoagulant Medications, Such as Warfarin. Deprexolet May Enhance the Effect of Warfarin. You Should Inform Your Doctor if You are Taking These Medications. In the Case of Combined Treatment with Deprexolet, it is Recommended to Monitor Blood Tests.
  • Medications that May Affect Heart Rhythm, Such as Certain Antibiotics and Antipsychotic Medications.

  Deprexolet with Food and Drink

  Do Not Drink Alcohol While Taking Deprexolet, as it Enhances the Effect of Alcohol.

  Pregnancy and Breastfeeding

  If You are Pregnant or Breastfeeding, Think You May be Pregnant, or Plan to Have a Child, Consult Your 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 Benefits of Mianserin Use During Pregnancy and Breastfeeding Should be Weighed Against the Possible Risk to the Fetus or Newborn.

  Driving and Operating Machines

  Deprexolet May Cause Drowsiness.
  Do Not Drive Vehicles, as Deprexolet Reduces Psychomotor Abilities. Do Not Operate Machines or Use Tools.

  3. How to Take Deprexolet

  This Medication Should Always be Taken as Directed by Your Doctor. If You Have Any Doubts, Consult Your Doctor or Pharmacist.
  Recommended Dose
  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.
  The Dosage is 60 to 90 mg per Day, Depending on the Severity of Depression. To Ensure the Effectiveness of Treatment, the Medication Should be Taken Every Day. You Should Strictly Follow the Recommended Doses and Instructions for Taking the Medication. Tablets Should be Taken Every Day at the Same Time, Preferably in a Single Dose Before Bedtime.
  If Your Doctor Recommends, Deprexolet Can Also be Taken in Divided Doses (One in the Morning and One in the Evening Before Bedtime).
  Tablets Should be Swallowed Without Chewing, with a Small Amount of Water or Other Fluids.
  Do Not Stop Treatment Abruptly After Improvement. Stopping Treatment Too Early or Suddenly May Lead to a Worsening of Your Condition.
  Consult Your Doctor, Who Will Decide How to Reduce the Dose and When to End Treatment.

  Elderly Patients:

  The Dose Should be Adjusted Individually for Each Patient. Initially, the Dose Should be 30 mg per Day. The Dose Can be Increased Every Few Days.
  Usually, a Lower Dose than 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 the Age of 18.

  Overdose of Deprexolet

  In Case of Taking a Higher Dose of Deprexolet than Recommended, Consult Your Doctor or Pharmacist Immediately.
  Induce Vomiting as Soon as Possible. Symptoms of Deprexolet 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.

  Missing a Dose of Deprexolet

  Do Not Take a Double Dose to Make Up for a Missed Dose.
  If You Miss a Dose and Take the Medication 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.
  If You Miss a Dose of One or Both, and You Take the Medication Twice a Day(One Dose in the Morning After Breakfast and One Before Bedtime):

  • If You Miss the Morning Dose, Take it with the Evening Dose;
  • If You Miss 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;
  • If You Miss Both Doses, Do Not Try to Make Them Up; the Next Day, Continue Treatment, Taking the Usual Doses: Morning and Evening.

  Stopping Deprexolet Treatment

  Although Deprexolet is Not Addictive, Stopping the Medication Abruptly After Long-Term Use May Cause Dizziness, Excitement, Anxiety, Headache, and Nausea. Therefore, the Dose of the Medication Should be Gradually Reduced.
  If You Have Any Further Questions About the Use of this Medication, Consult Your Doctor or Pharmacist.

  4. Possible Side Effects

  Like All Medications, Deprexolet Can Cause Side Effects, Although Not Everybody Gets Them.
  During Treatment with Deprexolet, the Following Side Effects Have Been Reported with an Unknown Frequency (Cannot be Estimated from the Available Data):

  • Low Blood Pressure, Which May Cause Dizziness, Fainting, or Fainting Spells 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 (Main Symptoms are Stiffness of the Whole Body, Involuntary Movements, Increased Body Temperature);
  • Joint Pain;
  • Restless Legs Syndrome (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.

  The Following May Also Occur Temporarily:

  • Drowsiness or Sleepiness,
  • Weight Gain,
  • Thoughts of Self-Harm or Suicidal Thoughts.

  In Case of Suicidal Thoughts or Self-Harm, Contact Your Doctor or Go to the Hospital Immediately.

  Deprexolet May Rarely 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, Consult Your Doctor and Have a Blood Test Immediately. These Symptoms Usually Occur After 4-6 Weeks of Treatment and Disappear After Stopping the Medication.

  Reporting Side Effects

  If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects Can be Reported Directly to the Department of Drug Safety Monitoring, 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: 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 this Medication.

  5. How to Store Deprexolet

  Keep the Medication Out of Sight and Reach of Children.
  Do Not Use this Medication After the Expiration Date Stated on the Carton After the Phrase "Expiration Date (EXP)". The Expiration Date Refers to the Last Day of the Specified Month.
  There are No Special Precautions for Storing the Medication.
  Medications Should Not be Disposed of in Sewers or Household Waste. Ask Your Pharmacist How to Dispose of Medications 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 Medication is Mianserin Hydrochloride. One Tablet Contains 60 mg of Mianserin Hydrochloride.
  • Other Ingredients are: Calcium Hydrogen Phosphate Dihydrate, Cornstarch, Methylcellulose, Colloidal Silicon Dioxide, Magnesium Stearate, Hypromellose E5, Hypromellose E15, Macrogol 8000, Hydroxypropylcellulose, Titanium Dioxide (E 171).

  What Deprexolet Looks Like and What the Pack Contains

  The Tablets are White or Almost White, Oblong, 18.08 mm/7.30 mm/5.50 mm in Size, Convex on Both Sides with a Score Line on One Side. The Tablets Can be Divided into Halves.
  Packaging with 60 mg Coated Tablets: PVC/Aluminum or PVC/PVDC/Aluminum Blisters in a Cardboard Box – 30 Tablets (3 Blisters of 10 Tablets Each).

  Marketing Authorization 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

  Date of the Last Update of the Package Leaflet: