Pramolan

Package Leaflet: Information for the Patient

Pramolan, 50 mg, Coated Tablets

Opipramol Dihydrochloride

Read the Package 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.
• 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 leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Pramolan and What is it Used For
• 2. Important Information Before Taking Pramolan
• 3. How to Take Pramolan
• 4. Possible Side Effects
• 5. How to Store Pramolan
• 6. Contents of the Pack and Other Information

1. What is Pramolan and What is it Used For

Pramolan (Opipramol Dihydrochloride) is a Tricyclic Antidepressant with Anxiolytic and Sedative Effects. It Facilitates Sleep, Relieves Depressed States, and Improves Well-being.
Pramolan is Indicated for the Treatment of:

• Generalized Anxiety Disorders and Somatic Disorders (Physical Discomfort Not Related or Insufficiently Related to Organic Disorders).

2. Important Information Before Taking Pramolan

When Not to Take Pramolan:

• If the Patient is Hypersensitive to Opipramol Dihydrochloride, Tricyclic Antidepressants, or Any of the Other Ingredients of this Medication (Listed in Section 6);
• If the Patient has Acute Intoxication with Alcohol, Hypnotics, Analgesics, or Psychotropic Drugs;
• If the Patient has Acute Urinary Retention;
• If the Patient is Confused (Disoriented), Agitated, Has Hallucinations, and Sometimes Severe Physical Disorders (So-called Delirium);
• If the Patient has Narrow-Angle Glaucoma that is Not Being Treated;
• If the Patient has Prostatic Hyperplasia with Urinary Retention;
• If the Patient has Paralytic Ileus;
• If the Patient has a Pre-existing Higher-Degree Atrioventricular Block or Supraventricular and Ventricular Conduction Disorders;
• If the Patient is Taking MAO Inhibitors (See Below "Pramolan and Other Medications").

Warnings and Precautions

Before Starting to Take Pramolan, Discuss the Following with Your Doctor:

• If the Patient has Prostatic Hyperplasia Without Urinary Retention;
• If the Patient has Liver and Kidney Diseases;
• If the Patient has an Increased Risk of Seizures (e.g., in the Case of Brain Damage of Various Origins, Epilepsy, Alcoholism);
• If the Patient has Insufficient Brain Blood Supply (Cerebrovascular Insufficiency) and Previous Heart Damage, Especially with Conduction Disorders;
• If the Patient has Blood Cell Production Disorders;
• If the Patient has a Pre-existing First-Degree Atrioventricular Block;
• If Fever, Flu-like Infections, or Sore Throat Occur During Treatment. In This Case, Contact Your Doctor, Who May Order a Blood Test.
• If Skin Allergic Reactions Occur. In This Case, Discontinue the Medication and Consult Your Doctor.
• During Long-term Treatment. In This Case, Liver Function Tests are Recommended.

Pramolan and Other Medications

Inform Your Doctor or Pharmacist About All Medications You are Currently Taking or Have Recently Taken, as Well as Any Medications You Plan to Take.
It is Especially Important to Inform Your Doctor About the Use of:

• Neuroleptics (e.g., Haloperidol, Risperidone);
• Sedatives (e.g., Barbiturates);
• Tranquilizers (e.g., Benzodiazepines);
• Tricyclic Antidepressants;
• Medications Used in Parkinson's Disease;
• Anticonvulsants;
• Phenothiazines;
• Selective Serotonin Reuptake Inhibitors (e.g., Sertraline);
• Fluoxetine and Fluvoxamine;
• Beta-Adrenergic Blockers (e.g., Propranolol);
• Antiarrhythmic Medications;
• Medications Affecting the Microsomal Enzyme System in the Liver;
• MAO Inhibitors - At Least 14 Days Before Planned Administration of Pramolan, MAO Inhibitors Should be Discontinued, and Similarly, Pramolan Should be Discontinued 14 Days Before Planned Administration of an MAO Inhibitor.

Pramolan May Also Enhance the Effects of Medications Used in General Anesthesia.

Pramolan and Alcohol

Do Not Drink Alcohol During Treatment. Concurrent Use with Alcohol May Cause Drowsiness.

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.
Pregnancy
The Medication Can be Used in Pregnant Women Only When Absolutely Necessary (Especially During the First Trimester).
Breastfeeding
Opipramol, the Active Substance of the Medication, Passes into Human Milk in Small Amounts. Do Not Take the Medication During Breastfeeding or Discontinue Breastfeeding if Taking Pramolan is Absolutely Necessary.

Driving and Operating Machines

There is a Possibility that the Ability to Drive and Operate Machines May be Impaired. Therefore, it is Recommended to Check Your Individual Reaction to the Medication Before Driving or Operating Machines.

Pramolan Contains Lactose

Each Coated Tablet Contains 0.84 mg of Lactose Monohydrate.
If You Have Been Diagnosed with an Intolerance to Some Sugars, Consult Your Doctor Before Taking the Medication.

Pramolan Contains Orange Yellow, Lake (E110) and Quinoline Yellow, Lake (E104)

The Medication May Cause Allergic Reactions.

3. How to Take Pramolan

Always Take this Medication Exactly as Your Doctor has Told You. If You are Not Sure, Ask Your Doctor or Pharmacist.
The Dose of the Medication is Determined by Your Doctor Individually for Each Patient.

Adult Administration

The Usual Recommended Dose for Adults is 50 mg (1 Coated Tablet) of Opipramol Dihydrochloride in the Morning and at Noon, and 100 mg (2 Coated Tablets) of Opipramol Dihydrochloride in the Evening.
Depending on the Efficacy and Tolerance of the Medication by the Patient, the Doctor May:

• Reduce the Dose to 50 mg (1 Coated Tablet) or 100 mg (2 Coated Tablets) of Opipramol Dihydrochloride Administered Once a Day, Usually in the Evening, or
• Increase the Dose to 100 mg (2 Coated Tablets) of Opipramol Dihydrochloride Administered Up to Three Times a Day.

Pediatric Administration

Experience with Opipramol Dihydrochloride in Children is Limited, Therefore, Treatment Should Only be Carried Out Under Medical Supervision.
Children Over 6 Years Old are Usually Given 3 mg of Opipramol Dihydrochloride per Kilogram of Body Weight. Maximum 100 mg (2 Coated Tablets) per Day.

Method of Administration

The Coated Tablets Should be Taken During Meals or Immediately After Meals, with a Glass of Water.
Since the Effect of Opipramol Dihydrochloride Does Not Appear Immediately, and Mood Changes Occur Gradually, the Medication Should be Taken Systematically for at Least 2 Weeks.
The Recommended Average Treatment Duration is from 1 to 2 Months.

Overdose of Pramolan

In Case of Overdose or Suspected Poisoning, Immediately Consult a Doctor or Go to the Nearest Hospital.
The Following Overdose Symptoms May Occur:

• Drowsiness, Insomnia, Dizziness, Agitation, Coma, Stupor, Transient Confusional States, Increasing Anxiety;
• Ataxia (Loss of Coordination), Seizures;
• Oliguria, Anuria;
• Accelerated Heart Rate or Slowed Heart Rate, Arrhythmia (Irregular Heartbeat), Atrioventricular Block, Decreased Blood Pressure, Shock, Breathing Difficulties, Rarely Cardiac Arrest.

In Case of Even Minor Overdose in a Child, Immediately Consult a Doctor, as Children are More Sensitive to Overdose.

Missed Dose of Pramolan

If a Dose is Missed, Take it as Soon as Possible. Do Not Take a Double Dose to Make Up for the Missed Dose.

Discontinuation of Pramolan

Treatment Should Only be Carried Out Under Medical Supervision, Therefore, the Decision to Discontinue Treatment Can Only be Made by a Doctor. Discontinuation of the Medication Should be Done Gradually by Slowly Reducing the Dose. Avoid Abrupt Discontinuation of the Medication, Especially When it Has Been Taken for a Long Time in High Doses, as this May Cause Withdrawal Symptoms, Such as:

• Anxiety;
• Sweating;
• Nausea, Vomiting;
• Sleep Disorders.

If You Have Any Further Questions About the Use of this Medication, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Pramolan Can Cause Side Effects, Although Not Everybody Gets Them.
The Following Side Effects Have Been Reported During Treatment with Pramolan:

Common (Occurs in Less Than 1 in 10 Patients):

• Fatigue, Dry Mouth and Stuffy Nose (Especially at the Beginning of Treatment);
• Hypotension and Blood Pressure Drops Associated with Changes in Body Position (Especially at the Beginning of Treatment).

Uncommon (Occurs in Less Than 1 in 100 Patients):

• Dizziness, Drowsiness, Urination Disorders, Accommodation Disorders, Tremors, Weight Gain, Feeling of Thirst;
• Accelerated Heart Rate, Palpitations;
• Constipation;
• Skin Allergic Reactions (Rash, Urticaria);
• Ejaculation Disorders, Erectile Dysfunction.

Rare (Occurs in Less Than 1 in 1,000 Patients):

• States of Agitation, Headaches, Paresthesia (Feeling of Pricking, Burning, or Tingling in the Limbs), Especially in Elderly Patients, Confusional States and Delirium (Especially Related to Sudden Discontinuation or Long-term Use of High Doses), Agitation, Sweating, Sleep Disorders;
• Cardiovascular Collapse, Conduction Disorders, Worsening of Existing Heart Failure;
• Nausea, Vomiting, Gastrointestinal Disorders, Altered Taste, Paralytic Ileus (Especially in Case of Sudden Discontinuation or Long-term Treatment with High Doses);
• Edema;
• Urinary Retention;
• Galactorrhea.

Very Rare (Occurs in Less Than 1 in 10,000 Patients):

• Cerebral Seizures, Coordination Disorders (Ataxia, Dyskinesia), Inability to Sit Still (Akathisia), Peripheral Neuropathies (Polyneuropathies), Sudden Glaucoma, Anxiety;
• Severe Liver Function Disorders, After Long-term Treatment Jaundice and Chronic Liver Damage;
• Hair Loss.

The Medication May Cause Changes in Blood Test Results and Therefore Your Doctor May Recommend Regular Blood Tests. During Treatment, the Following May Occur:

• Increased Activity of Liver Enzymes in Serum (Substances that Indicate Liver Function);
• Decreased White Blood Cell Count (Leukopenia);
• Absence of Granulocytes in the Blood (Agranulocytosis).

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in this Leaflet, Inform 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, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]. Side Effects Can Also be Reported to the Marketing Authorization Holder. By Reporting Side Effects, You Can Help Provide More Information on the Safety of this Medication.

5. How to Store Pramolan

Store the Medication Out of Sight and Reach of Children.
Store at a Temperature Not Exceeding 25°C. Store in the Original Packaging to Protect from Light.
Do Not Use this Medication After the Expiry Date Stated on the Carton and Blister. The Expiry Date Refers to the Last Day of the Month.
The Printing on the Packaging After the Abbreviation EXP Indicates the Expiry Date, and After the Abbreviation Lot/LOT Indicates the Batch Number.
Medications Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications No Longer Needed. This Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Pramolan Contains

• The Active Substance of the Medication is Opipramol Dihydrochloride. Each Coated Tablet Contains 50 mg of Opipramol Dihydrochloride.
• Other Ingredients of the Medication are:

Core of the Tablet: Microcrystalline Cellulose, Povidone K 30, Crospovidone, Colloidal Silica, Magnesium Stearate.
Coating of the Tablet: Hypromellose, Titanium Dioxide (E171), Lactose Monohydrate, Macrogol, Triacetin, Quinoline Yellow, Lake (E104), Indigo Carmine, Lake (E132), Orange Yellow, Lake (E110).

Appearance and Packaging of Pramolan

The Medication is in the Form of Round, Convex, Coated Tablets, Green in Color.
Pack Sizes: 20, 28, 56, 60, 84 Coated Tablets.
Not All Pack Sizes May be Marketed.

Marketing Authorization Holder and Manufacturer

Zakłady Farmaceutyczne POLPHARMA SA, ul. Pelplińska 19, 83-200 Starogard Gdański. For More Detailed Information, Contact the Local Representative of the Marketing Authorization Holder: POLPHARMA Biuro Handlowe Sp. z o.o., ul. Bobrowiecka 6, 00-728 Warsaw, tel. 22 364 61 01.

Date of Last Revision of the Leaflet: