Apropol

Package leaflet: information for the patient

APROPOL, 50 mg, coated tablets
Opipramol dihydrochloride
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so 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. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What APROPOL is and what it is used for

APROPOL (opipramol dihydrochloride) is a tricyclic antidepressant.
In humans, APROPOL exhibits anxiolytic, calming, and mild mood-enhancing effects.
APROPOL is indicated for the treatment of:

• generalized anxiety disorders,
• disorders manifesting in somatic form (physical discomfort unrelated or insufficiently related to organic disorders).

2. Important information before taking APROPOL

When not to take APROPOL

• if the patient is allergic to opipramol hydrochloride, tricyclic antidepressants, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has acute alcohol intoxication, intoxication with sleeping pills, painkillers, or psychotropic drugs;
• if the patient has acute urinary retention;
• if the patient is confused (disoriented), agitated, experiencing hallucinations, and sometimes severe physical disturbances (so-called delirium);
• if the patient has narrow-angle glaucoma;
• if the patient has benign prostatic hyperplasia with urinary retention;
• if the patient has paralytic ileus due to intestinal paralysis;
• if the patient has heart conduction disorders (pre-existing higher-degree atrioventricular block or supraventricular and ventricular conduction disturbances);
• if the patient is taking MAO inhibitors for the treatment of depressive disorders.

Warnings and precautions
Before starting to take APROPOL, discuss this with your doctor or pharmacist.
Particular caution is required when using APROPOL:

• if the patient has benign prostatic hyperplasia without urinary retention;
• if the patient has liver or kidney disease;
• if the patient has an increased predisposition to seizures (e.g. due to brain damage of various causes, epilepsy, alcoholism);
• if the patient has insufficient blood supply to the brain (cerebrovascular insufficiency) or previous heart damage, especially with conduction disturbances;
• if the patient has blood cell formation disorders;
• if the patient has pre-existing first-degree atrioventricular block;
• if fever, flu-like infections, or angina occur during treatment. In such cases, contact your doctor, who may order a blood test;
• if allergic skin reactions occur. In such cases, discontinue the drug and consult your doctor;
• during long-term treatment. Liver function tests are recommended in such cases.

Due to the possible adverse effects on the cardiovascular system, caution should be exercised in patients with hyperthyroidism or those taking thyroid medications.

Suicidal risk
Suicide attempts, some fatal, have been reported during treatment with medicines containing opipramol. When treating depressive disorders, there is a risk of suicide which may persist until significant improvement occurs. In patients with depressive disorders (adults as well as children and adolescents), depression and/or suicidal risk or other psychiatric symptoms may worsen, regardless of whether antidepressant medication is being taken.
Other psychiatric disorders may also be associated with an increased risk of suicidal behavior or may accompany depressive disorders (episodes of major depression).
Therefore, all patients treated with APROPOL, regardless of indication, should be closely monitored for clinical worsening, suicidal risk, and other psychiatric symptoms, especially at the beginning of treatment or after dose changes. The doctor will consider modifying the treatment regimen, including possible discontinuation of the drug, particularly if changes are significant, sudden, or were not part of the patient's previous symptoms.
Family members and caregivers of patients receiving antidepressant medications should monitor their patients for suicidal behaviors and other psychiatric symptoms. Any concerning symptoms should be reported immediately to the doctor.

Children and adolescents
The efficacy and safety of APROPOL in children and adolescents have not been established.
There is a lack of data on the effect of the drug on growth, maturation, and psychological and behavioral development.
For these reasons, the use of APROPOL in children and adolescents under 18 years of age is not recommended.
Additionally, in all age groups, the use of APROPOL is associated with a risk of cardiovascular adverse effects.

APROPOL with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
It is especially important to inform your doctor about the use of:

• neuroleptics (e.g. haloperidol, risperidone);
• sleeping pills (e.g. barbiturates);
• sedatives (e.g. benzodiazepines);
• tricyclic antidepressants;
• drugs used in Parkinson's disease;
• anticonvulsants;
• phenothiazines;
• serotonin reuptake inhibitors (e.g. sertraline, fluoxetine, fluvoxamine);
• beta-blockers (e.g. propranolol);
• antiarrhythmic drugs of class Ic;
• quinidine;
• cimetidine;
• drugs affecting liver enzyme activity;
• monoamine oxidase inhibitors (MAOIs) – MAO inhibitors must be discontinued at least 14 days before starting APROPOL, and similarly, APROPOL must be discontinued 14 days before starting an MAO inhibitor.

APROPOL may also enhance the effects of drugs used in general anesthesia.

APROPOL with food, drink, and alcohol
Take the medicine during or immediately after meals, with water.
Do not drink alcohol during treatment. Concurrent use with alcohol may cause drowsiness.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
APROPOL may be used during pregnancy only if, in the opinion of the doctor, it is absolutely necessary (especially regarding use during the first trimester).

Breastfeeding
Opipramol – the active substance of the medicine – passes into human milk in small amounts.
Do not take the medicine during breastfeeding, or discontinue breastfeeding if treatment with APROPOL is absolutely indicated.

Driving and operating machinery
The use of APROPOL may impair the ability to drive vehicles and operate machinery.
This particularly applies at the beginning of treatment and during combination therapy with other medicines acting on the central nervous system (painkillers, sleeping pills, psychotropic drugs).
Therefore, it is recommended to assess individual response to the medicine before driving or operating machinery.

APROPOL contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take APROPOL

This medicine should always be taken as directed by the doctor. If in doubt, consult a doctor or pharmacist.
The doctor determines the dose individually for each patient.

Use in adults
The usual recommended dose in adults is 50 mg (1 tablet) of opipramol dihydrochloride in the morning and at noon, and 100 mg (2 tablets) of opipramol dihydrochloride in the evening.
Depending on the efficacy and patient's tolerance to the medicine, the doctor may:

• reduce the dose to 50 mg (1 tablet) or 100 mg (2 tablets) of opipramol dihydrochloride administered once daily, usually in the evening, or
• increase the dose to 100 mg (2 tablets) of opipramol dihydrochloride administered up to three times daily.

Use in children and adolescents
APROPOL is not recommended for use in children and adolescents under 18 years of age due to lack of data on safety and efficacy.

Method of administration
APROPOL should be taken during or immediately after meals, with water.
Since the effect of opipramol dihydrochloride does not appear immediately and mood changes occur gradually, the medicine should be taken regularly for at least 2 weeks.
The recommended average duration of treatment is 1 to 2 months.

Taking more than the recommended dose of APROPOL
APROPOL may cause symptoms of poisoning if taken in excessive doses. Several hours after overdose, the following may occur: drowsiness, insomnia, dizziness, anxiety, coma, stupor, transient confusion, increased anxiety, coordination disorders (ataxia), seizures, urinary problems, accelerated or slowed heart rate, cardiac arrhythmias, atrioventricular block, decreased blood pressure, shock, breathing difficulties, and rarely cardiac arrest.
In case of taking more than the recommended dose, or in case of suspected poisoning, seek immediate medical advice or go to the nearest hospital. The doctor will initiate appropriate treatment.

Missed dose of APROPOL
Do not take a double dose to make up for a missed dose.
If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped and the next dose taken according to the usual dosing schedule. In case of doubt, consult a doctor.

Stopping APROPOL treatment
Always consult a doctor before stopping APROPOL, for example due to adverse effects. Premature discontinuation may jeopardize the success of therapy.
Treatment must be conducted exclusively under medical supervision; therefore, only a doctor may decide to discontinue treatment. Discontinuation of the medicine should be done gradually by slowly reducing the dose.
Sudden discontinuation of the medicine should be avoided, especially if it has been used for a long time and in high doses, as this may lead to withdrawal symptoms such as:

• anxiety;
• sweating;
• nausea, vomiting;
• sleep disturbances.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
WARNING: In case of allergic skin reactions (rash, urticaria), consult a doctor immediately.
In the event of sudden discontinuation of the medicine or long-term treatment with high doses, intestinal obstruction due to intestinal paralysis may occur (sudden abdominal pain, abdominal distension, nausea, vomiting, loss of appetite, difficulty defecating or absence of defecation). If symptoms of paralytic obstruction occur, consult a doctor as soon as possible.
The doctor should monitor liver function during long-term treatment.
The following adverse reactions have been reported during use of the medicine:

Common (affects less than 1 in 10 patients):

• fatigue (especially at the beginning of treatment), dry mouth and nasal congestion,
• hypotension and blood pressure drops related to change in body position (especially at the beginning of treatment).

Uncommon (affects less than 1 in 100 patients):

• dizziness, drowsiness,
• urinary disorders,
• accommodation disorders,
• tremor,
• weight gain,
• feeling of thirst,
• rapid heartbeat, palpitations,
• constipation,
• transient increase in liver enzyme activity,
• skin allergic reactions (rash, urticaria),
• sexual dysfunction (ejaculation disorders, erectile dysfunction).

Rare (affects less than 1 in 1,000 patients):

• blood morphology changes, particularly decreased white blood cell count (leukopenia),
• states of excitation,
• headache,
• paresthesia (sensation of pricking, burning or tingling in limbs), particularly in elderly patients,
• confusion and delirium (especially associated with sudden discontinuation or long-term use of high doses),
• agitation (restlessness),
• sweating,
• sleep disturbances,
• cardiovascular collapse, conduction disorders, worsening of existing heart failure,
• nausea, vomiting, gastrointestinal disturbances, altered taste,
• edema,
• urinary retention,
• galactorrhea.

Very rare (affects less than 1 in 10,000 patients):

• decreased number of white blood cells in blood (agranulocytosis),
• epileptic seizures,
• movement coordination disorders (ataxia, dyskinesia),
• inability to sit still (akathisia),
• peripheral nerve diseases (polyneuropathies),
• acute glaucoma,
• anxiety,
• severe liver function disorders, jaundice and chronic liver damage after long-term treatment,
• hair loss.

The medicine may cause changes in blood parameters, therefore the doctor may recommend regular blood tests. During treatment, the following may occur:

• increased serum liver enzyme activity (substances indicating liver function);
• decreased white blood cell count in blood (leukopenia);
• absence of granulocytes in blood (agranulocytosis).

Increased risk of fractures
Patients over 50 years of age taking APROPOL medicine are at higher risk of bone fractures.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables continued monitoring of the medicine's safety and helps provide more information on its safe use.

5. How to store APROPOL

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack.
The expiry date refers to the last day of the stated month.
Store below 25°C. Keep in the outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What APROPOL contains
The active substance in APROPOL is opipramol dihydrochloride.
Each coated tablet of APROPOL contains 50 mg of opipramol dihydrochloride.
The other ingredients are:
Tablet core: Microcrystalline cellulose type 101, crospovidone type A, povidone K-25,
anhydrous colloidal silicon dioxide, magnesium stearate.
Tablet coating: Lactose monohydrate, hypromellose 6 cP, titanium dioxide (E 171), macrogol 6000,
iron oxide yellow (E 172).
What APROPOL looks like and contents of the pack
APROPOL is a yellow, round, film-coated tablet, biconvex, without spots or damage.
Pack sizes: 20, 56, 60, 90 film-coated tablets in PVC/PVDC/Aluminium blisters, packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: + 48 24 357 44 44
Fax: + 48 24 357 45 45
e-mail: [email protected]