Apropol

Leaflet attached to the packaging: patient information

APROPOL, 50 mg, coated tablets

Opipramol dihydrochloride

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

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is APROPOL and what is it 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 packaging and other information

1. What is APROPOL and what is it used for

APROPOL (opipramol dihydrochloride) is a tricyclic antidepressant.
In humans, APROPOL has anxiolytic, sedative, and mildly mood-improving effects.
APROPOL is indicated for the treatment of:

• generalized anxiety disorders,
• disorders that occur in a somatic form (physical discomfort not related or insufficiently related to organ disorders).

2. Important information before taking APROPOL

When not to take APROPOL

• if the patient is allergic to opipramol dihydrochloride, tricyclic antidepressants, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had acute alcohol poisoning, sleeping pills, painkillers, 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 glaucoma with a narrow angle of filtration;
• if the patient has prostate enlargement with urinary retention;
• if the patient has paralytic ileus due to intestinal paralysis;
• if the patient has heart rhythm disorders (pre-existing atrioventricular block of a higher degree or supraventricular and ventricular conduction disorders);
• if the patient is taking MAO inhibitors for the treatment of depressive disorders.

Warnings and precautions

Before starting to take APROPOL, you should discuss it with your doctor or pharmacist.
Particular caution should be exercised when taking APROPOL:

• if the patient has prostate enlargement without urinary retention;
• if the patient has liver and kidney diseases;
• if the patient has an increased tendency to 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, during the use of the medicine, fever, flu-like infections, or angina occur. You should then contact your doctor, who may order a blood test;
• if skin allergic reactions occur. You should then discontinue the medicine and consult a doctor;
• during long-term treatment. It is then recommended to perform liver function tests.

Due to the possible adverse effect on the cardiovascular system, caution should be exercised in patients with hyperthyroidism or in patients taking thyroid medications.
Suicidal risk
During the use of medicines containing opipramol, suicidal attempts have been reported, some of which ended in death. In the treatment of depressive disorders, there is a risk of suicide, which may persist until significant improvement in the disease. In patients with depressive disorders (adults and children and adolescents), there may be an increase in depression and (or) suicidal risk or other psychiatric symptoms, regardless of whether they are taking antidepressant medications or not.
Other psychiatric disorders may also be associated with an increased risk of suicidal behavior or accompany depressive disorders (episodes of major depression).
Therefore, all patients who are being treated with APROPOL, regardless of the indication, should be frequently monitored for clinical worsening, suicidal risk, and other psychiatric symptoms, especially at the beginning of treatment or after a change in dosage. The doctor will consider changing the treatment regimen, including possible discontinuation of the medicine, especially if the changes are significant, occur suddenly, or were not part of the patient's previous symptoms.
Family members and nurses caring for patients who are taking antidepressant medications should observe their patients for suicidal behavior and other psychiatric symptoms. Any worrying symptoms should be reported immediately to the doctor.
Children and adolescents
The efficacy and safety of APROPOL have not been established in children and adolescents.
There is a lack of data on the effect of the medicine on growth, maturation, and psychological and behavioral development.
For these reasons, the use of APROPOL in children and adolescents under the age of 18 is not recommended.
Additionally, in all age groups, the use of APROPOL is associated with a risk of adverse effects on the cardiovascular system.

APROPOL and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as about the 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;
• medicines used in Parkinson's disease;
• antiepileptic drugs;
• phenothiazines;
• serotonin reuptake inhibitors (e.g., sertraline, fluoxetine, fluvoxamine);
• beta-blockers (e.g., propranolol);
• antiarrhythmic drugs of class I c;
• quinidine;
• cimetidine;
• medicines that affect liver enzyme activity;
• monoamine oxidase inhibitors (MAO) - at least 14 days before the planned intake of APROPOL, MAO inhibitors should be discontinued, and similarly, APROPOL should be discontinued 14 days before the planned intake of an MAO inhibitor.

APROPOL may also enhance the effect of medicines used in general anesthesia.

APROPOL with food, drink, and alcohol

The medicine should be taken during meals or immediately after meals, with a glass of water.
You should 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, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
APROPOL can be used in pregnant women only when, in the doctor's opinion, it is absolutely necessary (especially during the first trimester).
Breastfeeding
Opipramol, the active substance of the medicine, passes into human milk in small amounts.
You should not take the medicine during breastfeeding or should stop breastfeeding if taking APROPOL is absolutely necessary.

Driving and using machines

Taking APROPOL may impair your ability to drive and use machines.
This is especially true at the beginning of treatment and during combined therapy with other medicines that act on the central nervous system (painkillers, sleeping pills, psychotropic drugs).
Therefore, it is recommended to check your individual reaction to the medicine before driving or using machines.

APROPOL contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take APROPOL

This medicine should always be taken according to the doctor's recommendations. If you have any doubts, you should consult your doctor or pharmacist.
The dose of the medicine is determined by the doctor 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 effectiveness and tolerance of the medicine by the patient, the doctor may:

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

Use in children and adolescents

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

Method of administration

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

Taking a higher dose of APROPOL than recommended

APROPOL may cause symptoms of poisoning if taken in too high a dose. A few hours after overdosing, the following may occur: drowsiness, insomnia, dizziness, restlessness, coma, stupor, temporary confusion, increased anxiety, coordination disorders (ataxia), seizures, urinary disorders, accelerated or slowed heart rate, heart rhythm disorders, atrioventricular block, decreased blood pressure, shock, breathing difficulties, and rarely cardiac arrest.
In case of taking a higher dose of the medicine than recommended, as well as in case of suspected poisoning, you should immediately consult a doctor, who will provide appropriate treatment, or go to the nearest hospital.

Missing a dose of APROPOL

You should not take a double dose to make up for a missed dose.
If you miss a dose, you should take it as soon as possible. However, if it is soon time for the next dose, you should skip the missed dose and take the next one according to the usual dosing schedule. If you have any doubts, you should consult your doctor.

Stopping APROPOL

You should always consult your doctor before stopping APROPOL, for example, due to side effects. This may jeopardize the success of the therapy.
Treatment can only be carried out under medical supervision, so the decision to stop treatment can only be made by a doctor. Discontinuation of the medicine should be done gradually by slowly reducing the dose.
You should avoid sudden discontinuation of the medicine, especially when it has been used for a long time in high doses, as this may cause withdrawal symptoms, such as:

• restlessness;
• sweating;
• nausea, vomiting;
• sleep disorders.

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

4. Possible side effects

Like all medicines, APROPOL can cause side effects, although not everybody gets them.
WARNING:in case of allergic skin reactions (rash, hives), you should immediately consult a doctor. In case of sudden discontinuation of the medicine or long-term treatment with high doses, intestinal obstruction caused by intestinal paralysis (sudden abdominal pain, abdominal distension, nausea, vomiting, loss of appetite, difficulty with bowel movements or their absence) may occur. If symptoms of intestinal obstruction occur, you should consult a doctor as soon as possible.
The doctor should monitor liver function during long-term treatment.
The following side effects have been reported during the use of the medicine:

Common (occurring in 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 changes in body position (especially at the beginning of treatment).

Uncommon (occurring in less than 1 in 100 patients):

• dizziness, drowsiness,
• urinary disorders,
• accommodation disorders,
• tremors,
• weight gain,
• thirst,
• palpitations,
• constipation,
• transient increase in liver enzyme activity,
• skin allergic reactions (rash, hives),
• sexual disorders (ejaculation disorders, erectile dysfunction).

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

• blood morphology changes, especially a decrease in the number of white blood cells (leukopenia),
• states of agitation,
• headaches,
• paresthesia (tingling, burning, or numbness in the limbs), especially in elderly patients,
• states of confusion and delirium, (especially related to sudden discontinuation or long-term use of high doses),
• agitation (restlessness),
• sweating,
• sleep disorders,
• cardiovascular collapse, conduction disorders, worsening of existing heart failure,
• nausea, vomiting, gastrointestinal disorders, altered taste,
• edema,
• urinary retention,
• galactorrhea.

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

• a decrease in the number of white blood cells in the blood (agranulocytosis),
• brain seizures,
• coordination disorders (ataxia, dyskinesia),
• inability to sit still (akathisia),
• peripheral nerve diseases (polyneuropathies),
• sudden glaucoma,
• restlessness,
• severe liver function disorders, after long-term treatment jaundice and chronic liver damage,
• hair loss.

The medicine may cause changes in blood test results, and therefore, the doctor may recommend performing control blood tests. During treatment, the following may occur:

• an increase in liver enzyme activity in the serum (substances that indicate liver function);
• a decrease in the number of white blood cells in the blood (leukopenia);
• an absence of granulocytes in the blood (agranulocytosis).

Increased risk of fractures
Patients over 50 years of age taking APROPOL are more likely to experience bone fractures.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store APROPOL

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month stated.
Store in a temperature below 25°C. Store in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What APROPOL contains

The active substance of the medicine is opipramol dihydrochloride.
Each APROPOL coated tablet contains 50 mg of opipramol dihydrochloride.
The other ingredients of the medicine are:
Core: microcrystalline cellulose type 101, crospovidone type A, povidone K-25, colloidal silica anhydrous, magnesium stearate.
Coating: lactose monohydrate, hypromellose 6cP, titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172).

What APROPOL looks like and what the packaging contains

APROPOL has the form of round, yellow, biconvex coated tablets, without spots and damage.
Pack size: 20, 56, 60, 90 coated tablets, PVC/PVDC/Aluminum blister in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Tel.: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: [email protected]

Date of the last update of the leaflet: