Simpramol

Package Leaflet: Information for the User

Sympramol, 50 mg, Effervescent Tablets

Opipramol Dihydrochloride

Read the package leaflet carefully before taking the medicine, 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 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, 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 Sympramol and what is it used for
• 2. Important information before taking Sympramol
• 3. How to take Sympramol
• 4. Possible side effects
• 5. How to store Sympramol
• 6. Contents of the pack and other information

1. What is Sympramol and what is it used for

Sympramol is an anxiolytic and sedative medication.
Sympramol is used to treat:

• generalized anxiety disorders (anxiety characterized by excessive and uncontrollable worrying about everyday things),
• disorders that occur in a somatic form (physical discomfort not related or insufficiently related to a physical cause).

2. Important information before taking Sympramol

When not to take Sympramol:

• if the patient is allergic to opipramol dihydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking monoamine oxidase inhibitors (MAOIs) (substances used to treat, e.g., depression);
• if the patient has acute alcohol poisoning, sleeping pills, painkillers, or psychotropic substances;
• if the patient has acute confusion (disorientation), agitation with hallucinations and sometimes severe physical disorders (so-called delirium);
• if the patient has acute urinary retention;
• if the patient has prostatic hyperplasia with urinary retention;
• if the patient has paralytic ileus;
• if the patient has narrow-angle glaucoma that is not being treated;
• if the patient has certain heart damage (previously occurring atrioventricular block of a higher degree, supraventricular or ventricular conduction disorders);

Warnings and precautions

When to exercise special caution when taking Sympramol:

• if the patient has liver and kidney disease;
• if the patient has an increased predisposition to seizures (due to, among other things, brain damage of various origins, epilepsy, alcoholism);
• if the patient has prostatic hyperplasia without urinary retention;
• if the patient has blood disorders;
• if the patient has inadequate brain blood supply (cerebrovascular insufficiency);
• if the patient has previous heart damage, especially conduction disorders. In such cases, the patient may be treated with Sympramol only under the condition of regular ECG examination.

Since changes in the blood picture (neutropenia, agranulocytosis) may occur (very rarely) during treatment with opipramol tablets, blood tests should be performed, especially if fever, flu-like infections, or tonsillitis occur.
You should immediately consult a doctor if allergic skin reactions occur.
During long-term treatment, it is recommended to perform liver function tests.

Sympramol and other medicines

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.
Consider the following interactions with other medicines:

• Sympramol may enhance the effect of medicines used to treat certain mental disorders(neuroleptics, e.g., phenothiazines), certain sleeping pills, painkillers, and sedatives(so-called sleeping pills, general anesthetics, and anxiolytics, such as barbiturates, benzodiazepines).
• Sympramol may also enhance the effect of strong anticholinergic medicines(such as medicines used to treat Parkinson's disease).
• Concomitant use of Sympramol and certain antidepressant medicines- serotonin reuptake inhibitors, especially fluoxetine, fluvoxamine, may lead to mutual enhancement of the effect of these medicines and cause side effects. If necessary, the doctor will reduce the dose of Sympramol.
• Concomitant use of medicines used to treat high blood pressure(e.g., beta-adrenolytics, such as propranolol) or heart rhythm disorders(e.g., antiarrhythmic drugs of class IC), tricyclic antidepressant medicines(to which the active substance of Sympramol also belongs) and medicines that affect liver enzymesmay change the levels of the active substance of Sympramol in the blood.
• Concomitant administration of medicines used to treat certain mental disorders(neuroleptics, e.g., haloperidol and risperidone) may increase the level of the active substance of Sympramol in the blood.
• Certain sleeping pills(barbiturates) and medicines used to treat epileptic seizuresmay decrease the level of the active substance of Sympramol in the blood, and thus reduce its therapeutic effect. If necessary, the doctor will adjust the dose of Sympramol.
• Before starting treatment with Sympramol, MAOIs should be discontinued at least 14 days in advance. Similarly, Sympramol should be discontinued before starting treatment with MAOIs.

Sympramol with food, drink, and alcohol

Concomitant consumption of alcohol may cause drowsiness.
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Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Sympramol may be used during pregnancy, especially in the first three months of pregnancy, only after the doctor has carefully weighed the benefits and risks.
Sympramol should not be used during breastfeeding, as the active substance passes into breast milk in small amounts. If treatment is necessary, breastfeeding should be discontinued.

Driving and using machines

Reactions to the medicine vary from person to person, but the ability to drive and use machines may be impaired. This is especially true at the beginning of therapy and when changing the medicine. The patient may not be able to react quickly enough or act precisely in unexpected and sudden situations. In such cases, do not drive a car or other vehicles. Do not use electrical tools or operate machines. Alcohol may further impair the ability to drive vehicles.

Sympramol contains lactose monohydrate and sucrose

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

Sympramol contains sodium benzoate (E 211)

The medicine contains 0.100 mg of sodium benzoate in one tablet.

3. How to take Sympramol

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Usually, the following doses are used:

Adults

Adults usually take 1 tablet of Sympramol in the morning and 1 tablet at noon, and 2 tablets in the evening (which corresponds to 50 mg of opipramol dihydrochloride in the morning, 50 mg at noon, and 100 mg in the evening).
After consulting a doctor and depending on the effectiveness and tolerance of the medicine, the dose can be reduced to 1 or 2 tablets of Sympramol (which corresponds to 50-100 mg of opipramol dihydrochloride) taken once a day, usually in the evening, or increased to 2 tablets (which corresponds to 100 mg of opipramol dihydrochloride) taken up to 3 times a day.

Use in children over 6 years of age

Children over 6 years of age receive approximately 3 mg of opipramol dihydrochloride per kilogram of body weight.
The exact dose should be determined by a doctor.
Experience with the treatment of children with Sympramol is limited, so the recommended dose is only a suggestion.
Treatment of adults and children over 6 years of age must always be carried out under the supervision of a doctor.
Tablets should be taken with a liquid (water, fruit juice).

Duration of treatment

The therapeutic effect of Sympramol is not immediate, and mood changes occur gradually, so the medicine should be taken regularly for at least 2 weeks.
The doctor will decide on the duration of treatment. The recommended average treatment duration is from 1 to 2 months.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.

Using a higher dose of Sympramol than recommended

After taking too much Sympramol, the following symptoms of poisoning may occur within a few hours:

• cardiovascular disorders (accelerated or slowed heart rate, heart rhythm disorders, decreased blood pressure, rarely cardiac arrest);
• mental and/or neurological disorders (agitation, transient confusion, increasing anxiety, shock, coma);
• motor disorders [stupor, seizures, lack of coordination (ataxia)];
• other disorders (insomnia, drowsiness, dizziness, urinary problems - oliguria, anuria; breathing disorders).

Immediately consult a doctor or go to the nearest hospital if you have taken a significantly higher dose of Sympramol than recommended, as well as in case of suspected poisoning.
Children are more sensitive to overdose, so in case of even slight overdose, you should contact a doctor.
Consider that even after a small overdose, the ability to react is more impaired than after taking the usual dose.

Missing a dose of Sympramol

Do not take a double dose to make up for a missed tablet. Take the next dose of Sympramol as advised by your doctor.

Stopping treatment with Sympramol

Before you decide to stop or prematurely terminate treatment with Sympramol due to its side effects, you must consult your doctor. If treatment is to be stopped, it should be done gradually by slowly reducing the dose.
Avoid sudden withdrawal of Sympramol taken for a long time in high doses, as it may cause withdrawal symptoms, such as anxiety, sweating, nausea, vomiting, and sleep disorders.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sympramol can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows:
Very common:
especially at the beginning of treatment: fatigue, dry mouth and stuffy nose, low blood pressure (hypotension), decrease in blood pressure when changing position to standing (orthostatic hypotension).

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Uncommon:
sexual disorders in men (ejaculation disorders; impotence), tremors, blurred vision (accommodation disorders), urinary disorders, drowsiness, weight gain, increased thirst, constipation, transient increase in liver enzyme activity, allergic skin reactions (rash, urticaria), heart rhythm disorders (tachycardia, palpitations), dizziness.
Rare:
blood count changes, especially leukopenia; galactorrhea in women, agitation, sweating, sleep disorders, headache, skin sensation disorders (paresthesia), confusion and delirium (especially in elderly patients), nausea, vomiting, bowel obstruction (paralytic ileus), swelling, cardiovascular collapse, conduction disorders in the heart, worsening of existing heart failure, urinary retention.
Very rare:
loss of white blood cells in the blood (agranulocytosis), narrow-angle glaucoma (glaucoma attacks), anxiety, coordination disorders (dyskinesia, ataxia), inability to sit still (akathisia), peripheral nerve diseases (polyneuropathies), epileptic seizures, hair loss, severe liver dysfunction, after long-term treatment - jaundice and chronic liver damage.
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C, 02-222 Warsaw,
Phone: +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 the medicine.

5. How to store Sympramol

Keep the medicine out of the sight and reach of children.
Do not use Sympramol after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of the month.

Storage conditions

Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
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6. Contents of the pack and other information

What Sympramol contains

• The active substance of the medicine is opipramol dihydrochloride. One effervescent tablet contains 50 mg of opipramol dihydrochloride.
• The other ingredients are: Core of the tabletCornstarch Lactose monohydrate Povidone K 30 Microcrystalline cellulose Talc Magnesium stearate Coating of the tabletShellac Talc Calcium carbonate Sucrose Kaolin light (white clay) Gum arabic Titanium dioxide (E171) Iron oxide red (E172) Opaglos 6000 NS (yellow carnauba wax, white wax) Sodium benzoate (E 211) Povidone K 30

What Sympramol looks like and contents of the pack

Sympramol effervescent tablets are round, coated, reddish-brown.
Sympramol is available in packs containing 20, 40, 60, and 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Farmak International Sp. z o.o.
Koszykowa Street 65
00-667 Warsaw

Manufacturer

Klocke Pharma-Service GmbH
Strasburger Strasse 77
77767 Appenweier
Germany
or
Farmak International Sp. z o.o.
Chełmżyńska Street 249
04-458 Warsaw
Date of last revision of the leaflet:May 2025
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