Oropram 20 mg tabletki povlekane

Leaflet accompanying the packaging: patient information

Oropram 20 mg, coated tablets

Citalopram

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 Oropram 20 mg and what is it used for
• 2. Important information before taking Oropram 20 mg
• 3. How to take Oropram 20 mg
• 4. Possible side effects
• 5. How to store Oropram 20 mg
• 6. Contents of the packaging and other information

1. What is Oropram 20 mg and what is it used for

Oropram 20 mg belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines are selective inhibitors of serotonin reuptake in the brain and normalize the amount of neurotransmitters in the brain.
Disorders in the serotonin system in the brain are considered a major indicator of the development of depression and related diseases.
Oropram 20 mg is used to treat depressive disorders and anxiety disorders with panic attacks with or without agoraphobia (fear of public places).
The doctor may recommend other uses. You should follow the doctor's recommendations.

2. Important information before taking Oropram 20 mg

When not to take Oropram 20 mg:

• if the patient is allergic to citalopram or any of the other ingredients of this medicine (listed in section 6)
• if the patient is currently taking or has taken within the last two weeks a monoamine oxidase inhibitor (MAOI, a medicine used to treat depression). MAOIs include: selegiline, phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, and moclobemide. If the doctor changes the treatment from Oropram 20 mg to an MAOI, at least 7 days should pass before starting the MAOI.

The doctor will inform how to take Oropram 20 mg in case of stopping MAOIs (see "Other medicines and Oropram 20 mg").

• if the patient is taking a medicine containing linezolid (used to treat infections) (see "Other medicines and Oropram 20 mg")
• if the patient has congenital heart rhythm disorders or has had episodes of heart rhythm disorders in the past (visible in ECG - a test that evaluates heart function)
• if the patient is taking medicines that regulate heart rhythm or may affect heart rhythm. See below, "Other medicines and Oropram 20 mg".

Warnings and precautions

Use in children and adolescents under 18 years of age

Oropram 20 mg should not be used in children and adolescents under 18 years of age.
When using antidepressant medicines, patients under 18 years of age are at increased risk of suicidal behavior, such as suicide attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). Nevertheless, the attending physician may prescribe Oropram 20 mg to patients under 18 years of age if they consider it to be in their best interest. If the doctor prescribes Oropram 20 mg to a patient under 18 years of age and any doubts arise, please consult a doctor. In case of development or worsening of the above-mentioned symptoms in patients under 18 years of age taking Oropram 20 mg, the attending physician should be informed. Additionally, there is a lack of data on the safety of long-term use of Oropram 20 mg in children and adolescents, and how it affects their growth, maturation, cognitive development, and behavioral development.

Oropram 20 mg should be used with caution

• If the patient has panic attacks. The symptoms of anxiety may worsen during the initial treatment. These symptoms usually disappear within 2 weeks of starting treatment. The doctor may adjust the dose (see section 3, "How to take Oropram 20 mg").
• If the patient has manic-depressive illness. In some patients, a manic phase may occur. It is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, the doctor should be consulted.
• If the patient has diabetes (the antidiabetic treatment may need to be changed).
• If the patient has epilepsy. In case of seizures or increased frequency of seizures, the doctor will decide to discontinue the medicine.
• If the patient has a feeling of restlessness, agitation, and/or a need to move frequently, which is often accompanied by difficulty sitting or standing still. These symptoms occur more frequently in the first few weeks of treatment.
• If the patient is taking medicines that bind to serotonin receptors in the body (serotoninergic medicines), such as sumatriptan or other triptans, tramadol, buprenorphine, oxitriptan, and tryptophan. See section "Other medicines and Oropram 20 mg".
• If the patient is taking selective MAO-A inhibitors (monoamine oxidase inhibitors used to treat mental disorders). See section "Do not take Oropram 20 mg" and "Other medicines and Oropram 20 mg".
• If the patient has decreased sodium levels in the blood (visible in blood tests). Symptoms may include fatigue, confusion, muscle cramps. This type of medicine rarely causes a decrease in sodium levels in the blood, especially in older women. Sodium levels usually return to normal after discontinuation of treatment.
• If the patient has a history of bleeding disorders or is pregnant (see "Pregnancy, breastfeeding, and fertility"). Caution should be exercised when using medicines that increase the risk of bleeding, such as acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs). See also "Other medicines and Oropram 20 mg".
• In case of concurrent electroconvulsive therapy.
• If the patient is taking medicines containing St. John's Wort (Hypericum perforatum). Concurrent use with Oropram 20 mg may increase the risk of adverse reactions (see section "Other medicines and Oropram 20 mg").
• If the patient has severe kidney or liver disease. The doctor may recommend a dose reduction or discontinuation of the medicine.
• If the patient has mental illnesses such as psychosis or depression.
• If the patient or their family members have heart diseases that lead to prolongation of the QT interval.
• If the patient has or has had heart diseases or has had a heart attack recently.
• If the patient has a low resting heart rate and/or the patient knows they may have a sodium deficiency caused by prolonged diarrhea, vomiting, or use of diuretic medicines (diuretic tablets).
• If the patient has a feeling of rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate an abnormal heart rhythm.
• If the patient has decreased potassium or magnesium levels in the blood (hypokalemia/hypomagnesemia).
• If the patient has or has had glaucoma with closed-angle glaucoma.
• In case of discontinuation of the medicine, withdrawal symptoms may occur (see section 3, "Discontinuation of Oropram 20 mg").

Medicines like Oropram 20 mg (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.

Suicidal thoughts, worsening of depression or anxiety disorders

If the patient is suffering from depression or anxiety disorders, they may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually start working after 2 weeks, sometimes later.
The occurrence of suicidal thoughts, self-harm, or suicidal behavior is more likely if:

• the patient has had suicidal thoughts or self-harm in the past;
• the patient is a young adult; clinical trial data indicate an increased risk of suicidal behavior in people under 25 years of age with mental disorders who were treated with antidepressant medicines.

If the patient experiences suicidal thoughts or self-harm, they should immediately contact their doctor or go to the hospital.
It may be helpful to inform relatives or friendsabout depression or anxiety disorders and ask them to read this leaflet. The patient may ask their relatives or friends for help and ask them to inform them if they notice that depression or anxiety has worsened or if there are any worrying changes in behavior.

Serotonin syndrome

In some patients, Oropram 20 mg may lead to the development of serotonin syndrome. If the following symptoms occur simultaneously, such as high fever, muscle tremors, shivering, confusion, or agitation, which may indicate the development of this syndrome, the doctor should be contacted immediately.

Other medicines and Oropram 20 mg

The doctor or pharmacist should be informed about all medicines currently being taken or recently taken, as well as any medicines the patient plans to take.
This should include medicines taken 14 days ago or those that will be taken in the future.
Oropram 20 mg should not be takenif the patient is taking medicines that regulate heart rhythm or may affect heart rhythm, such as: antiarrhythmic medicines of class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressant medicines, some antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines, especially halofantrine), some antihistamine medicines (astemizole, mizolastine). In case of doubts, the doctor should be consulted.

Caution should be exercised when taking Oropram 20 mg with the following medicines:

Oropram 20 mg with food, drinks, and alcohol

Oropram 20 mg can be taken with food or drinks. Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Oropram 20 mg may be used during pregnancy only in clinically justified cases. The doctor should be informed that the patient may be pregnant or suspects they may be pregnant. Oropram 20 mg should not be taken if the patient is pregnant or plans to become pregnant, unless the doctor recommends otherwise, considering the risks and benefits of taking Oropram 20 mg. The medicine should not be stopped abruptly. The doctor and/or midwife should be informed about the use of Oropram 20 mg. Taking the medicine during pregnancy, especially in the last three months, may increase the risk of a serious condition in the child called persistent pulmonary hypertension of the newborn, characterized by breathing difficulties and bluish discoloration of the skin. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur, the midwife and/or doctor should be contacted immediately.
If Oropram 20 mg is taken in the last 3 months of pregnancy, the doctor should be informed; in children after birth, certain symptoms may occur. These symptoms usually occur within 24 hours after birth and include: difficulty sleeping, feeding, breathing, bluish discoloration of the skin, fluctuations in body temperature, vomiting, constant crying, stiffness or flaccidity of muscles, lethargy, tremors, irritability, or seizures. If such symptoms occur in the child after birth, the doctor should be consulted immediately.
Taking the medicine at the end of pregnancy may increase the risk of severe bleeding from the uterus, occurring shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Oropram 20 mg, they should inform their doctor or midwife so that they can provide appropriate advice.
Breastfeeding
Citalopram passes into breast milk in small amounts. There is a risk of affecting the child. When taking Oropram 20 mg, the doctor should be consulted before breastfeeding.
Fertility
In animal studies, citalopram has been shown to reduce sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

Oropram 20 mg may affect the ability to drive and use machines.
While taking the medicine, the patient should not drive vehicles or operate machines.

3. How to take Oropram 20 mg

Dosage

This medicine should always be taken as recommended by the doctor. Different people have different needs. Based on the patient's condition, the doctor will decide on the dose and duration of treatment. In case of doubts, the doctor or pharmacist should be consulted.
The recommended dose is:

Adults:

Depression

The recommended initial dose is 20 mg per day. The doctor may increase the dose to a maximum of 40 mg per day. Treatment should be continued for 4 to 6 months after the symptoms of the disease have disappeared.

Anxiety disorders with panic attacks

In the first week of treatment, the initial dose is 10 mg per day, and then the dose may be increased to 20-30 mg per day. The doctor may increase the dose to a maximum of 40 mg per day.

Elderly patients (over 65 years of age):

The initial dose should be reduced to half the recommended dose, e.g., 10-20 mg per day. Elderly patients should not take a dose higher than 20 mg per day.

Use in children and adolescents:

Oropram 20 mg is not recommended for use in children and adolescents under 18 years of age, as the safety and efficacy have not been established.

Kidney or liver function disorders

A dose reduction is necessary. The doctor's recommendations should be followed.
Patients with liver function disorders should not take a dose higher than 20 mg per day.
Oropram 20 mg should be taken in a single dose in the morning or evening, with or without food. The tablets should be swallowed with a glass of water.
The doctor should be consulted before changing treatment or discontinuing Oropram 20 mg. See special warnings above.

Overdose of Oropram 20 mg

In case of taking a higher dose than recommended in this leaflet or higher than prescribed by the doctor, the doctor, emergency department, or pharmacist should be contacted immediately.
Symptoms of overdose may include: drowsiness, loss of consciousness, seizures, rapid or slow heartbeat, dizziness, arrhythmia (e.g., QT interval prolongation), low blood pressure, high blood pressure, tremors, fainting, nausea, vomiting, excessive sweating, agitation, high fever, cardiac arrest, dilated pupils, changes in mental state, bluish discoloration of the skin due to lack of oxygen (cyanosis), hyperventilation. Serotonin syndrome may occur (see section 4), especially when taking other medicines.

Missed dose of Oropram 20 mg

If a dose of Oropram 20 mg is missed, the next dose should be taken at the scheduled time.
A double dose should not be taken to make up for the missed dose.

Discontinuation of Oropram 20 mg

Oropram 20 mg should not be stopped abruptly, as this may cause symptoms such as dizziness, tingling, sleep disturbances, irritability, tremors, disorientation, headache, nausea, nervousness, anxiety, or increased sweating (and the possibility of return of suicidal thoughts in patients with a tendency).
These symptoms usually disappear within two weeks, but they may be severe or prolonged in case of high doses of Oropram 20 mg.
If the patient intends to discontinue Oropram 20 mg, they should ask their doctor for advice, as the medicine should be discontinued gradually and slowly over weeks or months. It is essential for the doctor to monitor the patient during this period.
In case of further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Oropram 20 mg can cause side effects, although not everybody gets them.
During treatment with Oropram 20 mg, if any side effects occur, they usually occur within the first 8 to 14 days of treatment. Side effects usually disappear again.
In case of occurrence of any of the following symptoms, the patient should immediately stop taking Oropram 20 mg and inform their doctor or go to the nearest hospital:

• Serotonin syndrome:the doctor should be informed in case of high fever, muscle tremors, and sudden muscle contractions (tics), feelings of agitation; these symptoms may indicate the development of the syndrome. Oropram 20 mg should be discontinued immediately.
• Severe allergic reactions:the doctor should be informed immediately if swelling of the face, tongue, and/or throat and/or difficulty breathing or swallowing occurs. These symptoms are very severe and may be a sign of a severe allergic reaction to Oropram 20 mg. Immediate medical intervention or hospitalization may be necessary. These symptoms are rare.
• Rapid, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called Torsades de Pointes.

The doctor or emergency department should be contactedin case of suicidal thoughts and behaviors during treatment with citalopram.
The following side effects are usually mild and disappear after a few days of treatment: nausea (vomiting), diarrhea, increased sweating, dry mouth, fatigue, insomnia, and drowsiness.
The following side effects have been reported in the given frequencies:

Very common (may occur in more than 1 in 10 patients):

• palpitations
• headache
• nausea, dry mouth
• increased sweating
• drowsiness, insomnia

Common (may occur in up to 1 in 10 patients):

• tremors, dizziness
• decreased appetite, weight loss
• agitation, anxiety, nervousness, confusion
• decreased libido
• tingling, prickling, or burning sensation of the skin
• concentration disorders
• ringing in the ears (tinnitus)
• high blood pressure
• diarrhea, vomiting, constipation, indigestion, abdominal pain, bloating with gas
• increased salivation
• muscle pain, joint pain
• migraine
• rhinitis and sinusitis
• increased urination
• itching
• fatigue, yawning
• orgasm disorders in women, menstrual pain, impotence (in men), ejaculation disorders
• nightmares, memory loss (amnesia), lack of emotions and enthusiasm

Uncommon (may occur in up to 1 in 100 patients):

• slow heartbeat
• rapid heartbeat
• increased appetite, weight gain
• aggression, depersonalization, hallucinations, mania (feeling of excessive excitement, excessive activity, nervousness, and restlessness), euphoria (excessive state of optimism, good mood, and well-being), increased libido
• fainting
• dilated pupils
• cough
• hives
• rash
• hair loss
• redness of the skin or spots on the skin (erythema)
• photosensitivity (skin rash caused by exposure to sunlight)
• urination disorders (urinary retention)
• menstrual bleeding (heavy menstrual bleeding)
• edema

Rare (may occur in up to 1 in 1,000 patients):

• bleeding (e.g., from the uterus, gastrointestinal tract, skin, soft tissues)
• tonic-clonic seizures (grand mal seizures), involuntary movements (dyskinesias)
• taste disorders
• hepatitis (liver inflammation)
• fever
• low sodium levels in the blood (hyponatremia)

Unknown (frequency cannot be estimated from the available data)

• decreased platelet count (thrombocytopenia)
• heart rhythm disorders (arrhythmia)
• edema (angioedema) of the skin and internal organs (mucous membranes)
• sudden, severe allergic reactions (anaphylactic reaction) with a sudden drop in blood pressure, itching rash, swelling of the lips, tongue, and throat, and difficulty breathing
• allergy (hypersensitivity)
• syndrome of inappropriate antidiuretic hormone secretion (SIADH), especially in older adults
• decreased potassium levels in the blood
• panic attacks, teeth grinding (bruxism), feelings of agitation
• suicidal thoughts and behaviors
• seizures
• serotonin syndrome (with symptoms such as high fever, tremors, abnormal movements, and agitation)
• extrapyramidal disorders (e.g., involuntary muscle movements, tremors, stiffness, muscle contractions)
• restlessness and problems with sitting (akathisia)
• movement disorders
• vision disorders
• heart diseases leading to prolongation of the QT interval (irregular heartbeat detectable in ECG)
• dizziness when standing up quickly due to low blood pressure (orthostatic hypotension)
• nosebleeds
• blood in the stool (gastrointestinal or anal ulcers)
• abnormal liver function test results
• bleeding into the skin (bruises)
• milky secretion from the breasts in men
• painful erection of the penis (priapism)
• irregular menstrual periods
• severe bleeding from the uterus, occurring shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2
• in patients taking medicines from the same group as Oropram 20 mg, an increased risk of bone fractures has been observed.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Oropram 20 mg

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging after: {Expiry date}. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Oropram 20 mg contains

The active substance of the medicine is citalopram hydrobromide in an amount equivalent to 20 mg of citalopram.
Other ingredients of the medicine are: mannitol (E 421), microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, hypromellose, titanium dioxide (E 171), macrogol 6000.

What Oropram 20 mg looks like and contents of the pack

Round, white, biconvex, coated tablets with a score line on both sides and notches on the sides of the tablet, with a diameter of 8 mm.
Pack sizes: 10, 30, or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstraße 211
A-8054 Graz
Austria

Manufacturer

Genericon Pharma Gesellschaft m.b.H.
Hafnerstrasse 211
A-8054 Graz, Austria
Dragenopharm Apotheker Püschl GmbH
Göllstrasse 1
84529 Tittmoning, Germany
Actavis Nordic A/S
Ørnegårdsvej 16
DK-2820 Gentofte, Denmark
Actavis Ltd
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000, Malta
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600, Bulgaria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Citalopram +pharma
Czech Republic
Citalopram Actavis tablets
Estonia, Lithuania
Oropram 20 mg, coated tablets
Poland
Date of last revision of the leaflet:March 2021