Oroes

Leaflet accompanying the packaging: patient information

Oroes

10 mg, coated tablets

Escitalopram

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

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

Table of contents of the leaflet

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

1. What is Oroes and what is it used for

Oroes contains escitalopram and is used to treat:

• depression(major depressive episodes)
• anxiety disorders(such as: anxiety disorders with panic attacks with agoraphobia (e.g., fear of leaving the house, entering stores, crowds, and public places) or without agoraphobia, social anxiety disorders, generalized anxiety disorders, and obsessive-compulsive disorders).

Escitalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines work on the serotoninergic system in the brain, increasing serotonin levels. Disruptions to the serotoninergic system in the brain are considered a significant factor in the development of depression and related disorders.
The patient may not feel an improvement until after several weeks of treatment. It is essential to continue taking Oroes, even if it takes some time before the patient starts to feel better.
If the patient does not feel an improvement or feels worse, they should consult their doctor.

2. Important information before taking Oroes

When not to take Oroes

• if the patient is allergic to escitalopram or any other ingredient of this medicine (listed in section 6);
• if the patient is taking medicines that belong to a group called monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic used to treat bacterial infections) (see section 2 "Oroes and other medicines");
• if the patient has a congenital heart rhythm disorder or if the patient has had an episode of abnormal heart rhythm (visible on an ECG - a test that evaluates heart function);
• if the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section 2 "Oroes and other medicines").

Warnings and precautions

Before starting treatment with Oroes, the patient should discuss it with their doctor.
The patient should tell their doctor if they have any other disorders or diseases, as they may need to be taken into account. In particular, the patient should inform their doctor if:

• the patient has epilepsyor has had seizures in the past. Treatment with Oroes should be discontinued if seizures occur for the first time or if their frequency increases (see also section 4 "Possible side effects").
• the patient has liver function disorders. The doctor may need to adjust the dosage.
• the patient has kidney function disorders. The doctor may need to adjust the dosage.
• the patient has diabetes. Treatment with Oroes may disrupt glucose control (blood sugar levels). The patient's insulin dosage and/or oral hypoglycemic agents may need to be adjusted.
• the patient has a history of bleeding disorders(e.g., the patient has an increased tendency to bleed or bruise) or if the patient is pregnant (see section 2 "Pregnancy, breastfeeding, and fertility");
• the patient is taking medicines that affect blood clotting, such as acetylsalicylic acid and nonsteroidal anti-inflammatory drugs (painkillers), certain medicines used to treat mental disorders (atypical antipsychotics and phenothiazine), and most tricyclic antidepressants. The risk is also increased if the patient is taking ticlopidine or dipyridamole (used to reduce the risk of thrombosis) or oral anticoagulants (medicines used to reduce blood clotting) during treatment.
• the patient is being treated with electroconvulsive therapy
• the patient has ischemic heart disease
• the patient has a history of mania or hypomania. Mania is characterized by unusual and rapidly changing thoughts, exaggerated feelings of happiness, and excessive physical activity. If these symptoms occur, the patient should consult their doctor.
• the patient has had psychotic disorders(delusions, hallucinations, severe thought disorders, unusual mood swings, or unusual behaviors)
• the patient has had heart problemsor has recently had a heart attack
• the patient has a slow resting heart rateand/or may have low sodium levels in the blood(low sodium levels in the blood) due to prolonged, severe diarrhea and vomiting or the use of diuretics
• the patient experiences rapidor irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate heart rhythm disorders;
• the patient has had eye problems, such as certain types of glaucoma(increased pressure in the eye)
• medicines like Oroes (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was discontinued.

Note

As with other medicines used to treat depression or similar diseases, the patient's condition may not improve immediately after starting treatment. Improvement in mood may occur only after several weeks of taking Oroes.
In the case of anxiety disorders with panic attacks, improvement usually occurs after 2-4 weeks
of treatment. During the initial period of therapy, some patients may experience increased anxiety, which
will subside if treatment is continued. Therefore, the patient should strictly follow their doctor's recommendations
and not stop taking the medicine or change the dosage without consulting their doctor.
In some patients with bipolar affective disorder, 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 patient should consult their doctor.

Suicidal thoughts and worsening of depression or anxiety disorder

In the case of depression and/or anxiety disorders, suicidal thoughts or self-harm thoughts may also occur. They may intensify at the beginning of treatment with antidepressant medicines, as these medicines usually start working after about 2 weeks, sometimes later.
The likelihood of such thoughts occurring is higher if:

• the patient has had suicidal thoughts or self-harm thoughts before
• the patient is an adult at a young age. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with mental disorders treated with antidepressant medicines.

If suicidal thoughts or self-harm thoughts ever occur, the patient should immediately contact their doctor or go to the hospital.
It may be helpful to inform relatives or friendsabout their depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to monitor their condition and inform them if their depression or anxiety worsens or if they notice any disturbing changes in behavior.
During the first few weeks of treatment, the patient may also experience restlessnessor difficulty sitting or standing still. If these symptoms occur, the patient should immediately consult their doctor.
The patient should be cautious when taking Oroes with other medicines that have a serotoninergic effect (such as sumatriptan and other triptans, tryptophan, and tramadol (used to treat severe pain) or buprenorphine (used to treat severe pain and opioid dependence)). In rare cases, serotonin syndromemay occur, which has been observed not only in combination with serotoninergic medicines but also in very rare cases in patients taking selective serotonin reuptake inhibitors (SSRIs). If the patient experiences high fever, muscle tremors, confusion, agitation, tremors, or chills, they should immediately contact their doctor.
If any of these symptoms occur, the patient should stop taking Oroes and serotoninergic medicines and consult their doctor, who will immediately start appropriate treatment.
The patient should avoid taking Oroes and preparations containing St. John's Wort(Hypericum perforatum), as there is an increased risk of side effects (see section 2 "Oroes and other medicines").
When the patient finishes treatment with Oroes, it is recommended to gradually reduce the dose of the medicine over one to two weeks to avoid withdrawal symptoms (see section 3 "How to take Oroes").

Children and adolescents

Oroes should not be used in children and adolescents under 18 years of age. It should also be emphasized that in the case of taking medicines from this group, patients under 18 years of age are at increased risk of side effects, such as: suicide attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). Nevertheless, the doctor may prescribe Oroes to patients under 18 years of age if they believe it is in their best interest. If the patient under 18 years of age has been prescribed Oroes and has any doubts, they should consult their doctor again.
If the patient under 18 years of age taking Oroes experiences or worsens any of the above symptoms, they should inform their doctor. Additionally, the long-term effects of Oroes on safety regarding growth, maturation, and cognitive and behavioral development in this age group have not been established.

Oroes and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The following medicines may affect the action of Oroes, and Oroes may affect the action of other medicines. The patient should inform their doctor if they are taking any of the following medicines:

• non-selective monoamine oxidase inhibitors (MAOIs) containing substances such as phenelzine, iproniazid, isoniazid, isocarboxazid, nialamide, and tranylcypromine. These medicines should not be taken in combination with Oroes. Their concurrent use may lead to severe side effects, including serotonin syndrome (see section 2 "When not to take Oroes" and section 4 "Possible side effects"). If the patient has taken any of these medicines, they should wait 14 days before starting to take Oroes. After stopping treatment with Oroes, the patient should wait 7 days before taking any of these medicines.
• reversible, selective monoamine oxidase A inhibitors (MAO-A), including moclobemide (a medicine used to treat depression), should not be taken in combination with Oroes, and if their use is necessary, it should only be under medical supervision. These medicines increase the risk of serotonin syndrome (see section 2 "When not to take Oroes").
• irreversible monoamine oxidase B inhibitors (MAO-B), including selegiline (a medicine used to treat Parkinson's disease), should not be taken in combination with Oroes, and if their use is necessary, it should only be under medical supervision. These medicines increase the risk of serotonin syndrome (see section 2 "When not to take Oroes").
• the antibiotic linezolid - a reversible, non-selective monoamine oxidase inhibitor (MAO-A) - should not be taken in combination with Oroes, and if its use is necessary, it should only be under medical supervision. This medicine increases the risk of side effects, such as serotonin syndrome (see section 2 "When not to take Oroes").
• medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm, such as: antiarrhythmic drugs of class IA and III, antipsychotic drugs (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, and some antibacterial drugs (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial drugs, especially halofantrine), and some antihistamines (astemizole, mizolastine). These medicines should not be taken in combination with Oroes. The patient should consult their doctor if they have any further questions.
• lithium (used to treat bipolar affective disorder) and tryptophan (a dietary supplement that is converted to serotonin)
• imipramine and desipramine (used to treat depression)
• sumatriptan and other triptans (used to treat migraines), tramadol (used to treat severe pain), or buprenorphine (used to treat severe pain and opioid dependence). They may increase the risk of side effects, such as serotonin syndrome.
• cimetidine, omeprazole, esomeprazole, or lansoprazole (used to treat stomach ulcers), fluconazole (a medicine used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in escitalopram levels in the blood.
• St. John's Wort(Hypericum perforatum) - a herbal preparation used to treat depression - may increase the risk of side effects (see section 2 "Warnings and precautions").
• medicines that affect blood clotting, such as: acetylsalicylic acid and nonsteroidal anti-inflammatory drugs (painkillers), certain medicines used to treat mental disorders (atypical antipsychotics and phenothiazine), and most tricyclic antidepressants. The risk of prolonged bleeding time also increases if the patient is taking ticlopidine or dipyridamole (medicines used to reduce the risk of thrombosis) or oral anticoagulants (medicines used to reduce blood clotting), such as warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood). The doctor will likely monitor the patient's bleeding time at the beginning and end of treatment with Oroes to check if the dosage of anticoagulant medicines is still appropriate.
• mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the risk of lowering the seizure threshold
• neuroleptics (medicines used to treat schizophrenia and/or psychosis, such as phenothiazine derivatives, thioxanthenes, and butyrophenones) and antidepressants (tricyclic antidepressants, selective serotonin reuptake inhibitors), due to the risk of lowering the seizure threshold
• flecainide, propafenone, and metoprolol (used to treat cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). A dose adjustment of Oroes may be necessary.
• medicines that lower potassium or magnesium levels in the blood, as these conditions increase the risk of severe heart rhythm disorders that can be life-threatening.

Oroes with food, drink, and alcohol

Oroes can be taken with or without food (see section 3 "How to take Oroes").
As with many medicines, it is not recommended to take Oroes and alcohol at the same time.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. Oroes should not be taken during pregnancy or breastfeeding unless the patient has discussed the risks and benefits of treatment with their doctor.
Pregnancy
Oroes should never be stopped abruptly during pregnancy. If the patient is taking Oroes in the last three months of pregnancy, they should inform their doctor. The patient should be aware that the newborn may experience (usually within 24 hours after birth) the following symptoms: breathing difficulties, blue skin, seizures, temperature fluctuations, sucking difficulties, vomiting, low blood sugar (glucose) levels, muscle stiffness or flaccidity, increased reflex excitability, tremors, tremors, irritability, lethargy, constant crying, sleepiness, and difficulty falling asleep. If the newborn experiences any of these symptoms, the patient should immediately consult their doctor.
The patient should inform their doctor and/or midwife about taking Oroes. The use of medicines like Oroes during pregnancy, especially in the last three months, may increase the risk of severe complications in the newborn called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing in the child and blue discoloration and occurs usually within the first day after birth. If such symptoms occur in the newborn, the patient should immediately contact their doctor and/or midwife.
Taking Oroes at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if the patient has a history of bleeding disorders. If the patient is taking Oroes, they should inform their doctor or midwife so that they can provide appropriate advice.
Breastfeeding
It is assumed that Oroes passes into breast milk. Before taking any medicine, the patient should consult their doctor or pharmacist.
Fertility
In animal studies, it has been shown that citalopram, a medicine similar to escitalopram, affects sperm quality. This may theoretically affect fertility, but no effect on fertility has been observed in humans.

Driving and using machines

The patient should not drive or operate machinery until they know how Oroes affects them.

Oroes contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Oroes

This medicine should always be taken exactly as described in the patient information leaflet or as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

Recommended dose

Adults
Depression
The usual dose of Oroes is 10 mg once a day. The doctor may recommend further increasing the dose to a maximum of 20 mg per day.
Anxiety disorder with panic attacks
The initial dose of Oroes is 5 mg once a day for the first week of treatment, then the dose is increased to 10 mg per day. The doctor may recommend further increasing the dose to a maximum of 20 mg per day.
Social anxiety disorder
The usual dose of Oroes is 10 mg once a day. The doctor may recommend reducing the dose to 5 mg per day or increasing the dose to a maximum of 20 mg per day, depending on the patient's response to treatment.
Generalized anxiety disorder
The usual dose of Oroes is 10 mg once a day. The doctor may recommend further increasing the dose to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The usual dose of Oroes is 10 mg once a day. The doctor may recommend increasing the dose to a maximum of 20 mg per day.
Patients over 65 years of age
The recommended initial dose of Oroes is 5 mg once a day. The doctor may recommend increasing the dose to 10 mg per day.
Use in children and adolescents
Oroes should not normally be used in children and adolescents. Additional information is provided in section 2 "Important information before taking Oroes - Children and adolescents".
Patients at risk
The recommended initial dose in patients with mild to moderate liver function disorders should not exceed 5 mg per day for the first 14 days of treatment. The doctor may then increase the daily dose depending on the patient's individual response to treatment to 10 mg per day. The doctor should exercise particular caution when adjusting the dose in patients with severe liver function disorders.
In patients with mild to moderate kidney function disorders, a dose adjustment is not required. In patients with severe kidney function disorders (creatinine clearance <30 ml min), caution is recommended.
In patients with reduced metabolic activity of the cytochrome CYP2C19 enzyme (a specific liver enzyme), treatment should be started with a dose of 5 mg per day for the first two weeks. Depending on the patient's individual response to treatment, the dose may then be increased to 10 mg per day.

Method of administration

• Oroes can be taken with or without food.
• The tablet should be swallowed with water.
• The tablets should not be chewed, as they have a bitter taste.

Duration of treatment

It may take several weeks of treatment before the patient feels better.

• Treatment with Oroes should be continued, even if it takes some time before the patient feels better. In the case of treating anxiety disorders with panic attacks, the maximum therapeutic effect is usually achieved after about 3 months.
• The patient should not change the dosage without consulting their doctor.
• The total treatment time may vary significantly from patient to patient and will be determined by the doctor. The medicine should be taken for as long as the doctor recommends. If the patient stops treatment too early, the symptoms of the disease may return. Therefore, it is recommended to continue treatment for at least 6 months after feeling better.

If the patient feels that the effect of Oroes is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Oroes than recommended

If the patient has taken a higher dose of Oroes than prescribed or someone else has taken the medicine by mistake, they should immediately contact their doctor or go to the nearest hospital.
This should be done even if the patient does not feel any discomfort.
The patient should take the packaging (box) and any remaining tablets with them.
Symptoms of overdose may include:drowsiness, dizziness, tremors, agitation, seizures, coma, nausea, vomiting, heart rhythm disorders, decreased blood pressure, and electrolyte imbalance.

Missing a dose of Oroes

The patient should not take a double dose to make up for a missed dose. If the patient forgets to take a dose and remembers before going to bed, they should take the missed dose immediately. The patient should take the next dose at the usual time the next day. If the patient remembers missing a dose at night or the next day, they should skip the missed dose and take the next dose at the usual time.

Stopping treatment with Oroes

The patient should not stop taking Oroes unless their doctor recommends it. If the patient is finishing treatment, it is usually recommended to gradually reduce the dose of Oroes over a few weeks.
After stopping treatment with Oroes, especially if it is sudden, the patient may experience withdrawal symptoms. These symptoms are common when treatment with Oroes is stopped. The risk is higher if Oroes has been taken for a long time, in high doses, or if the dose has been reduced too quickly.
In most patients, the symptoms are mild and resolve on their own within two weeks. However, in some patients, their course may be severe and may last longer (2-3 months or longer). If the patient experiences severe withdrawal symptoms after stopping treatment with Oroes, they should consult their doctor. The doctor may recommend restarting treatment with Oroes and tapering it off more slowly.
Withdrawal symptomsinclude: dizziness (unsteady gait, balance disorders), feeling of tingling, prickling, or burning, and (less commonly) a sensation of electric shock (including in the head), sleep disturbances (vivid dreams, nightmares, insomnia), anxiety, headache, nausea (nausea or vomiting), sweating (including night sweats), restlessness or agitation, tremors, feeling of confusion and/or disorientation, emotional instability or irritability, diarrhea (loose stools), vision disturbances, heart palpitations or arrhythmias.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Oroes can cause side effects, although not everybody gets them.
Side effects usually disappear after a few weeks of treatment. It should be remembered that some of these side effects may also be symptoms of the treated disease and will disappear as the patient's condition improves.
If the patient experiences any of the following side effects, they should immediately contact their doctor or go to the hospital:
Uncommon(may affect up to 1 in 100 people)

• unusual bleeding, including bleeding from the gastrointestinal tract.

Rare(may affect up to 1 in 1,000 people)

• if the patient experiences swelling of the skin, tongue, lips, throat, or face, or difficulty breathing or swallowing (anaphylactic allergic reaction), they should immediately contact their doctor or go to the hospital
• if the patient has a high fever, is agitated, confused (disoriented), has tremors, and severe muscle contractions, which may be symptoms of a rare disorder called serotonin syndrome, they should contact their doctor.

Unknown(frequency cannot be estimated from the available data)

• difficulty urinating
• seizures, see also section 2 "Warnings and precautions"
• yellowing of the skin and whites of the eyes, which is a sign of liver function disorders and/or hepatitis
• rapid, irregular heartbeat, fainting, which may be symptoms of life-threatening heart rhythm disorders, called torsade de pointes
• suicidal thoughts related to self-harm, see also section 2 "Warnings and precautions"
• sudden swelling of the skin or mucous membranes (angioedema)
• severe postpartum hemorrhage, see additional information in section 2 "Pregnancy, breastfeeding, and fertility"

In addition to the above, the following side effects have also been reported:

Very common(may affect more than 1 in 10 people)

• nausea
• headache

Common(may affect up to 1 in 10 people)

• nasal congestion or sinusitis (sinus infection)
• decreased or increased appetite
• anxiety, restlessness, unusual dreams, sleep disturbances, drowsiness, dizziness, yawning, tremors, feeling of tingling, numbness or tingling in the hands and feet, paresthesia (sensitivity to temperature - hypersensitivity to cold/heat)
• diarrhea, constipation, vomiting, dry mouth
• increased sweating
• muscle and joint pain
• sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women)
• feeling of fatigue, fever
• weight gain.

Uncommon(may affect up to 1 in 100 people)

• hives, rash, itching
• grinding of the teeth (bruxism), agitation, nervousness, panic attack, confusion (disorientation)
• sleep disturbances, taste disorders, fainting
• dilated pupils, vision disturbances, ringing in the ears (tinnitus)
• hair loss
• heavy menstrual bleeding, irregular periods
• weight loss
• rapid heartbeat
• swelling of the arms or legs
• nosebleeds.

Rare(may affect up to 1 in 1,000 people)

• aggression, depersonalization (feeling of strangeness of one's own person), hallucinations
• slow heartbeat.

Some patients have also reported side effects with an unknown frequency(frequency cannot be estimated from the available data):

• low sodium levels in the blood (manifested by nausea and malaise with muscle weakness or confusion)
• dizziness when standing up due to decreased blood pressure (orthostatic hypotension)
• abnormal liver function test results (increased liver enzyme activity in the blood)
• movement disorders (involuntary muscle movements)
• painful erection (priapism)
• bleeding, including bruising in the skin and mucous membranes, and decreased platelet count (thrombocytopenia)
• sudden swelling of the skin or mucous membranes (angioedema)
• increased urine production (inappropriate antidiuretic hormone secretion)
• lactation in women who are not breastfeeding
• mania (euphoric mood)
• arrhythmias
• heart rhythm disorders (QT interval prolongation visible on an ECG, a method of recording the electrical activity of the heart)
• restlessness (akathisia)
• eating disorders, anorexia.

side effects observed after the use of a certain group of medicines - selective serotonin reuptake inhibitors. Oroes belongs to this group of medicines.
Patients taking medicines from the group of serotonin reuptake inhibitors or tricyclic antidepressants have been observed to have an increased risk of bone fractures.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety 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, http://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 this medicine.

5. How to store Oroes

The medicine should be stored out of sight and reach of children.
There are no special recommendations for storing the medicine.
Do not use this medicine after the expiry date stated on the blister pack and carton after "Expiry date" or "EXP". The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist 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 Oroes contains

• The active substance of Oroes is escitalopram.
• Each Oroes 10 mg coated tablet contains 10 mg of escitalopram (as escitalopram oxalate).
• The other ingredients are: Tablet core:microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate Tablet coating:hypromellose 6cP, titanium dioxide (E 171), macrogol 400

What Oroes looks like and contents of the pack

White, almost white, oval, coated tablets (approximately 8.1 mm x 5.6 mm in size), with a dividing line on one side.
The tablet can be divided into equal doses.
Oroes is available in pack sizes of 28, 30, 60, and 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Manufacturer

Genericon Pharma Gesellschaft m.b.H
Hafnerstraße 211
8054 Graz
Austria
HBM Pharma s.r.o.
Sklabinská 30
03680 Martin
Slovakia
Delorbis Pharmaceuticals LTD.
17 Athinon Street
Ergates Industrial Area
2643 Ergates, Nicosia
Cyprus
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
Phone: +48 12 262 32 36
Date of last revision of the leaflet:June 2024

The following information is intended for healthcare professionals only

Overdose symptoms
Symptoms observed after an overdose of escitalopram are mainly related to the central nervous system (ranging from dizziness, tremors, and agitation to rare cases of serotonin syndrome, seizures, and coma), gastrointestinal system (nausea, vomiting), and cardiovascular system (hypotension, tachycardia, QT interval prolongation, and heart rhythm disorders), as well as electrolyte imbalance.
Treatment in case of overdose
There is no specific antidote. The patient's airways should be cleared, and adequate oxygenation and ventilation should be ensured. Gastric lavage should be considered, and activated charcoal should be used. It is recommended to monitor the patient's heart rate and vital signs and to provide supportive treatment for symptoms.
As soon as possible after oral ingestion, gastric lavage should be performed, and activated charcoal should be used.