Oroes

Package leaflet: Information for the patient

Oroes
10 mg, film-coated tablets
Escitalopram
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Oroes is and what it is 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 package and other information

1. What Oroes is and what it is used for

Oroes contains escitalopram and is used to treat:

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

Escitalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonergic system in the brain by increasing serotonin levels. Disturbances in the brain's serotonergic system are considered an important factor in the development of depression and associated disorders.
Improvement may not be felt until after several weeks of treatment. It is important to continue taking Oroes even if it takes some time before the patient begins to feel better.
Please consult your doctor if there is no improvement or if the patient feels worse.

2. Important information before taking Oroes

When not to take Oroes

• if the patient is allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6);
• if the patient is currently taking medicines belonging to a group called monoamine oxidase inhibitors (MAOIs), including selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression), or linezolid (an antibiotic used to treat bacterial infections) (see section 2 "Oroes and other medicines");
• if the patient has a congenital irregular heart rhythm or has experienced an episode of irregular heart rhythm (visible on ECG – a test assessing 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, discuss this with your doctor.
You should inform your doctor if the patient has any other disorders or diseases, as these may need to be taken into account. In particular, inform your doctor if:

• the patient has epilepsy or a history of epileptic seizures. 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. Dose adjustment by the doctor may be necessary.
• the patient has kidney function disorders. Dose adjustment by the doctor may be necessary.
• the patient has diabetes. Treatment with Oroes may interfere with glucose control (blood sugar levels). Adjustment of insulin and/or oral glucose-lowering (antidiabetic) medicines may be required.
• the patient has a history of blood clotting disorders (e.g. the patient has increased tendency to bleed or bruise) or if the patient is pregnant (see section 2 "Pregnancy, breastfeeding and fertility");
• the patient is taking medicines affecting blood coagulation, such as acetylsalicylic acid and nonsteroidal anti-inflammatory drugs (painkillers), certain medicines used to treat psychiatric disorders (atypical antipsychotics and phenothiazines), 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 undergoing electroconvulsive therapy
• the patient has ischaemic heart disease
• the patient has previously experienced mania or hypomania. Mania is characterised by unusual and rapidly changing thoughts, exaggerated feelings of happiness, and excessive physical activity. If these symptoms occur, consult a doctor.
• the patient has experienced episodes of psychotic disorders (delusions, hallucinations, severe thought disorders, unusual mood swings, or unusual behaviours)
• the patient has or has had heart problems or recently suffered a heart attack
• the patient has a slow resting heart rate and/or if the patient may have low salt levels in the body (reduced sodium concentration in the blood) due to prolonged, severe diarrhoea and vomiting or use of diuretics
• the patient experiences rapid or irregular heartbeat, fainting, collapse or dizziness upon standing, symptoms which may indicate heart rhythm disorders;
• the patient has or has had eye problems, such as certain types of glaucoma (increased eye pressure)
• medicines such as Oroes (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.

Note
As with other medicines used to treat depression or similar conditions,
improvement in the patient's condition does not occur immediately after starting treatment. Improvement in well-being
may occur only after several weeks of taking Oroes.
In cases of anxiety disorders with panic attacks, improvement usually occurs after 2-4 weeks
of treatment. During the initial phase of therapy, some patients may experience increased anxiety, which
will subside if treatment is continued. Therefore, it is essential to strictly follow the doctor's instructions
and not discontinue or alter the dosage of the medicine without prior consultation
with the doctor.
In some patients with bipolar affective disorder, a manic phase may occur. This is characterised by
unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these
symptoms occur, consult a doctor.
Suicidal thoughts and worsening of depression or anxiety disorder
In cases of depression and/or anxiety disorders, thoughts of self-harm or suicidal thoughts may
also occur. These may worsen at the beginning of treatment with antidepressant medicines,
as these medicines usually take about 2 weeks, sometimes longer, to start working.
The likelihood of such thoughts is higher if:

• the patient has previously experienced suicidal or self-harming thoughts
• the patient is a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with antidepressants.

If thoughts of self-harm or suicidal thoughts ever occur, you should
contact your doctor immediately or go to a hospital.
It may be helpful to inform family members or friends about your depression
or anxiety disorders and ask them to read this leaflet. You may ask them
to inform you if they notice your depression or anxiety worsening or if worrying
changes in behaviour occur.
During the first weeks of treatment, symptoms such as: restlessness
or difficulty sitting or standing still may also occur. If such symptoms occur,
contact your doctor immediately.
Caution is advised when taking Oroes together with other medicines
that have a serotonergic effect (such as sumatriptan and other triptans, tryptophan, tramadol
(used to treat severe pain), or buprenorphine (used to treat severe pain
and opioid dependence)). In rare cases, serotonin syndrome may occur, which
has been observed not only in combination with serotonergic medicines but also, very rarely,
in patients taking selective serotonin reuptake inhibitors (SSRIs). If the patient develops high fever, muscle tremors, confusion, agitation,
trembling due to nervousness, or chills, contact a doctor immediately.
If any of these symptoms occur, discontinue Oroes and serotonergic medicines immediately and
contact your doctor, who will initiate appropriate treatment without delay.
Concomitant use of Oroes and preparations containing St. John's wort
(Hypericum perforatum) should be avoided, as this increases the likelihood
of adverse effects (see section 2 "Oroes and other medicines").
When the patient stops treatment with Oroes, gradual dose reduction over
one to two weeks is recommended 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 noted that patients under 18 years of age taking medicines from this group are at increased
risk of adverse effects such as: suicide attempts, suicidal thoughts,
and hostility (particularly aggression, defiant behaviours, and anger outbursts). Nevertheless, a doctor may
prescribe Oroes to patients under 18 years of age if they consider it to be in the patient's best interest. If Oroes has been prescribed to a patient under 18 years of age and you have
any doubts, contact your doctor again.
If any of the above-mentioned symptoms appear or worsen in a patient under 18 years of age taking Oroes, inform the doctor. Furthermore, the long-term impact of Oroes on safety regarding growth, maturation, and cognitive and behavioural development in this age group has not yet been established.
Oroes and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
The following medicines may affect the action of Oroes, and Oroes may also affect the action of other medicines. Inform your doctor if the patient is taking any of the following medicines:

• non-selective monoamine oxidase inhibitors (MAOIs) containing active substances such as: phenelzine, iproniazid, isoniazid, isocarboxazid, nialamide, and tranylcypromine. These medicines should not be used in combination with Oroes. Concurrent use may lead to severe adverse 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 Oroes. After discontinuing Oroes, wait 7 days before taking any of these medicines.
• reversible, selective monoamine oxidase A (MAO-A) inhibitors, including moclobemide (a medicine used to treat depression), should not be used in combination with Oroes, and if their use is necessary, only under medical supervision. These medicines increase the risk of serotonin syndrome (see section 2 "When not to take Oroes").
• irreversible monoamine oxidase B (MAO-B) inhibitors, including selegiline (a medicine used to treat Parkinson's disease), should not be used in combination with Oroes, and if their use is necessary, only 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 used in combination with Oroes, and if its use is necessary, only under medical supervision. This medicine increases the risk of adverse effects such as serotonin syndrome (see section 2 "When not to take Oroes").
• medicines used for heart rhythm disorders or medicines that may affect heart rhythm, such as: class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, and certain antibacterial medicines (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials especially halofantrine), certain antihistamines (astemizole, mizolastine). These medicines should not be used in combination with Oroes. Consult your doctor if you have any further questions.
• lithium (used to treat bipolar affective disorder) and tryptophan (a dietary supplement converted to serotonin)
• imipramine and desipramine (used to treat depression)
• sumatriptan and other triptans (used to treat migraine), tramadol (used to treat severe pain), or buprenorphine (used to treat severe pain and opioid dependence). These may increase the risk of adverse effects such as serotonin syndrome.
• cimetidine, omeprazole, esomeprazole, or lanzoprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase escitalopram blood concentration.
• St. John's wort (Hypericum perforatum) – an herbal preparation used for depression – may increase the risk of adverse effects (see section 2 "Warnings and precautions")
• medicines affecting blood coagulation, such as: acetylsalicylic acid and nonsteroidal anti-inflammatory drugs (painkillers), certain medicines used to treat psychiatric disorders (atypical antipsychotics and phenothiazines), and most tricyclic antidepressants. The risk of prolonged clotting time also increases if the patient uses ticlopidine or dipyridamole (medicines used to reduce the risk of thrombosis) or oral anticoagulants such as: warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood) during treatment. The doctor will likely monitor blood clotting time at the beginning and end of Oroes treatment to ensure the anticoagulant dose remains appropriate.
• mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used for severe pain) due to the risk of lowering the seizure threshold
• neuroleptics (medicines used to treat schizophrenia and/or psychosis, such as: phenothiazine, thioxanthene, and butyrophenone derivatives) and antidepressants (tricyclic antidepressants, selective serotonin reuptake inhibitors), due to the risk of lowering the seizure threshold
• flecainide, propafenone, and metoprolol (used for cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Oroes may be required.
• medicines that lower potassium or magnesium levels in the blood, as in such conditions the risk of severe, potentially life-threatening heart rhythm disorders increases.

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, concomitant use of Oroes and alcohol is not recommended.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine. Oroes should not be used during pregnancy or breastfeeding unless the patient has discussed the risks and benefits of treatment with her doctor.
Pregnancy
When taking Oroes during pregnancy, treatment should never be stopped abruptly.
If the patient is taking Oroes during the last three months of pregnancy, inform the doctor. The patient should be aware that the newborn may experience (usually within 24 hours after birth) the following symptoms: breathing difficulties, bluish skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood sugar (glucose) levels, muscle stiffness or floppiness, increased reflex excitability, tremors, jitteriness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If any of these symptoms occur in the newborn, contact a doctor immediately.
Inform the doctor and/or midwife about taking Oroes. Use during pregnancy of medicines such as Oroes, especially during the last three months of pregnancy, may increase the risk of serious complications in the newborn called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterised by rapid breathing and cyanosis in the infant and usually occurs within the first day after birth. If such symptoms occur in the newborn, contact a doctor and/or midwife immediately.
Taking Oroes towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Oroes, she should inform her doctor or midwife so they can provide appropriate advice.
Breastfeeding
Oroes is expected to pass into breast milk. Consult a doctor or pharmacist before taking any medicine.
Fertility
Animal studies have shown that citalopram – a medicine similar to escitalopram – affects sperm quality. This may theoretically affect fertility, but no effect on human fertility has been observed to date.
Driving and operating machinery
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, meaning 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
advised by your doctor. If in doubt, consult your doctor or pharmacist.
Recommended dose
Adults
Depression
The usual dose of Oroes is 10 mg once daily. Your doctor may recommend further increasing
the dose up to the maximum dose of 20 mg per day.
Panic disorder with agoraphobia
The initial dose of Oroes is 5 mg once daily during the first week of treatment, then the dose is
increased to 10 mg per day. Your doctor may recommend further increasing the dose up to the
maximum dose of 20 mg per day.
Social anxiety disorder
The usual dose of Oroes is 10 mg once daily. Your doctor may recommend reducing the dose
to 5 mg per day or increasing the dose up to the maximum dose 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 daily. Your doctor may recommend further increasing
the dose up to the maximum dose of 20 mg per day.
Obsessive-compulsive disorder
The usual dose of Oroes is 10 mg once daily. Your doctor may recommend increasing the dose
up to the maximum dose of 20 mg per day.
Elderly patients (over 65 years of age)
The recommended initial dose of Oroes is 5 mg once daily. Your doctor may recommend increasing
the dose to 10 mg once daily.
Use in children and adolescents
Oroes is not normally recommended for use 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 hepatic impairment should not
exceed 5 mg per day for the first 14 days of treatment. Thereafter, the daily dose may be increased
according to the individual patient's response to treatment up to 10 mg per day. Particular caution
is required when adjusting the dose in patients with severe hepatic impairment.
Dose adjustment is not required in patients with mild to moderate renal impairment. Caution is advised
in patients with severe renal impairment (creatinine clearance <30 ml/min).
In patients with reduced metabolic activity of cytochrome CYP2C19 (a specific liver enzyme),
treatment should be initiated at a dose of 5 mg per day for the first two weeks. Depending on the
individual patient's 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.
• Swallow the tablet with water.
• Do not chew the tablets, as they have a bitter taste.

Duration of treatment
It may take several weeks of treatment before the patient starts to feel better.

• Treatment with Oroes should be continued, even if it takes some time before improvement in well-being is noticed. In the treatment of panic disorder with agoraphobia, the maximum therapeutic effect is achieved after approximately 3 months.
• Do not change the dose without first discussing it with your doctor.
• The total duration of treatment may vary significantly between individual patients and will be determined by the doctor. The medicine should be taken for as long as your doctor recommends. If treatment is stopped too early, symptoms of the illness may return. Therefore, treatment should be continued for at least 6 months after recovery of well-being.

If you feel that the effect of Oroes is too strong or too weak, consult your doctor or pharmacist.
Taking more Oroes than recommended
If you have taken more Oroes than prescribed, or if someone else has taken the medicine by mistake,
you should contact your doctor immediately or go to the nearest hospital. This should be done even
if you do not feel any symptoms.
Take the packaging (box) and any remaining tablets with you.
Symptoms of overdose may include: drowsiness, dizziness, tremors, agitation, seizures, coma,
nausea, vomiting, cardiac arrhythmias, low blood pressure, and disturbances in water-electrolyte balance.
Missed dose of Oroes
Do not take a double dose to make up for a missed dose. If you forget to take a dose and remember
before going to sleep, take the missed dose immediately. Take the next dose at the usual time the
following day. If you remember about the missed dose during the night or the next day, skip the missed
dose and take the next dose at the usual time.
Stopping treatment with Oroes
Do not stop taking Oroes unless your doctor advises you to do so. When stopping treatment, it is
usually recommended to gradually reduce the dose of Oroes over several weeks.
After stopping Oroes, especially if stopped abruptly, you may experience withdrawal symptoms.
These symptoms are common when stopping treatment with Oroes. The risk is greater if Oroes has
been taken for a long time, at high doses, or if the dose was reduced too quickly.
In most patients, symptoms are mild and resolve spontaneously within two weeks. However, in some
patients, symptoms may be severe and may persist longer (2–3 months or more). If you experience
severe withdrawal symptoms after stopping Oroes, contact your doctor. Your doctor may recommend
resuming treatment and tapering the dose more slowly.
Withdrawal symptoms include: dizziness (unsteady gait, balance disturbances), tingling sensation,
pricking, burning sensation, and (less frequently) electric shock-like sensations (also in the head),
sleep disturbances (vivid dreams, nightmares, insomnia), feelings of anxiety, headache, nausea (nausea
or vomiting), sweating (including night sweats), motor restlessness or agitation, tremor, feeling of
confusion and (or) disorientation, emotional instability or irritability, diarrhoea (loose stools), visual
disturbances, palpitations or rapid heartbeat (palpitations).
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions usually resolve within a few weeks of treatment. It should be remembered that some
of these reactions may also be symptoms of the illness being treated and will resolve as the patient's condition improves.
If any of the following adverse reactions occur in a patient, contact a doctor immediately or go to hospital:

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

• Unusual bleeding, including gastrointestinal bleeding.

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

• If the patient develops swelling of the skin, tongue, lips, larynx or face, or has difficulty breathing or swallowing (anaphylactic allergic reaction), they should contact a doctor immediately or go to hospital.
• If the patient develops high fever, agitation, confusion (disorientation), tremors and sudden muscle spasms, which may be symptoms of a rare condition called serotonin syndrome, medical advice should be sought.

Not known (frequency cannot be estimated from available data)

• Difficulty passing urine
• Seizure attacks, see also section 2 "Warnings and precautions"
• Yellowing of the skin and whites of the eyes, indicating impaired liver function and/or hepatitis
• Rapid, irregular heartbeat, fainting, which may be symptoms of life-threatening cardiac arrhythmias, so-called torsade de pointes
• Thoughts related to self-harm or suicide, see also section 2 "Warnings and precautions"
• Sudden swelling of the skin or mucous membranes (angioedema)
• Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in section 2 "Pregnancy, breastfeeding and fertility"

In addition to those listed above, the following adverse reactions have also been reported:

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

• Nausea
• Headache

Common (may affect up to 1 in 10 patients)

• Nasal congestion or runny nose (sinusitis)
• Decreased or increased appetite
• Anxiety, restlessness, unusual dreams, difficulty sleeping, drowsiness, dizziness, yawning, tremor, skin tingling, numbness/tingling of hands and feet, disturbances in temperature sensation – hypersensitivity to cold/feeling of warmth (paresthesia)
• Diarrhea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain
• Sexual disorders (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 patients)

• Urticaria, rash, itching
• Teeth grinding (bruxism), agitation, nervousness, panic attack, confusion (disorientation)
• Sleep disturbances, taste disturbances, fainting
• Pupil dilation, visual disturbances, ringing in the ears (tinnitus)
• Hair loss
• Heavy menstrual bleeding, irregular menstruation
• Weight loss
• Rapid heartbeat
• Swelling of upper or lower limbs
• Nosebleeds

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

• Aggression, depersonalization (feeling of detachment from oneself), hallucinations
• Slow heartbeat

In some patients, adverse reactions of unknown frequency (frequency cannot be estimated from available data) have occurred:

• Decreased sodium levels in blood (manifesting as nausea, malaise, muscle weakness or confusion)
• Dizziness upon standing due to reduced blood pressure (orthostatic hypotension)
• Abnormal liver function tests (increased liver enzyme activity in blood)
• Movement disorders (involuntary muscle movements)
• Painful erection (priapism)
• Bleeding, including petechiae in the skin and mucous membranes, and decreased platelet count (thrombocytopenia)
• Sudden swelling of the skin or mucous membranes (angioedema)
• Increased urine output (inappropriate antidiuretic hormone secretion)
• Lactation in women who are not breastfeeding
• Mania (euphoric mood)
• Arrhythmias
• Heart rhythm disorders (so-called QT interval prolongation visible on ECG, a method recording the electrical activity of the heart)
• Restlessness (akathisia)
• Eating disorders, anorexia

Adverse reactions observed with a class of medicines – selective serotonin reuptake inhibitors. Oroes belongs to this group of medicines.
An increased risk of bone fractures has been observed in patients taking medicines from the group of serotonin reuptake inhibitors or tricyclic antidepressants.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Oroes

Keep this medicine out of the sight and reach of children.
There are no special requirements for the storage conditions of this medicine.
Do not use this medicine after the expiry date stated on the blister and carton after:
"Expiry date" or "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the package and other information

What Oroes contains

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

What Oroes looks like and contents of the pack
White to almost white, oval film-coated tablets (approximately 8.1 mm by 5.6 mm), with a score line on one side.
The tablet can be divided into equal doses.
Oroes is available in the following pack sizes: 28, 30, 60 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information, contact the marketing authorisation holder's representative:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
Tel. +48 12 262 32 36

The following information is intended for healthcare professionals only

Symptoms of overdose
Symptoms observed following escitalopram overdose primarily involved the
central nervous system (ranging from dizziness, tremor, and agitation to rare
cases of serotonin syndrome, seizures, and coma), gastrointestinal system
(nausea, vomiting), cardiovascular system (hypotension, tachycardia, QT interval prolongation,
and cardiac arrhythmias), as well as electrolyte imbalances (hypokalemia,
hyponatremia).
Treatment in case of overdose
There is no specific antidote. Ensure airway patency, provide adequate oxygenation,
and maintain respiratory function. Gastric lavage and administration of activated
charcoal should be considered. Gastric lavage should be performed as soon as possible after oral ingestion.
Continuous cardiac and vital function monitoring is recommended, along with supportive symptomatic treatment.