Escitalopram aurovitas

Patient Information Leaflet

Escitalopram Aurovitas, 10 mg, film-coated tablets
Escitalopram Aurovitas, 15 mg, film-coated tablets
Escitalopram Aurovitas, 20 mg, film-coated tablets
Escitalopramum
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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 you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Escitalopram Aurovitas is and what it is used for
2. What you need to know before taking Escitalopram Aurovitas
3. How to take Escitalopram Aurovitas
4. Possible side effects
5. How to store Escitalopram Aurovitas
6. Contents of the pack and other information

1. What Escitalopram Aurovitas is and what it is used for

Escitalopram Aurovitas contains the active substance escitalopram. Escitalopram Aurovitas belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain by increasing serotonin levels.
Escitalopram Aurovitas is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder).
It may take several weeks of treatment before improvement begins. You should continue taking Escitalopram Aurovitas even if it takes some time for your condition to improve.
If no improvement occurs or if you feel worse, please consult your doctor.

2. Important information before taking Escitalopram Aurovitas

When not to take Escitalopram Aurovitas

• if the patient is allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6),
• if the patient is taking other medicines belonging to a group called MAO inhibitors, containing selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression), or linezolid (an antibiotic),
• if the patient was born with a congenital abnormal heart rhythm or has experienced an episode of abnormal 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 "Escitalopram Aurovitas with other medicines").

Warnings and precautions
Before starting treatment with Escitalopram Aurovitas, discuss this with your doctor or pharmacist.
Inform your doctor if the patient has any other disorders or diseases, as the doctor should take such information into account. In particular, inform the doctor:

• If the patient has epilepsy. If seizures occur for the first time or increase in frequency, treatment with Escitalopram Aurovitas should be discontinued (see also section 4 "Possible side effects").
• If the patient has impaired liver or kidney function. Dose adjustment by the doctor may be required.
• If the patient has diabetes. Treatment with Escitalopram Aurovitas may affect blood glucose control. Adjustment of insulin dose and/or oral glucose-lowering medicines may be necessary.
• If the patient has low sodium levels in the blood.
• If the patient has an increased tendency to bleed or bruise easily, or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility").
• If the patient is undergoing electroconvulsive therapy.
• If the patient has ischemic heart disease.
• If the patient has heart problems or recently suffered a myocardial infarction (heart attack).
• If the patient has a slow resting heart rate and/or if electrolyte imbalances may occur due to prolonged severe diarrhoea, vomiting, or use of diuretics (water pills).
• If the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate an abnormal heart rate.
• If the patient has had or currently has eye problems, such as certain types of glaucoma (increased pressure inside the eyeball).
• Medicines such as escitalopram (so-called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.
• If the patient is taking medicinal products containing buprenorphine. Taking these medicines together with Escitalopram Aurovitas may lead to serotonin syndrome, a potentially life-threatening condition (see "Escitalopram Aurovitas with other medicines").

Note
Some patients with bipolar affective disorder may experience a manic phase. This is characterised by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, consult a doctor.
In the first weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may also occur. If such symptoms appear, inform the doctor immediately.
Suicidal thoughts and worsening of depression or anxiety disorder
People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, sometimes longer, to start working.
These symptoms are more likely in:

• patients who have previously experienced thoughts of self-harm or suicide;
• young adult patients. Clinical trial data show an increased risk of suicidal behaviour in individuals under 25 years of age with psychiatric disorders who were treated with antidepressant medicines.

If the patient develops thoughts of self-harm or suicide, seek immediate medical help
or go to hospital.
It may be helpful to inform family members or close friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform him/her if they notice that depression or medication effects have worsened or if there are disturbing changes in behaviour.
Children and adolescents
Escitalopram Aurovitas should not be used in children and adolescents under 18 years of age.
It should also be noted that when taking medicines of this class, patients under 18 years of age are at increased risk of experiencing adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and anger). Nevertheless, a doctor may prescribe Escitalopram Aurovitas to patients under 18 years of age if he or she considers it to be in their best interest. If your doctor has prescribed Escitalopram Aurovitas for a patient under 18 years of age and you have any doubts, please contact the prescribing doctor. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Escitalopram Aurovitas, inform your doctor immediately. Furthermore, there are currently no data on the long-term safety of Escitalopram Aurovitas in this age group regarding growth, maturation, and cognitive and behavioural development.

Escitalopram Aurovitas with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
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, isocarboxazid, nialamide, and tranylcypromine. If the patient has taken any of these medicines, they should wait 14 days before starting Escitalopram Aurovitas. After stopping Escitalopram Aurovitas, wait 7 days before taking any of these medicines.
• Reversible, selective monoamine oxidase A (MAO-A) inhibitors containing moclobemide (used in the treatment of depression).
• Irreversible monoamine oxidase B (MAO-B) inhibitors containing selegiline (used in the treatment of Parkinson's disease). These medicines increase the risk of adverse effects.
• The antibiotic linezolid.
• Lithium (used in the treatment of bipolar affective disorder) and tryptophan.
• Imipramine and desipramine (used in the treatment of depression).
• Sumatriptan and similar medicines (used in the treatment of migraine) and tramadol and similar medicines (opioids, used for severe pain). These may increase the risk of adverse effects.
• Cimetidine, lansoprazole, and omeprazole (used in the treatment of stomach ulcers), fluconazole (used in the treatment of fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase the blood concentration of escitalopram.
• St. John's wort (Hypericum perforatum) – a herbal remedy used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (painkillers or blood thinners, known as anticoagulants). These may increase the tendency to bleed.
• Warfarin, dipyridamole, and phenprocoumon (blood thinners, known as anticoagulants). Your doctor may order blood clotting time tests at the beginning and after stopping Escitalopram Aurovitas to determine whether the anticoagulant dose remains appropriately adjusted.
• Mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (used for severe pain) due to possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Escitalopram Aurovitas may be required.
• Medicines that lower potassium or magnesium levels in the blood, which increase the risk of life-threatening heart rhythm disturbances.

Some medicines may worsen the side effects of Escitalopram Aurovitas and sometimes may cause very serious reactions. Do not take any other medicines while taking Escitalopram Aurovitas without first consulting your doctor, especially:

• medicines containing buprenorphine. These medicines may interact with Escitalopram Aurovitas and may cause symptoms such as involuntary, rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, body temperature above 38°C. If such symptoms occur, contact your doctor.

Do not take Escitalopram Aurovitas together with 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, certain antibacterial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarials – particularly halofantrine), certain antihistamines (astemizole, hydroxyzine, mizolastine), etc. Consult your doctor if you have any further questions.

Escitalopram Aurovitas with food, drink and alcohol
Escitalopram Aurovitas can be taken with or without food (see section 3 "How to take Escitalopram Aurovitas").
As with many medicines, it is not recommended to drink alcohol while taking Escitalopram Aurovitas, although interactions (effects) between Escitalopram Aurovitas and alcohol are not expected.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before taking this medicine. The patient should not take Escitalopram Aurovitas during pregnancy or while breastfeeding unless she has discussed the risks and benefits of treatment with her doctor.
If the patient takes Escitalopram Aurovitas during the last three months of pregnancy, she should be aware that the newborn may experience the following symptoms: breathing difficulties, bluish skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose, 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, seek medical help immediately.
Inform your doctor and/or midwife about taking Escitalopram Aurovitas.
Taking medicines such as Escitalopram Aurovitas during pregnancy, especially during the last three months, may increase the risk of serious complications in the newborn called persistent pulmonary hypertension of the newborn (PPHN). It is characterised by rapid breathing and cyanosis (bluish skin). These symptoms usually appear within the first day after birth. If such symptoms occur in the newborn, contact your doctor and/or midwife immediately.
Do not suddenly stop taking Escitalopram Aurovitas during pregnancy.
If Escitalopram Aurovitas is taken towards the end of pregnancy, there may be an increased risk of severe vaginal bleeding shortly after delivery, especially if there has been a history of bleeding disorders. Your doctor or midwife should know that you are taking Escitalopram Aurovitas so they can advise you.
Escitalopram is expected to pass into breast milk.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen quality. This could theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines
The patient should not drive or operate machinery until they know how Escitalopram Aurovitas affects them.

Escitalopram Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Escitalopram Aurovitas

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Recommended dose
Adults:
Depression
The usual recommended dose of Escitalopram Aurovitas is 10 mg taken once daily. The dose may be
increased by the doctor up to a maximum of 20 mg daily.
Panic disorder
The initial dose of Escitalopram Aurovitas is 5 mg once daily during the first week of treatment,
after which the dose is increased to 10 mg daily. The dose may then be increased by the doctor up
to a maximum of 20 mg daily.
Social phobia
The usual recommended dose of Escitalopram Aurovitas is 10 mg taken once daily. The dose may
then be reduced by the doctor to 5 mg daily or increased up to a maximum of 20 mg daily,
depending on the patient's response to the medicine.
Generalised anxiety disorder
The usual recommended dose of Escitalopram Aurovitas is 10 mg taken once daily. The dose may
be increased by the doctor up to a maximum of 20 mg daily.
Obsessive-compulsive disorder
The usual recommended dose of Escitalopram Aurovitas is 10 mg taken once daily. The dose may
be increased by the doctor up to a maximum of 20 mg daily.
Elderly patients (over 65 years)
The recommended initial dose of Escitalopram Aurovitas is 5 mg taken once daily. The doctor may
recommend increasing the dose to 10 mg daily.
Use in children and adolescents
Escitalopram Aurovitas should not usually be used in children and adolescents. Additional
information is provided in section 2 “Warnings and precautions”.
Renal function disorders
Caution should be exercised in patients with severe renal impairment. The medicine should be
used as directed by the doctor.
Hepatic function disorders
Patients with hepatic impairment should not take a dose exceeding 10 mg daily. The medicine
should be used as directed by the doctor.
Patients who are poor metabolisers of drugs via the CYP2C19 isoenzyme
Patients with this known genotype should not take a dose of 10 mg daily. The medicine should be
used as directed by the doctor.
How to use Escitalopram Aurovitas
Escitalopram Aurovitas may be taken with or without food.
Tablets should be swallowed with water. Do not chew them, as they are bitter in taste.
If necessary, the tablets may be divided into two parts. To do this, place the tablet on a flat surface
with the groove facing upwards, then break it in half by pressing down with the index fingers of both
hands on each end, as shown in the illustration.

Duration of treatment
Improvement may not be felt until after several weeks of treatment. Therefore, continue using
Escitalopram Aurovitas even if it takes some time before feeling better.
Do not change the dosage without consulting a doctor.
The medicine should be used for as long as directed by the doctor. If treatment is stopped too
early, symptoms may return. Therefore, treatment should be continued for at least 6 months after
symptoms improve.
Taking more Escitalopram Aurovitas than recommended
If a patient has taken more than the prescribed dose of Escitalopram Aurovitas, they should
immediately contact a doctor or go to the emergency department of the nearest hospital. This
should be done even if the patient does not feel unwell. Symptoms of overdose include dizziness,
tremor, agitation, seizures, coma, nausea, vomiting, cardiac arrhythmias, hypotension, and
disturbances in water and electrolyte balance. The patient should bring the Escitalopram Aurovitas
packaging to the doctor's appointment or hospital visit.
If a dose of Escitalopram Aurovitas is missed
Do 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 sleep, they should take the
missed dose immediately. The next dose should be taken the following day as usual. If the patient
remembers the missed dose during the night or the next day, they should skip the missed dose and
take the next dose as usual.
Stopping use of Escitalopram Aurovitas
Do not stop using Escitalopram Aurovitas unless advised by a doctor. When discontinuing treatment,
it is usually recommended to gradually reduce the dose of Escitalopram Aurovitas over several weeks.
After stopping Escitalopram Aurovitas, especially if stopped abruptly, the patient may experience
withdrawal symptoms. These symptoms are common when stopping treatment with Escitalopram
Aurovitas. The risk is greater if Escitalopram Aurovitas has been used 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, they may be more severe or persist
longer (2–3 months or longer). If severe withdrawal symptoms occur after stopping Escitalopram
Aurovitas, contact a doctor. The doctor may recommend restarting the medicine and tapering it more
slowly.
Withdrawal symptoms include dizziness (unsteady gait, balance disturbances), tingling sensations,
burning sensations, and (less commonly) electric shock-like sensations, also in the head, sleep
disturbances (vivid dreams, nightmares, insomnia), feelings of unease, headache, nausea, sweating
(including night sweats), psychomotor agitation or restlessness, tremor, feelings of disorientation,
emotional instability or irritability, diarrhoea (loose stools), visual disturbances, palpitations or
pounding heartbeats.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Adverse reactions usually resolve within a few weeks of treatment. It is important to remember that some
of these reactions may also be symptoms of the illness itself and will subside as your condition improves.
If any of these adverse reactions occur during treatment, you should
contact your doctor or go to hospital immediately.

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

• Unusual bleeding, including gastrointestinal bleeding.

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

• Swelling of the skin, tongue, lips, larynx or face, urticaria, or difficulty breathing or swallowing (severe allergic reaction);
• High fever, agitation, confusion (disorientation), tremors, and violent muscle contractions, which may be symptoms of a rare condition called serotonin syndrome.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• Difficulty urinating;
• Seizures, see also section “Warnings and precautions”;
• Yellowing of the skin and whites of the eyes, indicating liver dysfunction/hepatitis;
• Rapid or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsade de pointes;
• Suicidal thoughts and behaviour, see also section “Warnings and precautions”;
• Sudden swelling of the skin or mucous membranes (angioedema).

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

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

• Nausea;
• Headache.

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

• Nasal congestion or cold symptoms (sinusitis);
• Decreased or increased appetite;
• Anxiety, psychomotor agitation, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin tingling;
• Diarrhoea, constipation, vomiting, dry mouth;
• Excessive 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 occur in up to 1 in 100 people):

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

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

• Aggression, depersonalisation (feeling of loss of self-identity, the person feels detached from themselves), hallucinations;
• Slow heartbeat.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• Decreased sodium concentration in blood (manifested by nausea and malaise with muscle weakness or confusion);
• Dizziness upon standing due to low blood pressure (orthostatic hypotension);
• Abnormal liver function test results (increased liver enzyme activity in blood);
• Movement disorders (involuntary muscle movements);
• Painful penile erection (priapism);
• Signs of unusual bleeding, e.g. from the skin or mucous membranes (petechiae);
• Increased secretion of antidiuretic hormone (ADH), causing water retention, blood dilution, and reduced sodium levels (syndrome of inappropriate ADH secretion);
• Galactorrhoea in men and in women who are not breastfeeding;
• Mania;
• In patients taking medicines of this class, an increased risk of bone fractures has been observed;
• Changes in heart rhythm (known as “QT interval prolongation”, visible on ECG, a test assessing heart function);
• Excessive vaginal bleeding shortly after childbirth (postpartum haemorrhage); for more information, see section 2, “Pregnancy, breastfeeding and fertility”.

Additionally, adverse reactions associated with medicines having a similar mechanism of action to escitalopram (the active substance in Escitalopram Aurovitas) are known. These include:

• Psychomotor agitation (akathisia);
• Loss of appetite.

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

5. How to store Escitalopram Aurovitas

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

6. Contents of the pack and other information

What Escitalopram Aurovitas contains

• The active substance is escitalopram. Each film-coated tablet contains 10 mg of escitalopram – Escitalopramum (as oxalate). Each film-coated tablet contains 15 mg of escitalopram – Escitalopramum (as oxalate). Each film-coated tablet contains 20 mg of escitalopram – Escitalopramum (as oxalate).
• The other ingredients are: Tablet core: Silicified microcrystalline cellulose, butylhydroxytoluene (E 321), butylhydroxyanisole (E 320), sodium croscarmellose, microcrystalline cellulose, colloidal anhydrous silica, talc, magnesium stearate. Tablet coating: Hypromellose, titanium dioxide (E 171), polyethylene glycol 400.

What Escitalopram Aurovitas looks like and contents of the pack
Film-coated tablet.
Escitalopram Aurovitas 10 mg:
White or almost white, oval, film-coated, biconvex tablets, with the letter ‘F’ engraved on one side and the number ‘54’ on the other side, with a deep score line dividing between ‘5’ and ‘4’. Tablet size: 8.1 mm x 5.6 mm. The tablet can be divided into equal doses.
Escitalopram Aurovitas 15 mg:
White or almost white, oval, film-coated, biconvex tablets, with the letter ‘F’ engraved on one side and the number ‘55’ on the other side, with a deep score line dividing between ‘5’ and ‘5’. Tablet size: 9.8 mm x 6.3 mm. The tablet can be divided into equal doses.
Escitalopram Aurovitas 20 mg:
White or almost white, oval, film-coated, biconvex tablets, with the letter ‘F’ engraved on one side and the number ‘56’ on the other side, with a deep score line dividing between ‘5’ and ‘6’. Tablet size: 11.6 mm x 7.1 mm. The tablet can be divided into equal doses.
Pack sizes:
PVC/Aclar/Aluminium blisters in cardboard packaging: 14, 20, 28, 50, 56, 100 or 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, no 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Escitalopram Aurovitas
Portugal: Escitalopram Aurovitas
Spain: ESCITALOPRAM AUROVITAS 10 mg/ 15 mg/ 20 mg comprimidos recubiertos con película EFG