Escitalopram aurovitas

Package leaflet: Information for the user

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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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 antidepressant medicines called 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 to feel better.
If no improvement occurs or if you feel worse, 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 if the patient 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.
Tell 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 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 bleeding and bruising or if the patient is pregnant (see "Pregnancy, breastfeeding and effect on fertility").
• If the patient is receiving electroconvulsive therapy.
• If the patient has ischemic heart disease.
• If the patient has heart problems or has recently had a myocardial infarction.
• 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 tablets).
• 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 current or past eye problems, such as certain types of glaucoma (increased pressure inside the eyeball).
• Medicines such as escitalopram (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of 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 thoughts, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, contact 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 about 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 had thoughts of self-harm or suicide;
• young adult patients. Clinical trial data show an increased risk of suicidal behaviour in people under 25 years of age with psychiatric disorders who were treated with antidepressant medicines.

If the patient develops thoughts about self-harm or suicide, seek medical advice immediately
or go to hospital.
It may be helpful to inform relatives or close friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform him or her if they notice that the depression or medication has worsened or if there are worrying 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 adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and manifestations of 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 doctor. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Escitalopram Aurovitas, inform your doctor. 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 the doctor if the patient is taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAO inhibitors) containing active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If the patient has taken any of these medicines, a 14-day interval should be observed 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 escitalopram blood levels.
• St John's wort (Hypericum perforatum) – a herbal medicine used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (painkillers or blood-thinning medicines, known as anticoagulants). These may increase the tendency to bleed.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, known as anticoagulants). Your doctor may order blood clotting tests at the beginning and after stopping Escitalopram Aurovitas to determine whether the anticoagulant dose is still appropriate.
• 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 in the treatment of 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 medicines (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 take Escitalopram Aurovitas and consume alcohol simultaneously, although interactions (effects) between Escitalopram Aurovitas and alcohol are not expected.
Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 3 months of pregnancy, she should be aware that the newborn may experience the following symptoms: breathing difficulties, blue skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose, muscle stiffness or floppiness, increased reflex excitability, tremors, shakiness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If any of these symptoms occur in the newborn, seek medical advice 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, known as persistent pulmonary hypertension of the newborn (PPHN). It is characterised by rapid breathing and cyanosis. 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 have been bleeding disorders in the past. 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 taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your 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 per day.
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 per day. The dose may then be increased by the doctor
up to a maximum of 20 mg per day.
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 per day or increased up to a maximum of 20 mg per day,
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 per day.
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 per day.
Elderly patients (over 65 years)
The recommended starting dose of Escitalopram Aurovitas is 5 mg taken once daily. The doctor may
recommend increasing the dose to 10 mg per day.
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 impairment
Caution should be exercised in patients with severe renal impairment. This medicine should be used
according to the doctor's instructions.
Hepatic impairment
Patients with impaired liver function should not take a dose higher than 10 mg per day. This
medicine should be used according to the doctor's instructions.
Patients who are poor metabolisers of drugs via the CYP2C19 isoenzyme
Patients with this known genotype should not take a dose of 10 mg per day. This medicine should be
used according to the doctor's instructions.
How to use Escitalopram Aurovitas
Escitalopram Aurovitas may be taken with or without food.
Tablets should be swallowed whole with water. Do not chew them, as they have a bitter taste.
If necessary, tablets may be divided into two equal parts. To do this, place the tablet on a flat
surface with the score line 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 in symptoms may not occur until after several weeks of treatment. Therefore, continue
taking Escitalopram Aurovitas as prescribed, even if it takes some time before you feel better.
Do not change the dose without consulting your doctor.
Continue taking this medicine for as long as your doctor recommends. If treatment is stopped too
early, symptoms may return. Therefore, treatment should be continued for at least 6 months after
symptoms have improved.
Taking more Escitalopram Aurovitas than prescribed
If you take more Escitalopram Aurovitas than prescribed, contact your doctor immediately or go to
the nearest hospital emergency department. This should be done even if you do not feel unwell.
Symptoms of overdose may include dizziness, tremors, agitation, seizures, coma, nausea, vomiting,
heart rhythm disturbances, low blood pressure, and disturbances in water and electrolyte balance.
Bring the medicine pack of Escitalopram Aurovitas with you when visiting the doctor or hospital.
If you miss a dose of Escitalopram Aurovitas
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 bed, take the missed dose immediately
and take the next dose the following day as usual. 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 Escitalopram Aurovitas
Do not stop taking Escitalopram Aurovitas unless your doctor advises you to do so. When stopping
treatment, your doctor will usually recommend gradually reducing the dose of Escitalopram
Aurovitas over several weeks.
After stopping Escitalopram Aurovitas, especially if stopped abruptly, you may experience
withdrawal symptoms. These symptoms are common when stopping treatment with Escitalopram
Aurovitas. The risk is greater if Escitalopram Aurovitas 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 more severe or
persist longer (2–3 months or more). If you experience severe withdrawal symptoms after stopping
Escitalopram Aurovitas, contact your doctor. Your doctor may recommend restarting the medicine
and tapering it more slowly.
Withdrawal symptoms may include dizziness (unsteady gait, balance disturbances), tingling
sensations, burning sensations, and (less commonly) electric shock-like sensations, including in the
head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headache, nausea,
sweating (including night sweats), psychomotor agitation or restlessness, tremors, feelings of
disorientation, emotional instability or irritability, diarrhoea (loose stools), visual disturbances,
palpitations or rapid heartbeat.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will get them.
Adverse effects usually resolve within a few weeks of treatment. It is important to remember that some
of these effects may also be symptoms of the underlying illness and will resolve as your condition improves.
If you experience any of these adverse effects during treatment, you should
contact your doctor or go to hospital immediately.

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

• unusual bleeding, including gastrointestinal bleeding.

Rare (may affect 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 effects with unknown frequency (frequency cannot be estimated from available data):

• difficulty passing urine;
• seizures, see also section “Warnings and precautions”;
• yellowing of the skin and whites of the eyes, indicating liver dysfunction/hepatitis;
• rapid, 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 the effects listed above, the following adverse 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 cold symptoms (sinusitis);
• decreased or increased appetite;
• anxiety, psychomotor agitation, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, tingling sensations in the skin;
• diarrhoea, constipation, vomiting, dry mouth;
• excessive 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 people):

• urticaria, rash, itching;
• teeth grinding, agitation, nervousness, panic attacks, states of 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 affect up to 1 in 1,000 people):

• aggression, depersonalization (feeling of loss of self-identity, feeling detached from oneself), hallucinations;
• slow heartbeat.

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

• decreased sodium levels in the blood (manifesting as nausea, malaise, muscle weakness, or confusion);
• dizziness upon standing due to low blood pressure (orthostatic hypotension);
• abnormal liver function tests (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), leading to water retention, blood dilution, and reduced sodium levels (syndrome of inappropriate secretion of ADH);
• galactorrhea in men and 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);
• heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); for more information, see section 2, "Pregnancy, breastfeeding and fertility".

In addition, adverse effects of medicines with a similar mechanism of action to escitalopram
(active substance in Escitalopram Aurovitas) are known. These include:

• psychomotor agitation (akathisia);
• loss of appetite.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects can
be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorisation holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Escitalopram Aurovitas

Keep this medicine out of the 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.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via the sewage system 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 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).
• 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 separating ‘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 separating ‘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 separating ‘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 under the following names:
Poland: Escitalopram Aurovitas
Portugal: Escitalopram Aurovitas
Spain: ESCITALOPRAM AUROVITAS 10 mg/ 15 mg/ 20 mg comprimidos recubiertos con película EFG