Escitalopram aurovitas

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Escitalopram Aurovitas (Escitalopram Aurobindo 20 mg), 20 mg, film-coated tablets
Escitalopramum
Escitalopram Aurovitas and Escitalopram Aurobindo 20 mg are different trade names for the
same medicinal product.
Please read this leaflet carefully before taking this medicine because it contains important
information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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 antidepressants called selective serotonin reuptake inhibitors (SSRIs).
These medicines act on the serotonin system in the brain by increasing the concentration of serotonin.
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 before your condition improves.
If no improvement occurs or if you feel worse, consult your doctor.

2. Important information before using 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 monoamine oxidase inhibitors (MAOIs), 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. You should 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 dosage 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 fertility").
• If the patient is receiving electroconvulsive therapy.
• If the patient has ischemic heart disease.
• If the patient has heart problems or has recently suffered 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 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 discontinuation of treatment.
• If the patient is taking medicinal products containing buprenorphine. Concomitant use of these medicines with Escitalopram Aurovitas may lead to serotonin syndrome, a potentially life-threatening condition (see "Escitalopram Aurovitas with other medicines").

Note
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, consult a doctor.
During 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 behaviors may worsen at the beginning of treatment with
antidepressants, as these medicines usually start working only after about 2 weeks, sometimes
later.
These symptoms are more likely in:

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

If the patient experiences thoughts of self-harm or suicide, seek immediate medical advice
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/her if they notice
worsening of depression or the medicine's effects, or concerning changes in behavior.
Children and adolescents
Escitalopram Aurovitas must not be used in children and adolescents under 18 years of age.
It should also be emphasized that patients under 18 years of age taking medicines of this class
are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and
hostility (particularly aggression, oppositional behavior, and manifestations of anger). Despite
this, a doctor may prescribe Escitalopram Aurovitas to patients under 18 years of age if he/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, long-term safety data regarding
growth, maturation, and cognitive and behavioral development with Escitalopram Aurovitas in
this age group are currently lacking.
Escitalopram Aurovitas with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or
planned for use.
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, a 14-day interval should be observed before starting Escitalopram Aurovitas. After discontinuing 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 gastric 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 ) – an herbal medicine used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (painkillers or blood-thinning agents, known as anticoagulants). These may increase the tendency to bleeding.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, 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 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 reduce potassium or magnesium levels in the blood increase the risk of life-threatening cardiac arrhythmias.

Some medicines may worsen side effects of Escitalopram Aurovitas and sometimes may
cause very serious reactions. While taking Escitalopram Aurovitas, do not take any other
medicines without prior consultation with 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 movements, 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 cardiac arrhythmias 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 during meals or independently of meals (see section 3
"How to take Escitalopram Aurovitas").
As with many medicines, it is not recommended to consume 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 have
a baby, she should consult her doctor or pharmacist before using this medicine. The patient
should not use 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,
bluish skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood 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, seek immediate medical advice.
Inform your doctor and/or midwife about the use of 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 characterized by rapid
breathing and cyanosis. These symptoms usually appear within the first 24 hours after birth.
If such symptoms occur in the newborn, contact your doctor and/or midwife immediately.
Do not abruptly 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 be aware 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 sperm
quality. This may theoretically affect fertility, although 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 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 take Escitalopram Aurovitas

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Escitalopram Aurovitas is available in the following strengths: 10 mg, 15 mg and 20 mg.
Recommended dose
Adults:
Depression
The usual recommended dose of Escitalopram Aurovitas is 10 mg taken once daily. The dose may be
increased by your doctor up to a maximum of 20 mg daily.
Panic disorder with or without agoraphobia
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 your 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 your 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 your 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 your 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. Your doctor may
advise 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 impairment
Caution should be exercised in patients with severe renal impairment. The medicine should be used
according to your doctor's instructions.
Hepatic impairment
Patients with hepatic impairment should not take a dose higher than 10 mg daily. The medicine
should be used according to your doctor's instructions.
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 according to your doctor's instructions.
How to take Escitalopram Aurovitas
Escitalopram Aurovitas tablets may be taken with or without food.
The tablets should be swallowed with water. Do not chew them, as they have a bitter taste.
If necessary, the tablets may be divided into two equal parts. To do this, place the tablet on a flat
surface with the score side facing up, then press down on each end with the index fingers of both
hands, as shown in the illustration.

Duration of treatment
You may not start to feel better until several weeks after starting treatment. It is therefore important
to continue taking Escitalopram Aurovitas, even if it takes some time before you feel an improvement
in your condition.
Do not change the dose without first consulting your doctor.
Continue taking the medicine for as long as your doctor recommends. If you stop treatment too
early, your symptoms may return. It is therefore recommended that treatment continues for at
least 6 months after improvement occurs.
Taking more Escitalopram Aurovitas than prescribed
If you have taken more Escitalopram Aurovitas than prescribed, you should 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, tremor, agitation, seizures,
coma, nausea, vomiting, cardiac arrhythmias, low blood pressure and disturbances in
water-electrolyte balance.
Take the medicine packaging with you when visiting your 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 as usual the following day. If you remember about the missed dose during
the night or the following 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 tells you to. When stopping treatment,
your doctor will usually recommend gradually reducing the dose of Escitalopram Aurovitas over a
period of 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 the medicine 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 last longer (2-3
months or longer). 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, tremor, 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 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 itself and will subside as the patient's condition improves.
If any of these adverse reactions occur 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, throat or face, hives or difficulty breathing or swallowing (severe allergic reaction);
• high fever, agitation, confusion (disorientation), tremors and severe 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 indicate 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 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 runny nose (sinusitis);
• decreased or increased appetite;
• anxiety, psychomotor agitation, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, tingling sensation in the skin;
• 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 affect up to 1 in 100 people):

• hives, rash, itching;
• teeth grinding, agitation, nervousness, panic attack, confusion (disorientation);
• sleep disturbances, taste disturbances, fainting (syncope);
• dilated pupils, 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, depersonalisation (feeling of loss of self-identity, feeling detached from oneself), hallucinations;
• slow heartbeat.

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

• decreased sodium concentration in blood (manifested by nausea, malaise, muscle weakness or confusion);
• dizziness upon standing due to drop in 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 in the body, dilution of blood, and decreased sodium levels (syndrome of inappropriate antidiuretic hormone secretion);
• milk production in men and in women who are not breastfeeding (galactorrhoea);
• mania;
• in patients taking medicines of this class, an increased risk of bone fractures has been observed;
• change in heart rhythm (called "QT interval prolongation", visible on ECG, a test assessing heart function);
• heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); for more information, see Pregnancy, breastfeeding and fertility in section 2.

Additionally, adverse reactions known from other medicines with a similar mechanism of action to escitalopram
(active substance in Escitalopram Aurovitas) include:

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can also 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

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 packaging. The expiry date refers to the last day of the stated month.
No special storage instructions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Escitalopram Aurovitas contains
Each film-coated tablet contains 20 mg of escitalopram - Escitalopramum (as oxalate).
The medicine also contains:
Tablet core: microcrystalline cellulose silicon dioxide, butylhydroxytoluene (E 321),
butylhydroxyanisole (E 320), sodium croscarmellose, microcrystalline cellulose, colloidal anhydrous silica, talc, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 400.

What Escitalopram Aurovitas looks like and contents of the pack
Film-coated tablets.
White or almost white, oval, biconvex, film-coated tablets with the letter ‘F’ engraved on one side and the number ‘56’ on the other side, separated by a deep score dividing ‘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 a cardboard box: 28 film-coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in the Netherlands, country of export:
Aurobindo Pharma B.V.
Baarnsche Dijk 1
3741 LN Baarn, the Netherlands

Manufacturer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
Generis Farmacêutica S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing authorisation number in the Netherlands, country of export: RVG 111568
Parallel import authorisation number: 61/24

This medicinal product is authorised for sale 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