Escitalopram Aurovitas

Leaflet accompanying the packaging: 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

Escitalopram

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Escitalopram Aurovitas and what is it 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 work on the serotonin system in the brain by increasing the levels of serotonin.

Escitalopram Aurovitas is used to treat depression (major depressive episodes), anxiety disorders (such as panic disorder with or without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder). It may take a few weeks of treatment before you start to feel better. You should continue to take Escitalopram Aurovitas even if you feel better, as it may take some time for the full benefits of the treatment to become apparent. If you do not feel better or feel worse, you should contact your doctor.

2. Important information before taking Escitalopram Aurovitas

When not to take Escitalopram Aurovitas

• if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6),
• if you are taking other medicines that belong to a group called monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic),
• if you have been born with a heart condition that affects your heart rhythm or if you have had a heart rhythm disturbance (seen on an ECG),
• if you are taking medicines that affect your heart rhythm or medicines that may affect your heart rhythm (see "Escitalopram Aurovitas and other medicines").

Warnings and precautions

Before taking Escitalopram Aurovitas, you should discuss it with your doctor or pharmacist.

You should tell your doctor if you have any other conditions or diseases, as your doctor should take this information into account.

In particular, you should inform your doctor:

• If you have epilepsy. If you experience seizures for the first time or if their frequency increases, you should stop taking Escitalopram Aurovitas (see also section 4 "Possible side effects").
• If you have liver or kidney problems. Your doctor may need to adjust the dose.
• If you have diabetes. Taking Escitalopram Aurovitas may affect your blood sugar control. You may need to adjust your insulin dose and/or oral hypoglycemic medications.
• If you have low sodium levels in your blood.
• If you have a history of bleeding or easy bruising or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").
• If you are undergoing electroconvulsive therapy.
• If you have coronary heart disease.
• If you have had heart problems or have recently had a heart attack.
• If you have a slow resting heart rate and/or if you may have low levels of electrolytes due to prolonged severe diarrhea, vomiting, or use of diuretics.
• If you experience fast or irregular heartbeats, fainting, collapse, or dizziness when standing up, which may indicate an abnormal heart rhythm.
• If you have had eye problems, such as certain types of glaucoma (increased pressure in the eye).
• Medicines like escitalopram (SSRIs/SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.
• If you are taking buprenorphine-containing products. Taking these medicines with Escitalopram Aurovitas may lead to a potentially life-threatening condition called serotonin syndrome (see "Escitalopram Aurovitas and other medicines").

Note

In some patients with bipolar affective disorder, a manic phase may occur. This is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, you should contact your doctor.

In the first few weeks of treatment, you may also experience symptoms such as restlessness or difficulty sitting or standing still. If you experience these symptoms, you should contact your 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 behaviors may worsen at the start of treatment with antidepressant medicines, as these medicines start to work usually after about 2 weeks, sometimes later.

These symptoms are more likely to occur in:

• patients who have had thoughts of self-harm or suicide before,
• young adults (under 25 years old). Clinical trial data have shown an increased risk of suicidal behavior in young adults with psychiatric disorders who were treated with antidepressant medicines.

If you experience thoughts of self-harm or suicide, you should contact your doctor or go to the hospital immediately.

It may be helpful to inform your relatives or close friendsabout your depression or anxiety disorder and ask them to read this leaflet. You may want to ask them to tell you if they notice that your depression or anxiety is getting worse or if you are experiencing any of the following symptoms:

Children and adolescents

Escitalopram Aurovitas should not be used in children and adolescents under 18 years of age.

It should also be noted that in the case of taking medicines of this class, patients under 18 years of age are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). However, your doctor may prescribe Escitalopram Aurovitas to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Escitalopram Aurovitas to a patient under 18 years of age and you have any concerns, please contact your doctor. If the above symptoms develop or worsen in patients under 18 years of age taking Escitalopram Aurovitas, you should inform your doctor. Additionally, as there is currently no data on the long-term safety of Escitalopram Aurovitas in this age group regarding growth, maturation, and cognitive and behavioral development.

Escitalopram Aurovitas and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

You should inform your doctor if you are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) containing substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you have taken any of these medicines, you should wait 14 days before starting to take Escitalopram Aurovitas. After stopping treatment with Escitalopram Aurovitas, you should wait 7 days before taking any of these medicines.
• Reversible, selective monoamine oxidase A inhibitors (MAO-A) containing moclobemide (used to treat depression).
• Irreversible monoamine oxidase B inhibitors (MAO-B) containing selegiline (used to treat Parkinson's disease). These medicines increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used to treat bipolar affective disorder) and tryptophan.
• Imipramine and desipramine (used to treat depression).
• Sumatriptan and similar medicines (used to treat migraines) and tramadol and similar medicines (opioids, used to treat severe pain). These medicines may increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (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 cause an increase in escitalopram levels in the blood.
• St. John's Wort (Hypericum perforatum), a herbal medicine used to treat depression.
• Aspirin and non-steroidal anti-inflammatory medicines (used to treat pain or to thin the blood, known as anticoagulants). These medicines may increase the risk of bleeding.
• Warfarin, dipyridamole, and phenprocoumon (used to thin the blood, known as anticoagulants). Your doctor may need to monitor your blood clotting time when starting or stopping treatment with Escitalopram Aurovitas to ensure that your anticoagulant dose is still appropriate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain), due to the potential risk of lowering the seizure threshold.
• Antipsychotics (used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs), due to the potential risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used to treat heart conditions), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Your doctor may need to adjust the dose of Escitalopram Aurovitas.
• Medicines that lower potassium or magnesium levels in the blood, which may increase the risk of life-threatening heart rhythm disorders.

Some medicines may increase the risk of side effects when taken with Escitalopram Aurovitas and may cause serious reactions. You should not take any other medicines without consulting your doctor first, especially:

• medicines containing buprenorphine. These medicines may interact with Escitalopram Aurovitas and cause symptoms such as involuntary, rhythmic muscle contractions, including those that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness, and body temperature above 38°C. If you experience these symptoms, you should contact your doctor.

You should not take Escitalopram Aurovitas at the same time as medicines used to treat heart rhythm disorders or medicines that may affect your heart rhythm, such as anti-arrhythmic medicines class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines - especially halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine), etc. You should 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 drink alcohol at the same time, although interactions between Escitalopram Aurovitas and alcohol are not expected.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.

You should not take Escitalopram Aurovitas during pregnancy and while breastfeeding, unless you have discussed the risks and benefits with your doctor.

If you take Escitalopram Aurovitas during the last 3 months of pregnancy, you should be aware that the following symptoms may occur in the newborn: breathing difficulties, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiffness or floppiness, increased reflexes, tremors, jitteriness, irritability, lethargy, constant crying, and sleep disturbances. If your baby experiences any of these symptoms, you should contact your doctor immediately.

You should inform your doctor and/or midwife that you are taking Escitalopram Aurovitas.

Taking medicines like Escitalopram Aurovitas, especially in the last 3 months of pregnancy, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and blue discoloration of the skin. These symptoms usually appear in the first day after birth. If your baby experiences these symptoms, you should contact your doctor and/or midwife immediately.

You should not stop taking Escitalopram Aurovitas during pregnancy.

If you take Escitalopram Aurovitas at the end of pregnancy, you may be at increased risk of severe bleeding from the uterus shortly after delivery, especially if you have had bleeding disorders in the past. Your doctor or midwife should be aware that you are taking Escitalopram Aurovitas so that they can advise you.

It is assumed that escitalopram passes into breast milk.

In animal studies, it has been shown that citalopram, a medicine similar to escitalopram, reduces sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

You should not drive or operate machinery until you know how Escitalopram Aurovitas affects you.

Escitalopram Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Escitalopram Aurovitas

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.

Recommended dose

Adults:

Depression

The usual recommended dose of Escitalopram Aurovitas is 10 mg, taken as a single dose once daily. The dose may be increased by your doctor to a maximum of 20 mg per day.

Panic disorder

The initial dose of Escitalopram Aurovitas is 5 mg once daily for the first week of treatment, then the dose is increased to 10 mg per day. The dose may then be increased by your doctor to a maximum of 20 mg per day.

Social phobia

The usual recommended dose of Escitalopram Aurovitas is 10 mg, taken as a single dose once daily. The dose may then be decreased by your doctor to 5 mg per day or increased to a maximum of 20 mg per day, depending on your response to the medicine.

Generalized anxiety disorder

The usual recommended dose of Escitalopram Aurovitas is 10 mg, taken as a single dose once daily. The dose may be increased by your doctor to a maximum of 20 mg per day.

Obsessive-compulsive disorder

The usual recommended dose of Escitalopram Aurovitas is 10 mg, taken as a single dose once daily. The dose may be increased by your doctor to a maximum of 20 mg per day.

Elderly patients (over 65 years old)

The recommended initial dose of Escitalopram Aurovitas is 5 mg, taken as a single dose once daily. Your doctor may increase the dose to 10 mg per day.

Use in children and adolescents

Escitalopram Aurovitas is not usually recommended for use in children and adolescents. Additional information can be found in section 2 "Warnings and precautions".

Renal impairment

Caution should be exercised in patients with severe renal impairment. The medicine should be taken as directed by your doctor.

Hepatic impairment

Patients with hepatic impairment should not take more than 10 mg per day. The medicine should be taken as directed by your doctor.

Patients who are poor metabolizers of medicines via the CYP2C19 enzyme

Patients with this known genotype should not take a dose of 10 mg per day. The medicine should be taken as directed by your doctor.

How to take Escitalopram Aurovitas

Escitalopram Aurovitas can be taken with or without food.

The tablets should be swallowed with water. They should not be chewed, as they have a bitter taste.

If necessary, the tablets can be broken in half. To do this, place the tablet on a flat surface with the groove facing upwards, then break it in half by pressing down on each end with your index fingers, as shown in the picture.

Duration of treatment

You may start to feel better after a few weeks of treatment. You should therefore continue to take Escitalopram Aurovitas, even if it takes some time for your condition to improve.

You should not change the dose without consulting your doctor.

The medicine should be taken for as long as your doctor recommends. If you stop treatment too early, your symptoms may return. It is recommended to continue treatment for at least 6 months after your symptoms have improved.

Taking a higher dose of Escitalopram Aurovitas than recommended

If you take more Escitalopram Aurovitas than prescribed, you should contact your doctor or go to the emergency room immediately. You should do this even if you do not feel any symptoms. Symptoms of overdose include dizziness, tremors, agitation, seizures, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure, and disturbances in water and electrolyte balance.

You should take the packaging of Escitalopram Aurovitas with you to the doctor or hospital.

Missing a dose of Escitalopram Aurovitas

You should not take a double dose to make up for a missed dose.

If you forget to take a dose and remember before bedtime, you should take the missed dose immediately. You should take the next dose at the usual time the next day. If you remember that you missed a dose in the night or the next day, you should skip the missed dose and take the next dose as usual.

Stopping treatment with Escitalopram Aurovitas

You should not stop taking Escitalopram Aurovitas without consulting your doctor first. When you stop treatment, your doctor will usually recommend that you gradually reduce the dose of Escitalopram Aurovitas over a few weeks.

After stopping treatment with Escitalopram Aurovitas, especially if it is stopped abruptly, you may experience withdrawal symptoms. These symptoms are common when treatment with Escitalopram Aurovitas is stopped. The risk is higher if Escitalopram Aurovitas has been taken for a long time, in high doses, or if the dose has been reduced too quickly. In most patients, the symptoms are mild and disappear on their own within two weeks. In some patients, however, they may be more severe or longer-lasting (2-3 months or longer). If you experience severe withdrawal symptoms after stopping treatment with Escitalopram Aurovitas, you should contact your doctor. Your doctor may recommend that you start taking the medicine again and taper it off more slowly.

Withdrawal symptoms 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), anxiety, headache, nausea (feeling sick), sweating (including night sweats), restlessness or agitation, tremors, disorientation, emotional instability or irritability, diarrhea (loose stools), vision disturbances, heart palpitations or arrhythmias.

If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Escitalopram Aurovitas can cause side effects, although not everybody gets them.

Side effects usually disappear after a few weeks of treatment. You should remember that some of these side effects may also be symptoms of your illness and will disappear as your condition improves.

If you experience any of the following side effects during treatment, you should contact your doctor or go to the hospital immediately.

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

• unusual bleeding, including bleeding from the gastrointestinal tract.

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

• 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 sudden muscle contractions, which can be symptoms of a rare condition called serotonin syndrome.

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

• difficulty urinating;
• seizures, see also section "Warnings and precautions";
• yellowing of the skin and whites of the eyes, which can be a sign of liver damage/hepatitis;
• fast or irregular heartbeat, fainting, which can be symptoms of a life-threatening condition called torsades de pointes;
• suicidal thoughts and behaviors, see also section "Warnings and precautions";
• sudden swelling of the skin or mucous membranes (angioedema).

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

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

• nausea;
• headache.

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

• nasal congestion or sinusitis (sinus infection);
• decreased or increased appetite;
• anxiety, restlessness, abnormal dreams, sleep disturbances, drowsiness, yawning, tremors, tingling sensations;
• diarrhea, constipation, vomiting, dry mouth;
• increased sweating;
• muscle and joint pain;
• sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women);
• fatigue, fever;
• weight gain.

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

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

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

• aggression, depersonalization (feeling of losing one's identity, feeling of not being oneself), hallucinations;
• slow heartbeat.

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

• decreased sodium levels in the blood (symptoms include nausea and malaise with muscle weakness or confusion);
• dizziness when standing up due to low blood pressure (orthostatic hypotension);
• abnormal liver function test results (increased liver enzyme activity in the blood);
• movement disorders (involuntary muscle movements);
• painful erection of the penis (priapism);
• symptoms of unusual bleeding, such as bleeding from the skin and mucous membranes (ecchymoses);
• increased secretion of antidiuretic hormone (ADH), leading to water retention in the body, dilutional hyponatremia (low sodium levels in the blood);
• galactorrhea (milk secretion) in men and in women who are not breastfeeding;
• mania;
• patients taking medicines of this class have been observed to have an increased risk of fractures;
• changes in heart rhythm (called "QT interval prolongation", visible on an ECG);
• heavy bleeding from the uterus shortly after delivery (postpartum hemorrhage), see also "Pregnancy, breastfeeding, and fertility" in section 2.

In addition, the following side effects have been reported for medicines with a similar mechanism of action to escitalopram (the active substance of Escitalopram Aurovitas):

• restlessness (akathisia);
• loss of appetite.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety Monitoring, 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Escitalopram Aurovitas

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label, carton, and blister after EXP. The expiry date refers to the last day of the month stated.

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Escitalopram Aurovitas contains

• The active substance of Escitalopram Aurovitas is escitalopram. Each film-coated tablet contains 10 mg of escitalopram (as escitalopram oxalate). Each film-coated tablet contains 15 mg of escitalopram (as escitalopram oxalate). Each film-coated tablet contains 20 mg of escitalopram (as escitalopram oxalate).
• The other ingredients are: Tablet core:microcrystalline cellulose, butylhydroxytoluene (E 321), butylhydroxyanisole (E 320), sodium croscarmellose, microcrystalline cellulose, silicon dioxide, magnesium stearate. Tablet coating:hypromellose, titanium dioxide (E 171), macrogol 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 a score line, engraved with the letter "F" on one side and the number "54" on the other side. The size of the tablets is 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 a score line, engraved with the letter "F" on one side and the number "55" on the other side. The size of the tablets is 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 a score line, engraved with the letter "F" on one side and the number "56" on the other side. The size of the tablets is 11.6 mm x 7.1 mm. The tablet can be divided into equal doses.

Pack sizes:

PVC/Aclar/Aluminum blisters in a cardboard box: 14, 20, 28, 50, 56, 100, or 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lokal 27

01-909 Warszawa

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 medicine is authorized in the Member States of 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

Date of last revision of the leaflet: 07/2023