Escitalopram Actavis

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Escitalopram Actavis

10 mg, coated tablets

Escitalopramum

You should carefully read the contents of the 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 doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Escitalopram Actavis contains the active substance escitalopram. Escitalopram Actavis 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 level of serotonin. Disturbances in the serotonin system in the brain are thought to be involved in the development of depression and other mood disorders.
Escitalopram Actavis is used to treat depression (major depressive episodes), anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).
It may take a few weeks for the treatment to start working. You should continue to take Escitalopram Actavis even if it takes some time before you feel better. If you do not feel better or feel worse, you should consult your doctor.

2. Important information before taking Escitalopram Actavis

When not to take Escitalopram Actavis

• if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6);
• if you are taking medicines that belong to a group called 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 or have had an episode of irregular heart rhythm (visible on an ECG; a test that allows you to check how your heart works);
• if you are taking medicines that affect the heart rhythm or medicines that may affect the heart rhythm (see section 2 "Escitalopram Actavis and other medicines").

Warnings and precautions

Before starting treatment with Escitalopram Actavis, you should consult 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. Treatment with Escitalopram Actavis should be discontinued if seizures occur for the first time or if their frequency increases (see also section 4 "Possible side effects");
• if you have liver or kidney disease. The dose may need to be adjusted by your doctor;
• if you have diabetes. Treatment with Escitalopram Actavis may affect blood sugar control. The dose of insulin and/or oral hypoglycemic medicines may need to be adjusted;
• if you have low sodium levels in the blood;
• if you have an increased tendency to bleed or bruise or if you are pregnant (see "Pregnancy, breastfeeding, and fertility");
• if you are being treated with electroconvulsive therapy;
• if you have coronary heart disease;
• if you have or have had heart problems or have recently had a heart attack;
• if you have low resting heart rate and/or know that you have low levels of salts due to prolonged, severe diarrhea and vomiting or the use of diuretic medicines;
• if you experience rapid or irregular heartbeat, fainting, or dizziness when changing position to standing, which may indicate abnormal heart function;
• if you have or have had eye problems, such as certain types of glaucoma (increased pressure inside the eyeball).

Warning

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 consult your doctor.
In the first few weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may also occur. If such symptoms appear, you should immediately inform your doctor.
Medicines like Escitalopram Actavis (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.

Suicidal thoughts and worsening of depression or anxiety disorder

In the case of depression and/or anxiety disorders, suicidal thoughts or self-harm thoughts may also occur. Such symptoms or behavior may worsen at the start of treatment with antidepressant medicines, as these medicines usually start working after about 2 weeks, sometimes later.
The likelihood of such thoughts occurring is higher if:

• the patient has had suicidal thoughts or self-harm thoughts before,
• the patient is an adult in young age. Information obtained in clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with mental disorders treated with antidepressant medicines. If suicidal thoughts or self-harm thoughts ever occur, you should contact your doctor or go to the hospital immediately. It may be helpful to inform your family or friendsabout your depression or anxiety disorder and ask them to read this leaflet. You may ask them to tell you if they notice that your depression or anxiety has worsened or if you have any worrying changes in your behavior.

Children and adolescents

Escitalopram Actavis 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 from this group, 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). Nevertheless, the doctor may prescribe Escitalopram Actavis to patients under 18 years of age, considering that it is in their best interest. If a patient under 18 years of age has been prescribed Escitalopram Actavis and you have any doubts, you should consult your doctor again. If a patient under 18 years of age taking Escitalopram Actavis experiences or worsens any of the above symptoms, you should inform your doctor.
Additionally, the long-term safety of Escitalopram Actavis regarding growth, maturation, and cognitive development in this age group has not been established yet.

Escitalopram Actavis and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken and about 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 active 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 Actavis. After stopping treatment with Escitalopram Actavis, you should wait 7 days before taking any of these medicines;
• reversible, selective monoamine oxidase A (MAO-A) inhibitors containing moclobemide (a medicine used to treat depression);
• irreversible monoamine oxidase B (MAO-B) inhibitors 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 migraine), tramadol, and buprenorphine (used to treat severe pain). These medicines may increase the risk of side effects;
• cimetidine, lansoprazole, omeprazole, and esomeprazole (used to treat stomach ulcers), fluconazole (a medicine used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in the level of escitalopram in the blood;
• St. John's wort ( Hypericum perforatum) -a herbal medicine used to treat depression
• acetylsalicylic acid and non-steroidal anti-inflammatory medicines (used as painkillers or to thin the blood, known as anticoagulants). They may increase the tendency to bleed;
• warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, known as anticoagulants). Your doctor may order a blood clotting test at the start and after stopping treatment with Escitalopram Actavis to check if the dose of the anticoagulant is still appropriate;
• mefloquine (used to treat malaria), bupropion (used to treat depression), and
• tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold;
• neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressants
• (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold;
• flecainide, propafenone, and metoprolol (used to treat heart conditions), desipramine, clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotic medicines). The dose of Escitalopram Actavis may need to be adjusted;
• medicines that lower the level of potassium or magnesium in the blood, as they increase the risk of life-threatening heart rhythm disorders.

DO NOT TAKE Escitalopram Actavisif you are taking medicines used to treat heart conditions or medicines that may affect the heart rhythm, such as: anti-arrhythmic medicines class IA and III, antipsychotic medicines (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, and some antibacterial medicines (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial medicines, especially halofantrine),
some antihistamine medicines (astemizole, hydroxyzine, mizolastine). If you have any doubts about taking the medicine, you should consult your doctor.

Escitalopram Actavis with food, drink, or alcohol

Escitalopram Actavis can be taken with or without food (see section 3 "How to take Escitalopram Actavis").
As with many medicines, it is not recommended to take Escitalopram Actavis and alcohol at the same time, although interactions between Escitalopram Actavis and alcohol are not expected.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, or if you are planning to become pregnant, you should consult your doctor or pharmacist before taking this medicine.
The patient should not take Escitalopram Actavis during pregnancy and breastfeeding, unless they have discussed the risks and benefits of treatment with their doctor.
If the patient takes Escitalopram Actavis during the last 3 months of pregnancy, they should be aware that the following symptoms may occur in the newborn: breathing difficulties, blue skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood sugar, muscle stiffness or flaccidity, increased reflexes, tremors, nervousness, irritability, lethargy, tearfulness, and sleep disturbances. If the newborn experiences any of these symptoms, you should immediately consult a doctor.
You should inform your doctor and/or midwife about taking Escitalopram Actavis. Taking medicines like Escitalopram Actavis, especially in the last three months of pregnancy, may increase the risk of serious complications in the newborn called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and blue skin, and usually occurs in the first day after birth. If such symptoms occur in the newborn, you should immediately consult a doctor and/or midwife.
Escitalopram Actavis should not be stopped abruptly during pregnancy.
Taking Escitalopram Actavis at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient takes Escitalopram Actavis, they should inform their doctor or midwife so that they can provide appropriate advice.
It is assumed that escitalopram passes into breast milk.
In animal studies, it has been shown that citalopram, a medicine similar to escitalopram, affects sperm quality. This may theoretically affect fertility, but no effect on fertility has been observed in humans.

Driving and using machines

The patient should not drive or operate machinery until they know how Escitalopram Actavis affects them.

Escitalopram Actavis contains sodium

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

3. How to take Escitalopram Actavis

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Escitalopram Actavis is available in the following strengths: 10 mg, 15 mg, 20 mg.
Adult patients

Depression

The recommended dose of Escitalopram Actavis is 10 mg and is taken as one dose per day. The dose may be increased by your doctor to a maximum of 20 mg per day.

Panic disorder with agoraphobia

The initial dose of Escitalopram Actavis is 5 mg per day 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 anxiety disorder

The recommended dose of Escitalopram Actavis is 10 mg and is taken as one dose per day. 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 the patient's response to the medicine.

Generalized anxiety disorder

The recommended dose of Escitalopram Actavis is 10 mg and is taken as one dose per day. The dose may be increased by your doctor to a maximum of 20 mg per day.

Obsessive-compulsive disorder

The recommended dose of Escitalopram Actavis is 10 mg and is taken as one dose per day. The dose may be increased by your doctor to a maximum of 20 mg per day.

Elderly patients (over 65 years)

The recommended initial dose of Escitalopram Actavis is 5 mg and is taken as one dose per day. The dose may be increased by your doctor to 10 mg per day.
Use in children and adolescents
Escitalopram Actavis should not normally be used in children and adolescents. For further information, see section 2 "Important information before taking Escitalopram Actavis".
Renal impairment
Caution should be exercised in patients with severe renal impairment. The medicine should be used as directed by your doctor.
Hepatic impairment
Patients with hepatic impairment should not exceed a dose of 10 mg per day. The medicine should be used as directed by your doctor.
Poor metabolizers of medicines via the CYP2C19 enzyme
Patients with this known genotype should not exceed a dose of 10 mg per day. The medicine should be used as directed by your doctor.
The tablets should be taken once daily, swallowed whole with sufficient fluid (preferably a glass of water). Escitalopram Actavis can be taken with or without food.
If necessary, the tablet can be divided into two equal doses by placing it on a flat surface with the score line facing upwards. The tablet can then be broken into two equal doses by pressing each end downwards with the index fingers of both hands, as shown in the picture.

Duration of treatment
The patient may not feel better until after a few weeks of treatment. Therefore, they should continue to take Escitalopram Actavis even if it takes some time before they feel better. The dose should not be changed without consulting a doctor.
Escitalopram Actavis should be used for as long as your doctor recommends. If the patient stops treatment too early, the symptoms may return. It is recommended to continue treatment for at least 6 months after feeling better.

Taking a higher dose of Escitalopram Actavis than recommended

If the patient has taken a higher dose of Escitalopram Actavis than prescribed, they should immediately consult their doctor or go to the emergency room of the nearest hospital. This should be done even if the patient does not feel any discomfort.
Symptoms of overdose include dizziness, tremors, agitation, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure, and electrolyte disturbances. When visiting the doctor or hospital, the patient should bring the packaging of Escitalopram Actavis.

Missing a dose of Escitalopram Actavis

The patient should not take a double dose to make up for a missed dose. If the patient forgets to take a dose and remembers before bedtime, they should take the missed dose immediately. The next dose should be taken the next day. If the patient remembers that they have missed a dose in the night or the next day, they should skip the missed dose and take the next dose as usual.

Stopping treatment with Escitalopram Actavis

The patient should not stop taking Escitalopram Actavis unless their doctor recommends it. When the patient stops treatment, it is usually recommended to gradually reduce the dose of Escitalopram Actavis over a period of several weeks.
After stopping treatment with Escitalopram Actavis, especially if it is stopped abruptly, the patient may experience withdrawal symptoms. These symptoms are common after stopping treatment with Escitalopram Actavis. The risk is higher if Escitalopram Actavis has been used 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 last longer (more than 2-3 months). If severe withdrawal symptoms occur, the patient should consult their doctor. The doctor may recommend restarting treatment with Escitalopram Actavis and tapering it off more slowly.
Withdrawal symptoms include: dizziness (unsteady gait, balance disturbances), tingling sensation, burning sensation, and (less commonly) a sensation like an electric shock, also in the head, sleep disturbances (intense dreams, nightmares, insomnia), anxiety, headache, nausea and/or vomiting, sweating (including night sweats), restlessness or agitation, tremors, disorientation, emotional instability or irritability, diarrhea, vision disturbances, palpitations (rapid or irregular heartbeat).
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Escitalopram Actavis can cause side effects, although not everybody gets them.
Side effects usually disappear after a few weeks of treatment. It should be remembered that some of these side effects may also be symptoms of the disease, and they will disappear as the patient's condition improves.

If any of the following side effects occur during treatment, the patient should consult their doctor or go to the 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 sudden muscle contractions, which may be symptoms of a rare disorder called serotonin syndrome.

Frequency not known(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 is a sign of liver disease/liver inflammation
• rapid or irregular heartbeat, fainting, which may 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)

The following side 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 sinusitis (sinus infection)
• decreased or increased appetite
• anxiety, restlessness, unusual dreams, difficulty sleeping, drowsiness, dizziness, yawning, tremors, tingling sensation in the skin
• diarrhea, constipation, vomiting, dry mouth
• increased sweating
• muscle and joint pain
• sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and possible difficulty achieving orgasm in women)
• fatigue, fever
• weight gain

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

• hives, rash, itching
• grinding of the teeth, 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 loss of one's own identity, the person feels that they are not themselves), hallucinations
• slow heartbeat

Frequency not known(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 in the skin and mucous membranes (ecchymoses)
• low platelet count (thrombocytopenia)
• increased secretion of antidiuretic hormone (ADH), leading to water retention in the body, dilutional hyponatremia, and decreased sodium levels
• galactorrhea (milk secretion) in men and women who are not breastfeeding
• severe postpartum hemorrhage (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2
• mania
• patients taking medicines from this group have been observed to have an increased risk of fractures
• change in heart rhythm (called "QT interval prolongation", visible on an ECG, a test that evaluates heart function)

Additionally, the following side effects are known for medicines with a similar mechanism of action to escitalopram (the active substance of Escitalopram Actavis):

• restlessness (akathisia)
• loss of appetite

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Escitalopram Actavis

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month.
Blister pack: Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Escitalopram Actavis contains

The active substance of Escitalopram Actavis is escitalopram. Each coated tablet contains 10 mg of escitalopram (as escitalopram oxalate).
The other ingredients of the medicine are:
Tablet core:
microcrystalline cellulose, anhydrous colloidal silica, sodium carmellose, talc, magnesium stearate;
Coating:
hypromellose 6 mPas, titanium dioxide (E 171), macrogol 6000.

What Escitalopram Actavis looks like and contents of the pack

Escitalopram Actavis, 10 mg:
Oval, biconvex, white coated tablets (6.4 mm x 9.25 mm) with a score line on one side and notches on the sides, marked with "E" on the other side. The tablet can be divided into equal doses.
Escitalopram Actavis is available in blister packs of 28, 30, 56, 60 coated tablets in a carton.
For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, the country of export:

Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturer:

Actavis Ltd
BLB 015-016
Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitza 2600
Bulgaria
TjoaPack Netherlands B.V.
Nieuwe Donk 9
4879 AC Etten-Leur
Netherlands

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Lithuania, the country of export:
LT/1/09/1815/013
LT/1/09/1815/014
LT/1/09/1815/015
LT/1/09/1815/016
LT/1/09/1815/018
LT/1/09/1815/019
LT/1/09/1815/020
LT/1/09/1815/021
LT/1/09/1815/022
Parallel import authorization number: 288/24

Date of approval of the leaflet: 11.07.2024

[Information about the trademark]