Escitalopram Actavis

Package Leaflet: Information for the Patient

Escitalopram Actavis, 10 mg, film-coated tablets
Escitalopram Actavis, 15 mg, film-coated tablets
Escitalopram Actavis, 20 mg, film-coated tablets
Escitalopram

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in the leaflet, they should inform 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).
Escitalopram Actavis 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 several weeks of treatment before the patient starts to feel better. The patient should continue taking Escitalopram Actavis, even if it takes some time to feel better.
If there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Escitalopram Actavis

When not to take Escitalopram Actavis

• 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 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 the patient was born with a heart rhythm disorder or has had an episode of irregular heart rhythm (visible on an ECG);
• if the patient is taking medicines for heart rhythm disorders or medicines that may affect heart rhythm (see section 2 "Escitalopram Actavis and other medicines").

Warnings and precautions

Before starting treatment with Escitalopram Actavis, the patient should consult their doctor or pharmacist.
The patient should tell their doctor if they have any other disorders or diseases, as the doctor should take this information into account. In particular, the patient should inform their doctor:

• if they 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 they have liver or kidney problems. The doctor may need to adjust the dose;
• if they have diabetes. Treatment with Escitalopram Actavis may affect blood sugar control. The dose of insulin and/or oral hypoglycemic agents may need to be adjusted;
• if they have low sodium levels in the blood;
• if they have an increased tendency to bleed or bruise or if they are pregnant (see "Pregnancy, breastfeeding, and fertility");
• if they are undergoing electroconvulsive therapy;
• if they have coronary heart disease;
• if they have or have had heart problems or have recently had a heart attack;
• if they have low resting heart rate and/or know that they have low salt levels due to prolonged, severe diarrhea and vomiting or the use of diuretic medicines;
• if they experience rapid or irregular heartbeats, fainting, collapse, or dizziness when changing position, which may indicate abnormal heart function;
• if they have or have had eye problems, such as certain types of glaucoma (increased pressure inside the eyeball).

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, the patient should consult their doctor.
In the first few weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may also occur. If these symptoms appear, the patient should immediately inform their 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 cases 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 only 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 their young age. Information from 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 occur, the patient should immediately contact their doctor or go to the hospital.

It may be helpful to inform the patient's family or friendsabout their depression or anxiety disorder and ask them to read this leaflet. The patient may ask their family or friends to monitor them and inform them if their depression or anxiety worsens or if they notice any worrying changes in 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 patients under 18 years of age taking medicines of this group, there is an increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). However, the doctor may prescribe Escitalopram Actavis to patients under 18 years of age if they consider it to be in the patient's best interest. If a patient under 18 years of age has been prescribed Escitalopram Actavis and has any doubts, they should consult their doctor again. If a patient under 18 years of age taking Escitalopram Actavis experiences any of the above symptoms, they should inform their doctor.

Escitalopram Actavis and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their doctor if they are taking any of the following medicines:

• non-selective monoamine oxidase inhibitors (MAOIs) containing substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If the patient has taken any of these medicines, they should wait 14 days before starting Escitalopram Actavis. After stopping Escitalopram Actavis, the patient should wait 7 days before taking any of these medicines;
• reversible, selective monoamine oxidase A (MAO-A) inhibitors containing moclobemide (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 migraines) and tramadol and similar medicines (opioids, 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 (an antifungal medicine), 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;
• acetylsalicylic acid and non-steroidal anti-inflammatory drugs (used as painkillers or to thin the blood, known as anticoagulants). They may increase the risk of bleeding;
• warfarin, dipyridamole, and phenprocoumon (used to thin the blood, known as anticoagulants). The doctor may order a blood test to check the blood clotting time at the start and after stopping Escitalopram Actavis to determine if the 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 possible risk of lowering the seizure threshold;
• neuroleptics (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 (antipsychotics). The dose of Escitalopram Actavis may need to be adjusted;
• medicines that lower potassium or magnesium levels in the blood, as they increase the risk of life-threatening heart rhythm disorders.

DO NOT TAKE Escitalopram Actavisif the patient is taking medicines used to treat heart conditions or medicines that may affect heart rhythm, such as:

anti-arrhythmic medicines of 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 antihistamines (astemizole, hydroxyzine, mizolastine). If the patient has any doubts about taking the medicine, they should consult their doctor.

Escitalopram Actavis with food, drink, and 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 the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their 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 with their doctor.
If the patient takes Escitalopram Actavis during the last 3 months of pregnancy, they should be aware that the newborn may experience the following symptoms: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflexes, tremors, nervousness, irritability, lethargy, crying, sleepiness, and difficulty sleeping. If the newborn experiences any of these symptoms, the patient should immediately consult their doctor.
The patient should inform their doctor and/or midwife about taking Escitalopram Actavis. Taking medicines like Escitalopram Actavis, especially in the last 3 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, the patient should immediately consult their doctor and/or midwife.
The patient should not stop taking Escitalopram Actavis 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 it is essentially "sodium-free".

3. How to take Escitalopram Actavis

The patient should always take this medicine exactly as their doctor has told them. If they are not sure, they should ask their doctor or pharmacist.
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 the doctor to a maximum of 20 mg per day.
Panic disorder with or without 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 the doctor to a maximum of 20 mg per day.
Social phobia
The recommended dose of Escitalopram Actavis is 10 mg and is taken as one dose per day. The dose may then be decreased by the 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 the 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 the 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 the doctor to 10 mg per day.
Use in children and adolescents
Escitalopram Actavis is not normally given to children and adolescents. For further information, see section 2 "Important information before taking Escitalopram Actavis".
Kidney problems
Caution should be exercised in patients with severe kidney problems. The medicine should be taken as directed by the doctor.
Liver problems
Patients with liver problems should not exceed a dose of 10 mg per day. The medicine should be taken as directed by the doctor.
Poor metabolizers of medicines that are metabolized by the CYP2C19 enzyme
Patients with this known genotype should not exceed a dose of 10 mg per day. The medicine should be taken as directed by the doctor.
The tablets should be taken once a day, swallowed whole with a sufficient amount of liquid (preferably a glass of water). Escitalopram Actavis can be taken with or without food.
If necessary, the tablet can be broken 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 down 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 taking Escitalopram Actavis, even if it takes some time to feel better.
The patient should not change the dose without consulting their doctor.
Escitalopram Actavis should be taken for as long as the 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 more Escitalopram Actavis than they should, they should contact their doctor or go to the emergency department of the nearest hospital immediately. They should do this even if they feel well.
Symptoms of overdose include dizziness, tremors, agitation, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure, and electrolyte disturbances. On a visit to the doctor or hospital, the patient should take the packaging of Escitalopram Actavis with them.

Forgetting to take a dose of Escitalopram Actavis

The patient should not take a double dose to make up for a forgotten dose. If the patient forgets to take a dose and remembers before going to bed, they should take the missed dose immediately. They should take the next dose at the usual time the next day. If the patient remembers 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 tells them to. 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 suddenly, 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 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 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 often) 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 (heart palpitations).
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 the patient experiences any of the following side effects during treatment, they should contact 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 may be a sign of liver problems/hepatitis
• 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, sleep disturbances, dizziness, yawning, tremors, tingling sensation
• 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
• 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 loss of one's own identity, feeling of not being oneself), hallucinations
• slow heartbeat

Frequency not known(frequency cannot be estimated from the available data):

• low 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 (priapism), symptoms of unusual bleeding in the skin and mucous membranes (ecchymoses) and low platelet count (thrombocytopenia)
• increased secretion of antidiuretic hormone (ADH), leading to water retention in the body, dilutional hyponatremia (low sodium levels in the blood)
• increased prolactin levels in the blood
• galactorrhea (milk secretion) in men and women who are not breastfeeding
• severe postpartum hemorrhage (see additional information in section "Pregnancy, breastfeeding, and fertility")
• mania
• in patients taking medicines of this group, an increased risk of bone fractures has been observed, change in heart rhythm (called "QT interval prolongation", visible on an ECG, a test that assesses heart function)
• in addition, side effects of medicines with a similar mechanism of action to escitalopram (the active substance of Escitalopram Actavis) are known. These include:
• restlessness (akathisia)
• loss of appetite

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their 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, more information can be gathered on the safety of the medicine.

5. How to store Escitalopram Actavis

The medicine should be stored out of the sight and reach of children.
The patient should not take this medicine 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 they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Escitalopram Actavis contains

The active substance is escitalopram. Each film-coated tablet contains 10 mg, 15 mg, or 20 mg of escitalopram (as escitalopram oxalate).
Other ingredients are:
tablet core:
microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, talc, magnesium stearate;
tablet 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 film-coated tablets (6.4 mm x 9.25 mm) with a score line on one side and notched edges, marked with "E" on the other side. The tablet can be divided into equal doses.
Escitalopram Actavis, 15 mg:
Oval, biconvex, white film-coated tablets (7.3 mm x 10.6 mm) with a score line on one side and notched edges, marked with "E" on the other side. The tablet can be divided into equal doses.
Escitalopram Actavis, 20 mg:
Oval, biconvex, white film-coated tablets (8 mm x 11.7 mm) with a score line on one side and notched edges, 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 film-coated tablets in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer

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

For further information, the patient should contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00.
Date of last revision of the leaflet:January 2025