Escitalopram Actavis

Patient Information Leaflet: Escitalopram Actavis

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

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

• You should keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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, tell your doctor or pharmacist. See section 4.

Contents of the pack

• 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 antidepressants 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 anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).
It may take a few weeks before you start to feel better. You should continue to take Escitalopram Actavis even if you do not feel better immediately. If you do not feel better or feel worse, you should tell 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 or have had a heart condition that affects your heart rhythm (seen on an ECG);
• if you are taking medicines that affect your heart rhythm (see section 2 "Escitalopram Actavis and other medicines").

Warnings and precautions

Before taking Escitalopram Actavis, tell your doctor or pharmacist if you have any other medical conditions, as your doctor should take them into account. In particular, tell your doctor:

• if you have epilepsy. Treatment with Escitalopram Actavis should be stopped if you have your first seizure or if the frequency of your seizures increases (see also section 4 "Possible side effects");
• if you have liver or kidney disease. Your doctor may need to adjust your dose;
• if you have diabetes. Treatment with Escitalopram Actavis may affect your blood sugar levels. You may need to adjust your insulin dose or your oral hypoglycemic medication;
• if you have low sodium levels in your blood;
• if you have an increased risk of bleeding or bruising or if you are pregnant (see "Pregnancy, breastfeeding, and fertility");
• if you are receiving electroconvulsive therapy;
• if you have coronary heart disease;
• if you have had a heart attack or have heart disease;
• if you have low resting blood pressure and (or) know that you have low levels of salts due to prolonged, severe diarrhea and vomiting or the use of diuretics (water pills);
• if you have a fast or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart function;
• if you have had eye problems, such as certain types of glaucoma (increased pressure in the eye).

Caution

In some patients with bipolar disorder, a manic phase may occur.
This is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If you experience these symptoms, 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.
Medicines like Escitalopram Actavis (SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety

In cases of depression and (or) anxiety disorders, suicidal thoughts or self-harm may also occur. Such symptoms or behavior may worsen at the start of treatment with antidepressants, as these medicines start to work usually after 2 weeks, sometimes later.
The likelihood of such symptoms occurring is higher if:

• you have had suicidal thoughts or self-harm before;
• you are an adult under 25 years old. Clinical trials have shown an increased risk of suicidal behavior in adults under 25 years old with mental health conditions treated with antidepressants. If you ever have thoughts of self-harm or suicide, you should contact your doctor or go to the hospital immediately.

It may be helpful to tell your family or 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 acting strangely.

Children and adolescents

Escitalopram Actavis should not be used in children and adolescents under 18 years old.
It should also be noted that in patients under 18 years old, taking medicines of this group, there is an increased risk of side effects, such as suicide attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and expressions of anger). However, your doctor may prescribe Escitalopram Actavis to patients under 18 years old if they consider it to be in their best interest. If you are under 18 years old and have been prescribed Escitalopram Actavis, and you have any concerns, you should contact your doctor again. If you are under 18 years old and taking Escitalopram Actavis, and you experience any of the above symptoms, you should tell your doctor. Additionally, there is no long-term data on the safety of Escitalopram Actavis regarding growth, maturation, and cognitive development in this age group.

Escitalopram Actavis and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.
Tell 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 Actavis. After stopping treatment with Escitalopram Actavis, you should wait 7 days before taking any of these medicines;
• reversible, selective inhibitors of monoamine oxidase A (RIMA) containing moclobemide (used to treat depression);
• irreversible inhibitors of monoamine oxidase B (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 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;
• aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) (used to treat pain or 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). Your doctor may need to monitor your blood clotting time at the start and end of treatment with Escitalopram Actavis 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 possible risk of lowering the seizure threshold;
• antipsychotics (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). Your doctor may need to adjust your dose of Escitalopram Actavis;
• 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 you are taking medicines used to treat heart conditions or medicines that may affect your heart rhythm, such as:

anti-arrhythmic drugs of class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, and some antibacterial drugs (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial drugs, especially halofantrine), some antihistamines (astemizole, hydroxyzine, mizolastine). If you have any doubts about taking the medicine, you should contact your 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 with alcohol, although interactions between Escitalopram Actavis and alcohol are not expected.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not take Escitalopram Actavis during pregnancy or while breastfeeding, unless your doctor considers it necessary. If you take Escitalopram Actavis during the last 3 months of pregnancy, you should be aware that your newborn baby may experience the following symptoms: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiffness or floppiness, increased reflexes, tremors, nervousness, irritability, lethargy, sleepiness, and difficulty sleeping. If your baby experiences any of these symptoms, you should contact your doctor immediately.
Tell your doctor and (or) midwife that you are taking Escitalopram Actavis. Taking medicines like Escitalopram Actavis, especially during 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 skin, and usually occurs in the first day after birth. If such symptoms occur in your baby, you should contact your doctor and (or) midwife immediately.
Do not stop taking Escitalopram Actavis during pregnancy without consulting your doctor.
Taking Escitalopram Actavis at the end of pregnancy may increase the risk of severe bleeding from the vagina, occurring shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Escitalopram Actavis, you should tell your doctor or midwife so that they can give you 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

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

Escitalopram Actavis contains sodium

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

3. How to take Escitalopram Actavis

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Adults
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
The initial dose of Escitalopram Actavis is 5 mg per day for the first week, 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 your 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 is not normally given to 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 taken 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 taken as directed by your doctor.
Poor metabolizers of CYP2C19
Patients known to be poor metabolizers of CYP2C19 should not exceed a dose of 10 mg per day. The medicine should be taken as directed by your doctor.
The tablets should be taken once daily, 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 divided into two equal doses by placing it on a flat surface with the score line facing upwards and pressing the ends down with your index fingers.

Duration of treatment
You may not feel better immediately. You should continue to take Escitalopram Actavis even if you do not feel better immediately. Do not change your dose without consulting your doctor.
Escitalopram Actavis 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 you feel better.

Taking more than the recommended dose of Escitalopram Actavis

If you have taken more than the recommended dose of Escitalopram Actavis, you should contact your doctor or go to the emergency department of your nearest hospital immediately. You should do this even if you do not feel any symptoms.
Symptoms of overdose include dizziness, tremors, agitation, unconsciousness, nausea, vomiting, changes in heart rhythm, low blood pressure, and changes in water and electrolyte balance. On a visit to your doctor or hospital, take the packaging of Escitalopram Actavis with you.

Forgetting to take a dose of Escitalopram Actavis

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose and remember before going to bed, you should take the missed dose immediately. Take the next dose at the usual time the next day. If you remember that you have 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 Actavis

Do not stop taking Escitalopram Actavis without consulting your doctor. When you stop treatment, your doctor will usually recommend that you reduce the dose of Escitalopram Actavis gradually over a few weeks.
After stopping treatment with Escitalopram Actavis, especially if it is stopped suddenly, you 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, they may be more severe or longer-lasting (more than 2-3 months). If you experience severe withdrawal symptoms, you should contact your doctor. Your doctor may recommend that you start taking the medicine again and reduce the dose more slowly.
Withdrawal symptoms include dizziness (unsteady gait, balance disorders), tingling sensations, burning sensations, and (less commonly) electric shock sensations, also in the head, sleep disturbances (vivid 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 you have any further questions about taking this medicine, you should ask your 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. Remember that some of these side effects may also be symptoms of your illness and will disappear as you get better.

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 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 2 "Important information before taking Escitalopram Actavis"
• yellowing of the skin and whites of the eyes, which may be a sign of liver damage or inflammation
• fast or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called Torsades de Pointes
• suicidal thoughts and behaviors, see also section 2 "Important information before taking Escitalopram Actavis"
• 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, unusual dreams, difficulty sleeping, sleepiness, dizziness, 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, changes in taste, fainting (syncope)
• dilated pupils, changes in vision, 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

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 tests (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 2 "Pregnancy, breastfeeding, and fertility")
• mania
• in patients taking medicines of this group, an increased risk of bone fractures has been observed, and changes in heart rhythm (called "QT interval prolongation", seen 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 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, 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 Actavis

Keep this medicine out of the sight and reach of children.
Do not use 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. 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 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, croscarmellose sodium, 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 engraved 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 engraved 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 engraved 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, contact 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