Escitalopram actavis

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Escitalopram Actavis
10 mg, coated tablets
Escitalopramum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed strictly for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Escitalopram Actavis is and what it is 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 Escitalopram Actavis is and what it is 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 act on the serotonin system in the brain by increasing serotonin levels.
Disturbances in the function of the brain's serotonin system play a key role in the development
of depression and similar disorders.
Escitalopram Actavis is used to treat depression (major depressive episodes) and
anxiety disorders (such as panic disorder with or without agoraphobia, social phobia,
generalized anxiety disorder, and obsessive-compulsive disorder).
It may take several weeks of treatment before improvement begins. You should continue
taking Escitalopram Actavis even if it takes some time for your condition to improve.
If no improvement occurs or if you feel worse, consult your doctor.

2. Important information before using Escitalopram Actavis

When not to use 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 currently taking medicines belonging to a group called monoamine oxidase inhibitors (MAOIs), including selegiline (used in the treatment of Parkinson's disease), moklobemide (used in the treatment of depression), or linezolid (an antibiotic);
• if the patient was born with an abnormal heart rhythm or has experienced episodes of irregular heart rhythm (visible on ECG; a test used to check how the heart works);
• if the patient is taking medicines used 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, consult a doctor or
pharmacist.
Inform the doctor if the patient has any other disorders or diseases, as the doctor should take such information into account. In particular, inform the doctor:

• if the patient has epilepsy. Treatment with Escitalopram Actavis should be discontinued if seizures occur for the first time or increase in frequency (see also section 4 "Possible side effects");
• if the patient has impaired liver or kidney function. The doctor may need to adjust the dose;
• if the patient has diabetes. Treatment with Escitalopram Actavis may affect blood glucose control. Adjustment of insulin and/or oral glucose-lowering medicines may be required;
• if the patient has low sodium levels in the blood;
• if the patient has an increased tendency to bleed or bruise, or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility");
• if the patient is undergoing electroconvulsive therapy;
• if the patient has ischaemic heart disease;
• if the patient has heart disease or has recently had a heart attack;
• if the patient has a slow resting heart rate and/or knows they have salt deficiency due to prolonged, severe diarrhoea and vomiting or use of diuretics (water tablets);
• if the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart function;
• if the patient has or has had eye problems, such as certain types of glaucoma (increased pressure inside the eye).

Note
In some patients with bipolar affective disorder, a manic phase may occur. This is characterised by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, consult a doctor.
During the first weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may also occur. If such symptoms appear, inform the doctor immediately.
Medicines such as Escitalopram Actavis (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety disorder
In cases of depression and/or anxiety disorders, thoughts of self-harm or suicidal thoughts may sometimes occur. These symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, sometimes longer, to start working.
The likelihood of such thoughts occurring is higher if:

• the patient has previously experienced thoughts of suicide or self-harm,
• the patient is a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with antidepressants. If thoughts of self-harm or suicidal thoughts occur at any time, seek immediate medical help or go to hospital. It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to alert him/her if they notice worsening depression or anxiety, or concerning changes in behaviour.

Children and adolescents
Escitalopram Actavis must not be used in children and adolescents under 18 years of age.
It should also be noted that patients under 18 years of age taking medicines from this group are at increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, oppositional behaviour, and anger). Nevertheless, a doctor may prescribe Escitalopram Actavis to patients under 18 years of age if they determine it is in the patient's best interest. If Escitalopram Actavis has been prescribed to a patient under 18 years of age and you have any doubts, contact your doctor again. If any of the symptoms listed above appear or worsen in a patient under 18 years of age taking Escitalopram Actavis, inform your doctor. Furthermore, the long-term impact of Escitalopram Actavis on safety regarding growth, maturation, and cognitive development in this age group has not yet been established.

Escitalopram Actavis and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Inform the doctor if the patient is taking any of the following medicines:

• non-selective monoamine oxidase inhibitors (MAOIs) containing active substances such as: phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If the patient has taken any of these medicines, they should wait 14 days before starting Escitalopram Actavis. After stopping Escitalopram Actavis, wait 7 days before taking any of these medicines;
• reversible, selective monoamine oxidase A (MAO-A) inhibitors containing moklobemide (a medicine used in the treatment of depression);
• irreversible monoamine oxidase B (MAO-B) inhibitors containing selegiline (used in the treatment of Parkinson's disease). These medicines increase the risk of adverse effects;
• the antibiotic linezolid;
• lithium (used in the treatment of bipolar affective disorder) and tryptophan;
• imipramine and desipramine (used in the treatment of depression);
• sumatriptan and similar medicines (used in the treatment of migraine), tramadol and buprenorphine (used for severe pain). These medicines may increase the risk of adverse effects;
• cimetidine, lansoprazole, omeprazole and esomeprazole (used in the treatment of stomach ulcers), fluconazole (a medicine used in the treatment of fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase the concentration of escitalopram in the blood;
• St John's wort (Hypericum perforatum) – an herbal medicine used for depression;
• acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to thin the blood, known as anticoagulants). These may increase the tendency to bleed;
• warfarin, dipyridamole and phenprocoumon (medicines used to thin the blood, known as anticoagulants). The doctor may order blood clotting tests at the start and after stopping Escitalopram Actavis to determine whether the dose of the anticoagulant remains appropriate;
• mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (used for severe pain) due to the possible risk of lowering the seizure threshold;
• neuroleptics (medicines used in the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold;
• flecainide, propafenone and metoprolol (used in cardiovascular diseases), desipramine, clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine and haloperidol (antipsychotics). A dose adjustment of Escitalopram Actavis may be required;
• medicines that lower potassium or magnesium levels in the blood, as they increase the risk of life-threatening heart rhythm disturbances.

DO NOT USE Escitalopram Actavis if the patient is taking medicines used for heart conditions or medicines that may affect heart rhythm, such as: class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, and certain antibacterial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials especially halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine). If the patient has any doubts about using the medicine, they should contact their doctor.
Escitalopram Actavis with food, drink or alcohol
Escitalopram Actavis can be taken during meals or independently of meals (see section 3 "How to take Escitalopram Actavis").
As with many medicines, it is not recommended to consume alcohol while taking Escitalopram Actavis, although interactions between Escitalopram Actavis and alcohol are not expected.
Pregnancy, breastfeeding and fertility
During pregnancy, breastfeeding, or if the woman suspects she is pregnant or is planning a pregnancy, she should consult her doctor or pharmacist before using this medicine.
The patient should not use Escitalopram Actavis during pregnancy or while breastfeeding unless she has discussed the risks and benefits of treatment with her doctor.
If the patient takes Escitalopram Actavis during the last three months of pregnancy, she should be aware that the newborn may experience the following symptoms: breathing difficulties, bluish skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose levels, muscle stiffness or floppiness, increased reflexes, tremors, nervousness, irritability, lethargy, crying, sleepiness, and difficulty falling asleep. If any of these symptoms occur in the newborn, seek immediate medical attention.
Inform the doctor and/or midwife about the use of Escitalopram Actavis. Taking medicines such as Escitalopram Actavis during pregnancy, especially during the last three months, may increase the risk of serious complications in the newborn called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterised by rapid breathing and cyanosis and usually occurs within the first day after birth. If such symptoms occur in the newborn, contact the doctor and/or midwife immediately.
Do not abruptly stop taking Escitalopram Actavis during pregnancy.
Taking Escitalopram Actavis late in pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Escitalopram Actavis, she should inform her doctor or midwife so they can provide appropriate advice.
Escitalopram is expected to pass into breast milk.
Animal studies have shown that citalopram, a medicine similar to escitalopram, affects sperm quality. This may theoretically affect fertility, but no effect on human fertility has been observed to date.
Driving and operating machinery
The patient should not drive or operate machinery until they know how Escitalopram Actavis affects them.
Escitalopram Actavis contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Escitalopram Actavis

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Escitalopram Actavis is available in the following strengths: 10 mg, 15 mg, 20 mg.
Adult patients
Depression
The usual recommended dose of Escitalopram Actavis is 10 mg taken as a single daily dose. The dose may be increased by your doctor up to a maximum dose of 20 mg per day.
Panic disorder with agoraphobia
The initial dose of Escitalopram Actavis is 5 mg once daily during the first week of treatment, after which the dose is increased to 10 mg per day. The dose may then be further increased by your doctor up to a maximum of 20 mg per day.
Social phobia
The usual recommended dose of Escitalopram Actavis is 10 mg taken as a single daily dose. The dose may then be reduced by your doctor to 5 mg per day or increased up to a maximum of 20 mg per day, depending on the patient's response to the medicine.
Generalized anxiety disorder
The usual recommended dose of Escitalopram Actavis is 10 mg taken as a single daily dose. The dose may be increased by your doctor up to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The usual recommended dose of Escitalopram Actavis is 10 mg taken as a single daily dose. The dose may be increased by your doctor up to a maximum of 20 mg per day.
Elderly patients (over 65 years of age)
The recommended initial dose of Escitalopram Actavis is 5 mg taken as a single daily dose. The dose may be increased by your doctor to 10 mg per day.
Use in children and adolescents
Escitalopram Actavis should normally not be used in children and adolescents. For further information, please refer to section 2, “Important information before taking Escitalopram Actavis”.
Renal function disorders
Caution is advised in patients with severe renal impairment. The medicine should be used according to the doctor’s instructions.
Hepatic function disorders
Patients with hepatic impairment should not exceed a dose of 10 mg per day. The medicine should be used according to the doctor’s instructions.
Patients who are poor metabolizers via the CYP2C19 isoenzyme
Patients with this known genotype should not exceed a dose of 10 mg per day. The medicine should be used according to the doctor’s instructions.
The coated tablets should be taken once daily, swallowed whole with sufficient liquid (preferably a glass of water). Escitalopram Actavis may be taken with or without food.
If necessary, the tablet can be divided into two equal parts by placing it on a flat surface with the groove facing upwards. The tablet can then be broken in half by pressing down with the index fingers on each end, as shown in the illustration.

Duration of treatment
Improvement may not be felt until after several weeks of treatment. Therefore, continue taking Escitalopram Actavis even if it takes some time before you feel better. Do not change the dosage without first consulting your doctor.
Escitalopram Actavis should be taken for as long as your doctor recommends. If treatment is stopped too early, symptoms may return. Therefore, it is recommended to continue treatment for at least 6 months after regaining good well-being.
Taking more than the recommended dose of Escitalopram Actavis
If you have taken more than the prescribed dose of Escitalopram Actavis, contact your doctor immediately or go to the emergency department of your nearest hospital. This should be done even if you do not feel unwell.
Symptoms of overdose may include dizziness, tremors, agitation, somnolence, nausea, vomiting, cardiac arrhythmias, low blood pressure, and disturbances in water and electrolyte balance. Take the medicine packaging with you when visiting the doctor or hospital.
Missing a dose of Escitalopram Actavis
Do not take a double dose to make up for a missed dose. If you forget to take a dose and remember before going to bed, take the missed dose immediately and take the next dose the following day as usual. If you remember about the missed dose during the night or the next day, skip the missed dose and take the next dose at the usual time.
Stopping treatment with Escitalopram Actavis
Do not stop taking Escitalopram Actavis unless your doctor tells you to. When stopping treatment, your doctor will usually recommend gradually reducing the dose of Escitalopram Actavis over several weeks.
After stopping Escitalopram Actavis, especially if stopped abruptly, you may experience withdrawal symptoms. These symptoms are common after discontinuation of Escitalopram Actavis. The risk is greater if Escitalopram Actavis has been taken for a long time, at high doses, or if the dose was reduced too quickly. In most patients, symptoms are mild and resolve spontaneously within two weeks. However, in some patients, symptoms may be more severe or last longer (more than 2–3 months). If severe withdrawal symptoms occur, contact your doctor. Your doctor may recommend restarting the medicine and tapering it more slowly.
Withdrawal symptoms may include: dizziness (unsteady gait, balance disturbances), tingling sensations, burning sensations, and (less commonly) electric shock-like sensations, including in the head; sleep disturbances (vivid dreams, nightmares, insomnia); feelings of anxiety; headache; nausea and/or vomiting; sweating (including night sweats); psychomotor agitation or restlessness; tremors; feelings of disorientation; emotional lability or irritability; diarrhoea; visual disturbances; palpitations (fluttering or pounding of the heart).
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions usually resolve within a few weeks of treatment. It should be remembered that some
of these reactions may also be symptoms of the illness itself and will subside as your condition improves.
If any of the following adverse reactions occur during treatment, you should
contact your doctor or go immediately to hospital:
Uncommon (may occur in up to 1 in 100 people):

• unusual bleeding, including gastrointestinal bleeding.

Rare (may occur in up to 1 in 1000 people):

• swelling of the skin, tongue, lips, larynx or face, urticaria, or difficulty breathing or swallowing (severe allergic reaction)
• high fever, agitation, confusion, tremors and severe muscle contractions, which may be symptoms of a rare disorder called serotonin syndrome.

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

• difficulty passing urine
• seizures, see also section "Warnings and precautions"
• yellowing of the skin and whites of the eyes indicating liver dysfunction/hepatitis
• rapid, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called Torsades de Pointes
• suicidal thoughts and behaviour, see also section "Warnings and precautions"
• sudden swelling of the skin or mucous membranes (angioedema)

In addition to the reactions listed above, the following adverse reactions have also been reported:
Very common (may occur in more than 1 in 10 people):

• nausea
• headache

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

• nasal congestion or rhinitis (sinusitis)
• decreased or increased appetite
• anxiety, psychomotor agitation, unusual dreams, difficulty sleeping, drowsiness, dizziness, yawning, tremors, tingling sensation in the skin
• diarrhoea, constipation, vomiting, dry mouth
• excessive sweating
• muscle and joint pain
• sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and possible difficulty achieving orgasm in women)
• feeling of fatigue, fever
• weight gain

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

• urticaria, rash, itching
• teeth grinding, agitation, nervousness, panic attack, confusion (disorientation)
• sleep disturbances, taste disturbances, fainting (syncope)
• dilated pupils, visual disturbances, ringing in the ears (tinnitus)
• hair loss
• heavy menstrual bleeding
• irregular menstruation
• weight loss
• rapid heartbeat
• swelling of the upper or lower limbs
• nosebleeds

Rare (may occur in up to 1 in 1000 people):

• aggression, depersonalization (feeling of loss of self-identity, feeling not oneself), hallucinations
• slow heartbeat

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

• decreased sodium concentration in blood (manifesting as nausea and malaise with muscle weakness or confusion)
• dizziness upon standing due to low blood pressure (orthostatic hypotension)
• abnormal liver function tests (increased liver enzyme activity in blood)
• movement disorders (involuntary muscle movements)
• painful penile erection (priapism)
• symptoms of unusual bleeding in the skin and mucous membranes (petechiae)
• low platelet count (thrombocytopenia)
• increased secretion of antidiuretic hormone (ADH), causing water retention, blood dilution, and decreased sodium levels (syndrome of inappropriate ADH secretion)
• galactorrhea in men and in women who are not breastfeeding
• severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy, breastfeeding and fertility" in section 2
• mania
• in patients taking medicines of this class, an increased risk of bone fractures has been observed
• change in heart rhythm (called "QT interval prolongation", visible on ECG, a test assessing heart function)

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

• psychomotor agitation (akathisia)
• loss of appetite

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse reactions helps to collect more information on the safety of the medicine.

5. How to store the medicine 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 pack and the cardboard
pack after "EXP". The expiry date refers to the last day of the stated 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 packaging and other information

What Escitalopram Actavis contains
The active substance is escitalopram. Each coated tablet contains 10 mg of escitalopram (as escitalopram oxalate).
Other ingredients are:
Tablet core: microcrystalline cellulose, colloidal anhydrous 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 coated tablets (6.4 mm x 9.25 mm) with a score line on one side, bevelled edges and marked "E" on the other side. The tablet can be divided into equal doses.
Escitalopram Actavis is available in blister packs of 28, 30, 56 and 60 coated tablets, packed in a cardboard box.

For more detailed information, please contact the marketing authorisation holder or parallel importer.

Marketing authorisation holder in Lithuania, country of export:
Teva B.V.
Swensweg 5
2031 GA Haarlem
The 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
The Netherlands

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Relabeled in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Numbers of marketing authorisation in Lithuania, 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

Number of parallel import authorisation: 288/24