Escitalopram actavis

Patient Information Leaflet

Caution! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Escitalopram Actavis, 10 mg, film-coated tablets
Escitalopram
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that it can be read again if necessary.
• If there are any questions, consult a doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are identical.
• If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents

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. Continue taking Escitalopram Actavis even if it takes some time for the patient's condition to improve. If no improvement occurs or if the patient feels worse, consult a 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), moclobemide (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 heartbeat (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 such information should be taken 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. Dose adjustment by the doctor may be required;
• 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 ischemic 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 eyeball).

Note
In some patients with bipolar affective disorder, a manic phase may occur. It 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 sexual dysfunction symptoms (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 greater 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 who were treated with antidepressants. If thoughts of self-harm or suicidal thoughts occur at any time, seek immediate medical attention or go to hospital.

Informing family or friends about depression or anxiety disorders and asking them to read this leaflet may be helpful. The patient may ask them to inform the patient if they notice worsening depression or anxiety, or concerning changes in behaviour.
Children and adolescents
Escitalopram Actavis should not be used in children and adolescents under 18 years of age.
It should also be emphasized that patients under 18 years of age taking medicines in this group are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and anger). Nevertheless, a doctor may prescribe Escitalopram Actavis to patients under 18 years of age if they determine it is in their best interest. If Escitalopram Actavis has been prescribed to a patient under 18 years of age and you have any concerns, 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 the doctor immediately. 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 moclobemide (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 (used in the treatment of fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase escitalopram blood levels;
• St John's wort (Hypericum perforatum) – an herbal medicine used for depression;
• acetylsalicylic acid and non-steroidal anti-inflammatory drugs (painkillers or blood-thinning medicines, known as anticoagulants). These may increase the tendency to bleed;
• warfarin, dipyridamole and phenprocoumon (blood-thinning medicines, known as anticoagulants). The doctor may order blood clotting time tests at the beginning and after stopping Escitalopram Actavis to ensure the anticoagulant dose remains appropriate;
• mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (used for severe pain) due to possible risk of lowering the seizure threshold;
• neuroleptics (medicines used in the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to 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). 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: antiarrhythmic drugs of class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, and certain antibacterial drugs (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials especially halofantrine), certain antihistamines (astemizole, hydroxyzine, mizolastine). If the patient has any doubts regarding concomitant use of medicines, they should contact their doctor.
Escitalopram Actavis with food, drink or alcohol
Escitalopram Actavis can be taken during or independent of meals (see section 3 "How to take Escitalopram Actavis").
As with many medicines, simultaneous use of Escitalopram Actavis and alcohol is not recommended, although interactions between Escitalopram Actavis and alcohol are not expected.
Pregnancy, breastfeeding and fertility
If pregnant, breastfeeding, suspecting pregnancy, or planning pregnancy, consult a doctor or pharmacist before using this medicine.
The patient should not use Escitalopram Actavis during pregnancy or breastfeeding unless the risks and benefits of treatment have been discussed with the doctor.
Inform the doctor and/or midwife about taking 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 (bluish skin) and usually occurs within the first day after birth. If these symptoms occur in the newborn, seek immediate medical attention.
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, bluish skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose levels, muscle stiffness or floppiness, increased reflexes, tremors, nervousness, irritability, lethargy, excessive crying, drowsiness, and difficulty sleeping. If any of these symptoms occur in the newborn, contact a doctor immediately.
Do not suddenly stop taking Escitalopram Actavis during pregnancy.
Taking Escitalopram Actavis towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Escitalopram Actavis, they should inform their doctor or midwife so appropriate advice can be provided.
Escitalopram is expected to pass into breast milk.
Animal studies have shown that citralopram, a medicine similar to escitalopram, affects sperm quality. This could theoretically affect fertility, but no effect on fertility in humans 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.

The following strengths of Escitalopram Actavis are available: 10 mg, 15 mg and 20 mg.

Adult patients

Depression
The usual recommended dose of Escitalopram Actavis is 10 mg taken once daily as a single dose. Your doctor may increase the dose up to a maximum of 20 mg per day.

Panic disorder with or without agoraphobia
The initial dose of Escitalopram Actavis is 5 mg once daily during the first week of treatment. The dose is then increased to 10 mg once daily. Your doctor may further increase the dose up to a maximum of 20 mg per day.

Social phobia (social anxiety disorder)
The usual recommended dose of Escitalopram Actavis is 10 mg taken once daily as a single 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.

Generalised anxiety disorder
The usual recommended dose of Escitalopram Actavis is 10 mg taken once daily as a single dose. Your doctor may increase the dose up to a maximum of 20 mg per day.

Obsessive-compulsive disorder
The usual recommended dose of Escitalopram Actavis is 10 mg taken once daily as a single dose. Your doctor may increase the dose up to a maximum of 20 mg per day.

Elderly patients (over 65 years)
The recommended initial dose of Escitalopram Actavis is 5 mg taken once daily as a single dose. Your doctor may increase the dose 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 impairment
Caution is advised in patients with severe renal impairment. This medicine should be used according to your doctor's instructions.

Hepatic impairment
Patients with impaired liver function should not exceed a dose of 10 mg per day. This medicine should be used according to your doctor's instructions.

Patients who are poor metabolisers of drugs metabolised by the CYP2C19 isoenzyme
Patients with this known genotype should not exceed a dose of 10 mg per day. This medicine should be used according to your 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 may be divided into two equal parts. To do this, place the tablet on a flat surface with the score side facing up. The tablet can then be broken in half by pressing down on each end with the index fingers of both hands, as shown in the illustration.

Duration of treatment
Improvement may not be felt until after several weeks of treatment. Therefore, continue taking Escitalopram Actavis as prescribed, even if it takes some time before you feel better. Do not change the dose without first consulting your doctor.

Continue taking Escitalopram Actavis for as long as your doctor recommends. If treatment is stopped too early, symptoms may return. It is therefore recommended to continue treatment for at least 6 months after regaining good well-being.

Taking more Escitalopram Actavis than prescribed
If you have taken more Escitalopram Actavis than prescribed, contact your doctor immediately or go to the nearest hospital emergency department. Do this even if you do not feel any discomfort.

Symptoms of overdose may include dizziness, tremor, agitation, somnolence, nausea, vomiting, cardiac arrhythmias, hypotension and disturbances in water and electrolyte balance. Take the medicine pack with you to the doctor's office or hospital.

If you forget to take 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 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 a period of 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 has been 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 you experience severe withdrawal symptoms, contact your doctor. Your doctor may recommend restarting the medicine and tapering it more slowly.

Withdrawal symptoms may include: dizziness (unsteadiness, impaired balance), tingling sensations, burning sensations, and (less commonly) electric shock-like sensations, also in the head; sleep disturbances (vivid dreams, nightmares, insomnia); feeling of anxiety; headache; nausea and/or vomiting; sweating (including night sweats); psychomotor agitation or restlessness; tremor; feeling of disorientation; emotional instability or irritability; diarrhoea; visual disturbances; palpitations (fluttering or pounding 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 will experience them.
Adverse reactions usually subside after a few weeks of treatment. It should be remembered that some
of these reactions may also be symptoms of the illness itself and will resolve as the patient's condition improves.
If any of the following adverse reactions occur during treatment, you should
contact your doctor or go to hospital immediately:
Uncommon (may affect up to 1 in 100 people):

• unusual bleeding, including from the gastrointestinal tract.

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

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

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

• difficulty in passing urine
• seizures, see also section “Warnings and precautions”
• yellowing of the skin and whites of the eyes, indicating impaired liver function/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 affect more than 1 in 10 people):

• nausea
• headache

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

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

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

• urticaria (hives), rash, itching
• teeth grinding, agitation, nervousness, panic attack, confusion (disorientation)
• sleep disturbances, taste disturbances, fainting (syncope)
• pupil dilation, 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 affect up to 1 in 1,000 people):

• aggression, depersonalization (feeling of loss of self-identity, the person feels they are not themselves), hallucinations
• slow heartbeat

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

• decreased sodium concentration in blood (manifested by nausea, malaise, muscle weakness or confusion)
• dizziness upon standing due to low blood pressure (orthostatic hypotension)
• abnormal results in liver function tests (increased activity of liver enzymes 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), leading to water retention in the body, dilution of blood, reduced sodium levels (syndrome of inappropriate antidiuretic hormone secretion)
• milk secretion 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 reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 provide more information on the safety of the 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 packaging. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 escitalopram (in the form of escitalopram oxalate).
Other components of the medicine are:
Tablet core: microcrystalline cellulose, colloidal anhydrous silica, sodium croscarmellose, talc, magnesium stearate;
Tablet coating: hypromellose 6cP, titanium dioxide (E 171), macrogol 6000.

What Escitalopram Actavis looks like and contents of the pack
Oval, biconvex, white film-coated tablets (6.4 mm x 9.25 mm) with a score line on one side, bevelled edges and marked with "E" on the other side. The tablet can be divided into equal doses.
Escitalopram Actavis is available in blister packs containing 28 film-coated tablets, packed in a cardboard box.

For more detailed information, please contact the Marketing Authorisation Holder or the 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

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Marketing Authorisation number in Lithuania, country of export: LT/1/09/1815/015
Parallel Import Authorisation number: 353/19