Lexapro

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Lexapro (Sipralexa)
10 mg, film-coated tablets
Escitalopram
Lexapro and Sipralexa are different brand names of the same medicine.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your 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 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:

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

1. What Lexapro is and what it is used for

Lexapro contains the active substance escitalopram. Lexapro 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.
Lexapro 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 Lexapro even if it takes some time before your condition improves.
If no improvement occurs or if you feel worse, consult your doctor.

2. Important information before using Lexapro

When not to use Lexapro:

• 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 other medicines belonging to a group called MAO inhibitors, containing 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 a congenital abnormal heart rhythm or if the patient has experienced an episode of abnormal heart rhythm (visible on ECG; a test assessing heart function);
• if the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section “Lexapro with other medicines”).

Warnings and precautions
Before starting treatment with Lexapro, discuss this with your doctor or pharmacist. You should
inform your 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. If seizures occur for the first time or increase in frequency, treatment with Lexapro should be discontinued (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 Lexapro may affect blood glucose control. Adjustment of insulin dose and/or oral glucose-lowering medicines may be necessary;
• if the patient has low sodium levels in the blood;
• if the patient has an increased tendency to bleeding and bruising or if the patient is pregnant (see “Pregnancy, breastfeeding and fertility”);
• if the patient is receiving electroconvulsive therapy;
• if the patient has ischemic heart disease;
• if the patient has heart problems or has recently had a heart attack;
• if the patient has a slow resting heart rate and/or low electrolyte levels due to prolonged severe diarrhoea, vomiting, or use of diuretics (water tablets);
• if the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate an abnormal heart rate;
• 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. It is characterized by
unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical
activity. If these symptoms occur, consult a doctor.
In 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 Lexapro (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
Patients with depression or anxiety disorders may sometimes have thoughts of self-harm or
suicide.
These symptoms or behaviors may worsen at the beginning of antidepressant treatment, as these
medicines usually start to work only after about 2 weeks, sometimes later.
These symptoms are more likely in:

• patients who previously had thoughts of self-harm or suicide;
• young adult patients. Clinical trial data show an increased risk of suicidal behavior in patients under 25 years of age with psychiatric disorders treated with antidepressants.

If the patient experiences thoughts of self-harm or suicide, seek immediate medical help
by contacting a doctor or going to hospital.
It may be helpful to inform relatives or close friends about the depression or anxiety disorder and
ask them to read this leaflet. The patient may ask them to inform him/her if they notice worsening
of depression or treatment, or disturbing changes in behavior.
Children and adolescents
Lexapro should not be used in children and adolescents under 18 years of age. It should also be
noted that when taking medicines of this class, patients under 18 years of age are at increased risk
of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly
aggression, oppositional behavior, and anger). Nevertheless, a doctor may prescribe Lexapro to
patients under 18 years of age if he/she considers it to be in their best interest. If your doctor has
prescribed Lexapro for a patient under 18 years of age and you have any doubts, please contact the
doctor. If the above-mentioned symptoms develop or worsen in patients under 18 years of age
taking Lexapro, inform your doctor. Furthermore, there are currently no data on the long-term
safety of Lexapro in this age group regarding growth, maturation, and cognitive and behavioral
development.
Lexapro with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has 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, a 14-day interval should be observed before starting Lexapro. After stopping Lexapro, a 7-day interval should be observed before taking any of these medicines;
• reversible, selective monoamine oxidase A (MAO-A) inhibitors containing moclobemide (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) and tramadol and similar medicines (opioids, used for severe pain). These may increase the risk of adverse effects;
• cimetidine, lansoprazole, and omeprazole (used in the treatment of stomach ulcers), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These 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 risk of bleeding;
• warfarin, dipyridamole, and phenprocoumon (blood-thinning medicines, known as anticoagulants). The doctor may order blood clotting time tests at the beginning and after stopping Lexapro to ensure the anticoagulant dose remains appropriate;
• mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used for severe pain) due to possible risk of lowering the seizure threshold;
• neuroleptics (medicines used to treat 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), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Lexapro may be required;
• medicines that lower potassium or magnesium levels in the blood, which increase the risk of life-threatening heart rhythm disturbances.

Do not take Lexapro together with medicines used for heart rhythm disorders or medicines that may
affect heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine
derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial agents (e.g.
sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarials – particularly
halofantrine), certain antihistamines (astemizole, hydroxyzine, mizolastine), etc. Consult your
doctor if you have any further questions.
Lexapro with food, drink, and alcohol
Lexapro can be taken with or without food (see section 3 “How to take Lexapro”).
As with many medicines, it is not recommended to drink alcohol while taking Lexapro, although
interactions (effects) between Lexapro and alcohol are not expected.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
baby, she should consult her doctor or pharmacist before using this medicine.
The patient should not use Lexapro during pregnancy or while breastfeeding unless she has
discussed the risks and benefits of treatment with her doctor.
If the patient takes Lexapro 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 reflex excitability, tremors, jitteriness, irritability, lethargy, constant
crying, drowsiness, and difficulty sleeping. If any of these symptoms occur in the newborn, seek
immediate medical attention.
Inform the doctor and/or midwife about the use of Lexapro. Taking medicines such as Lexapro
during pregnancy, especially during the last three months, may increase the risk of serious
complications in the newborn, known as persistent pulmonary hypertension of the newborn
(PPHN). It manifests as rapid breathing and cyanosis. These symptoms usually appear within the
first 24 hours after birth. If such symptoms occur in the newborn, contact the doctor and/or midwife
immediately.
Taking Lexapro 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 Lexapro, she should inform her doctor or midwife so they can provide appropriate
advice.
Do not abruptly stop taking Lexapro during pregnancy.
Escitalopram is expected to pass into human breast milk.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces sperm
quality. This may theoretically affect fertility, although no effect on human fertility has been
observed so far.
Driving and operating machinery
The patient should not drive or operate machinery until they know how Lexapro affects them.
Lexapro contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. the medicine
is considered “sodium-free”.

3. How to use Lexapro

This medicine should always be taken exactly as your doctor has instructed. If in doubt, consult your doctor or pharmacist.

Recommended dose

Adults:

Depression
The usual recommended dose of Lexapro is 10 mg taken once daily. Your doctor may increase the dose up to a maximum of 20 mg daily.

Panic disorder
The initial dose of Lexapro is 5 mg once daily during the first week of treatment, then increased to 10 mg daily. The dose may then be increased by your doctor up to a maximum of 20 mg daily.

Social phobia
The usual recommended dose of Lexapro is 10 mg taken once daily. The dose may then be reduced by your doctor to 5 mg daily or increased up to a maximum of 20 mg daily, depending on the patient's response to the medicine.

Generalised anxiety disorder
The usual recommended dose of Lexapro is 10 mg taken once daily. Your doctor may increase the dose up to a maximum of 20 mg daily.

Obsessive-compulsive disorder
The usual recommended dose of Lexapro is 10 mg taken once daily. Your doctor may increase the dose up to a maximum of 20 mg daily.

Elderly patients (over 65 years of age)
The recommended initial dose of Lexapro is 5 mg taken once daily. Your doctor may recommend increasing the dose to 10 mg daily.

Use in children and adolescents
Lexapro should generally not be used in children and adolescents. Additional information is provided in section 2, "Warnings and precautions".

Renal impairment
Caution should be exercised in patients with severe renal impairment. This medicine should be used as directed by your doctor.

Hepatic impairment
Patients with impaired liver function should not exceed a dose of 10 mg daily. The medicine should be used as directed by your doctor.

Patients who are poor metabolisers via the CYP2C19 isoenzyme
Patients with this known genotype should not exceed a dose of 10 mg daily. The medicine should be used as directed by your doctor.

How to take Lexapro
Lexapro may be taken with or without food. Swallow the tablets whole with water. Do not chew the tablets, as they have a bitter taste.
If necessary, the tablets may be divided into two equal parts. To do this, place the tablet on a flat surface with the score line facing upwards, then break it in half by pressing down with both index fingers on each end, as shown in the illustration.

Duration of treatment
You may not start to feel better until after several weeks of treatment. Therefore, continue taking Lexapro even if it takes some time before your symptoms improve.
Do not change the dose without first consulting your doctor.
Continue taking the medicine for as long as your doctor recommends. If you stop treatment too early, your symptoms may return. Therefore, treatment should be continued for at least 6 months after regaining good well-being.

Taking more Lexapro than prescribed
If you take more Lexapro than prescribed, contact your doctor immediately or go to the nearest hospital emergency department. Do this even if you do not feel any symptoms. Symptoms of overdose may include dizziness, tremors, agitation, seizures, coma, nausea, vomiting, cardiac arrhythmias, low blood pressure, and disturbances in water and electrolyte balance. Bring the Lexapro packaging with you when visiting your doctor or going to the hospital.

If you forget to take Lexapro
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 sleep, 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 Lexapro
Do not stop taking Lexapro unless your doctor tells you to. When stopping treatment, your doctor will usually recommend gradually reducing the dose of Lexapro over a period of several weeks.
After stopping Lexapro, especially if stopped abruptly, you may experience withdrawal symptoms. These symptoms are common when stopping Lexapro. The risk is greater if Lexapro 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 (2–3 months or more). If you experience severe withdrawal symptoms after stopping Lexapro, 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, sweating (including night sweats), psychomotor agitation or restlessness, tremors, feelings of disorientation, emotional instability or irritability, diarrhoea (loose stools), visual disturbances, palpitations or rapid heartbeat.

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 resolve 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 subside 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 gastrointestinal bleeding

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

• swelling of the skin, tongue, lips, larynx or face, urticaria, 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 condition called serotonin syndrome

Adverse reactions with unknown frequency (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, which may indicate liver dysfunction/hepatitis
• rapid or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsade de pointes
• suicidal thoughts and behaviours, 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, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin tingling
• diarrhoea, constipation, vomiting, dry mouth
• excessive sweating
• muscle and joint pain
• sexual disorders (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women)
• feeling of fatigue, fever
• weight gain

Uncommon (may affect 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, tinnitus (ringing in the ears)
• 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 detached from themselves), hallucinations
• slow heartbeat

Adverse reactions with unknown frequency (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 liver function test results (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)
• increased secretion of antidiuretic hormone (ADH), causing water retention in the body, blood dilution, and decreased sodium levels (syndrome of inappropriate ADH secretion)
• galactorrhea in men and women who are not breastfeeding
• mania
• in patients taking medicines of this class, an increased risk of bone fractures has been observed
• change in heart rhythm (known as "QT interval prolongation", visible on ECG, a test assessing heart function)
• severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy, breastfeeding and fertility" in section 2.

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

• psychomotor restlessness (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 for 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 provide more information on the safety of the medicine.

5. How to store the medicine Lexapro

Keep this medicine out of 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.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Lexapro contains
The active substance is escitalopram. Each Lexapro tablet contains 10 mg of escitalopram (as
escitalopram oxalate).
Other components of the medicine are:
Tablet core: microcrystalline cellulose, colloidal anhydrous silica, talc, sodium croscarmellose, and magnesium stearate.
Tablet coating: hypromellose, polyethylene glycol 400, titanium dioxide (E 171).

What Lexapro looks like and contents of the packaging
Lexapro is a film-coated tablet containing 10 mg of the active substance.
Below is a description of the tablets.
Oval, white, film-coated tablets measuring 8x5.5 mm. The tablets are bisected by a division line and marked with the letter "E" on one side and "L" on the other side of the line, on one tablet surface.

Lexapro is available in the following pack sizes:
Blister pack in a cardboard box:
14 tablets (one blister of 14 tablets) and 28 tablets (two blisters of 14 tablets).
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Belgium, country of export:
H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark

Manufacturer:
H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark

Parallel Importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland

Marketing Authorisation Number in Belgium, country of export: BE238971
Parallel Import Authorisation Number: 295/22

This medicinal product is authorised for sale in the European Economic Area countries under the following trade names:
Austria: Cipralex
Belgium: Sipralexa
Bulgaria: Cipralex
Cyprus: Cipralex
Czech Republic: Cipralex
Estonia: Cipralex
Denmark: Cipralex
Finland: Cipralex
France: Seroplex
Greece: Cipralex
Spain: Cipralex
Netherlands: Lexapro
Iceland: Cipralex
Ireland: Lexapro
Lithuania: Cipralex
Luxembourg: Sipralexa
Latvia: Cipralex 10 mg film-coated tablets
Malta: Cipralex
Germany: Cipralex
Norway: Cipralex
Poland: Lexapro
Portugal: Cipralex
Romania: Cipralex
Slovakia: Cipralex
Slovenia: Cipralex
Sweden: Cipralex
Hungary: Cipralex
Italy: Cipralex
United Kingdom: Cipralex