Lexapro

Patient Information Leaflet: Information for the User

Warning! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Lexapro (Sipralexa)
10 mg, film-coated tablets
Escitalopram
Lexapro and Sipralexa are different brand names for the same medicine.
Please read this leaflet carefully before taking 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 questions, please 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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).
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. Continue taking Lexapro even if it takes some time before your condition improves.
If there is no improvement 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 monoamine oxidase inhibitors (MAOIs), containing 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 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 your 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 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 bleed or bruise easily, 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 problems or has recently suffered 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 eyeball).

Note
In some patients with bipolar affective disorder, a manic phase may occur. This is characterized by
unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical
activity. If these symptoms occur, 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 your 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 treatment with antidepressants, as
these medicines usually take about 2 weeks, sometimes longer, to start working.
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 who were treated with antidepressants. If the patient develops thoughts of self-harm or suicide, seek immediate medical help by contacting a doctor or going to hospital.

It may be helpful to inform family members or close friends about the depression or
anxiety disorder and ask them to read this leaflet. The patient may ask them to inform him or her
if they notice worsening of depression or the medicine's effects, or concerning 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, defiant behavior, and anger). Nevertheless, a doctor may prescribe Lexapro to
patients under 18 years of age if he or 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 concerns, please contact
the prescribing 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 your 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 Lexapro. After stopping Lexapro, wait 7 days before taking any of these medicines;
• reversible, selective monoamine oxidase A (MAO-A) inhibitors containing moklobemide (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 medicines may increase escitalopram blood levels;
• St. John's wort (Hypericum perforatum) – a herbal remedy 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 (medicines used to thin the blood, known as anticoagulants). Your doctor may order blood clotting time tests at the beginning and after stopping Lexapro to determine whether 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), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Lexapro may be required;
• medicines that lower blood potassium or magnesium levels, 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 take Lexapro together with alcohol, 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 plans to become
pregnant, she should consult a doctor or pharmacist before using this medicine.
The patient should not take 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 3 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, muscle stiffness or
flaccidity, 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 your doctor and/or midwife about taking 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 is
characterized by rapid breathing and cyanosis (bluish skin). Symptoms usually appear within the
first day after birth. If such symptoms occur in the newborn, contact your 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 stop taking Lexapro suddenly 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 could theoretically affect fertility, although no effect on human fertility has been
observed so far.
Driving and using machines
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 coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Lexapro

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

Lexapro is available in 5 mg and 10 mg strengths.

Recommended dose

Adults:

Depression
The usual recommended dose of Lexapro is 10 mg taken once daily. The dose may be increased by your doctor 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, after which the dose is increased to 10 mg daily. The dose may then be further 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 treatment.

Generalised anxiety disorder
The usual recommended dose of Lexapro is 10 mg taken once daily. The dose may be increased by your doctor up to a maximum of 20 mg daily.

Obsessive-compulsive disorder
The usual recommended dose of Lexapro is 10 mg taken once daily. The dose may be increased by your doctor up to a maximum of 20 mg daily.

Elderly patients (over 65 years)
The recommended starting dose of Lexapro is 5 mg taken once daily. Your doctor may decide to increase 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 is advised in patients with severe renal impairment. The 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 daily. The medicine should be used according to your doctor's instructions.

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 according to your doctor's instructions.

How to take Lexapro
Lexapro may be taken with or without food. Swallow the tablets with water. Do not chew the tablets, as they have a bitter taste.

If necessary, the 10 mg tablets may be divided into two equal halves. 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 the index fingers of both hands on each end, as shown in the illustration.

The 10 mg tablets can be split into equal doses.

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 you feel improvement. Do not change the dose without consulting your doctor.

Continue taking this medicine for as long as your doctor recommends. If you stop treatment too early, your symptoms may return. Therefore, it is recommended to continue treatment for at least 6 months after recovery of well-being.

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

If you miss a dose of 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 bed, take the missed dose immediately and take the next dose the following day as usual. If you remember 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 advises you to do so. 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 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 (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), restlessness, headache, nausea, sweating (including night sweats), psychomotor agitation or activation, 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 effects

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

• unusual bleeding, including gastrointestinal bleeding.

Rare (may occur in 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, tremors, and sudden muscle contractions, which may be symptoms of a rare condition called serotonin syndrome.

Adverse effects with unknown frequency (frequency cannot be determined from available data):

• difficulty passing urine;
• seizures, see also section "Warnings and precautions";
• yellowing of the skin and whites of the eyes, indicating impaired liver function/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 above, the following adverse effects 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 runny nose (sinusitis);
• decreased or increased appetite;
• anxiety, psychomotor agitation, abnormal 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 difficulty achieving orgasm in women);
• feeling of fatigue, fever;
• weight gain.

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

• urticaria, rash, itching;
• bruxism (teeth grinding), agitation, nervousness, panic attacks, 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 occur in up to 1 in 1,000 people):

• aggression, depersonalization (feeling of loss of self-identity, feeling detached from oneself), hallucinations;
• slow heartbeat.

Adverse effects with unknown frequency (frequency cannot be determined 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);
• signs of unusual bleeding in the skin and mucous membranes (petechiae) and low platelet count (thrombocytopenia);
• increased secretion of antidiuretic hormone (ADH), leading to water retention, blood dilution, and reduced sodium levels (syndrome of inappropriate antidiuretic hormone secretion, SIADH);
• elevated levels of prolactin hormone in blood;
• galactorrhea (milk production) in men and in 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.

Additionally, adverse effects associated with medicines having a similar mechanism of action to escitalopram
(active substance in Lexapro) are known. These include:

• psychomotor agitation (akathisia);
• loss of appetite.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store 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 instructions apply.
Medicines must 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. Package contents and other information

What Lexapro contains
The active substance is escitalopram. Each Lexapro coated tablet contains 10 mg of escitalopram (as escitalopram oxalate).
The other ingredients are:
Tablet core: microcrystalline cellulose, colloidal anhydrous silica, talc, sodium croscarmellose, magnesium stearate.
Tablet coating: hypromellose, macrogol 400, titanium dioxide (E 171).

What Lexapro looks like and contents of the pack
Lexapro is a coated tablet containing 10 mg of active substance.
Oval, white, film-coated tablets measuring 8x5.5 mm. The tablets are marked on one side with a division line and the letters "E" and "L" on either side of the line.
The 10 mg tablets can be divided into equal doses.
Lexapro is available in PVC/PE/PVDC/Aluminium blisters packed in a cardboard box.
The pack contains 28 tablets (two blisters of 14 tablets each).

For further information, please contact the marketing authorisation holder 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

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

Belgian marketing authorisation number, country of export: BE238971
Parallel import authorisation number: 162/19

This medicinal product is authorised for sale in the European Economic Area under the following 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 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