Lexapro

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Lexapro (Sipralexa)

10 mg, coated tablets

Escitalopram
Lexapro and Sipralexa are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Lexapro and what is it 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 is Lexapro and what is it used for

Lexapro contains the active substance escitalopram. Lexapro belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines work on the serotonin system in the brain by increasing serotonin levels.
Lexapro is used to treat depression (major depressive episodes), 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 you start to feel better. You should continue to take Lexapro even if you do not feel better immediately.
If you do not feel better or feel worse, you should consult your doctor.

2. Important information before taking Lexapro

When not to take Lexapro:

• if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
• if you are taking other medicines that belong to a group called MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• if you have been born with a heart condition or have had an episode of irregular heart rhythm (visible on an ECG; a test that assesses heart function).
• if you are taking medicines used to treat irregular heart rhythms or medicines that may affect heart rhythm (see "Lexapro and other medicines").

Warnings and precautions

Before starting to take Lexapro, you should discuss this with your doctor or pharmacist. You should tell your doctor if you have other conditions or diseases, as your doctor should take this into account. In particular, you should inform your doctor:

• if you have epilepsy. If you experience a seizure for the first time or if the frequency of seizures increases, you should stop taking Lexapro (see also section 4 "Possible side effects");
• if you have liver or kidney disease. A dose adjustment may be required by your doctor;
• if you have diabetes. Taking Lexapro may affect blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic agents;
• if you have low sodium levels in the blood;
• if you have an increased tendency to bleeding or bruising easily or if you are pregnant (see "Pregnancy, breastfeeding, and fertility");
• if you are being treated with electroconvulsive therapy;
• if you have coronary heart disease;
• if you have or have had heart problems or if you have recently had a heart attack;
• if you have a slow resting heart rate and/or if you have low levels of electrolytes due to prolonged severe diarrhea, vomiting, or use of diuretics (medicines that increase urine production);
• if you experience rapid or irregular heartbeats, fainting, collapse, or dizziness when standing up, which may indicate an irregular heart rhythm;
• if you have or have had eye problems, such as certain types of glaucoma (increased pressure inside the eyeball).

Warning

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, you should consult your doctor.
In the first few weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may also occur.
If these symptoms occur, you should immediately inform your doctor.
Medicines like Lexapro (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety disorder

People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide.
These symptoms or behaviors may worsen at the start of treatment with antidepressant medicines, as these medicines usually start to work after about 2 weeks, sometimes later.
These symptoms are more likely to occur in:

• patients who have had thoughts of self-harm or suicide before;
• young adults. Clinical trial data have shown an increased risk of suicidal behavior in people under 25 with mental disorders who were treated with antidepressant medicines.

If you experience thoughts of self-harm or suicide, you should immediately
contact your doctor or go to the hospital.
It may be helpful to inform your relatives or close friendsabout your depression or anxiety disorder and ask them to read this leaflet. You may ask them to tell you if they notice that your depression or anxiety is getting worse or if you are experiencing worrying changes in your behavior.

Children and adolescents

Lexapro should not be used in children and adolescents under 18 years of age. It should also be noted that in the case of taking medicines of this class, patients under 18 years of age are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). However, your doctor may prescribe Lexapro to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Lexapro to a patient under 18 years of age and you have any doubts, please contact the doctor. If the above symptoms develop or worsen in patients under 18 years of age taking Lexapro, you should inform your doctor. Additionally, as yet, there are no data on the long-term safety of Lexapro in this age group regarding growth, maturation, and cognitive and behavioral development.

Lexapro and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
You should inform your doctor if you are taking any of the following medicines:

• non-selective monoamine oxidase inhibitors (MAOIs) containing active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you have taken any of these medicines, you should wait 14 days before starting to take Lexapro. After stopping treatment with Lexapro, you should wait 7 days before taking any of these medicines;
• reversible, selective monoamine oxidase A inhibitors (MAO-A) containing moclobemide (used to treat depression);
• irreversible monoamine oxidase B inhibitors (MAO-B) containing selegiline (used to treat Parkinson's disease). These medicines increase the risk of side effects;
• the antibiotic linezolid;
• lithium (used to treat bipolar affective disorder) and tryptophan;
• imipramine and desipramine (used to treat depression);
• sumatriptan and similar medicines (used to treat migraine) and tramadol and similar medicines (opioids, used to treat severe pain). They may increase the risk of side effects;
• cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (a medicine used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in escitalopram levels in the blood;
• St. John's Wort (Hypericum perforatum) - a herbal medicine used to treat depression;
• acetylsalicylic acid and non-steroidal anti-inflammatory medicines (used to treat pain or to thin the blood, known as anticoagulants). They may increase the risk of bleeding;
• warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, known as anticoagulants). Your doctor may order a blood test to check the blood clotting time when starting or stopping treatment with Lexapro to determine if the dose of the anticoagulant is still appropriate;
• mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold;
• neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressant medicines (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold;
• flecainide, propafenone, and metoprolol (used to treat heart conditions), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotic medicines). A dose adjustment of Lexapro may be required;
• medicines that lower potassium or magnesium levels in the blood increase the risk of life-threatening irregular heart rhythms.

You should not take Lexapro at the same time as medicines used to treat irregular heart rhythms or medicines that may affect heart rhythm, such as anti-arrhythmic medicines of class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines - especially halofantrine), certain antihistamines (astemizole, hydroxyzine, mizolastine), etc. You should 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 and drink alcohol at the same time, although interactions (effects) of Lexapro with alcohol are not expected.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
You should not take Lexapro if you are pregnant or breastfeeding, unless you have discussed the risks and benefits with your doctor.
If you take Lexapro during the last 3 months of pregnancy, you should be aware that the following symptoms may occur in the newborn: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflexes, tremors, tremors, irritability, lethargy, constant crying, and sleep disturbances. If any of these symptoms occur in the newborn, you should immediately consult a doctor.
You should inform your doctor and/or midwife about taking Lexapro. Taking medicines like Lexapro, especially in the last 3 months of pregnancy, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and blue skin. These symptoms usually occur within the first day of life. If such symptoms occur in the newborn, you should immediately contact a doctor and/or midwife.
Taking Lexapro at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. If you take Lexapro, you should inform your doctor or midwife so that they can provide you with appropriate advice.
You should not stop taking Lexapro during pregnancy.
It is assumed that escitalopram passes into breast milk.
In animal studies, it has been shown that citalopram, a medicine similar to escitalopram, reduces sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

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

Lexapro contains sodium

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

3. How to take Lexapro

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
Recommended dose
Adults:
Depression
The usual recommended dose of Lexapro is 10 mg, taken as one dose per day. The dose may be increased by your doctor to a maximum of 20 mg per day.
Panic disorder
The initial dose of Lexapro is 5 mg per day for the first week of treatment, then the dose is increased to 10 mg per day. The dose may then be increased by your doctor to a maximum of 20 mg per day.
Social phobia
The usual recommended dose of Lexapro is 10 mg, taken as one dose per day. The dose may then be decreased by your doctor to 5 mg per day or increased to a maximum of 20 mg per day, depending on your response to the medicine.
Generalized anxiety disorder
The usual recommended dose of Lexapro is 10 mg, taken as one dose per day. The dose may be increased by your doctor to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The usual recommended dose of Lexapro is 10 mg, taken as one dose per day. The dose may be increased by your doctor to a maximum of 20 mg per day.
Elderly patients (over 65 years)
The recommended initial dose of Lexapro is 5 mg, taken as one dose per day. Your doctor may recommend increasing the dose to 10 mg per day.
Use in children and adolescents
Lexapro should not normally 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. The medicine should be taken as directed by your doctor.
Hepatic impairment
Patients with hepatic impairment should not exceed a dose of 10 mg per day. The medicine should be taken as directed by your doctor.
Poor metabolizers of medicines via the CYP2C19 enzyme
Patients with this known genotype should not exceed a dose of 10 mg per day. The medicine should be taken as directed by your doctor.
How to take Lexapro
Lexapro can be taken with or without food. The tablets should be swallowed with water. They should not be chewed, as they have a bitter taste.
If necessary, the tablets can be broken into two pieces. To do this, you should place the tablet on a flat surface with the score line facing up, and then break it in half by pressing down on each end with your index fingers, as shown in the picture.

Duration of treatment

You may start to feel better after a few weeks of treatment. You should therefore continue to take Lexapro, even if it takes some time before you feel better.
You should not change the dose without consulting your doctor.
The medicine should be taken for as long as your doctor recommends. If you stop treatment too early, your symptoms may return. It is recommended to continue treatment for at least 6 months after you have recovered.

Taking a higher dose of Lexapro than recommended

If you have taken more Lexapro than prescribed, you should immediately contact your doctor or go to the emergency room at your nearest hospital. You should do this even if you do not feel any symptoms. Symptoms of overdose include dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, low blood pressure, and changes in water and electrolyte balance. When visiting your doctor or going to the hospital, you should take the Lexapro packaging with you.

Missing a dose of Lexapro

You should not take a double dose to make up for a missed dose.
If you have missed a dose and remember before going to bed, you should take the missed dose immediately. You should take the next dose at the usual time the next day. If you remember that you have missed a dose in the night or the next day, you should skip the missed dose and take the next dose as usual.

Stopping treatment with Lexapro

You should not stop taking Lexapro unless your doctor tells you to. When you stop treatment, it is usually recommended to gradually reduce the dose of Lexapro over a period of several weeks.
After stopping treatment with Lexapro, especially if it is stopped suddenly, you may experience withdrawal symptoms. These symptoms are common when treatment with Lexapro is stopped. The risk is higher if Lexapro has been taken for a long time, in high doses, or if the dose has been reduced too quickly. In most patients, the symptoms are mild and disappear on their own within two weeks. In some patients, however, they may be more severe or prolonged (2-3 months or longer). If you experience severe withdrawal symptoms after stopping treatment with Lexapro, you should contact your doctor. Your doctor may recommend restarting treatment with Lexapro and reducing the dose more slowly.
Withdrawal symptoms include dizziness (unsteady gait, balance disorders), tingling sensation, burning sensation, and (less commonly) a sensation like an electric shock, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headache, nausea (feeling sick), sweating (including night sweats), restlessness or agitation, tremors, disorientation, emotional instability or irritability, diarrhea (loose stools), vision disturbances, heart palpitations or rapid heartbeat.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lexapro can cause side effects, although not everybody gets them.
Side effects usually disappear after a few weeks of treatment. You should remember that some of these side effects may also be symptoms of the disease, and they will disappear as you recover.

If you experience any of the following side effects during treatment, you should contact your doctor or go to the hospital immediately:

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

• unusual bleeding, including bleeding from the gastrointestinal tract

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

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

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• difficulty urinating
• seizures, see also section "Warnings and precautions"
• yellowing of the skin and whites of the eyes, which is a sign of liver dysfunction/liver inflammation
• rapid or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsades de pointes
• suicidal thoughts and behaviors, see also section "Warnings and precautions"
• sudden swelling of the skin or mucous membranes (angioedema)

The following side effects 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 sinusitis (sinus infection)
• decreased or increased appetite
• anxiety, restlessness, vivid dreams, difficulty sleeping, drowsiness, dizziness, yawning, tremors, tingling sensation
• diarrhea, constipation, vomiting, dry mouth
• increased sweating
• muscle and joint pain
• sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women)
• fatigue, fever
• weight gain

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

• hives, rash, itching
• teeth grinding, agitation, nervousness, panic attacks, confusion (disorientation)
• sleep disturbances, changes in taste, fainting (syncope)
• dilated pupils, vision disturbances, ringing in the ears (tinnitus)
• hair loss
• heavy menstrual bleeding
• irregular menstrual periods
• weight loss
• rapid heartbeat
• swelling of the arms or legs
• nosebleeds

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

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

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• decreased sodium levels in the blood (symptoms include nausea and malaise with muscle weakness or confusion)
• dizziness when standing up due to low blood pressure (orthostatic hypotension)
• abnormal liver function test results (increased liver enzyme activity in the blood)
• movement disorders (involuntary muscle movements)
• painful erection of the penis (priapism)
• symptoms of unusual bleeding in the skin and mucous membranes (ecchymoses)
• increased secretion of antidiuretic hormone (ADH), leading to water retention in the body, dilutional hyponatremia, and decreased sodium levels
• lactation in men and women who are not breastfeeding
• mania
• patients taking medicines of this class have been observed to have an increased risk of fractures
• changes in heart rhythm (known as "QT interval prolongation", visible on an ECG, a test that assesses heart function)
• severe vaginal bleeding shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2.

The following side effects are also known for medicines with a similar mechanism of action to escitalopram (the active substance of Lexapro):

• restlessness (akathisia)
• loss of appetite

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lexapro

The medicine should be stored out of sight and reach of children.
You should not take this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lexapro contains

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

What Lexapro looks like and contents of the pack

Lexapro is available as coated tablets containing 10 mg of the active substance.
The tablets are described below.
Oval, white, coated tablets, 8x5.5 mm in size. The tablets are scored and marked with the letter "E" on one side and "L" on the other side of the score line.
Lexapro is available in the following packs:
Blister pack in a cardboard box:
14 tablets (one blister pack of 14 tablets) and 28 tablets (two blister packs of 14 tablets).
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Belgium, the 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Belgium, the country of export:BE238971
Parallel import authorization number:295/22

This medicinal product is authorized in the Member States of 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
Date of approval of the leaflet: 14.10.2022
[Information about the trademark]