Lexapro

Package Leaflet: Information for the User

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

Lexapro(Cipralex), 10 mg, film-coated tablets
Escitalopram
Lexapro and Cipralex are different trade names for the same medicine.

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 the levels of serotonin.
Lexapro is used to treat depression (major depressive episodes), anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).
It may take a few weeks for the treatment to start working. 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 see your doctor.

2. Important information before taking Lexapro

When not to take Lexapro:

Before taking Lexapro, read the leaflet carefully, as it contains important information for you.

• You should keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Warnings and precautions

Before starting treatment with Lexapro, tell your doctor if you have any other medical conditions or if you are taking any other medicines, as your doctor should take this into account when deciding on your treatment.
In particular, tell your doctor:

Warning

In some patients with bipolar 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, contact your doctor.
In the first few weeks of treatment, you may also experience symptoms such as restlessness or difficulty sitting or standing still. If these symptoms occur, contact your doctor immediately.
Medicines like Lexapro (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

Patients 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 start to work usually after 2 weeks, sometimes later.
These symptoms are more likely to occur in:

• patients who have previously had thoughts of self-harm or suicide;
• young adults. Clinical trial data have shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric conditions who were treated with antidepressant medicines.

Children and adolescents

Lexapro should not be used in children and adolescents under 18 years of age. It is also important to note that in clinical trials, patients under 18 years of age who took medicines of this class had an increased risk of side effects such as suicidal thoughts, suicidal attempts, and hostility (especially aggression, oppositional behavior, and anger). However, your doctor may prescribe Lexapro to patients under 18 years of age if they decide that it is in their best interest. If your doctor prescribes Lexapro to a patient under 18 years of age and you have any concerns, please contact the doctor. If these symptoms worsen in patients under 18 years of age taking Lexapro, contact your doctor. Additionally, there is 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

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

• non-selective monoamine oxidase inhibitors (MAOIs) containing substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you have taken any of these medicines, wait 14 days before starting Lexapro. After stopping Lexapro, wait 7 days before taking any of these medicines;
• reversible, selective monoamine oxidase inhibitors (MAOIs) containing moclobemide (used to treat depression);
• irreversible monoamine oxidase inhibitors (MAOIs) containing selegiline (used to treat Parkinson's disease). These medicines increase the risk of side effects;
• the antibiotic linezolid;
• lithium (used to treat bipolar 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). These medicines may increase the risk of side effects;
• cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (an antifungal medicine), 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). These medicines may increase the risk of bleeding;
• warfarin, dipyridamole, and phenprocoumon (used to thin the blood, known as anticoagulants). Your doctor may need to monitor your blood clotting time when starting or stopping Lexapro;

and

• mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the potential risk of lowering the seizure threshold;
• antipsychotics (used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the potential risk of lowering the seizure threshold;
• flecainide, propafenone, and metoprolol (used to treat heart conditions), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). A dose adjustment of Lexapro may be necessary;
• medicines that lower potassium or magnesium levels in the blood, which can increase the risk of life-threatening irregular heartbeats.

Do not take Lexapro at the same time as medicines used to treat irregular heartbeats or medicines that may affect the heart's rhythm, such as anti-arrhythmic medicines (class IA and III), antipsychotics (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. Contact 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 with alcohol, although interactions between Lexapro and 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, ask your doctor or pharmacist for advice before taking this medicine.
You should not take Lexapro during pregnancy or while breastfeeding, unless your doctor considers it necessary. If you take Lexapro during the last 3 months of pregnancy, you should be aware that the following symptoms may occur in the newborn: difficulty breathing, blue discoloration of the skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiffness or floppiness, increased reflexes, tremors, jitteriness, irritability, lethargy, constant crying, and sleep disturbances. If your baby experiences any of these symptoms, contact your doctor immediately.
Tell your doctor and/or midwife that you are taking Lexapro. Taking medicines like Lexapro during pregnancy, especially in the last 3 months, 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 discoloration of the skin. These symptoms usually appear in the first day after birth. If your baby experiences these symptoms, contact your doctor and/or midwife immediately.
Taking Lexapro towards the end of pregnancy may increase the risk of severe bleeding from the uterus, which can occur shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Lexapro, tell your doctor or midwife so they can provide you with appropriate advice.
Do not stop taking Lexapro during pregnancy unless your doctor tells you to.
It is assumed that escitalopram passes into breast milk.
In animal studies, citalopram, a medicine similar to escitalopram, has been shown to reduce 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 film-coated tablet, which is essentially "sodium-free".

3. How to take Lexapro

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Recommended dose
Adults:
Depression
The recommended dose of Lexapro is 10 mg 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, then increased to 10 mg per day. The dose may be increased by your doctor to a maximum of 20 mg per day.
Social anxiety disorder
The recommended dose of Lexapro is 10 mg per day. The dose may 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 recommended dose of Lexapro is 10 mg per day. The dose may be increased by your doctor to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The recommended dose of Lexapro is 10 mg 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 per day. Your doctor may increase the dose to 10 mg per day.
Use in children and adolescents
Lexapro should not normally be used in children and adolescents under 18 years of age. 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 used 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 used as directed by your doctor.
Patients who are poor metabolizers of CYP2C19
Patients with this known genotype should not exceed a dose of 10 mg per day. The medicine should be used as directed by your doctor.
How to take Lexapro
Lexapro can be taken with or without food. The tablets should be swallowed with water. Do not chew them, as they have a bitter taste.
If necessary, the tablets can be broken into two halves. To do this, place the tablet on a flat surface with the score line facing up, 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. Therefore, you should continue to take Lexapro, even if you do not feel better immediately. Do not change your dose without consulting your doctor.
Take Lexapro 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 feel better.

Overdose

If you have taken more Lexapro than you should, contact your doctor or go to the emergency room at your nearest hospital immediately. Do this even if you feel well, as you may not notice any signs of overdose. Signs of overdose include dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, low blood pressure, and changes in water and electrolyte balance. Take the Lexapro packaging with you to the doctor or hospital.

Missed dose

Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose and remember before going to bed, take the missed dose immediately. Take the next dose at the usual time the next day. If you remember in the night or the next day, skip the missed dose and take the next dose as usual.

Stopping treatment

Do 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 few weeks.
After stopping treatment with Lexapro, especially if it is stopped abruptly, you may experience withdrawal symptoms. These symptoms are common when treatment with Lexapro is stopped. The risk is higher if Lexapro has been used 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 within two weeks. In some patients, they can be more severe or longer-lasting (2-3 months or longer). If you experience severe withdrawal symptoms after stopping Lexapro, contact your doctor. Your doctor may recommend that you start taking the medicine again and gradually stop it more slowly.
Withdrawal symptoms 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 (feeling sick), vomiting, diarrhea (loose stools), visual disturbances, palpitations or pounding heart, and sweating (including night sweats), anxiety, agitation or irritability, tremors, confusion or disorientation, emotional instability or mood swings, and stomach problems.

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. Remember that some of these side effects may also be symptoms of your illness and will disappear as you get better.

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

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

• unusual bleeding, including bleeding from the digestive 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 can be symptoms of a rare condition called serotonin syndrome.

Frequency not known (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 can be a sign of liver damage or hepatitis;
• fast or irregular heartbeat, fainting, which can 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).

In addition to the above, the following side effects have been reported:

Very common (may affect more than 1 in 10 people):

• nausea;
• headache.

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

• blocked nose or sinusitis (inflammation of the sinuses);
• decreased or increased appetite;
• anxiety, restlessness, abnormal dreams, difficulty sleeping, sleepiness, dizziness, yawning, tremors, tingling sensations;
• diarrhea, constipation, vomiting, dry mouth;
• increased sweating;
• muscle and joint pain;
• sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty reaching orgasm in women);
• feeling tired, fever;
• weight gain.

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

• hives, rash, itching;
• grinding of the teeth, agitation, nervousness, panic attacks, confusion (disorientation);
• sleep disturbances, changes in taste, fainting (syncope);
• dilated pupils, changes in vision, 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 losing one's identity, feeling of not being oneself), hallucinations;
• slow heartbeat.

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

• low sodium levels in the blood (which can cause nausea and weakness with muscle weakness or confusion);
• dizziness when standing up due to low blood pressure (orthostatic hypotension);
• abnormal liver function tests (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 (SIADH)
• galactorrhoea (milk secretion) 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 prolongation, visible on an electrocardiogram);
• severe bleeding from the uterus, which can occur shortly after delivery (postpartum hemorrhage), see additional information in section "Pregnancy, breastfeeding, and fertility" in section 2.

In addition to the above, the following side effects have been reported with medicines of the same class as escitalopram (the active substance in Lexapro):

• restlessness (akathisia);
• loss of appetite.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Lexapro

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 month stated.
There are no special storage requirements.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lexapro contains

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

What Lexapro looks like and contents of the pack

Lexapro is a film-coated tablet containing 10 mg of the active substance.
Oval, white film-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 packs (transparent or white) PVC/PE/PVDC/Aluminum 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, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, 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:

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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 30/276/02-C

Parallel import authorization number: 358/17

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 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
Date of leaflet approval: 06.10.2022
[Information about trademark]