LEXAPRO 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Lexapro, 10 mg, Film-Coated Tablets
   1. Read All of This Leaflet Carefully Before You Start Taking This Medicine.
   2. Contents of the Pack and Other Information
3. What Lexapro Is and What It Is Used For
4. Before You Take Lexapro
   1. When Not to Take Lexapro:
   2. Warnings and Precautions
   3. Caution
   4. Suicidal Thoughts and Worsening of Depression or Anxiety
   5. Children and Adolescents
   6. Lexapro and Other Medicines
   7. Lexapro with Food, Drink, and Alcohol
   8. Pregnancy, Breast-Feeding, and Fertility
   9. Driving and Using Machines
   10. Lexapro Contains Sodium
5. How to Take Lexapro
   1. Duration of Treatment
   2. Overdose
   3. Missed Dose
   4. Stopping Treatment
6. Possible Side Effects
   1. If You Experience Any of the Following Side Effects, You Should Contact Your Doctor or Go to the Hospital Immediately:
   2. In Addition to the Above, the Following Side Effects Have Been Reported:
   3. Reporting of Side Effects
7. How to Store Lexapro
8. Contents of the Pack and Other Information
   1. What Lexapro Contains
   2. What Lexapro Looks Like and Contents of the Pack
   3. Marketing Authorization Holder and Manufacturer
   4. This Medicinal Product Is Authorized in the Member States of the European Economic Area Under the Following Names:
   5. Representative of the Marketing Authorization Holder
   6. Date of Last Revision of the Leaflet: 12/2023

Package Leaflet: Information for the User

Lexapro, 10 mg, Film-Coated Tablets

Escitalopram

Read All of This Leaflet Carefully Before You Start Taking This Medicine.

• Keep This Leaflet. You May Need to Read It Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medicine Has Been Prescribed for You. Do Not Pass It On to Others. It May Harm Them, Even if Their Symptoms Are the Same as Yours.
• If You Experience Any Side Effects, Talk to Your Doctor or Pharmacist. This Includes Any Possible Side Effects Not Listed in This Leaflet. See Section 4.

Contents of the Pack and Other Information

• 1. What Lexapro Is and What It Is Used For
• 2. Before You Take 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 Anxiety Disorder, Generalized Anxiety Disorder, and Obsessive-Compulsive Disorder). It May Take Several Weeks for the Medicine 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. Before You Take 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 MAOIs (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 a Heart Condition Such as a Heart Rhythm Disorder (Visible on an ECG).
• If You Are Taking Medicines That Can Affect the Heart Rhythm (See "Lexapro and Other Medicines").

Warnings and Precautions

Before Taking Lexapro, Tell Your Doctor or Pharmacist If You Have Any Other Medical Conditions or Diseases, as Your Doctor Should Consider This Information. In Particular, Tell Your Doctor:

• If You Have Epilepsy. If You Experience Seizures or an Increase in Seizure Frequency, Stop Taking Lexapro (See Also Section 4 "Possible Side Effects");
• If You Have Liver or Kidney Disease. Your Doctor May Need to Adjust the Dose;
• If You Have Diabetes. Taking Lexapro May Affect Blood Sugar Control. You May Need to Adjust the Dose of Insulin and/or Oral Hypoglycemic Medicines;
• If You Have Low Sodium Levels in the Blood;
• If You Have a History of Bleeding Disorders or Are Taking Medicines That Increase the Risk of Bleeding (See "Lexapro and Other Medicines");
• If You Are Being Treated with Electroconvulsive Therapy;
• If You Have Coronary Heart Disease;
• If You Have Had a Recent Heart Attack or Have Heart Problems;
• If You Have a Slow Heart Rate or Low Electrolyte Levels Due to Prolonged Diarrhea, Vomiting, or the Use of Diuretics (Medicines That Increase Urine Production);
• If You Experience Rapid or Irregular Heartbeats, Fainting, or Dizziness When Standing Up, Which May Indicate an Abnormal Heart Rhythm;
• If You Have a History of Eye Problems, Such as Certain Types of Glaucoma (Increased Pressure in the Eye).

Caution

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, You Should See Your Doctor. In the First Few Weeks of Treatment, You May Also Experience Symptoms Such as Anxiety or Difficulty Sitting or Standing Still. If You Experience These Symptoms, You Should Tell Your Doctor Immediately. Medicines Like Lexapro (SSRIs or SNRIs) May Cause Symptoms of Sexual Dysfunction (See Section 4). In Some Cases, These Symptoms Have Continued After Stopping Treatment.

Suicidal Thoughts and Worsening of Depression or Anxiety

People with Depression or Anxiety Disorders May Sometimes Have Thoughts of Harming Themselves or Committing Suicide. These Symptoms or Behavior May Worsen at the Beginning 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:

• Patient Who Have Had Thoughts of Self-Harm or Suicide Before;
• Young Adults. Clinical Trials Have Shown an Increased Risk of Suicidal Behavior in Young Adults (Under 25 Years Old) with Mental Health Conditions Who Were Treated with Antidepressant Medicines. If You Experience Thoughts of Self-Harm or Suicide, You Should Contact Your Doctor or Go to the Hospital Immediately.

It May Be Helpful to Tell Your Relatives or Close Friends That You Are Taking This Medicineand Ask Them to Read This Leaflet. You May Want to Ask Them to Tell You If They Notice Any Change in Your Depression or Anxiety or If You Experience Any of the Following Symptoms: Agitation, Aggression, or if You Experience Any Other Unusual Changes in Behavior.

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 This Type of Medicine Had an Increased Risk of Side Effects Such as Attempted Suicide, Suicidal Thoughts, and Hostility (Especially Aggression, Oppositional Behavior, and Anger). However, Your Doctor May Prescribe Lexapro to Patients Under 18 Years of Age If They Consider It Necessary. If Your Doctor Prescribes Lexapro to a Patient Under 18 Years of Age and You Have Any Concerns, You Should Discuss Them with Your Doctor. If the Above Symptoms Worsen or Appear in Patients Under 18 Years of Age Taking Lexapro, You Should Tell Your Doctor. Additionally, There Is Limited Experience with the Long-Term Safety of Lexapro in This Age Group Regarding Growth, Puberty, and Cognitive and Behavioral Development.

Lexapro and Other Medicines

Tell Your Doctor or Pharmacist About All the Medicines You Are Taking Now or Have Taken Recently, and About 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, 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 Inhibitors Type A (RIMA) Containing Moclobemide (Used to Treat Depression);
• Irreversible Monoamine Oxidase Inhibitors Type B (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 Disorder) and Tryptophan;
• Imipramine and Desipramine (Used to Treat Depression);
• Sumatriptan and Similar Medicines (Used to Treat Migraines) and Tramadol and Similar Medicines (Opioids Used for 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 the Blood Levels of Escitalopram;
• St. John's Wort (Hypericum Perforatum), a Herbal Remedy Used to Treat Depression;
• Acetylsalicylic Acid and Non-Steroidal Anti-Inflammatory Medicines (Used as Painkillers 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 Treatment with Lexapro;
• Mefloquine (Used to Treat Malaria), Bupropion (Used to Treat Depression), and Tramadol (Used for Severe Pain) Due to the Possible Risk of Lowering the Seizure Threshold;
• Antipsychotic 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, Thiordazine, and Haloperidol (Antipsychotic Medicines). A Dose Adjustment of Lexapro May Be Necessary;
• Medicines That Lower Potassium or Magnesium Levels in the Blood Increase the Risk of Life-Threatening Heart Rhythm Disorders.

Do Not Take Lexapro at the Same Time as Medicines Used to Treat Heart Rhythm Disorders or Medicines That May Affect the Heart Rhythm, Such as Anti-Arrhythmic Medicines Class IA and III, Antipsychotic Medicines (Such as Phenothiazine Derivatives, Pimozide, Haloperidol), Tricyclic Antidepressants, Certain Antibiotics (Such as Sparfloxacin, Moxifloxacin, Erythromycin IV, Pentamidine, Anti-Malarial Medicines - Especially Halofantrine), Certain Antihistamines (Astemizole, Hydroxyzine, Mizolastine), Etc. If You Have Any Further Questions, Ask Your Doctor.

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 the Interaction Between Lexapro and Alcohol Is Not Expected.

Pregnancy, Breast-Feeding, and Fertility

If You Are Pregnant or Breast-Feeding, 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 When Breast-Feeding, 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: Difficulty Breathing, Blue-Discolored Skin, Seizures, Changes in Body Temperature, Difficulty Feeding, Vomiting, Low Blood Sugar, Stiffness or Floppiness, Increased Reflexes, Tremors, Jitteriness, Irritability, Lethargy, Constant Crying, and Difficulty Sleeping. If the Newborn Experiences Any of These Symptoms, You Should Contact Your Doctor Immediately. You Should Tell Your Doctor and/or Midwife If You Are Taking Lexapro. Taking Medicines Like Lexapro, Especially in the Last 3 Months of Pregnancy, May Increase the Risk of a Serious Condition in the Newborn Called Persistent Pulmonary Hypertension of the Newborn (PPHN). This Condition Is Characterized by Rapid Breathing and Blue-Discolored Skin and Usually Appears in the First Day After Birth. If These Symptoms Occur in the Newborn, You Should Contact Your Doctor and/or Midwife Immediately. Taking Lexapro at the End of Pregnancy May Increase the Risk of Severe Bleeding from the Uterus, Which Can Occur Soon After Delivery, Especially If You Have a History of Bleeding Disorders. If You Are Taking Lexapro, You Should Tell Your Doctor or Midwife So That They Can Provide You with the Necessary Advice. You Should Not Stop Taking Lexapro During Pregnancy Without Consulting Your Doctor. It Is Believed That Escitalopram Passes into Breast Milk. In Animal Studies, Citalopram, a Medicine Similar to Escitalopram, Has Been Shown to Reduce Sperm Quality. This Could Affect Fertility, Although This Has Not 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 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. Check with Your Doctor or Pharmacist If You Are Not Sure. Recommended Dose Adults: The Usual 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 Usual 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 Usual 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 Usual 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 of Age): 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. For Further Information, See 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 Liver Impairment Should Not Exceed a Dose of 10 Mg per Day. The Medicine Should Be Used as Directed by Your Doctor. Poor Metabolizers of CYP2C19: Patients with a 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 the Tablets as They Have a Bitter Taste. If Necessary, the 10 Mg Tablets Can Be Divided into Two Equal Doses. To Do This, Place the Tablet on a Flat Surface with the Score Line Facing Upwards, Then Press Down on Each Side of the Tablet with Your Index Fingers, as Shown in the Picture.

The 10 Mg Tablets Can Be Divided into Equal Doses.

Duration of Treatment

You May Start to Feel Better After a Few Weeks of Treatment. You Should Continue to Take Lexapro as Long as Your Doctor Recommends. Do Not Change the Dose Without Consulting Your Doctor. You Should Continue to Take the Medicine for as Long as Your Doctor Tells You to. 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.

Overdose

If You Have Taken More Lexapro Than You Should, You Should Contact Your Doctor or Go to the Hospital Immediately. You Should Do This Even If You Do Not Feel Any Symptoms. Symptoms of Overdose Include Dizziness, Tremors, Agitation, Seizures, Coma, Nausea, Vomiting, Abnormal Heart Rhythm, Low Blood Pressure, and Electrolyte Imbalance. When You Go to the Hospital, Take the Lexapro Packaging with You.

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, You Should Take the Forgotten Dose as Soon as Possible. Take the Next Dose at the Usual Time the Next Day. If You Remember in the Night or the Next Day, You Should Skip the Forgotten Dose and Take the Next Dose as Usual.

Stopping Treatment

Do Not Stop Taking Lexapro Without Consulting Your Doctor. When You Stop Treatment, It Is Usually Recommended to Gradually Reduce the Dose of Lexapro Over a Few Weeks. After Stopping Treatment with Lexapro, You May Experience Withdrawal Symptoms. These Symptoms Are Common When Treatment with Lexapro Is Stopped, Especially If It Is Stopped Suddenly. The Risk Is Higher If You Have Been Taking Lexapro for a Long Time, in High Doses, or If the Dose Is Reduced Too Quickly. In Most Patients, the Symptoms Are Mild and Disappear Within Two Weeks. In Some Patients, They May Be More Severe or Last Longer (2-3 Months or Longer). If You Experience Severe Withdrawal Symptoms After Stopping Lexapro, You Should Contact Your Doctor. Your Doctor May Recommend Restarting the Treatment and Reducing the Dose More Gradually. Withdrawal Symptoms Include Dizziness (Unsteady Gait, Balance Disorders), Tingling, Burning, and (Less Commonly) Electric Shock-Like Sensations, Also in the Head, Sleep Disturbances (Vivid Dreams, Nightmares, Insomnia), Anxiety, Headache, Nausea (Nausea), Sweating (Including Night Sweats), Psychomotor Agitation or Excitement, Tremors, Disorientation, Emotional Instability or Irritability, Diarrhea (Loose Stools), Visual Disturbances, Heart Palpitations or Arrhythmias.

4. Possible Side Effects

Like All Medicines, This Medicine 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 Improve as You Get Better.

If You Experience Any of the Following Side Effects, 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, Face, or Throat, Hives, or Difficulty Breathing or Swallowing (Severe Allergic Reaction)
• High Fever, Agitation, Confusion, Tremors, and Rapid 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 2 "Warnings and Precautions"
• Yellowing of the Skin and Whites of the Eyes, Which May Be a Sign of Liver Damage or Hepatitis
• Rapid or Irregular Heartbeats, Fainting, Which May Be Symptoms of a Life-Threatening Heart Rhythm Disorder Called Torsades de Pointes
• Suicidal Thoughts and Behaviors, See Also Section 2 "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):

• Nasal Congestion or Sinusitis (Sinus Infection)
• Decreased or Increased Appetite
• Anxiety, Psychomotor Agitation, Vivid Dreams, Insomnia, Drowsiness, Dizziness, Yawning, Tremors, Tingling
• 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)
• Fatigue, Fever
• Weight Gain

Uncommon (May Affect Up to 1 in 100 People):

• Hives, Rash, Itching
• Teeth Grinding, Agitation, Nervousness, Panic Attacks, Confusion
• Sleep Disturbances, Abnormal Taste, Fainting
• Dilated Pupils, Visual 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 Losing One's Identity), Hallucinations
• Slow Heartbeat

Side Effects with Unknown Frequency (Frequency Cannot Be Estimated from the Available Data):

• Decreased Sodium Levels in the Blood (Which May 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 (Priapism)
• Symptoms of Unusual Bleeding in the Skin and Mucous Membranes (Purpura) and Low Platelet Count (Thrombocytopenia)
• Increased Secretion of Antidiuretic Hormone (ADH), Which Can Cause Water Retention in the Body, Dilutional Hyponatremia, and Decreased Sodium Levels
• Increased Prolactin Levels in the Blood
• Milk Secretion in Men and Women Who Are Not Breast-Feeding;
• Mania
• In Patients Taking This Type of Medicine, an Increased Risk of Bone Fractures Has Been Observed;
• Change in Heart Rhythm (Called "QT Interval Prolongation", Visible on an ECG)
• Severe Bleeding from the Uterus, Which Can Occur Soon After Delivery (Postpartum Hemorrhage), See Additional Information in Section 2 "Pregnancy, Breast-Feeding, and Fertility"

In Addition, the Following Side Effects Have Been Reported for Medicines with a Similar Mechanism of Action to Escitalopram (the Active Substance of Lexapro):

• Psychomotor Agitation (Akathisia)
• Loss of Appetite

Reporting of Side Effects

If You Experience Any Side Effects, Talk to Your Doctor or Pharmacist. You Can Also Report Side Effects Directly to the Department of Drug Safety Monitoring 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. You Can Also Report Side Effects to the Marketing Authorization Holder. By Reporting Side Effects, You Can Help Provide 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 Which Is Stated on the Label or Carton. The Expiry Date Refers to the Last Day of the Month. No Special Precautions for Storage Are Required. 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 Contains 10 Mg of Escitalopram (as Oxalate). The Other Ingredients Are: Tablet Core: Microcrystalline Cellulose, Silica Colloidal Anhydrous, Talc, Sodium Starch Glycolate Type a Potato, and Magnesium Stearate. Tablet Coating: Opadry OY-S-28849 White: Hypromellose (5 Cp), 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. Below Is a Description of the Tablets. The 10 Mg Tablets Can Be Divided into Equal Doses. Lexapro Is Available in the Following Packs: Blister (Transparent) in a Carton: 14 (One Blister of 14 Tablets) and 28 Tablets (Two Blisters of 14 Tablets). Not All Pack Sizes May Be Available.

Marketing Authorization Holder and Manufacturer

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

This Medicinal Product Is Authorized in the Member States of the European Economic Area Under the Following Names:

Austria: Cipralex Belgium: Cipralex Bulgaria: Cipralex Cyprus: Cipralex Czech Republic: Cipralex Estonia: Sipralexa Cipralex Cipralex Cipralex Cipralex Denmark: Cipralex Finland: Cipralex France: Seroplex Greece: Cipralex Spain: Cipralex Netherlands: Lexapro Iceland: Cipralex Ireland: Cipralex Lithuania: Lexapro Cipralex Luxembourg: Cipralex Latvia: Cipralex Malta: Sipralexa Cipralex 10 Mg Film-Coated Tablets: Cipralex 20 Mg Film-Coated Tablets Cipralex Germany: Cipralex Norway: Cipralex Poland: Cipralex Lexapro Portugal: Cipralex Romania: Cipralex Slovakia: Cipralex Slovenia: Cipralex Cipralex Cipralex Cipralex Sweden: Cipralex Hungary: Cipralex Cipralex Italy: Cipralex United Kingdom: Cipralex

Representative of the Marketing Authorization Holder

PolandLundbeck Poland Sp. z o.o., ul. Marszałkowska 142, 00-061 Warsaw, Tel.: +48 22 626 93 00, Fax: +48 22 626 93 01

Date of Last Revision of the Leaflet: 12/2023