Escitalopram
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.
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:
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.
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:
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.
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.
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:
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 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.
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.
You Should Not Drive or Operate Machinery Until You Know How Lexapro Affects You.
This Medicine Contains Less Than 1 Mmol Sodium (23 Mg) per Film-Coated Tablet, Which Is Essentially Sodium-Free.
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.
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.
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.
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.
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.
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.
Uncommon (May Affect Up to 1 in 100 People):
Rare (May Affect Up to 1 in 1,000 People):
Side Effects with Unknown Frequency (Frequency Cannot Be Estimated from the Available Data):
Very Common (May Affect More Than 1 in 10 People):
Common (May Affect Up to 1 in 10 People):
Uncommon (May Affect Up to 1 in 100 People):
Rare (May Affect Up to 1 in 1,000 People):
Side Effects with Unknown Frequency (Frequency Cannot Be Estimated from the Available Data):
In Addition, the Following Side Effects Have Been Reported for Medicines with a Similar Mechanism of Action to Escitalopram (the Active Substance of Lexapro):
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.
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.
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).
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.
10 Mg: | 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. |
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