ESCITALOPRAM SUN 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Escitalopram SUN 20 mg film-coated tablets EFG

escitalopram (as oxalate)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 signs of illness 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.

Contents of the pack:

1. What is Escitalopram Sun and what is it used for
2. What you need to know before you take Escitalopram Sun
3. How to take Escitalopram Sun
4. Possible side effects
5. Storage of Escitalopram Sun
6. Contents of the pack and other information

1. What is Escitalopram SUN and what is it used for

Escitalopram Sun contains the active substance escitalopram. Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines work on the serotonin system in the brain by increasing the level of serotonin.

Escitalopram Sun contains escitalopram and is indicated for the treatment of 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 a couple of weeks before you start to feel better. Continue to take Escitalopram Sun even if it takes some time to notice an improvement.

You should consult a doctor if you get worse or if you do not improve.

2. What you need to know before you take Escitalopram Sun

Do not take Escitalopram Sun

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you take other medicines that belong to the group of medicines called MAO inhibitors, including selegiline (used for the treatment of Parkinson's disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic).
• If you have had or been born with an abnormal heart rhythm (seen on ECG; an examination to evaluate heart function)
• If you are taking medicines for heart rhythm problems or that may affect the heart rhythm (see section 2 “Using other medicines”).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Escitalopram Sun. Inform your doctor if you have any other condition or disease, as your doctor may need to take it into account. In particular, tell your doctor:

• If you have epilepsy. Treatment with Escitalopram Sun should be discontinued if seizures occur for the first time or if you observe an increase in the frequency of seizures (see also section 4 “Possible side effects”).
• If you have liver or kidney impairment. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Sun may alter glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• If you have low sodium levels in the blood,

• If you tend to develop bleeding or bruising easily, or if you are pregnant (see “Pregnancy, breastfeeding, and fertility”).

• If you are receiving electroconvulsive therapy,
• If you have coronary heart disease
• If you have or have had heart problems or have recently had a heart attack.
• If you have a low heart rate and/or know you have a decrease in salts due to severe prolonged diarrhea and vomiting (disorder) or the use of diuretics.
• If you experience a fast or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart function.
• If you have or have had eye problems, such as certain types of glaucoma (increased pressure in the eye).

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by a change in ideas that is uncommon and rapid, disproportionate joy, and excessive physical activity. If you experience this, contact your doctor.

Symptoms such as restlessness or difficulty sitting or standing, may also occur during the first few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Medicines like Escitalopram Sun (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. These may increase when you first start taking antidepressants, as these medicines take time to start working, usually around two weeks, although in some cases it may be longer.

You will be more likely to have these thoughts:

• If you have previously had thoughts of killing yourself or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders who were treated with an antidepressant.

If at any time you have thoughts of harming or killing yourself, contact your doctor or go directly to a hospital.

It may be helpful for you to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety disorder has gotten worse, or if they are worried about changes in your attitude.

Children and adolescents under 18 years:

Escitalopram Sun should not normally be used in the treatment of children and adolescents under 18 years. Also, you should know that in patients under 18 years, there is a greater risk of side effects such as suicidal attempts, suicidal ideas, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking this type of medicine. Nevertheless, your doctor may prescribe Escitalopram Sun to patients under 18 years when they decide it is most convenient for the patient. If the doctor who corresponds to you has prescribed Escitalopram Sun to a patient under 18 years and you want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms described above progress or if you experience complications when patients under 18 years are taking Escitalopram Sun. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Escitalopram Sun in this age group have not yet been demonstrated.

Using Escitalopram Sun with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

Tell your doctor if you are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs)”, which contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If you have taken any of these medicines, you will need to wait 14 days before starting to take Escitalopram Sun. After finishing Escitalopram Sun, 7 days must pass before taking any of these medicines.

• “Reversible MAO-A inhibitors”, which contain moclobemide (used in the treatment of depression).

• “Irreversible MAO-B inhibitors”, which contain selegiline (used in the treatment of Parkinson's disease). These increase the risk of side effects.

• The antibiotic linezolid.

• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.

• Imipramine and desipramine (both used for the treatment of depression).

• Sumatriptan and similar medicines (used for the treatment of migraine), tramadol and similar medicines (opioids, used against severe pain). These increase the risk of side effects.

• Cimetidine, lansoprazole, esomeprazole, and omeprazole (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in blood levels of Escitalopram.

• St. John's Wort (Hypericum perforatum) – a medicinal plant used for depression.

• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the tendency to bleed.

• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably check your blood coagulation time at the start and end of treatment with Escitalopram Sun to ensure that the dose of anticoagulant is still adequate.

• Mefloquine (used for the treatment of malaria), bupropion (used for the treatment of depression), and tramadol (used for the treatment of severe pain) due to the possible risk of lowering the seizure threshold.

• Neuroleptics (medicines used for the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold.

• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases) and desipramine, clomipramine, and nortriptyline (antidepressants) and risperidone, thioridazine, and haloperidol (antipsychotics). It may be necessary to adjust the dose of Escitalopram Sun.

• Medicines that decrease blood levels of potassium or magnesium, as these conditions increase the risk of life-threatening heart rhythm disorders.

Do not take Escitalopram Sunif you are taking medicines for heart rhythm problems or that may affect the heart rhythm, such as Class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibiotics (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, particular antimalarial treatment, especially halofantrine), certain antihistamines (e.g., astemizole, hydroxyzine, mizolastine).

If you have any further questions, consult your doctor.

Taking Escitalopram Sun with food, drinks, and alcohol

Escitalopram Sun can be taken with or without food (see section 3 “How to take Escitalopram Sun”).

As with many medicines, it is not recommended to combine Escitalopram Sun and alcohol, although it is not expected that Escitalopram Sun will interact with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Do not take Escitalopram Sun if you are pregnant or breastfeeding unless you and your doctor have discussed the risks and benefits involved.

If you take Escitalopram Sun during the last 3 months of your pregnancy, be aware that the following effects may be observed in the newborn: difficulty breathing, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflexes, tremors, restlessness, irritability, lethargy, constant crying, and difficulty sleeping. If your newborn has any of these symptoms, please contact your doctor immediately.

If you take Escitalopram Sun in the final stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Escitalopram Sun so they can advise you.

Make sure your midwife and/or doctor know that you are taking Escitalopram Sun. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Escitalopram Sun may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and have a bluish color. These symptoms usually start during the first 24 hours after the baby is born. If your baby experiences any of these symptoms at birth, tell your midwife and/or doctor immediately.

If Escitalopram Sun is used during pregnancy, it should never be stopped abruptly.

It is expected that Escitalopram Sun will be excreted into breast milk.

Citalopram, a medicine similar to Escitalopram, has been shown to reduce sperm quality in animal studies. This could theoretically affect fertility, but no impact on human fertility has been observed so far.

Driving and using machines

During treatment with escitalopram, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with Escitalopram Sun affects you.

Escitalopram Sun contains lactose monohydrate and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is essentially “sodium-free”.

3. How to take Escitalopram Sun

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults

Depression

The normally recommended dose of escitalopram is 10 mg taken as a single dose per day. Your doctor may increase it up to a maximum of 20 mg per day.

Anxiety Disorder

The initial dose of escitalopram is 5 mg as a single dose per day for the first week before increasing the dose to 10 mg per day. Your doctor may increase it later up to a maximum of 20 mg per day.

Social Anxiety Disorder

The normally recommended dose is 10 mg taken as a single dose per day. Your doctor may decrease your dose to 5 mg per day or increase the dose up to a maximum of 20 mg per day, depending on how you respond to the medication.

Generalized Anxiety Disorder

The normally recommended dose of escitalopram is 10 mg taken as a single dose per day. Your doctor may increase it up to a maximum of 20 mg per day.

Obsessive-Compulsive Disorder

The normally recommended dose of escitalopram is 10 mg taken as a single dose per day. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Elderly patients (over 65 years old)

The initial recommended dose of escitalopram is 5 mg taken as a single dose per day. Your doctor may increase your dose up to 10 mg per day.

Use in children and adolescents (under 18 years old)

Escitalopram should not normally be administered to children and adolescents. For additional information, please see section 2 "Before taking Escitalopram Sun".

Renal impairment

Caution is advised in patients with severely decreased renal function. Take as prescribed by your doctor.

Hepatic impairment

Patients with liver problems should not receive more than 10 mg per day. Take as prescribed by your doctor.

Poor metabolizers of CYP2C19

Patients with this genotype should not receive more than 10 mg per day. Take as prescribed by your doctor.

You can take escitalopram with or without food. Swallow the tablets with water.

Do not chew them, as they have a bitter taste.

If necessary, you can split the tablets by placing the tablet on a flat surface with the score line facing up. The tablets can be broken by pressing down on each end of the tablet.

Duration of treatment

It may take a couple of weeks before you start to feel better. Continue taking escitalopram even if you start to feel better before the expected time.

Do not change the dose of the medication without talking to your doctor first.

Continue taking escitalopram for the recommended time by your doctor. If you interrupt the treatment too early, the symptoms may reappear. It is recommended that the treatment continues for at least 6 months after you feel better again.

If you take more Escitalopram Sun than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Do this even if you do not observe discomfort or signs of intoxication. Some of the signs of overdosing may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, decrease in blood pressure, and changes in the body's hydroelectrolytic balance. Bring the Escitalopram Sun packaging with you when you go to the doctor or hospital.

If you forget to take Escitalopram Sun

Do not take a double dose to make up for forgotten doses. If you forgot to take a dose and remember before going to bed, take it immediately. The next day, follow the usual routine. If you remember during the night or the next day, skip the forgotten dose and follow the usual routine.

If you stop taking Escitalopram Sun

Do not stop taking escitalopram until your doctor tells you to. When you have finished your treatment course, it is generally recommended that the dose of escitalopram be gradually reduced over several weeks.

When you stop taking escitalopram, especially if it is sudden, you may feel withdrawal symptoms. These are common when treatment with escitalopram is suspended. The risk is greater when escitalopram has been used for a long time, in high doses, or when the dose is reduced too quickly. Most people find that these symptoms are mild and disappear on their own within two weeks. However, in some patients, they can be intense or prolonged (2-3 months or more). If you have severe withdrawal symptoms when you stop taking escitalopram, please contact your doctor. He or she may ask you to start taking your tablets again and stop them more slowly.

Withdrawal symptoms include: feeling dizzy (unstable or without balance), feeling tingling, feeling prickling, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling restless, headache, feeling nauseous (nausea), sweating (including night sweats), feeling anxious or agitated, trembling (instability), feeling confused or disoriented, feelings of emotion or irritation, diarrhea (loose stools), visual disturbances, rapid or strong heartbeat (palpitations).

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Escitalopram Sun can cause side effects, although not everyone will experience them.

Side effects usually disappear after a few weeks of treatment. Please be aware that many of the effects can be symptoms of your illness and will improve when you start to feel better.

If you experience any of the following symptoms, contact your doctor or go to the nearest hospital immediately:

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

• Unusual bleeding, including gastrointestinal bleeding.

Rare (may affect up to 1 in 1000 people):

• Swelling of the skin, tongue, lips, or face, hives, or difficulty breathing or swallowing (severe allergic reaction).
• High fever, agitation, confusion, tremors, and sudden muscle contractions may be signs of a rare condition called serotonin syndrome.

Unknown (frequency cannot be determined from available data)

• Difficulty urinating.
• Seizures (attacks), see the "Warnings and precautions" section.
• Yellowing of the skin and eyes, are signs of liver function alteration/hepatitis.
• Rapid heartbeat, irregular heartbeat, fainting that can be symptoms of a life-threatening condition known as Torsade de Pointes.
• Thoughts of harming yourself or thoughts of killing yourself, 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):

• Feeling nauseous (nausea).
• Headache

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

• Nasal congestion or runny nose (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty sleeping, feeling sleepy, dizziness, yawning, tremors, skin itching.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia)
• Sexual disturbances (delayed ejaculation, erection problems, decreased sexual behavior, and women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain.

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

• Hives, skin rash, itching (pruritus).
• Teeth grinding, agitation, nervousness, anxiety attacks, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Pupil dilation (mydriasis), vision changes, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding.
• Irregular menstrual period.
• Weight loss.
• Rapid heartbeat.
• Swelling of arms and legs.
• Nosebleeds.

Rare (may affect up to 1 in 1000 people):

• Aggression, depersonalization, hallucinations.
• Slow heartbeat.

Unknown (frequency cannot be estimated from available data):

• Decrease in sodium levels in the blood (symptoms are feeling dizzy and discomfort with muscle weakness or confusion).
• Dizziness when standing up due to low blood pressure (orthostatic hypotension).
• Altered liver function tests (increased liver enzymes in blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of bleeding, for example, skin and mucous membranes (ecchymosis).
• Increased secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing the amount of sodium (inadequate ADH secretion).
• Milk flow in men and women who are not breastfeeding.
• Mania (feeling unusually excited, hyperactive, and uninhibited).
• An increased risk of bone fractures has been observed in patients taking this type of medication.
• Alteration of heart rhythm (called "prolongation of the QT interval", seen on the ECG, a measure of the heart's electrical activity).
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Other side effects are known to occur with drugs that work similarly to Escitalopram (the active ingredient of Escitalopram Sun). These are:

• Motor restlessness (akathisia).
• Lack of appetite.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Escitalopram Sun

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Escitalopram Sun

The active ingredient is escitalopram (as oxalate). Each film-coated tablet contains 20 mg of escitalopram.

The other ingredients are:

Intragranular excipients: microcrystalline cellulose, lactose monohydrate, copovidone (K-90-100), cornstarch.

Extragranular excipients: silified microcrystalline cellulose, sodium croscarmellose, talc, anhydrous colloidal silica, magnesium stearate.

Coating: Opadry OY-S-58910, which contains hypromellose, titanium dioxide (E-171), macrogol 400, and talc.

Appearance of the product and package contents

Escitalopram Sun 20 mg is presented in the form of film-coated tablets, oval and biconvex, white or almost white, and engraved with an "E" and "9" on either side of the score line on one face, and smooth on the other face. The oval-shaped tablets measure 11.6 mm ± 0.40 mm in length and 7.1 mm ± 0.40 mm in width.

Escitalopram Sun is available in 10 mg and 20 mg film-coated tablets in packages of 14, 20, 28, 30, 50, 56, or 100 tablets, packaged in Poliamida/Alu/PVC/Alu blisters.

Not all package sizes may be marketed.

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87, 2132JH Hoofddorp

Netherlands

or

TERAPIA S.A.

124, Fabricii Street

400 632 Cluj-Napoca

Romania

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona, Spain

Phone: +34 93 342 78 90

This medication is authorized in the following member states, with the following names:

Date of the last revision of this leaflet:February 23

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/