Patient Information Leaflet: Package Insert

Escitalopram Viatris 15 mg Film-Coated Tablets

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

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

2. What you need to know before taking Escitalopram Viatris

3. How to take Escitalopram Viatris

4. Possible side effects

5. Storage of Escitalopram Viatris

6. Contents of the pack and additional information

Escitalopram belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These medications act on the serotonin system in the brain by increasing the level of serotonin.

Escitalopram may be administered to treat the following disorders:

• Major depressive episodes.
• Anxiety disorder with or without agoraphobia (fear of open spaces).
• Social anxiety disorder.
• Generalized anxiety disorder.
• Obsessive-compulsive disorder.

Do not take Escitalopram Viatris:

• If you are allergic to escitalopram or any of the other ingredients in this medication (listed in section 6).
• If you are taking other medications that belong to the group called monoamine oxidase inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• If you were born with an abnormal heart rhythm episode or have had one (detected on an ECG, a test to evaluate how your heart works).
• If you are taking medications for heart rhythm problems or that may affect heart rhythm (see section 2 “Other medications and Escitalopram Viatris”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take escitalopram:

• If you have liver or kidney insufficiency. Your doctor may need to adjust your dose.
• If you are an elderly person.
• If you have epilepsy or a history of seizures. Escitalopram treatment should be interrupted if seizures occur for the first time or if you experience an increase in seizure frequency (see also section 4 “Possible side effects”).
• If you are receiving electroconvulsive therapy.
• If you are prone to bleeding or bruising easily, or if you are pregnant (see “Pregnancy, breastfeeding, and fertility”).
• If you have diabetes. Escitalopram treatment may affect blood sugar control (blood sugar levels). Your doctor may need to adjust your insulin and/or oral hypoglycemic medication dose.
• If you have low sodium levels in your blood.
• If you have coronary artery disease.
• If you have or have had heart problems or have recently had a heart attack.
• If you have a low resting heart rate and/or know you may have hyponatremia, such as due to prolonged and intense diarrhea and vomiting (feeling sick) or the use of diuretics (diuretic tablets).
• If you experience rapid or irregular heart rhythm, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart rhythm.
• If you have glaucoma (increased eye pressure).

Important information

Some patients with manic-depressive illness may enter a manic phase. This is characterized by unusual and rapidly changing ideas, excessive and disproportionate happiness without apparent reason, and excessive physical activity. If you experience this, contact your doctor.

You may experience symptoms such as agitation or difficulty sitting or remaining still during the first weeks of treatment. If you experience these symptoms, contact your doctor immediately.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may, at times, have thoughts of harming yourself or committing suicide. These may increase when taking antidepressants for the first time, as all these medications require time to start working, usually around two weeks, although in some cases it may be longer.

You may be more prone to having these thoughts:

• If you have previously had thoughts of harming yourself or committing suicide.
• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in adults under 25 years old with psychiatric illnesses treated with an antidepressant.

If you ever have thoughts of harming yourself or committing suicide, contact your doctor or go directly to a hospital.It may be helpful for you to tell a family member or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your attitude.

Sexual dysfunction

Medications like escitalopram (also called ISRS/IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

Children and adolescents under 18 years

Escitalopram should not be used, usually, in the treatment of children and adolescents under 18 years old. Also, be aware that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe escitalopram to patients under 18 years old when they decide it is the best option for the patient. If your doctor has prescribed escitalopram to a patient under 18 years old and wants to discuss this decision, please return 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 old are taking escitalopram.Additionally, the long-term safety effects of escitalopram on growth, maturation, and cognitive and behavioral development in this age group have not been demonstrated.

Other medications and Escitalopram Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

It is very important to inform your doctor if you are taking any of the following medications:

• “Non-selective monoamine oxidase inhibitors (IMAOs)”, containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients (used to treat depression). If you have taken any of these medications, you will need to wait 14 days before starting escitalopram. After stopping escitalopram, 7 days must pass before taking any of these medications.
• Reversible selective MAO-A inhibitors, containing moclobemide (used to treat depression).
• Linezolid (an antibiotic).
• Irreversible MAO-B inhibitors, containing selegiline (used to treat Parkinson's disease). These increase the risk of adverse effects.
• Sumatriptan and similar medications (used to treat migraines) or buprenorphine and tramadol (used to treat severe pain). These medications may interact with escitalopram and you may experience symptoms such as involuntary muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience these symptoms.
• Cimetidine, omeprazole, and lansoprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause increased escitalopram blood levels.
• St. John's Wort (Hypericum perforatum) – a medicinal plant used to treat depression.
• Lithium or tryptophan (used to treat depression), as they may increase the effects of escitalopram.
• Aspirin (used to relieve pain or reduce the risk of thrombosis) and non-steroidal anti-inflammatory drugs (NSAIDs) (medications used to relieve pain). This may increase the risk of bleeding.
• Warfarin, dipiridamol, phenprocoumon, or other anticoagulants (medications used to reduce the risk of thrombosis). Your doctor will probably monitor your blood clotting time at the start and end of escitalopram treatment to check that your anticoagulant dose is still adequate.
• Mefloquine (used to treat malaria), bupropion (used to treat smoking cessation or to treat depression), and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medications used to treat schizophrenia, psychosis) and antidepressants and other ISRS, due to the possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases) and imipramine, desipramine, clomipramine, and nortriptyline (used to treat depression) and risperidone, thioridazine, and haloperidol (antipsychotics). You may need to adjust your escitalopram dose.
• Medications that cause low potassium levels in the blood (hypokalemia) or low magnesium levels in the blood (hypomagnesemia).

Do not take escitalopramif you are taking medications for heart rhythm problems or medications that may affect heart rhythm, such as antiarrhythmic Class IA and III, antipsychotics (for example, phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (for example, sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatment, especially halofantrine), and some antihistamines (for example, astemizole, hydroxyzine, mizolastine).If you are unsure about this, you should talk to your doctor.

Escitalopram Viatris with food, drinks, and alcohol

Escitalopram can be taken with or without food (see section 3 “How to take Escitalopram Viatris”). You should avoid consuming alcohol while taking this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before taking this medication.

Pregnancy

Inform your doctor if you are pregnant or plan to become pregnant. Do not take escitalopram unless you and your doctor have analyzed the risks and benefits involved. Do not stop escitalopram treatment abruptly.

Make sure your midwife and/or doctor know that you are taking escitalopram. When taken during pregnancy, especially in the last three months of pregnancy, medications like escitalopram may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear blue. These symptoms usually start 24 hours after the baby's birth. If this happens to your baby, contact your midwife and/or doctor immediately.

Other symptoms that may occur when taking escitalopram in the last stages of pregnancy are difficulty sleeping and feeding, irregular breathing, being too hot or cold, feeling sick, constant crying, low blood sugar, muscle stiffness or weakness, hyperreflexia, irritability, drowsiness, tremors, shakiness, or seizures. If your baby is born with any of these symptoms, contact your doctor immediately, and they will advise you.

Escitalopram taken in the final stages of pregnancy may increase the risk of excessive vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking escitalopram to advise you.

Breastfeeding

Inform your doctor if you are breastfeeding. Escitalopram may be excreted in breast milk.Do not breastfeed while taking escitalopram.Your doctor will decide whether you should continue or stop breastfeeding or continue or stop escitalopram treatment.

Fertility

It has been demonstrated that citalopram, a medication similar to escitalopram, reduces sperm quality in animal studies. In theory, this may affect fertility, but so far, no impact on human fertility has been observed.

Driving and operating machinery

Do not drive or operate tools or machines until you know how escitalopram treatment affects you.

Escitalopram Viatris contains lactose and sodium

This medication contains lactose. If your doctor has warned you that you are intolerant to some sugars, contact your doctor before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”.

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

Remember that you may need to take escitalopram tablets for 2 or more weeks before starting to feel better.

Adults

Depression-The recommended dose is 10 mg of escitalopram per day. Your doctor may increase it up to a maximum of 20 mg per day.It may take between 2 and 4 weeks before you start to feel better..It is recommended that treatment continue for at least 6 months after you feel better..

Anxiety Disorder- The initial recommended dose is 5 mg of escitalopram per day. After the first week, your doctor may increase the dose to 10 mg per day and, if necessary, up to a maximum of 20 mg per day. The maximum effect is achieved after 3 months.

Social Anxiety Disorder-The recommended dose is 10 mg of escitalopram per day.It may take between 2 and 4 weeks before you start to feel better.After this, your dose may be reduced to 5 mg per day or increased to 20 mg per day, depending on how you are responding to the medication. Normally, the recommended treatment is 12 weeks.

Generalized Anxiety Disorder- The recommended dose is 10 mg per day of escitalopram. Your doctor may increase it up to a maximum of 20 mg per day. Your doctor should regularly review your dose.

Obsessive-Compulsive Disorder-The recommended dose is 10 mg of escitalopram per day.Your doctor may increase it up to a maximum of 20 mg per day.Your doctor should regularly review your dose.

Older Adults (65 years and older)

In addition to the above, your doctor will prescribe a lower dose to start, as older adults may be more sensitive to the effects of escitalopram.

The initial recommended dose of escitalopram is 5 mg taken as a single dose per day.

The dose may be increased by your doctor to 10 mg per day.

Children and Adolescents (under 18 years)

Escitalopram should not, normally, be administered to children and adolescents under 18 years. For more information, see section 2 “What you need to know before taking Escitalopram”.

If you have liver or severe kidney problems, your doctor will prescribe a lower dose than indicated above.

You can take escitalopram with or without food. Swallow the tablets with water. Do not chew them, as the taste is bitter.

Do not stop treatment until your doctor tells you to and do not interrupt it, even after starting to feel better. After recovery, you should continue treatment for a period of between three and six months to avoid the recurrence of your symptoms.

The tablets can be divided into equal doses.

If you take more Escitalopram Viatris than you should

In case of overdose or accidental ingestion,consult your doctor immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested. Go, even if you do not have symptoms of discomfort.

Some of the signs of overdose may be dizziness, tremor, agitation, convulsion, coma, feeling of discomfort (nausea, vomiting), changes in heart rhythm (slow or fast heartbeat), decrease in blood pressure, and changes in the body's electrolyte balance. Bring the packaging and any remaining escitalopram tablets with you to the doctor or hospital.

If you forget to take Escitalopram Viatris

Do not takea double dose to compensate for the missed doses.If you forget to take a dose and remember before bedtime, take it immediately. The next day, continue as usual. If you remember during the night, or the next day, leave the missed dose and continue as usual.

If you interrupt treatment withEscitalopram Viatris

Do not interrupttreatment with escitalopram until your doctor tells you to..When you have completed your treatment course, it is usually recommended that the escitalopram dose be gradually reduced over several weeks..

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

Withdrawal symptoms include: feeling of dizziness (unstable or loss of balance), feeling of tingling, feeling of prickling, and (less frequently) feeling of electric discharge, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of nausea (dizziness), sweating (including night sweats), feeling of anxiety or agitation, tremors (instability), feeling of confusion or disorientation, feelings of emotion or irritability, diarrhea (loose stools), visual disturbances or strong heartbeats (palpitations).

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Side effects usually disappear after a few weeks of treatment. Note that some of the side effects may also be symptoms of your illness and will improve as you start to feel better.

If you experience any of the following symptoms, consult your doctor or go directly to the hospital:

Rare(may affect up to 1 in 100 people)

• Unusual bleeding, including gastrointestinal bleeding.

Uncommon(may affect up to 1 in 1,000 people)

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

Frequency not known(cannot be estimated from available data)

• Difficulty urinating.
• Seizures (convulsions), see also section 2 “Warnings and precautions”.
• Yellowing of the skin and the white of the eyes,are signs of liver damage/hepatitis.
• Fast and irregular heartbeat, fainting, which could be symptoms of a potentially fatal condition known as Torsade de Pointes.
• Thoughts of self-harm or suicide, see also section 2 “Warnings and precautions”.

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

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

• Headache.
• Feeling dizzy (nausea).

Common(may affect up to 1 in 10 people)

• Decreased appetite.
• Increased appetite.
• Weight gain.
• Anxiety, agitation.
• Difficulty falling asleep.
• Feeling drowsy.
• Abnormal dreams.
• Feeling of tingling or numbness in hands and feet.
• Tremors.
• Dizziness.
• Yawning.
• Inflammation or swelling of the nasal sinuses, which causes pain, high fever, and sensitivity (known as sinusitis).
• Diarrhea.
• Constipation.
• Vomiting.
• Dry mouth.
• Increased sweating.
• Fever.
• Muscle and joint pain.
• Feeling unusually tired.
• Sexual problems (delayed ejaculation, erectile dysfunction, decreased libido, and women may experience difficulty reaching orgasm).

Rare(may affect up to 1 in 100 people)

• Weight loss.
• Confusion.
• Agitation.
• Nervousness.
• Clicking of teeth while sleeping.
• Panic attack.
• Alterations in taste.
• Alterations in sleep.
• Fainting.
• Pupil dilation (mydriasis), visual disturbance.
• Tinnitus (ringing in the ears).
• Fast heartbeat.
• Nasal bleeding.
• Hair loss.
• Urticaria.
• Skin rash.
• Itching.
• Heavy menstrual bleeding or bleeding between periods.
• Excess fluid in the body.

Uncommon(may affect up to 1 in 1,000 people)

• Feeling aggressive or depersonalized.
• Hallucinations.
• Slow heartbeat.

Frequency not known(cannot be estimated from available data)

• Thrombocytopenia (decreased platelet count), which increases the risk of bleeding and hematoma.
• Increased levels of a hormone (ADH) that causes fluid retention or water retention.
• Decreased sodium levels in the blood, symptoms are feeling dizzy and unwell with muscle weakness or confusion.
• Mania (feeling of euphoria or overexcitement, which causes unusual behavior).
• Abnormal muscle movements.
• Dizziness when standing due to low blood pressure (orthostatic hypotension).
• Altered liver function tests.
• Persistent painful erection of the penis.
• Abnormal milk production in the breasts of men and women.
• A higher risk of bone fracture has been observed in patients taking this class of medication.
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy” in section 2 for more information.

In addition, other side effects have been reported with medications that act similarly to escitalopram. These are:

• Difficulty staying still or difficulty sitting still (psychomotor restlessness/akathisia).
• Anorexia.

Reporting of side effects

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

Keep this medication out of the sight and reach of children.

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

Store below 25 °C.

Bottles: Keep the bottle perfectly closed.

Blister packs: Keep in the original packaging.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Escitalopram Viatris

The active ingredient is escitalopram.One tablet contains 15 mg of escitalopram (as oxalate).The other components are: microcrystalline cellulose, anhydrous colloidal silica, talc, sodium croscarmellose, magnesium stearate, lactose monohydrate, hypromellose, macrogol 400, and titanium dioxide (E-171). See section 2, “Escitalopram Viatris contains lactose and sodium”.

Appearance of the product and contents of the package

Escitalopramis presented in the form of film-coated tablets.

The film-coated tabletis oval, white, scored, and marked with"EC|15"on one sideand “G” on the other.The tabletscan be divided into two equal halves.

Escitalopram is available inbottles of 28, 49, 100, 200, 250, and 500film-coated tablets,in blisters of 10, 14, 20, 28, 30, 49, 50, 56, 60, 90, 100, 180, and 200 film-coated tablets,and in perforated single-dose blisters of 28 x 1 and 56 x 1 film-coated tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing:

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

Or

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the Member States of the European Economic Area with the following names:

Belgium: Escitalopram Mylan 15 mg filmomhulde tabletten

Denmark: Escitalopram Mylan

Spain: Escitalopram Viatris 15 mg comprimidos recubiertos con película EFG

France: Escitalopram Mylan 15 mg, comprimé pelliculé sécable

Ireland: Escitalpro 15 mgfilm-coatedtablets

Italy:Escitalopram Mylan

Luxembourg:Escitalopram Mylan15 mg comprimés pelliculés

Norway: Escitalopram Mylan

Netherlands: Escitalopram Mylan 15 mg filmomhulde tabletten

Portugal: Escitalopram Mylan

Czech Republic: Escitalopram Mylan

Sweden:Escitalopram Mylan 15 mg

Last review date of this leaflet:August 2022

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/