ESCITALOPRAM FLAS CINFA 15 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

escitalopram flas cinfa 15 mg buccal dispersible tablets EFG

Escitalopram

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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as 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

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

1. What is escitalopram flas cinfa and what is it used for

escitalopram flas cinfa 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. Alterations of the serotonin system are considered to be an important factor in the development of depression and related diseases.

escitalopram flas cinfa 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).

2. What you need to know before you take escitalopram flas cinfa

Do not takeescitalopram flas cinfa

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines that belong to the group of 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 been born with or have had an episode of altered heart rhythm (detected on an electrocardiogram, a test that evaluates how the heart works).
• If you are taking medicines for heart rhythm disorders or that may affect heart rhythm (see section 2 "Other medicines and escitalopram flas cinfa").

Warnings and precautions

Talk to your doctor or pharmacist before starting to take escitalopram flas cinfa.

Please inform your doctor if you have any other disorder or disease, as your doctor may need to take it into account. In particular, inform your doctor:

• If you have epilepsy. Treatment with escitalopram flas cinfa should be discontinued if seizures occur for the first time or if there is an increase in the frequency of seizures (see also section 4 "Possible side effects").
• If you have liver or kidney failure. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with escitalopram flas cinfa may alter glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• If you have a decreased level of sodium in the blood.
• If you tend to develop bleeding or bruising easily.
• If you are receiving electroconvulsive treatment.
• If you have coronary heart disease.
• If you have or have had any heart problems or have recently had a heart attack.
• If your resting heart rate is slow (this is known as bradycardia) and/or you think you may have a decrease in salt due to intense and prolonged diarrhea and vomiting for several days (due to illness) or because you have used diuretics (medicines to urinate).
• If you experience rapid or irregular heartbeats, fainting, syncope, or dizziness when getting up from a sitting or lying position. This could indicate that you have some heart rhythm disorder.
• If you have eye problems, such as a certain type of glaucoma or have a history of glaucoma.
• If you take buprenorphine. The use of these medicines with escitalopram flas cinfa can cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and escitalopram flas cinfa").
• If you have a history of bleeding disorders, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").

Some medicines in the group to which escitalopram cinfa belongs (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment is stopped.

Please note

Some patients with manic-depressive illness may enter a manic phase. This is characterized by an uncommon and rapid change of ideas, 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.

Suicidal thoughts and worsening of your depression or anxiety disorder

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

Youwould 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 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 friendthat 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.

Children and adolescents

escitalopram flas cinfa should not normally be used in the treatment of children and adolescents under 18 years of age. Also, be aware that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this type of medicine. Nevertheless, your doctor may prescribe escitalopram flas cinfa to patients under 18 years of age when they decide what is best for the patient. If your doctor has prescribed escitalopram flas cinfa to a patient under 18 years of age 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 worsen or if you experience complications when patients under 18 years of age are taking escitalopram flas cinfa. Also, the long-term effects on safety, growth, maturity, and cognitive and behavioral development of escitalopram flas cinfa in this age group have not yet been demonstrated.

Other medicines and escitalopram flas cinfa

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• "Non-selective monoamine oxidase inhibitors (MAOIs)" that contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances, used for the treatment of depression. If you have taken any of these medicines, you will need to wait 14 days before starting to take escitalopram flas cinfa. After finishing escitalopram flas cinfa, 7 days must pass before taking any of these medicines (see the section "Do not take escitalopram flas cinfa").
• "Reversible MAO-A inhibitors" that contain moclobemide (used for the treatment of depression).
• "Irreversible MAO-B inhibitors" that contain selegiline (used in the treatment of Parkinson's disease). These increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used for the treatment of manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used for the treatment of depression).
• Sumatriptan and similar medicines (used to treat migraines) and tramadol, buprenorphine (used for severe pain). These medicines can interact with escitalopram flas cinfa and cause symptoms such as involuntary muscle contractions and rhythmic movements, including those responsible for eye movements, agitation, hallucinations, coma, excessive sweating, tremors, hyperactive reflexes, increased muscle tone, body temperature above 38°C. If you experience these symptoms, contact your doctor.
• Cimetidine, lansoprazole, 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). They 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 for pain relief and inflammation or to reduce the risk of thrombosis, also called anticoagulants). These may increase the tendency to bleeding.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably check the blood coagulation time at the start and end of treatment with escitalopram flas cinfa to ensure that the anticoagulant dose is still adequate.
• Mefloquine (used for the treatment of malaria), bupropion (used to help quit smoking), and tramadol (used for the treatment of intense pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines for the treatment of schizophrenia, psychosis) due to the possible risk of lowering the seizure threshold and antidepressants.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). It may be necessary to adjust the dose of escitalopram flas cinfa.
• Medicines that decrease potassium or magnesium levels in the blood, as these situations affect heart rhythm and increase the risk of life-threatening conditions.

Do not takeescitalopram flas cinfaif you are taking medicines for any heart rhythm disorder or if you are taking medicines that may affect heart rhythm, such as antiarrhythmics Class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medicines against malaria, particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have doubts about this, consult your doctor.

Takingescitalopram flas cinfawith food, drinks, and alcohol

escitalopram flas cinfa can be taken with or without food (see section 3 "How to take escitalopram flas cinfa").

As with many medicines, it is not recommended to combine escitalopram flas cinfa and alcohol, although it is not expected that escitalopram flas cinfa 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 flas cinfa if you are pregnant or breastfeeding unless you and your doctor have analyzed the risks and benefits involved.

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

If escitalopram flas cinfa is used during pregnancy, it should never be stopped abruptly.

Make sure your midwife and/or doctor know that you are being treated with escitalopram flas cinfa. During pregnancy, particularly in the last 3 months, medicines like escitalopram flas cinfa may increase the risk of a serious disease in newborns, called persistent pulmonary hypertension (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually start during the first 24 hours after birth. If they appear in your baby, you should contact your midwife and/or doctor immediately.

If you take escitalopram flas cinfa in the final stage of pregnancy, there may be a greater risk of abundant 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 flas cinfa to be able to advise you.

It is expected that escitalopram will be excreted in breast milk.

Citalopram, a medicine like escitalopram, has shown reduced sperm quality in animal studies. This could theoretically affect fertility, but the impact on human fertility has not yet been studied.

Driving and using machines

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

escitalopram flas cinfa contains lactose.

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

escitalopram flas cinfa contains sodium.

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

3. How to take escitalopram flas cinfa

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

Escitalopram flas cinfa orally disintegrating tablets will be administered in a single daily dose with or without food.

Instructions for use

Escitalopram flas cinfa tablets break easily, so they should be handled with care. Do not handle the tablets with wet hands because they can disintegrate.

In cases where 5 mg doses are required, another medication containing 5 mg of escitalopram should be used.

1. Hold the blister pack by the ends and separate one of the cells, breaking it gently along the perforations that surround it.
2. Gently remove the back of the cell.
3. Carefully extract the tablet.
4. Place the tablet on your tongue. It will dissolve directly in the mouth, so it can be swallowed without water.

Adults

Depression

The normally recommended dose of escitalopram flas cinfa 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 flas cinfa is 5 mg as a single dose per day for the first week (in this case, use another medication that contains 5 mg of escitalopram) before increasing the dose to 10 mg per day. Your doctor may subsequently increase it up to a maximum of 20 mg per day.

Social anxiety disorder

The normally recommended dose of escitalopram flas cinfa is 10 mg taken as a single dose per day. Your doctor may decrease your dose to 5 mg per day (in this case, use another medication that contains 5 mg of escitalopram) 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 flas cinfa 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.

Obsessive-compulsive disorder (OCD)

The normally recommended dose of escitalopram flas cinfa 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 flas cinfa is 5 mg taken as a single dose per day (in this case, use another medication that contains 5 mg of escitalopram). The dose may be increased by your doctor up to 10 mg per day.

Children and adolescents (under 18 years old)

Escitalopram flas cinfa should not normally be administered to children and adolescents (under 18 years old). For additional information, consult the section 2 "What you need to know before taking escitalopram flas cinfa".

Duration of treatment

It may take a couple of weeks before you start to feel better. Continue treatment with escitalopram flas cinfa 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 flas cinfa for the time recommended by your doctor. If you interrupt treatment too early, symptoms may reappear. It is recommended that treatment continue for at least 6 months after you feel better again.

If you take more escitalopram flas cinfa 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 when you do not observe discomfort or signs of intoxication. Some signs of overdosing may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, decrease in blood pressure, and changes in body hydroelectrolyte balance. It is recommended to bring the package and the prospectus of the medication to the healthcare professional.

If you forget to take escitalopram flas cinfa

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, leave the forgotten dose and follow the usual routine.

If you interrupt treatment with escitalopram flas cinfa

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

When you stop taking escitalopram flas cinfa, especially if it is sudden, you may feel withdrawal symptoms. These are common when treatment with escitalopram flas cinfa is suspended. The risk is greater when escitalopram flas cinfa 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 flas cinfa, contact your doctor. They may ask you to take your tablets again and leave them more slowly.

Withdrawal symptoms include: feeling of dizziness (unstable or without balance), feeling of tingling, feeling of itching, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of dizziness (nausea) and/or vomiting, sweating (including night sweats), feeling of unease or agitation, tremors (instability), feeling of confusion or disorientation, feelings of emotion or irritation, diarrhea (loose stools), visual disturbances, rapid or irregular heartbeat.

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

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

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

Visit your doctor if you have any of the following adverse effects during treatment:

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

• Unusual bleeding, including gastrointestinal bleeding.

Rare (may affect up to 1 in 1,000 patients):

• If you notice swelling of the skin, tongue, lips, or face, or have difficulty breathing or swallowing (allergic reaction), contact your doctor or go to the hospital immediately.
• If you have a high fever, agitation, confusion, tremors, and sudden muscle contractions, they may be signs of a rare condition called serotonin syndrome. If you feel this way, contact your doctor.

If you experience the following adverse effects, you should contact your doctor or go to the hospital immediately:

• Difficulty urinating.
• Seizures (attacks), see also the section "Be especially careful with escitalopram flas cinfa").
• Yellowish skin and whitening of the eyes, are signs of liver function alteration/hepatitis.
• Fast and irregular heartbeats or feeling of fainting, as they could be symptoms of a serious heart problem known as Torsades de Pointes.

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

• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

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

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

• Feeling nauseous.
• Headache.

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

• Nasal congestion or mucosity (sinusitis).
• Decrease or increase in appetite.
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling sleepy, dizziness, yawning, tremors, skin itching.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (in men, 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 patients):

• Hives, skin rash, itching (pruritus).
• Teeth grinding, agitation, nervousness, anxiety attacks, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbance, ringing in the ears (tinnitus).
• Hair loss.
• Vaginal bleeding.
• Weight loss.
• Fast heart rate.
• Swelling of arms and legs.
• Nosebleeds.

Rare (may affect up to 1 in 1,000 patients):

• Aggression, depersonalization, hallucinations.
• Slow heart rate.

Some patients have reported (frequency not known, cannot be determined from the available data):

• Thoughts of harming oneself or thoughts of committing suicide, see also the section "Be especially careful with escitalopram flas cinfa".
• 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 (increase in liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Coagulation disorders including skin and mucous membrane bleeding (ecchymosis) and low platelet count in the blood (thrombocytopenia).
• Sudden swelling of the skin or mucous membranes (angioedema).
• Increased urine output (inadequate ADH secretion).
• Milk flow in non-lactating women.
• Mania.
• An increased risk of bone fractures has been observed in patients treated with this type of medication.
• Alteration of the heart rhythm (called QT interval prolongation, observed by electrocardiogram).

Other adverse effects are known to occur with drugs that work similarly to escitalopram, the active ingredient of escitalopram flas cinfa. These are:

• Motor restlessness (akathisia).
• Anorexia.

Reporting of adverse effects

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

5. Conservation of escitalopram flas cinfa

Keep this medication out of sight and reach of children.

This medication does not require any special storage temperature; keep it in the original packaging to protect it from light and moisture.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in 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 flas cinfa

• The active ingredient is escitalopram. Each orally disintegrating tablet contains 15 mg of escitalopram equivalent to 19.1625 mg of escitalopram oxalate.
• The other components are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, potassium polacrilin, potassium acesulfame, neohesperidin dihydrochalcone, magnesium stearate, peppermint flavor [containing maltodextrin (corn), modified corn starch E-1450, and peppermint oil [Mentha arvensis]], and concentrated hydrochloric acid (for pH adjustment).

Appearance of the product and package contents

Escitalopram flas cinfa 15 mg are white or off-white, round, flat, beveled tablets with a diameter of 11 mm, engraved with a "15" on one of their faces.

Escitalopram flas cinfa 15 mg orally disintegrating tablets are available in 28 and 56 tablet formats.

Other presentations

Escitalopram flas cinfa 10 mg orally disintegrating tablets EFG, 28 and 56 tablets.

Escitalopram flas cinfa 20 mg orally disintegrating tablets EFG, 28 and 56 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta. 31620 Huarte (Navarra) - Spain

Manufacturer

Genepharm, S.A.

18 km Marathon Avenue

15351 Pallini

Greece

Phone: +30 210 60 39 336

Fax: +30 210 60 39 402

e-mail: info@genepharm.com

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) – Spain

or

Pharmapath S.A.

28is Oktovriou 1,

Agia Varvara, 123 51,

Greece

Date of the last revision of this prospectus: February 2021

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

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78606/P_78606.html

QR code to: https://cima.aemps.es/cima/dochtml/p/78606/P_78606.html