Leaflet: information for the user

escitalopram flas cinfa 15 mg buccal dispersible tablets EFG

Escitalopram

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, consult your doctor or pharmacist.

- This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to 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 additional information

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

escitalopram flas cinfacontains 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).

Do not takeescitalopram flas cinfa

- If you are allergic to the active ingredient or to any of the other components of this medicine (listed in section 6).

- If you are taking other medicines that belong to the group called monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).

- If you have had a birth or have experienced an episode of abnormal heart rhythm (detected by 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 andescitalopram flas cinfa").

Warnings and precautions

Consult your doctor or pharmacist before starting to takeescitalopram flas cinfa.

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

- If you have epilepsy. Treatment withescitalopram flas cinfashould be discontinued if seizures occur for the first time or if you observe an increase in seizure frequency (see also section4"Possible side effects").

- If you have liver or kidney insufficiency. Your doctor may need to adjust your dose.

- If you have diabetes. Treatment withescitalopram flas cinfamay affect blood sugar control. You may need to adjust your insulin and/or oral hypoglycemic dose.

- If you have low sodium levels in your blood.

- If you are prone to bleeding or bruising easily.

- If you are receiving electroconvulsive therapy.

- If you have coronary 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 if you think you may have low sodium levels due to intense and prolonged diarrhea and vomiting over several days (due to illness) or because you have taken diuretics (medicines to urinate).

- If you experience rapid or irregular heartbeats, dizziness, fainting, or dizziness when getting up from a sitting or lying position. This may indicate an abnormal heart rhythm.

- 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 withescitalopram flas cinfamay cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines andescitalopram 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 sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Please note

Some patients with manic-depressive illness may enter a manic phase. This is characterized by unusual and rapid changes in ideas, excessive joy, and excessive physical activity. If you experience it, contact your doctor.

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

Thoughts of suicide and worsening of depression or anxiety disorder

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

Youmay be more prone to having these types of thoughts:

• If you have previously had thoughts of harming yourself or committing suicide.

• If you are anadult young person.Information from clinical trials has shown an increased risk of suicidal behavior in adults under25years with psychiatric disorders 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 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 cinfashould not be used normally 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 thoughts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this class of medicines. However, your doctor may prescribeescitalopram flas cinfato patients under 18 years old when deciding what is best for the patient. If your doctor has prescribedescitalopram flas cinfato a patient under18years 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 takingescitalopram flas cinfa. Also, the long-term effects regarding safety and related to growth, maturity, and cognitive and behavioral development ofescitalopram flas cinfain this age group have not yet been demonstrated.

Other medicines and escitalopram flas cinfa

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

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

• "Non-selective monoamine oxidase inhibitors (MAOIs)", containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients, used to treat depression. If you have taken any of these medicines, you will need to wait 14 days before starting to takeescitalopram flas cinfa. After stoppingescitalopram flas cinfa, 7 days must pass before taking any of these medicines (see section "Do not takeescitalopram flas cinfa").

• "Reversible MAO-A inhibitors" containing moclobemide (used to treat depression).

• "Irreversible MAO-B inhibitors", containing selegiline (used to treat Parkinson's disease). These increase the risk of adverse effects.

• The antibiotic linezolid.

• Lithium (used to treat manic-depressive disorder) and tryptophan.

• Imipramine and desipramine (both used to treat depression).

• Sumatriptan and similar medicines (used to treat migraines) and tramadol, buprenorphine (used to treat severe pain). These medicines may interact withescitalopram flas cinfaand cause symptoms such as involuntary and rhythmic muscle contractions, 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 to treat stomach ulcers),fluconazole (used to treat fungal infections),fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). They may cause an increase inescitalopramblood levels.

• St. John's Wort(Hypericum perforatum) - a medicinal plant used to treat depression.

• Aspirin and non-steroidal anti-inflammatory drugs (medicines used to relieve pain and inflammation or to reduce the risk of blood clots, also called anticoagulants). These may increase the risk of bleeding.

• Warfarin, dipiridamol, and phenprocoumon (medicines used to reduce the risk of blood clots, also called anticoagulants). Your doctor will probably check your blood clotting time at the start and end of treatment withescitalopram flas cinfato ensure that the anticoagulant dose is still adequate.

• Mefloquine (used to treat malaria), bupropion (used to help quit smoking) and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold.

• Neuroleptics (medicines used to treat 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). You may need to adjust yourescitalopram flas cinfadose.

• Medicines that lower 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, for example antiarrhythmic 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.

Escitalopram flas cinfa can be taken with or without food (see section3"How to takeescitalopram flas cinfa").

As with many medicines, it is not recommended tocombineescitalopram flas cinfawith alcohol, although it is not expected to interact with alcohol.

Pregnancy, breastfeeding and fertility

Ifyou arepregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Do not takeescitalopram flas cinfaif you are pregnant or breastfeeding unless you and your doctor have analyzed the risks and benefits involved.

If you takeescitalopram flas cinfain the last 3 months of pregnancy, be aware that you may observe the following effects in the newborn baby: respiratory difficulty, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, tremors, restlessness, irritability, drowsiness, and difficulty falling asleep. If your newborn baby has any of these symptoms, please contact your doctor immediately.

Ifescitalopram flas cinfais used during pregnancy, it should never be stopped abruptly.

Make sure your midwife and/or doctor know that you are being treated withescitalopram flas cinfa. During pregnancy, especially in the last 3 months, medicines likeescitalopram flas cinfamay increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually start within the first 24 hours after birth. If they appear in your baby, contact your midwife and/or doctor immediately.

If you takeescitalopram flas cinfain the final stages of pregnancy, there may be a higher risk of excessive vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are takingescitalopram flas cinfato be able to advise you.

It is expected thatescitalopramwill be excreted through breast milk.

Citalopram, a medicine likeescitalopram, has shown reduced sperm quality in animal studies. Theoretically, this could affect fertility, but the impact on human fertility has not yet been studied.

Driving and operating machines

During treatment withescitalopram flas cinfa, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know howescitalopram flas cinfatreatment 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; that is, it is essentially "sodium-free".

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

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

Instructions for use

Escitalopram flas cinfa tablets break easily, so they must 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 must be used.

1. Hold the blister pack by the ends and separate one of the cells, breaking it gently through the perforations that surround it.

2. Remove the back part of the cell gently.

3. Carefully extract the tablet.

4. Place the tablet on your tongue. It will dissolve directly in your mouth, so you can swallow it without water.

Adults

Depression

The normally recommended dose of escitalopram flas cinfa is 10 mg taken as a single daily dose. 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 daily dose for the first week (in this case, use another medication containing 5 mg of escitalopram) before increasing the dose to 10 mg per day. Your doctor may increase it further 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 daily dose. Your doctor may reduce your dose to 5 mg per day (in this case, use another medication containing 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 daily dose. 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 daily dose. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Older adults (over 65 years)

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

Children and adolescents (under 18 years)

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

Treatment duration

You may feel better in a couple of weeks. Continue treatment with escitalopram flas cinfa even if you start feeling better before the expected time.

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

Continue taking escitalopram flas cinfa as recommended by your doctor. If you interrupt treatment too soon, symptoms may reappear. It is recommended that treatment continue for at least 6 months after you feel well 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Do it even if you do not observe discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and changes in the body's electrolyte balance. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take escitalopram flas cinfa

Do not take a double dose to compensate for the missed doses. If you forgot to take a dose and remember before going to bed, take it immediately. The next day, follow your usual schedule. If you remember during the night or the next day, leave the missed dose and follow your usual schedule.

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 usually recommended to gradually reduce the dose of escitalopram flas cinfa over several weeks.

When you stop taking escitalopram flas cinfa, especially if it is done abruptly, you may experience withdrawal symptoms. These are common when treatment with escitalopram flas cinfa is discontinued. The risk is higher 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 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 flas cinfa, contact your doctor. They may ask you to take your tablets again and taper them off more slowly.

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

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

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

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

Visit your doctor if you experience any of the following side effects during treatment:

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

• Unusual bleeding, including gastrointestinal bleeding.

Very 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 side effects, you must contact your doctor or go to the hospital immediately:

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

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

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

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

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

• Feeling dizzy (nausea).
• Headache.

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

• Blockage or nasal mucus (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling drowsy, dizziness, yawning, tremors, skin itching.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthritis and myalgia).
• Sexual disturbances (in men, delayed ejaculation, erection problems, decreased sexual behavior, and women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain.

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

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

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

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

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

• Thoughts of harming oneself or thoughts of suicide, see also the section 'Be especially careful with escitalopram flas cinfa'.
• Decreased sodium levels in the blood (symptoms are feeling dizzy and muscle weakness or confusion).
• Dizziness when standing due to low blood pressure (orthostatic hypotension).
• Altered liver function tests (increased liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Blood clotting disorders, including skin and mucous membrane bleeding (ecchymosis) and low platelet count in the blood (thrombocytopenia).
• Sudden skin or mucous membrane swelling (angioedema).
• Inadequate ADH secretion, resulting in increased urine production.
• Milk flow in women who are not breastfeeding.
• Mania.
• An increased risk of bone fractures has been observed in patients treated with this type of medication.
• Alteration of the heart rhythm (called prolongation of the QT interval, observed through electrocardiogram).

Other side effects that have been reported with medications that work similarly to escitalopram, the active ingredient of escitalopram flas cinfa, are:

• Motor 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 Pharmacovigilance of Medicines for Human Usehttps://www.notificaRAM.es.By reporting side effects, you can contribute to providing more information about the safety of this medicine

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

This medication does not require any special storage temperature; store 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 afterCAD.The expiration date is the last day of the month indicated.

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

Composition of escitalopram flas cinfa

-The active ingredient is escitalopram. Each buccal dispersible tablet contains15mgof 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 aroma [containing cornstarch (maize), modified cornstarch E-1450 (carnauba wax) andpeppermint oil [Mentha arvensis]) and concentrated hydrochloric acid (for pH adjustment).

Appearance of the product and contents of the package

escitalopram flas cinfa15 mg are white or off-white, rounded, flat, bisected, and 11 mm in diameter tablets, engraved with a “15” on one of their faces.

escitalopram flas cinfa15 mg buccal dispersible tablets are available in a 28 and 56 tablet format.

Other presentations

escitalopram flas cinfa10mgbuccal dispersible tablets EFG,28 and 56tablets.

escitalopram flas cinfa20mgbuccal dispersible tablets EFG,28 and 56tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

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

Responsible for manufacturing

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

Last review date of this leaflet:February 2021

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

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet 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