Escitalopram Flas CINFA 15 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

escitalopram flas cinfa 15 mg orodispersible tablets EFG

Escitalopram

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

escitalopram flas cinfa belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain by increasing the level of serotonin. Disturbances in the serotonin system are considered an important factor in the development of depression and related disorders.

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 taking escitalopram flas cinfa

Do not take escitalopram 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 belonging to the group known as MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), or linezolid (an antibiotic).
• If you were born with or have experienced episodes of heart rhythm disorders (detected on an electrocardiogram, a test used to assess heart function).
• If you are taking medicines for heart rhythm disorders or medicines 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 escitalopram flas cinfa.

Please inform your doctor if you have any other disorders or illnesses, as your doctor may need to take them into account. Specifically, tell your doctor:

• If you have epilepsy. Treatment with escitalopram flas cinfa should be discontinued if you experience seizures for the first time or notice an increase in seizure frequency (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 flas cinfa may alter blood glucose control. Adjustment of insulin and/or oral hypoglycemic agent dosage may be necessary.
• 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 heart disease.
• If you have or have had heart problems or recently suffered a heart attack.
• If your resting heart rate is slow (known as bradycardia) and/or if you suspect you may have low salt levels due to severe and prolonged diarrhea and vomiting over several days (due to illness) or because you have used diuretics (medicines for urination).
• If you experience rapid or irregular heartbeat, fainting, syncope, or dizziness when standing up from a sitting or lying position. This could indicate a heart rhythm disorder.
• If you have eye problems, such as certain types of glaucoma or a history of glaucoma.
• If you are taking buprenorphine. Using this medicine together with escitalopram flas cinfa may 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 same group as escitalopram flas cinfa (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.

Please note

Some patients with bipolar disorder may enter a manic phase. This is characterized by unusually rapid and frequent shifts in thoughts, excessive happiness, and excessive physical activity. If you experience this, contact your doctor.

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

Suicidal thoughts and worsening of depression or anxiety disorder

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

You are more likely to have such thoughts:

• If you have previously had thoughts of harming or killing yourself.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in psychiatric patients under 25 years of age 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 help to tell a close family member or friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them whether they think your depression or anxiety disorder has worsened or if they are concerned about changes in your behavior.

Children and adolescents

escitalopram flas cinfa is not normally used to treat children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe escitalopram flas cinfa to patients under 18 years of age if they decide it is in the patient's best interest. If your doctor has prescribed escitalopram flas cinfa to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the previously mentioned symptoms worsen or complications arise while patients under 18 years of age are taking escitalopram flas cinfa. In addition, the long-term effects on safety and on growth, maturation, and cognitive and behavioral development of escitalopram flas cinfa in this age group have not yet been fully established.

Other medicines and escitalopram flas cinfa

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

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

• "Non-selective monoamine oxidase inhibitors (MAOIs)" containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active ingredients, used to treat depression. If you have taken any of these medicines, you must wait 14 days before starting escitalopram flas cinfa. After stopping escitalopram flas cinfa, you must wait 7 days before taking any of these medicines (see section "Do not take escitalopram flas cinfa").
• "Reversible selective 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 side effects.
• The antibiotic linezolid.
• Lithium (used to treat bipolar disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol, buprenorphine (used for severe pain). These medicines may interact with escitalopram flas cinfa and cause symptoms such as involuntary rhythmic muscle contractions, including those responsible for eye movements, agitation, hallucinations, coma, excessive sweating, tremors, hyperactive reflexes, increased muscle tone, and 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 (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase blood levels of escitalopram.
• St. John's wort (Hypericum perforatum)—a herbal remedy used for depression.
• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medicines used for pain and inflammation or to reduce the risk of thrombosis, also called anticoagulants). These may increase the tendency to bleed.
• Warfarin, dipyridamole, and fenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of treatment with escitalopram flas cinfa to ensure the anticoagulant dose remains appropriate.
• 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 for cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of escitalopram flas cinfa may need to be adjusted.
• Medicines that reduce potassium or magnesium levels in the blood, as these conditions affect heart rhythm and increase the risk of life-threatening events.

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

Taking escitalopram flas cinfa with 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, combining escitalopram flas cinfa with alcohol is not recommended, although no interaction between escitalopram flas cinfa and alcohol is expected.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 discussed the risks and benefits involved.

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

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

Ensure that your midwife and/or doctor know 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 condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually begin within the first 24 hours after birth. If they occur in your baby, contact your midwife and/or doctor immediately.

If you take escitalopram flas cinfa in the late 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 be aware that you are taking escitalopram flas cinfa so they can advise you accordingly.

escitalopram is expected to be excreted in breast milk.

Citalopram, a medicine similar to escitalopram, has been shown in animal studies to reduce sperm quality. Theoretically, this could 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 machinery until you know how escitalopram flas cinfa affects you.

escitalopram flas cinfa contains lactose.

If your doctor has informed you of 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; hence, it is essentially "sodium-free".

3. How to take escitalopram flas cinfa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Escitalopram flas cinfa orodispersible tablets are taken as 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, as they may disintegrate.

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

1. Hold the blister pack at the edges and separate one of the compartments by gently breaking along the perforations surrounding it.
2. Gently peel back the backing of the compartment.
3. Carefully remove 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 daily dose. Your doctor may increase this up to a maximum of 20 mg per day.

Panic 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 medicine containing 5 mg of escitalopram) before increasing the dose to 10 mg per day. Your doctor may subsequently increase the dose 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 medicine containing 5 mg of escitalopram) or increase the dose up to a maximum of 20 mg per day, depending on your response to the medicine.

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.

Elderly patients (over 65 years of age)

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

Children and adolescents (under 18 years of age)

Escitalopram flas cinfa should not normally be given to children and adolescents (under 18 years of age). For further information, please see section 2, "What you need to know before taking escitalopram flas cinfa".

Duration of treatment

It may take a few 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 medicine without first talking to your doctor.

Continue taking escitalopram flas cinfa for the length of time recommended by your doctor. If you stop treatment too early, symptoms may return. It is recommended that treatment continues 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

Do this even if you do not observe any discomfort or signs of poisoning. Some signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

If you forget to take escitalopram flas cinfa

Do not take a double dose to make up for missed doses. If you forget to take a dose and remember before going to bed, take it immediately. The next day, continue as usual. If you remember during the night or the following day, skip the missed dose and continue as usual.

If you stop taking escitalopram flas cinfa

Do not stop treatment with escitalopram flas cinfa until your doctor tells you to. When you have completed your course of treatment, 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 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, at high doses, or when the dose is reduced too quickly. Most people find that these symptoms are mild and resolve on their own within two weeks. However, in some patients, they may be severe or prolonged (2–3 months or more). If you experience severe withdrawal symptoms when stopping escitalopram flas cinfa, contact your doctor. They may advise you to restart taking your tablets and taper off more slowly.

Withdrawal symptoms include: dizziness (feeling unsteady or off-balance), tingling sensations, burning sensations, and (less frequently) electric shock-like sensations, even in the head; sleep disturbances (vivid dreams, nightmares, inability to sleep); restlessness; headache; dizziness (nausea) and/or vomiting; sweating (including night sweats); feelings of unease or agitation; tremor (shakiness); confusion or disorientation; feelings of emotion or irritability; diarrhoea (loose stools); visual disturbances; rapid pulse or palpitations.

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

4. Possible adverse effects

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

Adverse effects usually disappear after a few weeks of treatment. Please be aware that many of these effects may be symptoms of your illness and will therefore improve as you start to feel better.

Visit your doctor if you experience 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 hospital immediately.
• If you have high fever, agitation, confusion, tremors, and sudden muscle contractions, these may be signs of a rare condition called serotonin syndrome. If you feel this way, contact your doctor.

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

• Difficulty urinating.
• Seizures (fits), see also section "Take special care with escitalopram flas cinfa").
• Yellowing of the skin and whites of the eyes, which are signs of liver function impairment/hepatitis.
• Rapid or irregular heartbeat or feeling faint, as these could be symptoms of a serious heart problem known as Torsades de Pointes.

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

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

In addition to those listed 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 runny nose (sinusitis).
• Decreased or increased appetite.
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, feeling drowsy, dizziness, yawning, tremors, skin itching.
• Diarrhoea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual dysfunction (in men, delayed ejaculation, problems with erection, decreased sexual drive; 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, restlessness, nervousness, panic attacks, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Vaginal bleeding.
• Weight loss.
• Rapid heartbeat.
• Swelling of arms and legs.
• Nosebleeds.

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

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

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

• Thoughts of harming yourself or thoughts of killing yourself, see also the section 'Take special care with escitalopram flas cinfa'.
• Decreased sodium levels in the blood (symptoms include dizziness and malaise with muscle weakness or confusion).
• Dizziness upon standing due to low blood pressure (orthostatic hypotension).
• Abnormal liver function tests (elevated liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Bleeding disorders including skin and mucosal bleeding (bruising) and low platelet counts in the blood (thrombocytopenia).
• Sudden swelling of the skin or mucous membranes (angioedema).
• Increased urine output (inappropriate antidiuretic hormone secretion).
• Milk production in women not breastfeeding.
• Mania.
• An increased risk of bone fractures has been observed in patients treated with this type of medicine.
• Changes in heart rhythm (known as QT interval prolongation, observed on electrocardiogram).

Other adverse effects are known to occur with drugs that act similarly to escitalopram, the active substance in escitalopram flas cinfa. These include:

• Motor restlessness (akathisia).
• Anorexia.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of escitalopram flas cinfa

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

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of escitalopram flas cinfa

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

Appearance of the product and contents of the pack

escitalopram flas cinfa 15 mg are white or almost white, round, flat, bevelled tablets with a diameter of 11 mm, marked with "15" on one side.

escitalopram flas cinfa 15 mg orodispersible tablets are available in packs of 28 and 56 tablets.

Other presentations

escitalopram flas cinfa 10 mg orodispersible tablets EFG, packs of 28 and 56 tablets.

escitalopram flas cinfa 20 mg orodispersible tablets EFG, packs of 28 and 56 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Tel.: +30 210 60 39 336

Fax: +30 210 60 39 402

e-mail: [email protected]

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 most recent revision of this leaflet: February 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) at http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. 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