ESCITALOPRAM FLAS STADA 15 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Escitalopram Flas Stada 15 mg Orodispersible Tablets EFG

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. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor 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 Stada and what is it used for.
2. What you need to know before you take Escitalopram Flas Stada.
3. How to take Escitalopram Flas Stada.
4. Possible side effects.
5. Storing Escitalopram Flas Stada.
6. Contents of the pack and other information

1. What is Escitalopram Flas Stada and what is it used for

Escitalopram Flas Stada contains the active substance escitalopram. Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines work by increasing the levels of serotonin in the brain. Changes in the levels of serotonin in the brain are believed to be important in the development of depression and other mood disorders.

Escitalopram contains escitalopram and is indicated for the treatment of depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).

It may take a couple of weeks before you start to feel better. Continue to take escitalopram even if it takes some time to start feeling better.

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

2. What you need to know before you take Escitalopram Flas Stada

Do not take Escitalopram Flas Stada:

• if you are allergic to escitalopram or 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 irregular heart rhythm (detected on an ECG, a test that evaluates heart function),
• if you are taking medicines for heart rhythm problems or that may affect heart rhythm (see section 2 “Using Escitalopram Flas Stada with other medicines”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Escitalopram Flas Stada. 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 with Escitalopram Flas Stada should be discontinued if seizures occur for the first time or if you observe an increase in the frequency of seizures (see also section 4 “Possible side effects”),
• if you have problems with liver or kidney function. Your doctor may need to adjust your dose,
• if you have diabetes. Treatment with Escitalopram Flas Stada may alter blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic agent,
• if you have low sodium levels in the blood,
• if you tend to develop bleeding or bruising easily,
• if you have a history of bleeding disorders, or if you are pregnant (see “Pregnancy, breastfeeding, and fertility”).
• if you are receiving electroconvulsive therapy,
• if you have coronary heart disease,
• if you have or have had heart problems or have recently had a heart attack,
• if your resting heart rate is slow and/or you know you may have low salt levels as a result of severe and prolonged diarrhea and vomiting (being sick) or use of diuretics,
• if you experience rapid or irregular heartbeats, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart rhythm function,
• if you have or have had eye problems, such as certain types of glaucoma (increased pressure in the eye).

Some medicines in the same group as Escitalopram Flas Stada (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Be aware

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

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

You may be more likely to have these thoughts:

• if you have previously had thoughts of suicide or self-harm,
• if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders who were treated with an antidepressant.

If at any time you have thoughts of self-harm or suicide, contact your doctor or go directly to a hospital. It may help to tell a relative or close friendthat you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety has got worse, or if they are worried about changes in your behavior.

Children and adolescents

Escitalopram Flas Stada should not normally be used in the treatment of children and adolescents under 18 years. Also, you should know that in patients under 18 years, there is an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Escitalopram Flas Stada orodispersible tablets to patients under 18 years when they decide it is the most suitable for the patient. If your doctor has prescribed Escitalopram Flas Stada orodispersible tablets to a patient under 18 years and you wish 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 are taking Escitalopram Flas Stada. Additionally, the long-term effects on safety regarding growth, maturity, and cognitive and behavioral development of Escitalopram Flas Stada orodispersible tablets in this age group have not been established yet.

Using Escitalopram Flas Stada with other medicines

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

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

• Non-selective monoamine oxidase inhibitors (MAOIs), which contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If you have taken any of these medicines, you must wait 14 days before starting to take Escitalopram Flas Stada. After stopping Escitalopram Flas Stada, 7 days must pass before taking any of these medicines.
• Reversible MAO-A inhibitors, which contain moclobemide (used in the treatment of depression).
• Irreversible MAO-B inhibitors, which contain selegiline (used in the treatment of Parkinson's disease). These increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used for the treatment of depression).
• Sumatriptan and similar medicines (used for the treatment of migraine) and tramadol (used for the treatment of severe pain). These increase the risk of side effects.
• 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). These may cause increased blood levels of escitalopram.
• St. John's Wort (Hypericum perforatum) – a medicinal herb used for depression.
• Aspirin and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce the risk of blood clots, also called anticoagulants). These may increase the tendency to bleeding.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, also called anticoagulants). Your doctor will probably monitor your blood clotting time at the start and end of treatment with Escitalopram Flas Stada to check that the dose of anticoagulant is still appropriate.
• Mefloquine (used for the treatment of malaria), bupropion (used for the treatment of depression), and tramadol (used for the treatment of severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used for the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). It may be necessary to adjust the dose of Escitalopram Flas Stada.
• Medicines that lower potassium or magnesium levels in the blood, as this increases the risk of life-threatening heart rhythm disorders.

Do not take Escitalopram Flas Stada if you are taking medicines for heart rhythm problems or that may affect heart rhythm, e.g., antiarrhythmics Class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatment, particularly halofantrine), certain antihistamines (astemizole, mizolastine). Contact your doctor for any additional questions.

Taking Escitalopram Flas Stada with food, drinks, and alcohol

Escitalopram Flas Stada orodispersible tablets can be taken with or without food (see section 3 “How to take Escitalopram Flas Stada”).

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take Escitalopram Flas Stada if you are pregnant or breastfeeding unless you and your doctor have discussed the risks and benefits involved.

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

Make sure your midwife and/or doctor know you are being treated with Escitalopram Flas Stada.

During pregnancy, particularly in the last 3 months, medicines like escitalopram may increase the risk of a serious condition in newborns called persistent pulmonary hypertension (PPHN), in which the baby breathes rapidly and becomes blue. These symptoms usually start during the first 24 hours after birth. If they appear in your baby, you must contact your midwife and/or doctor immediately.

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

If Escitalopram Flas Stada is used during pregnancy, it should never be stopped abruptly. It is expected that Escitalopram Flas Stada will be excreted in breast milk.

Citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality in animal models. This effect could theoretically affect fertility, but to date, no impact on human fertility has been observed.

Driving and using machines

Do not drive or use tools or machines until you know how Escitalopram Flas Stada affects you.

This medicine contains lactose

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

This medicine contains sodium

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

3. How to take Escitalopram Flas Stada

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 orally disintegrating tablets are taken every day as a single daily dose. You can take escitalopram with or without food.

Escitalopram orally disintegrating tablets break easily, so you should handle the tablets with care. Do not handle the tablets with wet hands as the tablets can break.

1. Hold the blister strip by the edges and separate a blister from the rest of the strip by gently tearing along the perforated line.
2. Carefully remove the rear flap of the blister.
3. Place the tablet on your tongue. The tablet will dissolve quickly and can be swallowed without water.

1. 2. 3.

Escitalopram Flas Stada is not suitable for all the doses described below. For these doses, you will need to take another medication available on the market. Consult your doctor or pharmacist.

Adults

Depression

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

Anxiety Disorder

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

Social Anxiety Disorder

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

Generalized Anxiety Disorder

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

Obsessive-Compulsive Disorder

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

Elderly patients (over 65 years)

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

Use in children and adolescents

Escitalopram should not normally be given to children and adolescents. For additional information, see section 2 "What you need to know before taking Escitalopram Flas Stada".

Duration of treatment

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

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

Continue taking escitalopram 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 feeling better again.

If you take moreEscitalopram Flas Stadathan you should

If you take more than the prescribed dose of escitalopram, contact your doctor immediately, go to the emergency department of the nearest hospital, or consult the Toxicology Information Service, phone 915.620.420. Do this even if you do not observe discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, decrease in blood pressure, and changes in the body's hydro/salt balance. Bring the escitalopram packaging if you go to the doctor or hospital.

If you forget to take Escitalopram Flas Stada

Do not take a double dose to make up for forgotten 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 next day, leave the forgotten dose and continue as usual.

If you stop treatment with Escitalopram Flas Stada

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

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

Withdrawal symptoms include: feeling dizzy (unstable or without balance), feeling tingling, feeling prickling, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling restless, headache, feeling nauseous (nausea), sweating (including night sweats), feeling anxious or agitated, tremors (instability), feeling confused or disoriented, 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 side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

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

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

• unusual bleeding, including gastrointestinal bleeding.

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

• swelling of the skin, tongue, lips, or face, or having difficulty breathing or swallowing (allergic reaction),
• high fever, agitation, confusion, tremors, and sudden muscle contractions, can be signs of a rare condition called serotonin syndrome.

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

• difficulty urinating,
• seizures (attacks), see also the subsection "Warnings and precautions",
• yellowing of the skin and whitening of the eyes, are signs of liver function alteration / hepatitis,
• thoughts of harming yourself (self-harm) or thoughts of suicide, see also the subsection "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):

• feeling nauseous (nausea),
• headache.

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

• nasal congestion or mucous (sinusitis),
• decreased or increased appetite,
• anxiety, agitation, vivid dreams, difficulty sleeping, feeling sleepy, dizziness, yawning, tremors, itching of the skin,
• diarrhea, constipation, vomiting, dry mouth,
• increased sweating,
• muscle and joint pain (arthralgia and myalgia),
• sexual disturbances (delayed ejaculation, erection problems, decreased sexual behavior, and women may experience difficulty reaching orgasm),
• fatigue, fever,
• weight gain.

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

• hives, skin rash, itching (pruritus),
• grinding of teeth, agitation, nervousness, anxiety attacks, confusion,
• sleep disturbances, taste disturbances, fainting (syncope),
• pupil dilation (mydriasis), vision changes, ringing in the ears (tinnitus),
• hair loss,
• excessive menstrual bleeding,
• irregular menstrual period,
• weight loss,
• rapid heartbeat,
• swelling of arms and legs,
• nasal bleeding.

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

• aggression, depersonalization, hallucinations,
• slow heartbeat.

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

• decrease in sodium levels in the blood (symptoms are feeling dizzy and discomfort with muscle weakness or confusion),
• dizziness when standing up due to low blood pressure (orthostatic hypotension),
• altered liver function tests (increased liver enzymes in the blood),
• movement disorders (involuntary muscle movements),
• painful erections (priapism),
• signs of increased bleeding, e.g., from the skin or mucous membranes (ecchymosis),
• sudden swelling of the skin or mucous membranes (angioedema),
• increased urine production (inadequate secretion of the ADH hormone),
• milk production in men and 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 heart rhythm (called "prolongation of the QT interval", observed in the ECG, electrical activity of the heart).
• abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Other side effects are known to occur with medications that work similarly to escitalopram (the active ingredient in Escitalopram Flas Stada), these are:

• motor restlessness (akathisia),
• loss of appetite.

Reporting 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 national reporting system: Spanish Medication Surveillance System for Human Use Website: www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Escitalopram Flas Stada

Keep this medication out of sight and reach of children.

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

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

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

6. Package contents and additional information

Composition of Escitalopram Flas Stada

• 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 [contains: maltodextrin (from corn), modified starch E1450 (corn starch), and peppermint oil (mentha arvensis)], concentrated hydrochloric acid (for pH adjustment).

Appearance of the product and package contents

Escitalopram Flas Stada 15 mg: white or almost white, round, flat tablets with a diameter of 11 mm with beveled edges and engraved with "15" on one side.

Escitalopram Flas Stada 15 mg is available in packages containing:

28, 30, 56, 98 orally disintegrating tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Genepharm S.A.

18 km Marathon Avenue,

15351 Pallini Athens

Greece

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000

Malta

or

Stada Arzneimittel AG

Stadastrasse 2 – 18,

61118 Bad Vilbel

Germany

or

Rontis Hellas S.A.

Medical and Pharmaceutical Products

Industrial Area of Larissa,

P.O. Box 3012, GR41004 Larissa

Greece

or

PharmaPath, S.A.

28is Oktovriou 1

123 51 Agia Varvara

Greece

Date of the last revision of this leaflet:December 2023

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/