Package Insert: Information for the User

Escitalopram Flas Stada 10 mg Bucodispersible Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Escitalopram Flas Stadacontains the active ingredient escitalopram.Escitaloprambelongs 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 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).

You may notice improvement in a couple of weeks. Continue takingescitaloprameven if it takes time to notice some improvement.

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

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 called 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 a history of or have experienced an episode of abnormal heart rhythm (detected on an ECG, a test that evaluates the heart's function),
• if you are taking medicines for heart rhythm problems or that may affect heart rhythm (see section 2 “Taking 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 the frequency of seizures increases (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 affect blood sugar control. You may need to adjust your dose of insulin and/or oral hypoglycaemic medication,
• if you have low sodium levels in the blood,
• if you are prone to 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 that you may have low sodium levels as a result of severe and prolonged diarrhoea and vomiting (being sick) or the use of diuretics,
• if you experience rapid or irregular heartbeats, dizziness, fainting or dizziness when standing up, which may indicate abnormal heart rhythm,
• if you have or have had eye problems, such as certain types of glaucoma (increased pressure in the eye).

Some medicines in the group to which Escitalopram Flas Stada belongs (called SSRIs) may cause sexual dysfunction symptoms (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 characterised by unusual and rapid changes in 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.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed or have an anxiety disorder, you may occasionally have thoughts of harming yourself or of suicide. These may increase when you first start taking antidepressants, as they take time to start working, usually around two weeks, although in some cases it may take 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 behaviour in adults under 25 years with psychiatric illnesses who were treated with an antidepressant.

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

Children and adolescents

Escitalopram Flas Stada should not normally be used in the treatment of children and adolescents under 18 years. You should also be aware that in patients under 18 years there is a higher risk of side effects such as suicidal thoughts, suicidal behaviour and hostility (mainly aggression, confrontational behaviour and irritability) when taking this type of medicine. However, your doctor may prescribe Escitalopram Flas Stada tablets to patients under 18 years if they decide it is the best option for the patient. If your doctor has prescribed Escitalopram Flas Stada tablets to a patient under 18 years and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms described above worsen or if complications occur when patients under 18 years are taking Escitalopram Flas Stada. Furthermore, the long-term effects on safety, growth, maturity and cognitive and behavioural development of Escitalopram Flas Stada tablets in this age group have not yet been demonstrated.

Taking Escitalopram Flas Stada with other medicines

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. 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 selective MAO-A inhibitors”, containing moclobemide (used in the treatment of depression).
• “Irreversible MAO-B inhibitors”, containing selegiline (used in the treatment of Parkinson's disease). These increase the risk of side effects.
• Linezolid (an antibiotic).
• Lithium (used in the treatment of manic-depressive illness) and tryptophan.
• Imipramine and desipramine (both used in the treatment of depression).
• Sumatriptan and similar medicines (used in the treatment of migraine) and tramadol (used for severe pain). These increase the risk of side effects.
• Cimetidine, lansoprazole and omeprazole (used in the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant) and ticlopidine (used to reduce the risk of stroke). These may cause an increase in escitalopram blood levels.
• St. John's Wort (Hypericum perforatum) – a medicinal plant used for depression.
• Aspirin and non-steroidal anti-inflammatory drugs (medicines used to relieve pain 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 thin the blood, also called anticoagulants). Your doctor will probably check your blood clotting time at the start and end of treatment with Escitalopram Flas Stada to ensure that the anticoagulant dose is still adequate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression) and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used to treat 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). You may need to adjust your dose of Escitalopram Flas Stada.
• Medicines that lower potassium or magnesium levels in the blood, as this increases the risk of abnormal heart rhythm, which is life-threatening.

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

Taking Escitalopram Flas Stada with food, drinks and alcohol

Escitalopram Flas Stada 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 with alcohol, although it is not expected to interact with alcohol.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine. Do not take Escitalopram Flas Stada if you are pregnant or breastfeeding unless you and your doctor have weighed up the risks and benefits.

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 baby: difficulty breathing, blue skin, convulsions, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, tremors, restlessness, irritability, drowsiness and difficulty sleeping. If your newborn baby has any of these symptoms, contact your doctor immediately.

Make sure your midwife and/or doctor know that 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 newborn babies, 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 occur in your baby, 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 be able to advise you.

Escitalopram Flas Stada should not be stopped abruptly. It is expected that Escitalopram Flas Stada will be excreted in breast milk.

Citalopram, a similar medicine to escitalopram, has been shown to reduce sperm quality in animal models. Theoretically, this effect could affect fertility, but to date, it has not been observed in humans.

Driving and operating machines

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

This medicine contains lactose

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

This medicine contains sodium

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

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

Escitalopramtabletsare taken every day as a single daily dose. You can takeescitalopramwith or without food.

Escitalopramtabletsare easily broken, so you must handle the tablets carefully. 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. Remove the rear flap of the blister carefully.
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 ofescitalopramis 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 ofescitalopramis 5 mg as a single daily dose for the first week 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 recommended dose ofescitalopramis 10 mg taken as a single daily dose. Your doctor may reduce 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 ofescitalopramis 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

The recommended dose ofescitalopramis 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 (65 years and older)

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

Use in children and adolescents

Escitalopramis usually not given to children and adolescents. For further information, see section 2 “What you need to know before takingEscitalopram Flas Stada”.

Treatment duration

You may feel better in a couple of weeks. Continue takingescitaloprameven if you start feeling better before the expected time for your condition.

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

Continue takingescitalopramfor the recommended time by your doctor. If you interrupt the treatment too soon, the symptoms may reappear. It is recommended that the treatment continue for at least 6 months after you feel better.

If you take moreEscitalopram Flas Stadathan you should

If you take more than the prescribed dose ofescitalopram, contact your doctor immediately, go to the nearest hospital emergency room, or consult the Toxicology Information Service, phone 915.620.420. Do it even if you do not observe any 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 hydro/saline balance. Bring theescitaloprampackage with you to the doctor or hospital.

If you forgot to take Escitalopram Flas Stada

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 the treatment with Escitalopram Flas Stada

Do not stop takingescitalopramuntil your doctor tells you to. When you have finished your treatment course, it is usually recommended that theescitalopramdose be gradually reduced over several weeks.

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

The withdrawal symptoms include: feeling of dizziness (unstable or loss of balance), feeling of tingling, feeling of prickling, and (less frequently) electric shock, even in the head, sleep disturbances (too intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of nausea (dizziness), sweating (including night sweats), feeling of anxiety or agitation, tremor (unsteadiness), 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. Be aware that many of the side effects may be symptoms of your illness and will therefore improve as you start to feel better.

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

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

• unusual bleeding, including gastrointestinal bleeding.

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

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

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

• difficulty urinating,
• seizures (convulsions), see also the subsection “Warnings and precautions”,
• yellowing of the skin and whitening of the eyes, which are signs of liver function impairment/hepatitis,
• if you experience rapid or irregular heartbeats or dizziness, symptoms that may indicate a life-threatening condition called Torsade de Pointes,
• thoughts of self-harm or suicidal thoughts, 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 dizzy (nausea),
• headache.

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

• nasal congestion or mucous (sinusitis),
• decrease or increase in appetite,
• anxiety, agitation, strange dreams, difficulty falling asleep, feeling drowsy, dizziness, yawning, tremors, skin itching,
• diarrhea, constipation, vomiting, dry mouth,
• increased sweating,
• muscle and joint pain (arthralgia and myalgia),
• sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased sexual behavior, and women may experience difficulty reaching orgasm),
• fatigue, fever,
• weight gain.

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

• hives, skin rash, itching (pruritus),
• teeth grinding, agitation, nervousness, anxiety attack, confusion,
• sleep disturbances, taste alterations, fainting (syncope),
• pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus),
• hair loss,
• excessive menstrual bleeding,
• irregular menstrual periods,
• weight loss,
• rapid heart rate,
• swelling of arms and legs,
• nasal bleeding.

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

• aggression, depersonalization, hallucinations,
• slow heart rate.

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

• 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 (elevated liver enzymes in the blood),
• movement disorders (involuntary muscle movements),
• painful erections (priapism),
• signs of increased bleeding, such as skin or mucous membrane bleeding (ecchymosis),
• sudden skin or mucous membrane swelling (angioedema),
• increased urine production (inadequate secretion of the ADH hormone),
• production of milk in men and women who are not breastfeeding,
• mania,
• a higher risk of bone fractures has been observed in patients treated with this type of medication,
• alteration of heart rhythm (known as “prolongation of the QT interval”, observed on the ECG, heart electrical activity).
• excessive vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy, breastfeeding, and fertility” in section 2 for more information.

Other side effects have been reported with medications that act similarly to escitalopram (active ingredient of Escitalopram Flas Stada), these are:

• restlessness (akathisia),
• loss of appetite.

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 national notification system:Spanish System for the Pharmacovigilance of Medicinal Products for Human UseWebsite:www.notificaram.es.

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

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

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

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

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

Composition of Escitalopram Flas Stada:

• The active ingredient is escitalopram.

Each buccal dispersible tablet contains 10 mg of escitalopram equivalent to12,775 mg of escitalopram oxalate.

• The other components are: microcrystalline cellulose,lactose monohydrate, croscarmellose sodium, potassium polacrilinate, acesulfame potassium, neohesperidin dihydrochalcone, magnesium stearate, peppermint aroma [contains: corn maltodextrin, modified cornstarch E1450 (certain corn starch), and peppermint oil (Arvensis mint)], concentrated hydrochloric acid (for pH adjustment).

Appearance of the product and contents of the package

Escitalopram Flas Stada 10 mg: white or off-white, round, flat, 9 mm in diameter tablets with beveled edges and engraved with “10” on one side.

Escitalopram Flas Stada 10 mg is presented in packages containing:

10, 20, 28, 30, 50, 56, 60, 98, 100 buccal dispersible tablets

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer responsible

Genepharm S.A.

18 km Marathon Avenue,

15351 Pallini Atenas

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

Last review date of this leaflet:December 2023

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