ESCITALOPRAM STADA 20 mg FILM-COATED TABLETS

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

Do not take Escitalopram Stada

• If you are allergic (hypersensitive) 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 medicines called MAOIs, 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 abnormal heart rhythm (observed in an ECG, an examination to evaluate how the heart is functioning)
• If you take medicines for heart rhythm problems or that may affect the heart rhythm (see section 2 "Taking Escitalopram Stada with other medicines")

Warnings and precautions

Consult your doctor or pharmacist before starting to take Escitalopram Stada. In particular, inform your doctor:

• if you have epilepsy. Treatment with Escitalopram Stada should be discontinued if seizures occur or if you observe an increase in the frequency of seizures (see also section 4 "Possible side effects").
• if you have liver or kidney failure. Your doctor may need to adjust your dose.
• if you have diabetes. Treatment with Escitalopram Stada may alter blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• if you have a low sodium level 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 you have a low resting heart rate and/or know that you may experience a decrease in salt as a result of prolonged and intense diarrhea and vomiting (disorder) or with the use of diuretics.
• if you experience rapid or irregular heartbeats, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart function.
• 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 STADA belongs (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by an uncommon and rapid change of ideas, disproportionate joy, and excessive physical activity. If you experience this, contact your doctor.

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

Suicidal thoughts and worsening of your depression or anxiety disorder

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

You would be more likely to have these thoughts:

• If you have previously had thoughts of killing yourself or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were treated with an antidepressant.

If at any time you have thoughts of harming or killing yourself, contact your doctor or go directly to a hospital.

It may be helpful for you to tell a relative ora 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 Stada should not normally be used in the treatment of children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, your doctor may prescribe Escitalopram Stada to patients under 18 years of age when they decide it is most convenient for the patient. If the doctor who corresponds to you has prescribed Escitalopram Stada to a patient under 18 years of age and you wish 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 of age are taking Escitalopram Stada. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Escitalopram Stada in this age group have not yet been demonstrated.

Taking Escitalopram 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 ingredients. If you have taken any of these medicines, you will need to wait 14 days before starting to take Escitalopram Stada. After finishing Escitalopram 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 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 an increase in blood levels of Escitalopram Stada.
• St. John's Wort (Hypericum perforatum) - a medicinal plant used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the tendency to bleeding.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably monitor the blood coagulation time at the start and end of treatment with Escitalopram Stada to check that the anticoagulant dose is still adequate.
• 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 and antidepressants.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). It may be necessary to adjust the dose of Escitalopram Stada.
• Medicines that decrease potassium or magnesium levels in the blood, as this increases the risk of heart rhythm disorders, which pose a risk to life.

Do not takeEscitalopram Stada if you are taking medicines for heart rhythm problems or medicines that may affect the heart rhythm, such as:

• Class IA and III antiarrhythmics
• Antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol)
• Tricyclic antidepressants
• Certain antimicrobials (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, particular antimalarial treatment, especially halofantrine)
• Certain antihistamines (astemizole, mizolastine)

If you have any doubts about this, you should contact your doctor.

Taking Escitalopram Stada with food, drinks, and alcohol

Escitalopram Stada can be taken with or without food (see section 3 "How to take Escitalopram Stada").

As with many medicines, it is not recommended to combine Escitalopram Stada and alcohol, although it is not expected that Escitalopram 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. Do not take Escitalopram Stada if you are pregnant or breastfeeding, unless you and your doctor have discussed the risks and benefits involved.

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

Make sure your midwife and/or doctor know that you are taking Escitalopram Stada. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Escitalopram Stada may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), causing the newborn to breathe faster and acquire a bluish tone in the skin. These symptoms usually appear during the first 24 hours after birth. If this happens, you should contact your midwife and/or doctor immediately.

If you take escitalopram in the final stage 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.

If Escitalopram Stada is used during pregnancy, it should never be stopped abruptly.

It is expected that Escitalopram Stada will be excreted in breast milk.

Citalopram, a medicine like escitalopram, has shown in animal studies a reduction in sperm quality. This could theoretically affect fertility, although the impact on fertility in humans has not been observed.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

It is advised that you should not drive or use machinery until you know how Escitalopram Stada affects you.

This medicine contains sodium

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

3. How to take Escitalopram Stada

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

Adults

Depression

The normally recommended dose of Escitalopram Stada 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 Stada 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 normally recommended dose of Escitalopram Stada 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 normally recommended dose of Escitalopram Stada 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 Stada 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

The initial recommended dose of Escitalopram Stada is 5 mg taken as a single dose per day. The dose may be increased by the doctor to 10 mg/day.

Use in Children and Adolescents

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

You can take Escitalopram Stada with or without food. Swallow the tablets with water. Do not chew them, as they have a bitter taste.

If necessary, you can split the tablets by placing the tablet on a flat surface with the score line facing up. The tablets can be broken by pressing down on each end of the tablet with your index fingers.

Duration of Treatment

It may take a couple of weeks before you start to feel better. Continue taking Escitalopram Stada even if you start to feel better before the expected time.

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

Continue taking Escitalopram Stada for the time recommended by your doctor. If you interrupt the treatment too early, the symptoms may reappear. It is recommended that the treatment continues for at least 6 months after you feel better.

If you take more Escitalopram Stada than you should

If you take more doses of Escitalopram Stada than prescribed, contact your doctor immediately, go to the emergency department of the nearest hospital, or consult the Toxicology Information Service, phone 915.620.420, indicating the medication and the amount ingested. 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 body water balance. Bring the packaging of Escitalopram Stada if you go to the doctor or hospital.

If you forget to take Escitalopram Stada

Do not take a double dose to make up for forgotten doses. If you forgot to take a dose and remember before going to bed, take it immediately. The next day, follow the usual routine. If you remember during the night or the next day, skip the forgotten dose and follow the usual routine.

If you stop taking Escitalopram Stada

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

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

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

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 have side effects, although not all people suffer from them.

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

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

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

• Unusual bleeding, including gastrointestinal bleeding.

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

• 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, these 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 should contact your doctor or go to the hospital immediately:

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

• Difficulty urinating.
• Seizures (attacks), see section "Warnings and precautions".
• Yellowing of the skin and whites of the eyes, which are signs of liver function alteration/hepatitis.
• Rapid, irregular heartbeat, fainting that can be symptoms that may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of harming yourself or thoughts of killing yourself, see also section "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, abnormal dreams, difficulty falling asleep, 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).
• Teeth grinding, agitation, nervousness, anxiety attacks, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbance, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding.
• Irregular menstrual period.
• Weight loss.
• Rapid heartbeat.
• Swelling of arms and legs.
• Nosebleeds.

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

• Aggression, depersonalization, hallucinations.
• Slow heartbeat.

Some patients have reported (frequency 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 (increase in liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Bleeding disorders including skin and mucous membrane bleeding (ecchymosis) and low platelet count in the blood (thrombocytopenia).
• Sudden swelling of the skin or mucous membranes (angioedema).
• Increased urine production (inadequate ADH secretion).
• Milk flow in non-lactating women.
• Mania.
• An increased risk of bone fractures has been observed in patients treated with this type of medication.
• Alteration of heart rhythm (called "prolongation of the QT interval", observed in an ECG, heart electrical activity).
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

In addition, other side effects are known to occur with drugs that work similarly to escitalopram (the active ingredient of Escitalopram STADA). These 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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Escitalopram Stada

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

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

This medication does not require special storage conditions.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE point of the pharmacy. 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 Stada

The active ingredient is escitalopram. Each tablet contains 20 mg of escitalopram (as oxalate).

The other components are:

Core: microcrystalline cellulose (E 460), sodium croscarmellose (E 468), anhydrous colloidal silica, and magnesium stearate (E 470b).

Coating: hypromellose (E 464), titanium dioxide (E-171), and macrogol 400.

Appearance of the product and package contents

Escitalopram Stada is presented in the form of film-coated tablets of 20 mg. The tablets are described below:

Escitalopram Stada 20 mg are film-coated tablets, oval (approximately 11.6 x 7.1 mm), white, and with a score line on one face. The tablets can be divided into equal doses.

Escitalopram Stada 20 mg is available in the following package sizes:

Blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 120, or 200 tablets

It is possible that only some package sizes are marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Manufacturer

STADA Arzneimittel AG,

Stadastraße 2 – 18,

61118 Bad Vilbel,

Germany

or

Clonmel Healthcare Ltd,

Waterford Road,

Clonmel, Co. Tipperary,

Ireland

or

LAMP SANPROSPERO S.p.A.,

Via della Pace, 25/A,

41030 San Prospero (Modena),

Italy

or

HBM Pharma s.r.o.

Sklabinská 30

036 80 Martin

Slovak Republic

or

STADA Arzneimittel GmbH,

Muthgasse 36/2,

1190 Vienna,

Austria

or

Sanico NV,

Veedijk 59,

2300 Turnhout,

Belgium

or

DRAGENOPHARM APOTHEKER PÜSCHL GMBH

Göllstrasse, 1 (Tittmoning),

D-84529

Germany

or

ITC Farma S.R.L

Via Pontina KM 29

00071 Pomezia (RM)

Italy

or

Delorbis Pharmaceuticals LTD.

17 Athinon Street,

Ergates Industrial Area,

Ergates, Lefkosia, 2643

Cyprus

This medication is authorized in the Member States of the European Economic Area with the following names:

Austria Escitalopram STADA 20 mg Filmtabletten

Belgium Escitalopram EG 20 mg filmomhulde tabletten

Denmark Escitalopram Stada

Spain Escitalopram STADA 20 mg film-coated tablets EFG

France ESCITALOPRAM EG 20 mg, comprimé pelliculé sécable

Germany Escitalopram AL 20 mg Filmtabletten Ireland Etaloporo 20 mg film-coated tablets

Iceland Escitalopram STADA 20 mg filmuhúðuð tafla

Italy ESCITALOPRAM EG 20 mg

Luxembourg Escitalopram EG 20 mg comprimés pelliculés

Portugal Escitalopram Ciclum

Sweden Escitalopram STADA film-coated tablets 20 mg

Date of the last revision of this prospectus: June 2024

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