Package Leaflet: Information for the User

Escitalopram Stada 15 mg Film-Coated Tablets EFG

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2.What you need to know before you start taking Escitalopram Stada.

3.How to take Escitalopram Stada

4.Possible side effects.

5.Storage of Escitalopram Stada

6.Contents of the pack and additional information.

Escitalopram belongs 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 Stada 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 an improvement in a couple of weeks. Continue taking Escitalopram Stada even if you do not notice any improvement right away.

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

Do not take Escitalopram Stada

•If you are allergic (hypersensitive) to escitalopram or to any of the other ingredients in this medicine (see section 6).

•If you are taking other medicines that belong to a group called MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).

•If you were born with or have had an episode of abnormal heart rhythm (observed on an ECG, a test to evaluate how your heart is functioning)

•If you are taking medicines for heart rhythm problems or that may affect 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, tell your doctor:

•If you have epilepsy. Treatment with Escitalopram Stada should be interrupted if seizures occur or if you observe an increase in seizure frequency (see also section 4 “Possible side effects”).

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

•If you have diabetes. Treatment with Escitalopram Stada may alter blood sugar control. You may need to adjust your insulin and/or oral hypoglycaemic dose.

•If you have a low sodium level in your 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, lactation and fertility”).

•If you are receiving electroconvulsive therapy.

•If you have coronary heart disease.

•If you have or have had heart problems or recently had a heart attack.

•If you have a low resting heart rate and/or know that you may experience a decrease in sodium as a result of intense prolonged diarrhoea and vomiting (gastrointestinal upset) 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 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 Stada belongs (called SSRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterised by unusual and rapid changes in ideas, excessive and inappropriate 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 weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of harming or killing yourself. These may increase when you first start taking antidepressants, as they can take several weeks to start working, 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 harming or killing yourself.

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

It may be helpful to you to tell a relative ora close friendthat you are depressed or have an anxiety disorder and ask them to read this leaflet. You may 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. Also, you should be aware that in patients under 18 years there is a greater 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 Stada for patients under 18 years if they decide it is in the best interest of the patient. If the doctor who prescribed Escitalopram Stada for you is under 18 years and wants to discuss this decision, please return 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 Stada. At the same time, the long-term effects on safety and related to growth, maturity and cognitive and behavioural development of Escitalopram Stada in this age group have not yet been demonstrated.

Taking Escitalopram Stada with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take 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 will need to wait 14 days before starting to take Escitalopram Stada. After stopping Escitalopram Stada, 7 days must pass before taking any of these medicines.

•“Reversible MAO-A inhibitors”, containing moclobemide (used to treat depression).

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

•Antibiotic linezolid.

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

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

•Sumatriptan and similar medicines (used to treat migraines) and tramadol (used to treat severe pain). These increase the risk of side effects.

•Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers),fluconazole (used to treat fungal infections),fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These may cause an increase in Escitalopram Stada blood levels.

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

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

•Warfarin, dipiridamol and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably check your blood clotting time at the start and end of treatment with Escitalopram 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 and antidepressants.

•Flecainide, propafenone and metoprolol (used in cardiovascular diseases), desipramine, clomipramine and nortriptyline (antidepressants) and risperidone, thioridazine and haloperidol (antipsychotics). You may need to adjust your Escitalopram Stada dose.

•Medicines that lower potassium or magnesium levels in the blood, as this increases the risk of abnormal heart rhythm, which is a life-threatening risk.

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

• Class IA and III antiarrhythmics
• Antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol)
• Tricyclic antidepressants
• Some antimicrobials (e.g. sparfloxacine, moxifloxacine, erythromycin IV, pentamidine, particular antimalarial treatment halofantrine)
• Some antihistamines (astemizol, 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, lactation and fertility

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

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, 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 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 more rapidly and develop blue skin tone. These symptoms usually appear within the first 24 hours after birth. If this occurs, you should contact your midwife and/or doctor immediately.

If you take escitalopram in the final stage of pregnancy, there may be a greater 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 so that they can advise you.

Escitalopram Stada should not be stopped abruptly.

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

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

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

It is recommended that you do not drive or operate machinery until you know how Escitalopram Stada may affect you.

This medicine contains sodium

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

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

Adults

Depression

The usual 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 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 usually 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 usually 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.

Older 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 the section 2 “What you need to know before starting to take Escitalopram Stada”.

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

If necessary, you can break the tablets by placing the tablet on a flat surface with the notch facing upwards. The tablets can be broken by pressing down on each end of the tablet with your two index fingers.

Treatment Duration

You may feel better in a couple of weeks. Continue taking Escitalopram Stada even if you start feeling better before the expected time.

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

Continue taking Escitalopram Stada for the recommended time by your doctor. If you interrupt the treatment too soon, symptoms may reappear. It is recommended that treatment continue for at least 6 months after feeling well again.

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 nearest hospital emergency room, or consult the Toxicology Information Service, phone 915.620.420, indicating the medication and the amount ingested. Do it even when you do not observe discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and changes in the body's electrolyte balance. Bring the Escitalopram Stada packaging if you visit your doctor or the hospital.

If You Forget to Take Escitalopram Stada

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

If You Interrupt Treatment with Escitalopram Stada

Do not interrupt treatment with Escitalopram Stada until your doctor tells you to. When you have completed your treatment course, it is usually recommended that the Escitalopram Stada dose be gradually reduced over several weeks.

When you stop taking Escitalopram Stada, especially if it is done abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Stada is suspended. The risk is higher when Escitalopram Stada 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 disappear on their own in two weeks. However, in some patients, they can be intense or prolonged (2-3 months or more). If you experience severe withdrawal symptoms when stopping Escitalopram Stada, please contact your doctor. They may ask you to take your tablets again and taper off them more slowly.

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 heartbeat or palpitations.

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

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

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

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

Rare (may affect up to 1 in 100 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, they may be signs of a rare condition called serotonin syndrome. If you feel this way, contact your doctor.

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

Frequency unknown (cannot be estimated from available data):

•Difficulty urinating.

•Seizures (convulsions), see "Warnings and precautions" section.

•Yellowing of the skin and eyes, which are signs of liver dysfunction/hepatitis.

•Fast, irregular heartbeat, fainting, which may be symptoms that can indicate a life-threatening condition known as Torsade de Pointes.

•Thoughts of self-harm or suicidal thoughts, see also "Warnings and precautions" section.

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):

•Blockage or nasal mucus (sinusitis).

•Decreased or increased appetite.

•Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling drowsy, dizziness, yawning, tremors, skin itching.

•Diarrhea, constipation, vomiting, dry mouth.

•Increased sweating.

•Muscle and joint pain (arthritis and myalgia).

•Sexual 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 chattering, agitation, nervousness, anxiety attack, state of confusion.

•Sleep disturbances, taste disturbances, fainting (syncope).

•Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus).

•Hair loss.

•Excessive menstrual bleeding.

•Irregular menstrual period.

•Weight loss.

•Fast heartbeat.

•Swelling of arms and legs.

•Nasal bleeding.

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

•Aggression, depersonalization, hallucinations.

•Slow heartbeat.

Some patients have reported (the frequency 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).

•Blood clotting 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).

•Inadequate ADH secretion, resulting in increased urine output.

•Milk flow in women who are not lactating.

•Mania.

•An increased risk of bone fractures has been observed in patients treated with this type of medication.

•Alteration of the heart rhythm (known as "prolongation of the QT interval", observed on an ECG, heart electrical activity).

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

In addition, other side effects are known to appear with medications that act similarly to escitalopram (the active ingredient in Escitalopram STADA). These are:

•Restlessness (akathisia).

•Anorexia.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://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.

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.

Do not dispose of medications through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. 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 Stada

The active ingredient is escitalopram. Each tablet contains 15 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 contents of the package

Escitalopram Stada is presented in the form of film-coated tablets with a 15 mg film coating. The tablets are described below:

Escitalopram Stada 15 mg are film-coated tablets, oval (approximately 10.4 x 5.6 mm), white and with a groove on one side. The grooveserves onlyfor breaking and facilitating swallowing.

Escitalopram Stada 15 mgis availablein the following package sizes:

Blister packs containing10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 120 or 200 tablets

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Responsible for manufacturing

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

AustriaEscitalopram STADA 15 mg Filmtabletten

DenmarkEscitalopram Stada

SpainEscitalopram STADA 15mg comprimidos recubiertos con película EFG

FranceESCITALOPRAM EG 15mg, comprimé pelliculé sécable

IrelandEtaloporo 15mg film-coated tablets

IslandEscitalopram STADA 15 mgfilmuhúðuð tafla

SwedenEscitalopram STADA filmdragerade tabletter 15 mg

Last review date of this leaflet: June 2024

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/