Package Insert: Information for the Patient

Escitalopram Sandoz 10 mg Bucodispersable Tablets EFG

Escitalopram Sandoz 15mg Bucodispersable Tablets EFG

Escitalopram Sandoz 20 mg Bucodispersable 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 refer to 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 who may 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 Sandoz contains the active ingredient escitalopram. Escitalopram belongs to a group of antidepressants called 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 diseases.

Escitalopram Sandoz 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 even if it takes time to notice some improvement.

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

Do not take Escitalopram Sandoz

• 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 to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic),
• if you have a history of or have experienced an 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 “Other medicines and Escitalopram Sandoz”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Escitalopram Sandoz. Inform your doctor if you have any other medical condition, as your doctor may need to take this into account. In particular, inform your doctor:

• if you have epilepsy. Treatment with Escitalopram Sandoz should be stopped if seizures occur for the first time, or if you notice an increase in the frequency of seizures (see also section 4 “Possible side effects”),
• if you have liver or kidney function abnormalities. Your doctor may need to adjust your dose,
• if you have diabetes. Treatment with Escitalopram Sandoz may affect blood sugar control. You may need to adjust your insulin and/or oral hypoglycaemic dose,
• if you have low sodium levels in the blood,
• if you are prone to bleeding or bruising easily, 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 a low salt level 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).

Important information

Some patients with manic-depressive illness may enter a manic phase. This is characterised by unusual and rapid changes in ideas, excessive happiness, 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.

Some medicines, such as escitalopram (also known as ISRS/IRSN), may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

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 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. Clinical trial information 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. 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 Sandoz should not normally be used to treat children and adolescents under 18 years. Also, you should know 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 Sandoz chewable tablets to patients under 18 years if they decide it is the best option for the patient. If your doctor has prescribed Escitalopram Sandoz chewable tablets to a patient under 18 years and you want 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 Sandoz chewable tablets. Additionally, the long-term safety, growth, maturity, and cognitive and behavioural development of Escitalopram Sandoz chewable tablets in this age group have not yet been demonstrated.

Other medicines and Escitalopram Sandoz

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 Sandoz. After stopping Escitalopram Sandoz, 7 days must pass before taking any of these medicines.
• “Reversible MAO-A inhibitors”, containing moclobemide (for the treatment of depression).
• “Irreversible MAO-B inhibitors”, containing selegiline (for the treatment of Parkinson's disease). These increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (for the treatment of manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both for the treatment of depression).
• Sumatriptan and similar medicines (for the treatment of migraine) and tramadol (used for intense pain). These increase the risk of side effects.
• Buprenorphine(used for intense pain) as it increases the risk of serotonin syndrome, a potentially fatal syndrome.
• Cimetidine, lansoprazole, and omeprazole (for the treatment of stomach ulcers), fluconazole (for the treatment of fungal infections), fluvoxamine (an antidepressant), and ticlopidine (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 thrombosis, 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 Sandoz to ensure that the anticoagulant dose is still adequate.
• Mefloquine (for the treatment of malaria), bupropion (for the treatment of depression), and tramadol (for the treatment of intense pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines for the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and ISRSs) 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 Escitalopram Sandoz dose.
• 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 Sandoz 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, some antimicrobials (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, particular antimalarial treatment halofantrine), some antihistamines (astemizole, hydroxyzine, mizolastine). Contact your doctor for any further consultation.

Taking Escitalopram Sandoz with food, drinks, and alcohol

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

As with many medicines, it is not recommended to combine Escitalopram Sandoz 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 if you are pregnant or breastfeeding unless you and your doctor have weighed up the risks and benefits.

If you take escitalopram 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 taking escitalopram.

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 appear in your baby, contact your midwife and/or doctor immediately.

Escitalopram should not be stopped abruptly during pregnancy.

If you take escitalopram in the final stages of pregnancy, there may be a higher 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.

It is expected that escitalopram will be excreted through 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 affects you.

Escitalopram Sandoz contains lactose and sodium

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

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

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

Escitalopram Sandoz tablets are taken every day as a single daily dose. You can take Escitalopram Sandoz with or without food.

Escitalopram Sandoz tablets are 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 one 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 the tongue. The tablet will disintegrate quickly and can be swallowed without water.

Escitalopram Sandoz tablets are not available for all the doses described below. For these doses, you must take other available medications. Consult your doctor or pharmacist.

Adults

Depression

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

Anxiety disorder

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

Use in children and adolescents

Escitalopram Sandoz is usually not administered to children and adolescents. For additional information, see section 2 “What you need to know before taking Escitalopram Sandoz”.

Renal impairment

Caution is advised in patients with severely impaired renal function. Take it as prescribed by your doctor.

Liver impairment

Patients with liver problems should not take more than 10 mg per day. Take it as prescribed by your doctor.

Patients considered as slow metabolizers of CYP2C19

Patients with this known genotype should not take more than 10 mg per day. Take it as prescribed by your doctor.

Treatment duration

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

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

Continue taking escitalopram 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 Sandoz than you should

If you take more than the prescribed dose of Escitalopram Sandoz, consult your doctor immediately, go to the nearest hospital emergency room, or call the Toxicology Information Service, phone: 91 562 04 20, 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 hydro/saline balance. Bring the Escitalopram Sandoz packaging if you go to the doctor or hospital.

If you forget to take Escitalopram Sandoz

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 the treatment with Escitalopram Sandoz

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

When you stop taking Escitalopram Sandoz, especially if it is done abruptly, you may experience withdrawal symptoms. These are common when stopping escitalopram treatment. The risk is higher when escitalopram 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 to 3 months or more). If you experience severe withdrawal symptoms when stopping escitalopram, contact your doctor. You can ask them to have you take the tablets again and taper them off more slowly.

Withdrawal symptoms include: dizziness (unstable or loss of balance), tingling sensation, prickling sensation, and (less frequently) electric shock, even in the head, sleep disturbances (too intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, dizziness (nausea), sweating (including nocturnal sweating), 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 questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may 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 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 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 (see section 2).

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

• difficulty urinating,
• seizures (convulsions), see also the "Warnings and precautions" section,
• 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 known as Torsade de Pointes,
• thoughts of self-harm or suicidal thoughts, see also the "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):

• nasal congestion or mucous buildup (sinusitis),
• decreased or increased 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 experiencing 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, e.g., skin or mucous membranes (ecchymosis),
• sudden swelling of skin or mucous membranes (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 work similarly to escitalopram (active ingredient of Escitalopram Sandoz), 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 theSistema Español de Farmacovigilancia de medicamentos de Uso Humano: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.

Do not use this medication after the expiration date that appears on the packaging and blister after CAD/EXP. 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 thrown into the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of 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 Sandoz

• The active ingredient is escitalopram.

Escitalopram Sandoz 10 mg: each buccal dispersible tablet contains 10 mg of escitalopram (as oxalate).

Escitalopram Sandoz 15 mg: each buccal dispersible tablet contains 15 mg of escitalopram (as oxalate).

Escitalopram Sandoz 20 mg: each buccal dispersible tablet contains 20 mg of escitalopram (as oxalate).

• The other components are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, potassium polacrilex, potassium acesulfame, neohesperidin dihydrochalcone, magnesium stearate, peppermint aroma [contains: corn maltodextrin, modified corn starch E 1450 (cereals starch) and peppermint oil (Mentha arvensis)], concentrated hydrochloric acid (for pH adjustment).

Appearance of the product and contents of the package

Escitalopram Sandoz 10 mg buccal dispersible tablets:white to white opaque tablets, round, flat with beveled edges, 9 mm in diameter, and engraved with "10" on one side.

Escitalopram Sandoz 15 mg buccal dispersible tablets:white to white opaque tablets, round, flat with beveled edges, 11 mm in diameter, and engraved with "15" on one side.

Escitalopram Sandoz 20 mg buccal dispersible tablets:white to white opaque tablets, round, flat with beveled edges, 12 mm in diameter, and engraved with "20" on one side.

Escitalopram Sandoz buccal dispersible tablets are packaged in blisters of paper / PET / aluminum // PVC / aluminum / or OPa, inserted in a cardboard box.

Package sizes:

7, 10, 12, 14, 20, 28, 30, 35, 50, 56, 60, 90, 98, 100, and 200 buccal dispersible tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben

Germany

or

Genepharm S.A.

18th km Marathon Avenue,

Pallini Attiki, 15351

Greece

or

LEK, S.A.

Ul Domaniewska 50 C

Warsaw, PL 02-672

Poland

or

Lek Pharmaceuticals

d.d.

Verovškova

57

SL-1526

Ljubljana

Slovenia

or

S.C. Sandoz, S.R.L.

7A Livezeni Street, Targu-Mures

540472 Mures County,

Romania

or

Rontis Hellas S.A. Medical and Pharmaceutical Products

Industrial Area of Larissa, P.O. Box 3012

GR41004 Larissa, Greece

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000

Malta

Fecha de la última revisión de este prospecto:11/2024

The detailed information of this medicine is available on the website of theAgencia Española de Medicamentos y Productos Sanitarios (AEMPS)http://www.aemps.gob.es/