ESCITALOPRAM SANDOZ 15 mg FILM-COATED TABLETS

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

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 take other medicines that belong to the group of MAO inhibitors, including selegiline (used for the treatment of Parkinson's disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic),
• if you have been born with or have had an episode of irregular heart rhythm (detected on an ECG, a test that evaluates heart function),
• if you are taking medicines for heart rhythm problems or that may affect the 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 disorder or disease, as your doctor may need to take it into account. In particular, inform your doctor if:

• you have epilepsy. Treatment with escitalopram should be discontinued if seizures occur for the first time or if there is an increase in seizure frequency (see also section 4 "Possible side effects"),
• you have liver or kidney problems. Your doctor may need to adjust your dose,
• you have diabetes. Treatment with escitalopram may alter glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic agent,
• you have a low level of sodium in the blood,
• you tend to develop bleeding or bruisingeasily or if you are pregnant (see "Pregnancy"),
• you are receiving electroconvulsive therapy,
• you have coronary heart disease,
• you have had heart problems or have recently had a heart attack,
• your resting heart rate is slow and/or you know you may have low levels of potassium or magnesium in the blood as a result of severe and prolonged diarrhea and vomiting (being sick) or the use of diuretics,
• you experience rapid or irregular heartbeats, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart rhythm,
• you have or have had eye problems, such as certain types of glaucoma (increased pressure in the eye).

Be aware

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

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

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

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may sometimes have thoughts of harming yourself or of suicide. These may increase when you first start taking antidepressants, as all these medicines take time to start working, usually around 2 weeks, although in some cases it may be longer.

You may be more likely to have these thoughts:

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

If at any time you have thoughts of self-harm or suicide, contact your doctor or go directly to a hospital.

It may help to tell a relative or close friendthat you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety has got worse, or if they are worried about changes in your behavior.

Children and adolescents

Escitalopram should not normally be used in the treatment of children and adolescents under 18 years. Also, you should know that in patients under 18 years, there is a greater risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe escitalopram to patients under 18 years when they decide it is the most suitable for the patient. If your doctor has prescribed escitalopram to a patient under 18 years and you wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms described above worsen or if complications occur when patients under 18 years are taking escitalopram. Additionally, the long-term effects on safety regarding growth, maturity, and cognitive and behavioral development of escitalopram in this age group have not yet been established.

Other medicines and Escitalopram Sandoz

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 MAO inhibitors, which contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If you have taken any of these medicines, you must wait 14 days before starting to take escitalopram. After stopping escitalopram, 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 in the treatment of depression).
• Sumatriptan and similar medicines(used for the treatment of migraine) and tramadol(used for the treatment of severe pain). These increase the risk of side effects.
• Buprenorphine(used for severe pain) as it increases the risk of serotonin syndrome, a potentially life-threatening condition.
• Cimetidine, lansoprazole, and omeprazole(used for the treatment of stomach ulcers), fluconazole(used to treat fungal infections), fluvoxamine(antidepressant), and ticlopidine(used to reduce the risk of stroke). These may cause increased blood levels of escitalopram.
• St. John's Wort(Hypericum perforatum) – a medicinal herb used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs)(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 thin the blood, also called anticoagulants). Your doctor will probably monitor your blood clotting time at the start and end of treatment with escitalopram to check that the dose of anticoagulant 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.
• Flecainide, propafenone, and metoprolol(used in cardiovascular diseases), clomipramine and nortriptyline(antidepressants), and risperidone, thioridazine, and haloperidol(antipsychotics). It may be necessary to adjust the dose of escitalopram.
• Medicines that decrease potassium or magnesium levels in the blood, as this increases the risk of heart rhythm disturbances, which can be life-threatening.

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

Taking Escitalopram Sandoz with food, drinks, and alcohol

Escitalopram Sandoz 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 and alcohol, although it is not expected that Escitalopram Sandoz will interact with alcohol.

Pregnancy, breastfeeding, and fertility

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

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: breathing difficulties, blue discoloration of the skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, and sleep disturbances. If your newborn has any of these symptoms, contact your doctor immediately.

Make sure your midwife and/or doctor know you are being treated with escitalopram.

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

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

It is expected that escitalopram will be excreted into breast milk.

If you take Escitalopram Sandoz 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 Sandoz so they can advise you.

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

Driving and using machines

Do not drive or use machines until you know how the treatment with escitalopram affects you.

Escitalopram Sandoz contains lactose and sodium

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

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

3. How to Take Escitalopram Sandoz

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

Adults

Depression

The recommended dose 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 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 later up to a maximum of 20 mg per day.

Social Anxiety Disorder

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

Generalized Anxiety Disorder

The recommended dose 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 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 (over 65 years)

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

Use in Children and Adolescents (under 18 years)

Escitalopram should not normally be administered to children and adolescents. For additional information, see section 2 "Warnings and Precautions".

Renal Insufficiency

Cautious use is advised in patients with severely decreased renal function. Take as prescribed by your doctor.

Hepatic Insufficiency

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

Patients Considered as Slow Metabolizers of CYP2C19

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

Method of Administration

You can take escitalopram with or without food. Swallow the tablet with a little water.

Escitalopram Sandoz 10 mg:

If necessary, you can divide the tablets into two equal parts.

Escitalopram Sandoz 15 mg:

If necessary, you can divide the tablets into three equal parts.

Escitalopram Sandoz 20 mg:

If necessary, you can divide the tablets into four equal parts.

Duration of Treatment

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

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

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

If You Take More Escitalopram Sandoz Than You Should

If you have taken more Escitalopram Sandoz than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used. Do this even when you do not observe discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, decrease in blood pressure, and changes in the body's hydro/salt balance. Bring the package of escitalopram if you go to the doctor or hospital.

If You Forget to Take Escitalopram Sandoz

Do not take a double dose to make up for forgotten doses. If you forgot to take a dose, and you 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, leave the forgotten dose and follow the usual routine.

If You Interrupt Treatment with Escitalopram Sandoz

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

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

Withdrawal Symptoms Include: feeling 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 or palpitations.

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

4. Possible Adverse Effects

Like all medications, this medication can cause adverse effects, although not all people suffer from them.

Adverse effects usually disappear after a few weeks of treatment. Be aware that many of the effects can 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:

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

• unusual bleeding, including gastrointestinal bleeding.

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

• swelling of the skin, tongue, lips, pharynx, or face, hives, or difficulty breathing or swallowing (severe allergic reaction),
• high fever, agitation, confusion, tremors, and sudden muscle contractions, can be signs of a rare condition called serotonin syndrome (see section 2).

Frequency Not Known(cannot be estimated from available data):

• difficulty urinating,
• seizures (attacks), see also the subsection "Warnings and Precautions",
• yellow skin and whitening of the eyes, are signs of liver function alteration / hepatitis,
• thoughts of self-harm or suicidal thoughts, see also the section "Warnings and Precautions",
• sudden swelling of the skin mucosa (angioedema).

In Addition to the Above, the Following Adverse 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, strange 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),
• grinding of teeth, 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 heart rate,
• swelling of arms and legs,
• nasal bleeding.

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

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

Frequency Not Known(cannot be estimated from 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),
• signs of increased bleeding, e.g., from the skin or mucous membranes (ecchymosis),
• sudden swelling of the skin or mucous membranes (angioedema),
• increase in the secretion of the ADH hormone, which causes water retention in the body and dilution of the blood, reducing the amount of sodium (inappropriate ADH secretion),
• milk production in men and in women who are not breastfeeding,
• mania,
• alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, electrical activity of the heart),
• abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, Breastfeeding, and Fertility" in section 2 for more information.

Other adverse effects are known to occur with medications that work similarly to escitalopram (the active ingredient in escitalopram Sandoz), these are:

• motor restlessness (akathisia),
• loss of appetite,
• increased risk of bone fractures.

Reporting of Adverse Effects

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

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

5. Conservation of Escitalopram Sandoz

Keep this medication out of sight and reach of children.

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

This medication does not require any special storage temperature.

HDPE Bottle

After the first opening, the tablets can be stored in the HDPE bottle for a maximum of 6 months. Do not store the open bottle at a temperature above 25°C.

At the end of the 6-month period, do not take the remaining tablet in the open HDPE bottle, and dispose of the medication.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in 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. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Escitalopram Sandoz

• The active ingredient is escitalopram.

Escitalopram Sandoz 10 mg: Each film-coated tablet contains 10 mg of escitalopram (as oxalate).

Escitalopram Sandoz 15 mg: Each film-coated tablet contains 15 mg of escitalopram (as oxalate).

Escitalopram Sandoz 20 mg: Each film-coated tablet contains 20 mg of escitalopram (as oxalate).

• The other components are:

Core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, magnesium stearate, and anhydrous colloidal silica.

Coating: hypromellose, macrogol 6000, titanium dioxide (E171), and talc.

Appearance of the Product and Package Contents

Escitalopram Sandoz 10 mg: Film-coated tablet, white, oval, and with a break line on one face of the tablet and a length of 7.7-8.3 mm and a width of 5.2-5.8 mm.

Escitalopram Sandoz 15 mg: Film-coated tablet, white, oval, and with two break lines on both faces of the tablet and a length of 12.7-13.3 mm and a width of 4.7-5.3 mm.

Escitalopram Sandoz 20 mg: Film-coated tablet, white, round, with a cross-shaped break line on both faces and a diameter of 9.2-9.8 mm.

Escitalopram Sandoz film-coated tablets are presented in the following package sizes:

OPA-Al-PVC/Al blister pack included in a box

7, 10, 14, 20, 28, 30, 50, 56, 56x1, 60, 60x1, 90, 98, 98x1, 100, 100x1, 200, and 500 film-coated tablets.

HDPE bottles with screw cap and desiccant

28, 30, 56, 60, 98, 100, and 250 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

or

LEK S.A.

ul. Domaniewska 50 C

02-672 Warszawa

Poland

or

Lek S.A.

Ul. Podlipie 16

95 010 Strykow

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Date of the Last Revision of this Leaflet:11/2024

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