ESCITALOPRAM SANDOZ 15 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Escitalopram Sandoz 10 mg Orodispersible Tablets EFG

Escitalopram Sandoz 15mg Orodispersible Tablets EFG

Escitalopram Sandoz 20 mg Orodispersible Tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Escitalopram Sandoz and what is it used for.
2. What you need to know before you take Escitalopram Sandoz.
3. How to take Escitalopram Sandoz.
4. Possible side effects.
5. Storage of Escitalopram Sandoz.
6. Contents of the pack and other information.

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

Escitalopram Sandoz contains the active substance escitalopram. Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines work by increasing the level of serotonin in the brain. Alterations in the serotonin system are considered to be a major 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).

It may take a couple of weeks before you start to feel better. Continue to take escitalopram even if it takes some time to feel any improvement.

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

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 are taking 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 alteration of heart rhythm (detected in an ECG, a test that evaluates heart 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 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 Sandoz should be discontinued if seizures occur for the first time, or if you observe an increase in the frequency of seizures (see also section 4 "Possible side effects"),
• if you have liver or kidney function disorders. Your doctor may need to adjust your dose,
• if you have diabetes. Treatment with Escitalopram Sandoz may alter glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic,
• if you have low sodium levels in the blood,
• if you tend to develop 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 you may have low salt levels as a result of severe and prolonged diarrhea and vomiting (being sick) or 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).

Be aware

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.

Some medicines like escitalopram (also 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 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 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 if they think your depression or anxiety has got worse, or if they are worried about changes in your behavior.

Children and adolescents

Escitalopram Sandoz 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 (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Escitalopram Sandoz orodispersible tablets to patients under 18 years when they decide what is best for the patient. If your doctor has prescribed Escitalopram Sandoz orodispersible tablets 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 progress or if you experience complications when patients under 18 years are taking Escitalopram Sandoz orodispersible tablets. Additionally, the long-term effects on safety regarding growth, maturity, and cognitive and behavioral development of Escitalopram Sandoz orodispersible tablets in this age group have not been established yet.

Other medicines and Escitalopram Sandoz

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Inform your doctor if you are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) that 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 Sandoz. After finishing Escitalopram Sandoz, 7 days must pass before taking any of these medicines.
• Reversible MAO-A inhibitors that contain moclobemide (for the treatment of depression).
• Irreversible MAO-B inhibitors that contain 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 condition.
• Cimetidine, lansoprazole, and omeprazole (for the treatment of stomach ulcers), fluconazole (for the treatment of fungal infections), fluvoxamine (antidepressant), and ticlopidine (to reduce the risk of stroke). These may cause an increase in blood levels of escitalopram.
• St. John's Wort (Hypericum perforatum) – a medicinal plant used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory medicines (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 check the blood coagulation time at the start and end of treatment with Escitalopram Sandoz to check that the dose of anticoagulant 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 reducing the seizure threshold.
• Neuroleptics (medicines for the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of reducing 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 Sandoz.
• 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 take Escitalopram Sandoz if you are taking medicines for heart rhythm problems or that may affect 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, particular antimalarial treatment, especially halofantrine), some antihistamines (astemizole, hydroxyzine, mizolastine). Contact your doctor for any additional consultation.

Taking Escitalopram Sandoz with food, drinks, and alcohol

Escitalopram Sandoz orodispersible 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 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 that 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 becomes 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.

If you take escitalopram in the final stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking escitalopram to be able to advise you.

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

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 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 some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per orodispersible 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. If you are in doubt, consult your doctor or pharmacist again.

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

The orally disintegrating tablets of Escitalopram Sandoz break easily, so you should handle the tablets with care. 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. Carefully remove the rear flap of the blister.
3. Place the tablet on the tongue. The tablet will disintegrate quickly and can be swallowed without water.

Escitalopram Sandoz orally disintegrating tablets are not available for all the doses described below. For these doses, you must take other medications available on the market. 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 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 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 taken per day as a single dose. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Elderly Patients (over 65 years)

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 should not normally be 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 decreased renal function. Take it as prescribed by your doctor.

Hepatic 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.

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 continues for at least 6 months after feeling better.

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 emergency department of the nearest hospital, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. 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 packaging of Escitalopram Sandoz 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 forget to take a dose, and you remember before going to bed, take it immediately. The next day, continue as usual. If you remember during the night or the next day, leave the forgotten dose and continue as usual.

If You Interrupt Treatment with Escitalopram Sandoz

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

When you stop taking Escitalopram Sandoz, especially if it is sudden, you may feel withdrawal symptoms. These are common when treatment with escitalopram is suspended. 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. They may ask you to start taking the tablets again and to 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 (too 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 disease and will therefore improve when you start to feel better.

If you have any of the following symptoms, you should 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, or face, or having difficulty breathing or swallowing (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 the available data):

• difficulty urinating,
• seizures (attacks), see also the section "Warnings and Precautions",
• yellowish skin and whitening of the eyes, are signs of altered liver function / hepatitis,
• thoughts of self-harm (self-injury) or thoughts of suicide, see also the section "Warnings and Precautions".

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 mucosity (sinusitis),
• decreased or increased appetite,
• anxiety, agitation, vivid dreams, difficulty falling asleep, feeling drowsy, 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 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),
• signs of increased bleeding, e.g., from the skin or mucous membranes (ecchymosis),
• sudden swelling of the skin or mucous membranes (angioedema),
• increased urine production (inadequate secretion of the ADH hormone),
• milk production in men and in women who are not breastfeeding,
• 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 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 of Escitalopram Sandoz), these are:

• motor restlessness (akathisia),
• loss of appetite.

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 Spanish Pharmacovigilance System for Human Use Medications: 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 and blister after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require any special temperature for conservation.

Keep it in the original packaging to protect it from light and moisture.

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. 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 orally disintegrating tablet contains 10 mg of escitalopram (as oxalate).

Escitalopram Sandoz 15 mg: each orally disintegrating tablet contains 15 mg of escitalopram (as oxalate).

Escitalopram Sandoz 20 mg: each orally disintegrating tablet contains 20 mg of escitalopram (as oxalate).

• The other components are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, potassium polacrilin, potassium acesulfame, neohesperidin dihydrochalcona, magnesium stearate, peppermint flavor [contains: maltodextrin (from corn), modified starch E 1450 (waxy corn starch) and peppermint oil (mentha arvensis)], concentrated hydrochloric acid (for pH adjustment).

Appearance of the Product and Package Contents

Escitalopram Sandoz 10 mg orally disintegrating tablets: white to off-white colored tablets, round, flat with beveled edges, 9 mm in diameter and engraved with "10" on one side.

Escitalopram Sandoz 15 mg orally disintegrating tablets: white to off-white colored tablets, round, flat with beveled edges, 11 mm in diameter and engraved with "15" on one side.

Escitalopram Sandoz 20 mg orally disintegrating tablets: white to off-white colored tablets, round, flat with beveled edges, 12 mm in diameter and engraved with "20" on one side.

Escitalopram Sandoz orally disintegrating tablets are packaged in peelable/push-through blisters of paper/PET/aluminum or PVC/aluminum/oPA, inserted in a cardboard box.

Package sizes:

7, 10, 12, 14, 20, 28, 30, 35, 50, 56, 60, 90, 98, 100, and 200 orally disintegrating 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

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

Varsovia, 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

Date of Last Revision of this Leaflet:11/2024

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