Escitalopram Sandoz 10 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Escitalopram Sandoz 10 mg film-coated tablets EFG

Escitalopram Sandoz 15 mg film-coated tablets EFG

Escitalopram Sandoz 20 mg film-coated tablets EFG

Read all of 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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet

What Escitalopram Sandoz is and what it is used for
What you need to know before taking Escitalopram Sandoz
How to take Escitalopram Sandoz
Possible side effects
How to store Escitalopram Sandoz

Contents of the pack and other information

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

Escitalopram Sandoz contains the active substance escitalopram. Escitalopram belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain by increasing the level of serotonin. Disturbances in the serotonin system are considered an important factor in the development of depression and related disorders.

Escitalopram 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 taking escitalopram even if it takes some time to notice improvement.

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

2. What you need to know before taking 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 belonging to the group known as MAO inhibitors, including selegiline (used for the treatment of Parkinson's disease), moclobemide (used for the treatment of depression), or linezolid (an antibiotic),
if you were born with or have had an episode of heart rhythm disorder (detected on 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

Talk to your doctor or pharmacist before starting to take Escitalopram Sandoz. Inform your doctor if you have any other disorder or illness, as your doctor may need to take this into account. Specifically, inform your doctor if:

you have epilepsy. Treatment with escitalopram should be discontinued if you experience seizures for the first time or notice an increase in seizure frequency (see also section 4 “Possible side effects”),
you have liver or kidney function problems. Your doctor may need to adjust your dose,
you have diabetes. Treatment with escitalopram may alter glucose control. A dose adjustment of insulin and/or oral hypoglycemic agents may be necessary,
you have low sodium levels in the blood,
you are prone to developing bleeding or bruising easily, or if you are pregnant (see “Pregnancy”),
you are receiving electroconvulsive therapy,
you have coronary artery disease,
you have or have previously had heart problems or recently suffered a heart attack,
your resting heart rate is slow and/or you know you may have low salt levels due to severe and prolonged diarrhea and vomiting (being unwell) or use of diuretics,
you experience rapid or irregular heartbeats, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm,
you have or have previously had eye problems, such as certain types of glaucoma (increased pressure in the eye).

Please note

Some patients with bipolar disorder may enter a manic phase. This is characterized by unusually rapid and frequent changes in thoughts, disproportionate happiness, and excessive physical activity. If you experience this, contact your doctor.

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

Some medicines in the same group as Escitalopram Sandoz (called SSRIs/SNRIs) 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 occasionally have thoughts of harming yourself or of suicide. These may increase when starting antidepressants, as all such medicines require time to begin working—usually about two weeks, although sometimes longer.

You may be more likely to have such thoughts:

if you have previously had suicidal or self-harming thoughts,
if you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in psychiatric patients under 25 years of age treated with an antidepressant.

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

It may help to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them whether they think your depression or anxiety disorder has worsened or if they are concerned about changes in your behavior.

Children and adolescents

Escitalopram is not normally used to treat children and adolescents under 18 years of age. Also, be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide 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 of age if they decide it is in the patient’s best interest. If your doctor has prescribed escitalopram to a patient under 18 years of age and you wish to discuss this decision, please contact your doctor again. You should inform your doctor if any of the symptoms described above worsen or complications arise while patients under 18 years of age are taking escitalopram. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioral development of escitalopram in this age group have not yet been fully established.

Other medicines and Escitalopram Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting escitalopram. After stopping escitalopram, you must wait 7 days before taking any of these medicines.
Reversible selective MAO-A inhibitors containing moclobemide (used in the treatment of depression).
Irreversible MAO-B inhibitors containing 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 bipolar disorder) and tryptophan.
Imipramine and desipramine (both used in the treatment of depression).
Sumatriptan and similar medicines (used for the treatment of migraine), tramadol (used for 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 (an 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 herbal remedy 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 bleed.
Warfarin, dipyridamole, and fenprocoumon (medicines used to thin the blood, also called anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of treatment with escitalopram to ensure the anticoagulant dose remains appropriate.
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 for cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of escitalopram may need to be adjusted.
Medicines that reduce potassium or magnesium levels in the blood, as this increases the risk of life-threatening heart rhythm disturbances.

Do not take escitalopram if you are taking medicines for heart rhythm problems or that may affect heart rhythm, e.g., Class IA and III antiarrhythmics, antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarials particularly halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine). Contact your doctor for any further questions.

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, combining Escitalopram Sandoz with alcohol is not recommended, although an interaction between escitalopram and alcohol is not expected.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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 discussed the risks and benefits involved.

If you take escitalopram during the last 3 months of pregnancy, be aware that the following effects may occur in the newborn baby: breathing difficulties, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and sleep disturbances. If your newborn baby shows any of these symptoms, contact your doctor immediately.

Ensure 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 of the newborn (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually begin within the first 24 hours after birth. If they occur in your baby, contact your midwife and/or doctor immediately.

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

Escitalopram is expected to be excreted in breast milk.

If you take Escitalopram Sandoz in the late 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 be aware 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. Theoretically, this effect could affect fertility, but to date, no impact on human fertility has been observed.

Driving and using machines

Do not drive or operate machinery until you know how escitalopram affects you.

Escitalopram Sandoz contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with 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 exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults

Depression

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

Panic disorder

The initial dose is 5 mg as a single daily dose for the first week before increasing the dose to 10 mg per day. Your doctor may subsequently increase it up to a maximum of 20 mg per day.

Social anxiety disorder

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

Generalized anxiety disorder

The recommended dose is 10 mg taken as a single daily dose. 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 daily dose. 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 daily dose. The dose may be increased by your doctor to 10 mg per day.

Use in children and adolescents (under 18 years of age)

Escitalopram should normally not be given to children and adolescents. For further information, see section 2 “Warnings and precautions”.

Renal impairment

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

Hepatic impairment

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 may take escitalopram with or without food. Swallow the tablet with some water.

Escitalopram Sandoz 10 mg:

If necessary, the tablets may be divided into two equal parts.

Escitalopram Sandoz 15 mg:

If necessary, the tablets may be divided into three equal parts.

Escitalopram Sandoz 20 mg:

If necessary, the tablets may be divided into four equal parts.

Duration of treatment

It may take a few weeks before you start to feel better. Continue taking escitalopram even if you start to feel better earlier than expected.
Do not change the dose of the medicine without first talking to your doctor.
Continue taking escitalopram for the length of time recommended by your doctor. If you stop treatment too early, symptoms may return. It is recommended that treatment continues for at least 6 months after you have recovered.

If you take more Escitalopram Sandoz than you should

If you have taken more Escitalopram Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, stating the medication and amount taken. Do this even if you do not notice any discomfort or signs of poisoning. Some of the signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rate, decreased blood pressure, and disturbances in the body's water/salt balance. Take the escitalopram packaging with you 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 missed doses. If you forget to take a dose and remember before going to bed, take it immediately. The next day, continue as usual. If you remember during the night or the following day, skip the missed dose and continue as usual.

If you stop taking Escitalopram Sandoz

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

When you stop taking escitalopram, especially if abruptly, you may experience withdrawal symptoms. These are common when stopping treatment with escitalopram. 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 resolve on their own within two weeks. However, in some patients, they may be severe or prolonged (2 to 3 months or more). If you experience severe withdrawal symptoms when stopping escitalopram, contact your doctor. He or she may ask you to restart taking your tablets and taper off more slowly.

Withdrawal symptoms include: dizziness (feeling unsteady or off-balance), tingling sensations, burning sensations, and (less frequently) electric shock-like sensations, even in the head; sleep disturbances (vivid dreams, nightmares, inability to sleep); restlessness; headache; dizziness (nausea); sweating (including night sweats); feelings of unease or agitation; tremor (shakiness); feelings of confusion or disorientation; emotional or irritable feelings; diarrhea (loose stools); visual disturbances; rapid pulse or palpitations.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects usually disappear after a few weeks of treatment. Be aware that many of these effects may be symptoms of your illness and will therefore improve as you start to feel better.

If you experience any of the following symptoms, you must contact your doctor or go to 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, throat or face, hives, or difficulty breathing or swallowing (severe 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 (fits), see also subsection “Warnings and precautions”,
yellowing of the skin and whites of the eyes, signs of liver dysfunction/hepatitis,
if you experience rapid or irregular heartbeats or fainting, symptoms which may indicate a life-threatening condition known as Torsade de Pointes,
thoughts of harming yourself (self-harm) or suicidal thoughts, see also section “Warnings and precautions”,
sudden swelling of the skin or mucous membranes (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,
headache.

Common (may affect up to 1 in 10 people):

nasal congestion or mucus (sinusitis),
decreased or increased appetite,
anxiety, restlessness, strange dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin itching,
diarrhoea, constipation, vomiting, dry mouth,
increased sweating,
muscle and joint pain (arthralgia and myalgia),
sexual dysfunction (delayed ejaculation, erection problems, reduced sexual interest, and women may experience difficulty achieving orgasm),
fatigue, fever,
weight gain.

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

hives, skin rash, itching (pruritus),
teeth grinding, restlessness, nervousness, panic attacks, confusion,
sleep disturbances, taste disturbances, 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,
nosebleeds.

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

aggression, depersonalisation, hallucinations,
slow heart rate.

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

decreased sodium levels in the blood (symptoms include dizziness and malaise with muscle weakness or confusion),
dizziness upon standing due to low blood pressure (orthostatic hypotension),
abnormal liver function tests (increased 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 (bruising, ecchymosis),
signs of increased bleeding, e.g. from the skin and mucous membranes (ecchymosis) and low platelet count in the blood (thrombocytopenia),
increased secretion of ADH hormone, causing water retention in the body and dilution of the blood, reducing sodium levels (inappropriate antidiuretic hormone secretion, SIADH),
increased blood levels of the hormone prolactin,
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 medicine,
changes in heart rhythm (called “prolongation of the QT interval”, seen on ECG, the heart's electrical activity),
heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see “Pregnancy, breastfeeding and fertility” in section 2 for more information.

Other adverse effects are known to occur with medicines that work in a similar way to escitalopram (active substance in escitalopram San), these include:

motor restlessness (akathisia),
loss of appetite.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the national reporting system: Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es .

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Escitalopram Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

HDPE bottle

After first opening, the tablets may be stored in the HDPE bottle for up to 6 months. Do not store the opened bottle at temperatures above 25°C.

At the end of the 6-month period, any remaining tablets in the opened HDPE bottle must not be taken and the medicine should be disposed of.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Escitalopram Sandoz

The active substance 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 colloidal anhydrous silica.

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

Appearance of the product and contents of the pack

Escitalopram Sandoz 10 mg: White, oval, film-coated tablet with a break line on one side of the tablet, measuring 7.7–8.3 mm in length and 5.2–5.8 mm in width.

Escitalopram Sandoz 15 mg: White, oval, film-coated tablet with two break lines on both sides, measuring 12.7–13.3 mm in length and 4.7–5.3 mm in width.

Escitalopram Sandoz 20 mg: White, round, film-coated tablet with a cross-shaped notch on both sides, with a diameter of 9.2–9.8 mm.

Escitalopram Sandoz film-coated tablets are available in the following pack sizes:

OPA-Al-PVC/Al blister packs, included in a carton:

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 PP screw cap containing desiccant:

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

Only some pack 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

LEK S.A.

ul. Domaniewska 50 C

02-672 Warszawa

Poland

Lek S.A.

Ul. Podlipie 16

95 010 Strykow

Poland

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Lek Pharmaceuticals d.d.,

Trimlini 2D,

9220 Lendava

Slovenia

Date of the most recent revision of this package leaflet: 03/2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es