Package Insert: Information for the Patient

Escitalopram Sandoz 10 mg Film-Coated Tablets

Escitalopram Sandoz 15 mg Film-Coated Tablets

Escitalopram Sandoz 20 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they 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.

Contents of the package and additional information

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 is indicatedfor 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 do not improve or if you get worse.

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 for the treatment of Parkinson's disease), moclobemide (used for the treatment of depression) and linezolid (an antibiotic),
• if you have had a birth or have experienced an episode of 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 disorder or disease, as your doctor may need to take this into account. In particular, inform your doctor if:

• you haveepilepsy. Treatment with escitalopram should be interrupted if seizures occur for the first time or if you observe an increase in seizure frequency (see also section 4 “Possible side effects”),
• you haveproblems with thefunctioningof yourliverorkidneys. Your doctor may need to adjust your dose,
• you havediabetes. Treatment with escitalopram may alter blood sugar control. You may need to adjust your insulin and/or oral hypoglycaemic dose,
• you have alow sodium level in the blood,
• you are prone to developingbleedingorbruising, or if you are pregnant (see “Pregnancy”),
• you are receivingelectroconvulsive therapy,
• you havecoronary heart disease,
• you have or have had heart problems or have recently had a heart attack,
• your resting heart rate is slow and/or you know that you may have a low sodium level as a result of severe and prolonged diarrhoea and vomiting (being sick) or the use of diuretics,
• you experience rapid or irregular heartbeats, dizziness, fainting 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 withbipolar disordermay enter a manic phase. This is characterised by unusual and rapid changes in ideas, excessive and inappropriate happiness and excessive physical activity. If you experience this, contact your doctor.

Symptoms such asrestlessness 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 in the group to which Escitalopram Sandoz belongs (called SSRIs/SNRIs) 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 can take some weeks to start working. 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 behaviour in adults under 25 years with psychiatric disorders who were treated with an antidepressant.

If you have any of these thoughts at any time, 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. They may be able to help you remember to take your medicine at the right time and to remind you of any important checks you need to have.

Children and adolescents

Escitalopram should not normally be used in the treatment of children and adolescents under 18 years. You should also be aware that in patients under 18 years there is a greater risk of side effects such as suicidal thoughts, suicidal behaviour and hostility (mainly aggression, confrontational behaviour and irritability) when taking this type of medicine. However, your doctor may prescribe escitalopram for patients under 18 years if they decide it is the best course of action for the patient. If your doctor has prescribed escitalopram for a patient under 18 years and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms described above worsen or if you experience complications when patients under 18 years are taking escitalopram. Furthermore, the long-term safety, growth, maturity and cognitive and behavioural development of escitalopram in this age group have not yet been demonstrated.

Other medicines and Escitalopram Sandoz

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

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

• Non-selective monoamine oxidase inhibitors (MAOIs), containing phenelzine, iproniazid, isocarboxazid, nialamide and tranylcypromine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting to take escitalopram. After stopping escitalopram, 7 days must pass before taking any of these medicines.
• Selective reversible 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 antibioticlinezolid.
• Lithium(used in the treatment of bipolar disorder) andtryptophan.
• Imipramine and desipramine(both used in the treatment of depression).
• Sumatriptan and similar medicines(used for the treatment of migraine), andtramadol(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 fatal condition.
• Cimetidine, lansoprazole and omeprazole(used for the treatment of stomach ulcers),fluconazole(used to treat fungal infections),fluvoxamine(an antidepressant) andticlopidine(used 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.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs)(medicines used to relieve pain or to reduce the risk of thrombosis, also called anticoagulants). These may increase the risk of bleeding.
• Warfarin, dipiridamolandfenprocoumon(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 to ensure that the anticoagulant dose is still adequate.
• Mefloquine(used for the treatment of malaria),bupropion(used for the treatment of depression) andtramadol(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) andrisperidone, thioridazine and haloperidol(antipsychotics). You may need to adjust your escitalopram 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 if you are taking medicines for heart rhythm problems or that may affect heart rhythm, e.g. antiarrhythmic Class IA and III, antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobials (e.g. sparfloxacine, moxifloxacine, erythromycin IV, pentamidine, particular antimalarial treatment halofantrine), some antihistamines (astemizol, hydroxyzine, mizolastine). Contact your doctor for any further consultation.

Taking Escitalopram Sandoz with food, drink and alcohol

Escitalopram Sandozcan be taken with or without food (see section 3 “How to takeEscitalopram 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, 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 that 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 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.

It is expected that escitalopram will be excreted in 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 that they can advise you.

Citalopram, a similar medicine to escitalopram, has been shown to reduce sperm quality in animal models. Theoretically, this effect could affect fertility, but there is currently no evidence of its impact on human fertility.

Driving and operating machines

Do not drive or operate 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 are intolerant to certain sugars, consult with them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per coated 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.

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 during 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 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.

Advanced age (65 years or older)

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 is usually not to be administered to children and adolescents. For additional information, see section 2 “Warnings and precautions”.

Renal insufficiency

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

Liver 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.

Administration form

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.

Treatment duration

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

• Do not change 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 the treatment continue for at least 6 months after feeling well again.

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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used. 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 packaging if you go to the doctor or hospital.

If you forgot to take Escitalopram Sandoz

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

If you interrupt the treatment with Escitalopram Sandoz

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

When you stop taking escitalopram, especially if it is done abruptly, you may experience withdrawal symptoms. These are common when the treatment with escitalopram is suspended. 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 have severe withdrawal symptoms when stopping escitalopram, contact your doctor. They may ask you to take your tablets again and leave them more slowly.

Withdrawal symptoms include: feeling of dizziness (unstable or without balance), feeling of tingling, feeling of prickling, and (less frequently) electric shock, even in the head, sleep disturbances (too intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of nausea (dizziness), sweating (including nocturnal sweating), feeling of anxiety or agitation, tremor (instability), feeling of confusion or disorientation, feelings of emotion or irritability, diarrhea (loose stools), visual disturbances, rapid pulse or palpitations.

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

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

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 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, urticaria, 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).

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,
• sudden swelling of the skin mucosa (angioedema).

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 (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, 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):

• urticaria, skin rash, itching (pruritus),
• teeth grinding, agitation, nervousness, anxiety attack, confusion,
• sleep disturbances, taste alterations, fainting (syncope),
• enlarged pupils (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.

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

• aggression, depersonalization, hallucinations,
• low 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, such as skin or mucous membrane bleeding (ecchymosis),
• sudden swelling of the skin or mucous membranes (angioedema),
• increased secretion of the ADH hormone, which causes water retention in the body and dilution of the blood, reducing sodium levels (inappropriate ADH secretion),
• production of milk in men and women who are not breastfeeding,
• mania,
• 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 act similarly to escitalopram (active ingredient of escitalopram San), these are:

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

Reporting of side effects

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

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

Keep this medication out of the reach and sight 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.

BottleHDPE

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 tablet that remains in the open HDPE bottle, and dispose of the medication.

Medications should not be thrown away through the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE drop-off point at 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 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 contents of the package

Escitalopram Sandoz 10 mg: Film-coated tablet, white, oval, with a breaking notch 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, with two breaking notches on both faces 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 breaking notch on both faces with a diameter of 9.2-9.8 mm.

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

OPA-Al-PVC/Al blister pack, 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 with desiccant

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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

Last review date of thisleaflet:11/2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es