Escitalopram Aurovitas 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Escitalopram Aurovitas 10 mg film-coated tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Escitalopram Aurovitas contains the active substance escitalopram, which 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.

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 your condition worsens or does not improve.

2. What you need to know before taking Escitalopram Aurovitas

Do not take Escitalopram Aurovitas

• if you are allergic to escitalopram or to any of the other ingredients of this medicine (listed in section 6).
  • if you are taking other medicines belonging to the group called monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson’s disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
  • if you have been 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 Aurovitas”).

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

Please inform your doctor if you suffer from any other disorder or illness, as your doctor may need to take this into account. Specifically, tell 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”).
• If you have liver or kidney problems. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with escitalopram may alter glycaemic control. Adjustment of insulin and/or oral hypoglycaemic agent dosage may be necessary.
• If you have low sodium levels in your blood.
• If you are prone to bleeding or bruising easily, or if you are pregnant (see “Pregnancy”).
• If you are receiving electroconvulsive therapy.
• If you have coronary artery disease.
• If you have heart problems or have recently had a heart attack.
• If your resting heart rate is slow and/or you know you may have low levels of salts due to severe and prolonged diarrhoea and vomiting (being unwell) or use of diuretics (medicines to remove fluid).
• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm.
• If you have or have previously had eye problems, such as certain types of glaucoma (increased pressure in the eye).
• Some medicines in the same group as escitalopram (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.
• If you are taking medicines containing buprenorphine. Using these medicines together with escitalopram may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Escitalopram Aurovitas”).

Please note:

Some patients with bipolar disorder may enter a manic phase. This is characterised by unusually rapid and frequent changes of thought, excessive 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 few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

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 about harming yourself or ending your life. These may increase when you first start taking antidepressants, as all these medicines take time to begin working—usually about two weeks, although in some cases it may take longer. You are more likely to have these types of thoughts:

• If you have previously had thoughts of killing yourself or harming yourself.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with an antidepressant.

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

It may be helpful for you to tell a close family member or 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 behaviour.

Children and adolescents

Escitalopram should not normally be used in the treatment of children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behaviour, 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 the most appropriate treatment. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. 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 behavioural development of escitalopram in this age group have not yet been fully established.

Other medicines and Escitalopram Aurovitas

Tell 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 to treat depression).
• "Irreversible MAO-B inhibitors" containing selegiline (used to treat Parkinson’s disease). These increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used to treat bipolar disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol and similar medicines (opioids, used for severe pain). These increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase blood concentrations of escitalopram.
• St. John’s wort (Hypericum perforatum) – a herbal remedy used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the tendency to bleed.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, 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 to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used to treat 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.

Some medicines may increase the side effects of escitalopram and in some cases may cause very serious reactions. Do not take any other medicine while taking escitalopram without first consulting your doctor, especially:

• Medicines containing buprenorphine. These medicines may interact with escitalopram and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience these symptoms.

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

Taking Escitalopram Aurovitas with food, drinks, and alcohol

Escitalopram Aurovitas may be taken with or without food (see section 3 “How to take Escitalopram Aurovitas”).

As with many medicines, combining escitalopram 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 are planning 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, the newborn baby may experience the following effects: 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 difficulties. If your newborn baby shows any of these symptoms, please contact your doctor immediately.

Ensure that your midwife and/or doctor know you are being treated with this medicine. 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.

If you take Escitalopram Aurovitas in late 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 Aurovitas so they can advise you.

Escitalopram is expected to be excreted in breast milk.

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

You are advised not to drive or operate machinery until you know how escitalopram affects you.

Escitalopram Aurovitas contains sodium

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

3. How to take Escitalopram Aurovitas

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

.

Adults

Depression

The normally recommended dose of escitalopram 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 of escitalopram 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 normally recommended dose of escitalopram 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 how you respond to treatment.

Generalized anxiety disorder

The normally recommended dose of escitalopram 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 normally recommended dose of escitalopram 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 patients (over 65 years of age)

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

Use in children and adolescents

Escitalopram should not normally be given to children and adolescents. For further information, please 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 poor metabolizers of the CYP2C19 enzyme

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

How to take the tablets

You may take escitalopram with or without food. Swallow the tablets with water. Do not chew them, as they have a bitter taste.

If necessary, you may split the tablets by placing the tablet on a flat surface with the score facing upwards. The tablets can be broken by pressing down on each end of the tablet with your index fingers, as shown in the figure.

Duration of treatment

It may take a few weeks before you start to feel better. Continue taking escitalopram even if it takes some time before you notice any improvement in your condition.

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 feel well again.

If you take more Escitalopram Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or go immediately to the nearest hospital emergency department or contact the Toxicology Information Service at telephone number 915.620.420, indicating the medicine and the amount ingested. Do this even if you do not observe discomfort or signs of poisoning. Some of the signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the Escitalopram Aurovitas packaging with you if you go to the doctor or hospital.

If you forget to take Escitalopram Aurovitas

Do not take a double dose to make up for forgotten 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 with your regular schedule.

If you stop taking Escitalopram Aurovitas

Do not stop treatment with this medicine until your doctor tells you to do so. 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 treatment with escitalopram is discontinued. 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 within two weeks. However, in some patients they may be severe or prolonged (2–3 months or more). If you experience severe withdrawal symptoms when stopping escitalopram, please contact your doctor. He or she may ask you to resume taking your tablets and taper them 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 lability or irritability; 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, Escitalopram Aurovitas may cause adverse effects, although not everyone experiences them.

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

Visit your doctor or go to hospital immediately if you experience any of the following adverse effects during treatment:

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.

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

• Difficulty urinating.
• Seizures (fits); see also section “Warnings and precautions”.
• Yellowing of the skin or whites of the eyes, signs of liver dysfunction/hepatitis.
• If you experience fast or irregular heartbeats or fainting, symptoms which may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of harming yourself or thoughts of killing yourself; see also section 2 “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 sick (nausea).
• Headache.

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

• Nasal congestion or mucus (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty sleeping, feeling drowsy, dizziness, yawning, tremors, skin itching.
• Diarrhoea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (delayed ejaculation, erection problems, reduced sexual drive, 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, agitation, nervousness, panic attacks, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Vaginal bleeding.
• Weight loss.
• Fast heartbeat.
• Swelling of arms and legs.
• Nosebleeds.

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

• Aggression, depersonalization, hallucinations.
• Slow heartbeat.

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

• Decreased levels of sodium 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 abnormal bleeding, e.g. of the skin and mucous membranes (bruising).
• Increased secretion of ADH hormone, causing the body to retain water and dilute the blood, reducing sodium levels (inappropriate ADH secretion).
• Milk discharge in men and in women not breastfeeding.
• Mania.
• An increased risk of bone fractures has been observed in patients treated with this type of medicine.
• Changes in heart rhythm (known as “prolongation of the QT interval”, seen on ECG, the heart's electrical activity).
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy” in section 2 for more information.

In addition, other adverse effects are known to occur with medicines that act similarly to escitalopram (the active substance in Escitalopram Aurovitas). These include:

• Motor restlessness (akathisia).
• Anorexia.

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the 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 Aurovitas

Keep out of sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, 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 container and other information

Composition of Escitalopram Aurovitas

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

The other components are:

Tablet core: silicified microcrystalline cellulose, butylhydroxytoluene (E321), butylhydroxyanisole (E320), sodium croscarmellose, microcrystalline cellulose, colloidal anhydrous silica, talc and magnesium stearate.

Tablet coating: hypromellose, macrogol 400 and titanium dioxide (E171).

Appearance of the product and contents of the container

White to off-white film-coated oval biconvex tablets marked with “F” on one side and “54” on the other, with a distinct break line between “5” and “4”. Size: 8.1 mm x 5.6 mm.

The tablets can be divided into equal doses.

Pack sizes:

PVC/Aclar-Aluminium blisters: 14, 20, 28, 50, 56, 100 and 500 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19,

2700-487 Amadora,

Portugal

This medicinal product is authorized in the European Economic Area member states under the following names:

Poland: Escitalopram Aurovitas

Portugal: Escitalopram Aurovitas

Spain: Escitalopram Aurovitas 10 mg film-coated tablets EFG

Date of the most recent revision of this leaflet: July 2023

Detailed 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)