Escitalopram Aurovitas Pharma 10 mg orodispersible tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Escitalopram Aurovitas Pharma 10 mg orodispersible tablets EFG

Escitalopram Aurovitas Pharma 15 mg orodispersible tablets EFG

Escitalopram Aurovitas Pharma 20 mg orodispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult 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 could 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

What Escitalopram Aurovitas Pharma is and what it is used for.
What you need to know before taking Escitalopram Aurovitas Pharma.
How to take Escitalopram Aurovitas Pharma.
Possible adverse effects.
Storage of Escitalopram Aurovitas Pharma.

Contents of the pack and other information.

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

Escitalopram Aurovitas Pharma contains the active substance escitalopram. Escitalopram Aurovitas Pharma 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 Aurovitas Pharma 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 taking Escitalopram Aurovitas Pharma, even if it takes some time before you notice any improvement. You should speak with your doctor if you do not feel well or if you feel worse.

2. What you need to know before taking Escitalopram Aurovitas Pharma

Do not take Escitalopram Aurovitas Pharma:

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), and linezolid (an antibiotic).
If you were born with or have previously experienced 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 “Use of Escitalopram Aurovitas Pharma with other medicines”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Escitalopram Aurovitas Pharma.

Please inform your doctor if you have any other disorders or illnesses, as your doctor may need to take them into account. Specifically, tell your doctor:

If you have epilepsy. Treatment with Escitalopram Aurovitas Pharma should be discontinued if seizures occur for the first time or if there is an increase in seizure frequency (see also section 4 “Possible side effects”).
If you have hepatic or renal impairment. Your doctor may need to adjust your dose.
If you have diabetes. Treatment with Escitalopram Aurovitas Pharma may alter glucose control. Adjustment of insulin and/or oral hypoglycemic agent doses may be necessary.
If you have low sodium levels in the 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 or have had heart problems or have recently suffered a heart attack.
If you have a low resting heart rate and/or you know you may have salt depletion due to prolonged and severe diarrhea and vomiting (you feel dizzy) or due to the use of diuretics (water tablets).
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 eye pressure).
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 Pharma”).
Some medicines in the same class as Escitalopram Aurovitas Pharma (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

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.

You may experience symptoms such as restlessness or difficulty sitting still or staying still during the first weeks of treatment. If you experience these symptoms, contact your doctor immediately.

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 or killing yourself. These may increase when starting antidepressants, as all such medicines require time to take effect—usually around 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 or harming yourself.
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 or killing yourself, contact your doctor or go directly to a hospital.

It may help you to tell a family member 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 Aurovitas Pharma should not normally be used to treat 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 (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Escitalopram Aurovitas Pharma to patients under 18 years of age if they decide it is the most appropriate treatment for the patient. If your doctor has prescribed Escitalopram Aurovitas Pharma to a patient under 18 years of age and you wish to discuss this decision, please speak to your doctor again. You should inform your doctor if any of the symptoms described above worsen or become complicated while patients under 18 years of age are taking Escitalopram Aurovitas Pharma. In addition, the long-term effects on safety and on growth, maturation, and cognitive and behavioral development of Escitalopram Aurovitas Pharma in this age group have not yet been established.

Other medicines and Escitalopram Aurovitas Pharma

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 Aurovitas Pharma. After stopping Escitalopram Aurovitas Pharma, you must wait 7 days before taking any of these medicines.
"Reversible selective MAO-A inhibitors" containing moclobemide (used for the treatment of depression).
"Irreversible MAO-B inhibitors" containing selegiline (used for the treatment of Parkinson's disease). These increase the risk of side effects.
The antibiotic linezolid.
Lithium (used for the treatment of bipolar disorder) and tryptophan.
Imipramine and desipramine (both used for the treatment of depression).
Sumatriptan and similar medicines (used for the treatment of migraine) and tramadol (used for severe pain). These increase the risk of side effects.
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 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 (NSAIDs) (medicines used to relieve pain or reduce the risk of thrombosis). 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 Aurovitas Pharma 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 serotonin reuptake inhibitors (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 Aurovitas Pharma may need to be adjusted.
Medicines that reduce potassium and magnesium levels in the blood, as this could increase the risk of heart rhythm disorders, which may be life-threatening.

Some medicines may increase the side effects of escitalopram and sometimes 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, restlessness, 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 Aurovitas Pharma if you are taking medicines for heart rhythm problems or that may 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 treatments, especially halofantrine), and certain antihistamines (astemizole, mizolastine). If you have any doubts about this, you should speak with your doctor.

Taking Escitalopram Aurovitas Pharma with food, drinks, and alcohol

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

As with many medicines, the combination of Escitalopram Aurovitas Pharma and alcohol is not recommended, although no interaction between Escitalopram Aurovitas Pharma and alcohol is 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 Aurovitas Pharma if you are pregnant or breastfeeding unless you and your doctor have discussed the risks and benefits involved.

If you take Escitalopram Aurovitas Pharma 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, jitteriness, irritability, lethargy, constant crying, drowsiness, and sleep difficulties. If your newborn baby shows any of these symptoms, contact your doctor immediately.

Ensure that your midwife and/or doctor know that you are taking Escitalopram Aurovitas Pharma. Medicines such as Escitalopram Aurovitas Pharma, when taken during pregnancy—particularly during the last 3 months—may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

If Escitalopram Aurovitas Pharma is used during pregnancy, it should never be stopped abruptly. Escitalopram Aurovitas Pharma is expected to be excreted in breast milk.

If you take Escitalopram Aurovitas Pharma 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 Aurovitas Pharma so they can advise you.

Citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality in animal studies. In theory, this could affect fertility, but no impact on human fertility has been observed so far.

Driving and using machines

It is advised not to drive or operate machinery until you know how Escitalopram Aurovitas Pharma affects you.

Escitalopram Aurovitas Pharma contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Escitalopram Aurovitas Pharma contains sodium

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

3. How to take Escitalopram Aurovitas Pharma

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

Escitalopram Aurovitas Pharma orodispersible tablets are taken daily as a single daily dose. Escitalopram Aurovitas Pharma may be taken with or without food.

Escitalopram Aurovitas Pharma orodispersible tablets break easily, so the tablets should be handled with care. Do not handle the tablets with wet hands, as they may break.

Hold the blister strip by the edges and separate one blister from the rest of the strip by carefully tearing along the perforations surrounding it.
Carefully peel back the adhesive backing.
Place the tablet on the tongue. The tablet dissolves rapidly and can be swallowed without water.

Adults

Depression

The normally recommended dose of Escitalopram Aurovitas Pharma is 10 mg taken as a single daily dose. Your doctor may increase this up to a maximum of 20 mg per day.

Panic disorder

The recommended starting dose is 5 mg of Escitalopram Aurovitas Pharma per day for the first week, then increased to 10 mg per day, and if necessary up to a maximum of 20 mg per day.

Social anxiety disorder

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

Generalized anxiety disorder

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

Obsessive-compulsive disorder

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

Elderly patients (over 65 years of age)

The recommended dose of Escitalopram Aurovitas Pharma is 5 mg taken as a single daily dose. Your doctor may increase the dose to 10 mg per day.

Children and adolescents (under 18 years of age)

Escitalopram Aurovitas Pharma should not normally be given to children and adolescents. For further information, see section 2 "Before taking Escitalopram Aurovitas Pharma".

Duration of treatment

It may take a few weeks before you start to feel better. Continue taking Escitalopram Aurovitas Pharma even if you start to feel better before the expected time.

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

Continue taking Escitalopram Aurovitas Pharma 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 Pharma than you should

If you take more Escitalopram Aurovitas Pharma than prescribed, contact your doctor immediately, go to the nearest hospital emergency department, or contact the Poison Information Service at telephone number 915 620 420. Do so 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 rhythm, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the Escitalopram Aurovitas Pharma packaging with you if you go to the doctor or hospital.

If you forget to take Escitalopram Aurovitas Pharma

Do not take a double dose to make up for a forgotten dose. 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 Aurovitas Pharma

Do not stop taking Escitalopram Aurovitas Pharma unless your doctor tells you to. When you have completed your course of treatment, it is generally recommended that the dose of Escitalopram Aurovitas Pharma be gradually reduced over several weeks.

When you stop taking Escitalopram Aurovitas Pharma, especially if abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Aurovitas Pharma is stopped. The risk is greater when Escitalopram Aurovitas Pharma has been used for a long time, at high doses, or when the dose is reduced too quickly. Most people find 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 Aurovitas Pharma, please contact your doctor. They may ask you to resume taking your tablets and to stop 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 (overly vivid dreams, nightmares, inability to sleep); restlessness; headache; nausea (feeling dizzy); sweating (including night sweats); feelings of anxiety or agitation; tremor (shakiness); feelings of confusion or disorientation; emotional lability or irritability; diarrhoea (loose stools); visual disturbances; 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 will experience them.

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

If you experience any of the following symptoms, you should contact your doctor or go to hospital immediately:

Uncommon (may affect between 1 and 100 patients):

Unusual bleeding, including gastrointestinal bleeding.

Rare (may affect between 1 and 1,000 patients):

Swelling of the skin, tongue, lips, or face, or difficulty breathing or swallowing (allergic reaction), contact your doctor or go to hospital immediately.
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 and whites of the eyes, indicating impaired liver function/hepatitis.
Rapid and irregular heartbeat, fainting, which could be symptoms of a potentially life-threatening condition known as Torsade de Pointes.
Thoughts of harming yourself or taking your own life, see also 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 patients):

Feeling nauseous (nausea)
Headache

Common (may affect between 1 and 10 patients):

Nasal congestion or runny nose (sinusitis).
Decreased or increased appetite.
Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin itching.
Diarrhea, constipation, vomiting, dry mouth.
Increased sweating.
Muscle and joint pain (arthralgia and myalgia).
Sexual disturbances (delayed ejaculation, erection problems, decreased sexual drive; women may experience difficulty achieving orgasm).
Fatigue, fever.
Weight gain

Uncommon (may affect between 1 and 100 patients):

Hives, skin rash, itching (pruritus).
Teeth grinding, restlessness, nervousness, panic attacks, confusion.
Sleep disturbances, taste disturbances, fainting (syncope).
Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus).
Hair loss.
Excessive menstrual bleeding.
Irregular menstrual periods.
Weight loss.
Rapid heartbeat.
Swelling of arms and legs.
Nosebleeds

Rare (may affect between 1 and 1,000 patients):

Aggression, depersonalization, hallucinations
Slow heart rate

Not known (frequency cannot be estimated from available data):

Decreased sodium levels in the blood, symptoms of which include dizziness, malaise, 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, for example from the skin and mucous membranes (bruising).
Sudden swelling of the skin or mucous membranes (angioedema).
Increased urine output (inappropriate ADH secretion).
Milk discharge 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 (known as "QT interval prolongation", seen on ECG, electrical activity of the heart).
Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

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

Motor restlessness (akathisia)
Loss of appetite

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: Website: www.notificaRAM.es

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

5. Storage of Escitalopram Aurovitas Pharma

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP.

The expiry date refers to the last day of the month indicated.

This medicine does not require special storage temperature conditions. Store in the original packaging to protect it from moisture and light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Escitalopram Aurovitas Pharma

The active substance is escitalopram.

Escitalopram Aurovitas Pharma 10 mg: Each orodispersible tablet of Escitalopram Aurovitas Pharma contains 10 mg of escitalopram, equivalent to 12.775 mg of escitalopram oxalate, or

Escitalopram Aurovitas Pharma 15 mg: Each orodispersible tablet of Escitalopram Aurovitas Pharma contains 15 mg of escitalopram, equivalent to 19.1625 mg of escitalopram oxalate, or

Escitalopram Aurovitas Pharma 20 mg: Each orodispersible tablet of Escitalopram Aurovitas Pharma contains 20 mg of escitalopram, equivalent to 25.55 mg of escitalopram oxalate.

The other components are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, polacriline potassium, acesulfame potassium, neohesperidin dihydrochalcone, magnesium stearate, mint flavouring [contains maltodextrin (corn), modified corn starch (E-1450) and peppermint oil (Mentha arvensis)], concentrated hydrochloric acid (for pH adjustment).

Appearance of the product and contents of the pack

Escitalopram Aurovitas Pharma 10 mg: white to off-white, circular, biconvex tablets with bevelled edges, 9 mm in diameter, marked with "10" on one side.

Escitalopram Aurovitas Pharma 15 mg: white to off-white, circular, biconvex tablets with bevelled edges, 11 mm in diameter, marked with "15" on one side.

Escitalopram Aurovitas Pharma 20 mg: white to off-white, circular, biconvex tablets with bevelled edges, 12 mm in diameter, marked with "20" on one side.

Blister packs in containers of: 12, 14, 20, 28, 50, 56, 60, 98, 100 and 200 orodispersible tablets.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D.

28036 Madrid,

Spain

Manufacturer

Genepharm S.A

18km Marathon Avenue,

15351 Pallini Attiki,

Greece

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

Rontis Hellas, S.A.

Medical and Pharmaceutical Products Industrial Area of Larissa, P.O. Box 3012 Larisa Industrial Area, 41004,

Greece

Pharmapath S.A.

28is Oktovriou 1,

Agia Varvara, 123 51,

Greece

Date of the most recent review of this leaflet: December 2022

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