Escertal: detailed information

Package leaflet: information for the user

Escertal 10 mg orodispersible tablets, 20 mg orodispersible tablets

Escitalopram
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Escertal is and what it is used for
What you need to know before taking Escertal
How to take Escertal
Possible side effects
How to store Escertal
Contents of the pack and other information

1. What Escertal is and what it is used for

Escertal belongs to a group of antidepressant medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). These medicines act on the brain's serotonin system by increasing the level of serotonin. Alterations in the serotonin system are considered important factors in the development of depression and related disorders.
Escertal contains escitalopram and is used to treat 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).

2. What you need to know before taking Escertal

Do not take Escertal:

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 a group called MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
If you were born with or have experienced an episode of abnormal heart rhythm (detectable via ECG [electrocardiogram], a test to assess heart function).
If you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm (see section 2 “Other medicines and Escertal”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Escertal.
Inform your doctor if you have any other condition or illness, as your doctor may need to take this into account. In particular, inform your doctor:

If you have epilepsy. Treatment with Escertal must be discontinued if seizures occur for the first time or if the frequency of epileptic seizures increases (see also section 4 “Possible side effects”).
If you have impaired liver or kidney function. Your doctor may need to adjust your dose.
If you have diabetes. Treatment with Escertal may alter blood glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic agents.
If you have low sodium levels in the blood.
If you have a tendency to bleed or bruise easily.
If you are undergoing electroconvulsive therapy.
If you have coronary heart disease.
If you have or have had heart problems or have recently had a heart attack.
If you have a slow resting heart rate and/or if you know your body may have lost salt due to severe and prolonged diarrhea and vomiting or due to diuretic use (water tablets).
If you experience a fast or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate an abnormal heart rhythm.
If you have eye problems, such as certain types of glaucoma or have previously had glaucoma.

Please note
Some patients with bipolar disorder may enter a manic phase. This is characterized by unusual and rapidly changing thoughts, inappropriate happiness, and excessive physical activity. If you experience these feelings, contact your doctor.
Symptoms such as restlessness or difficulty sitting or standing still may also occur during the first weeks of treatment. If these symptoms occur, inform your doctor immediately.

Suicidal thoughts and worsening of depression or anxiety disorder
If you suffer from depression and/or anxiety disorders, you may occasionally have thoughts of harming yourself or committing suicide.
These thoughts may be more common at the beginning of treatment with antidepressants, as these medicines usually take about two weeks, and sometimes longer, to show their effect.
You are more likely to have these thoughts:

If you have previously had thoughts of suicide or self-harm.
If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with an antidepressant.

If at any time you have thoughts of harming yourself or committing suicide, contact your doctor or go to hospital immediately.
It may be helpful to inform a family member or a close friend that you suffer from depression or an anxiety disorder, and ask them to read this leaflet. You may ask them to tell you if they think your depression or anxiety is worsening, or if they are concerned about any changes in your behaviour.

Children and adolescents
Escertal is generally not intended for use in children and adolescents under 18 years of age.
Furthermore, you should know that patients under 18 years of age taking this class of medicines have an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, oppositional behaviour, and anger). Nevertheless, your doctor may prescribe Escertal to patients under 18 years of age if they consider it the best treatment option. If your doctor has prescribed Escertal to a patient under 18 years of age and you would like more information, please contact your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen during treatment with Escertal in patients under 18 years of age. In addition, the long-term safety effects of Escertal on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.

Other medicines and Escertal
Tell your doctor or pharmacist if you are taking, have recently taken, or might 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, isocarboxazide, nialamide, or tranylcypromine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting Escertal. After stopping Escertal, 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 medicines 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 (used for severe pain). These medicines increase the risk of side effects.
Cimetidine and omeprazole (used to treat stomach ulcers), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in Escertal levels in the blood.
St. John's wort (Hypericum perforatum) – a herbal preparation used for depression.
Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or to thin the blood, so-called antiplatelet agents). These may increase the tendency to bleed.
Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of Escertal treatment to ensure your anticoagulant dose remains appropriate.
Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used for severe pain), due to the possible risk of lowering the seizure threshold.
Neuroleptics (medicines for treating schizophrenia, psychosis) due to the possible risk of lowering the seizure threshold, and antidepressants.
Flecainide, propafenone, and metoprolol (used for cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Escertal may be necessary.
Medicines that reduce potassium or magnesium levels in the blood, as these conditions increase the risk of life-threatening heart rhythm disturbances.

Do not take Escertal if you are taking medicines for heart rhythm problems or medicines 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, intravenous erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), and certain antihistamines (astemizole, mizolastine).

If you have any further doubts, contact your doctor.

Escertal with food, drinks, and alcohol
Escertal can be taken with or without food (see section 3 “How to take Escertal”).
As with many medicines, combining Escertal with alcohol is not recommended; however, no significant interaction between Escertal and alcohol is expected.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Escertal if you are pregnant or breastfeeding unless your doctor has discussed the risks and benefits of treatment with you.
If you take Escertal during the last 3 months of pregnancy, you should be aware that the following side effects may occur in the newborn: breathing difficulties, bluish skin colour, seizures, unstable body temperature, feeding difficulties, vomiting, low blood glucose levels, muscle stiffness or floppiness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, persistent crying, drowsiness, and sleep difficulties. If the newborn shows any of these symptoms, contact your doctor immediately.
Escertal must never be stopped abruptly if taken during pregnancy.
Ensure that your midwife and/or doctor know that you are taking Escertal.
Medicines such as Escertal, when taken during pregnancy, particularly during the last 3 months, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually appear within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
Citalopram, a medicine similar to escitalopram, has been shown in animal studies to reduce sperm quality. In theory, this could affect fertility, but the impact on human fertility has not yet been observed.

Driving and using machines
It is advisable not to drive or operate machinery until you know how Escertal affects you.

Escertal contains lactose.
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Escertal

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Escertal orodispersible tablets are taken daily as a single daily dose. You may
take Escertal with or without food.
Escertal orodispersible tablets break easily, so you must handle the
tablets with care.
Do not handle the tablets with wet hands, as the tablets may break.
The tablet has no score line and cannot be divided into equal parts. You must use
another pharmaceutical form if you require a 5 mg or 15 mg dose. If you are unsure, consult your doctor or pharmacist.

Hold the blister by the edges and gently tear off one blister cell along the perforated line.
Gently peel back the backing.
Place the tablet on your tongue. The tablet will dissolve rapidly and can be swallowed without water.

Adults
Depression
The normally recommended dose of Escertal is 10 mg once daily, as a single dose. Your doctor may
increase the dose up to a maximum of 20 mg daily.
Panic disorder
The initial dose of Escertal for the first week of treatment is 5 mg once daily, then increased to 10 mg
once daily. The dose may be further increased by your doctor up to a maximum of 20 mg daily.
Social anxiety disorder
The normally recommended dose of Escertal is 10 mg once daily, as a single dose. Your doctor may
either reduce the dose to 5 mg daily or increase it up to a maximum of 20 mg daily, depending on
your individual response to the medicine.
Generalized anxiety disorder
The normally recommended dose of Escertal is 10 mg once daily, as a single dose. The dose may be
increased by your doctor up to a maximum of 20 mg daily.
Obsessive-compulsive disorder
The normally recommended dose of Escertal is 10 mg once daily, as a single dose. The dose may be
increased by your doctor up to a maximum of 20 mg daily.
Elderly patients (over 65 years of age)
The recommended starting dose of Escertal is 5 mg once daily, as a single dose. The dose may be
increased by your doctor up to 10 mg daily.
Use in children and adolescents
Escertal should normally not be taken by children and adolescents. For further information,
see also section 2 “What you need to know before taking Escertal”.
Duration of treatment
It may take a few weeks before you start to feel better. Continue taking
Escertal even if you do not experience immediate improvement in your condition.
The dose should never be changed without first consulting your doctor.
Continue taking Escertal for as long as your doctor recommends. If treatment is stopped too early, symptoms may return. It is recommended to continue treatment for at least six months after symptoms have resolved.
If you take more Escertal than you should
If you have taken more Escertal than prescribed, contact your doctor or go
immediately to the nearest hospital emergency department. Do this even if you
have no signs of discomfort. Some signs of overdose may include dizziness, tremor, agitation,
seizures, coma, nausea, vomiting, changes in heart rhythm, low blood pressure, and disturbances in electrolyte balance. Take the Escertal pack with you when you go to the doctor or hospital.
If you forget to take Escertal
Do not take a double dose to make up for the missed dose. If you forget to take a dose and remember before going to bed, take it immediately. Continue taking the medicine as usual the next day. If you remember only during the night or the following day, skip the missed dose and continue with your normal dosing schedule.
If you stop taking Escertal
Do not stop taking Escertal unless your doctor tells you to. When completing treatment, it is generally recommended that the dose of Escertal be gradually reduced over several weeks.
When stopping Escertal, especially if stopped suddenly, you may experience withdrawal symptoms. These are common when stopping treatment with Escertal.
The risk is higher if you have taken Escertal for a long time, at high doses, or if the dose is reduced too quickly. Most patients find that such symptoms are mild and resolve spontaneously within a couple of weeks. However, in some patients, withdrawal symptoms may be severe or may persist for a longer time (2–3 months or more). If you experience severe withdrawal symptoms when stopping treatment with Escertal, inform your doctor, who may advise you to restart taking the tablets and then taper the dose more gradually.
Withdrawal symptoms include: dizziness (feeling unsteady or off balance), sensations of pins and needles, burning sensations, and (less commonly) electric shock-like sensations, even in the head; sleep disturbances (vivid dreams, nightmares, difficulty sleeping); feelings of anxiety; headache; malaise (nausea); sweating (including night sweats); restlessness or agitation; tremor (shaking); confusion or disorientation; emotional lability or irritability; diarrhoea (loose stools); visual disturbances; disturbances in heart rhythm (palpitations).
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects usually disappear after a few weeks of treatment. Please note that many of the side effects may also be symptoms of your illness and therefore decrease as you start to feel better.
If you experience any of the following side effects during treatment, consult your doctor:
Uncommon (may affect up to 1 in 100 people):

Abnormal bleeding, including gastrointestinal bleeding.

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

If you experience swelling of the skin, tongue, lips, or face, or have difficulty breathing or swallowing (allergic reaction), contact your doctor or go to hospital immediately.
If you develop high fever, agitation, confusion, tremor, and sudden muscle contractions, which may be signs of a rare condition called serotonin syndrome. If you experience these symptoms, contact your doctor.

If you experience any of the following side effects, you must contact your doctor immediately or go to hospital:

Difficulty urinating
Seizures (epileptic fits), see also section “Warnings and precautions”
Yellowing of the skin or whites of the eyes, which are signs of impaired liver function/hepatitis
Rapid or irregular heartbeat, feeling faint, which may be symptoms of a life-threatening condition known as Torsades de Pointes.

The following side effects have been reported in addition to those listed above:
Very common (may affect more than 1 in 10 people):

Feeling unwell (nausea)
Headache.

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

Stuffy or runny nose (sinusitis)
Decreased or increased appetite
Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, tingling of the skin
Diarrhoea, constipation, vomiting, dry mouth
Increased sweating
Muscle and joint pain (arthralgia and myalgia)
Sexual dysfunction (delayed ejaculation, erection problems, reduced sexual drive, and women may have difficulty achieving orgasm)
Fatigue, fever
Weight gain.

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

Hives, skin rash, itching
Teeth grinding, agitation, nervousness, panic attacks, confusion
Disturbed sleep, 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 or legs
Nosebleeds.

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

Aggression, depersonalization, hallucinations
Slowed heart rate.

Some patients have reported side effects with unknown frequency (frequency cannot be estimated from the available data):

Thoughts of self-harm (harming oneself) or suicide, see also section “Warnings and precautions”
Decreased sodium levels in the blood (symptoms include feeling unwell with muscle weakness or confusion)
Dizziness upon standing due to a drop in blood pressure (orthostatic hypotension)
Abnormalities in liver function tests (increased levels of liver enzymes in the blood)
Movement disorders (involuntary muscle movements)
Painful erections (priapism)
Abnormal bleeding, including bleeding of the skin and mucous membranes (bruising) and low platelet counts in the blood (thrombocytopenia)
Sudden swelling of the skin or mucous membranes (angioedema)
Increased urine volume (inappropriate ADH secretion)
Milk secretion in women who are not breastfeeding
Mania
An increased risk of bone fractures has been observed in patients taking this type of medicine
Changes in heart rhythm (called “prolongation of the QT interval”, assessed by an ECG that records the heart's electrical activity).

In addition, a number of side effects are known to occur with medicines that act like escitalopram (the active substance in Escertal). These include:

Motor restlessness (akathisia)
Anorexia.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Escertal

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 that month.
This medicine does not require any special storage temperature; store in the
original packaging to protect the medicine from moisture and light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Escertal contains
The active substance is escitalopram.
Escertal 10 mg: Each orodispersible tablet of Escertal contains 10 mg of escitalopram, equivalent
to 12.775 mg of escitalopram oxalate.
Escertal 20 mg: Each orodispersible tablet of Escertal contains 20 mg of escitalopram, equivalent
to 25.55 mg of escitalopram oxalate.
The other components are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose,
polacrilin potassium, potassium acesulfame, neohesperidin dihydrochalcone, magnesium stearate, peppermint flavour [containing maltodextrin (from maize), modified starch E1450 (waxy maize), and peppermint oil (Mentha arvensis)], concentrated hydrochloric acid (for pH adjustment).

Description of the appearance of Escertal and contents of the pack
Escertal 10 mg: tablets white to off-white in colour, round, flat, with bevelled edges and a diameter of 9 mm, marked "10" on one side.
Escertal 20 mg: tablets white to off-white in colour, round, flat, with bevelled edges and a diameter of 12 mm, marked "20" on one side.
Blister packs containing: 7, 10, 14, 20, 28, 30, 56, 60, 90 and 100 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva Italia Srl, Viale L.Bodio n. 37/b - 20158 Milano, Italy

Responsible manufacturers for batch release
Genepharm S.A.
18 km Marathonos Avenue – 15351 Pallini Attiki, Greece
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park – PLA 3000 Paola, Malta
Rontis Hellas S.A.
Medical and Pharmaceutical Products
P.O. Box 3012 Larissa Industrial Area – 41004 Larissa, Greece
S.C. ZENTIVA S.A.
B-dul Theodor Pallady n. 50 sector 3 – 032266 Bucuresti, Romania

This medicinal product is authorised in the European Economic Area countries under the following names:
Portugal: Escitalopram Zentiva 10 mg comprimidos orodispersíveis
Escitalopram Zentiva 20 mg comprimidos orodispersíveis
Czech Republic: Escitalopram Zentiva 10 mg tablety dispergovatelné v ústech
Escitalopram Zentiva 20 mg tablety dispergovatelné v ústech
Greece: ESLOREX δισκίο διασπειρόμενο στο στόμα 10 mg
ESLOREX δισκίο διασπειρόμενο στο στόμα 20 mg
France: ESCITALOPRAM ZENTIVA 10 mg comprimé orodispersible
ESCITALOPRAM ZENTIVA 20 mg comprimé orodispersible
Hungary: Escitalopram-Zentiva 10 mg szájban diszpergálódó tabletta
Escitalopram-Zentiva 20 mg szájban diszpergálódó tabletta
Italy: Escertal
Romania: Eslorex 10 mg comprimate orodispersabile
Eslorex 20 mg comprimate orodispersabile
Slovenia: Escertal 10 mg orodisperzibilne tablete
Escertal 20 mg orodisperzibilne tablete
Slovak Republic: Escitalopram Zentiva 10 mg orodispergovateľné tablety
Escitalopram Zentiva 20 mg orodispergovateľné tablety

This instruction leaflet was last updated on