ESCERTAL 10 mg Orodispersible Tablet

Зміст інструкції

1. Escertal 10 mg orodispersible tablets, 20 mg orodispersible tablets
   1. What is Escertal and what is it used for
   2. What you need to know before taking Escertal
   3. How to take Escertal
   4. Possible side effects
   5. How to store Escertal
   6. Package contents and other information
2. Escertal 20 mg orodispersible tablets

Escertal 10 mg orodispersible tablets, 20 mg orodispersible tablets

Escitalopram
Generic medicine
Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Escertal and what is it used for

Escertal belongs to a group of antidepressant medications called Selective Serotonin Reuptake Inhibitors (SSRIs). These medications act on the serotonergic system of the brain by increasing the level of serotonin. Alterations of the serotonergic 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 any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines that belong to a 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 were born with or have had an episode of abnormal heart rhythm (visible via ECG (electrocardiogram), an examination to assess how your heart is working).
• If you are taking medicines for heart rhythm problems or that can affect the heart rhythm (see section 2 “Other medicines and Escertal”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Escertal.
Tell your doctor if you have any other conditions or illnesses, as your doctor may need to take them into
consideration. In particular, tell your doctor:

• if you suffer from epilepsy. Treatment with Escertal should be stopped if you experience convulsions for the first time or if the frequency of epileptic seizures increases (see also section 4 “Possible side effects");
• if you suffer from impaired liver or kidney function. An adjustment of the dosage may be necessary by your doctor;
• if you suffer from diabetes. Treatment with Escertal may alter blood glucose control. It may be necessary to adjust the dosage of insulin and/or oral hypoglycemic agents;
• if you have a low level of sodium in your blood;
• if you have a tendency to bleed or bruise;
• if you are undergoing electroconvulsive therapy;
• if you suffer from coronary heart disease;
• if you suffer from or have suffered from heart problems or have recently had a heart attack;
• if you have a low resting heart rate and/or if you know that your body may have experienced a loss of salt following severe and prolonged diarrhea and vomiting or the use of diuretics (water tablets);
• if you experience a fast or irregular heartbeat, fainting, collapse or dizziness when getting up, which may indicate an abnormality of the heart rate;
• if you suffer from eye problems, such as certain types of glaucoma or have suffered from glaucoma in the past.

Keep in mind
Some patients with manic-depressive illness may enter a manic phase. This is
characterized by unusual and rapidly changing ideas, inappropriate and excessive physical
activity. If you experience these feelings, contact your doctor.
Symptoms such as restlessness or difficulty sitting still or standing up may also occur during the
first weeks of treatment. If these symptoms occur, inform your doctor immediately.

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

• If you have previously thought about suicide or self-harm.
• If you are a young adult. Data from clinical studies have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders treated with an antidepressant.

If at any time you should think about harming yourself or committing suicide, contact your doctor or go
immediately to hospital.
It may be helpful to tell a relativeor a good friendthat you are suffering from depression or that
they think your depression or anxiety is getting worse, or if they are worried about any
change in your behavior.

Children and adolescents
Normally Escertal should not be taken by children and adolescents under 18 years of age.
In addition, you should know that, if this class of medicines is taken, patients under 18
years of age have an increased risk of side effects such as suicide attempts, suicidal ideation and hostility (essentially aggression, oppositional behavior and anger). Despite
the above, your doctor may prescribe Escertal to patients under 18 years of age if they believe that
this is the best solution for them. If your doctor has prescribed Escertal to a patient under 18 years of age and you would like more information, contact your doctor. You should inform your
doctor if any of the symptoms listed above appear or worsen during the taking of Escertal by
patients under 18 years of age. In addition, the effects on long-term safety of Escertal
relating to growth, maturation and cognitive and behavioral development have not yet been
demonstrated 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.
Tell your doctor if you are taking any of the following medicines:

• “Non-selective monoamine oxidase inhibitors (MAOIs)”, containing phenelzine, iproniazide, isocarboxazide, nialamide and tranylcypromine as active ingredients. If you have taken any of these medicines you must wait 14 days before starting to take Escertal. After stopping taking Escertal you must wait 7 days before taking any of these medicines;
• “Selective reversible 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 medicines increase the risk of side effects;
• The antibiotic linezolid;
• Lithium (used for the treatment of manic-depressive 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 medicines increase the risk of side effects;
• Cimetidine and omeprazole (used for the treatment of stomach ulcers), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These medicines can cause an increase in the levels of Escertal 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, the so-called antiplatelet agents). These can increase the tendency to bleed,
• Warfarin, dipyridamole and phenprocoumone (medicines used to thin the blood, the so-called anticoagulants). Your doctor will probably check your blood clotting time at the beginning and end of therapy with Escertal, so as to verify whether your dose of anticoagulant is still adequate,
• 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 a lowering of the seizure threshold.
• Neuroleptics (medicines for the treatment of schizophrenia, psychosis) due to the possible risk of a lowering of the seizure threshold, and antidepressants;
• Flecainide, propafenone and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants) and risperidone, thioridazine and haloperidol (antipsychotics). The dosage of Escertal may need to be adjusted;
• Medicines that reduce the levels of potassium or magnesium in the blood as these conditions increase the risk of life-threatening heart rhythm disorders.

Do not take Escertal if you are taking medicines for heart rhythm problems or medicines that can
affect the heart rhythm, such as Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (e.g.
sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatments, in particular
halofantrine), some 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, the combination of Escertal and alcohol is not recommended, however
Escertal is not expected to interact with alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Escertal if you are pregnant or breastfeeding unless your doctor has discussed with
you the risks and benefits of treatment.
If you take Escertal in the last 3 months of pregnancy, you should be aware that the following effects
may be observed in the newborn: difficulty breathing, bluish skin color, convulsions, instability of body temperature, difficulty feeding, vomiting, low blood glucose levels, muscle stiffness and flaccidity, vivid reflexes, tremor, nervousness, irritability,
lethargy, continuous crying, difficulty falling asleep. If the newborn presents any of these
symptoms, contact your doctor immediately.
Escitalopram, if taken during pregnancy, should never be stopped abruptly.
Make sure your midwife and/or doctor know that you are taking Escertal.
When taken during pregnancy, especially in the last 3 months of pregnancy, medicines such as
Escertal can increase the risk of a serious condition in children, called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and makes them appear
bluish. These symptoms usually appear within the first 24 hours of the baby's birth. If
this happens to your baby, you should contact your midwife and/or doctor immediately.
Citalopram, a medicine similar to escitalopram, in studies on animals, has been shown to reduce the quality
of sperm. 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 vehicles or use machines until you know what effect
Escertal has on you.
Escertal contains lactose.
If you have been told by your doctor that you have intolerance to some sugars, consult your doctor before
taking this medicine.

3. How to take Escertal

Take this medicine always exactly as your doctor or pharmacist has told you. If you have
any doubts ask your doctor or pharmacist.
Escertal orodispersible tablets are taken every day as a single daily dose. You can
take Escertal with or without food.
The orodispersible tablets of Escertal break easily, therefore you must handle the
tablets with care.
Do not handle the tablets with wet hands as the tablets may break.
The tablet does not have a score line and cannot be divided into equal parts. You should use
another pharmaceutical form if you want the 5 mg or 15 mg dose. If you are not sure, ask your doctor or
pharmacist.

• 1. Hold the blister pack by the edges and separate one cell from the rest by gently tearing along the perforated line.
• 2. Gently peel off the backing.
• 3. Place the tablet on your tongue. The tablet will dissolve quickly and can be swallowed without water.

Adults

Depression
The normally recommended dose of Escertal is 10 mg per day, as a single dose. The dose may be
increased by your doctor up to a maximum of 20 mg per day.

Panic disorder
The initial dose of Escertal for the first week of treatment is 5 mg per day, as a single dose, for
then to be increased to 10 mg per day. The dose may be further increased by your doctor up to
a maximum of 20 mg per day.

Social anxiety disorder
The normally recommended dose of Escertal is 10 mg per day, as a single dose. Your doctor may both
decrease the dose to 5 mg per day or increase it up to a maximum of 20 mg per day, based
on your individual response to the medicine.

Generalized anxiety disorder
The normally recommended dose of Escertal is 10 mg per day, as a single 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 Escertal is 10 mg per day, as a single 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 Escertal is 5 mg per day, as a single dose. The dose may be
increased by your doctor up to 10 mg per day.

Use in children and adolescents
Normally Escertal should not be taken by children and adolescents. For further information
see also paragraph 2 “What you need to know before you take Escertal”.

Duration of treatment
It may take a couple of weeks before you start to feel better. Continue to take
Escertal even if there is no immediate improvement in your condition.
The dose should never be changed without first consulting your doctor.
Continue to take Escertal for as long as your doctor has recommended. If the treatment
is stopped too early, the symptoms may return. It is recommended to continue the treatment
for at least six months after the symptoms have resolved.

If you take more Escertal than you should
If you have taken a dose of Escertal higher than that prescribed, contact your doctor or go
immediately to the Emergency Room of the nearest hospital. Do this even if you have
no signs of discomfort. Some of the signs of overdose may be dizziness, tremor, agitation,
convulsions, coma, nausea, vomiting, altered heart rhythm, decreased blood
pressure and altered electrolyte balance. Bring the Escertal pack with you when you go to your
doctor or to the hospital.

If you forget to take Escertal
Do not take a double dose to make up for a missed dose. If you forget to take a
dose and remember before bedtime, take it immediately. Continue taking as usual the next day. If instead you only remember during the night, or the next day, skip the missed dose
and continue with the normal dosage.

If you stop taking Escertal
Do not stop taking Escertal until your doctor tells you to. When you have completed
the treatment, it is generally recommended that the dose of Escertal is gradually reduced over
a few weeks.
When you stop taking Escertal, especially if you stop it suddenly, you may
experience withdrawal symptoms. These are common when stopping treatment with Escertal.
The risk is greater if you have taken Escertal for a long time or in high doses or if the dose is reduced
too quickly. Most patients have found that these symptoms are mild and
disappear spontaneously within a couple of weeks. However, in some patients, the
withdrawal symptoms may be severe or may persist over time (2-3 months or
more). If you experience severe withdrawal symptoms when stopping treatment with Escertal, tell
your doctor who may ask you to take the tablets again and continue reducing them more
gradually.
Withdrawal symptoms include: dizziness (feeling unstable or off balance), tingling sensation
like pins and needles, burning sensation and (less commonly) electric shock sensation, even
in the head, sleep disturbances (vivid dreams, nightmares, difficulty sleeping), feeling anxious, headache, unwellness (nausea), sweating (including night sweats), restlessness or agitation,
tremor (shaking), confusion or disorientation, emotionality or irritability, diarrhea (loose stools),
visual disturbances, heart rhythm disturbances (palpitations).
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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. Please note that many of the side effects can also be symptoms of your illness and, therefore,
decrease when you start to feel better.

If you experience any of the following side effects during treatment, see 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):

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

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

• Difficulty urinating
• Convulsions (seizures), see also paragraph “Warnings and precautions”
• Yellowing of the skin and whites of the eyes are signs of impaired liver function/hepatitis
• Rapid, 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):

• Nasal congestion or nasal secretions (sinusitis)
• Decreased or increased appetite
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin tingling
• Diarrhea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain (arthralgia and myalgia)
• Sexual dysfunction (delayed ejaculation, problems with erection, decreased sexual drive, and women may have difficulty reaching orgasm)
• Fatigue, fever
• Weight gain.

Uncommon (may affect up to 1 in 100):

• Hives, skin rashes, itching
• Teeth grinding, agitation, nervousness, panic attacks, confusion
• Disturbed sleep, altered taste, fainting (syncope)
• Pupil dilation (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):

• Aggression, depersonalization, hallucinations
• Slowed heartbeat.

Some patients have reported side effects with unknown frequency (frequency cannot be
defined based on available data):

• Thoughts of self-harm or suicide, see also paragraph "Warnings and precautions"
• Decreased sodium levels in the blood (symptoms are feeling unwell with muscle weakness or confusion)
• Dizziness when assuming an upright position, due to a drop in blood pressure (orthostatic hypotension)
• Abnormalities in liver function tests (increased liver enzyme levels in the blood)
• Movement disorders (involuntary muscle movements)
• Painful erections (priapism)
• Abnormal bleeding including that of the skin and mucous membranes (ecchymosis) and low platelet counts in the blood (thrombocytopenia)
• Sudden swelling of the skin or mucous membranes (angioedema)
• Increased urine output (inappropriate secretion of ADH)
• Secretion of milk in women who are not breastfeeding
• Mania
• An increased risk of bone fractures has been observed in patients taking this type of medicine
• Alteration of the heart rhythm (called “prolongation of the QT interval”, assessed by an ECG that records the electrical activity of the heart).

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

• Motor restlessness (akathisia)
• Anorexia.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili . By reporting
side effects, you can contribute to providing 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 which is stated on the package and on the blister after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature; store in the
original packaging to protect the medicine from moisture and light.
Do not dispose of any medicine in 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 ingredient 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 ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose,
potassium polyacrilin, acesulfame potassium, neohesperidin dihydrochalcone, magnesium stearate, mint
flavor [containing maltodextrin (from corn), modified starch E1450 (cerous corn) and peppermint oil
(mentha arvensis)], concentrated hydrochloric acid (for pH adjustment).

Description of the appearance of Escertal and package contents
Escertal 10 mg: tablets of colour from white to off-white, round, flat, with bevelled edges and a
diameter of 9 mm and with "10" imprinted on one side.
Escertal 20 mg: tablets of colour from white to off-white, round, flat, with bevelled edges and a
diameter of 12 mm and with "20" imprinted on one side.
Blisters in packs of: 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 Milan

Manufacturers responsible for batch release
Genepharm S.A.
18 km Marathonos Avenue – 15351 Pallini Attiki, Greece
Pharmadox Helthcare 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 Bucharest, Romania

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Portugal: Escitalopram Zentiva 10 mg orodispersible tablets
Escitalopram Zentiva 20 mg orodispersible tablets
Czech Republic: Escitalopram Zentiva 10 mg orodispersible tablets
Escitalopram Zentiva 20 mg orodispersible tablets
Greece: ESLOREX mouth disintegrating tablet 10 mg
ESLOREX mouth disintegrating tablet 20 mg
France: ESCITALOPRAM ZENTIVA 10 mg orodispersible tablet
ESCITALOPRAM ZENTIVA 20 mg orodispersible tablet
Hungary: Escitalopram-Zentiva 10 mg orally disintegrating tablet
Escitalopram-Zentiva 20 mg orally disintegrating tablet
Italy: Escertal
Romania: Eslorex 10 mg orodispersible tablets
Eslorex 20 mg orodispersible tablets
Slovenia: Escertal 10 mg orodispersible tablets

Escertal 20 mg orodispersible tablets

Slovak Republic: Escitalopram Zentiva 10 mg orodispersible tablets
Escitalopram Zentiva 20 mg orodispersible tablets