ESCITALOPRAM 10 mg Фильм-Coated Таблетки

Содержание инструкции

1. ESCITALOPRAM LABORATORI ALTER 5 mg film-coated tablets, 10 mg film-coated tablets, 15 mg film-coated tablets, 20 mg film-coated tablets
   1. What ESCITALOPRAM LABORATORI ALTER is and what it is used for
   2. What you need to know before taking ESCITALOPRAM LABORATORI ALTER
   3. How to take ESCITALOPRAM LABORATORI ALTER
   4. Possible side effects
   5. How to store ESCITALOPRAM LABORATORI ALTER
   6. Package Contents and Other Information

ESCITALOPRAM LABORATORI ALTER 5 mg film-coated tablets, 10 mg film-coated tablets, 15 mg film-coated tablets, 20 mg film-coated tablets

Generic medicine

Read this leaflet carefully before 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 they have the same symptoms as you, as it may 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 ESCITALOPRAM LABORATORI ALTER is and what it is used for
• 2. What you need to know before you take ESCITALOPRAM LABORATORI ALTER
• 3. How to take ESCITALOPRAM LABORATORI ALTER
• 4. Possible side effects
• 5. How to store ESCITALOPRAM LABORATORI ALTER
• 6. Contents of the pack and other information

1. What ESCITALOPRAM LABORATORI ALTER is and what it is used for

ESCITALOPRAM LABORATORI ALTER contains the active ingredient escitalopram which belongs to the
group of antidepressant medications, called selective serotonin reuptake inhibitors, which
work by regulating mood.
This medicine is indicated for the treatment of the following conditions:

• depressive episodes (major depressive episodes);
• panic attacks, including those caused by fear of open spaces (panic disorder with or without agoraphobia);
• anxiety (social phobia, generalized anxiety disorder);
• repetitive thoughts or behaviors (obsessive-compulsive disorder).

2. What you need to know before taking ESCITALOPRAM LABORATORI ALTER

Do not take ESCITALOPRAM LABORATORI ALTER
if you are allergic to escitalopram oxalate or to any of the other ingredients of this medicine
(listed in section 6);
if you are taking:

• other medicines used for the treatment of depression or for the treatment of disorders associated with depression (MAO inhibitors such as moclobemide). The simultaneous administration of these medicines with ESCITALOPRAM LABORATORI ALTER can cause a disorder called serotonin syndrome which is manifested by agitation, tremor and increased body temperature (See section “Possible side effects”);
• linezolid, a medicine used for the treatment of infections caused by bacteria. Also in this case, the simultaneous use of the two medicines can cause the serotonin syndrome described above;
• medicines that can cause heart rhythm disorders (prolongation of the QT interval). suffer or have suffered in the past from heart rhythm disorders (prolongation of the QT interval or congenital long QT syndrome).

Warnings and precautions
Talk to your doctor or pharmacist before taking ESCITALOPRAM LABORATORI ALTER.
Take this medicine with caution and inform your doctor if:

• you suffer from panic attacks (panic disorder), as you may experience severe anxiety (paradoxical anxiety) at the beginning of treatment. In this case, the doctor will start the treatment with the minimum effective dose. These symptoms usually subside after 2 weeks of treatment;
• you suffer from a form of epilepsy (such as controlled epilepsy) or experience seizures. In this case, the doctor will monitor you and advise you to discontinue treatment if your symptoms worsen. Avoid taking ESCITALOPRAM LABORATORI ALTER if you suffer from unstable epilepsy;
• you suffer from mania/hypomania, because during treatment with ESCITALOPRAM LABORATORI ALTER a shift to the manic phase can be observed, characterized by rapid and unusual changes in thought, physical hyperactivity and excitement. If you experience these symptoms, stop treatment;
• you suffer from diabetes, as treatment with these medicines can cause an alteration of blood sugar levels (hypoglycemia, hyperglycemia). In this case, the doctor will need to adjust the dose of the medicines used to control this disease (insulin, oral hypoglycemic agents);
• you are taking medicines that make the blood more fluid (oral anticoagulants) or other medicines that affect platelet activity (atypical antipsychotics, phenothiazines, tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory drugs, ticlopidine and dipyridamole), if you are predisposed to the risk of bleeding. In this case, bruising (ecchymosis) and red spots on the skin due to capillary rupture (purpura) may occur;
• you are undergoing electroconvulsive therapy (electroshock);
• you are taking medicines used for the treatment of depression (tryptophan), headaches (sumatriptan or other triptans) or to relieve pain (tramadol) (See section “Other medicines and ESCITALOPRAM LABORATORI ALTER”).
• you are taking herbal products containing St. John's Wort ( Hypericum perforatum), as it may increase the risk of side effects (See section “Other medicines and ESCITALOPRAM LABORATORI ALTER”);
• you suffer from heart disease (coronary heart disease);
• you suffer or have suffered in the past from heart problems (significant prolongation of the QT interval, bradycardia, uncompensated heart failure), have recently had a heart attack (acute myocardial infarction), have low levels of potassium or magnesium in the blood (hypokalemia, hypomagnesemia), because the risk of developing heart rhythm disorders, especially in female patients, is greater (prolongation of the QT interval, ventricular arrhythmias including Torsade de Pointes). In this case, the doctor will correct these alterations before starting treatment with ESCITALOPRAM LABORATORI ALTER;
• you or a family member suffers from a disease characterized by increased pressure inside the eye (closed-angle glaucoma).

Immediately stop treatment with this medicine and inform your doctor if you experience:

• agitation, tremor, involuntary muscle contractions (myoclonus), increased body temperature (hyperthermia);
• alteration of the heart rhythm (cardiac arrhythmia).

Talk to your doctor if you experience the following conditions after taking ESCITALOPRAM LABORATORI
ALTER (See also section “Possible side effects”):
akathisia, a condition characterized by restlessness, anguish, need to move frequently and
inability to fall asleep (insomnia), especially at the beginning of treatment;

• reduction of sodium levels in the blood (hyponatremia). This effect is reversible after discontinuation of therapy. Elderly people, people with a severe liver disease (cirrhosis) or who are being treated with medicines that reduce sodium levels in the blood are more exposed to the risk of developing this disorder;

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 or more to show their effect.
For this reason, the doctor will need to monitor you closely.
You are more likely to have these thoughts:

• if you had already thought about suicide or self-harm in the past;
• if you are a young adult. Data from clinical studies have shown a greater risk of suicide-related 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 the hospital.
It may be helpful to inform a relative or close friendthat you are suffering from depression or an anxiety disorder
are worsening or if they are concerned about any change in your
behavior.

Children and adolescents
This medicine is normally not recommended in children and adolescents under the age of 18
years, as there is no information on long-term safety. However, the doctor may prescribe
ESCITALOPRAM LABORATORI ALTER to patients under the age of 18 if they believe this is the
best solution for them. In this case, it is necessary to immediately inform the doctor if suicide attempts occur or suicidal ideation and hostility occur during treatment with
ESCITALOPRAM LABORATORI ALTER.

Other medicines and ESCITALOPRAM LABORATORI ALTER
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Do not take ESCITALOPRAM LABORATORI ALTER and ask your doctor or pharmacist if you are taking
any of the following medicines, the association of which is contraindicated (see section “Do not take
ESCITALOPRAM LABORATORI ALTER”):
non-selective irreversible monoamine oxidase inhibitors (MAOIs), used for the treatment
of depression, because adverse effects, including fatal ones, such as serotonin syndrome, may occur (See section “Do not take ESCITALOPRAM LABORATORI ALTER” and
“Possible side effects”). 14 days must elapse from the end of treatment with the MAO inhibitor before starting treatment with ESCITALOPRAM LABORATORI
ALTER. Also, if you stop
taking ESCITALOPRAM LABORATORI ALTER and need to start treatment with an MAO-
inhibitor, at least 7 days must elapse;
moclobemide (reversible selective MAO-A inhibitor), a medicine used for the treatment
of depression and linezolid (reversible non-selective MAO inhibitor), a medicine used for the
treatment of infections caused by bacteria, except in cases of absolute necessity and under the control of
the doctor who will prescribe the minimum effective dose;

• selegiline (irreversible selective MAO-B inhibitor), a medicine for the treatment of Parkinson's disease;
• medicines that can cause heart rhythm disorders (prolongation of the QT interval) such as:
• antiarrhythmic medicines (class IA and III), used for the treatment of heart rhythm disorders;
• antipsychotic medicines, used for the treatment of mental disorders, such as phenothiazine derivatives, pimozide, haloperidol;
• tricyclic antidepressants
• antimicrobial medicines, used for the treatment of infections caused by bacteria, such as sparfloxacin, moxifloxacin, erythromycin IV, pentamidine;
• antimalarial medicines, such as halofantrine, used for the treatment of an infectious disease called malaria;
• antihistamine medicines, used for the treatment of allergies, such as astemizole and mizolastine.

Take this medicine with caution and inform your doctor if you are taking the following medicines:
sumatriptan and other triptans, medicines used for the treatment of headache (migraine) and tramadol, a
medicine used for the treatment of pain, because the simultaneous administration of these
medicines with ESCITALOPRAM LABORATORI ALTER can, in rare cases, cause a disorder called
serotonin syndrome which is manifested by agitation, tremor and increased body temperature;
medicines that can cause seizures such as: SSRI antidepressants, tricyclic
antidepressants and bupropion used for the treatment of depression; phenothiazines, thioxanthenes and butyrophenones
for the treatment of some mental disorders; tramadol, for relieving severe pain and mefloquine,
used for the treatment of malaria;

• lithium and tryptophan, medicines used for the treatment of some mental disorders;
• products used for the treatment of depression that contain St. John's Wort ( Hypericumperforatum);
• oral anticoagulant medicines, used to make the blood more fluid and other medicines that affect platelet activity such as non-steroidal anti-inflammatory drugs (acetylsalicylic acid) and ticlopidine. In this case, the doctor must monitor you closely, as the risk of bleeding (hemorrhage) is greater;
• medicines that cause a reduction in potassium or magnesium levels in the blood (hypokalemia/hypomagnesemia), because they may increase the risk of developing heart rhythm disorders (malignant arrhythmias);
• medicines for the treatment of stomach disorders (cimetidine, omeprazole, esomeprazole, lansoprazole);
• medicines used for the treatment of heart rhythm disorders (flecainide, propafenone);
• metoprolol, a medicine used for the treatment of heart activity disorders (heart failure);
• other medicines used for the treatment of depression (desipramine, clomipramine, nortriptyline, fluvoxamine);
• medicines used for the treatment of mental disorders (risperidone, thioridazine and haloperidol).

ESCITALOPRAM LABORATORI ALTER with alcohol
ESCITALOPRAM LABORATORI ALTER is not expected to interact with alcohol. However, as
happens with many medicines, the association of ESCITALOPRAM LABORATORI ALTER and alcohol is not
recommended.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy
Do not take ESCITALOPRAM LABORATORI ALTER if you are pregnant , especially in
the last three months (third trimester ), unless absolutely necessary and under strict medical supervision.
If you take ESCITALOPRAM LABORATORI ALTER in the last trimester of pregnancy, you should be aware that the following effects may be observed in the newborn: difficulty breathing, bluish skin discoloration, convulsions, instability of body temperature, difficulty feeding, vomiting,
hypoglycemia (low blood glucose levels), hypertonia or hypotonia, hyperreflexia, tremor, nervousness,
irritability, lethargy, difficulty falling asleep, and difficulty sleeping. If the newborn presents any of
these symptoms, contact your doctor immediately.
This medicine may also increase the risk of a serious condition in babies, 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.
Also, if you take this medicine during pregnancy, avoid abruptly stopping treatment
(See section “If you stop taking ESCITALOPRAM LABORATORI ALTER”).
Breastfeeding
This medicine is not recommended if you are breastfeeding.
Fertility
This medicine may affect the quality of sperm. This effect disappears after
stopping treatment.
No effects on fertility have been reported.

Driving and using machines
This medicine may alter your ability to drive vehicles or use machines because it may reduce
your ability to judge and react in dangerous situations. Therefore, be careful before driving and
using machines.

3. How to take ESCITALOPRAM LABORATORI ALTER

Take this medicine always exactly as your doctor or pharmacist has told you. If you have
any doubts ask your doctor or pharmacist.
Take this medicine in a single dose.
ESCITALOPRAM LABORATORI ALTER can be taken with or without food.
The dosage should never be changed without first consulting your doctor.
Continue to take ESCITALOPRAM LABORATORI ALTER for the entire time that your doctor has recommended
to you. If the treatment is stopped too early, the symptoms may reappear.
If necessary, the tablets (10 mg, 15 mg and 20 mg) can be divided. Place the tablet with the
break line facing upwards, on a flat surface. Press down on the sides of the tablet, as
shown in the figure.

Treatment of major depressive episodes
The recommended dose is 10 mg, once a day. If necessary, your doctor may increase the dose up
to a maximum of 20 mg per day.
It takes 2-4 weeks of treatment to obtain an improvement in symptoms. After the resolution
of the symptoms, continue therapy for at least 6 months.

Treatment of panic disorder with or without agoraphobia
During the first week of treatment, the recommended dose is 5 mg, once a day. Subsequently, the
doctor may increase the dose up to 10 mg per day. Depending on your health condition, the dose may
be further increased up to a maximum of 20 mg per day.
Maximum efficacy is achieved after about 3 months. The treatment lasts for several months.

Treatment of social anxiety disorder
The recommended dose is 10 mg, once a day. Generally, 2-4 weeks are needed to obtain
an improvement in symptoms. Subsequently, based on your health condition, the dose may be
reduced to 5 mg or increased up to a maximum of 20 mg per day.

Social anxiety disorder is a chronic illness, therefore it is recommended to continue treatment for 12
weeks. The benefits of therapy will be evaluated periodically by your doctor.
Social anxiety disorder should not be confused with excessive shyness; treatment is indicated only
if the disorder significantly interferes with your professional and social activities.

Treatment of generalized anxiety disorder
The initial dose is 10 mg, once a day. The dose may be increased up to a maximum of 20 mg
per day, based on your health condition.
The benefits of treatment and the dose of medicine must be checked periodically by your doctor.

Treatment of obsessive-compulsive disorder
The recommended starting dose is 10 mg, once a day, up to a maximum of 20 mg per day, in
based on your health condition.
Since obsessive-compulsive disorder is a chronic illness, patients should be treated until the
symptoms disappear.
The benefits of treatment and the dose of medicine must be checked periodically by your doctor.

Use in the elderly
If you are over 65 years of age, the recommended starting dose is 5 mg, once a day. If necessary, the doctor, in
based on your health condition, may increase the dose up to 10 mg per day. There is no data available in
regarding the effectiveness of ESCITALOPRAM LABORATORI ALTER in the treatment of social anxiety
disorder in elderly people.

Children and adolescents
This medicine is not recommended for children and adolescents under the age of 18 years.

Use in people with kidney problems
If you suffer from severe kidney disorders (severe reduction in kidney function), your doctor must
keep you under close control during treatment with ESCITALOPRAM LABORATORI ALTER.

Use in people with liver problems
If you have liver problems, the recommended starting dose for the first 2 weeks of treatment is 5
mg per day. Based on your health condition, your doctor may decide to increase the dose to 10 mg
per day. If you have severe liver problems, a further dose adjustment is necessary.

If you take more ESCITALOPRAM LABORATORI ALTER than you should
In case of taking an excessive dose of this medicine, the following symptoms may occur:
dizziness, tremors, agitation, increased levels of serotonin (serotonin syndrome);
seizures and coma;

• nausea, vomiting;
• decreased blood pressure (hypotension);
• increased heart rate (tachycardia), altered heartbeat (prolongation of the QT interval, arrhythmias);
• decreased levels of potassium and/or sodium in the blood (hypokalemia, hyponatremia).

In case of accidental ingestion/taking of an excessive dose of this medicine, immediately warn
your doctor or go to the nearest hospital.

If you forget to take ESCITALOPRAM LABORATORI ALTER
Do not take a double dose to make up for the missed tablet.
Just take the next dose, at the usual time.

If you stop taking ESCITALOPRAM LABORATORI ALTER
Do not abruptly stop treatment with this medicine because, within the first few days of
discontinuation, the following symptoms may occur: dizziness, sensory disturbances (sensorium) such as
tingling sensation in the arms and legs (paresthesia) and electric shock sensation, sleep disturbances such as inability to fall asleep (insomnia) and vivid dreams, agitation or
anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhea, increased
perception of heartbeat (palpitations), emotional instability, irritability and visual disturbances.
Generally, these symptoms are mild or moderate in severity and resolve on their own within 2 weeks, although they can sometimes be severe and last for a long time (2-3 months or more).
Discontinuation of treatment must take place under the control of the doctor who will gradually reduce the doses
over 1-2 weeks or several months, if necessary.
If you have any doubts 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 everybody gets 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.
The following side effects may occur:

Very common(may affect more than 1 in 10 people)

• headache;
• nausea.

Common(may affect up to 1 in 10 people)

• decreased or increased appetite, increased body weight;
• anxiety, restlessness, abnormal dreams, sexual dysfunction (decreased libido, anorgasmia in women, ejaculation disorders, impotence);
• insomnia, drowsiness, dizziness, altered sensation in arms and legs (paresthesia), tremor;
• inflammation of the nasal cavities (sinusitis), yawning;
• diarrhea, constipation, vomiting, dry mouth;
• increased sweating;
• joint pain (arthralgia) and muscle pain (myalgia);
• fatigue, fever.

Uncommon(may affect up to 1 in 100 people)

• decreased body weight;
• teeth grinding (bruxism), agitation, nervousness, panic attacks, confusion;
• altered sense of taste, sleep disorders, fainting with loss of consciousness (syncope);
• pupil dilation (mydriasis), vision disorders;
• perception of ringing in the ears (tinnitus);
• increased heart rate (tachycardia);
• nosebleeds (epistaxis);
• bleeding of the stomach or intestines (gastrointestinal hemorrhages);
• skin irritation (urticaria, skin rashes), itching;
• hair loss (alopecia);
• vaginal bleeding at irregular intervals, irregular menstrual cycle (metrorrhagia), heavy and prolonged menstrual bleeding (menorrhagia);
• swelling due to fluid retention (edema).

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

• severe allergic reaction (anaphylaxis);
• aggression;
• personality disorders (depersonalization);
• hallucinations;
• increased levels of serotonin (serotonin syndrome);
• slowed heart rate (bradycardia).

Not known(frequency cannot be estimated from available data)

• decreased number of platelets in the blood (thrombocytopenia);
• increased urine volume (inappropriate secretion of ADH);
• decreased levels of sodium in the blood (hyponatremia), loss of appetite (anorexia);
• mental disorders (mania), suicidal thoughts and suicidal behaviors (See section “Warnings and precautions”);
• movement disorders and difficulty staying still (dyskinesia, psychomotor restlessness, akathisia);
• convulsions;
• heart rhythm disorders (prolongation of the QT interval, ventricular arrhythmias, torsades de pointes);
• feeling of dizziness when getting up due to a drop in pressure (orthostatic hypotension);
• liver inflammation (hepatitis) and altered liver activity (altered liver function tests);
• bruising (ecchymosis), swelling due to fluid accumulation, especially around the mouth and eyes (angioedema);
• decreased need to urinate (urinary retention);
• production of milk in women who are not breastfeeding (galactorrhea);
• painful erection in men (priapism);

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. 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 help provide more information on the safety of this medicine.

5. How to store ESCITALOPRAM LABORATORI ALTER

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 packaging after “Exp”.
The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Do not dispose of any medicine in waste water 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 ESCITALOPRAM LABORATORI ALTER contains
ESCITALOPRAM LABORATORI ALTER 5 mg film-coated tablets

• The active ingredient is escitalopram. Each tablet contains 5 mg of escitalopram (as escitalopram oxalate).
• The other ingredients are:
• tablet core: microcrystalline cellulose, anhydrous colloidal silicon dioxide, talc, sodium croscarmellose, magnesium stearate;
• coating: OPADRY OY-S-28849 containing hypromellose/HPC2910, macrogol 400/PEG400, titanium dioxide (E -171).

ESCITALOPRAM LABORATORI ALTER 10 mg film-coated tablets

• The active ingredient is escitalopram. Each tablet contains 10 mg of escitalopram (as escitalopram oxalate).
• The other ingredients are:
• tablet core: microcrystalline cellulose, anhydrous colloidal silicon dioxide, talc, sodium croscarmellose, magnesium stearate;
• coating: OPADRY OY-S-28849 containing hypromellose/HPC2910, macrogol 400/PEG400, titanium dioxide (E -171).

ESCITALOPRAM LABORATORI ALTER 15 mg film-coated tablets

• The active ingredient is escitalopram. Each tablet contains 15 mg of escitalopram (as escitalopram oxalate).
• The other ingredients are:
• tablet core: microcrystalline cellulose, anhydrous colloidal silicon dioxide, talc, sodium croscarmellose, magnesium stearate;
• coating: OPADRY OY-S-28849 containing hypromellose/HPC2910, macrogol 400/PEG400, titanium dioxide (E -171).

ESCITALOPRAM LABORATORI ALTER 20 mg film-coated tablets

• The active ingredient is escitalopram. Each tablet contains 20 mg of escitalopram (as escitalopram oxalate).
• The other ingredients are:
• tablet core: microcrystalline cellulose, anhydrous colloidal silicon dioxide, talc, sodium croscarmellose, magnesium stearate;
• coating: OPADRY OY-S-28849 containing hypromellose/HPC2910, macrogol 400/PEG400, titanium dioxide (E -171).

Description of the appearance of ESCITALOPRAM LABORATORI ALTER and package contents
ESCITALOPRAM LABORATORI ALTER 5 mg film-coated tablets:pack of 28
tablets.

ESCITALOPRAM LABORATORI ALTER 10 mg film-coated tablets:pack of 14 or 28
tablets.

ESCITALOPRAM LABORATORI ALTER 15 mg film-coated tablets:pack of 28
tablets.

ESCITALOPRAM LABORATORI ALTER 20 mg film-coated tablets:pack of 14 or 28
tablets.

Marketing Authorisation Holder and Manufacturer
Laboratori Alter S.r.l - Via Egadi, 7 - 20144 MILAN - Italy

Manufacturers
West Pharma – Produções de Especialidades Farmacêuticas S.A. - João de Deus, nº11 - Venda Nova, 2700 .

• 486 Amadora - Portugal Atlantic Pharma - Produções Farmacêuticas, S.A. - R. da Tapada Grande, nº2 Abrunheira - 2710-089 Sintra
• Portugal

Only for 10 and 20 mg dosages
Laboratorios Alter S.A. – C/Mateo Inurria, 30 – Madrid (Spain)