Escitalopram Laboratori Alter

Package leaflet: Information for the patient

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
Please read this leaflet carefully before taking 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult 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 taking 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 substance escitalopram, which belongs to a
group of antidepressant medicines known as selective serotonin reuptake inhibitors, which
work by regulating mood.
This medicine is indicated for the treatment of the following disorders:

• 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 behaviours (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 to treat depression or conditions associated with depression (MAO inhibitors such as moclobemide). Taking these medicines together with ESCITALOPRAM LABORATORI ALTER may cause a condition called serotonin syndrome, which is characterized by agitation, tremor, and increased body temperature (See section “Possible side effects”);
• linezolid, a medicine used to treat infections caused by bacteria. In this case too, taking both medicines together may cause the serotonin syndrome described above;
• medicines that may cause disturbances in heart rhythm (QT interval prolongation). You suffer from or have previously suffered from heart rhythm disorders (QT interval prolongation 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, your doctor will start treatment with the lowest effective dose. These symptoms usually decrease after 2 weeks of treatment;
• you suffer from a form of epilepsy (such as controlled epilepsy) or have seizures. In this case, your doctor will monitor you closely and may advise you to stop treatment if your symptoms worsen. Avoid taking ESCITALOPRAM LABORATORI ALTER if you have unstable epilepsy;
• you suffer from mania/hypomania, because during treatment with ESCITALOPRAM LABORATORI ALTER a switch to the manic phase may occur, 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 may alter blood sugar levels (hypoglycaemia, hyperglycaemia). In this case, your doctor may need to adjust the dose of medicines used to control this condition (insulin, oral hypoglycaemics);
• you are taking medicines that make the blood thinner (oral anticoagulants) or other medicines that affect platelet function (atypical antipsychotics, phenothiazines, tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory drugs, ticlopidine and dipyridamole), and you are predisposed to bleeding. In this case, bruising (ecchymoses) and red spots on the skin due to capillary rupture (purpura) may occur;
• you are undergoing electroconvulsive therapy (electroshock);
• you are taking medicines used to treat depression (tryptophan), migraine (sumatriptan or other triptans), or pain (tramadol) (See section “Other medicines and ESCITALOPRAM LABORATORI ALTER”);
• you are taking herbal remedies containing St. John’s Wort ( Hypericum perforatum ), as this may increase the risk of side effects (See section “Other medicines and ESCITALOPRAM LABORATORI ALTER”);
• you have heart disease (coronary heart disease);
• you suffer from or have previously suffered from heart problems (significant QT interval prolongation, marked bradycardia, uncompensated heart failure), have recently had a heart attack (acute myocardial infarction), or have low levels of potassium or magnesium in the blood (hypokalaemia, hypomagnesaemia), because the risk of developing heart rhythm disorders, especially in female patients, is higher (QT prolongation, ventricular arrhythmias including Torsade de Pointes). In this case, your doctor will correct these abnormalities before starting treatment with ESCITALOPRAM LABORATORI ALTER;
• you or someone in your family suffers from a condition characterized by increased pressure inside the eye (closed-angle glaucoma).

Stop treatment with this medicine immediately and contact your doctor if you experience:

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

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

• reduced sodium levels in the blood (hyponatraemia). This effect is reversible after stopping treatment. Elderly people, those with severe liver disease (cirrhosis), or those taking medicines that reduce sodium levels in the blood are at higher risk of developing this condition.

Suicidal thoughts and worsening of depression or anxiety disorder
If you suffer from depression and/or anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide. These thoughts may be more common at the beginning of treatment with antidepressants, as these medicines usually take about two weeks or more to show their effect.
For this reason, your doctor must monitor you closely.
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 psychiatric patients under 25 years of age treated with an antidepressant.

If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go immediately to hospital.
It may be helpful to inform a close relative or 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
This medicine is not normally recommended for children and adolescents under 18 years of age, as there is insufficient information on long-term safety. However, your doctor may prescribe ESCITALOPRAM LABORATORI ALTER to patients under 18 years of age if they consider it the best treatment option. In such cases, you must inform your doctor immediately if suicide attempts, suicidal ideation, or hostility occur during treatment with ESCITALOPRAM LABORATORI ALTER.

Other medicines and ESCITALOPRAM LABORATORI ALTER
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take ESCITALOPRAM LABORATORI ALTER and consult your doctor or pharmacist if you are taking any of the following medicines, whose combination is contraindicated (see section “Do not take ESCITALOPRAM LABORATORI ALTER”):
non-selective irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression, because serious, even fatal, side effects may occur, including serotonin syndrome (See section “Do not take ESCITALOPRAM LABORATORI ALTER” and “Possible side effects”). At least 14 days must pass between stopping treatment with an MAO inhibitor and starting ESCITALOPRAM LABORATORI ALTER. Furthermore, if you stop taking ESCITALOPRAM LABORATORI ALTER and need to start treatment with an MAO inhibitor, at least 7 days must pass;
moclobemide (reversible selective MAO-A inhibitor), a medicine used to treat depression, and linezolid (reversible non-selective MAO inhibitor), a medicine used to treat bacterial infections, except in cases of absolute necessity and under medical supervision, with the lowest effective dose prescribed;

• selegiline (irreversible selective MAO-B inhibitor), a medicine used to treat Parkinson’s disease;
• medicines that may cause disturbances in heart rhythm (QT interval prolongation), such as:
• antiarrhythmic medicines (class IA and III), used to treat heart rhythm disorders;
• antipsychotic medicines, used to treat mental disorders, such as phenothiazine derivatives, pimozide, haloperidol;
• tricyclic antidepressants;
• antimicrobial medicines, used to treat bacterial infections, such as sparfloxacin, moxifloxacin, IV erythromycin, pentamidine;
• antimalarial medicines, such as halofantrine, used to treat an infectious disease called malaria;
• antihistamine medicines, used to treat 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 to treat headache (migraine), and tramadol, a medicine used to treat pain, because taking these medicines together with ESCITALOPRAM LABORATORI ALTER may rarely cause a condition called serotonin syndrome, characterized by agitation, tremor, and increased body temperature;
medicines that may cause seizures, such as: SSRIs, tricyclic antidepressants, and bupropion used to treat depression; phenothiazines, thioxanthenes, and butyrophenones used to treat certain mental disorders; tramadol, used to relieve severe pain, and mefloquine, used to treat malaria;
lithium and tryptophan, medicines used to treat certain mental disorders;

• herbal remedies containing St. John’s Wort ( Hypericum perforatum );
• oral anticoagulants, used to make the blood thinner, and other medicines that affect platelet function such as non-steroidal anti-inflammatory drugs (acetylsalicylic acid) and ticlopidine. In this case, your doctor must monitor you closely, as the risk of bleeding (haemorrhage) is increased;
• medicines that cause reduced levels of potassium or magnesium in the blood (hypokalaemia/hypomagnesaemia), because they may increase the risk of developing heart rhythm disorders (malignant arrhythmias);
• medicines used to treat stomach disorders (cimetidine, omeprazole, esomeprazole, lansoprazole);
• medicines used to treat heart rhythm disorders (flecainide, propafenone);
• metoprolol, a medicine used to treat heart conditions (heart failure);
• other medicines used to treat depression (desipramine, clomipramine, nortriptyline, fluvoxamine);
• medicines used to treat mental disorders (risperidone, thioridazine, haloperidol).

ESCITALOPRAM LABORATORI ALTER and alcohol
An interaction between ESCITALOPRAM LABORATORI ALTER and alcohol is not expected. However, as with many medicines, the combination of ESCITALOPRAM LABORATORI ALTER and alcohol is not recommended.

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.

Pregnancy
Do not take ESCITALOPRAM LABORATORI ALTER if you are pregnant, especially during the last three months (third trimester), except in cases of absolute necessity and under strict medical supervision.
If you take ESCITALOPRAM LABORATORI ALTER during the third trimester of pregnancy, be aware that the following effects may occur in the newborn: breathing difficulties, bluish skin colour, seizures, unstable body temperature, feeding difficulties, vomiting, hypoglycaemia (low blood glucose levels), hypertonia or hypotonia, hyperreflexia, tremor, restlessness, irritability, lethargy, persistent crying, drowsiness, and sleep difficulties. If the newborn shows any of these symptoms, contact your doctor immediately.
This medicine may also 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 occur within the first 24 hours after birth. If this happens to your baby, 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 sperm quality. This effect disappears after stopping treatment.
No effects on fertility have been reported.

Driving and using machines
This medicine may impair your ability to drive or operate machinery, as it may reduce your judgment and reactivity in dangerous situations. Therefore, exercise caution before driving or operating machinery.

3. How to take ESCITALOPRAM LABORATORI ALTER

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take this medicine as a single daily dose.
ESCITALOPRAM LABORATORI ALTER may be taken with or without food.
The dosage must never be changed without first consulting your doctor.
Continue taking ESCITALOPRAM LABORATORI ALTER for as long as your doctor has
recommended. If treatment is stopped too early, symptoms may return.
If necessary, the tablets (10 mg, 15 mg, and 20 mg) can be divided. Place the tablet with the
score line facing upwards on a flat surface. Press down on both sides of the tablet, as shown in the figure.

Treatment of major depressive episodes
The recommended dose is 10 mg once daily. If necessary, your doctor may increase the dose up
to a maximum of 20 mg per day.
Treatment for 2–4 weeks is required to achieve symptom improvement. After symptoms have resolved,
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 daily. Afterwards, your doctor may
increase the dose to 10 mg per day. Depending on your clinical condition, the dose may be further increased
up to a maximum of 20 mg per day.
Maximum effectiveness is achieved after approximately 3 months. Treatment lasts for several months.

Treatment of social anxiety disorder
The recommended dose is 10 mg once daily. Symptom improvement generally requires 2–4 weeks.
Thereafter, depending on your clinical 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 condition; therefore, treatment is recommended for at least 12 weeks.
The benefits of therapy will be periodically evaluated by your doctor.
Social anxiety disorder must 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 daily. The dose may be increased up to a maximum of 20 mg per day, depending
on your clinical condition.
The benefits of treatment and the dose of medicine must be periodically reviewed by your doctor.

Treatment of obsessive-compulsive disorder
The recommended initial dose is 10 mg once daily, up to a maximum of 20 mg per day, depending on your
clinical condition.
Since obsessive-compulsive disorder is a chronic condition, patients should be treated until symptoms have
disappeared.
The benefits of treatment and the dose of medicine must be periodically reviewed by your doctor.

Use in elderly patients
If you are over 65 years old, the recommended initial dose is 5 mg once daily. If necessary, your doctor may,
depending on your clinical condition, increase the dose to 10 mg per day. There are no data available regarding
the efficacy of ESCITALOPRAM LABORATORI ALTER in the treatment of social anxiety disorder in elderly
patients.

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

Use in patients with kidney problems
If you suffer from severe impairment of kidney function (severe reduction in renal function), your doctor must
closely monitor you during treatment with ESCITALOPRAM LABORATORI ALTER.

Use in patients with liver problems
If you have liver problems, the recommended initial dose for the first 2 weeks of treatment is 5 mg per day.
Depending on your clinical condition, your doctor may decide to increase the dose to 10 mg per day. If you
have severe liver problems, further dose adjustment is required.

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

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

If you accidentally take too much of this medicine, contact your doctor immediately 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.
Take only the next dose at your usual time.

If you stop taking ESCITALOPRAM LABORATORI ALTER
Do not stop treatment abruptly with this medicine, as the following symptoms may occur within the first few days after discontinuation: dizziness, sensory disturbances such as tingling in the arms and legs (paresthesia) and electric shock sensations, sleep disturbances such as difficulty falling asleep (insomnia) and vivid dreams, agitation or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache (cephalalgia), diarrhea, increased awareness of heartbeats (palpitations), emotional instability, irritability, and visual disturbances.
Generally, these symptoms are mild to moderate in intensity and resolve spontaneously within 2 weeks, although they can sometimes be severe and last for a long time (2–3 months or more).
Discontinuation of treatment should be done under medical supervision, with doses gradually reduced over 1–2 weeks or several months, if necessary.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Please bear in mind that many of the side effects may also be symptoms of your illness and therefore improve as 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, weight gain;
• anxiety, restlessness, abnormal dreams, sexual dysfunction (reduced libido, anorgasmia in women, ejaculation disorders, impotence);
• insomnia, drowsiness, dizziness, altered sensation in arms and legs (paraesthesia), tremor;
• inflammation of the nasal sinuses (sinusitis), yawning;
• diarrhoea, constipation, vomiting, dry mouth;
• increased sweating;
• joint pain (arthralgia) and muscle pain (myalgia);
• fatigue, fever.

Uncommon (may affect up to 1 in 100 people)

• weight loss;
• teeth grinding (bruxism), agitation, nervousness, panic attacks, confusion;
• altered taste perception, sleep disorders, fainting with loss of consciousness (syncope);
• dilation of the pupils (mydriasis), visual disturbances;
• perception of ringing in the ear (tinnitus);
• increased heart rate (tachycardia);
• nosebleeds (epistaxis);
• bleeding from the stomach or intestine (gastro-intestinal haemorrhage);
• skin irritation (urticaria, rashes), itching;
• hair loss (alopecia);
• irregular vaginal bleeding, irregular menstrual cycle (metrorrhagia), prolonged and heavy menstrual bleeding (menorrhagia);
• swelling due to fluid retention (oedema).

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

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

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

• reduced number of platelets in the blood (thrombocytopenia);
• increased urine volume (inappropriate ADH secretion);
• reduced sodium levels in the blood (hyponatraemia), loss of appetite (anorexia);
• mental disturbances (mania), suicidal thoughts and suicidal behaviour (See section “Warnings and precautions”);
• movement disorders and difficulty remaining still (dyskinesia, psychomotor restlessness, akathisia);
• seizures;
• disturbances in heart rhythm (prolongation of QT interval, ventricular arrhythmias, torsade de pointes);
• dizziness upon standing due to a drop in blood pressure (orthostatic hypotension);
• liver inflammation (hepatitis) and altered liver function (abnormal liver function tests);
• bruising (ecchymosis), swelling due to fluid accumulation, particularly around the mouth and eyes (angioedema);
• reduced need to urinate (urinary retention);
• milk production in women who are not breastfeeding (galactorrhoea);
• painful erection in men (priapism).

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 ESCITALOPRAM LABORATORI ALTER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in 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 substance is escitalopram. Each tablet contains 5 mg of escitalopram (as escitalopram oxalate).
• The other components are:
• tablet core: microcrystalline cellulose, anhydrous colloidal silica, 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 substance is escitalopram. Each tablet contains 10 mg of escitalopram (as escitalopram oxalate).
• The other components are:
• tablet core: microcrystalline cellulose, anhydrous colloidal silica, 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 substance is escitalopram. Each tablet contains 15 mg of escitalopram (as escitalopram oxalate).
• The other components are:
• tablet core: microcrystalline cellulose, anhydrous colloidal silica, 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 substance is escitalopram. Each tablet contains 20 mg of escitalopram (as escitalopram oxalate).
• The other components are:
• tablet core: microcrystalline cellulose, anhydrous colloidal silica, 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 contents of the pack
ESCITALOPRAM LABORATORI ALTER 5 mg film-coated tablets: pack containing 28 tablets.
ESCITALOPRAM LABORATORI ALTER 10 mg film-coated tablets: pack containing 14 or 28 tablets.
ESCITALOPRAM LABORATORI ALTER 15 mg film-coated tablets: pack containing 28 tablets.
ESCITALOPRAM LABORATORI ALTER 20 mg film-coated tablets: pack containing 14 or 28 tablets.

Marketing authorization 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

For 10 mg and 20 mg strengths only
Laboratorios Alter S.A. – C/Mateo Inurria, 30 – Madrid (Spain)