ESCITALOPRAM 20 mg /Ml Oral Drops, Solution

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1. Escitalopram Zentiva Italia 20 mg/ml oral drops, solution
   1. What is Escitalopram Zentiva Italia and what is it used for
   2. What you need to know before taking Escitalopram Zentiva Italia
   3. How to take Escitalopram Zentiva Italia
   4. Possible side effects
   5. How to store Escitalopram Zentiva Italia
   6. Contents of the pack and other information

Escitalopram Zentiva Italia 20 mg/ml oral drops, solution

Generic medicine
Read this leaflet carefully before using 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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Escitalopram Zentiva Italia and what is it used for

Escitalopram Zentiva Italia belongs to the group of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs) antidepressants. These medicines help to increase the levels of serotonin in the brain. Alterations of the brain's serotonergic system are considered important factors in the development of depression and related disorders.
The active substance of Escitalopram Zentiva Italia is escitalopram and is used to treat depression (major depressive episodes) and anxiety (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder and obsessive-compulsive disorder) in adults over 18 years of age.
It may take a couple of weeks before you start to feel better. Continue taking Escitalopram Zentiva Italia even if it takes some time before you notice an improvement in your condition.
Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Escitalopram Zentiva Italia

Do not take Escitalopram Zentiva Italia:

• 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 that belong to a group called monoamine oxidase inhibitors (MAO inhibitors), including selegiline (treatment of Parkinson's disease), moclobemide (treatment of depression) and linezolid (an antibiotic);
• if you were born with or have had an episode of abnormal heart rhythm (visible on an electrocardiogram (ECG), a test to assess how your heart is working);
• if you are taking medicines for heart rhythm problems or that can affect your heart rhythm (see section 2 “Other medicines and Escitalopram Zentiva Italia”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Escitalopram Zentiva Italia.
Tell your doctor if you have any other medical 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 Escitalopram Zentiva Italia should be stopped if you experience seizures for the first time or if the frequency of epileptic seizures increases (see also section 4 “Possible side effects");
• if you have thoughts of harming yourself or suicide. See the sub-section “Thoughts of suicide and worsening of depression or anxiety”;
• if you suffer from impaired liver or kidney function. Your doctor may need to adjust the dosage of your medicine;
• if you suffer from diabetes. Treatment with Escitalopram Zentiva Italia may alter blood sugar control. It may be necessary to adjust the dosage of insulin and/or oral hypoglycemic agents;
• if your sodium level in the blood is low;
• if you are under 18 years of age;
• if you have suffered from mania or manic depression in the past;
• if you have a tendency to bleed or bruise easily;
• if you are taking another medicine, including herbal medicines. See the sub-section “Other medicines and Escitalopram Zentiva Italia”;
• if you are undergoing electroconvulsive therapy (ECT);
• if you suffer from closed-angle glaucoma or have suffered from glaucoma in the past;
• if you suffer from coronary heart disease;
• if you are pregnant or breastfeeding;
• 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 think your body may have lost a lot 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 standing up, which may indicate an irregular heart rate.
• if you use this medicine together with buprenorphine. This combination can lead to serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Escitalopram Zentiva Italia").
• if you have a history of bleeding disorders or if you are pregnant (see "Pregnancy").

Keep in mind
Some patients with manic-depressive illness may enter a manic phase. This is
characterized by rapidly changing unusual ideas, 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 occur during the
first weeks of treatment. If you experience these symptoms, tell your doctor immediately.
If you suffer from panic disorder, you may experience an increase in anxiety symptoms at the beginning of
treatment. Tell your doctor immediately if you experience these symptoms.
Medicines such as Escitalopram Zentiva Italia (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) can cause symptoms of sexual
dysfunction (see section 4). In some cases, persistence of these symptoms has been observed after
discontinuation of treatment.

Thoughts of suicide and worsening of your depression or anxiety
If you have 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.
You are more likely to have these thoughts:

• if you have previously had thoughts of harming yourself or committing suicide;
• if you are a young adult. Data from clinical studies have shown an increased 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 hospital.
It may help to tell a relativeor a good friendthat you suffer from depression or that your depression or anxiety is getting worse or if they are concerned about any
change in your behavior.
Use in children and adolescents under 18 years of age
Normally Escitalopram Zentiva Italia should not be taken by children and adolescents under
18 years of age. You should also know that, if this class of medicines is taken, the
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, the doctor may prescribe Escitalopram Zentiva Italia to
patients under 18 years of age if they believe this is the best solution for them. If the doctor
has prescribed Escitalopram Zentiva Italia to a patient under 18 years of age and you want to have
more information, contact the doctor again. You should tell the doctor if any of the above symptoms
appear or worsen during the taking of Escitalopram Zentiva Italia by a patient of
under 18 years of age. Furthermore, the effects on long-term safety of Escitalopram Zentiva Italia
relating to growth, maturation and cognitive and behavioral development have not yet been
demonstrated in this age group.

Other medicines and Escitalopram Zentiva Italia
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 and isocarboxazide, nialamide and tranylcypromine as active ingredients. If you have taken any of these medicines you must wait 14 days before starting to take Escitalopram Zentiva Italia. After stopping taking Escitalopram Zentiva Italia you must allow 7 days to pass 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 (an amino acid).
• Other medicines used for the treatment of depression such as tricyclic antidepressants or other selective serotonin reuptake inhibitors (SSRIs) such as imipramine, desipramine and fluvoxamine.
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used for severe pain). These medicines increase the risk of side effects.
• Buprenorphine (strong painkiller). These medicines may interact with Escitalopram Zentiva Italia and symptoms such as involuntary and rhythmic muscle contractions, including muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exacerbation of reflexes, increased muscle tension, body temperature above 38° C may occur. Contact your doctor when you experience these symptoms, they increase the risk of side effects.
• Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers or dyspepsia (indigestion)), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These medicines can cause an increase in the levels of escitalopram 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 anticoagulants). These can increase the tendency to bleed.
• Warfarin, dipyridamole and phenprocoumone (medicines used to thin the blood, so-called anticoagulants). Your doctor will probably check your blood clotting time at the beginning and end of therapy with Escitalopram Zentiva Italia, so as to verify whether your dose of anticoagulant is still adequate.
• Mefloquine (used to treat malaria), tricyclic antidepressants or selective serotonin reuptake inhibitors (SSRIs), bupropion (used to treat depression), tramadol (used to treat severe pain), and neuroleptics (medicines for the treatment of schizophrenia, psychosis), due to the possible risk of a lowering of the convulsive threshold.
• Flecainide, propafenone and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants) and risperidone, thioridazine and haloperidol (antipsychotics). The dosage of Escitalopram Zentiva Italia 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 takeEscitalopram Zentiva Italia if you are taking medicines for heart rhythm problems or that
can affect your heart rhythm, such as, for example, Class IA and III antiarrhythmics, antipsychotics
(such as phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial
agents (such as sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatments, in
particular halofantrine), some antihistamines (astemizole, mizolastine).
If you have any further doubts, contact your doctor.

Escitalopram Zentiva Italia with food, drinks and alcohol
Escitalopram Zentiva Italia can be taken with or without food (see section 3 “How
to take Escitalopram Zentiva Italia”).
Escitalopram Zentiva Italia is not expected to interact with alcohol. However, as is the case with
many medicines, the combination of Escitalopram Zentiva Italia and alcohol is not recommended.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Do not take Escitalopram Zentiva Italia if you are pregnant or breastfeeding unless your doctor
has discussed the risks and benefits of treatment with you.
If you take Escitalopram Zentiva Italia in the last 3 months of pregnancy, you should be aware that the
following side effects may be observed in the newborn: difficulty breathing, bluish skin discoloration, seizures, instability of body temperature, difficulty feeding, vomiting,
hypoglycemia (low blood glucose levels), hypertonia or hypotonia, hyperreflexia, tremor, nervousness,
irritability, lethargy, persistent crying, drowsiness and difficulty sleeping. If the newborn presents any
of these symptoms, contact your doctor immediately.
Make sure that your midwife and/or doctor know that you are taking Escitalopram Zentiva Italia.
When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines such as
Escitalopram Zentiva Italia can increase the risk of a serious condition in babies, called
persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster
and 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.
If you take Escitalopram Zentiva Italia towards the end of pregnancy, there may be an increased
risk of heavy vaginal bleeding immediately after birth, especially if you have a history of bleeding
disorders. Your doctor or midwife should be informed that you are taking Escitalopram Zentiva
Italia so that they can advise you.
Sudden discontinuation of treatment with Escitalopram Zentiva Italia should be avoided
during pregnancy.
Citalopram, a medicine similar to escitalopram, has shown in animal studies to reduce
sperm quality. Theoretically, this could affect fertility, but the impact on human fertility
has not yet been observed.

Driving and using machines
It is recommended not to drive vehicles or use machines until you know what effect
Escitalopram Zentiva Italia has on you.

Escitalopram Zentiva Italia 20 mg/ml oral drops, solution contains alcohol and sodium
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose. Each drop
contains 4.8 mg of ethanol.
This medicine contains less than 1mmol of sodium (23 mg) per dose, meaning it is essentially “sodium-free”.

3. How to take Escitalopram Zentiva Italia

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Count the necessary number of drops to pour into the drink (water, orange juice or apple juice),
briefly shake the glass and drink all of the drink.
Escitalopram Zentiva Italia oral drops should not be mixed with liquids other than water, orange juice or
apple juice, nor should it be mixed with other medicines.

Adults

Depression
The usual recommended dose of Escitalopram Zentiva Italia is 10 mg (10 drops) per day, in a single
dose. This dose may be increased by your doctor up to a maximum of 20 mg (20 drops) per day.

Panic disorder
The initial dose of Escitalopram Zentiva Italia for the first week of treatment is 5 mg (5 drops)
per day, then increased to 10 mg (10 drops) per day. Your doctor may increase this dose
up to a maximum of 20 mg (20 drops) per day.

Social anxiety disorder
The normally recommended dose of Escitalopram Zentiva Italia is 10 mg (10 drops) per day, in a
single dose.
Your doctor may decrease the dose to 5 mg (5 drops) per day or increase it up to a maximum of 20 mg
(20 drops) per day, based on your individual response to treatment.

Generalized anxiety disorder
The normally recommended dose of Escitalopram Zentiva Italia is 10 mg (10 drops) per day, in a
single dose. This dose may be increased by your doctor up to a maximum of 20 mg (20 drops) per
day.

Obsessive-compulsive disorder
The normally recommended dose of Escitalopram Zentiva Italia is 10 mg (10 drops) per day, in a
single dose. This dose may be increased by your doctor up to a maximum of 20 mg (20 drops) per
day .

Elderly (over 65 years of age)
The recommended initial dose of Escitalopram Zentiva Italia is 5 mg (5 drops) per day, in a single
dose. This dose may be increased by your doctor up to 10 mg (10 drops) per day.

Children and adolescents (under 18 years of age)
Normally Escitalopram Zentiva Italia should not be taken by children and adolescents. For
further information see also paragraph 2 “What you need to know before you take Escitalopram
Zentiva Italia”).

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

If you take more Escitalopram Zentiva Italia than you should
If you have taken a dose of Escitalopram Zentiva Italia higher than that prescribed, you should contact your
doctor or go immediately to the Emergency Room of the nearest hospital, even if you have no signs of
illness. Some of the symptoms of overdose may be
dizziness, tremor, agitation, convulsions, coma, nausea, vomiting, altered heart rate,
decreased blood pressure and changes in electrolyte balance. Bring with you the
bottle/box of Escitalopram Zentiva Italia when you go to a doctor or to the hospital.

If you forget to take Escitalopram Zentiva Italia
If you forget to take a dose of Escitalopram Zentiva Italia, do not take a double dose.
If you forget to take a dose of Escitalopram Zentiva Italia and remember before bedtime, take it
immediately.
Continue taking as usual the next day. If instead you remember during the night
or the next day, skip the missed dose and continue with the normal dosage.

If you stop taking Escitalopram Zentiva Italia
Do not stop taking Escitalopram Zentiva Italia until your doctor tells you to. When
you have completed the treatment with Escitalopram Zentiva Italia, it is generally recommended that
the dose of Escitalopram Zentiva Italia be gradually reduced over a couple of weeks.
When you stop taking Escitalopram Zentiva Italia, especially if you stop it
suddenly, you may experience withdrawal symptoms. These are common when stopping
treatment with Escitalopram Zentiva Italia. The risk is greater if you have taken Escitalopram Zentiva
Italia 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 generally 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 Escitalopram Zentiva
Italia, tell your doctor. They may ask you to restore treatment and continue reducing the
doses more gradually.
Withdrawal symptoms include: dizziness (feeling unstable or off balance), tingling sensations, burning
sensation (less common), electric shock sensation, even
in the head, sleep disturbances (vivid dreams, nightmares, difficulty sleeping), anxiety, headache, malaise
(nausea), sweating (including night sweats), restlessness or agitation, tremor
(shaking), confusion or disorientation, excessive emotionality or irritability, diarrhea (loose stools),
visual disturbances, heart rhythm disturbances (palpitations).
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 everyone 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.

If you experience the following side effects during treatment, contact your
doctor immediately:
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 on the skin, tongue, lips or face or if you have difficulty breathing or a feeling of suffocation (allergic reaction), contact your doctor or go to hospital immediately
• high fever, agitation, confusion, tremors and sudden muscle contractions may be symptoms 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
hospital:

• difficulty urinating
• seizures (convulsions), 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):

• discomfort (nausea)
• headache.

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

• blocked or runny nose (sinusitis)
• decreased or increased appetite
• anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin changes
• 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, confused state
• disturbed sleep, changes in taste, fainting (syncope)
• pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• hair loss
• vaginal bleeding
• weight loss
• increased heart rate (tachycardia)
• swelling of arms or legs
• nosebleeds
• Heavy vaginal bleeding immediately after childbirth (postpartum hemorrhage), see "Pregnancy" in paragraph 2 for more information

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

• aggression, depersonalization, hallucinations
• slowing of the heartbeat.

Some patients have reported (based on available data the frequency cannot be estimated):

• thoughts of self-harm or suicide (see also paragraph 2 “What you need to know before taking Escitalopram Zentiva Italia”)
• decreased sodium levels in the blood (symptoms are feeling unwell with muscle weakness or confusion)
• dizziness when getting up due to a drop in blood pressure (orthostatic hypotension)
• abnormalities in liver function tests (increased liver enzyme levels in the blood) and in the ECG (electrocardiogram)
• 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)
• increased levels of the hormone prolactin in the blood
• 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 for drugs that act like escitalopram
(active ingredient of Escitalopram Zentiva Italia). And they are:

• motor restlessness (akathisia), the urge or need to move to stop an unpleasant sensation (akathisia)
• anorexia.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. Side effects can also be reported directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. Reporting side effects helps to provide more information
about the safety of this medicine.

5. How to store Escitalopram Zentiva Italia

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 label of the
bottle after Exp. (the expiry date).
The expiry date refers to the last day of that month.
After first opening, the oral drops solution must be used within 8 weeks and stored at a
temperature below 25°C.
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. Contents of the pack and other information

What Escitalopram Zentiva Italia contains
The active ingredient is escitalopram. Each ml of Escitalopram Zentiva Italia oral drops contains 20 mg of
escitalopram (equivalent to 25.551 mg of escitalopram oxalate).
1 drop contains 1 mg of escitalopram.
The other excipients are:
propyl gallate
anhydrous citric acid
96% ethanol
sodium hydroxide
purified water.

Description of the appearance of Escitalopram Zentiva Italia and contents of the pack
Escitalopram Zentiva Italia oral drops, solution is available in a dark glass dropper bottle of
15 ml and child-resistant closure.
Escitalopram Zentiva Italia oral drops, solution is a transparent solution, from almost colorless to
yellowish.

Marketing Authorisation Holder
Zentiva Italia Srl, Via P. Paleocapa 7, 20121 Milano - Italy

Manufacturer
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe 1, 29016 Cortemaggiore (PC)-Italy
Vamfarma S.r.l. , Via Kennedy 5, 26833 Comazzo (LO) – Italy