Package leaflet: Information for the user

Escitalopram Alter

20 mg/ml oral drops, solution
Escitalopram
Equivalent medicine
Please read all of 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, because it may be harmful.
If you experience any adverse reaction, including those not listed in this
leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What is Escitalopram Alter and what is it used for

Escitalopram Alter belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain, increasing the level of serotonin. Disorders of the serotonin system are considered an important factor in the development of depression and related illnesses.
Escitalopram Alter contains escitalopram, which is used to treat:

depression (major depressive episodes)
anxiety disorders (such as panic disorder with and without agoraphobia (fear of crowds/bridges/open spaces))
social anxiety disorder
generalized anxiety disorder 1/13
obsessive-compulsive disorder.

2. What you should know before taking Escitalopram Alter

Do not take Escitalopram Alter

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
if you are taking other medicines belonging to a group called monoamine oxidase inhibitors (MAO inhibitors), including selegiline (used to treat Parkinson’s disease), moclobemide (used to treat depression), or linezolid (an antibiotic)
if you were born with or have had an episode of abnormal heart rhythm (detectable via electrocardiogram (ECG), a test to assess heart function)
if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm (see section 2 “Other medicines and Escitalopram Alter”)

Warnings and precautions
Talk to your doctor or pharmacist before taking Escitalopram Alter. Inform your doctor if you have ever had any of the following conditions or illnesses, as your doctor may need to take them into account:

if you suffer from epilepsy. Treatment with Escitalopram Alter must be discontinued if seizures occur for the first time or if the frequency of epileptic seizures increases (see also section 4 “Possible side effects”)
if you have thoughts of suicide or of harming yourself. See subsection “Suicidal thoughts and worsening of depression or anxiety disorder”
if you have impaired liver or kidney function. Your doctor may need to adjust your dose
if you have diabetes. Treatment with Escitalopram Alter may alter blood glucose control. It may be necessary to adjust the dose of insulin and/or oral antidiabetic medicines
if your blood sodium level is low
if you are under 18 years of age
if you have previously suffered from mania or bipolar depression
if you have a tendency to bleeding or easy bruising
if you are taking any other medicine, including herbal medicines. See subsection “Other medicines and Escitalopram Alter”
if you are undergoing electroconvulsive therapy (ECT)
if you have closed-angle glaucoma or have previously suffered from glaucoma
if you suffer from coronary heart disease
if you are pregnant or breastfeeding
if you have suffered from or currently suffer 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 undergone significant salt loss due to severe and prolonged diarrhoea and vomiting (feelings of malaise) or due to 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 rhythm
taking medicines containing buprenorphine together with ESCITALOPRAM ALTER may lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and ESCITALOPRAM ALTER”). If you suffer from bipolar disorder, you may enter a manic phase, characterized by unusual and rapid changes in thinking, unjustified happiness, and excessive physical activity. If you experience such symptoms, contact your doctor. Symptoms such as restlessness or difficulty remaining seated or standing still (akathisia) may also occur during the first weeks of treatment. Inform your doctor immediately if you experience such symptoms. If you suffer from panic disorder, you may experience an increase in anxiety symptoms at the beginning of treatment. Inform your doctor immediately if you experience these symptoms. Medicines such as Escitalopram Alter (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.

Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of harming yourself or even of suicide. These thoughts may increase at the beginning of treatment with antidepressants, as these medicines take time to work, usually about two weeks but sometimes longer. You may be more likely to have such thoughts if:

you have previously had thoughts of suicide or of harming yourself
you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with an antidepressant. If at any time you have thoughts of harming yourself or of suicide, contact your doctor immediately or go to hospital straight away. You may find it helpful to inform a close family member or friend about your depression or anxiety disorder and ask them to read this leaflet. You may wish to ask them to alert you if they think your depression or anxiety is worsening, or if they are concerned about any changes in your behaviour.

Children and adolescents
Escitalopram Alter should not normally be used in children and adolescents under 18 years of age. In addition, you should know that patients under 18 years of age have a higher risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) when taking this class of medicines. However, your doctor may still prescribe Escitalopram Alter to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Escitalopram Alter to a patient under 18 years of age and you wish to discuss this, speak to your doctor again. You must inform your doctor if any of the symptoms described above appear or worsen while the patient under 18 years of age is taking Escitalopram Alter. In addition, the long-term safety of Escitalopram Alter with regard to growth, maturation, and cognitive and behavioural development in this age group has not yet been established.

Other medicines and Escitalopram Alter
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Inform your doctor if you are taking any of the following medicines:

Non-selective monoamine oxidase inhibitors (MAOIs), containing phenelzine, iproniazid, isocarboxazide, nialamide, or tranilcypramine as active substances. If you have taken any of these medicines, you must wait 14 days before starting Escitalopram Alter. After stopping Escitalopram Alter, you must wait 7 days before taking any of these medicines.
Reversible selective MAO-A inhibitors, containing moclobemide (used to treat depression).
Irreversible MAO-B inhibitors, containing selegiline (used to treat Parkinson’s disease). These medicines increase the risk of side effects.
The antibiotic linezolid.
Lithium (used to treat bipolar disorder) and tryptophan (an amino acid).
Other medicines used to treat depression, such as tricyclic antidepressants or other selective serotonin reuptake inhibitors (SSRIs) such as imipramine, desipramine, fluvoxamine.
Medicines containing buprenorphine. These medicines may interact with ESCITALOPRAM ALTER and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, and body temperature above 38°C. If you experience these symptoms, contact your doctor.
Sumatriptan and similar medicines (used to treat migraine) and tramadol (used for severe pain). These medicines increase the risk of side effects.
Cimetidine, lansoprazole, and omeprazole (used to treat gastric ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in escitalopram levels.
St. John’s wort (Hypericum perforatum), a herbal preparation used for depression.
Aspirin and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or to thin the blood, so-called anticoagulants). Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). Your doctor will likely monitor your blood clotting time at the start and end of treatment with Escitalopram Alter to ensure your anticoagulant dose remains appropriate.
Mefloquine (used to treat malaria), tricyclic antidepressants or selective serotonin reuptake inhibitors (SSRIs), bupropion (used to treat depression), tramadol (used for severe pain), and neuroleptics (medicines used to treat schizophrenia, psychosis), due to the possible risk of lowering the seizure threshold.
Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). A dose adjustment of Escitalopram Alter may be necessary.
Medicines that reduce blood potassium or magnesium levels, as these conditions increase the risk of life-threatening heart rhythm disturbances.

Do not take Escitalopram Alter if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm, such as, for example, class IA and III antiarrhythmics, antipsychotics (such as phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), or certain antihistamines (astemizole, mizolastine). If you have any further doubts, contact your doctor.

Escitalopram Alter with food, drinks, and alcohol
Escitalopram Alter can be taken regardless of meals (see section 3 “How to take Escitalopram Alter”).
As with many medicines, it is not recommended to combine Escitalopram Alter with alcohol, although no interactions between Escitalopram Alter and alcohol are expected.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist before taking this medicine.
Do not take Escitalopram Alter if you are pregnant or breastfeeding, unless you have already discussed the associated risks and benefits with your doctor. If you take Escitalopram Alter during the last 3 months of pregnancy, you should be aware that the newborn may experience the following effects: breathing difficulties, bluish skin colouration, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar levels, muscle rigidity or floppiness, overactive reflexes, tremor, nervousness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping or falling asleep. If your baby shows any of these symptoms, contact your doctor immediately.
Ensure that your midwife and/or doctor know that you are being treated with Escitalopram Alter. When taken during pregnancy, particularly in the last trimester, medicines such as Escitalopram Alter may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster than normal and have a bluish skin colour. These symptoms usually appear within the first 24 hours after the baby’s birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
If used during pregnancy, Escitalopram Alter must never be stopped abruptly.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces sperm quality. This could theoretically affect fertility, but no impact on human fertility has been observed to date.
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.

Driving and using machines
It is recommended not to drive or operate machinery until you know how Escitalopram Alter affects you.

Escitalopram Alter contains ethanol and sodium
This medicine contains 96 mg of alcohol (ethanol) in each ml (20 drops). The amount in 20 drops (1 ml) of this medicine is equivalent to less than 3 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml (20 drops), i.e., it is essentially “sodium-free”.

3. How to take Escitalopram Alter

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Count the required number of drops into a drink (water, orange juice, or apple juice), mix briefly, and then drink the entire mixture.
Instructions for use:
Turn the bottle completely upside down. If no drops come out, gently tap the bottle to start the flow.
Do not mix Escitalopram Alter with liquids other than water, orange juice, or apple juice, and do not mix it with other medicines.
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Adults
Depression
The recommended dose of Escitalopram Alter is 10 mg (10 drops) as a single daily dose.
Your doctor may increase the dose up to a maximum of 20 mg (20 drops) per day.
Panic disorder
The initial dose of Escitalopram Alter is 5 mg (5 drops) per day for the first week, before increasing to 10 mg (10 drops) per day. The dose may be further increased by your doctor up to a maximum of 20 mg (20 drops) per day.
Social anxiety disorder
The usual recommended dose of Escitalopram Alter is 10 mg (10 drops) as a single daily dose. Your doctor may reduce the dose to 5 mg (5 drops) per day or increase it up to a maximum of 20 mg (20 drops) per day, depending on your response to the medicine.
Generalized anxiety disorder
The recommended dose of Escitalopram Alter is 10 mg (10 drops) as a single daily dose.
The dose may be increased by your doctor up to a maximum of 20 mg (20 drops) per day.
Obsessive-compulsive disorder
The recommended dose of Escitalopram Alter is 10 mg (10 drops) as a single daily dose.
The dose may be increased by your doctor up to a maximum of 20 mg (20 drops) per day.
Elderly patients (over 65 years of age)
The recommended initial dose of Escitalopram Alter is 5 mg (5 drops) as a single daily dose. The dose may be increased by your doctor to 10 mg (10 drops) per day.
Use in children and adolescents
Escitalopram Alter must not be used in children and adolescents. For further information, see section 2 “What you need to know before taking Escitalopram Alter”.
Duration of treatment
It may take a few weeks before you start to feel better. Continue taking Escitalopram Alter even if you need to wait some time before noticing an improvement in your condition.
Do not change your dose without first discussing it with your doctor.
Continue taking Escitalopram Alter for as long as your doctor has recommended. If you stop treatment too early, your symptoms may return. It is recommended to continue treatment for at least 6 months after recovery.
If you take more Escitalopram Alter than you should
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If you have taken more Escitalopram Alter than prescribed, contact your doctor or the nearest hospital emergency department immediately, even if you do not feel any symptoms or discomfort. Some signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rate, low blood pressure, and disturbances in fluid and electrolyte balance. Take the box/container of Escitalopram Alter with you when going to the doctor or hospital.
If you forget to take Escitalopram Alter
Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose and remember before going to bed, take the missed dose immediately and continue as usual the next day. If you only remember during the night or the following day, skip the missed dose and continue with your regular schedule.
If you stop taking Escitalopram Alter
Do not stop taking Escitalopram Alter until your doctor tells you it is safe to do so.
Once the treatment course is completed, it is generally recommended to gradually reduce the dose of Escitalopram Alter over several weeks.
When stopping Escitalopram Alter, especially if abruptly, you may experience the following symptoms:

dizziness (unsteady, unstable balance), tingling sensations, burning sensations, and (less commonly) electric shock-like sensations (including in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), feelings of anxiety, headache, malaise (nausea), sweating (including night sweats), feelings of restlessness or agitation, tremor (shakiness), feelings of confusion or disorientation, emotional lability or irritability, diarrhoea (loose stools), visual disturbances, pounding or racing heartbeat (palpitations). These symptoms are common when stopping treatment with Escitalopram Alter. The risk is higher if Escitalopram Alter has been used for a long time, at high doses, or if the dose is reduced too quickly. Most people find these symptoms mild and they resolve on their own within two weeks. However, in some patients, symptoms may be severe or prolonged (2–3 months or longer). If you experience severe withdrawal symptoms when stopping Escitalopram Alter, contact your doctor. Your doctor may advise you to restart the drops and then discontinue treatment more gradually.

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 everyone gets them.
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The side effects usually disappear after a few weeks of treatment.
However, consider that many of these side effects may also be symptoms of your illness, which will therefore improve as you start feeling better.
If you experience the following side effects, you must contact your doctor immediately or go to hospital:

Difficulty urinating
Seizures (convulsions), see also section "Warnings and precautions"
Yellowing of the skin or whites of the eyes, which may be signs of impaired liver function/hepatitis
Rapid or irregular heartbeat, feeling faint, which may be symptoms of a life-threatening condition known as torsade de pointes.

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

Unusual bleeding, including gastrointestinal and rectal bleeding

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

If you notice swelling of the skin, tongue, lips or face, or have difficulty breathing or swallowing (allergic reaction)
If you experience high fever, agitation, confusion, tremor and sudden muscle contractions, these may be signs of a condition called serotonin syndrome.

The following side effects have been reported in addition to those mentioned above:

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

Feeling unwell (nausea)
Headache

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

Stuffy or runny nose (sinusitis)
Altered appetite, weight gain
Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, tingling sensation on the skin
Diarrhoea, constipation, vomiting, dry mouth
Increased sweating
Muscle and joint pain (arthralgia and myalgia)
Sexual disorders (delayed ejaculation, erection problems, decreased sexual desire, while women may experience difficulty achieving orgasm)
Fatigue, fever

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

Hives, skin rash, itching
Teeth grinding, agitation, nervousness, panic attacks, confusion
Disturbed sleep, altered taste, fainting (syncope)
Enlarged pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
Hair loss
Vaginal bleeding
Weight loss
Fast heartbeat (tachycardia)
Swelling of arms or legs
Nosebleeds

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

Aggression, depersonalization/derealization, seeing or hearing things that are not real (hallucinations)
Slow heartbeat (bradycardia)

Frequency not known (frequency cannot be estimated from the available data):

Thoughts of harming yourself or of suicide; see also section "Warnings and precautions"
Reduction in sodium levels in the blood (symptoms include feeling unwell, muscle weakness or confusion)
Dizziness when standing up due to low blood pressure (orthostatic hypotension)
Abnormalities in liver function tests (increased liver enzyme levels in blood) and in ECG (electrocardiogram)
Movement disorders (involuntary muscle movements)
Painful erection (priapism)
Bleeding disorders, including bleeding of the skin and mucous membranes (bruising) and low platelet count (thrombocytopenia)
Sudden swelling of the skin and mucous membranes (angioedema)
Increased urine output (inappropriate ADH secretion)
Milk production in women who are not breastfeeding
Mania
An increased risk of bone fractures has been observed in patients taking this type of medicine.
Changes in heart rhythm (known as "QT interval prolongation", detectable on ECG, the heart's electrical activity).

In addition, there are side effects that occur with medicines that act similarly to escitalopram (the active substance in Escitalopram Alter), such as:

Psychomotor hyperactivity, restlessness, urgency or need to move to relieve an unpleasant sensation (akathisia).
Poor appetite (anorexia).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Escitalopram Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of that month.
After first opening, the drops must be used within 8 weeks and not stored at temperatures above 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Escitalopram Alter contains
The active substance is escitalopram. Each ml of Escitalopram Alter contains 20 mg of
escitalopram (as 25.55 mg of escitalopram oxalate).
1 drop contains 1 mg of escitalopram.
The other components are: propyl gallate; anhydrous citric acid; 96% ethanol; sodium
hydroxide; purified water.
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Description of the appearance of Escitalopram Alter and contents of the pack
Escitalopram Alter oral drops, solution is a clear, almost colourless to yellowish solution supplied in a dark glass bottle containing 15 ml, with a dropper.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare S.r.l.,
Via Marghera, 29
20149 Milan
Italy

Marketing Authorization Holder (Responsible for commercialization):
Laboratori Alter Srl
Via Egadi, 7
20144- Milan
Italy

Manufacturer
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)
Italy

Neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Straße 23
40764 Langenfeld
Germany

This medicinal product is authorized in the Member States of the European Economic Area
under the following names:
Germany: Escitalopram-neuraxpharm 20 mg/ml Tropfen zum Einnehmen, Lösung
Spain: Diprex 20 mg/ml Gotas orales en solución
Italy: Escitalopram Alter
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