Escitalopram Sandoz GmbH: detailed information

Package leaflet: Information for the patient

Escitalopram Sandoz GmbH 20 mg/ml oral drops, solution

Equivalent medicine
Please read this leaflet carefully before using 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 side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Escitalopram Sandoz GmbH is and what it is used for

Escitalopram Sandoz GmbH contains the active substance escitalopram. Escitalopram Sandoz GmbH belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain by increasing levels of serotonin. Alterations in the serotonin system are considered important factors in the development of depression and related disorders.
Escitalopram Sandoz GmbH is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).
It may take a few weeks before you start to feel better. Continue taking Escitalopram Sandoz GmbH 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 should know before taking Escitalopram Sandoz GmbH

Do not take Escitalopram Sandoz GmbH
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 known as monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson’s disease), moclobemide (used to treat depression), or linezolid (an antibiotic).
if you were born with or have experienced an episode of abnormal heart rhythm (identified by an ECG, a test performed to assess heart function).
if you are taking medicines for heart rhythm problems or that may affect your heart rhythm (see section 2 “Other medicines and Escitalopram Sandoz GmbH”).

Warnings and precautions
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Talk to your doctor or pharmacist before taking Escitalopram Sandoz GmbH. Inform your doctor
if you have any other conditions or illnesses, as these may need to be considered. In particular, inform your doctor:
If you suffer from epilepsy. Treatment with Escitalopram Sandoz GmbH should be discontinued 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 impaired liver or kidney function. Your doctor may need to adjust your dose.
If you have diabetes. Treatment with Escitalopram Sandoz GmbH may alter blood glucose control. In such cases, it may be necessary to adjust the dose of insulin and/or oral hypoglycemic agents.
If your blood sodium levels are low.
If you have a tendency to bleed or bruise easily, or if you are pregnant (see section “Pregnancy”).
If you are undergoing electroconvulsive therapy.
If you suffer from coronary heart disease.
If you have heart problems or have had a recent heart attack.
If you have a slow resting heart rate and/or if you think your body may have lost a significant amount of salt due to prolonged and severe diarrhea or vomiting, or if you are taking diuretics (medicines that increase urine production).
If you experience a fast or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate an irregular heart rhythm.
If you have or have previously had eye problems, including certain types of glaucoma (increased pressure inside the eye).

Please note
Some patients with bipolar disorder may enter a manic phase. This is characterized by unusual thoughts that change rapidly, inappropriate happiness, and excessive physical activity. If you experience these feelings, contact your doctor.
Symptoms such as restlessness or difficulty sitting still or standing still may occur during the first weeks of treatment. If you experience these symptoms, inform your doctor immediately.
Medicines such as Escitalopram Sandoz GmbH (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine 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 suffer from depression and/or anxiety disorders, you may occasionally 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.
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 patients 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 or go immediately to the hospital.
It may be helpful to inform a family member or close 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
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Escitalopram Sandoz GmbH is generally not intended for use in children and adolescents under 18 years of age. It is also important to know that patients under 18 years of age taking this class of medicines may have a higher risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger). Nevertheless, your doctor may prescribe Escitalopram Sandoz GmbH to patients under 18 years of age if they consider it to be in the patient's best interest. If your doctor has prescribed Escitalopram Sandoz GmbH for a patient under 18 years of age and you would like more information, please contact your doctor again.
You must inform your doctor if any of the symptoms listed above appear or worsen during treatment with Escitalopram Sandoz GmbH in patients under 18 years of age.
In addition, the long-term safety effects of Escitalopram Sandoz GmbH on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.

Other medicines and Escitalopram Sandoz GmbH
Inform 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, iproniazide, isocarboxazide, nialamide, or tranylcypromine as active substances. If you have taken any of these medicines, you must wait 14 days before starting treatment with Escitalopram Sandoz GmbH. After stopping treatment with Escitalopram Sandoz GmbH, 7 days must pass 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 increase the risk of adverse effects.
The antibiotic linezolid.
Lithium (used to treat bipolar disorder) and tryptophan.
Imipramine and desipramine (both used to treat depression).
Sumatriptan and similar medicines (used to treat migraine), tramadol (used to treat severe pain). These increase the risk of adverse 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 may cause an increase in escitalopram levels in the blood.
St. John’s wort ( Hypericum perforatum ) – a herbal remedy used for depression.
Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to reduce blood clotting, known as anticoagulants). These may increase the tendency to bleed.
Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce blood clotting, known as anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of treatment with Escitalopram Sandoz GmbH to ensure your anticoagulant dose remains appropriate.
Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain), due to a possible risk of reduced seizure threshold.
Neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs), due to a possible risk of reduced seizure threshold.
Flecainide, propafenone, and metoprolol (used for cardiovascular disorders), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). A dose adjustment of Escitalopram Sandoz GmbH may be necessary.
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Medicines that reduce potassium or magnesium levels in the blood, as these conditions increase the risk of life-threatening heart rhythm disturbances.

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

Escitalopram Sandoz GmbH with food, drinks, and alcohol
Escitalopram Sandoz GmbH may be taken with or without food (see section 3 "How to take Escitalopram Sandoz GmbH"). As with many medicines, it is not recommended to combine Escitalopram Sandoz GmbH with alcohol; however, no significant interaction between Escitalopram Sandoz GmbH and alcohol is expected.

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. Do not take Escitalopram Sandoz GmbH during pregnancy or while breastfeeding unless your doctor has discussed the risks and benefits of treatment with you.
If you take Escitalopram Sandoz GmbH during the third trimester of pregnancy, you should be aware that the following effects may occur in the newborn: breathing difficulties, bluish skin colour, seizures, unstable body temperature, feeding difficulties, vomiting, low blood glucose levels, stiff or floppy muscles, increased reflexes, tremors, restlessness, irritability, lethargy, persistent crying, drowsiness, and sleep disturbances. If the newborn shows any of these symptoms, contact your doctor immediately.
Ensure that your midwife and/or doctor know that you are taking Escitalopram Sandoz GmbH.
Medicines such as Escitalopram Sandoz GmbH, when taken during pregnancy, particularly during the last three months, may 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 appear within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
When used during pregnancy, Escitalopram Sandoz GmbH should not be stopped abruptly.
If you take Escitalopram Sandoz GmbH near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed easily). Inform your doctor or midwife that you are taking Escitalopram Sandoz GmbH so they can advise you on appropriate measures.

Citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality in animal studies. In theory, this could affect fertility, but effects on human fertility have not yet been observed.

Driving and using machines
You are advised not to drive or operate machinery until you know how Escitalopram Sandoz GmbH affects you.

Escitalopram Sandoz GmbH contains ethanol and sodium
This medicine contains 94 mg of alcohol (ethanol) in each ml of oral drops, solution. The total amount in each 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 have any significant effect.
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This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of oral drops, solution, i.e., it is essentially “sodium-free”.
For individuals engaged in sports, the use of medicines containing ethyl alcohol may lead to a positive result in doping tests, depending on the blood alcohol concentration limits set by certain sports federations.

3. How to take Escitalopram Sandoz GmbH

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Recommended dose
Adults
Depression
The usual dose of Escitalopram Sandoz GmbH is 10 mg (10 drops) taken 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 Sandoz GmbH is 5 mg (5 drops) per day for the first week, before increasing to 10 mg (10 drops) per day. Your doctor may increase the dose up to a maximum of 20 mg (20 drops) per day.

Social anxiety disorder
The normally recommended dose of Escitalopram Sandoz GmbH is 10 mg (10 drops) taken 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 individual response to treatment.

Generalized anxiety disorder
The normally recommended dose of Escitalopram Sandoz GmbH is 10 mg (10 drops) taken as a single daily dose. Your doctor may increase the dose up to a maximum of 20 mg (20 drops) per day.

Obsessive-compulsive disorder
The normally recommended dose of Escitalopram Sandoz GmbH is 10 mg (10 drops) taken as a single daily dose. Your doctor may increase the dose up to a maximum of 20 mg (20 drops) per day.

Elderly (over 65 years of age)
The recommended starting dose of Escitalopram Sandoz GmbH is 5 mg (5 drops) taken as a single daily dose. Your doctor may increase the dose to 10 mg per day.

Use in children and adolescents
Escitalopram Sandoz GmbH should normally not be used in children and adolescents. For further information, see section 2 "What you need to know before taking Escitalopram Sandoz GmbH".

Method of administration
For oral use. Add the required number of drops to a drink (water, orange juice or apple juice), stir briefly and then drink the entire mixture.
Do not mix Escitalopram Sandoz GmbH with other liquids and do not mix it with other medicines.
You may take Escitalopram Sandoz GmbH with or without food.

Duration of treatment
It may take a few weeks before you start to feel better. Continue taking Escitalopram Sandoz GmbH even if it takes time before you notice an improvement in your condition.
Do not change your dose without first consulting your doctor.
Continue taking Escitalopram Sandoz GmbH 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 you start feeling better.

If you take more Escitalopram Sandoz GmbH than you should
If you have taken more Escitalopram Sandoz GmbH than prescribed, contact your doctor or go immediately to the nearest hospital emergency department. Do this even if you do not feel unwell. Some symptoms of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rhythm, low blood pressure, and disturbances in electrolyte balance. Take the pack/container of Escitalopram Sandoz GmbH with you when going to the doctor or hospital.

If you forget to take Escitalopram Sandoz GmbH
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 it immediately and continue your usual dosing schedule the next day. If you remember during the night or the following day, skip the missed dose and continue with your regular dosing schedule.

If you stop taking Escitalopram Sandoz GmbH
Do not stop taking Escitalopram Sandoz GmbH unless your doctor tells you to. When completing treatment, it is generally recommended that the dose of Escitalopram Sandoz GmbH be gradually reduced over several weeks.

When stopping Escitalopram Sandoz GmbH, especially if stopped abruptly, you may experience withdrawal symptoms. These are common when discontinuing treatment with Escitalopram Sandoz GmbH. The risk is higher if you have taken Escitalopram Sandoz GmbH for a long time or at high doses, or if the dose is reduced too quickly. Most patients find that these symptoms are mild and usually resolve spontaneously within a couple of weeks. However, in some patients, withdrawal symptoms may be severe or may persist for a longer time (2–3 months or more). If you experience severe withdrawal symptoms when stopping treatment with Escitalopram Sandoz GmbH, inform your doctor. Your doctor may ask you to restart treatment and then gradually reduce the dose more slowly.

Withdrawal symptoms include: dizziness (feeling unsteady or off balance), tingling sensations, burning sensations, and (less frequently) electric shock-like sensations (also in the head), sleep disturbances (vivid dreams, nightmares, difficulty sleeping), anxiety, headache, malaise (nausea), sweating (including night sweats), restlessness or agitation, tremors, confusion or disorientation, excessive emotionality or irritability, diarrhoea (loose stools), visual disturbances, and disturbances in heart rhythm (palpitations).

If you have any doubts about how to use 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.
The side effects usually disappear after a few weeks of treatment. Please note that many of the side
effects may also be symptoms of your illness and will therefore improve as you start to feel better.
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If you experience any of the following symptoms, you must contact your doctor or go to hospital
immediately:
Uncommon (may affect up to 1 in 100 people):
Abnormal bleeding, including gastrointestinal bleeding
Rare (may affect up to 1 in 1,000 people)
Swelling of the skin, tongue, lips, face, hives, or if you have difficulty breathing or swallowing
(allergic reaction).
High fever, agitation, confusion, tremor, and sudden muscle contractions, which may be
symptoms of a rare condition called serotonin syndrome (see section 2).
Not known (frequency cannot be estimated from the available data):
Difficulty urinating
Seizures (epileptic fits), see also section 2 "Warnings and precautions"
Yellowing of the skin and whites of the eyes, signs of liver dysfunction/hepatitis
Rapid or irregular heartbeat, feeling faint, which could be symptoms of a life-threatening
condition known as Torsade de Pointes
Thoughts of harming yourself or of suicide, see also section 2 "Warnings and precautions".
In addition to those listed above, the following side effects have been reported:
Very common (may affect more than 1 in 10 people):
Feeling unwell (nausea)
Headache
Common (may affect up to 1 in 10 people):
Stuffy nose or nasal discharge (sinusitis)
Decreased or increased appetite
Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning,
tremor, skin irritation
Diarrhoea, constipation, vomiting, dry mouth
Increased sweating
Muscle and joint pain (arthralgia and myalgia)
Sexual disorders (delayed ejaculation, erection problems, decreased sexual desire, and women
may have difficulty achieving orgasm)
Fatigue, fever
Weight gain
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)
Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
Hair loss
Excessive menstrual blood loss
Irregular menstrual cycle
Weight loss
Increased heart rate
Swelling of arms and legs
Nosebleeds
Rare (may affect up to 1 in 1,000 people)
Aggression, depersonalization, hallucinations
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Slowed heart rate
Not known (frequency cannot be estimated from the available data):
Decreased sodium levels in the blood (symptoms include nausea, feeling unwell with muscle
weakness or confusion)
Dizziness when standing up, due to a drop in blood pressure (orthostatic hypotension)
Changes in liver function tests (increased liver enzymes in the blood)
Movement disorders (involuntary muscle movements)
Painful erections (priapism)
Signs of abnormal bleeding, for example under the skin and mucous membranes (bruising)
Low platelet count in the blood (thrombocytopenia)
Sudden swelling of the skin or mucous membranes (angioedema)
Increased secretion of a hormone called ADH, causing the body to retain water and dilute the
blood, reducing sodium levels (inappropriate ADH secretion)
Increased blood levels of the hormone prolactin
Milk production in men and 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 (called "QT interval prolongation", assessed by an ECG, which records
the heart's electrical activity)
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see section 2,
Pregnancy, for further information.
In addition, a number of side effects are known to occur with medicines that work in a similar way to
escitalopram. These include:
Motor restlessness (akathisia)
Loss of appetite
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
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 Sandoz GmbH

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 blister and the cardboard package after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The drops must be used within 8 weeks after opening and stored at a temperature below 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 Sandoz GmbH contains
The active substance is escitalopram. Each ml of Escitalopram Sandoz GmbH oral drops contains 20 mg
of escitalopram (as oxalate). Each drop contains 1 mg of escitalopram.
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The other components are propyl gallate; anhydrous citric acid; 96% ethanol; sodium hydroxide and
purified water.

Description of the appearance of Escitalopram Sandoz GmbH and contents of the pack
Escitalopram Sandoz GmbH oral drops solution is available in 15 ml or 15 ml x 5 packs in amber glass bottles with dropper. It is a clear solution. Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl (Austria)
Representative in Italy: Sandoz S.p.A. - Viale Luigi Sturzo 43, 20154 Milan, Italy

Manufacturer
Chanelle Medical Unlimited Company
Loughrea
Co. Galway
Ireland

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

This medicinal product is authorized in the European Economic Area Member States under the
following names:
Netherlands: Escitalopram Sandoz 20mg/ml druppels voor oraal gebruik, oplossing
Italy: Escitalopram Sandoz GmbH
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