Escitalopram Sun

Package leaflet: Information for the user

Escitalopram SUN 10 mg film-coated tablets, 20 mg film-coated tablets

escitalopram (as oxalate)
Generic medicine
Please read all of this leaflet carefully before you take 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Escitalopram SUN contains the active substance escitalopram.
Escitalopram SUN belongs to a group of antidepressant medicines known as Selective Serotonin Reuptake Inhibitors (SSRIs).
Escitalopram SUN 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 up to two weeks before you start to feel better. Continue taking Escitalopram SUN 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 SUN

Do not take Escitalopram SUN:

• 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 belonging to a group known as MAO inhibitors, including selegiline (used in the treatment of Parkinson’s disease), moclobemide (used in the treatment of depression), and linezolid (an antibiotic).
• If you have been born with or have experienced an episode of heart rhythm disorder (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 SUN").

Warnings and precautions
Tell your doctor, pharmacist, or nurse before taking Escitalopram SUN. Inform your doctor if you have any other condition or illness, as your doctor may need to take this into account. In particular, inform your doctor:

• If you suffer from epilepsy. Treatment with Escitalopram SUN should be discontinued if seizures occur for the first time or if there is an increase in seizure frequency (also see 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 SUN may alter blood glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic agents.
• If you have low levels of sodium in the blood.
• If you have a tendency to develop bleeding or bruising, or if you are pregnant (see section “Fertility, pregnancy and breastfeeding”).
• If you are receiving electroconvulsive therapy.
• If you have coronary heart disease.
• If you suffer or have suffered from heart problems or have recently had a heart attack.
• If you have a slow resting heart rate and/or if you know you have salt deficiencies due to prolonged severe diarrhoea and vomiting (nausea) or are using diuretics.
• If, when standing up, you experience a rapid or irregular heartbeat, fainting, collapse, or dizziness, which may indicate a heart rhythm disorder.
• If you suffer or have suffered in the past from eye problems, such as a certain type of glaucoma (increased pressure in the eye).

Please note
Some patients with bipolar disorder may enter a manic phase. This is characterised by unusual thoughts, inappropriate and excessive happiness, and increased 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. Inform your doctor immediately if these symptoms occur.
Medicines such as Escitalopram SUN (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 have been observed to persist after discontinuation of treatment.
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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.
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. Data from clinical studies 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 or go immediately to hospital. It may be helpful to inform a close family member 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 under 18 years of age
Escitalopram SUN is normally not to be taken by children and adolescents under 18 years of age. In addition, you should know that, when taking this class of medicines, patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, oppositional behaviour, and anger). Nevertheless, your doctor may prescribe Escitalopram SUN to patients under 18 years of age if they consider it the best option for them. If your doctor has prescribed Escitalopram SUN to a patient under 18 years of age and you wish to obtain further information, contact your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen during treatment with Escitalopram SUN in a patient under 18 years of age. In addition, the long-term safety effects of Escitalopram SUN on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.
Other medicines and Escitalopram SUN
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, isocarboxazid, nialamide, or tranylcypromine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting treatment with Escitalopram SUN. After stopping treatment with Escitalopram SUN, 7 days must pass before taking any of these medicines.
• "Reversible selective MAO-A inhibitors" containing moclobemide (used in the treatment of depression).
• "Irreversible MAO-B inhibitors" containing selegiline (used in the treatment of Parkinson’s disease). These increase the risk of adverse effects.
• The antibiotic linezolid.

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• Lithium (used in the treatment of bipolar disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol and similar medicines (opioids, used to treat severe pain). These increase the risk of adverse effects.
• Cimetidine, lansoprazole, and omeprazole (used to treat gastric ulcer), 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, so-called anticoagulants). These may increase the tendency to bleed.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce blood clotting, also called anticoagulants). Your doctor may perform coagulation tests at the beginning and end of treatment with Escitalopram SUN to verify that the anticoagulant dose remains appropriate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the possible risk of reduced seizure threshold.
• Neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRIs)) due to the possible risk of reduced seizure threshold.
• Flecainide, propafenone, and metoprolol (used in cardiovascular conditions), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Escitalopram SUN may be necessary.
• Medicines that reduce blood potassium or magnesium levels, as these conditions increase the risk of life-threatening heart rhythm disorders.

Do not take Escitalopram SUN if you are taking medicines for heart rhythm problems or that may affect heart rhythm, such as, for example, class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), and certain antihistamines (e.g. astemizole, hydroxyzine, mizolastine). If you have any further questions, consult your doctor.
Escitalopram SUN with food, drinks, and alcohol
Escitalopram SUN can be taken with or without food (see section 3 "How to take Escitalopram SUN").
An interaction between Escitalopram SUN and alcohol is not expected. However, as with many medicines, the combination of Escitalopram SUN and alcohol is not recommended.
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Fertility, pregnancy and breastfeeding
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 SUN during pregnancy or while breastfeeding unless you have discussed the risks and benefits with your doctor.
If you take Escitalopram SUN during the last three months 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, hypoglycaemia (low blood glucose levels), hypertonia or hypotonia, hyperreflexia, tremor, 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 knows that you are being treated with Escitalopram SUN. Medicines such as Escitalopram SUN, 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 begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
If you take Escitalopram SUN 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 SUN so they can advise you on what to do.
If used during pregnancy, Escitalopram SUN should not be stopped abruptly.
Escitalopram is expected to be excreted in breast milk.
In animal studies, a medicine similar to escitalopram, citalopram, has been shown to reduce sperm quality. In theory, this does not affect fertility, but the impact on male fertility has not yet been studied.
Driving and using machines
You are advised not to drive or operate machinery until you know how Escitalopram SUN affects you.
Escitalopram SUN contains lactose monohydrate and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Escitalopram SUN

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
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Adults
Depression
The usual recommended dose of Escitalopram SUN is 10 mg once daily, as a single dose. Your doctor may increase this dose up to a maximum of 20 mg per day.

Panic disorder
The initial dose of Escitalopram SUN for the first week is 5 mg once daily, as a single dose. The dose may then be increased to 10 mg per day. Your doctor may further increase the dose up to a maximum of 20 mg per day.

Social anxiety disorder
The usual recommended dose of Escitalopram SUN is 10 mg once daily, as a single dose. Your doctor may reduce the dose to 5 mg per day or increase it up to a maximum of 20 mg per day, depending on your individual response to treatment.

Generalised anxiety disorder
The usual recommended dose of Escitalopram SUN is 10 mg per day, as a single dose. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Obsessive-compulsive disorder
The usual recommended dose of Escitalopram SUN is 10 mg per day, as a single dose. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Elderly patients (over 65 years of age)
The recommended initial dose of Escitalopram SUN is 5 mg per day, as a single dose. The dose may be increased by your doctor up to 10 mg per day.

Use in children and adolescents (under 18 years of age)
Escitalopram SUN should normally not be taken by children and adolescents. For further information, see section 2 "Warnings and precautions".

Reduced kidney function
Caution is advised in patients with severely reduced kidney function. Take as prescribed by your doctor.

Reduced liver function
Patients with liver impairment should not take more than 10 mg per day. Take as prescribed by your doctor.

Patients known to be slow metabolisers of the enzyme CYP2C19
Patients with this known genotype should not receive more than 10 mg per day. Take as prescribed by your doctor.

How should the tablets be taken?
You may take Escitalopram SUN with or without food. Swallow the tablet with water. Do not chew the tablet as it has a bitter taste.

If necessary, the tablet may be split in half.
Place it on a flat surface with the score side facing upwards, then press on each end of the score line using both fingers, as shown in the figure below.
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Duration of treatment
It may take a few weeks before you notice any improvement. Continue taking Escitalopram SUN even if it takes time for your condition to improve.
Do not change the dose of this medicine without first discussing it with your doctor.
Continue taking Escitalopram SUN for as long as your doctor has recommended. If you stop treatment too early, symptoms may return. It is recommended to continue treatment for at least six months after symptoms have resolved.

If you take more Escitalopram SUN than you should
If you take more Escitalopram SUN than prescribed, contact your doctor or go immediately to the nearest hospital emergency department. Go 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. When going to the doctor or hospital, bring the Escitalopram SUN packaging with you.

If you forget to take Escitalopram SUN
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.
Continue taking your usual dose the next day. If you remember during the night or the following day, skip the missed dose and take the next dose at the usual time.

If you stop taking Escitalopram SUN
Do not stop taking Escitalopram SUN unless your doctor tells you to.
When you have completed treatment with Escitalopram SUN, it is generally recommended that the dose be gradually reduced over a period of a few weeks.
When stopping Escitalopram SUN, especially if stopped suddenly, you may experience withdrawal symptoms. These are common when stopping treatment with Escitalopram SUN. The risk is greater if you have taken Escitalopram SUN 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 disappear spontaneously within a few 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 SUN, consult your doctor. Your doctor may advise you to restart treatment and then reduce the dose more gradually.

Withdrawal symptoms include: dizziness (feeling unsteady or off balance), pins and needles sensation, burning sensation (less frequent), electric shock-like sensations, 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, diarrhoea (loose stools), visual disturbances, heart rhythm disturbances (palpitations).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Side effects usually disappear after a few weeks of treatment. Please bear in mind that many of the side effects may also be symptoms of your illness and therefore decrease as you start to feel better.
If you experience any of the following symptoms, contact your doctor or go immediately to the Emergency Department of the nearest hospital:
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 or face, hives or difficulty breathing or a feeling of suffocation (serious allergic reaction).
• High fever, agitation, confusion, tremor and sudden muscle contractions, which may be symptoms of a rare condition called serotonin syndrome.

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

• Difficulty urinating
• Seizures (epileptic fits); see also section "Warnings and precautions"
• Yellowing of the skin and whites of the eyes, signs of impaired liver function/hepatitis
• Rapid or irregular heartbeat, fainting, which may 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"
• Sudden swelling of the skin or mucous membranes (angioedema)

In addition to the side effects listed above, the following have also 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 or runny nose (sinusitis)
• Decreased or increased appetite
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, tingling of the skin
• Diarrhoea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain (arthralgia and myalgia)

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• Sexual difficulties (delayed ejaculation, erectile problems, decreased sexual drive, 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, taste disturbances, fainting (syncope)
• Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• Hair loss
• Excessive menstrual bleeding
• Irregular menstruation
• Weight loss
• Increased heart rate
• Swelling of arms or legs
• Nosebleeds

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

• Aggression, depersonalization, hallucinations
• Slowed heart rate

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

• Decreased sodium levels in the blood (symptoms include feeling unwell with muscle weakness; or confusion)
• Dizziness when standing upright, due to a drop in blood pressure (orthostatic hypotension)
• Changes in liver function test results (increased levels of liver enzymes in the blood)
• Movement disorders (involuntary muscle movements)
• Painful erections (priapism)
• Abnormal bleeding, for example of the skin and mucous membranes (ecchymoses), and reduced platelet count in the blood (thrombocytopenia)
• Increased secretion of a hormone called ADH, causing water retention and dilution of the blood, reducing sodium levels (inappropriate antidiuretic hormone secretion)
• Increased blood levels of the hormone prolactin
• Milk secretion in men and in women who are not breastfeeding
• Mania (feeling unexpectedly over-excited, hyperactive or uninhibited)
• 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 ECG, a test that records the heart's electrical activity)
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 “Fertility, pregnancy and breastfeeding” for further information

In addition, a number of side effects are known to occur with medicines that work in the same way as escitalopram (the active substance in Escitalopram SUN).
These include:

• Motor restlessness (akathisia)
• Loss of appetite

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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: http://www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Escitalopram SUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label or the packaging after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 SUN contains
The active substance is escitalopram (as oxalate).
Each film-coated tablet contains 10 mg or 20 mg of escitalopram.
The other components are:
Intragranular excipients: Microcrystalline cellulose, Lactose monohydrate, Copovidone (K90-
100), Maize starch.
Extragranular excipients:
Silicified microcrystalline cellulose, Sodium croscarmellose, Talc, Anhydrous colloidal silica,
Magnesium stearate.
Tablet coating: Opadry OY-S-58910 composed of Hypromellose, Titanium dioxide (E171),
Macrogol 400, Talc.

Description of the appearance of Escitalopram SUN and package contents
Escitalopram SUN is available as 10 mg or 20 mg film-coated tablets.
Description of the tablets
10 mg: white to off-white, oval-shaped, biconvex, film-coated tablet, marked with “E” and “8” on both sides of the break line on one side and smooth on the other side. Tablets are approximately 8.1 mm ± 0.40 mm in length and 5.6 mm ± 0.40 mm wide.
20 mg: white to off-white, oval-shaped, biconvex, film-coated tablet, marked with “E” and “9” on both sides of the break line on one side and smooth on the other side. Tablets are approximately 11.6 mm ± 0.40 mm in length and 7.1 mm ± 0.40 mm wide.
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Escitalopram SUN 10 mg film-coated tablets: available in packs of 14, 20, 28, 30, 50, 56, and 100 tablets in blisters made of Polyamide/Al/PVDC/Al.
Escitalopram SUN 20 mg film-coated tablets: available in packs of 14, 20, 28, 30, 50, 56, and 100 tablets in blisters made of Polyamide/Al/PVDC/Al.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands

Local representative:
Sun Pharma Italia Srl - Viale Giulio Richard, 3 - 20143 Milano, Italy

Batch release
Terapia S.A.
124, Fabricii Str. 400 632 Cluj Napoca – Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87 - 2132JH Hoofddorp – The Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Poland Nexpram
Romania Serodeps 10/20 mg film-coated tablets
Spain Escitalopram SUN 10/20 mg coated tablets (film-coated) EFG
Germany ESCITALOPRAM BASICS 10/20 mg Film tablets
France ESCITALOPRAM SUN 10/20 mg, tablet coated with a film
Italy Escitalopram SUN 10/20 mg film-coated tablets
Sweden Escitalopram SUN 10/20 mg film-coated tablets
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