ESCITALOPRAM DOC GENERICI

Patient Information Leaflet

ESCITALOPRAM DOC 20 mg/ml oral drops, solution

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ESCITALOPRAM DOC is and what it is used for

ESCITALOPRAM DOC belongs to a group of antidepressant medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). These medicines help increase serotonin levels in the brain. Alterations in the brain's serotonergic system are considered important factors in the development of depression and related disorders.
The active substance of ESCITALOPRAM DOC is escitalopram, and it 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 aged 18 years and over.
It may take a couple of weeks before you start to feel better. Continue taking ESCITALOPRAM DOC 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 DOC

Do not take ESCITALOPRAM DOC:

• if you are allergic to escitalopram or to any of the excipients 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 experienced an episode of abnormal heart rhythm (visible on an electrocardiogram (ECG), a test 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 DOC”).

Warnings and precautions
Talk to your doctor or pharmacist before taking ESCITALOPRAM DOC.
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 DOC 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 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 DOC may alter blood glucose control. The dose of insulin and/or oral antidiabetic medicines may need to be adjusted.
• if your blood sodium level is low.
• if you are under 18 years of age.
• if you have previously suffered from mania or manic depression.
• if you have a tendency to bleeding or easy bruising, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
• if you are taking another medicine, including herbal remedies. See subsection “Other medicines and ESCITALOPRAM DOC”.
• if you are undergoing electroconvulsive therapy (ECT).
• if you have closed-angle glaucoma or have previously suffered from glaucoma.
• if you have coronary heart disease.
• if you are pregnant or breastfeeding.
• if you suffer 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 experienced a significant loss of salt due to prolonged and severe diarrhoea and vomiting or due to 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 rhythm.
• if you are taking medicines containing buprenorphine, as they increase the risk of serotonin syndrome (see also section “Other medicines and ESCITALOPRAM DOC”).

Medicines such as ESCITALOPRAM DOC (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.

Please note
Some patients with bipolar disorder may enter a manic phase. This is characterised 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 or standing still may occur during the first weeks of treatment. If you experience these symptoms, inform your doctor immediately.
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.

Suicidal thoughts and worsening of your depression or anxiety disorder
If you suffer from depression and/or anxiety disorders, you may sometimes think about harming yourself or committing 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 adults under 25 years of age with psychiatric disorders treated with an antidepressant.

If at any time you think about harming yourself or committing suicide, contact your doctor
or go immediately to hospital.
It may be helpful to inform a family member or a 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
Normally, ESCITALOPRAM DOC should not 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 side effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, oppositional behaviour, and anger). Despite this, your doctor may prescribe ESCITALOPRAM DOC to patients under 18 years of age if they consider it the best option for them. If your doctor has prescribed ESCITALOPRAM DOC to a patient under 18 years of age and you would like more information, contact your doctor again. You must inform your doctor if any of the above symptoms appear or worsen during treatment with ESCITALOPRAM DOC in a patient under 18 years of age.
In addition, the long-term safety effects of ESCITALOPRAM DOC on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.

Other medicines and ESCITALOPRAM DOC
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, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting ESCITALOPRAM DOC. After stopping ESCITALOPRAM DOC, 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 adverse 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, and fluvoxamine.
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used for severe pain). These medicines increase the risk of adverse effects.
• Medicines containing buprenorphine (used for opioid detoxification and pain treatment).
• Cimetidine and omeprazole (used to treat stomach ulcers or dyspepsia (indigestion)), fluconazole (used to treat fungal infections), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in ESCITALOPRAM DOC levels 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). Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and after stopping treatment with ESCITALOPRAM DOC 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 for the treatment of schizophrenia, psychosis). These may increase the possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used for cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of ESCITALOPRAM DOC 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 DOC if you are taking medicines for heart rhythm problems or that may 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, intravenous erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), or certain antihistamines (astemizole, mizolastine).
If you have any further doubts, contact your doctor.

ESCITALOPRAM DOC with food, drinks and alcohol
ESCITALOPRAM DOC can be taken with or without food (see section 3 “How to take ESCITALOPRAM DOC”).
No interaction between ESCITALOPRAM DOC and alcohol is expected. However, as with many medicines, the combination of ESCITALOPRAM DOC and alcohol is not recommended.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Do not take ESCITALOPRAM DOC if you are pregnant or breastfeeding, unless your doctor has discussed the risks and benefits of treatment with you.
If you take ESCITALOPRAM DOC 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.
Make sure your midwife and/or doctor know that you are taking ESCITALOPRAM DOC.
When taken during pregnancy, particularly during the last three months, medicines such as ESCITALOPRAM DOC 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 happens to your baby, contact your midwife and/or doctor immediately.
Sudden discontinuation of ESCITALOPRAM DOC treatment should be avoided during pregnancy.
If you take ESCITALOPRAM DOC 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). Inform your doctor or midwife that you are taking ESCITALOPRAM DOC so they can advise you on what to do.
Citalopram, a medicine similar to escitalopram, has been shown in animal studies to reduce sperm quality. In theory, this could affect fertility, but no impact on human fertility has been observed so far.

Driving and using machines
We advise you not to drive or operate machinery until you know how ESCITALOPRAM DOC affects you.

ESCITALOPRAM DOC 20 mg/ml oral drops, solution contains ethanol
This medicine contains 96 mg of alcohol (ethanol) per 20 mg daily dose. The amount of 20 mg/day 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.

ESCITALOPRAM DOC 20 mg/ml oral drops, solution contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, i.e., essentially ‘sodium-free’.

3. How to take ESCITALOPRAM DOC

Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Count the required number of drops to add to a drink (water, orange juice or apple juice),
briefly stir the glass and drink the entire beverage.
ESCITALOPRAM DOC oral drops must not be mixed with liquids other than water, orange
juice or apple juice, and must not be mixed with other medicines.

Adults
Depression
The usual recommended dose of ESCITALOPRAM DOC is 10 mg (10 drops) once daily.
Your doctor may increase this dose up to a maximum of 20 mg (20 drops) per day.

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

Social anxiety disorder
The usual recommended dose of ESCITALOPRAM DOC is 10 mg (10 drops) once daily.
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 usual recommended dose of ESCITALOPRAM DOC is 10 mg (10 drops) once daily.
This dose may be increased by your doctor up to a maximum of 20 mg (20 drops) per day.

Obsessive-compulsive disorder
The usual recommended dose of ESCITALOPRAM DOC is 10 mg (10 drops) once daily.
This 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 DOC is 5 mg (5 drops) once daily. This
dose may be increased by your doctor up to 10 mg (10 drops) per day.

Children and adolescents (under 18 years of age)
ESCITALOPRAM DOC is normally not recommended for children and adolescents. For
further information, see also section 2 “What you need to know before taking ESCITALOPRAM DOC”.

Duration of treatment
It may take a few weeks before you notice any improvement. Continue taking ESCITALOPRAM DOC even if you do not experience immediate improvement in your condition.
Dosage must never be changed without first consulting your doctor.
Continue taking ESCITALOPRAM DOC for as long as your doctor has recommended. If treatment is stopped 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 DOC than you should
If you have taken more ESCITALOPRAM DOC than prescribed, contact your doctor or go immediately to the nearest hospital Emergency Department, 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 ESCITALOPRAM DOC bottle/packaging with you when going to a doctor or hospital.

If you forget to take ESCITALOPRAM DOC
Do not take a double dose if you forget a dose. If you remember you missed a dose before going to bed, take it immediately.
Continue taking the medicine as usual 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 DOC
Do not stop taking ESCITALOPRAM DOC unless your doctor tells you to.
When completing treatment with ESCITALOPRAM DOC, it is generally recommended that the dose be gradually reduced over a period of a few weeks.
When stopping ESCITALOPRAM DOC, especially if stopped abruptly, you may experience withdrawal symptoms. These are common when stopping treatment with ESCITALOPRAM DOC. The risk is greater if you have taken ESCITALOPRAM DOC 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 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 DOC, inform 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), prickling or tingling sensations, burning sensations (less frequent), electric shock-like sensations, including 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, increased emotional sensitivity or irritability, diarrhoea (loose stools), visual disturbances, and disturbances in heart rhythm (palpitations).

If you have any questions 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. Keep in mind that many of the
side effects may also be symptoms of your illness and therefore decrease as you start to feel
better.
Contact your doctor if you experience any of the following side effects during treatment:

• difficulty urinating
• seizures (epileptic fits), see also section “Warnings and precautions”
• yellowing of the skin or whites of the eyes, which are signs of liver dysfunction/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):

• abnormal bleeding, including gastrointestinal bleeding.

Rare (may affect up to 1 in 1000 people):

• if you experience swelling of the skin, tongue, lips, or face, or have difficulty breathing or a choking sensation (allergic reaction), contact your doctor or go to hospital immediately
• high fever, agitation, confusion, tremor, and sudden muscle contractions may be symptoms of a rare condition called serotonin syndrome. If you experience these symptoms, contact your doctor.

In addition to the side effects listed above, the following have also been reported:
Very common (may affect more than 1 in 10 people):

• discomfort (nausea)
• headache

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

• blocked nose or nasal discharge (sinusitis)
• decreased or increased appetite
• anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, skin reactions
• diarrhoea, constipation, vomiting, dry mouth
• increased sweating
• muscle and joint pain (arthralgia and myalgia)
• sexual disorders (delayed ejaculation, erection 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 rashes, 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
• vaginal bleeding
• weight loss
• increased heart rate (tachycardia)
• swelling of arms or legs
• nosebleeds

Rare (may affect up to 1 in 1000 people):

• aggression, depersonalization, hallucinations
• slowed heart rate

In some patients (based on available data, frequency cannot be estimated):

• thoughts of self-harm (hurting yourself) or suicide (see also section 2 “What you need to know before taking ESCITALOPRAM DOC”)
• decreased sodium levels in the blood (symptoms include feeling unwell with muscle weakness or confusion)
• dizziness upon standing due to a drop in blood pressure (orthostatic hypotension)
• abnormalities in liver function tests (increased liver enzyme values in blood) and in ECG (electrocardiogram)
• movement disorders (involuntary muscle movements)
• painful erections (priapism)
• abnormal bleeding, including bleeding of the skin and mucous membranes (bruising), and low platelet counts in the blood (thrombocytopenia)
• heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, Pregnancy, breastfeeding and fertility, for further information
• sudden swelling of the skin or mucous membranes (angioedema)
• increased urine volume (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 (called “prolongation of the QT interval”, assessed by ECG which records the electrical activity of the heart)

In addition, a number of side effects are known for medicines that act like escitalopram (the active substance in ESCITALOPRAM DOC). These include:

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.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 DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack 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 not exceeding 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 DOC contains
The active substance is escitalopram. Each ml of ESCITALOPRAM DOC oral drops contains 20 mg of escitalopram (as escitalopram oxalate).
1 drop contains 1 mg of escitalopram.
The other excipients are:
propyl gallate
anhydrous citric acid
ethanol 96%
sodium hydroxide
purified water.

Description of the appearance of ESCITALOPRAM DOC and contents of the pack
ESCITALOPRAM DOC oral drops, solution is available in a dropper bottle (LDPE) made of dark glass (type III) with a child-resistant closure (polyethylene), containing 15 ml of oral drops, solution.
ESCITALOPRAM DOC oral drops, solution is a transparent solution, almost colourless to yellowish.

Marketing Authorisation Holder
DOC Generici S.r.l. Via Turati, 40 - 20121 Milan, 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