Escitalopram Zentiva Italia: detailed information

Package leaflet: Information for the user

Escitalopram Zentiva Italia 20 mg/ml oral drops, solution

Generic medicine
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 they have the same symptoms as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Escitalopram Zentiva Italia 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 Zentiva Italia 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 Zentiva Italia even if it takes some time before you notice an improvement in your condition.
Speak to your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Escitalopram Zentiva Italia

Do not take Escitalopram Zentiva Italia:

if you are allergic to escitalopram or to any of the other ingredients of this medicine (listed in section 6);
if you are taking other medicines 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 (visible on an electrocardiogram (ECG), a test to assess how the heart is working);
if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm (see section 2 “Other medicines and Escitalopram Zentiva Italia”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Escitalopram Zentiva Italia.
Inform your doctor if you have any other illness or medical condition, as this may need to be taken into account. In particular, inform your doctor:

if you suffer from epilepsy. Treatment with Escitalopram Zentiva Italia must be stopped if you experience seizures for the first time or if the frequency of epileptic seizures increases (see also section 4 “Possible side effects”);
if you have thoughts of suicide or of harming yourself. See the 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 Zentiva Italia may alter blood glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycaemic agents;
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;
if you are taking any other medicine, including herbal medicines. See the subsection “Other medicines and Escitalopram Zentiva Italia”;
if you are undergoing electroconvulsive therapy (ECT);
if you have closed-angle glaucoma or have previously had 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 lost a large amount 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 use this medicine together with buprenorphine. This combination may lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Escitalopram Zentiva Italia”).
- if you have a history of bleeding disorders or if you are pregnant (see “Pregnancy”).

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 few 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.
Medicines such as Escitalopram Zentiva Italia (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.

Suicidal thoughts and worsening of your 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. Clinical study data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with an antidepressant.

If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go to the hospital immediately.
It may be helpful to inform a relative 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 change in your behaviour.

Use in children and adolescents under 18 years of age
Escitalopram Zentiva Italia is normally not recommended for use in 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).
Despite this, your doctor may prescribe Escitalopram Zentiva Italia to patients under 18 years of age if they consider it to be the best treatment option. If your doctor has prescribed Escitalopram Zentiva Italia to a patient under 18 years of age and you would like more information, please contact your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen during treatment with Escitalopram Zentiva Italia in a patient under 18 years of age. Furthermore, the long-term safety effects of Escitalopram Zentiva Italia on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.

Other medicines and Escitalopram Zentiva Italia
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 Zentiva Italia. After stopping Escitalopram Zentiva Italia, 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.
Buprenorphine (a strong painkiller). These medicines may interact with Escitalopram Zentiva Italia and may cause symptoms such as rhythmic, involuntary muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience such symptoms, as they increase the risk of adverse effects.
Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers or dyspepsia (indigestion)), 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 in the blood.
St. John’s wort (Hypericum perforatum), a herbal preparation used for depression.
Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or to thin the blood, so-called anticoagulants). These may increase the tendency to bleed.
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 Zentiva Italia 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 antipsychotics (medicines used to treat schizophrenia, psychosis), due to 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). A dose adjustment of Escitalopram Zentiva Italia 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 Zentiva Italia 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), and certain antihistamines (astemizole, mizolastine).
If you have any further doubts, contact your doctor.

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

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Escitalopram Zentiva Italia if you are pregnant or breastfeeding, unless your doctor has discussed the risks and benefits of treatment with you.
If you take Escitalopram Zentiva Italia during the last three months of pregnancy, you should be aware that the following adverse 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 know that you are taking Escitalopram Zentiva Italia.
When taken during pregnancy, particularly during the last three months, medicines like Escitalopram Zentiva Italia 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.
If you take Escitalopram Zentiva Italia towards the end of pregnancy, there may be an increased risk of severe vaginal bleeding immediately after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking Escitalopram Zentiva Italia so they can provide appropriate advice.
Abrupt discontinuation of treatment with Escitalopram Zentiva Italia should be avoided during pregnancy.
Citalopram, a medicine similar to escitalopram, has been shown in animal studies to reduce sperm quality. In theory, this could affect fertility, but the impact on human fertility has not been observed.

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

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

3. How to take Escitalopram Zentiva Italia

Take this medicine exactly as directed by your doctor. If you are unsure, 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 Zentiva Italia 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 Zentiva Italia 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 Zentiva Italia for the first week of treatment is 5 mg (5 drops) daily, which is then increased to 10 mg (10 drops) daily. Your doctor may increase this dose up to a maximum of 20 mg (20 drops) per day.

Social anxiety disorder
The normally recommended dose of Escitalopram Zentiva Italia is 10 mg (10 drops) once daily.
Your doctor may reduce the dose to 5 mg (5 drops) daily 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 Zentiva Italia 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 normally recommended dose of Escitalopram Zentiva Italia 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 (over 65 years of age)
The recommended initial dose of Escitalopram Zentiva Italia 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 Zentiva Italia should normally not be used in children and adolescents. For further information, see also section 2 “What you need to know before taking Escitalopram Zentiva Italia”.

Duration of treatment
It may take a few weeks before you notice any improvement. Continue taking Escitalopram Zentiva Italia even if you do not experience immediate improvement in your condition.
Do not change your dosage without first consulting your doctor.
Continue taking Escitalopram Zentiva Italia for as long as your doctor recommends. 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 Zentiva Italia than you should
If you have taken more Escitalopram Zentiva Italia 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 bottle/box of Escitalopram Zentiva Italia with you when going to a doctor or hospital.

If you forget to take Escitalopram Zentiva Italia
If you forget to take a dose of Escitalopram Zentiva Italia, do not take a double dose.
If you remember before going to bed, take the missed dose immediately.
Continue with 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 normal dosing regimen.

If you stop taking Escitalopram Zentiva Italia
Do not stop taking Escitalopram Zentiva Italia unless your doctor tells you to.
When completing treatment with Escitalopram Zentiva Italia, it is generally recommended that the dose be gradually reduced over a couple of weeks.
When stopping Escitalopram Zentiva Italia, especially if stopped suddenly, you may experience withdrawal symptoms. These are common when stopping treatment with Escitalopram Zentiva Italia. The risk is greater if you have taken Escitalopram Zentiva Italia for a long time or 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 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 Zentiva Italia, 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, 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, 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 everybody gets them.
The 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 the following side effects during treatment, contact your doctor immediately:
Uncommon (may affect up to 1 in 100 people):

abnormal bleeding, including gastrointestinal bleeding.

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

if you experience swelling of the skin, tongue, lips or face, or have difficulty breathing or a feeling of suffocation (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 feel like this, contact your doctor.

If you experience the following side effects, you must contact your doctor immediately or go to
hospital:

difficulty passing urine
seizures (epileptic fits), see also section “Warnings and precautions”
yellowing of the skin and whites of the eyes are 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.

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)
decreased or increased appetite
anxiety, restlessness, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, skin disorders
diarrhoea, constipation, vomiting, dry mouth
increased sweating
muscle and joint pain (arthralgia and myalgia)
sexual disorders (delayed ejaculation, erection problems, reduced sex drive and women may have difficulty reaching orgasm)
tiredness, 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
vaginal bleeding
weight loss
increased heart rate (tachycardia)
swelling of arms or legs
nosebleeds
Severe vaginal bleeding immediately after childbirth (postpartum haemorrhage), see "Pregnancy" in section 2 for further information.

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

aggression, depersonalisation, hallucinations
slowed heartbeat.

Some patients have reported (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 Zentiva Italia”)
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 levels of liver enzymes in the blood) and in the 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)
sudden swelling of the skin or mucous membranes (angioedema)
increased volume of urine (inappropriate ADH secretion)
increased levels of the hormone prolactin in the blood
milk secretion 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 “QT interval prolongation”, assessed by an ECG which records the electrical activity of the heart).

In addition, a number of side effects are known to occur with medicines that act like escitalopram
(active substance in Escitalopram Zentiva Italia). These are:

motor restlessness (akathisia), urgency or need to move to relieve an unpleasant sensation (akathisia)
anorexia.

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

5. How to store Escitalopram Zentiva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the label of the
bottle after Exp. (the expiry date).
The expiry date refers to the last day of that month.
After first opening, the oral drops solution must be used within 8 weeks and stored at a temperature below 25°C.
Do not dispose of any medicine 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 Zentiva Italia contains
The active substance is escitalopram. Each ml of Escitalopram Zentiva Italia oral drops contains 20 mg of
escitalopram (equivalent to 25,551 mg of escitalopram oxalate).
1 drop contains 1 mg of escitalopram.
The other excipients are:
propyl gallate
anhydrous citric acid
ethanol 96%
sodium hydroxide
purified water.

Description of the appearance of Escitalopram Zentiva Italia and contents of the pack
Escitalopram Zentiva Italia oral drops, solution is available in a 15 ml amber glass bottle with dropper cap and child-resistant closure.
Escitalopram Zentiva Italia oral drops, solution is a clear, almost colourless to slightly yellow solution.

Marketing Authorization Holder
Zentiva Italia Srl, Via P. Paleocapa 7, 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