Escitalopram Doc Generici: detailed information

PATIENT LEAFLET: INFORMATION FOR THE USER

ESCITALOPRAM DOC Generici 10 mg film-coated tablets, 20 mg film-coated tablets

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 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT ESCITALOPRAM DOC Generici IS AND WHAT IT IS USED FOR

ESCITALOPRAM DOC Generici contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, which is the fear of being in places where help may not be available, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).
Escitalopram 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.
It may take a couple of weeks before you start to feel better. Continue taking ESCITALOPRAM DOC Generici 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 DOC Generici

Do not take ESCITALOPRAM DOC Generici

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 suffer from congenital arrhythmia or have had an episode of arrhythmia (detected by ECG, a test to assess your heart function)
if you are taking medicines for heart rhythm disorders or medicines that may affect heart rhythm (see section 2 “Other medicines and ESCITALOPRAM DOC Generici”)

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

if you suffer from epilepsy. Treatment with ESCITALOPRAM DOC Generici should be discontinued if seizures occur for the first time or if the frequency of epileptic seizures increases (see also section 4 “Possible side effects”).
if you have impaired liver or kidney function. Your doctor may need to adjust your dose.
if you have diabetes. Treatment with ESCITALOPRAM DOC Generici may alter glycaemic 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 have a tendency to bleed or bruise easily.
if you are undergoing electroconvulsive therapy.
if you suffer from coronary heart disease.
if you have or have previously had heart problems or have recently had a heart attack.
if you have a slow resting heart rate and/or if you think your body may have undergone a significant loss of salts due to prolonged and severe diarrhoea or vomiting, or due to the use of diuretics (tablets that increase urine production).
if you experience a fast or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate an irregular heart rhythm.
if you have or have previously had eye problems, such as certain types of glaucoma (increased pressure in the eye).

Please note
As with other medicines used to treat depression and related disorders, improvement is not
immediate. After starting treatment with ESCITALOPRAM DOC Generici, it may take several
weeks before you start to feel better. In the treatment of panic disorder, improvement usually occurs after 2-4 weeks. At the beginning of treatment, some patients may experience increased anxiety, which subsides as treatment continues. It is therefore very important that you strictly follow your doctor’s instructions and do not stop treatment or change your dose without first consulting your doctor.
Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may occasionally have self-harming or suicidal thoughts.
These thoughts may increase when you first start taking antidepressants, as all medicines of this type require time to take effect, usually about two weeks, but sometimes longer.
You are more likely to have these thoughts:

if you have previously had suicidal or self-harming thoughts.
if you are a young adult. Clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders being treated with antidepressants.

If you experience self-harming or suicidal thoughts at any time, contact your doctor or go to hospital immediately.
It may help to inform a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them to inform you if they think your depression or anxiety is worsening or if they are concerned about changes in your behaviour.
Some patients with bipolar disorder may enter a manic phase. This is characterised by unusual and rapidly changing thoughts, inappropriate and excessive physical activity, and excessive happiness. If you feel this way, contact your doctor.
Symptoms such as restlessness or difficulty sitting still may also occur during the first few weeks of treatment. If these symptoms appear, inform your doctor immediately.
You may not always be aware that you are experiencing the symptoms listed above, so it may help to ask a friend or family member to assist you in identifying possible signs of changes in your behaviour.
If you experience distressing thoughts or hallucinations, or if any of the symptoms listed above occur during treatment, contact your doctor immediately or go to the nearest hospital.

Children and adolescents
ESCITALOPRAM DOC Generici should not normally be used to treat children and adolescents under 18 years of age. You should be aware that patients under 18 years of age taking this class of medicines have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger). Nevertheless, your doctor may prescribe ESCITALOPRAM DOC Generici to patients under 18 years of age if they consider it to be the best option. If your doctor has prescribed ESCITALOPRAM DOC Generici for a patient under 18 years of age and you would like more information, please consult them again. You should inform your doctor if any of the symptoms listed above appear or worsen during treatment with ESCITALOPRAM DOC Generici in a patient under 18 years of age. In addition, the long-term effects of ESCITALOPRAM DOC Generici on growth, maturation, and cognitive and behavioural development in this patient group have not yet been established.

Other medicines and ESCITALOPRAM DOC Generici
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 the active ingredient. If you have taken any of these medicines, you must wait 14 days before starting ESCITALOPRAM DOC Generici. After stopping ESCITALOPRAM DOC Generici, you must wait 7 days before taking any of these medicines.
“Reversible, selective monoamine oxidase A (MAO-A) inhibitors” containing moclobemide (used to treat depression).
“Irreversible monoamine oxidase B (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.
Imipramine and desipramine (both used to treat depression).
Sumatriptan and similar medicines (used to treat migraine) and tramadol (used to treat severe pain). These medicines increase the risk of adverse effects.
Cimetidine, lansoprazole, and omeprazole (used to treat gastric ulcers), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase blood levels of ESCITALOPRAM DOC Generici.
St. John’s wort (Hypericum perforatum) – a herbal remedy for depression.
Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or to thin the blood, so-called anticoagulants). These medicines may increase the tendency to bleed.
Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). Your doctor will likely check your blood clotting time at the beginning and end of treatment with ESCITALOPRAM DOC Generici 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 lowering the seizure threshold.
Neuroleptics (used to treat schizophrenia, psychosis), due to a possible risk of lowering the seizure threshold, and other antidepressants.
Flecainide, propafenone, and metoprolol (used to treat cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of ESCITALOPRAM DOC Generici 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 Generici if you are taking medicines for heart rhythm disorders 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, 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 Generici with food and drink
ESCITALOPRAM DOC Generici can be taken with or without food (see section 3 “How to take ESCITALOPRAM DOC Generici”).
An interaction between ESCITALOPRAM DOC Generici and alcohol is not expected. However, as with many medicines, the combination of ESCITALOPRAM DOC Generici and alcohol is not recommended.

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 DOC Generici if you are pregnant or breastfeeding unless your doctor has explained all the risks and benefits to you.
If you take ESCITALOPRAM DOC Generici during the last three months of pregnancy, you should be aware that your newborn may experience the following effects: breathing difficulties, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, hypoglycaemia, hypertonia or hypotonia, exaggerated reflexes, tremor, restlessness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If you notice any of these symptoms in your baby, contact your doctor immediately.
Make sure to inform your midwife and/or doctor that you are taking ESCITALOPRAM DOC Generici.
When medicines such as ESCITALOPRAM DOC Generici are taken during pregnancy, particularly during the last three months, they may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the newborn to breathe faster and appear blue. These symptoms usually occur within the first 24 hours after birth. If your baby shows these symptoms, contact your midwife and/or doctor immediately.
When used during pregnancy, ESCITALOPRAM DOC Generici must never be stopped abruptly.
ESCITALOPRAM DOC Generici is believed to be excreted in breast milk.
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.
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
It is recommended not to drive or operate machinery until you know how ESCITALOPRAM DOC Generici affects you.

3. HOW TO TAKE ESCITALOPRAM DOC Generici

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Adults
Depression
The usual recommended dose of ESCITALOPRAM DOC Generici is 10 mg taken as a single daily dose. Your doctor may increase this dose up to a maximum of 20 mg per day.
Panic disorder
For the first week of treatment, the initial dose of ESCITALOPRAM DOC Generici is 5 mg per day, which is then increased to 10 mg per day. Your doctor may further increase this dose up to a maximum of 20 mg per day.
Social anxiety disorder
The usual recommended dose of ESCITALOPRAM DOC Generici is 10 mg taken as a single daily dose. Depending on your response to the medication, your doctor may reduce the dose to 5 mg per day or increase it up to a maximum of 20 mg per day.
Generalized anxiety disorder
The usual recommended dose of ESCITALOPRAM DOC Generici is 10 mg taken as a single daily dose. Your doctor may increase this dose up to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The usual recommended dose of ESCITALOPRAM DOC Generici is 10 mg taken as a single daily dose. Your doctor may increase this dose up to a maximum of 20 mg per day.
Elderly patients (over 65 years of age)
The recommended initial dose of ESCITALOPRAM DOC Generici is 5 mg per day, taken as a single daily dose. Your doctor may increase this dose up to a maximum of 10 mg per day.
Use in children and adolescents
ESCITALOPRAM DOC Generici should not normally be used to treat children and adolescents. For further information, please refer to section 2 “Before taking ESCITALOPRAM DOC Generici”.
ESCITALOPRAM DOC Generici may be taken with or without food. Swallow the tablet with water. Do not chew it, as it has a bitter taste.
If necessary, you may split the tablets by first placing them on a flat surface with the score side facing upwards. The tablets can then be divided by pressing with both index fingers on the ends of the tablet.
Duration of treatment
It may take a few weeks before you start to feel better. Continue taking ESCITALOPRAM DOC Generici even if it takes some time for your condition to improve.
Do not change the dose of this medicine without first talking to your doctor.
Continue taking ESCITALOPRAM DOC Generici for as long as your doctor prescribes it. If you stop treatment too early, your symptoms may return. It is advisable to continue treatment for at least 6 months after you start feeling better.
If you take more ESCITALOPRAM DOC Generici than you should
If you have taken more ESCITALOPRAM DOC Generici than prescribed, contact your doctor or go to the nearest hospital emergency department immediately. Do this even if there are no obvious signs of discomfort. Some symptoms of overdose may include: dizziness, tremors, agitation, seizures, coma, nausea, vomiting, changes in heart rhythm, low blood pressure, and disturbances in water and electrolyte balance. Take the ESCITALOPRAM DOC Generici packaging with you to the doctor or hospital.
If you forget to take ESCITALOPRAM DOC Generici
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 the medicine as usual the next day. If you remember during the night or the following day, skip the missed dose and continue as usual.
If you stop taking ESCITALOPRAM DOC Generici
Do not stop taking ESCITALOPRAM DOC Generici unless your doctor tells you to. At the end of the treatment course, it is generally recommended to gradually reduce the dose of ESCITALOPRAM DOC Generici over several weeks.
If you stop taking ESCITALOPRAM DOC Generici, especially abruptly, withdrawal symptoms may occur. These are common when stopping treatment with ESCITALOPRAM DOC Generici. The risk is higher when ESCITALOPRAM DOC Generici has been used for long periods or at high doses, or when the dose is reduced too quickly. Most patients report that symptoms are mild and disappear spontaneously within two weeks. However, in some patients, these symptoms may be more severe or last longer (2–3 months or more). If you experience severe withdrawal effects after stopping treatment with ESCITALOPRAM DOC Generici, contact your doctor. Your doctor may advise you to restart taking the tablets and to discontinue them more gradually.
Withdrawal symptoms include: dizziness (lightheadedness or loss of balance), pins and needles sensations, burning sensations (less frequently, electric shock-like sensations, including in the head), sleep disturbances (vivid dreams, nightmares, insomnia), anxiety, headache, malaise (nausea), sweating (including night sweats), restlessness or agitation, tremors (shaking), confusion or disorientation, emotional lability or irritability, diarrhea (loose stools), visual disturbances, palpitations (rapid or irregular heartbeat).
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions usually disappear after a few weeks of treatment. Please bear in mind that many of these effects may also be symptoms of your underlying illness and will therefore improve as you start to feel better.

Contact your doctor if you experience any of the following adverse reactions during treatment:

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

Unusual 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 swallowing (allergic reaction), contact your doctor or go immediately to the Emergency Department.
If you develop high fever, agitation, confusion, tremors, and sudden muscle contractions, these may be signs of a rare condition known as serotonin syndrome. If you feel this way, contact your doctor immediately.

If any of the following adverse reactions occur, contact your doctor or go immediately to
the hospital:

Difficulty urinating
Seizures (epileptic fits); see also section 2 "Warnings and precautions"
Yellowing of the skin or whites of the eyes, which are signs indicating impaired liver function/hepatitis
Rapid or irregular heartbeat, fainting, which may be signs of a life-threatening condition known as Torsades de Pointes
Thoughts of self-harm or suicide; see also section 2 "Warnings and precautions"

In addition to the above, the following adverse reactions 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, tremors, skin tingling
Diarrhea, constipation, vomiting, dry mouth
Excessive sweating
Muscle and joint pain (arthralgia and myalgia)
Sexual disorders (delayed ejaculation, erection problems, decreased sexual desire, and in women, 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
Restless sleep, altered sense of taste, fainting (syncope)
Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
Hair loss
Vaginal bleeding
Weight loss
Rapid heartbeat
Swollen 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):

Reduced blood sodium levels (with symptoms such as feeling unwell and unwellness associated with muscle weakness or confusion)
Dizziness upon standing due to a drop in blood pressure (orthostatic hypotension)
Abnormal liver function tests (increased blood levels of liver enzymes)
Movement disorders (involuntary muscle movements)
Painful erections (priapism)
Bleeding disorders affecting the skin and mucous membranes (bruising) and low platelet counts in the blood (thrombocytopenia)
Sudden swelling of the skin and mucous membranes (angioedema)
Increased urine production (inappropriate ADH secretion)
Milk discharge from the breasts in women who are not breastfeeding
Mania
Changes in heart rhythm (known as "QT interval prolongation" detected by electrocardiogram, electrical activity of the heart)

In addition, a number of adverse reactions are known to occur with medicines that act similarly to escitalopram (the active substance in ESCITALOPRAM DOC Generici). These include:

Motor restlessness (akathisia)
Anorexia

An increased risk of bone fractures has been observed in patients taking this type of medicine.

Reporting of adverse reactions

If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/it/responsabili
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ESCITALOPRAM DOC Generici

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
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. PACK CONTENT AND OTHER INFORMATION

What ESCITALOPRAM DOC Generici contains:
The active substance is escitalopram. One tablet of ESCITALOPRAM DOC Generici contains
10 mg or 20 mg of escitalopram (as oxalate).
The other components are:
Core: microcrystalline cellulose (E 460), sodium croscarmellose (E 468), anhydrous colloidal silica,
magnesium stearate (E 470b).
Coating: hypromellose (E 464), titanium dioxide (E 171), and macrogol 400.
Presentation of ESCITALOPRAM DOC Generici film-coated tablets and contents of the pack
ESCitalopram DOC Generici is available as 10 mg and 20 mg film-coated tablets.
The tablets are described below:
ESCITALOPRAM DOC Generici 10 mg: white, oval-shaped (approx. 8.1 x 5.6 mm) film-coated tablet with a break line on one side. The tablet can be divided into two equal doses.
ESCITALOPRAM DOC Generici 20 mg: white, oval-shaped (approx. 11.6 x 7.1 mm) film-coated tablet with a break line on one side. The tablet can be divided into two equal doses.
ESCITALOPRAM DOC Generici is available in the following pack sizes:
7, 10, 14, 15, 20, 28, 30, 30x1, 49, 49x1, 50, 56, 60, 84, 90, 98, 100, 100x1, 200, 500 tablets (in blisters).
Not all pack sizes may be marketed.
Marketing Authorization Holder
DOC Generici Srl
Via Turati 40
20121 Milan, Italy
Manufacturer
HBM Pharma s.r.o.
Sklabinská 30
036 80 Martin
Slovak Republic