Escitalopram PensA

Package leaflet: Information for the user

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

Equivalent 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 they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Escitalopram Pensa contains the active substance escitalopram. Escitalopram Pensa
belongs to a group of antidepressant medicines called Selective Serotonin Reuptake
Inhibitors (SSRIs). These medicines act on the brain's serotonin system by increasing
serotonin levels. Alterations in the brain's serotonin system are considered important
factors in the development of depression and related disorders.
Escitalopram Pensa is used to treat depression (major depressive episodes) and anxiety
disorders (such as panic disorder with or without agoraphobia, social anxiety disorder,
generalized anxiety disorder, and obsessive-compulsive disorder).
It may take a couple of weeks before you start to feel better. Continue taking Escitalopram
Pensa even if it takes some time before you begin to notice any improvement in your
condition.
Consult your doctor if you do not feel well or feel worse.

2. What you should know before taking Escitalopram Pensa

Do not take Escitalopram Pensa:

• 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 heart rhythm (see section 2 "Escitalopram Pensa and other medicines").

Warnings and precautions
Talk to your doctor or pharmacist before using Escitalopram Pensa.
Inform your doctor if you have any other condition or illness, as the doctor may need to take this into account. In particular, inform your doctor:

• If you suffer from epilepsy. Treatment with Escitalopram Pensa must be discontinued if seizures occur or if there is an increase in seizure frequency (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 Pensa may alter blood glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic agents.
• If you have low sodium levels in the blood.
• If you have a tendency to develop bleeding or bruising.
• If you are receiving electroconvulsive therapy.
• If you have coronary artery disease.
• 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 know you have salt deficiencies following prolonged severe diarrhea and vomiting (illness) or if you are using diuretics.
• If, when standing up, you experience a rapid or irregular heartbeat, fainting, collapse, or dizziness, which may indicate an abnormality in heart rhythm function.
• If you suffer or have suffered from eye problems, such as certain types of glaucoma (increased eye pressure).

Warning
Some patients with bipolar disorder may enter a manic phase.
This is characterized by unusual thoughts that change rapidly, inappropriate happiness, and excessive physical activity. If you experience these feelings, contact your doctor.
Symptoms such as restlessness or difficulty sitting or standing still may occur during the first weeks of treatment. Inform your doctor immediately if these symptoms occur.
Medicines such as Escitalopram Pensa (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 depression or anxiety disorder
If you suffer from depression and/or have 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 study data have shown an increased risk of suicidal behaviour in patients under 25 years of age with psychiatric disorders treated with an antidepressant. If at any time you 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 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.
Use in children and adolescents
Normally, Escitalopram Pensa 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 adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, oppositional behaviour, and anger). Despite this, your doctor may prescribe Escitalopram Pensa to patients under 18 years of age if they consider it the best treatment option. If your doctor has prescribed Escitalopram Pensa 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 above symptoms appear or worsen during treatment with Escitalopram Pensa in a patient under 18 years of age. Furthermore, the long-term safety effects of Escitalopram Pensa on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.
Other medicines and Escitalopram Pensa
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 treatment with Escitalopram Pensa. After stopping treatment with Escitalopram Pensa, 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.
• 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 (used to treat severe pain). These increase the risk of adverse effects.
• Cimetidine, omeprazole (used to treat gastric ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in escitalopram levels in the blood.
• St. John's Wort (Hypericum perforatum), a herbal remedy used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to reduce blood clotting, also 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 time checks at the beginning and end of treatment with Escitalopram Pensa 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 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 Pensa may be necessary.
• "Medicines that lower potassium or magnesium levels in the blood, as these conditions increase the risk of life-threatening heart rhythm disorders."

Do not take Escitalopram Pensa 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 further questions, consult your doctor.
Escitalopram Pensa with food, drinks, and alcohol
Escitalopram Pensa can be taken with or without food (see section 3 "How to take Escitalopram Pensa").
As with many medicines, combining Escitalopram Pensa with alcohol is not recommended, although no interaction between Escitalopram Pensa and alcohol is expected.
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 Pensa if you are pregnant or breastfeeding, unless you have discussed the risks and benefits of treatment with your doctor.
If you take Escitalopram Pensa 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, hypertonia or hypotonia, hyperreflexia, tremor, restlessness, irritability, lethargy, persistent crying, drowsiness, and sleep difficulties. 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 Pensa. When taken during pregnancy, particularly during the last three months of pregnancy, medicines such as Escitalopram Pensa may increase the risk in newborns of a serious condition 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 happens to your baby, contact your midwife and/or doctor immediately.
If used during pregnancy, Escitalopram Pensa should not be stopped abruptly.
Escitalopram Pensa is expected to be excreted in breast milk.
In animal studies, citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality. In theory, this does not affect fertility, but the impact on human fertility has not yet been studied.
Driving and using machines
You are advised not to drive or operate machinery until you know how Escitalopram Pensa affects you.
Escitalopram Pensa contains Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is practically "sodium-free".

3. How to take Escitalopram Pensa

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

Adults

Depression
The usual recommended dose of Escitalopram Pensa is 10 mg once daily, as a single dose. Your doctor may increase the dose up to a maximum of 20 mg per day.

Panic disorder
The initial dose of Escitalopram Pensa for the first week is 5 mg once daily, as a single dose, which is then 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 Pensa 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 Pensa 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 Pensa 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 Pensa is 5 mg per day, as a single dose. The dose may be increased by your doctor up to 10 mg per day.

Children and adolescents
Escitalopram Pensa is generally not recommended for use in children and adolescents. For further information, see section 2 "Warnings and precautions".

You may take Escitalopram Pensa with or without food. Swallow the tablet with water. Do not chew the tablet, as it has a bitter taste.
The tablet may be divided into two equal halves.

Duration of treatment
It may take a few weeks before you notice any improvement. Continue taking Escitalopram Pensa 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 Pensa 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 Pensa than you should
If you take more Escitalopram Pensa 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 package of Escitalopram Pensa with you.

If you forget to take Escitalopram Pensa
Do not take a double dose to make up for the missed dose. If you forget to take a dose and remember before going to bed, take it immediately and continue as usual the next day. If you remember during the night or the following day, skip the missed dose and take the next dose as scheduled.

If you stop taking Escitalopram Pensa
Do not stop treatment with Escitalopram Pensa unless your doctor advises you to do so. When completing treatment with Escitalopram Pensa, it is generally recommended that the dose be gradually reduced over a couple of weeks.
When you stop taking Escitalopram Pensa, especially if stopped abruptly, you may experience withdrawal symptoms. These are common when stopping treatment with Escitalopram Pensa. The risk is higher if you have taken Escitalopram Pensa 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 period (2–3 months or more). If you experience severe withdrawal symptoms when stopping treatment with Escitalopram Pensa, consult your doctor. Your doctor may advise you to restart treatment and then gradually reduce the dose more slowly.

Withdrawal symptoms include: dizziness (feeling unsteady or off balance), prickling or tingling sensations, burning sensations (less common), 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, and heart rhythm disturbances (palpitations).

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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.
If you experience any of the following side effects during treatment, contact your doctor or go immediately to the nearest emergency room:

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, throat or face, hives or difficulty breathing or swallowing (severe 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 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 Torsades de Pointes.
• Suicidal or self-harming thoughts; see also section "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, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin reactions.
• Diarrhoea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual problems (delayed ejaculation, erection problems, decreased sex drive; women may have difficulty achieving orgasm).
• Tiredness, fever.
• Weight gain.

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

• Skin rashes (urticaria), skin rash, itching.
• Teeth grinding, agitation, nervousness, panic attacks, confusion.
• Disturbed sleep, taste disturbances, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Vaginal bleeding.
• Irregular menstrual cycle.
• 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 available data):

• 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).
• Changes in liver function tests (increased levels of liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of abnormal bleeding, e.g. of the skin and mucous membranes (bruising).
• Increased secretion of a hormone called ADH, causing the body to retain water and dilute the blood, thereby reducing sodium levels (inappropriate ADH secretion).
• Milk production in men and women who are not breastfeeding.
• Mania.
• An increased risk of fractures has been observed in patients taking this type of medicine.
• Changes in heart rhythm (known as "prolongation of the QT interval", detected by an ECG that records the heart's electrical activity).

Additionally, certain side effects are known to occur with medicines that work in the same way as escitalopram (the active substance in Escitalopram Pensa). These include:

• Motor restlessness (akathisia).
• Loss of appetite.

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
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 Pensa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after "Exp.". The expiry date refers to the last day of that month.
Store below 30 °C.
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 Pensa contains
The active substance is escitalopram.
Each tablet contains 10 mg or 20 mg of escitalopram (as oxalate).
The other components are:
Tablet core: Microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose,
talc and magnesium stearate.
Tablet coating: Titanium dioxide (E171), hypromellose, macrogol 400 (E1521) and
Polysorbate 80 (E433).
Description of the appearance of Escitalopram Pensa and package contents
Escitalopram Pensa is available as 10 mg or 20 mg film-coated tablets.
Description of the tablets
10 mg: White to off-white, oval-shaped, marked, biconvex, film-coated tablet,
imprinted with “J” on one side and “2” on the other side.
20 mg: White to off-white, oval-shaped, marked, biconvex, film-coated tablet,
imprinted with “J” on one side and “4” on the other side.
Escitalopram Pensa is available in the following pack sizes:
Blister packs (white) in cardboard boxes containing: 20, 28, 50, 100 tablets
HDPE bottle: 200 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano
Italy
Manufacturer responsible for batch release
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola PLA 3000
Malta
This medicinal product is authorised in the European Economic Area countries
under the following names:
Italy: Escitalopram Pensa 10 mg film-coated tablets
Escitalopram Pensa 20 mg film-coated tablets
Poland: Betesda
Portugal: Escitalopram Hetero 10 mg Film-coated tablets
Escitalopram Hetero 20 mg Film-coated tablets
This Patient Information Leaflet was last approved on: