Entact

Package leaflet: Information for the user

Entact 5 mg film-coated tablets, 10 mg film-coated tablets, 15 mg film-coated tablets, 20 mg film-coated tablets

escitalopram
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 pass it on to others, 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:

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

1. What Entact is and what it is used for

Entact contains the active substance escitalopram. Entact belongs to a group of antidepressant medicines called Selective Serotonin Reuptake Inhibitors (SSRIs).
The active substance in Entact 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, and generalized anxiety disorder).
It may take a few weeks before you start to feel better. Continue taking Entact 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 Entact

Do not take Entact

• 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 were born with or have had 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 medicines that may affect your heart rhythm (see section 2 “Other medicines and Entact”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Entact. 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 Entact should be discontinued if seizures occur for the first time 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 Entact 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 your blood.
• if you have a tendency to develop bleeding or bruising, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
• if you are receiving electroconvulsive therapy.
• if you have coronary heart disease (heart-related coronary 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 know you have salt deficiencies due to prolonged severe diarrhea and vomiting (feeling unwell) or if you are using diuretics (medicines to increase urination).
• if, when standing up, you experience a rapid or irregular heartbeat, fainting, collapsing, or dizziness, which may indicate an abnormal heart rhythm.
• if you have or have previously had eye problems, such as certain types of glaucoma (increased pressure inside the eye).

Please note
Some patients with bipolar disorder may enter a manic phase. This is characterized by rapidly changing unusual thoughts, 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 these symptoms occur, inform your doctor immediately.
Medicines such as Entact (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 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 behavior in psychiatric patients under 25 years of age treated with an antidepressant. If at any time you have thoughts of harming yourself or committing suicide, contact your doctor or go immediately to the hospital. It may be helpful to inform a relative 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 behavior.

Children and adolescents
Entact is generally not intended 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 side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behavior, and anger). Despite this, your doctor may prescribe Entact to patients under 18 years of age if they consider it the best option for them. If your doctor has prescribed Entact to a patient under 18 years of age and you would like more information, please contact your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen during Entact treatment in a patient under 18 years of age. Furthermore, the long-term safety effects of Entact on growth, maturation, and cognitive and behavioral development have not yet been established in this age group.

Other medicines and Entact
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 Entact. After stopping treatment with Entact, 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 and similar medicines (opioids, used to treat severe pain). These increase the risk of adverse effects.
• Cimetidine, lansoprazole, and 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 antiplatelets). 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 Entact treatment to ensure 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 lowered seizure threshold.
• Neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs), due to the possible risk of lowered seizure threshold.
• Flecainide, propafenone, and metoprolol (used in cardiovascular conditions), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Entact may be necessary.
• Medicines that reduce potassium or magnesium levels in the blood, as these conditions increase the risk of life-threatening heart rhythm disturbances.

Do not take Entact if you are taking medicines for heart rhythm problems or medicines that may affect your 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, hydroxyzine, mizolastine).
If you have any further questions, contact your doctor.

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

Pregnancy, breastfeeding, and fertility
Inform your doctor if you are pregnant or planning a pregnancy. Do not take Entact if you are pregnant or breastfeeding unless your doctor has discussed the risks and benefits of treatment with you.
If you take Entact during the third trimester of pregnancy, you should be aware that the following effects may occur in the newborn: breathing difficulties, bluish skin coloration, seizures, unstable body temperature, feeding difficulties, vomiting, hypoglycemia (low blood glucose levels), hypertonia or hypotonia, hyperreflexia, tremor, nervousness, 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 Entact. Medicines such as Entact, when taken during pregnancy, particularly during the last three months of pregnancy, 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, you must contact your midwife and/or doctor immediately.
If you take Entact near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (a tendency to bleed). Inform your doctor or midwife that you are taking Entact so they can advise you on what to do.
Sudden discontinuation of Entact treatment should be avoided during pregnancy.
Escitalopram is expected 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.

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

Entact contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially ‘sodium-free’.

3. How to take Entact

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Adults
Depression
The usual recommended dose of Entact is 10 mg once daily. Your doctor may increase this dose up to a
maximum of 20 mg daily.
Panic disorder
The initial dose of Entact for the first week of treatment is 5 mg daily, which is then increased to 10 mg
daily. Your doctor may increase this dose up to a maximum of 20 mg daily.
Social anxiety disorder
The dose of Entact normally recommended is 10 mg once daily. Your doctor may reduce the dose to 5 mg
daily or increase it up to a maximum of 20 mg daily, depending on your individual response to treatment.
Generalized anxiety disorder
The dose of Entact normally recommended is 10 mg once daily. This dose may be increased by your doctor
up to a maximum of 20 mg daily.
Elderly patients (over 65 years of age)
The recommended initial dose of Entact is 5 mg once daily. This dose may be increased by your doctor up to
10 mg daily.
Children and adolescents
Entact should normally not be taken by children and adolescents. For further information, see section 2
“What you should know before taking Entact”.
Reduced renal function
Caution is advised in patients with severely reduced renal function. Take the medicine as prescribed by
your doctor.
Reduced hepatic function
Patients with liver disorders should not receive more than 10 mg daily. Take the medicine as prescribed by
your doctor.
Patients known to be poor metabolizers of the CYP2C19 enzyme
Patients with this known genotype should not receive more than 10 mg daily. Take the medicine as
prescribed by your doctor.
Entact may be taken regardless of food intake. Swallow the tablets with a glass of water. Do not chew them,
as the taste is bitter.
If necessary, the 10 mg, 15 mg, and 20 mg tablets can be split by placing them on a flat surface with the
score line facing upwards. The tablets can be divided by pressing down on each end of the tablet using both
index fingers, as shown in the illustration.

The 10 mg, 15 mg, and 20 mg tablets can be divided into equal doses.
Duration of treatment
It may take a couple of weeks before you notice any improvement. Continue taking Entact even if you do
not immediately feel better.
The dosage should never be changed without first consulting your doctor.
Continue taking Entact 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 Entact than you should
If you have taken more Entact 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 Entact bottle with you when going to see a doctor or to the
hospital.
If you forget to take Entact
If you forget to take a dose of Entact, do not take a double dose. If you remember before going to bed, take
the missed dose immediately and continue 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 Entact
Do not stop taking Entact unless your doctor tells you to. When you have completed treatment with
Entact, it is generally recommended that the dose be gradually reduced over a couple of weeks.
When stopping Entact, especially if stopped abruptly, you may experience withdrawal symptoms. These
are common when stopping treatment with Entact. The risk is greater if you have taken Entact for a long
time or in high doses, or if the dose is reduced too quickly. Most patients find that these symptoms are mild
and usually resolve 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 Entact, inform your doctor.
Your doctor may ask you to resume treatment and continue with a more gradual dose reduction.
Withdrawal symptoms include: dizziness (feeling unsteady or off balance), sensations of pins and needles,
burning sensations, and (less frequently) 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 disturbances in heartbeat (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. Please note that many of the side effects may also be symptoms of your illness and therefore decrease as you start to feel better.
If any of the following symptoms occur, you must contact your doctor or go to hospital immediately:
Uncommon (may affect up to 1 in 100 people):

• Abnormal bleeding, including gastrointestinal haemorrhage

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

• Swellings of the skin, tongue, lips or face, or difficulty breathing or a sensation of suffocation (allergic reaction)
• High fever, agitation, confusion, tremor and sudden muscle contractions may be symptoms of a rare condition called serotonin syndrome

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

• Difficulty passing urine
• Seizures (fits), see also section “Warnings and precautions”
• Yellowing of the skin and whites of the eyes, which 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
• Thoughts of self-harm or suicide, see also section “Warnings and precautions”

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 nose or nasal discharge (sinusitis)
• Decreased or increased appetite
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, skin changes
• Diarrhoea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain (arthralgia and myalgia)
• Sexual disorders (delayed ejaculation, erection problems, reduced sexual drive, and women may have difficulty achieving orgasm)
• Tiredness, 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)
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• Hair loss
• Excessive menstrual bleeding
• Irregular menstrual periods
• Weight loss
• Increased heart rate
• Swelling of arms or legs
• Nosebleeds

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

• Aggression, depersonalisation, hallucinations
• Slowing of the heart rate

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

• Decreased sodium levels in the blood (symptoms include feeling unwell with muscle weakness or confusion)
• Dizziness upon standing due to a drop in blood pressure (orthostatic hypotension)
• Changes in liver function test results (increased levels of liver enzymes in the blood)
• Movement disorders (involuntary muscle movements)
• Painful erections (priapism)
• Signs of increased bleeding such as bruising of the skin and mucous membranes (ecchymoses) and low platelet levels in the blood (thrombocytopenia)
• Sudden swelling of the skin or mucous membranes (angioedema)
• Increased production of a hormone called ADH, causing fluid retention and blood dilution, resulting in reduced sodium levels (inappropriate ADH secretion)
• Increased levels of the hormone prolactin in the blood
• Milk secretion in men and 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”), detected by ECG measuring the heart's electrical activity
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 “Pregnancy, breastfeeding and fertility” for further information

In addition, a number of side effects are known to occur with medicines that act like escitalopram (the active substance in Entact). 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: https://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 Entact

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 blister after Exp (the
expiry date). The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
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 Entact contains
The active substance is escitalopram. Each Entact tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of
escitalopram (as oxalate).
The other excipients are:
Tablet core: silicified microcrystalline cellulose, talc, sodium croscarmellose, and magnesium stearate.
Coating: hypromellose, macrogol 400, titanium dioxide (E 171).
Description of the appearance of Entact and package contents
Entact is available as film-coated tablets of 5 mg, 10 mg, 15 mg, and 20 mg. The tablets are described below.
Entact 5 mg: round, white, film-coated tablet marked with "EK" on one side of the tablet.
Entact 10 mg: oval, white, scored, film-coated tablet marked with "E" and "L" on either side of the tablet.
Entact 15 mg: oval, white, scored, film-coated tablet marked with "E" and "M" on either side of the tablet.
Entact 20 mg: oval, white, scored, film-coated tablet marked with "E" and "N" on either side of the tablet.
Tablets of 10 mg, 15 mg, and 20 mg can be divided into equal doses.
Entact is available in the following pack sizes:
Blister packs with outer cardboard carton
5 mg, 10 mg, 15 mg, and 20 mg: 14, 28, 56, and 98 tablets
Single-dose packaging
5 mg, 10 mg, 15 mg, 20 mg: 49x1, 100x1, and 500x1 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
H. Lundbeck A/S
Ottiliavej 9
Valby
Denmark
Local Representative for Italy
Lundbeck Italia S.p.A.
Via Joe Colombo, 2 - 20124 Milano
Manufacturer:
H. Lundbeck A/S, Copenhagen, Valby, Denmark
This medicinal product is authorized in the European Economic Area countries under the following names:
Greece: Escitalopram Lundbeck
Cyprus: Escitalopram Lundbeck
Italy: Entact
Spain: Esertia
Sweden: Prilect

Package leaflet: information for the user

Entact 20 mg/ml oral drops, solution

escitalopram
Please read this leaflet carefully before using this medicine because it contains important information for you.

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

Contents of this leaflet:

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

1. What Entact is and what it is used for

Entact contains the active substance escitalopram. Entact belongs to a group of antidepressant medicines known as Selective Serotonin Reuptake Inhibitors (SSRIs).
The active substance in Entact is escitalopram, which is used to treat depression (major depressive episodes) and anxiety (such as panic disorder with or without agoraphobia, social anxiety disorder, and generalized anxiety disorder) in adults aged 18 years and over.
It may take a couple of weeks before you start to feel better. Continue taking Entact 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 Entact

Do not take Entact

• if you are allergic to escitalopram or to any of the other excipients 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 abnormal heart rhythm (identified by an ECG; a test performed to assess heart function).
• if you are taking medicines for heart rhythm problems or that may affect your heart rhythm (see section 2 “Other medicines and Entact”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Entact. 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 Entact must be discontinued if seizures occur for the first time 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 dosage.
• if you have diabetes. Treatment with Entact may alter glycaemic control. It may be necessary to adjust the dose of insulin and/or oral hypoglycaemic agents.
• if you have low levels of sodium in your blood.
• if you have a tendency to develop bleeding or bruising, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
• if you are receiving electroconvulsive therapy.
• if you have coronary heart disease (heart-related coronary 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 due to prolonged severe diarrhoea and vomiting (feeling unwell) or if you are using diuretics (medicines to increase urination).
• 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 have or have previously had eye problems, such as certain types of glaucoma (increased pressure inside the eye).

Please note
Some patients with bipolar disorder may enter a manic phase. This is
characterized by rapidly changing unusual thoughts, 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 these symptoms occur, inform your doctor immediately.
Medicines such as Entact (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 persisted after discontinuation of treatment.
Suicidal thoughts and worsening of your 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 frequent 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 thought about suicide or self-harm;
• if you are a young adult. Clinical study 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 relative 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.

Children and adolescents
Entact is normally not to be taken by children and adolescents under 18 years of age. In addition,
you should know that, when taking this class of medicines, patients under 18 years of age
have an increased risk of side effects such as suicide attempts, suicidal ideation, and hostility
(mainly aggression, oppositional behaviour, and anger). Despite this, your doctor
may prescribe Entact to patients under 18 years of age if they consider it the best option
for them. If your doctor has prescribed Entact to a patient under 18 years of age and you wish to obtain further
information, please contact your doctor again. You must inform your doctor if any of the symptoms listed above appear or
worsen during Entact treatment in a patient under 18 years of age. In addition, the long-term safety effects of Entact on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.

Other medicines and Entact
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine.
Inform your doctor if you are taking any of the following medicines:

• “Non-selective monoamine oxidase inhibitors (MAOIs)” containing phenelzine, iproniazide, isocarbazide, nialamide, or tranylcypromine as the active ingredient. If you have taken any of these medicines, you must wait 14 days before starting treatment with Entact. After stopping treatment with Entact, 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 and similar medicines (opioids, used to treat severe pain). These increase the risk of adverse effects.
• Cimetidine, lansoprazole, and 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 product used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to reduce blood clotting, also called antiplatelets). These may increase the tendency to bleed.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce blood clotting, also called anticoagulants). Your doctor may perform checks on your blood clotting time at the beginning and end of Entact treatment 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 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), and clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). A dosage adjustment of Entact may be necessary.
• Medicines that reduce potassium or magnesium levels in the blood, as these conditions increase the risk of life-threatening cardiac rhythm disturbances.

Do not take Entact 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, certain antimicrobial agents (such as sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine).
If you have further doubts, contact your doctor.
Entact with food, drinks and alcohol
Entact can be taken on an empty or full stomach (see section 3 “How to take Entact”).
An interaction between Entact and alcohol is not expected. However, as with many medicines,
the combination of Entact and alcohol is not recommended.
Pregnancy, breastfeeding and fertility
Inform your doctor if you are pregnant or planning a pregnancy. Do not take Entact if you are
pregnant or breastfeeding, unless your doctor has discussed the risks and benefits of treatment with you.
If you take Entact during the third trimester of pregnancy, you should be aware that the following effects
may be observed in the newborn: breathing difficulties, bluish skin colour, seizures,
body temperature instability, feeding difficulties, vomiting, hypoglycaemia (low blood glucose
levels), hypertonia or hypotonia, hyperreflexia, tremor, nervousness, 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 know that you are taking Entact. When taken during
pregnancy, particularly during the last 3 months of pregnancy, medicines like Entact 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, you must contact your midwife and/or doctor immediately.
If you take Entact near the end of pregnancy, there may be an increased risk of heavy
vaginal bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed easily). Inform your doctor or midwife that you are taking Entact, so they can advise you on what to do.
Abrupt discontinuation of Entact treatment should be avoided during pregnancy.
Escitalopram is expected to be excreted in breast milk.
Citalopram, a medicine similar to escitalopram, in animal studies, has been shown to reduce sperm quality. In theory, this could affect fertility, but the impact on human fertility has not yet been observed.
Driving and using machines
We recommend that you do not drive or operate machinery until you know how Entact
affects you.
Entact 20 mg/ml oral drops, solution contains alcohol.
This medicine contains 100 mg of alcohol (96% ethanol) per ml, equivalent to 11.8% v/v. The
amount in 1 ml 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 have noticeable effects.
Entact 20 mg/ml oral drops, solution contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per ml, i.e. essentially
‘sodium-free’.

3. How to take Entact

Always take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Turn the bottle completely upside down. If no drops come out, tap the bottle gently to start the flow.

Count the required number of drops to pour into a drink (water, orange juice or apple juice), stir the glass
briefly and drink the entire beverage.
Entact oral drops must not be mixed with other liquids nor combined with other medicines.

Adults
Depression
The usual recommended dose of Entact is 10 mg (10 drops) daily, taken as a single dose. This dose may
be increased by your doctor up to a maximum of 20 mg (20 drops) daily.

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

Social anxiety disorder
The dose of Entact normally recommended is 10 mg (10 drops) daily, taken as a single dose. Your doctor
may reduce the dose to 5 mg (5 drops) daily or increase it up to a maximum of 20 mg (20 drops) daily,
depending on your individual response to treatment.

Generalized anxiety disorder
The dose of Entact normally recommended is 10 mg (10 drops) daily, taken as a single dose. This dose
may be increased by your doctor up to a maximum of 20 mg (20 drops) daily.

Elderly patients (over 65 years of age)
The recommended starting dose of Entact is 5 mg (5 drops) daily, taken as a single dose. This dose may
be increased by your doctor up to 10 mg (10 drops) daily.

Children and adolescents
Entact should normally not be taken by children and adolescents. For further information, see section 2
“What you need to know before taking Entact”.

Reduced renal function
Caution is advised in patients with severely impaired renal function. Take the medicine as prescribed by
your doctor.

Reduced liver function
Patients with liver disorders should not receive more than 10 mg daily. Take the medicine as prescribed
by your doctor.

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

Duration of treatment
It may take a few weeks before you notice any improvement. Continue taking Entact even if you do not
immediately feel better.
The dosage must never be changed without first consulting your doctor.
Continue taking Entact 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 Entact than you should
If you have taken more Entact 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, decreased blood
pressure, and disturbances in electrolyte balance. Take the Entact bottle with you when going to a doctor or
to hospital.

If you forget to take Entact
If you forget to take a dose of Entact, do not take a double dose. If you remember before going to bed,
take the missed dose immediately and continue 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 Entact
Do not stop taking Entact unless your doctor tells you to. When completing treatment with Entact, it is
generally recommended that the dose be gradually reduced over a couple of weeks.
When stopping Entact, especially if stopped abruptly, you may experience withdrawal symptoms. These
are common when discontinuing treatment with Entact. The risk is greater if you have taken Entact for a
long time or at high doses, or if the dose is reduced too quickly. Most patients find that such symptoms are
mild and usually disappear spontaneously within a few weeks. However, in some patients, withdrawal
symptoms may be severe or may persist over time (2–3 months or longer).
If you experience severe withdrawal symptoms when stopping Entact, inform your doctor. Your doctor
may ask you to restart treatment and continue with a more gradual dose reduction.
Withdrawal symptoms include: dizziness (feeling unsteady or off balance), sensations of pins and needles,
burning sensations, and (less frequently) 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; emotional lability or
irritability; diarrhoea (loose stools); visual disturbances; and disturbances in heart rhythm (palpitations).

If you have any questions about the use of 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. Please note that many of the side effects may also be symptoms of your illness, and therefore improve as you start to feel better.
If any of the following symptoms occur, you must contact your doctor or go to hospital 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):

• Swelling of the skin, tongue, lips or face, or difficulty breathing or a feeling of suffocation (allergic reaction)
• High fever, agitation, confusion, tremor and sudden muscle contractions may be symptoms of a rare condition called serotonin syndrome

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

• Difficulty urinating
• Seizures (fits), see also section “Warnings and precautions”
• Yellowing of the skin and whites of the eyes, signs of liver dysfunction/hepatitis
• Rapid or irregular heartbeat, feeling faint—these may be symptoms of a life-threatening condition known as Torsades de Pointes
• Thoughts of self-harm or suicide, see also section “Warnings and precautions”

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 nose or nasal discharge (sinusitis)
• Decreased or increased appetite
• Anxiety, restlessness, unusual 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 problems (delayed ejaculation, erection problems, reduced sexual drive, and women may have difficulty achieving orgasm)
• Tiredness, 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)
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• Hair loss
• Excessive menstrual bleeding
• Irregular menstrual periods
• Weight loss
• Increased heart rate
• Swelling of arms or legs
• Nosebleeds

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

• Aggression, depersonalization, hallucinations
• Slowing of the heart rate

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

• Decreased sodium levels in the blood (symptoms include feeling unwell with muscle weakness or confusion)
• Dizziness 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 increased bleeding, for example bruising of the skin and mucous membranes (ecchymoses), and low platelet counts in the blood (thrombocytopenia)
• Sudden swelling of the skin or mucous membranes (angioedema)
• Increased production of a hormone called ADH, causing fluid retention and blood dilution, leading to reduced sodium levels (inappropriate ADH secretion)
• Increased levels of the hormone prolactin in the blood
• Milk secretion in men and 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 an ECG that records the heart's electrical activity)
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 “Pregnancy, breastfeeding and fertility” for further information

Additionally, a number of side effects are known to occur with medicines that act like escitalopram (the active substance in Entact). These include:

• Motor restlessness (akathisia)
• Loss of appetite

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: https://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 Entact

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 packaging and label of the
bottle after Exp (expiry date). The expiry date refers to the last day of that month.
After opening, the drops 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 Entact contains
The active substance is escitalopram. Each ml of Entact 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 Entact and contents of the pack
Entact oral drops, solution, is available in a 15 ml amber glass bottle with a dropper dispenser.
Not all pack sizes may be marketed.
Entact oral drops is a transparent solution, nearly colourless to slightly yellow.

Marketing Authorisation Holder and Manufacturer
H. Lundbeck A/S
Ottiliavej 9
Valby
Denmark

Local Representative for Italy
Lundbeck Italia S.p.A.
Via Joe Colombo, 2 - 20124 Milano

Manufacturer:
H. Lundbeck A/S, Copenhagen, Valby, Denmark

This medicinal product is authorised in the European Economic Area countries under the
following names:
Greece: Escitalopram Lundbeck
Cyprus: Escitalopram Lundbeck
Italy: Entact
Spain: Esertia
Sweden: Prilect