Package leaflet: Information for the patient

Prameffex 10 mg film-coated tablets, 20 mg film-coated tablets

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

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

Contents of this leaflet:

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

1. What Prameffex is and what it is used for

Prameffex contains the active substance escitalopram. Prameffex belongs to a group of antidepressant medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). These medicines help increase serotonin levels in the brain. Changes in the brain's serotonin system are considered important factors in the development of depression and related disorders.
Prameffex contains escitalopram used to treat depression (major depressive episodes) and anxiety (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder) in adults aged 18 years and over.
It may take a couple of weeks before you start to feel better. Continue taking Prameffex 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 Prameffex

Do not take Prameffex:

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 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 Prameffex”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Prameffex.
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 Prameffex 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 dose.
if you have diabetes. Treatment with Prameffex 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 undergoing electroconvulsive therapy.
if you have coronary heart disease (coronary artery disease).
if you suffer or have suffered from 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 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 eye pressure).

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 Prameffex (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 trial data have shown a higher risk of suicide-related 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 to hospital immediately.
It may be helpful to inform a close family member or 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
Prameffex is generally not recommended for use in children and adolescents under 18 years of age. In addition, you should know that, when taking this class of medicines, patients under 18 years of age have an increased risk of side effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, oppositional behaviour, and anger).
Despite this, your doctor may prescribe Prameffex to patients under 18 years of age if they consider it the best treatment option. If your doctor has prescribed Prameffex 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 above symptoms appear or worsen during treatment with Prameffex in a patient under 18 years of age. In addition, the long-term safety effects of Prameffex on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.

Other medicines and Prameffex
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 treatment with Prameffex. After stopping Prameffex, you must wait 7 days 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, 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 viscosity, also known as antiplatelet agents). These may increase the tendency to bleed.
warfarin, dipyridamole, and phenprocoumon (medicines used to reduce blood viscosity, also known as anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of Prameffex 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), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Prameffex may be necessary.
medicines that reduce blood potassium or magnesium levels, as these conditions increase the risk of life-threatening cardiac rhythm disturbances.

Do not take Prameffex if you are taking medicines for heart rhythm problems or that may affect your heart rhythm, such as 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), or certain antihistamines (astemizole, hydroxyzine, mizolastine). If you have any further doubts, contact your doctor.

Prameffex with food, drinks and alcohol
Prameffex can be taken with or without food (see section 3 “How to take Prameffex”).
An interaction between Prameffex and alcohol is not expected. However, as with many medicines, the combination of Prameffex 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 using this medicine. Do not take Prameffex if you are pregnant or breastfeeding unless your doctor has discussed the risks and benefits of treatment with you.
If you take Prameffex during the third trimester of pregnancy, you should be aware that the following effects may occur in the newborn: breathing difficulties, bluish skin colour, seizures, unstable body temperature, feeding difficulties, vomiting, hypoglycaemia (low blood glucose levels), hypertonia or hypotonia, hyperreflexia, tremor, restlessness, irritability, lethargy, persistent crying, drowsiness, and sleep disturbances. If the newborn shows any of these symptoms, contact your doctor immediately.
Ensure that your midwife and/or doctor know that you are taking Prameffex.
When taken during pregnancy, particularly during the last three months, medicines such as Prameffex 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 occurs in your baby, contact your midwife and/or doctor immediately.
If you take Prameffex 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 Prameffex so they can advise you on what to do.
Abrupt discontinuation of Prameffex 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 effects on human fertility have not yet been observed.

Driving and using machines
We recommend that you do not drive or operate machinery until you know how Prameffex affects you.

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

3. How to take Prameffex

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 Prameffex is 10 mg once daily. Your doctor may increase this dose up to a maximum of 20 mg per day.

Panic disorder
The initial dose of Prameffex for the first week of treatment is 5 mg per day, which is then increased to 10 mg per day. Your doctor may increase this dose up to a maximum of 20 mg per day.

Social anxiety disorder
The normally recommended dose of Prameffex is 10 mg once daily. 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.

Generalized anxiety disorder
The normally recommended dose of Prameffex is 10 mg once daily. This dose may be increased by your doctor up to a maximum of 20 mg per day.

Obsessive-compulsive disorder
The normally recommended dose of Prameffex is 10 mg once daily. 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 Prameffex is 5 mg once daily. This dose may be increased by your doctor up to 10 mg per day.

Use in children and adolescents
Prameffex should normally not be taken by children and adolescents. For further information, see section 2 "Prameffex: Warnings and precautions".

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

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

How to take the tablets
Prameffex may be taken with or without food. Swallow the tablets with a glass of water. Do not chew them, as they have a bitter taste.
If necessary, the tablets can be split by placing them on a flat surface with the break line facing upwards. The tablets can be split by pressing down on each end of the tablet using both index fingers, as shown in the drawing.

Two hands with index fingers pointing toward a round tablet placed at the center to indicate it

Duration of treatment
It may take a couple of weeks before you notice any improvement. Continue taking Prameffex even if you do not experience immediate improvement in your condition.
The dose should never be changed without first consulting your doctor.
Continue taking Prameffex 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 Prameffex than you should
If you have taken more Prameffex 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 Prameffex pack or container with you when visiting a doctor or going to hospital.

If you forget to take Prameffex
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose of Prameffex 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 continue with your regular dosing schedule.

If you stop taking Prameffex
Do not stop taking Prameffex unless your doctor tells you to. When completing treatment with Prameffex, it is generally recommended that the dose be gradually reduced over a couple of weeks.
When you stop taking Prameffex, especially if stopped abruptly, you may experience withdrawal symptoms. These are common when stopping treatment with Prameffex. The risk is greater if you have taken Prameffex 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 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 Prameffex, inform your doctor. Your doctor may advise you to restart treatment and then reduce the dose more gradually.

Withdrawal symptoms include: dizziness (feeling unsteady or off balance), prickling or pinprick 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Prameffex can cause side effects, although not everyone experiences them.
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 you experience any of the following symptoms, 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, pharynx or face, hives, or difficulty breathing or a feeling of suffocation (severe 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 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 of fainting, which may be symptoms of a life-threatening condition known as Torsade de Pointes
thoughts of self-harm (hurting yourself) or suicide. 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):

discomfort (nausea)
headache

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

blocked nose or nasal discharge (sinusitis)
decreased or increased appetite
anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin reactions
diarrhoea, constipation, vomiting, dry mouth
increased sweating
muscle and joint pain (arthralgia and myalgia)
sexual disorders (delayed ejaculation, erection problems, decreased sexual drive; women may have difficulty achieving orgasm)
fatigue, fever
weight gain

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

hives, skin rashes, itching
teeth grinding, agitation, nervousness, panic attacks, confusion
disturbed sleep, taste disturbances, fainting (syncope)
dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
hair loss
increased menstrual flow
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):

decrease in blood sodium levels (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, for example, on the skin and mucous membranes (bruising)
increased production of a hormone called ADH, causing water retention and blood dilution, leading to reduced sodium levels (inappropriate ADH secretion)
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 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 Prameffex). 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 Prameffex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp.. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Prameffex contains
The active substance is escitalopram. Each Prameffex tablet contains 10 mg or 20 mg of
escitalopram (as oxalate).
The other components are:
Tablet core: microcrystalline cellulose, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica, talc.
Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171).
Description of the appearance of Prameffex and package contents
Prameffex is available as 10 mg and 20 mg film-coated tablets.
The tablets are described below.
10 mg: white, oval, biconvex, film-coated tablet, with a score line and engraved with "10 mg". The tablet can be divided into two equal doses.
20 mg: white, oval, biconvex, film-coated tablet, with a score line and engraved with "20 mg". The tablet can be divided into two equal doses.
Prameffex is available in the following pack sizes:
Opaque white blisters in PVC/PE/PVDC/Aluminum containing 28 film-coated tablets.
Marketing Authorization Holder
Neuraxpharm Italy S.p.A.
Via Piceno Aprutina, 47
63100 Ascoli Piceno (AP),
Italy
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo 1,
03012 Anagni (FR),
Italy

Patient Information Leaflet

Prameffex 20 mg/ml oral drops, solution

Escitalopram
Generic medicine
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, ask 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:

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

1. What Prameffex is and what it is used for

Prameffex contains the active substance escitalopram. Prameffex 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 serotonin system are considered important factors in the development of depression and related disorders.
The active substance in Prameffex is escitalopram, and it is used to treat depression (major depressive episodes) and anxiety (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder) in adults aged 18 years and older.
It may take a couple of weeks before you start to feel better. Continue taking Prameffex 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 Prameffex

Do not take Prameffex:

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 experienced an episode of cardiac arrhythmia (identified by an ECG, a test performed to assess heart function).
if you are taking medicines for heart rhythm disorders or medicines that may affect your heart rhythm (see section 2 “Other medicines and Prameffex”).

if you suffer from epilepsy. Treatment with Prameffex 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 Prameffex 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 tend to develop bleeding or bruising easily, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”)
if you are receiving electroconvulsive therapy.
if you have coronary heart disease (cardiac 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.
if you have or have previously had eye problems, such as certain types of glaucoma (increased eye pressure).

Please note
Some patients with bipolar disorder (manic-depressive illness) 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 Prameffex (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
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 to the
hospital immediately.
It may be helpful to inform a close family member or friend that you suffer from depression or an
anxiety disorder, and ask them to read this leaflet. You may ask them to tell you if they think your depression or anxiety is worsening or if they are concerned about any change in your behaviour.
Children and adolescents
Prameffex is normally not intended for use in children and adolescents under 18 years of age. In addition, you should know that patients under 18 years of age taking this class of medicines have an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, oppositional behaviour, and anger).
Despite the above, your doctor may prescribe Prameffex to patients under 18 years of age if they consider it the best treatment option. If your doctor has prescribed Prameffex to a patient under 18 years of age and you would like more information, contact your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen during treatment with Prameffex in a patient under 18 years of age. In addition, the long-term safety effects of Prameffex on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.
Other medicines and Prameffex
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 Prameffex. After stopping treatment with Prameffex, 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, 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 blood levels.
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 antiplatelet agents). These may increase the tendency to bleed.
Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce blood clotting, also called anticoagulants). Your doctor will likely monitor your coagulation time at the beginning and end of Prameffex 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, a 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 Prameffex 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 Prameffex if you are taking medicines for heart rhythm disorders 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, IV erythromycin, pentamidine, antimalarial treatments, particularly
halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine).
If you have any further doubts, contact your doctor.
Prameffex with food, drinks and alcohol
Prameffex can be taken with or without food (see section 3 “How to take Prameffex”).
Prameffex is not expected to interact with alcohol. However, as with many medicines, the combination of Prameffex and alcohol is not recommended.
Pregnancy, breastfeeding and fertility
Inform your doctor if you are pregnant or planning a pregnancy. Do not take Prameffex if you are pregnant or breastfeeding, unless your doctor has discussed the risks and benefits of treatment with you.
If you take Prameffex during the third trimester of pregnancy, you should be aware that the following effects may occur in the newborn: breathing difficulties, bluish skin colouration, seizures, unstable body temperature, feeding difficulties, vomiting, hypoglycaemia (low blood glucose levels), hypertonia or hypotonia, hyperreflexia, tremor, restlessness, irritability, lethargy, persistent crying, drowsiness, and sleep disturbances. If the newborn shows any of these symptoms, contact your doctor immediately.
Ensure that your midwife and/or doctor know that you are taking Prameffex.
When taken during pregnancy, particularly during the last three months of pregnancy, medicines such as Prameffex may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually appear within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.
If you take Prameffex 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 Prameffex so they can advise you on what to do.
Abrupt discontinuation of Prameffex treatment should be avoided during pregnancy.
Prameffex 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 recommend that you do not drive or operate machinery until you know how Prameffex affects you.
Prameffex 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.
Prameffex 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 Prameffex

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

Black and white drawing of a hand holding an inverted glass bottle from which a single drop of liquid is falling

Count the required number of drops and dispense them into a drink (water, orange juice or apple juice), briefly shake the glass and drink the entire beverage.
Prameffex oral drops must not be mixed with other liquids, nor should it be combined with other medicines.

Adults
Depression
The usual recommended dose of Prameffex is 10 mg (10 drops) per day, taken as a single dose. This dose may be increased by your doctor up to a maximum of 20 mg (20 drops) per day.
Panic disorder
The initial dose of Prameffex for the first week of treatment is 5 mg (5 drops) per day, then increased to 10 mg (10 drops) per day. Your doctor may increase this dose up to a maximum of 20 mg (20 drops) per day.
Social anxiety disorder
The normally recommended dose of Prameffex is 10 mg (10 drops) per day, taken as a single dose. Your doctor may reduce the dose to 5 mg (5 drops) per day or increase it up to a maximum of 20 mg (20 drops) per day, depending on your individual response to treatment.
Generalized anxiety disorder
The normally recommended dose of Prameffex is 10 mg (10 drops) per day, taken as a single dose. This dose may be increased by your doctor up to a maximum of 20 mg (20 drops) per day.
Obsessive-compulsive disorder
The normally recommended dose of Prameffex is 10 mg (10 drops) per day, taken as a single dose. This dose may be increased by your doctor up to a maximum of 20 mg (20 drops) per day.

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

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

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

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

Duration of treatment
It may take a few weeks before you notice any improvement. Continue taking Prameffex even if you do not immediately feel better.
The dose should never be changed without first consulting your doctor.
Continue taking Prameffex 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 Prameffex than you should
If you have taken more Prameffex than prescribed, contact your doctor or go immediately to the nearest hospital emergency department. Do this 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 Prameffex bottle with you when going to a doctor or hospital.

If you forget to take Prameffex
If you forget to take a dose of Prameffex, do not take a double 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 with your regular dosing schedule.

If you stop taking Prameffex
Do not stop taking Prameffex unless your doctor tells you to. When you have completed treatment with Prameffex, it is generally recommended that the dose be gradually reduced over a couple of weeks.
When stopping Prameffex, especially if stopped suddenly, you may experience withdrawal symptoms. These are common when stopping treatment with Prameffex. The risk is higher if you have taken Prameffex for a long time, at high doses, or if the dose is reduced too quickly. Most patients find that these symptoms are mild and usually disappear spontaneously within a couple of weeks. However, in some patients, withdrawal symptoms may be severe or may persist for a longer time (2–3 months or more). If you experience severe withdrawal symptoms when stopping Prameffex, inform your doctor. Your doctor may ask 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 frequent), electric shock-like sensations, even in the head, sleep disturbances (vivid dreams, nightmares, difficulty sleeping), anxiety, headache, malaise (nausea), sweating (including night sweats), restlessness or agitation, tremor (shaking), confusion or disorientation, excessive emotionality or irritability, diarrhoea (loose stools), visual disturbances, and disturbances in heart rhythm (palpitations).

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects usually disappear after a few weeks of treatment. Please bear in mind that many of the side effects may also be symptoms of your illness, and therefore improve as you start to feel better.

If you experience any of the following symptoms, 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 if you have 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 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 (hurting yourself) 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):

blocked or runny nose (sinusitis)
decreased or increased appetite
anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, skin reactions
diarrhoea, constipation, vomiting, dry mouth
increased sweating
muscle and joint pain (arthralgia and myalgia)
sexual disorders (delayed ejaculation, erection problems, 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, altered taste, fainting (syncope)
dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
hair loss
increased menstrual flow
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, depersonalisation, hallucinations
slowing of the heartbeat

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, for example, of the skin and mucous membranes (bruising)
sudden swelling of the skin or mucous membranes (angioedema)
increased production of a hormone called ADH, causing fluid retention and dilution of the blood, leading to reduced sodium levels (inappropriate ADH secretion)
milk secretion in men and 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 (known as “prolongation of the QT interval”, detected 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

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

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 on the label of the
bottle after Exp. (the expiry date).
The expiry date refers to the last day of that month.
After opening, the oral drops solution must be used within 8 weeks and stored at a temperature
below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Prameffex contains
The active substance is escitalopram. Each ml of Prameffex oral drops contains 20 mg of escitalopram
(as escitalopram oxalate).
1 drop contains 1 mg of escitalopram.
The other components are: anhydrous citric acid, purified water, 96% ethanol, propyl gallate, sodium
hydroxide.
Description of the appearance of Prameffex and contents of the pack
Prameffex oral drops, solution is available in a 15 ml amber glass bottle with a dropper applicator.
It is possible that not all pack sizes are marketed.
Prameffex oral drops, solution is a clear solution, almost colourless to slightly yellowish.
Marketing Authorisation Holder
Neuraxpharm Italy S.p.A.
Via Piceno Aprutina, 47
63100 Ascoli Piceno (AP),
Italy
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo 1,
03012 Anagni (FR),
Italy