Gomeisa

Package leaflet: Information for the user

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

Escitalopram
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine, as 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 their
symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this
leaflet, contact your doctor or pharmacist.
Contents of this leaflet:

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

1. What GOMEISA is and what it is used for

GOMEISA belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines help increase serotonin levels in the brain. Disorders of the serotonin system are considered an important factor in the development of depression and related illnesses.
GOMEISA contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with and 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 GOMEISA 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 GOMEISA

Do not take GOMEISA

• if you are allergic to escitalopram or to any of the excipients of this medicine (listed in section 6)
• if you are taking other medicines belonging to a group called MAO inhibitors, including selegiline (used for the treatment of Parkinson’s disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic)
• if you were born with or have experienced an episode of abnormal heart rhythm (detectable via electrocardiogram - ECG, a test to assess heart function)
• if you are taking medicines for heart rhythm disorders or that may affect your heart rhythm (see section “Other medicines and GOMEISA”)

Warnings and precautions
Talk to your doctor or pharmacist before taking GOMEISA.
Inform your doctor about any condition or illness you have previously suffered from, as your doctor may need to take this into account.
In particular, inform your doctor:

• if you suffer from epilepsy. Treatment with GOMEISA should be discontinued if you experience seizures for the first time or if the frequency of epileptic seizures increases (also see section 4 “Possible side effects”)
• if you have thoughts of suicide or of harming yourself. See subsection “Suicidal thoughts and worsening of depression or anxiety disorder”
• if your liver or kidney function is reduced. Your doctor may need to adjust your dose
• if you have diabetes. Treatment with GOMEISA may alter glycaemic control. Adjustment of insulin and/or oral hypoglycaemic agents may be necessary
• if your blood sodium levels are low
• if you are under 18 years of age
• if you have previously suffered from mania or manic depression
• if you have a predisposition to bleeding or easy bruising
• if you are taking any other medicine, including herbal medicines. See subsection “Other medicines and GOMEISA”
• if you are undergoing electroconvulsive therapy (ECT)
• if you have or have had eye problems, such as certain types of glaucoma (increased pressure in the eye)
• if you are pregnant or breastfeeding
• if you suffer or have suffered from heart problems, including coronary artery disease, heart attack, or heart failure
• if you have a low resting heart rate and/or if you think your body may have experienced significant salt loss due to severe and prolonged diarrhoea and vomiting or use of diuretics (water tablets)
• if your heartbeat is fast or irregular, or if you experience symptoms such as fainting, collapse, or dizziness when standing up, which may indicate an irregular heart rhythm

Please note
Some patients with bipolar disorder may enter a manic phase.
This is characterised by unusual and rapid changes in thinking, inappropriate happiness, and excessive physical activity. If you experience such symptoms, contact your doctor.
Symptoms such as restlessness or difficulty sitting or standing still may also occur during the first weeks of treatment. Inform your doctor immediately if you notice such symptoms.
Medicines such as GOMEISA (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have been observed to persist after discontinuation of treatment.

Suicidal thoughts and worsening of depression or anxiety disorder
If you suffer from depression and/or anxiety disorders, you may sometimes feel the urge to harm yourself or even commit suicide. These thoughts may increase at the beginning of treatment with antidepressants, as these medicines take about two weeks or longer 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. Data from clinical trials have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with an antidepressant

If at any time you think about harming yourself or committing suicide, contact your doctor or go to hospital immediately.
It may be helpful to inform a relative or a close friend that you suffer from depression or an anxiety disorder, and ask them to read this leaflet. You may ask them to tell you if they think your depression or anxiety is worsening or if they are concerned about any changes in your behaviour.

Use in children and adolescents under 18 years of age
GOMEISA should generally not be used in children and adolescents under 18 years of age. Furthermore, you should know that patients under 18 years of age have a higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) when taking this class of medicines.
Despite the above, your doctor may still prescribe GOMEISA to patients under 18 years of age if they consider it the best treatment option. If your doctor has prescribed GOMEISA to a patient under 18 years of age and you wish to discuss this, please speak to your doctor again.
If you would like more information, please contact your doctor.
You must inform your doctor if any of the symptoms listed above appear or worsen during treatment with GOMEISA in a patient under 18 years of age. In addition, the long-term safety effects of GOMEISA on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.

Other medicines and GOMEISA
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, and tranylcypromine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting GOMEISA. After stopping GOMEISA, you must wait 7 days before taking any of these medicines.
• Reversible selective MAO-A inhibitors, containing moclobemide (used for the treatment of depression).
• Irreversible MAO-B inhibitors, containing selegiline (used to treat Parkinson’s disease). These medicines increase the risk of adverse effects.
• The antibiotic linezolid.
• Lithium (used for the treatment of bipolar disorder) and tryptophan (an amino acid).
• Other medicines used to treat depression, such as tricyclic antidepressants or other selective serotonin reuptake inhibitors (SSRIs) such as imipramine, desipramine, and fluvoxamine.
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used for severe pain). These medicines increase the risk of adverse effects.
• 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 blood levels of GOMEISA.
• St John’s wort (Hypericum perforatum), a herbal preparation used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain).
• Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). Your doctor will likely monitor your blood clotting time at the start and end of GOMEISA treatment to ensure your anticoagulant dose remains appropriate.
• Mefloquine (used to treat malaria), tricyclic antidepressants or selective serotonin reuptake inhibitors (SSRIs), bupropion (used to treat depression), tramadol (used for severe pain), and neuroleptics (medicines for the treatment of schizophrenia, psychosis), due to the possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of GOMEISA 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 GOMEISA if you are taking medicines for heart rhythm disorders or that may affect your heart rhythm, such as:

• 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);
• Certain antihistamines (astemizole, mizolastine). If you have any further doubts, contact your doctor.

GOMEISA with food and drink and alcohol
GOMEISA can be taken with or without food (see section 3 “How to take GOMEISA”).
As with many medicines, combining GOMEISA with alcohol is not recommended, although an interaction between GOMEISA and alcohol is not expected.

Pregnancy, breastfeeding and fertility
Inform your doctor if you are pregnant or planning a pregnancy.
Do not take GOMEISA if you are pregnant or breastfeeding unless your doctor has discussed the risks and benefits of treatment with you.
If you take GOMEISA during the last 3 months of pregnancy, you should be aware that the following effects may occur in the newborn: breathing difficulties, bluish skin colour, seizures, unstable body temperature, feeding difficulties, vomiting, hypoglycaemia (low blood glucose), 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 GOMEISA.
When taken during pregnancy, particularly during the last 3 months, medicines like GOMEISA 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.
Sudden discontinuation of GOMEISA treatment should be avoided during pregnancy.
Citalopram, a medicine similar to escitalopram, has been shown in animal studies to reduce sperm quality. In theory, this could affect fertility, but no impact on human fertility has been observed to date.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

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

Always take GOMEISA exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults

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

Panic disorder
The initial dose of GOMEISA is 5 mg as a single daily dose for the first week, then increased to 10 mg per day. The dose may be further increased by your doctor up to a maximum of 20 mg per day.

Social anxiety disorder
The usual recommended dose of GOMEISA is 10 mg as a single daily dose. Your doctor may either reduce the dose to 5 mg per day or increase it up to a maximum of 20 mg per day, depending on your response to the medicine.

Generalised anxiety disorder
The usual recommended dose of GOMEISA is 10 mg as a single daily dose. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Obsessive-compulsive disorder
The usual recommended dose of GOMEISA is 10 mg as a single daily dose. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Elderly patients (over 65 years of age)
The recommended initial dose of GOMEISA is 5 mg as a single daily dose. The dose may be increased by your doctor to 10 mg per day.

Use in children and adolescents (under 18 years of age)
GOMEISA should not normally be used in children and adolescents. For further information, see section 2 “What you need to know before taking GOMEISA”.

GOMEISA may be taken with or without food. Swallow the tablet with some water. Do not chew the tablets as they have a bitter taste.

For GOMEISA 10 mg and 20 mg film-coated tablets
If necessary, you may divide the tablet.

Duration of treatment
It may take a couple of weeks before you notice any improvement. Continue taking GOMEISA even if you do not immediately feel better.
The dosage should never be changed without first consulting your doctor.
Continue taking GOMEISA 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 6 months after symptoms have resolved.

If you take more GOMEISA than you should
If you have taken more GOMEISA than prescribed, you must 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 GOMEISA bottle/packaging with you when going to a doctor or hospital.

If you forget to take GOMEISA
Do not take a double dose if you have missed a dose.
If you remember you missed a dose before going to bed, take it immediately.
Continue with your usual dosing schedule the next day.
If you remember during the night or the following day, skip the missed dose and continue with your regular dosing schedule.

If you stop taking GOMEISA
Do not stop taking GOMEISA unless your doctor tells you it is safe to do so.
When you complete treatment with GOMEISA, it is generally recommended that the dose be gradually reduced over a couple of weeks.
When stopping GOMEISA, especially if stopped abruptly, you may experience withdrawal symptoms. These are common when discontinuing treatment with GOMEISA. The risk is higher if you have taken GOMEISA for a long time or at high doses, or if the dose is reduced too quickly. Most patients find these symptoms are mild and usually disappear spontaneously within a couple of weeks. However, in some patients, withdrawal symptoms may be severe or may last longer (2–3 months or more). If you experience severe withdrawal symptoms when stopping GOMEISA, inform your doctor. Your doctor may ask you to restart treatment and then reduce the dose more gradually.

Withdrawal symptoms include: dizziness (feeling unsteady or off balance), prickling or tingling sensations, burning sensations (less frequent), electric shock-like sensations, even in the head, sleep disturbances (vivid dreams, nightmares, difficulty sleeping), anxiety, headache, malaise (nausea), sweating (including night sweats), restlessness or agitation, tremor (shaking), confusion or disorientation, excessive emotionality or irritability, diarrhoea (loose stools), visual disturbances, and disturbances in heartbeat (palpitations).

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

As with all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects generally 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 will decrease as you start to feel better.
Contact your doctor if you experience any of the following side effects during treatment:

• difficulty in urination
• seizures (epileptic 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.

In addition to the side effects listed above, the following have also been reported:
Uncommon (may affect up to 1 in 100 people):

• abnormal bleeding, including gastrointestinal bleeding.

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

• if you experience swelling of the skin, tongue, lips or face, or have difficulty breathing or a choking sensation (allergic reaction), contact your doctor or go to hospital immediately
• high fever, agitation, confusion, tremor and sudden muscle contractions may be symptoms of a rare condition called serotonin syndrome. If you feel like this, contact your doctor.

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, erectile problems, reduced sexual drive, and women may have difficulty achieving orgasm)
• fatigue, fever
• weight gain

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

• urticaria, 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
• vaginal bleeding
• weight loss
• increased heart rate (tachycardia)
• swelling of arms or legs
• nosebleeds

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

• aggression, depersonalization, hallucinations
• slowing of the heartbeat

Some patients have reported (based on available data, frequency cannot be estimated):

• thoughts of self-harm (hurting yourself) or suicide (see also section 2 “What you need to know before taking GOMEISA”)
• decreased sodium levels in the blood (symptoms include feeling unwell with muscle weakness or confusion)
• dizziness upon standing due to a drop in blood pressure (orthostatic hypotension)
• abnormalities in liver function tests (increased liver enzyme values in blood) and in ECG (electrocardiogram)
• movement disorders (involuntary muscle movements)
• painful erections (priapism)
• abnormal bleeding, including bleeding of the skin and mucous membranes (bruising), and low platelet counts in the blood (thrombocytopenia)
• sudden swelling of the skin or mucous membranes (angioedema)
• increased urine volume (inappropriate ADH secretion)
• milk secretion in women who are not breastfeeding
• mania
• an increased risk of bone fractures has been observed in patients taking this type of medicine
• changes in heart rhythm (called “prolongation of the QT interval”, assessed by ECG measuring the heart’s electrical activity)

In addition, a number of side effects are known for medicines that act like escitalopram (the active substance in GOMEISA). These are:

• motor restlessness (akathisia), an urge or need to move to relieve an unpleasant sensation (akathisia)
• anorexia

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at the website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
Reporting side effects helps provide more information on the safety of this medicine.

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 label and on the carton 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.

What GOMEISA contains
The active substance is escitalopram.
GOMEISA 10 mg film-coated tablets:
Each tablet contains 10 mg of escitalopram (equivalent to 12.775 mg of escitalopram oxalate).
GOMEISA 20 mg film-coated tablets:
Each tablet contains 20 mg of escitalopram (equivalent to 25.551 mg of escitalopram oxalate).
The other components are:
Tablet core
Microcrystalline cellulose
Anhydrous colloidal silica
Talc
Sodium croscarmellose
Magnesium stearate
Tablet coating
Hypromellose
Titanium dioxide (E171)
Macrogol 400

Description of the appearance of GOMEISA and contents of the pack
GOMEISA 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.
GOMEISA is available in the following pack sizes:
Opaque white blisters in PVC/PE/PVDC-Aluminium containing 28 film-coated tablets.

Marketing Authorization Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Rome
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR), Italy

Package leaflet: information for the user

GOMEISA 20mg/ml oral drops, solution

Equivalent medicinal product
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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

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

1. What GOMEISA is and what it is used for

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

Do not take GOMEISA:

• if you are allergic to escitalopram or to any of the excipients of this medicine (listed in section 6)
• if you are taking other medicines belonging to a group called monoamine oxidase inhibitors (MAO inhibitors), including selegiline (used to treat Parkinson’s disease), moclobemide (used to treat depression), or linezolid (an antibiotic)
• if you were born with or have had an episode of abnormal heart rhythm (visible on an electrocardiogram, ECG), a test used to assess heart function
• if you are taking medicines for heart rhythm disorders or medicines that may affect heart rhythm (see section 2 “Other medicines and GOMEISA”)

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

• if you suffer from epilepsy. Treatment with GOMEISA should be discontinued if you experience seizures for the first time or if the frequency of epileptic seizures increases (see also section 4 “Possible side effects”)
• if you have thoughts of suicide or of harming yourself. See subsection “Suicidal thoughts and worsening of depression or anxiety disorder”
• if you have impaired liver or kidney function. Your doctor may need to adjust your dose
• if you have diabetes. Treatment with GOMEISA may alter glycaemic control. It may be necessary to adjust the dose of insulin and/or oral hypoglycaemic agents
• if your blood sodium level is low
• if you are under 18 years of age
• if you have previously experienced mania or manic depression
• if you have a tendency to bleeding or easy bruising
• if you are taking any other medicine, including herbal remedies. See subsection “Other medicines and GOMEISA”
• if you are undergoing electroconvulsive therapy (ECT)
• if you have or have had eye problems, such as certain types of glaucoma (increased pressure in the eye)
• if you are pregnant or breastfeeding
• if you have or have had heart problems, including coronary artery disease, heart attack, or heart failure
• if you have a low resting heart rate and/or if you think your body may have experienced a significant loss of salt due to prolonged and severe diarrhoea or vomiting, or due to the use of diuretics (water tablets)
• if your heartbeat is fast or irregular, or if you experience symptoms such as fainting, collapse, or dizziness when standing up, which may indicate an irregular heart rhythm

Please note
Some patients with bipolar disorder may enter a manic phase. This is characterized by unusual and rapid changes in thinking, inappropriate happiness, and excessive physical activity. If you experience such symptoms, 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.
If you suffer from panic disorder, you may experience an increase in anxiety symptoms at the beginning of treatment. Inform your doctor immediately if you experience these symptoms.
Medicines such as GOMEISA (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 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 such thoughts:

• if you have previously had thoughts of suicide or self-harm
• if you are a young adult. Data from clinical studies 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 hospital immediately.
It may be helpful to inform a relative or a close friend that you suffer from depression or an anxiety disorder, and ask them to read this leaflet. You may ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about any changes in your behaviour.

Use in children and adolescents under 18 years of age
GOMEISA 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 GOMEISA to patients under 18 years of age if they consider it the best treatment option. If your doctor has prescribed GOMEISA to a patient under 18 years of age and you would like more information, please contact your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen during treatment with GOMEISA in a patient under 18 years of age. In addition, the long-term effects of GOMEISA on growth, maturation, and cognitive and behavioural development have not been established in this age group.

Other medicines and GOMEISA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell 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 GOMEISA. After stopping GOMEISA, you must wait 7 days before taking any of these medicines.
• Reversible selective MAO-A inhibitors, containing moclobemide (used to treat depression).
• Irreversible MAO-B inhibitors, containing selegiline (used to treat Parkinson’s disease). These medicines increase the risk of adverse effects.
• The antibiotic linezolid.
• Lithium (used to treat bipolar disorder) and tryptophan (an amino acid).
• Other medicines used to treat depression, such as tricyclic antidepressants or other selective serotonin reuptake inhibitors (SSRIs) such as imipramine, desipramine, and fluvoxamine.
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used for severe pain). These medicines increase the risk of adverse effects.
• 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 blood levels of GOMEISA.
• St. John’s wort (Hypericum perforatum), a herbal preparation used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or to thin the blood, so-called anticoagulants). Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). Your doctor may monitor your blood clotting time at the beginning and end of treatment with GOMEISA to ensure your anticoagulant dose remains appropriate.
• Mefloquine (used to treat malaria), tricyclic antidepressants or selective serotonin reuptake inhibitors (SSRIs), bupropion (used to treat depression), tramadol (used for severe pain), and neuroleptics (medicines used to treat schizophrenia, psychosis), due to the possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used for cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of GOMEISA may be necessary.
• Medicines that reduce blood potassium or magnesium levels, as these conditions increase the risk of life-threatening heart rhythm disturbances.

Do not take GOMEISA if you are taking medicines for heart rhythm disorders or medicines that may affect heart rhythm, such as, for example, class IA and III antiarrhythmics, antipsychotics (such as phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (such as sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), or certain antihistamines (astemizole, mizolastine).
If you have any further doubts, contact your doctor.

GOMEISA with food, drinks and alcohol
GOMEISA can be taken with or without food (see section 3 “How to take GOMEISA”).
GOMEISA is not expected to interact with alcohol. However, as with many medicines, the combination of GOMEISA and alcohol is not recommended.

Pregnancy, breastfeeding and fertility
Inform your doctor if you are pregnant or planning a pregnancy.
Do not take GOMEISA if you are pregnant or breastfeeding unless your doctor has discussed the risks and benefits of treatment with you.
If you take GOMEISA during the last trimester (last 3 months) of pregnancy, you should be aware that the following effects may occur in the newborn: breathing difficulties, bluish skin colour, seizures, unstable body temperature, feeding difficulties, vomiting, hypoglycaemia (low blood glucose), hypertonia or hypotonia, hyperreflexia, tremor, restlessness, irritability, lethargy, persistent crying, drowsiness, and sleep difficulties. If the newborn shows any of these symptoms, contact your doctor immediately.
Make sure your midwife and/or doctor know that you are taking GOMEISA.
When taken during pregnancy, particularly during the last 3 months, medicines such as GOMEISA 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.
Abrupt discontinuation of GOMEISA treatment should be avoided during pregnancy.
Citalopram, a medicine similar to escitalopram, has been shown in animal studies to reduce sperm quality. In theory, this could affect fertility, but no impact on human fertility has been observed so far.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

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

GOMEISA 20 mg/ml oral drops, solution contains alcohol
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose. Each drop contains 4.7 mg of ethanol.
For individuals engaged in sports, the use of medicines containing ethyl alcohol may result in a positive anti-doping test, depending on the blood alcohol concentration limits set by certain sports federations.

3. How to take GOMEISA

Always take GOMEISA exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Count the required number of drops to add to your drink (water, orange juice, or apple juice), gently shake the glass, and drink the entire beverage.
GOMEISA oral drops must not be mixed with liquids other than water, orange juice, or apple juice, and must not be mixed with other medicines.

Adults
Depression
The usual recommended dose of GOMEISA is 10 mg (10 drops) once daily. Your doctor may increase this dose up to a maximum of 20 mg (20 drops) per day.

Panic disorder
The initial dose of GOMEISA 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) per day.

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

Generalized anxiety disorder
The normally recommended dose of GOMEISA is 10 mg (10 drops) once daily. Your doctor may increase this dose up to a maximum of 20 mg (20 drops) per day.

Obsessive-compulsive disorder
The normally recommended dose of GOMEISA is 10 mg (10 drops) once daily. Your doctor may increase this dose up to a maximum of 20 mg (20 drops) per day.

Elderly patients (over 65 years of age)
The recommended starting dose of GOMEISA is 5 mg (5 drops) once daily. This dose may be increased by your doctor up to 10 mg (10 drops) per day.

Children and adolescents (under 18 years of age)
GOMEISA is generally not recommended for use in children and adolescents. For further information, see section 2 “What you need to know before taking GOMEISA”.

Duration of treatment
It may take a couple of weeks before you notice any improvement. Continue taking GOMEISA even if you do not immediately feel better. The dosage must never be changed without first consulting your doctor.
Continue taking GOMEISA for as long as your doctor has advised. 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 GOMEISA than you should
If you have taken more GOMEISA 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 GOMEISA bottle/box with you when visiting a doctor or going to hospital.

If you forget to take GOMEISA
Do not take a double dose if you miss a dose.
If you forget to take a dose of GOMEISA but remember before going to bed, take it immediately and continue your treatment 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 GOMEISA
Do not stop taking GOMEISA unless your doctor tells you to. When completing treatment with GOMEISA, it is generally recommended that the dose be gradually reduced over a couple of weeks.
When stopping GOMEISA, especially if stopped suddenly, you may experience withdrawal symptoms. These are common when discontinuing treatment with GOMEISA. The risk is greater if you have taken GOMEISA 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 GOMEISA, 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), pins and needles 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, increased emotional sensitivity or irritability, diarrhoea (loose stools), visual disturbances, and heart rhythm disturbances (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 everyone gets them.
The side effects usually disappear after a few weeks of treatment. Please bear in mind that many of the side effects may also be symptoms of your illness and therefore will decrease as you start feeling better.
Contact your doctor if you experience any of the following side effects during treatment:

• difficulty urinating
• seizures (epileptic fits), see also section “Warnings and precautions”
• yellowing of the skin or 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.

In addition to the side effects listed above, the following have also been reported:
Not common (may affect up to 1 in 100 people):

• abnormal bleeding, including gastrointestinal bleeding.

Rare (may affect up to 1 in 1000 people):

• if you experience swelling of the skin, tongue, lips or face, or have difficulty breathing or a feeling of suffocation (allergic reaction), contact your doctor or go to hospital immediately
• high fever, agitation, confusion, tremor and sudden muscle contractions may be symptoms of a rare condition called serotonin syndrome. If you feel like this, contact your doctor.

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, 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 disorders (delayed ejaculation, erection problems, decreased sexual drive, and women may have difficulty reaching orgasm)
• tiredness, fever
• weight gain

Not common (may affect up to 1 in 100 people):

• hives, skin rash, itching
• teeth grinding, agitation, nervousness, panic attacks, confusion
• disturbed sleep, taste disturbances, fainting (syncope)
• dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• hair loss
• vaginal bleeding
• weight loss
• increased heart rate (tachycardia)
• swelling of arms or legs
• nosebleeds

Rare (may affect up to 1 in 1000 people):

• aggression, depersonalization, hallucinations
• slow heart rate

Some patients have reported (based on available data, frequency cannot be estimated):

• thoughts of self-harm (hurting yourself) or suicide (see also section 2 “What you need to know before taking GOMEISA”)
• decreased sodium levels in the blood (symptoms include feeling unwell with muscle weakness or confusion)
• dizziness upon standing due to a drop in blood pressure (orthostatic hypotension)
• abnormalities in liver function tests (increased liver enzyme levels in the blood) and in ECG (electrocardiogram)
• movement disorders (involuntary muscle movements)
• painful erections (priapism)
• abnormal bleeding including bleeding of the skin and mucous membranes (bruising) and low platelet counts in the blood (thrombocytopenia)
• sudden swelling of the skin or mucous membranes (angioedema)
• increased urine volume (inappropriate ADH secretion)
• milk secretion in women who are not breastfeeding
• mania
• an increased risk of bone fractures has been observed in patients taking this type of medicine
• changes in heart rhythm (called “QT interval prolongation”, assessed via ECG which records the heart's electrical activity)

In addition, a number of side effects are known for medicines that act like escitalopram (the active substance in GOMEISA). These include:

• motor restlessness (akathisia), an urge or need to move in order to relieve an unpleasant sensation
• anorexia

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at the website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
Reporting side effects helps provide more information on the safety of this medicine.

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

6. Contents of the pack and other information

What GOMEISA contains
The active substance is escitalopram. Each ml of GOMEISA oral drops contains 20 mg of escitalopram (as escitalopram oxalate).
1 drop contains 1 mg of escitalopram.
The other ingredients are:
propyl gallate (E310)
anhydrous citric acid (E330)
ethanol 96%
sodium hydroxide
purified water.

Description of the appearance of GOMEISA and contents of the pack
GOMEISA oral drops, solution is available in a dropper bottle (LDPE) made of dark glass (type III) with child-resistant closure (polyethylene) containing 15 ml of oral solution.
GOMEISA oral drops, solution is a clear, almost colourless to slightly yellow solution.

Marketing Authorisation Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Rome
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR), Italy
This leaflet was last updated in: March 2020