Package leaflet: Information for the user

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

Escitalopram
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further 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, because it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet,
contact your doctor or pharmacist.
Contents of this leaflet:

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

1. What GIACHELA is and what it is used for

GIACHELA belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines help increase serotonin levels in the brain. Serotonin system disturbances are considered an important factor in the development of depression and related disorders.
GIACHELA contains escitalopram and 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 over 18 years.
It may take a couple of weeks before you start to feel better. Continue taking GIACHELA 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 need to know before taking GIACHELA

Do not take GIACHELA

if you are allergic to escitalopram or 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 (MAOIs), including selegiline (used to treat Parkinson’s disease), moclobemide (used to treat depression), or 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 problems or that may affect heart rhythm (see section “Other medicines and GIACHELA”).

Warnings and precautions

Talk to your doctor or pharmacist before taking GIACHELA.
Inform your doctor about any conditions or illnesses you have previously suffered from, as your doctor may need to consider them.
In particular, inform your doctor:

if you suffer from epilepsy. Treatment with GIACHELA must 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 self-harm. 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 dosage;
if you have diabetes. Treatment with GIACHELA 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 predisposition to bleeding or easy bruising;
if you are taking buprenorphine. Using these medicines together with GIACHELA may lead to serotonin syndrome, a condition that can be fatal (see “Other medicines and GIACHELA”);
if you are taking any other medicine, including herbal medicines. See subsection “Other medicines and GIACHELA”;
if you are undergoing electroconvulsive therapy (ECT);
if you have closed-angle glaucoma or have previously suffered from glaucoma;
if you have coronary heart disease;
if you are pregnant or breastfeeding;
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 think your body may have experienced a significant loss of salt due to prolonged and severe diarrhoea and vomiting or due to diuretic use (water tablets);
if you experience rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate an irregular heart rhythm.

Medicines such as GIACHELA (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.

Please note
Some patients with bipolar disorder may enter a manic phase. This is characterised by unusual and rapid changes in mood, 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.

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 more to show their effect.
You are more likely to have these thoughts:

if you have previously thought about suicide or self-harm;
if you are a young adult. Data from clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with an antidepressant.

If at any time you think about harming yourself or committing suicide, contact your doctor or go immediately to hospital.
It may be helpful to inform a relative or 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 change in your behaviour.

Children and adolescents
GIACHELA should not normally be used in children and adolescents under 18 years of age. In addition, 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 GIACHELA to patients under 18 years of age if they consider it the best option for them. If your doctor has prescribed GIACHELA to a patient under 18 years of age and you wish to discuss it, speak again with your doctor. You should inform your doctor if you want more information or wish to follow up. You must inform your doctor if any of the above symptoms appear or worsen during GIACHELA treatment in a patient under 18 years of age. Furthermore, the long-term safety effects of GIACHELA on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.

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

Non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting GIACHELA. After stopping GIACHELA, 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.
Sumatriptan and similar medicines (used to treat migraine) and tramadol or buprenorphine (used for severe pain) or buprenorphine. These medicines may interact with GIACHELA and may cause symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, fever above 38°C. Contact your doctor if you experience such symptoms, as they 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 and omeprazole (used to treat stomach ulcers or dyspepsia (indigestion)), fluconazole (used to treat fungal infections), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in GIACHELA levels in the blood.
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 will likely monitor your blood clotting time at the beginning and end of GIACHELA treatment to verify whether 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 to treat 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). Dosage adjustment of GIACHELA 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 GIACHELA if you are taking medicines for heart rhythm problems or that may affect heart rhythm, such as, for example, class IA and III antiarrhythmics, antipsychotics (such as phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), and certain antihistamines (astemizole, mizolastine). If you have any further doubts, contact your doctor.

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

Pregnancy, breastfeeding and fertility
Inform your doctor if you are pregnant or planning a pregnancy.
Do not take GIACHELA if you are pregnant or breastfeeding, unless your doctor has discussed the risks and benefits of treatment with you.
If you take GIACHELA 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 levels), hypertonia or hypotonia, hyperreflexia, tremor, restlessness, irritability, lethargy, persistent crying, drowsiness, and sleep difficulties. If the newborn shows any of these symptoms, contact your doctor immediately.
Ensure that your midwife and/or doctor know that you are taking GIACHELA.
When taken during pregnancy, particularly during the last 3 months, medicines like GIACHELA 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.
Sudden discontinuation of GIACHELA 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 the impact on human fertility has not yet been observed.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you take GIACHELA 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). Inform your doctor or midwife that you are taking GIACHELA so they can advise you on what to do.

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

3. How to take GIACHELA

Always take GIACHELA 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 GIACHELA is 10 mg once daily. Your doctor may increase the dose up to a maximum of 20 mg per day.

Panic disorder
The initial dose of GIACHELA is 5 mg once daily for the first week, then increased to 10 mg per day. Your doctor may further increase the dose up to a maximum of 20 mg per day.

Social anxiety disorder
The usual recommended dose of GIACHELA 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 response to the medicine.

Generalized anxiety disorder
The usual recommended dose of GIACHELA is 10 mg once daily. Your doctor may increase the dose up to a maximum of 20 mg per day.

Obsessive-compulsive disorder
The usual recommended dose of GIACHELA is 10 mg once daily. Your doctor may increase the dose up to a maximum of 20 mg per day.

Elderly patients (over 65 years of age)
The recommended initial dose of GIACHELA is 5 mg once daily. Your doctor may increase the dose to 10 mg per day.

Use in children and adolescents
GIACHELA should normally not be used in children and adolescents. For further information, see section 2 "What you need to know before taking GIACHELA".

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

For GIACHELA 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 GIACHELA even if you do not immediately feel better.

Do not ever change your dosage without first consulting your doctor.

Continue taking GIACHELA 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 GIACHELA than you should
If you have taken more GIACHELA 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 GIACHELA bottle/pack with you when going to a doctor or hospital.

If you forget to take GIACHELA
Do not take a double dose to make up for a forgotten tablet.

If you forget to take a dose of GIACHELA and remember before going to bed, take it immediately.

Continue taking your medicine as usual the next day.

If you remember during the night or the following day, skip the missed dose and take the next dose at your usual time.

If you stop taking GIACHELA
Do not stop taking GIACHELA unless your doctor tells you to do so.

When completing treatment with GIACHELA, it is generally recommended that the dose be gradually reduced over a couple of weeks.

When stopping GIACHELA, especially if stopped abruptly, you may experience withdrawal symptoms. These are common when stopping treatment with GIACHELA. The risk is higher if you have taken GIACHELA for a long time or at high doses, or if the dose is reduced too quickly. Most patients find that such symptoms are mild and usually 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 GIACHELA, inform your doctor. Your doctor may advise you to restart treatment and then taper the dose more gradually.

Withdrawal symptoms include: dizziness (feeling unsteady or off-balance), prickling or "pins and needles" 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, diarrhea (loose stools), visual disturbances, 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, this medicine can cause side effects, although not everybody gets them.
Side effects usually disappear after a few weeks of treatment. Keep in mind that many of the side effects may also be symptoms of your illness, and therefore 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 and whites of the eyes, which are signs of liver dysfunction/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 notice 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 disorders
diarrhoea, constipation, vomiting, dry mouth
increased sweating
muscle and joint pain (arthralgia and myalgia)
sexual disorders (delayed ejaculation, erection problems, decreased sex drive, and women may have difficulty achieving orgasm)
tiredness, fever
weight gain

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

hives, skin rashes, itching
teeth grinding, agitation, nervousness, panic attacks, confusion
disturbed sleep, taste disturbances, fainting (syncope)
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, depersonalisation, 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 GIACHELA”)
low 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 which records the electrical activity of the heart). In addition, a number of side effects are known for medicines that act like escitalopram (the active substance in GIACHELA). These include:
motor restlessness (akathisia), urgency or need to move to relieve an unpleasant sensation (akathisia)
anorexia
heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see section 2, Pregnancy, for further information

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store GIACHELA
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 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information
What GIACHELA contains
The active substance is escitalopram.
Each GIACHELA tablet contains 10 mg or 20 mg of escitalopram (as oxalate).
The other components are:
Tablet core
Microcrystalline cellulose
Anhydrous colloidal silica
Talc
Sodium croscarmellose
Magnesium stearate
Tablet coating
Hypromellose
Titanium dioxide (E171)
Polyethylene glycol 400

Description of the appearance of GIACHELA and contents of the pack
GIACHELA 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 marked with “10” on one side. The tablet can be divided into two equal doses.
20 mg: White, oval, biconvex, film-coated tablet, with a score line and marked with “20” on one side. The tablet can be divided into two equal doses.
GIACHELA is available in the following pack sizes:
Opaque white PVC/PE/PVDC-Aluminium blisters containing 28 film-coated tablets.

Marketing Authorisation Holder
So.Se.PHARM S.r.l. – Via dei Castelli Romani, 22 – 00040 Pomezia (RM), Italy
Manufacturer
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR), Italy

Package leaflet: Information for the user

GIACHELA 20mg/ml oral drops, solution

Generic medicine
Please read 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, 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, because it could be dangerous.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.
Contents of this leaflet:

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

1. What GIACHELA is and what it is used for

GIACHELA belongs to a group of antidepressant medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). These medicines help increase serotonin levels in the brain. Alterations in the brain's serotonergic system are considered important factors in the development of depression and related disorders.
The active substance in GIACHELA 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 over 18 years.
It may take a few weeks before you start to feel better. Continue taking GIACHELA 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 need to know before taking GIACHELA
Do not take GIACHELA:

if you are allergic to escitalopram or to any of the excipients in 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 experienced an episode of abnormal heart rhythm (visible on an electrocardiogram [ECG], a test 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 GIACHELA”).

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

if you have epilepsy. Treatment with GIACHELA must 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 self-harm. 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 GIACHELA may alter blood glucose control. The dose of insulin and/or oral hypoglycemic agents may need to be adjusted;
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 bleed easily or bruise;
if you are taking buprenorphine. Using these medicines together with GIACHELA may lead to serotonin syndrome, a condition that can be fatal (see “Other medicines and GIACHELA”);
if you are taking any other medicine, including herbal remedies. See subsection “Other medicines and GIACHELA”;
if you are undergoing electroconvulsive therapy (ECT);
if you have closed-angle glaucoma or have previously had glaucoma;
if you have coronary heart disease;
if you are pregnant or breastfeeding;
if you have heart problems or have recently had a heart attack;
if you have a slow resting heart rate and/or think your body may have lost a significant amount of salt due to prolonged and severe diarrhea or vomiting, or due to diuretic use (water tablets);
if you experience a fast or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate an irregular heart rhythm.

Medicines such as GIACHELA (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.

Please note
Some patients with bipolar disorder may enter a manic phase. This is characterized by unusual and rapid changes in thinking, inappropriate and excessive happiness, and excessive physical activity. If you experience such symptoms, contact your doctor.
Symptoms such as restlessness or difficulty sitting still may occur during the first weeks of treatment. If you experience these symptoms, 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.

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 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 studies have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with an antidepressant.

If at any time you think about harming yourself or committing suicide, contact your doctor or go immediately to hospital.
It may be helpful to inform a relative or 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.

Children and adolescents
GIACHELA 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 side effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, oppositional behaviour, and anger). Nevertheless, your doctor may prescribe GIACHELA to patients under 18 years of age if they consider it the best option for them. If your doctor has prescribed GIACHELA to a patient under 18 years of age and you wish to obtain further information, please contact your doctor. You must inform your doctor if any of the above symptoms appear or worsen during treatment with GIACHELA in a patient under 18 years of age. In addition, the long-term safety effects of GIACHELA on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.

Other medicines and GIACHELA
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 substances. If you have taken any of these medicines, you must wait 14 days before starting GIACHELA. After stopping GIACHELA, 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 side effects.
Sumatriptan and similar medicines (used to treat migraine), tramadol or buprenorphine (used for severe pain), or buprenorphine. These medicines may interact with GIACHELA and cause symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle contraction, and fever above 38°C. Contact your doctor if you experience such symptoms, as they increase the risk of side 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 side effects.
Cimetidine and omeprazole (used to treat stomach ulcers or dyspepsia [indigestion]), fluconazole (used to treat fungal infections), and ticlopidine (used to reduce the risk of stroke). These medicines may increase GIACHELA levels in the blood.
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 thin the blood, so-called anticoagulants). 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 treatment with GIACHELA 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 GIACHELA 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 GIACHELA if you are taking medicines for heart rhythm problems or that may affect 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), or certain antihistamines (astemizole, mizolastine).
If you have any further doubts, contact your doctor.

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

Pregnancy, breastfeeding, and fertility
Inform your doctor if you are pregnant or planning a pregnancy.
Do not take GIACHELA if you are pregnant or breastfeeding unless your doctor has discussed the risks and benefits of treatment with you.
If you take GIACHELA during the last three months of pregnancy, you should be aware that the following effects may occur in the newborn: breathing difficulties, bluish skin colour, seizures, unstable body temperature, feeding difficulties, vomiting, hypoglycaemia (low blood glucose levels), hypertonia or hypotonia, hyperreflexia, tremor, restlessness, irritability, lethargy, persistent crying, drowsiness, and sleep difficulties. If the newborn shows any of these symptoms, contact your doctor immediately.
Ensure that your midwife and/or doctor know that you are taking GIACHELA.
When taken during pregnancy, particularly during the last three months, medicines such as GIACHELA 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.
Abrupt discontinuation of GIACHELA 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 an impact on human fertility has not yet been observed.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

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

Important information about some excipients
GIACHELA oral drops, solution contains ethanol (ethyl alcohol) and sodium.

This medicine contains 94 mg of alcohol (ethanol) per ml, equivalent to 94 mg/ml (9.4% w/v). The amount in 1 ml of this medicine is equivalent to less than 2.5 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e., essentially 'sodium-free'.

3. How to take GIACHELA

Always take GIACHELA exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Count the required number of drops to add to a drink (water, orange juice, or apple juice), briefly shake the glass, and drink the entire beverage.
GIACHELA oral drops must not be mixed with liquids other than water, orange juice, or apple juice, nor mixed with other medicines.

Adults
Depression
The usual recommended dose of GIACHELA is 10 mg (10 drops) daily, taken as a single dose. Your doctor may increase this dose up to a maximum of 20 mg (20 drops) daily.

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

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

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

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

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

Use in children and adolescents
GIACHELA is normally not intended for use in children and adolescents. For further information, see section 2 “What you need to know before taking GIACHELA”.

Duration of treatment
It may take a few weeks before you notice any improvement. Continue taking GIACHELA even if you do not experience immediate improvement.
Do not change your dosage without first consulting your doctor.
Continue taking GIACHELA for as long as your doctor recommends. 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 GIACHELA than you should
If you take more GIACHELA 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, irregular heartbeat, low blood pressure, and electrolyte imbalance. Bring the GIACHELA bottle/packaging with you when you visit a doctor or go to hospital.

If you forget to take GIACHELA
If you forget to take a dose of GIACHELA, do not take a double dose.
If you remember before going to bed, take the missed dose immediately and continue as usual the next day. If you remember during the night or the next day, skip the missed dose and continue with your regular dosing schedule.

If you stop taking GIACHELA
Do not stop taking GIACHELA unless your doctor tells you to. When completing treatment with GIACHELA, it is generally recommended that the dose be gradually reduced over a few weeks.
When stopping GIACHELA, especially if stopped abruptly, you may experience withdrawal symptoms. These are common when stopping treatment with GIACHELA. The risk is higher if you have taken GIACHELA 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 disappear spontaneously within a few weeks. However, in some patients, withdrawal symptoms may be severe or prolonged (2–3 months or longer). If you experience severe withdrawal symptoms when stopping GIACHELA, inform your doctor. Your doctor may advise you to resume treatment and gradually reduce the dose more slowly.

Withdrawal symptoms include: dizziness (feeling unsteady or off-balance), pins and needles sensation, burning sensation (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 using this medicine, consult your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects usually disappear after a few weeks of treatment. Note that many of these side effects may also be symptoms of your illness and will therefore improve as you feel 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, fainting, 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 feeling of suffocation (allergic reaction), contact your doctor or go immediately to hospital
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):

malaise (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 changes
diarrhoea, constipation, vomiting, dry mouth
increased sweating
muscle and joint pain (arthralgia and myalgia)
sexual disorders (delayed ejaculation, erection problems, decreased sexual desire, and women may have difficulty reaching 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
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 (frequency cannot be estimated from available data):

thoughts of self-harm or suicide (see also section 2 “What you need to know before taking GIACHELA”)
low sodium levels in the blood (symptoms include feeling unwell with muscle weakness or confusion)
dizziness upon standing due to low blood pressure (orthostatic hypotension)
abnormalities in liver function tests (increased liver enzyme levels in blood) and in ECG (electrocardiogram)
movement disorders (involuntary muscle movements)
painful erections (priapism)
abnormal bleeding, including bleeding from 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 recording the heart’s electrical activity)

In addition, a number of side effects are known for medicines acting like escitalopram (the active substance in GIACHELA), including:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store GIACHELA
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 label 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 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. Contents of the pack and other information
What GIACHELA contains
The active substance is escitalopram. Each ml of GIACHELA oral drops contains 20 mg of escitalopram (as escitalopram oxalate).
1 drop contains 1 mg of escitalopram.
The other excipients are:
propyl gallate (E310)
anhydrous citric acid (E330)
ethanol 96%
sodium hydroxide
purified water.

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

Marketing Authorisation Holder
So.Se.PHARM S.r.l. - Via dei Castelli Romani, 22 – 00040 Pomezia (RM), Italy
Manufacturer
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR), Italy

Giachela

Package leaflet: Information for the user

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

1. What GIACHELA is and what it is used for

3. How to take GIACHELA

4. Possible side effects

Package leaflet: Information for the user

GIACHELA 20mg/ml oral drops, solution

1. What GIACHELA is and what it is used for