Amasci

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Escitalopram oxalate
Equivalent medicine
Read all of this leaflet carefully before taking this medicine
because it contains important information for you.

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

Contents of this leaflet:

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

1. What Amasci is and what it is used for

Amasci contains the active substance escitalopram. Amasci belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs).
Amasci 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).
It may take a couple of weeks before you start to feel better. Continue taking Amasci 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 Amasci

Do not take Amasci

• If you are allergic to escitalopram or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines belonging to a group known as monoamine oxidase inhibitors (MAOIs), including selegiline (used in the treatment of Parkinson’s disease), moclobemide (used in the treatment of depression), or linezolid (an antibiotic).
• If you were born with or have had an episode of cardiac arrhythmia (identified by ECG, a test performed to assess heart function).
• If you are taking medicines for heart rhythm problems or that may affect your heart rhythm (see section 2 "Other medicines and Amasci").

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

• If you suffer from epilepsy. Treatment with Amasci should be discontinued if seizures occur for the first time or if there is an increase in the frequency of seizures (see also section 4 "Possible side effects").
• If you have impaired liver or kidney function. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Amasci may alter glycaemic control. It may be necessary to adjust your insulin and/or oral hypoglycaemic agent dosage.
• If you have low sodium levels in the blood.
• If you have a tendency to bleed or bruise easily, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
• If you are receiving electroconvulsive therapy.
• If you have coronary heart disease.
• If you suffer or have suffered from heart problems or have recently had a heart attack.
• If you have a slow resting heart rate and/or if you know you have salt deficiencies due to prolonged severe diarrhoea and vomiting or are using diuretics (medicines to increase urination).
• If, when standing up, you experience a rapid or irregular heartbeat, fainting, collapse, or dizziness, which may indicate an abnormality in heart rhythm function.
• If you have or have previously had eye problems, such as certain types of glaucoma (increased eye pressure).
• If you have depression or other conditions treated with antidepressants. The use of these medicines together with buprenorphine or buprenorphine/naloxone may lead to serotonin syndrome, a condition that can be fatal (see “Other medicines and Amasci”).

Please note
Some patients with bipolar disorder may enter a manic phase, characterised by rapidly changing unusual thoughts, inappropriate and excessive happiness, and excessive physical activity. If you experience these feelings, contact your doctor.
Symptoms such as restlessness or difficulty sitting or standing still may occur during the first weeks of treatment. Inform your doctor immediately if these symptoms appear.
Medicines such as Amasci (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or have anxiety disorders, you may sometimes think about harming yourself or committing suicide.
These thoughts may be more common at the beginning of treatment with antidepressants, as these medicines may take some time to become effective, usually about two weeks but sometimes longer.
You may be more likely to have such thoughts:

• If you have previously had suicidal or self-harming thoughts.
• If you are a young adult. Clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric conditions requiring treatment with an antidepressant.

If at any time you have thoughts of self-harm or suicide, contact your doctor or go immediately to hospital.
It may be helpful to inform a family member or close friend about your depression or 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 changes in your behaviour.
Use in children and adolescents
Amasci is generally 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 type of medicine have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger). Nevertheless, your doctor may prescribe Amasci to patients under 18 years of age if they consider it the best treatment option. If your doctor has prescribed Amasci to a patient under 18 years of age and you have questions, consult your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen while patients under 18 years of age are taking Amasci. Furthermore, the long-term safety effects of Amasci on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.
Other medicines and Amasci
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 treatment with Amasci. After stopping Amasci, you must wait 7 days before taking any of these medicines.
• “Reversible selective MAO-A inhibitors” containing moclobemide (used in the treatment of depression).
• “Irreversible MAO-B inhibitors” containing selegiline (used in the treatment of Parkinson’s disease). These medicines increase the risk of adverse effects.
• The antibiotic linezolid.
• Lithium (used in the treatment of bipolar disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol and similar medicines (opioids, used to treat severe pain). These 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 escitalopram blood levels.
• St. John’s wort (Hypericum perforatum): a herbal product used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce blood thickness, also called anticoagulants). These may increase the tendency to bleed.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce blood thickness, also called anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of Amasci treatment to ensure your anticoagulant dose remains appropriate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain), due to the possible risk of reduced seizure threshold.
• Neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of reduced seizure threshold.
• Flecainide, propafenone, and metoprolol (used in cardiovascular conditions), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). A dose adjustment of escitalopram may be necessary.
• Medicines that increase potassium or magnesium levels in the blood, as these conditions increase the risk of potentially life-threatening heart rhythm disturbances.
• Antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines may interact with buprenorphine or buprenorphine/naloxone 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, and fever above 38°C. Contact your doctor if you experience such symptoms.

Do not take escitalopram if you are taking medicines for heart rhythm problems or that may affect heart rhythm, such as, for example, class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), or certain antihistamines (e.g. astemizole, hydroxyzine, mizolastine). If you have any further doubts, consult your doctor.
Amasci with food, drinks and alcohol
Amasci can be taken with or without food (see section 3 “How to take Escitalopram”).
As with many medicines, combining Amasci with alcohol is not recommended, although no interaction between escitalopram and alcohol is expected.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
Do not take Amasci during pregnancy or while breastfeeding unless your doctor has discussed the risks and benefits of treatment with you.
Pregnancy
If you take Amasci near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed easily). Inform your doctor or midwife that you are taking Amasci so they can advise you on what to do.
If you take Amasci during the last trimester of pregnancy, you should know that the following effects may occur in the newborn: breathing difficulties, bluish skin colouration, seizures, unstable body temperature, feeding difficulties, vomiting, hypoglycaemia (low blood glucose levels), hypertonia or hypotonia, hyperreflexia, tremor, restlessness, irritability, lethargy, persistent crying, drowsiness, and sleep disturbances. If the newborn shows any of these symptoms, contact your doctor immediately.
Make sure to inform your midwife and/or doctor that you are taking Amasci. Medicines such as Amasci, when taken during pregnancy, especially during the last three months, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension in neonates (PPHN), which causes the baby to breathe faster and have a bluish skin colouration. These symptoms usually appear within the first 24 hours after birth. If this occurs, contact your midwife and/or doctor immediately.
Amasci should never be stopped abruptly if taken during pregnancy.
Escitalopram is expected to be excreted in breast milk.
Citalopram, a medicine similar to escitalopram, has been shown in animal studies to reduce sperm quality. In theory, this could affect fertility, but no impact on human fertility has been observed.
Driving and using machines
It is advised not to drive or operate machinery until you know how Amasci affects you.
This medicine contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Amasci

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Adults
Depression
The usual recommended dose of Amasci 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 Amasci is 5 mg once daily for the first week, before increasing 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 Amasci 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 Amasci is 10 mg once daily. 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 Amasci is 10 mg once daily. The dose may be increased by your doctor up to a maximum of 20 mg per day.
Elderly patients (over 65 years of age)
The recommended starting dose of Amasci is 5 mg once daily. The dose may be increased by your doctor up to 10 mg per day.
Use in children and adolescents
Amasci should normally not be given to children and adolescents. For further information, see section 2 “Warnings and precautions”.
Reduced renal function
Caution is advised in patients with severely reduced kidney function. Take the medicine as prescribed by your doctor.
Reduced hepatic function
Patients with liver impairment should not receive more than 10 mg per day. Take the medicine as prescribed by your doctor.
Patients known to be poor metabolizers of the enzyme CYP2C19
Patients with this known genotype should not receive more than 10 mg per day. Take the medicine as prescribed by your doctor.
How to take the tablets
You may take Amasci with or without food. Swallow the tablet with some water. Do not chew it, as the taste is bitter.
If necessary, you may split the tablets by placing them on a flat surface with the score line facing upwards. The tablets can be broken by pressing downwards on the edges of the two halves using both index fingers, as shown in the drawing.

The 10 mg and 20 mg tablets can be divided into equal doses.
Duration of treatment
It may take a few weeks before you notice any improvement. Continue taking Amasci even if it takes some time before you feel better.
Do not change the dose of this medicine without first consulting your doctor.
Continue taking Amasci for as long as your doctor has recommended. If you stop treatment too early, symptoms may return. It is recommended to continue treatment for at least 6 months after you start feeling well again.
If you take more Amasci than you should
If you take more Amasci than prescribed, contact your doctor or go immediately to the nearest hospital emergency department. Do this even if you do not have any symptoms of discomfort. 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 Amasci package/container with you when going to the doctor or hospital.
If you forget to take Amasci
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose and remember before going to bed, take it immediately. Continue taking the medicine as usual the next day. If you remember during the night or the following day, skip the missed dose and continue with your regular dosing schedule.
If you stop taking Amasci
Do not stop taking Amasci unless your doctor tells you to. When completing treatment, it is generally advisable to gradually reduce the dose of Amasci over several weeks.
When stopping Amasci, especially if stopped abruptly, you may experience withdrawal symptoms, which are common when discontinuing treatment with Amasci. The risk is higher if you have taken Amasci for a long time or at high doses, or if the dose is reduced too quickly. Most people find that symptoms are mild and disappear spontaneously within two weeks. However, in some patients, withdrawal symptoms may be severe or may persist over time (2–3 months or longer). If you experience severe withdrawal symptoms when stopping Amasci, inform your doctor, who may ask you to restart treatment and then gradually reduce the dose more slowly.
Withdrawal symptoms include: dizziness (feeling unsteady or off balance), tingling sensations, burning sensations (less commonly), electric shock-like sensations, even in the head, sleep disturbances (vivid dreams, nightmares, difficulty sleeping), feeling anxious, headache, malaise (nausea), sweating (including night sweats), feeling restless or agitated, tremor (shaking), feeling confused or disoriented, emotional lability or irritability, diarrhoea (loose stools), visual disturbances, heart rhythm disturbances (palpitations).
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects usually disappear after a few weeks of treatment. Please note that many of the side
effects may also be symptoms of your illness and therefore will diminish as you start to feel better.
If you experience any of the following symptoms, you must contact your doctor or go to
hospital immediately:
Uncommon (may affect up to 1 in 100 people):

• Abnormal bleeding, including gastrointestinal haemorrhage.

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

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

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

• Difficulty urinating.
• Seizures (epileptic fits), see also section 2 "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 potentially life-threatening condition known as Torsade de Pointes.
• Thoughts of self-harm (hurting yourself) or suicide. See also section 2 “Warnings and precautions”.
• Sudden swelling of the skin or mucous membranes (angioedema).

In addition to those listed above, the following side effects have also been reported:
Very common (may affect more than 1 in 10 people):

• 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 sleeping, drowsiness, dizziness, yawning, tremor, tingling of the skin
• diarrhoea, constipation, vomiting, dry mouth
• increased sweating
• muscle and joint pain (arthralgia and myalgia)
• sexual disorders (delayed ejaculation, erection problems, reduced sexual drive, and women may have difficulty achieving orgasm)
• 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, altered taste, fainting (syncope)
• pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• hair loss
• increased menstrual flow
• irregular menstrual cycle
• weight loss
• rapid heartbeat
• swelling of arms or legs
• nosebleeds

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

• aggression, depersonalisation, hallucinations
• slow heartbeat

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

• decrease in blood sodium levels (symptoms include feeling unwell with muscle weakness or confusion)
• dizziness upon standing due to a drop in blood pressure (orthostatic hypotension)
• changes in liver function test values (increased levels of liver enzymes in the blood)
• movement disorders (involuntary muscle movements)
• painful erections (priapism)
• signs of abnormal bleeding, e.g. of the skin and mucous membranes (bruising) and low platelet count in the blood (thrombocytopenia)
• increased production of a hormone called ADH, causing fluid retention and dilution of the blood, leading to reduced sodium levels (inappropriate ADH secretion)
• increased levels of the hormone prolactin in the blood
• milk secretion in men and in women who are not breastfeeding
• mania
• an increased risk of bone fractures has been observed in patients taking this type of medicine
• changes in heart rhythm (called "QT interval prolongation", assessed by ECG, which measures the heart's electrical activity)
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see section 2, Pregnancy, breastfeeding and fertility, for further information.

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

• motor restlessness (akathisia)
• loss of appetite

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

5. How to store Amasci

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 or 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.

6. Package contents and other information

What Amasci contains
The active substance is escitalopram. Each Amasci tablet contains 10 mg or 20 mg of escitalopram
(as oxalate).
The other components are:
Core: monohydrate lactose, anhydrous colloidal silica, sodium croscarmellose, sodium carboxymethylcellulose,
propyl gallate, talc and magnesium stearate.
Coating: HPMC 2910/hypromellose 6cP, titanium dioxide (E171) and macrogol 400.

Description of the appearance of Amasci and package contents
Amasci is available as 10 mg and 20 mg film-coated tablets. The tablets are described below.
10 mg: film-coated, biconvex, round tablet, white to off-white in colour, imprinted with "ML 60" on one side, a score line on the opposite side and notches on both sides of the score line (approximate size: 7.14 mm).
20 mg: film-coated, biconvex, round tablet, white to off-white in colour, imprinted with "ML 61" on one side, a score line on the opposite side and notches on both sides of the score line (approximate size: 9.5 mm).

Amasci tablets are supplied in cold-form laminated blisters made of OPA 25µ / aluminium 45µ / PVC 60µ – aluminium foil lid.
Pack sizes: 20, 28, 50, 56, 98 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ecupharma S.r.l. - Via Mazzini 20 - 20123 Milano (Italy).

Manufacturers
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Poland
Macleods Pharma UK Limited
Wynyard Park House,
Wynyard Avenue, Wynyard,
Billingham, TS22 5TB
United Kingdom
IDIFARMA DESARROLLO FARMACÉUTICO, S.L.
Poligono Mocholi
C/Noain, 1
31110 Noain (Navarra)
Spain

This summary of product characteristics was last approved on