Eutimil

Package leaflet: Information for the user

EUTIMIL 20 mg film-coated tablets

Paroxetine (as hemihydrochloride)
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

Contents of this leaflet:

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

1. What EUTIMIL is and what it is used for

EUTIMIL is a treatment for adults with depression and/or anxiety disorders. The anxiety disorders for which
treatment with EUTIMIL is indicated are: obsessive-compulsive disorder (repetitive, obsessive thoughts with
uncontrollable behaviours), panic disorder (panic attacks, including those caused by agoraphobia, i.e. fear of open spaces),
social anxiety disorders (fear of or avoidance of social situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (persistent feelings of intense anxiety or nervousness).
EUTIMIL belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). A substance called serotonin is naturally present in the brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how EUTIMIL and other SSRIs work, but they may help increase serotonin levels in the brain.
Appropriately treating depression or anxiety disorders is important to help you feel better.

2. What you need to know before taking EUTIMIL

Do not take EUTIMIL

• If you are taking other medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)), or if you have taken them at any time within the last two weeks. Your doctor will advise you on how to start taking EUTIMIL after you have stopped taking MAOIs.
• If you are taking an antipsychotic called thioridazine or an antipsychotic called pimozide.
• If you are allergic to paroxetine or to any of the other ingredients of this medicine (listed in section 6). If any of these situations apply to you, speak with your doctor before taking EUTIMIL.

Warnings and precautions
Talk to your doctor or pharmacist before taking EUTIMIL.

• Are you taking any other medicines? (See inside this leaflet, Other medicines and EUTIMIL?)
• Are you taking tamoxifen for the treatment of breast cancer or fertility problems? EUTIMIL may reduce the effectiveness of tamoxifen, so your doctor may recommend that you take another antidepressant.
• Do you have kidney, liver, or heart problems?
• Do you suffer from epilepsy or have you previously experienced seizures?
• Have you ever had episodes of mania (hyperactive behaviour or thoughts)?
• Are you receiving electroconvulsive therapy?
• Have you previously experienced bleeding, or are you taking other medicines that may increase the risk of bleeding (these include blood-thinning medicines such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines used for pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)?
• Do you have diabetes?
• Are you on a low-sodium diet?
• Do you have glaucoma (high pressure in the eye)?
• Are you pregnant or planning to become pregnant? (See inside this leaflet Pregnancy, breastfeeding and fertility.)
• Are you under 18 years of age? (See inside this leaflet Children and adolescents under 18 years of age.) If you answered YES to any of these questions and have not already discussed this with your doctor, return to your doctor and ask what to do about taking EUTIMIL.

Children and adolescents under 18 years of age
EUTIMIL must not be used in children and adolescents under 18 years of age.
Furthermore, patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) when taking EUTIMIL. If your doctor has prescribed EUTIMIL for you (or your child) and you wish to discuss this, return to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while you (or your child) are taking EUTIMIL. In addition, in this age group, the long-term effects of EUTIMIL on growth, maturation, and cognitive and behavioural development have not yet been established.
In studies with EUTIMIL in patients under 18 years of age, the common adverse effects occurring in less than 1 in 10 children/adolescents were: increased suicidal thoughts and suicide attempts, deliberate self-harm, hostile behaviour, aggressive or unfriendly behaviour, loss of appetite, tremors, unusual sweating, hyperactivity (excessive energy), restlessness, emotional changes (including crying and mood changes), and unusual bruising or bleeding (such as nosebleeds). These studies also showed that the same symptoms occurred in children and adolescents taking sugar pills (placebo) instead of EUTIMIL, although less frequently.
In these studies conducted in patients under 18 years of age, some patients experienced withdrawal symptoms after stopping EUTIMIL. These symptoms were mostly similar to those observed in adults after discontinuation of EUTIMIL (see section 3, How to take EUTIMIL, inside this leaflet).
Additionally, patients under 18 years of age commonly experienced (in less than 1 in 10 cases) stomach pain, nervousness, and emotional changes (including crying, mood changes, self-harm attempts, suicidal thoughts, and suicide attempts).

Suicidal thoughts and worsening of depression or anxiety disorders
If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of harming yourself or taking your own life.
These thoughts may be more common when you first start taking antidepressants, as all these medicines take time to work—usually about two weeks, but sometimes longer.
You may be more likely to have these types of thoughts:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with an antidepressant.

If at any time you have thoughts of harming yourself or taking your own life, contact your doctor or go directly to hospital.
You may find it helpful to tell a relative or friend that you suffer from depression or anxiety disorders 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 changes in your behaviour.

Important adverse effects observed with EUTIMIL
Some patients taking EUTIMIL experience a condition called akathisia, meaning they feel restless and unable to sit or stand still. Other patients may experience what is called serotonin syndrome or neuroleptic malignant syndrome, which may include some or all of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle rigidity, sudden muscle contractions, or rapid heartbeat. The condition may worsen, leading to loss of consciousness. If you notice any of these symptoms, contact your doctor. For more information on these or other side effects of EUTIMIL, see section 4, Possible side effects, inside this leaflet.
Medicines such as EUTIMIL (so-called selective serotonin reuptake inhibitors, SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.

Other medicines and EUTIMIL
Some medicines may interfere with the action of EUTIMIL or may make it more likely that you experience adverse effects. EUTIMIL may also interfere with the action of other medicines. These include:

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)) – see inside this leaflet, Do not take EUTIMIL.
• Thioridazine or pimozide, which are antipsychotics – see inside this leaflet, Do not take EUTIMIL.
• Acetylsalicylic acid, ibuprofen, or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib, etodolac, diclofenac, and meloxicam, used for pain and inflammation
• Tramadol and pethidine, painkillers
• Medicines called triptans, such as sumatriptan, used to treat migraine
• Other antidepressants, including other SSRIs, tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine
• A dietary supplement called tryptophan
• Mivacurium and succinylcholine (used in anaesthesia)
• Medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotics) used to treat certain psychiatric conditions
• Fentanyl, used in anaesthesia or for treating chronic pain
• A combination of fosamprenavir and ritonavir, used to treat Human Immunodeficiency Virus (HIV) infection
• St. John’s wort (Hypericum perforatum), a herbal remedy for depression
• Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizures or epilepsy
• Atomoxetine, used to treat attention deficit hyperactivity disorder (ADHD)
• Procyclidine, used to treat tremors, especially in Parkinson’s disease
• Warfarin or other medicines (called anticoagulants) used to thin the blood
• Propafenone, flecainide, and medicines used to treat irregular heartbeat
• Metoprolol, a beta-blocker used to treat high blood pressure and heart problems
• Pravastatin, used to treat high cholesterol
• Rifampicin, used to treat tuberculosis and leprosy
• Linezolid, an antibiotic
• Tamoxifen, used for the treatment of breast cancer or fertility problems.

If you are taking or have recently taken any of the medicines listed above, and have not yet discussed this with your doctor, return to your doctor and ask what to do. It may be necessary to adjust your dose or you may need to take a different medicine.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

EUTIMIL with food, drinks, and alcohol
Do not drink alcohol while taking EUTIMIL. Alcohol may worsen your symptoms and side effects. Taking EUTIMIL in the morning with food will reduce the likelihood of feeling unwell (nausea).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
In children of mothers who took EUTIMIL during the first months of pregnancy, there have been some reports indicating an increased risk of birth defects, particularly heart defects.
In the general population, about 1 in 100 children is born with a heart defect.
This rate increases to 2 in 100 children in mothers taking EUTIMIL. You and your doctor can decide whether it is better for you to switch to another treatment or gradually discontinue EUTIMIL during pregnancy. However, depending on the circumstances, your doctor may advise that it is better for you to continue taking EUTIMIL.
Ensure that your midwife or doctor knows that you are taking EUTIMIL. When medicines such as EUTIMIL are taken during pregnancy, particularly in late pregnancy, they may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the pressure in the blood vessels between the baby’s heart and lungs is too high. If you take EUTIMIL during the last three months of pregnancy, your newborn may also experience other conditions, which usually begin within the first 24 hours after birth. Symptoms include:

• breathing difficulties
• bluish skin colour, or being too hot or too cold
• blue lips
• vomiting or feeding poorly
• being very tired, inability to sleep, or excessive crying
• stiff or floppy muscles
• tremors, agitation, or seizures
• exaggerated reflexes. If your baby shows any of these symptoms at birth, or if you are concerned about your baby’s health, contact your doctor or midwife, who will be able to advise you. EUTIMIL can pass into breast milk in very small amounts. If you are taking EUTIMIL, return to your doctor and discuss this before starting breastfeeding. You and your doctor can decide whether you can breastfeed while taking EUTIMIL. Paroxetine has been shown to reduce sperm quality in animal studies. Theoretically, this could affect fertility, but no impact on human fertility has been observed so far.

Driving and using machines
Possible side effects of EUTIMIL include dizziness, confusion, drowsiness, or blurred vision. If you experience these side effects, do not drive or operate machinery.

3. How to take EUTIMIL

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Sometimes it may be necessary to take more than one tablet or half a tablet. This table will show you how many tablets to take.

The usual doses for the different conditions are reported in the table below.

Your doctor will tell you what dose to take when you start taking EUTIMIL. Most
people feel better after a couple of weeks. If you do not start feeling better after this period of
time, talk to your doctor, who will advise you. Your doctor may decide to gradually increase your dose by
10 mg at a time, up to the maximum daily dose.
Take the tablets in the morning with food.
Swallow them with water.
Do not chew them.
Your doctor will tell you how long you will need to take your tablets. This may be for several months or even
longer.
Elderly patients
The maximum dose for patients over 65 years of age is 40 mg per day.
Patients with liver or kidney disease
If you have liver problems or severe kidney disease, your doctor may decide to reduce your dose of EUTIMIL
compared to the usual dose.
If you take more EUTIMIL than you should
Do not take more tablets than your doctor has recommended. If you take more EUTIMIL tablets than you
should (or if someone else has done so), contact your doctor or go to a hospital immediately. Show them the
pack of tablets.
People who have taken an overdose of EUTIMIL may experience one of the symptoms listed in Section 4, Possible
side effects, or one of the following symptoms: fever, uncontrollable muscle stiffness.
If you forget to take EUTIMIL
Take your medicine every day at the same time.
If you forget to take a dose and remember before going to bed, take it immediately.
Continue as usual the next day.
If you only remember during the night or the following day, do not take the missed dose. You may experience
withdrawal effects, but these should disappear once you take your next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
What to do if you do not feel better
EUTIMIL does not improve your symptoms immediately – all antidepressants need time to work.
Some people start to feel better within a couple of weeks, but for others it may take a little longer. Some people taking antidepressants may feel worse before they start to feel better. If you do not start to feel better after a couple of weeks, return to your doctor, who will advise you. Your doctor should arrange to see you again a couple of weeks after starting treatment. Inform your doctor that you have not started to feel better.
If you stop taking EUTIMIL
Do not stop taking EUTIMIL unless your doctor tells you to do so.
When stopping EUTIMIL, your doctor will help you gradually reduce the dose over a number of weeks or months – this should help reduce the likelihood of withdrawal effects. One way to do this is to gradually reduce your dose of EUTIMIL by 10 mg per week.
Most people find that any EUTIMIL withdrawal symptoms are mild and disappear on their own within two weeks. For some people, these symptoms may be more severe or last longer.
If you experience withdrawal effects when stopping the tablets, your doctor may decide to stop them more slowly. If you have severe withdrawal effects when stopping EUTIMIL, contact your doctor. Your doctor may ask you to start taking the tablets again and then stop more gradually.
If you experience withdrawal effects, you will still be able to stop EUTIMIL.
Possible withdrawal effects when stopping treatment
Studies show that 3 out of 10 patients notice one or more symptoms when stopping EUTIMIL.
Some withdrawal effects occur more frequently than others when stopping treatment.
Common side effects, which may affect up to 1 in 10 people:

• Dizziness, feeling unsteady, or loss of balance
• Prickling sensations, burning sensations, (less commonly) electric shock-like sensations, even in the head, and ringing, buzzing, hissing, or other persistent noises in the ear (tinnitus)
• Sleep disturbances (vivid dreams, nightmares, inability to sleep)
• Feeling anxious
• Headache

Uncommon side effects, which may affect up to 1 in 100 people:

• Feeling unwell (nausea)
• Sweating (including night sweats)
• Feeling restless or agitated
• Tremors
• Feeling confused or disoriented
• Diarrhoea (loose stools)
• Feeling emotional or irritable
• Visual disturbances
• Fast or strong heartbeat (palpitations)

Talk to your doctor if you are concerned about withdrawal effects when stopping EUTIMIL.
If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are more likely to occur during the first weeks of treatment with EUTIMIL.
Contact your doctor if you experience any of the following side effects during treatment.
You may need to contact your doctor or go directly to hospital.

Uncommon side effects, which may affect up to 1 in 100 patients:

• If you have unusual bruising and bleeding, including blood in vomit or stools, contact your doctor or go directly to hospital.
• If you are unable to pass urine, contact your doctor or go directly to hospital.

Rare side effects, which may affect up to 1 in 1,000 patients:

• If you have seizures (convulsive fits), contact your doctor or go directly to hospital.
• If you feel restless and feel as though you cannot sit or stand still, you may be experiencing a condition called akathisia. Increasing the dose of EUTIMIL may worsen these sensations. If you feel this way, contact your doctor.
• If you feel tired, weak, or confused and have sore, stiff, or uncoordinated muscles, this may be due to low sodium levels in the blood. If you have these symptoms, contact your doctor.

Very rare side effects, which may affect up to 1 in 10,000 patients:

• Allergic reactions to EUTIMIL, which may be severe. If you develop a skin rash with red, raised areas, swelling of the eyelids, face, lips, mouth, or tongue, onset of itching, and have difficulty breathing (shortness of breath) or swallowing, or feel weak or dizzy to the point of collapsing or losing consciousness, contact your doctor or go directly to hospital.
• If you have some or all of the following symptoms, you may be experiencing serotonin syndrome or neuroleptic malignant syndrome. Symptoms include: feeling very restless or irritable, feeling confused, feeling agitated, feeling hot, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. Severity may increase, leading to loss of consciousness. If you feel this way, contact your doctor.
• Acute glaucoma. If you begin to experience eye pain and blurred vision, contact your doctor.

Frequency not known
Some people have had thoughts of harming themselves or of suicide while taking EUTIMIL or immediately after stopping treatment (see Section 2, What you should know before taking EUTIMIL).
Some people have shown aggression while taking EUTIMIL.
If you experience these side effects, consult your doctor.

Other possible side effects during treatment

Very common side effects, which may affect more than 1 in 10 patients:

• Feeling unwell (nausea). Taking the medicine in the morning with food will reduce the likelihood of this occurring.
• Changes in sexual behaviour or sexual function. For example, lack of orgasm and, in men, abnormalities of erection and ejaculation.

Common side effects, which may affect up to 1 in 10 patients:

• Increased blood cholesterol levels
• Loss of appetite
• Poor sleep (insomnia) or feeling drowsy
• Abnormal dreams (including nightmares)
• Dizziness or tremors
• Headache
• Difficulty concentrating
• Feeling restless
• Unusual weakness
• Blurred vision
• Yawning, dry mouth
• Diarrhoea or constipation
• Vomiting
• Weight gain
• Sweating

Uncommon side effects, which may affect up to 1 in 100 patients:

• Short-term increase or decrease in blood pressure, which may cause dizziness or fainting when standing up suddenly
• Faster than normal heartbeat
• Lack of movement, stiffness, tremor, or abnormal movements of the mouth and tongue
• Dilated pupils
• Skin rash
• Itching
• Feeling confused
• Hallucinations (strange visions or sounds)
• Inability to pass urine (urinary retention) or involuntary and uncontrollable loss of urine (urinary incontinence)
• If you are a diabetic patient, you may notice a loss of control of your blood sugar levels while taking EUTIMIL. Consult your doctor for adjustment of insulin or diabetes medication dosage.

Rare side effects, which may affect up to 1 in 1,000 patients:

• Abnormal production of milk from the breasts in men and women
• Slower heartbeat
• Liver effects detectable through blood tests of liver function
• Panic attacks
• Hyperactive behaviour and thoughts (mania)
• Feeling detached from oneself (depersonalisation)
• Feeling anxious
• Irresistible urge to move the legs (Restless Legs Syndrome)
• Joint or muscle pain
• Increased blood levels of a hormone called prolactin
• Menstrual cycle disorders (including heavy or irregular periods, bleeding between periods, or absence or delay of periods)

Very rare side effects, which may affect up to 1 in 10,000 patients:

• Skin rash, which may appear as blisters and resemble small targets (dark central spots surrounded by a paler area, with a dark ring around the edge), known as erythema multiforme
• Widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• Widespread skin rash with blisters and peeling of the skin over most of the body surface (toxic epidermal necrolysis)
• Liver problems causing yellowing of the skin and whites of the eyes
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body retains excess water and has reduced sodium concentration (a salt), as a result of improper chemical signals. Patients with SIADH may become seriously ill or may have no symptoms at all.
• Fluid or water retention, which may cause swelling of the arms or legs
• Sensitivity to sunlight
• Painful erection of the penis that does not go away
• Low platelet count

Frequency not known

• Teeth grinding (bruxism)

Some patients have experienced ringing, buzzing, hissing, whistling, or other persistent noises in the ear (tinnitus) while taking EUTIMIL.
An increased risk of bone fractures has been observed in patients taking this type of medicine.

Reporting of side effects
If you experience any side effect, 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 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 EUTIMIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack, bottle or carton. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original packaging to protect the medicine from light.
If you use split tablets, store them carefully in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What EUTIMIL contains
Film-coated tablets 20 mg
The active substance is paroxetine (20 mg) as paroxetine hydrochloride hemihydrate.

• Excipients:
  Tablet core: dibasic calcium phosphate dihydrate (E341), magnesium stearate (E470b), sodium carboxymethyl starch (Type A)
  Film coating: hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80 (E433)

Description of the appearance of EUTIMIL and contents of the pack
The 20 mg film-coated tablets of EUTIMIL are white, oval-shaped, engraved with "20" on one side and a score line on the other side. Each EUTIMIL pack contains child-resistant blisters of 1x50, 4, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 250 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona, Italy
Manufacturer:
GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka 189, 60-322 Poznań (Poland)
or
Famar Italia S.p.A. – Via Zambeletti, 25 - Baranzate (MI), Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Authorization number 567/01 film-coated tablets 20 mg
France Paroxétine Biogaran
Germany Tagonis 20 mg Filmtabletten
Hungary Paroxat 20 mg filmtabletta
Italy Eutimil
Netherlands Paroxetine GSK 20 mg
Slovenia Paroxat 20 mg
Spain Frosinor

You may find it helpful to contact a support group or patient association to learn more about your condition. Your doctor can provide further details.

Package leaflet: information for the user

EUTIMIL 2 mg/ml oral suspension

Paroxetine (as hydrochloride hemihydrate)
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

Contents of this leaflet:

7. What EUTIMIL is and what it is used for
8. What you need to know before taking EUTIMIL
9. How to take EUTIMIL
10. Possible side effects
11. How to store EUTIMIL
12. Contents of the pack and other information

1. What EUTIMIL is and what it is used for

EUTIMIL is a treatment for adults with depression and/or anxiety disorders. The anxiety disorders for which
treatment with EUTIMIL is indicated are: obsessive-compulsive disorder (repetitive, obsessive thoughts with
uncontrollable behaviours), panic disorder (panic attacks, including those caused by agoraphobia, i.e. fear of open spaces), social anxiety disorders (fear of or avoidance of social situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (feeling excessively anxious or nervous in general).
EUTIMIL belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). A substance called serotonin is naturally present in the brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully known how EUTIMIL and other SSRIs work, but they may help increase serotonin levels in the brain.
Appropriately treating depression or anxiety disorders is important to help you feel better.

2. What you should know before taking EUTIMIL

Do not take EUTIMIL

• If you are taking other medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)), or if you have taken them at any time within the last two weeks. Your doctor will advise you on how to start taking EUTIMIL after stopping MAOIs.
• If you are taking an antipsychotic called thioridazine or an antipsychotic called pimozide.
• If you are allergic to paroxetine or to any of the other ingredients of this medicine (listed in section 6). If any of these situations apply to you, speak to your doctor before taking EUTIMIL.

Warnings and precautions
Talk to your doctor or pharmacist before taking EUTIMIL

• Are you taking any other medicines? (See Other medicines and EUTIMIL within this leaflet)
• Are you taking tamoxifen for the treatment of breast cancer or fertility problems? EUTIMIL may reduce the effectiveness of tamoxifen, so your doctor may recommend that you take another antidepressant.
• Do you have kidney, liver or heart problems?
• Do you have epilepsy or have you previously had seizures?
• Have you ever experienced episodes of mania (hyperactive behaviour or thoughts)?
• Are you receiving electroconvulsive therapy?
• Have you previously experienced bleeding, or are you taking other medicines that may increase the risk of

bleeding (these include blood-thinning medicines such as warfarin, antipsychotics
such as perphenazine or clozapine, tricyclic antidepressants, medicines used for pain and
inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid,
ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)?

• Do you have diabetes?
• Are you on a low-sodium diet?
• Do you have glaucoma (high eye pressure)?
• Are you pregnant or planning to become pregnant? (See Pregnancy, breastfeeding and fertility within this leaflet)
• Are you under 18 years of age? (See Children and adolescents under 18 years within this leaflet)
  If you have answered YES to any of these questions and have not already discussed this with your doctor, return to your doctor and ask what you should do about taking EUTIMIL.

Children and adolescents under 18 years
EUTIMIL must not be used in children and adolescents under 18 years of age.
Furthermore, patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal thoughts and hostility (mainly aggression, oppositional behaviour and anger) when taking EUTIMIL. If your doctor has prescribed EUTIMIL for you (or your child) and you wish to discuss this, speak to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while you (or your child) are taking EUTIMIL. In addition, in this age group, the long-term effects of EUTIMIL on growth, maturation, and cognitive and behavioural development have not yet been established.
In clinical studies of EUTIMIL in patients under 18 years of age, common adverse effects occurring in less than 1 in 10 children/adolescents were: increased suicidal thoughts and suicide attempts, deliberate self-harm, hostile behaviour, aggressive or unfriendly attitude, loss of appetite, tremors, unusual sweating, hyperactivity (excess energy), restlessness, emotional changes (including crying and mood changes), and unusual bruising or bleeding (such as nosebleeds). These studies also showed that the same symptoms occurred in children and adolescents taking sugar pills (placebo) instead of EUTIMIL, although less frequently.
In these studies conducted in patients under 18 years of age, some patients experienced withdrawal symptoms after stopping EUTIMIL. These symptoms were mostly similar to those observed in adults after discontinuation of EUTIMIL (see section 3, How to take EUTIMIL, within this leaflet).
Additionally, patients under 18 years of age commonly experienced (in less than 1 in 10 cases) stomach pain, nervousness, and emotional changes (including crying, mood changes, self-harm attempts, suicidal thoughts and suicide attempts).

Suicidal thoughts and worsening of depression or anxiety disorders
If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of harming yourself or taking your life. These thoughts may be more common when you first start taking antidepressants, as all these medicines take time to work—usually about two weeks, but sometimes longer.
You may be more likely to have these types of thoughts:

• If you have previously had thoughts of taking your life or harming yourself.
• 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 who were treated with an antidepressant.
  If at any time you have thoughts of harming yourself or taking your life, contact your doctor or go directly to hospital.
  It may be helpful to tell a relative or friend that you are suffering from depression or anxiety disorders, 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 changes in your behaviour.

Important adverse effects observed with EUTIMIL
Some patients taking EUTIMIL experience a condition called akathisia, meaning they feel restless and unable to sit still or stand still. Other patients may develop what is called serotonin syndrome or neuroleptic malignant syndrome, which may include some or all of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. The condition may worsen, leading to loss of consciousness. If you notice any of these symptoms, contact your doctor. For more information on these or other side effects of EUTIMIL, see section 4, Possible side effects, within this leaflet.
Medicines such as EUTIMIL (so-called selective serotonin reuptake inhibitors, SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.

Other medicines and EUTIMIL
Some medicines may interfere with the action of EUTIMIL or make adverse effects more likely. EUTIMIL may also interfere with the action of other medicines. These include:

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)) – see Do not take EUTIMIL within this leaflet.
• Thioridazine or pimozide, which are antipsychotics – see Do not take EUTIMIL within this leaflet.
• Acetylsalicylic acid, ibuprofen or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib, etodolac, diclofenac and meloxicam, used for pain and inflammation
• Tramadol and pethidine, painkillers
• Medicines called triptans, such as sumatriptan, used to treat migraine
• Other antidepressants, including other SSRIs, tricyclic antidepressants such as clomipramine, nortriptyline and desipramine
• A dietary supplement called tryptophan
• Mivacurium and succinylcholine (used in anaesthesia)
• Medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotics) used to treat certain psychiatric conditions
• Fentanyl, used in anaesthesia or for treating chronic pain
• A combination of fosamprenavir and ritonavir, used to treat Human Immunodeficiency Virus (HIV) infection
• St John’s wort (Hypericum perforatum), a herbal remedy for depression
• Phenobarbital, phenytoin, sodium valproate or carbamazepine, used to treat seizures or epilepsy
• Atomoxetine, used to treat attention deficit hyperactivity disorder (ADHD)
• Procyclidine, used to treat tremor, especially in Parkinson’s disease
• Warfarin or other medicines (called anticoagulants) used to thin the blood
• Propafenone, flecainide and medicines used to treat irregular heartbeat
• Metoprolol, a beta-blocker used to treat high blood pressure and heart problems
• Pravastatin, used to treat high cholesterol
• Rifampicin, used to treat tuberculosis and leprosy
• Linezolid, an antibiotic
• Tamoxifen, used for the treatment of breast cancer or fertility problems
• Medicines such as cimetidine and omeprazole, used to reduce stomach acid production
  If you are taking or have recently taken any of the medicines listed above and have not yet discussed this with your doctor, return to your doctor and ask what you should do. It may be necessary to adjust your dose or you may need to take a different medicine. Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription.

EUTIMIL with food, drinks and alcohol
Do not drink alcohol while taking EUTIMIL. Alcohol may worsen your symptoms and side effects. Taking EUTIMIL in the morning with food will reduce the likelihood of feeling unwell (nausea).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
In children of mothers who took EUTIMIL during the first months of pregnancy, there have been some reports suggesting an increased risk of birth defects, particularly heart defects.
In the general population, about 1 in 100 children is born with a heart defect.
This rate increases to 2 in 100 children in mothers taking EUTIMIL. You and your doctor can decide whether it is better for you to switch to another treatment or gradually discontinue EUTIMIL during pregnancy. However, depending on the circumstances, your doctor may advise you that it is better for you to continue taking EUTIMIL.
Ensure that your midwife or doctor knows that you are taking EUTIMIL. When medicines such as EUTIMIL are taken during pregnancy, particularly in late pregnancy, they may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the pressure in the blood vessels between the baby’s heart and lungs is too high. If you take EUTIMIL during the last three months of pregnancy, your newborn may also experience other conditions, which usually begin within the first 24 hours after birth. Symptoms include:

• breathing difficulties
• bluish skin colour or being too hot or too cold
• blue lips
• vomiting or feeding problems
• being very tired, inability to sleep or excessive crying
• stiff or floppy muscles
• tremors, agitation or seizures
• exaggerated reflexes.

If your baby shows any of these symptoms at birth, or if you are concerned about your baby’s health, contact your doctor or midwife, who will be able to advise you.
EUTIMIL can pass into breast milk in very small amounts. If you are taking EUTIMIL, return to your doctor and discuss this before starting breastfeeding. You and your doctor can decide whether you can breastfeed while taking EUTIMIL.
Paroxetine has been shown to reduce sperm quality in animal studies. Theoretically, this could affect fertility, but no impact on human fertility has been observed so far.

Driving and using machines
Possible side effects of EUTIMIL include dizziness, confusion, drowsiness or blurred vision. If you experience these side effects, do not drive or operate machinery.

EUTIMIL contains

• This medicine contains a sugar, sorbitol E420. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking EUTIMIL.
• Methyl 4-hydroxybenzoate (E218) and propyl 4-hydroxybenzoate (E216) may cause allergic reactions (including delayed reactions).
• Orange Yellow FCF (E110) is used as a colouring agent and may cause allergic reactions.

3. How to take EUTIMIL

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The usual doses for the different conditions are listed in the table below:

Your doctor will tell you what dose to take when you start taking EUTIMIL. Most
people feel better after a couple of weeks. If you do not start to feel better after this period of
time, talk to your doctor, who will advise you. Your doctor may decide to gradually increase your dose by 5 ml (10 mg
of paroxetine) at a time, up to the maximum daily dose.
Shake the bottle before use.
Take EUTIMIL in the morning with food.
Your doctor will tell you how long you need to take your medicine. This may be for many
months or even longer.
Elderly patients
The maximum dose for patients over 65 years of age is 20 ml (40 mg of paroxetine) per day.
Patients with liver or kidney disease
If you have liver problems or severe kidney disease, your doctor may decide to reduce the dose of EUTIMIL
compared to the usual dose.
If you take more EUTIMIL than you should
Do not take more medicine than your doctor has recommended. If you take more EUTIMIL than you should
(or if someone else has done so), inform your doctor or a hospital immediately. Show them the
pack.
People who have taken an overdose of EUTIMIL may experience one of the symptoms listed in Section 4, Possible
side effects, or one of the following symptoms: fever, uncontrollable muscle stiffness.
If you forget to take EUTIMIL
Take your medicine every day at the same time.
If you forget to take a dose and remember before going to bed, take it immediately.
Continue as usual the next day.
If you only remember during the night or the following day, do not take the missed dose. You may
experience withdrawal effects, but these should disappear once you take the next dose at the usual
time.
Do not take a double dose to make up for a forgotten dose.
What to do if you do not feel better
EUTIMIL does not improve your symptoms immediately – all antidepressants need time
to work.
Some people start to feel better within a couple of weeks, but for others it may take a little longer. Some people taking antidepressants feel worse before they start to feel better. If you do not start to feel better after a couple of weeks, go back to your doctor, who will advise you. Your doctor should arrange to see you again a couple of weeks after starting treatment. Tell your doctor that you have not started to feel better.
If you stop taking EUTIMIL
Do not stop taking EUTIMIL unless your doctor tells you to do so.
When stopping EUTIMIL, your doctor will help you gradually reduce the dose over a number
of weeks or months – this should help reduce the possibility of withdrawal effects. One
way to do this is to gradually reduce your dose of EUTIMIL by 5 ml (10 mg of
paroxetine) per week. Most people find that any withdrawal symptoms from EUTIMIL are mild and disappear on their own within two weeks. For some people, these symptoms may
be more severe or last longer.
If you experience withdrawal effects while stopping the medicine, your doctor may decide
to stop it more slowly. If you have severe withdrawal effects when stopping
EUTIMIL, contact your doctor. Your doctor may ask you to start taking the medicine again and then stop more
slowly.
Even if you experience withdrawal effects, you will still be able to stop EUTIMIL.
Possible withdrawal effects when stopping treatment
Studies show that 3 out of 10 patients notice one or more symptoms when stopping EUTIMIL.
Some withdrawal effects occur more frequently than others when stopping treatment.
Common side effects, which may affect up to 1 in 10 people:

• Dizziness, feeling unsteady or loss of balance
• Prickling sensations, burning sensations and (less commonly) electric shock-like sensations, even in the head, and ringing, buzzing, hissing, or other persistent noises in the ear (tinnitus)
• Sleep disturbances (vivid dreams, nightmares, inability to sleep)
• Feeling anxious
• Headache

Uncommon side effects, which may affect up to 1 in 100 people:

• Feeling unwell (nausea)
• Sweating (including night sweats)
• Feeling restless or agitated
• Tremor
• Feeling confused or disoriented
• Diarrhoea (loose stools)
• Feeling emotional or irritable
• Visual disturbances
• Fast or strong heartbeat (palpitations)

Talk to your doctor if you are concerned about withdrawal effects when stopping EUTIMIL.
If you have any further 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. Side effects are more likely to occur during the first weeks of treatment with EUTIMIL.
Contact your doctor if you experience any of the following side effects during treatment.
You may need to contact your doctor or go directly to hospital.

Uncommon side effects, which may affect up to 1 in 100 people:

• If you have unusual bruising or bleeding, including blood in your vomit or stools, contact your doctor or go directly to hospital.
• If you are unable to urinate, contact your doctor or go directly to hospital.

Rare side effects, which may affect up to 1 in 1,000 people:

• If you have seizures (fits), contact your doctor or go directly to hospital.
• If you feel restless and feel as though you cannot sit or stand still, you may be experiencing a condition called akathisia. Increasing the dose of EUTIMIL may worsen these sensations. If you feel this way, contact your doctor.
• If you feel tired, weak, or confused and have sore, stiff, or uncoordinated muscles, this may be due to low levels of sodium in the blood. If you experience these symptoms, contact your doctor.

Very rare side effects, which may affect up to 1 in 10,000 people:

• Allergic reactions, which may be severe, to EUTIMIL. If you develop a skin rash with red, raised patches, swelling of the eyelids, face, lips, mouth, or tongue, onset of itching, difficulty breathing (shortness of breath) or swallowing, and feel weak or dizzy leading to collapse or loss of consciousness, contact your doctor or go directly to hospital.
• If you have some or all of the following symptoms, you may be experiencing serotonin syndrome or neuroleptic malignant syndrome. Symptoms include: feeling very restless or irritable, confusion, restlessness, feeling hot, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. Severity may increase, leading to loss of consciousness. If you feel this way, contact your doctor.
• Acute glaucoma. If you begin to experience eye pain and blurred vision, contact your doctor.

Frequency not known
Some people have had thoughts of harming themselves or of suicide while taking EUTIMIL or immediately after stopping treatment (see Section 2, What you should know before taking EUTIMIL).
Some people have shown aggression while taking EUTIMIL.
If you experience these side effects, consult your doctor.

Other possible side effects during treatment
Very common side effects, which may affect more than 1 in 10 people:

• Feeling unwell (nausea). Taking the medicine in the morning with food will reduce the likelihood of this occurring.
• Changes in sexual behaviour or sexual function. For example, lack of orgasm and, in men, abnormalities of erection and ejaculation.

Common side effects, which may affect up to 1 in 10 people:

• Increased level of cholesterol in the blood
• Loss of appetite
• Difficulty sleeping (insomnia) or feeling drowsy
• Abnormal dreams (including nightmares)
• Dizziness or tremors
• Headache
• Difficulty concentrating
• Feeling restless
• Unusually weak feeling
• Blurred vision
• Yawning, dry mouth
• Diarrhoea or constipation
• Vomiting
• Weight gain
• Sweating

Uncommon side effects, which may affect up to 1 in 100 people:

• Short-term increase or decrease in blood pressure, which may cause dizziness or fainting when standing up suddenly
• Faster than normal heartbeat
• Lack of movement, stiffness, tremor, or abnormal movements of the mouth and tongue
• Dilated pupils
• Skin rash
• Itching
• Feeling confused
• Hallucinations (strange visions or sounds)
• Inability to urinate (urinary retention) or involuntary and uncontrollable loss of urine (urinary incontinence)
• If you are a diabetic patient, you may notice a loss of control of your blood sugar levels while taking EUTIMIL. Consult your doctor for adjustment of insulin or diabetes medicine dosage.

Rare side effects, which may affect up to 1 in 1,000 people:

• Abnormal milk production from the breasts in men and women
• Slower heartbeat
• Liver effects detectable by liver function blood tests
• Panic attacks
• Hyperactive behaviour and thoughts (mania)
• Feeling detached from oneself (depersonalization)
• Feeling anxious
• Irresistible urge to move the legs (Restless Legs Syndrome)
• Joint or muscle pain
• Increased blood levels of a hormone called prolactin
• Menstrual cycle disorders (including heavy or irregular periods, bleeding between periods, or absence or delay of periods)

Very rare side effects, which may affect up to 1 in 10,000 people:

• Skin rash, which may appear as blisters and resemble small targets (dark central spots surrounded by a paler area, with a dark ring around the edge), known as erythema multiforme
• Widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• Widespread skin rash with blisters and peeling of the skin over most of the body surface (toxic epidermal necrolysis)
• Liver problems causing yellowing of the skin and whites of the eyes
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body retains excess water and has reduced sodium concentration (a salt), as a result of improper chemical signals. Patients with SIADH may become seriously ill or may have no symptoms at all.
• Fluid or water retention, which may cause swelling of the arms or legs
• Sensitivity to sunlight
• Painful erection of the penis that does not go away
• Low platelet count

Frequency not known

• Teeth grinding

Some patients have experienced ringing, buzzing, hissing, whistling, or other persistent noises in the ear (tinnitus) while taking EUTIMIL.
An increased risk of bone fractures has been observed in patients taking this type of medicine.

Reporting of side effects
If you experience any side effect, 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 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 EUTIMIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack, bottle, and carton. The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original bottle.
Discard the contents of the bottle one month after opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What EUTIMIL contains
The active substance is paroxetine (2 mg/ml) as hemihydrate hydrochloride.

• The excipients are: Polacrilin potassium, dispersible cellulose (E460), propylene glycol, glycerol (E422), sorbitol (E420), methyl 4-hydroxybenzoate (E218), propyl 4-hydroxybenzoate (E216), disodium citrate dihydrate (E331), anhydrous citric acid (E330), sodium saccharin (E954), natural orange flavour, natural lemon flavour, orange yellow FCF dye (E110), simethicone emulsion, purified water.

Description of the appearance of EUTIMIL and contents of the pack
EUTIMIL 2 mg/ml oral suspension is an orange-coloured liquid with an orange odour and a sweet taste. It is available in 150 ml bottles with a dosing cup.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – 37135 Verona, Italy
Manufacturers:
Farmaclair - Hérouville-Saint-Clair (France)
Aspen Bad Oldesloe GmbH - Bad Oldesloe (Germany)
This medicinal product is authorised in the European Economic Area Member States under the following
names:
Authorisation Number 567/03:
Italy Eutimil
Netherlands Paroxetine GSK suspension 2 mg/ml
You may find it helpful to contact a support group or patient association to learn more about your condition. Your doctor can provide further details.