Ecutin

Package leaflet: Information for the user

Ecutin 10 mg/ml, oral drops, solution

Paroxetine
Equivalent 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ecutin is and what it is used for

Ecutin contains the active substance paroxetine, an antidepressant which belongs to a group of medicines called "selective serotonin reuptake inhibitors" (SSRIs). Everyone has a substance in the brain called serotonin. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Ecutin and other SSRIs work, but they may help by increasing the level of serotonin in the brain.

Other medicines and psychotherapy can also treat depression and anxiety. Appropriate treatment of depression and anxiety disorders is important to help you feel better. If left untreated, your condition may not improve and could become more severe and harder to treat. You may find it helpful to talk to a friend or relative about your depression or anxiety disorder, and you may ask them to read this leaflet. You could ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour.

Ecutin is used in adults for the treatment of:

• Depression (major depressive episode)
• Obsessive-compulsive disorder
• Panic disorder with or without agoraphobia
• Social anxiety disorder/social phobia (intense fear of any everyday social situation)
• Generalised anxiety disorder
• Post-traumatic stress disorder

Speak to your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Ecutin

Do not take Ecutin

• If you are currently taking other medicines known as monoamine oxidase inhibitors (MAOIs, including moclobemide), or have taken them within the last two weeks. Your doctor will advise you on how to start taking Ecutin after stopping the MAOI.
• If you are taking an antipsychotic medicine 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 apply to you, speak with your doctor before taking Ecutin.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ecutin
If you are taking other medicines (see “Other medicines and Ecutin”). If you have eye, kidney, liver, or heart problems.
If you are taking tamoxifen for the treatment of breast cancer or fertility issues, Ecutin may reduce the effectiveness of tamoxifen; therefore, your doctor may recommend taking another antidepressant.
If you have epilepsy or have had seizures or convulsions.
If you have episodes of mania (manic thoughts or behaviors).
If you are undergoing electroconvulsive therapy (ECT).
If you have previously experienced bleeding or are taking other medicines that may increase the risk of bleeding (including blood-thinning medicines such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, pain and anti-inflammatory medicines known as non-steroidal anti-inflammatory drugs or NSAIDs, such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam).
If you have diabetes.
If you are on a low-sodium diet.
If you have glaucoma (increased eye pressure).
If you are pregnant or planning a pregnancy (see inside this leaflet Pregnancy, breastfeeding and fertility).
If you are under 18 years of age.
Medicines such as Ecutin (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
If you answer 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 Ecutin.
Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or have anxiety disorders, you may occasionally experience self-harming or suicidal thoughts. These may increase when starting antidepressant treatment for the first time, as these medicines take time to work—usually about two weeks, but sometimes longer.
You may be more prone to such thoughts:
If you have previously had suicidal or self-harming thoughts.
If you are a young adult. Adults under 25 years of age with psychiatric disorders treated with an antidepressant have shown an increased risk of suicidal behavior. If at any time you experience suicidal or self-harming thoughts, contact your doctor
or go to hospital immediately.
You may find it helpful to talk to a friend or relative about your depression or anxiety disorder
and you may ask them to read this leaflet. You could ask them to inform you if they notice your depression or anxiety worsening or if they are concerned about changes in your behavior.
If you develop restlessness, agitation, or inability to sit still or stand still, usually associated with personal discomfort. This is more likely to occur during the first few weeks of treatment. If you develop these symptoms, increasing the dose may be harmful.
If you develop a specific syndrome called serotonin syndrome/neuroleptic malignant syndrome, which presents as a combination of symptoms such as increased body temperature, muscle rigidity, sudden muscle contractions (myoclonus), fluctuation in vital signs, and changes in mental status including confusion, irritability, extreme restlessness progressing to delirium and coma. These syndromes may lead to potentially life-threatening conditions; if such events occur, paroxetine must be discontinued and symptomatic supportive treatment should be initiated.
If you develop manic behavior. In this case, treatment must be discontinued.
If you develop liver or kidney problems, your doctor may need to adjust the dosage.
If you have diabetes.
If you have or have ever had high pressure in the eye (glaucoma).
If you are elderly, taking other medicines, or have liver problems, as this may reduce sodium levels in the blood (hyponatremia).
If you have an increased tendency to bleed. Caution is advised if you are concurrently taking oral anticoagulants, e.g., medicines known to affect platelet function, or other medicines that may increase the risk of bleeding (such as atypical antipsychotics like clozapine, phenothiazines, most tricyclic antidepressants, acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors) and if you have a clinical history of bleeding disorders or conditions that may cause bleeding.
If you wish to discontinue treatment with paroxetine. You may experience withdrawal symptoms, especially if treatment is stopped abruptly (see section “If you stop taking Ecutin”).
If any of these apply to you, speak with your doctor.
Children and adolescents
Ecutin is not recommended for children and adolescents.
Paroxetine should not be used in children and adolescents under 18 years of age, as they are more likely to develop suicidal behavior (suicide attempts and suicidal ideation) and hostility (mainly aggression, oppositional behavior, and anger). If, based on medical need, a decision is made to prescribe treatment, the patient must be closely monitored for the emergence of suicidal symptoms.
Other medicines and Ecutin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Other medicines may affect the action of Ecutin or make side effects more likely. Ecutin may also interfere with the action of other medicines.
These include:
Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide). See section “Do not take Ecutin”.
Thioridazine or pimozide, which are antipsychotic medicines. See section “Do not take Ecutin” in this leaflet.
Acetylsalicylic acid, ibuprofen, and other medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) such as celecoxib, etodolac, diclofenac, meloxicam, and rofecoxib, used for pain and inflammation.
The painkillers tramadol and pethidine.
Medicines called triptans such as sumatriptan, used to treat migraine.
Other antidepressants, including other SSRIs, tryptophan, and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
Medicines containing buprenorphine.
A dietary supplement called tryptophan.
Mivacurium and succinylcholine (used in anesthesia).
Medicines such as lithium, risperidone, perphenazine, pimozide (called antipsychotics or neuroleptics) used to treat certain psychiatric disorders.
Fentanyl, used in anesthesia or for chronic pain treatment.
A combination of fosamprenavir and ritonavir, used to treat Human Immunodeficiency Virus (HIV) infection.
St. John’s wort, a herbal remedy for depression.
Phenobarbital, phenytoin, carbamazepine used to treat seizures or epilepsy.
Atomoxetine used to treat attention deficit hyperactivity disorder (ADHD).
Procyclidine, used to relieve tremors, especially in Parkinson’s disease.
Warfarin or other medicines (called anticoagulants) used to thin the blood.
Propafenone, flecainide, and medicines used for irregular heartbeat.
Metoprolol, a beta-blocker used to treat high blood pressure and other heart problems.
Pravastatin, used to treat high cholesterol levels.
Rifampicin used to treat tuberculosis (TB) and leprosy.
Linezolid, an antibiotic.
Tamoxifen, used to treat breast cancer or fertility problems.
If you are taking or have recently taken any medicine from this list, and have not yet discussed it with your doctor, return to your doctor and ask what you should do. It may be necessary to adjust the dose or change the medicine.
Ecutin with food and drink
Do not drink alcohol while taking Ecutin. Alcohol may worsen your symptoms or side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
In newborns whose mothers took Ecutin during the first months of pregnancy, there has been evidence of an increased risk of birth defects, particularly heart defects. You and your doctor will decide whether it is best for you to gradually discontinue Ecutin during pregnancy. However, based on your clinical condition, your doctor may advise that it is better to continue taking Ecutin.
Ensure that your midwife or doctor knows you are taking Ecutin. When medicines such as Ecutin are taken during pregnancy, especially during the last three months of pregnancy, they may increase the risk in the baby of a serious condition called persistent pulmonary hypertension in the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the newborn’s heart and lungs is too high. If you take Ecutin during the last three months of pregnancy, your baby may also experience other symptoms, which usually appear within the first 24 hours after birth.
These symptoms include:
breathing difficulties
bluish, too hot, or too cold skin
blue lips
vomiting or feeding difficulties
lethargy, inability to sleep, or excessive crying
stiff or floppy muscles
tremors, nervousness, or seizures.
If your baby shows any of these symptoms at birth or you are concerned about your baby’s health, contact your doctor or midwife who will advise you.
Pregnancy
If you take Ecutin close to the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders. Inform your doctor or midwife that you are taking Ecutin so they can advise you on what to do.
Breastfeeding
Ecutin may pass into breast milk in very small amounts. If you are taking Ecutin, return to your doctor and discuss it before starting breastfeeding. You and your doctor can decide whether you may breastfeed while taking Ecutin.
Fertility
Paroxetine has been shown to reduce sperm quality. Although the impact on fertility is unknown, fertility may be impaired in some men while taking Ecutin.
Driving and using machines
Possible side effects of Ecutin include dizziness, confusion, or blurred vision. If you experience these side effects, do not drive and do not operate machinery.
Ecutin contains benzoic acid
Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to take Ecutin

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Take Ecutin drops, diluted in water, in the morning with breakfast.
Take the drops with 100 ml of plain water, then rinse the glass with another 100 ml of plain water and drink it within one minute.
Your doctor will tell you the dose to take when you first start using Ecutin.
Most people start to feel better after a couple of weeks. If you do not start to feel better after this time, inform your doctor, who may decide to gradually increase the dose up to the maximum allowed daily dose.
The recommended doses for different indications are listed below:

Your doctor will inform you about the daily dose and how long you should take the
medicinal product. This may be for several months or longer.

Use in children and adolescents
Ecutin must not be used in children and adolescents under 18 years of age, as efficacy has not been
demonstrated in these age groups. Furthermore, patients under 18 years of age who take Ecutin have an increased risk of undesirable effects such as suicidal thoughts and self-harming behaviours. If your doctor has prescribed Ecutin for you (or for your child) and you wish to discuss this, please consult your doctor again.

Elderly
The maximum recommended dose for people over 65 years of age is 4 ml per day.

Patients with liver or kidney disorders
If you have liver or kidney problems, your doctor may decide to adjust the dose of Ecutin compared to the usual dose.

If you take more Ecutin than you should
Do not take more Ecutin than recommended by your doctor.
If you take more Ecutin than prescribed, you may experience the symptoms listed in Section 4, Possible undesirable effects, or develop one of the following symptoms: vomiting, dilated pupils, fever, changes in blood pressure, headache, involuntary muscle contractions, agitation, anxiety, and abnormally rapid heartbeat.
If you take more Ecutin than you should (or if someone else does), inform your doctor or go immediately to hospital, taking the medicine bottle with you.

If you stop taking Ecutin
Do not stop treatment with Ecutin unless your doctor tells you to do so.
When stopping treatment with Ecutin, your doctor will help you gradually reduce the dose over several weeks or months—this will help reduce the likelihood of withdrawal effects. One way to do this is to gradually reduce your daily dose of Ecutin by 10 mg per week.
Most people find that Ecutin withdrawal symptoms are mild and disappear spontaneously within two weeks. For some people, these symptoms may be more severe or last longer.

If you experience withdrawal effects when stopping the drops, your doctor may decide to discontinue the medicine more slowly. If you experience severe withdrawal effects when stopping Ecutin, contact your doctor. Your doctor may advise you to restart the medicine and then stop treatment more gradually.
Despite withdrawal effects, you will still be able to discontinue Ecutin. For a complete list of possible undesirable effects during discontinuation of this medicine, see section 4: “Possible undesirable effects”.

Possible withdrawal effects when stopping treatment
Common (may affect up to 1 in 10 people)
Dizziness, feeling unsteady or loss of balance.
Tingling, burning sensation, and (less commonly) electric shock-like sensations, including in the head, and ringing, buzzing, hissing, or other persistent noises in the ears (tinnitus).
Sleep disturbances (vivid dreams, nightmares, difficulty falling asleep).
Anxiety.
Headache.

Uncommon (may affect up to 1 in 100 people)
Feeling unwell (nausea).
Sweating (including night sweats).
Restlessness or agitation.
Tremors.
Confusion or disorientation.
Diarrhoea (loose stools).
Emotional lability or irritability.
Visual disturbances.
Rapid heartbeat (palpitations).

Inform your doctor if you are concerned about these withdrawal effects when stopping
treatment with Ecutin.

What to do if you do not feel better
Ecutin will not improve your symptoms immediately—antidepressants all require time to take effect.
Some people start to feel better within a couple of weeks, while others need more time. Some people taking antidepressants may feel worse before they start to improve. If you do not feel better after a couple of weeks, contact your doctor, who will advise you.
Your doctor should review you a few weeks after you have started treatment. Inform your doctor if you do not feel better.
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 everybody gets them.
Side effects are more likely to occur during the first weeks of treatment with Ecutin.
Contact your doctor if you experience any of the following side effects during treatment:
You may need to contact your doctor or go to hospital immediately.
Allergic reactions to Ecutin, which can be serious.
Very rare (may affect up to 1 in 10,000 people)
If you develop skin rashes with redness and nodules, swelling of the eyelids, face, lips, mouth or tongue, onset of itching, or have difficulty breathing (shortness of breath) or swallowing, and if you feel weak or experience dizziness leading to collapse or loss of consciousness, contact your doctor or go to hospital immediately.
Syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Uncommon (may affect up to 1 in 100 people)
If you experience unusual bruising or bleeding, including blood in vomit or stools, contact your doctor or go to hospital immediately.
If you have difficulty urinating, contact your doctor or go to hospital immediately.
Rare (may affect up to 1 in 1,000 people)
If you have seizures (epileptic fits), contact your doctor or go to hospital immediately.
If you feel restless or unable to sit still, you may be experiencing a condition called akathisia. Increasing your dose of Ecutin could worsen these symptoms. If you feel this way, contact your doctor.
If you feel tired, weak or confused and have muscle pain, stiffness or incoordination, this may be due to a rare effect of Ecutin that can lead to low sodium levels in your blood. If you have these symptoms, contact your doctor.
Very rare (may affect up to 1 in 10,000 people)
Allergic reactions to Ecutin, which can be serious. If you develop skin rashes with redness and nodules, swelling of the eyelids, face, lips, mouth or tongue, onset of itching, or have difficulty breathing (shortness of breath) or swallowing, and if you feel weak or experience dizziness leading to collapse or loss of consciousness, contact your doctor or go to hospital immediately.
If you have some or all of the following symptoms, you may be experiencing what is called serotonin syndrome or neuroleptic malignant syndrome. Symptoms include: feeling confused, restless, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle rigidity, sudden muscle contractions, or rapid heartbeat.
Acute glaucoma.
If your eyes become painful and you experience blurred vision, contact your doctor.
Gastrointestinal bleeding.
Other possible side effects of lesser severity that may occur during treatment
Very common (may affect more than 1 in 10 people)
Feeling unwell (nausea). Taking the medicine in the morning with breakfast will reduce the likelihood of these symptoms occurring.
Changes in sexual habits or sexual function. For example, lack of orgasm and, in men, abnormal erection and ejaculation.
Common (may affect up to 1 in 10 people)
Increased blood cholesterol levels.
Loss of appetite.
Sleep disturbances (insomnia) or drowsiness.
Abnormal dreams (including nightmares).
Dizziness or shaking (tremors).
Headache.
Difficulty concentrating.
Feeling agitated.
Feeling weak.
Blurred vision.
Yawning, dry mouth.
Diarrhoea or constipation.
Vomiting.
Weight gain.
Sweating.
Uncommon (may affect up to 1 in 100 people)
Transient increase or decrease in blood pressure, with dizziness or fainting when standing up suddenly.
Impaired control of blood sugar levels in diabetic patients.
Extrapyramidal disorders (movement disorders).
Faster than normal heartbeat.
Inability to move, stiffness, shaking, or abnormal movements of the mouth and tongue.
Dilated pupils.
Skin rashes, itching.
Feeling confused.
Hallucinations (strange visions and sounds).
Inability to urinate (urinary retention) or uncontrolled and involuntary loss of urine (urinary incontinence).
Reduced number of white blood cells.
Rare (may affect up to 1 in 1,000 people)
Abnormal milk production in the mammary glands of men and women.
Menstrual cycle disturbances (including menorrhagia, metrorrhagia, amenorrhoea, delayed menstruation and irregular periods).
Slower heartbeat.
Panic attacks.
Hyperactive behaviour or thoughts (mania).
Effects on the liver indicated by specific blood tests for liver function.
Feeling detached from oneself (depersonalization).
Feeling anxious.
Increased levels in the blood of a hormone called prolactin.
Irresistible urge to move the legs (Restless Legs Syndrome).
Joint or muscle pain.
Very rare (may affect up to 1 in 10,000 people)
Skin rash, which may present with blisters and resemble small targets (dark central spots surrounded by a lighter 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 a large part of the body (toxic epidermal necrolysis).
Severe skin reactions.
Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body accumulates excess water and has reduced sodium (salt) concentration due to improper chemical signals. Patients with SIADH may become seriously ill or may have no symptoms at all.
Low platelet count in the blood.
Liver problems causing yellowing of the skin or whites of the eyes.
Fluid or water retention that may cause swelling of the arms or legs.
Effects on the liver indicated by specific blood tests for liver function.
Sensitivity to sunlight.
Prolonged and painful erection of the penis.
Unexpected bleeding, for example bleeding gums, blood in urine or vomit, or unexpected bruising or blood vessel rupture (vein rupture).
Frequency not known (frequency cannot be estimated from the available data)
Suicidal ideation, suicidal behaviour and aggression.
Inflammation of the colon (causing diarrhoea).
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 “Pregnancy, breastfeeding and fertility” for further information.
Teeth grinding.
Some patients have developed ringing, buzzing, hissing, whistling or other persistent noises in the ear (tinnitus) when taking Ecutin.
An increased risk of bone fractures has been observed in patients taking this type of medicine.
If you have any concerns while taking Ecutin, speak with your doctor and/or pharmacist, who will be able to advise you.
Additional side effects in children and adolescents:
Common (may affect up to 1 in 10 people)
Increased suicidal thoughts and suicide attempts.
Deliberate self-harm.
Hostile, aggressive or withdrawn behaviour.
Loss of appetite.
Tremor.
Abnormal sweating.
Hyperactivity (excessive energy).
Agitation.
Changes in emotions (including crying and mood changes).
Unusual bruising or bleeding (such as nosebleeds).
Withdrawal effects similar to those observed in adults after stopping treatment with Ecutin.
Stomach ache.
Feeling nervous and changes in emotions (including crying and mood changes, attempts of self-harm, suicidal thoughts and suicide attempts).
Reporting of side effects
If you experience any side effects, 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 Ecutin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and on the carton after "Exp".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Store in the original packaging.
Period of validity after first opening of the vial: 2 months.
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 Ecutin contains

• The active substance is paroxetine (10 mg/ml) as paroxetine hydrochloride hemihydrate. Each ml of liquid (1 ml corresponds to 14 drops) contains 10 mg of paroxetine.
• The other components are: povidone K30, benzoic acid E210, sucralose, curcumin 8% (E100), natural orange/lemon flavour, purified water.

Description of the appearance of Ecutin and contents of the pack
Ecutin 10 mg/ml is a clear yellow liquid.
It is available in a 60 ml amber glass bottle with a tamper-evident screw cap, child-resistant closure and dropper.

Marketing Authorization Holder
Ecupharma S.r.l.
Via G. Mazzini 20
20123 Milan
Italy

Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48
20089 Quinto de’ Stampi – Rozzano
(Milan) – Italy
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)
Italy
Vamfarma S.r.l.
Via Kennedy 5,
26833 Comazzo (LO)
Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Ecutin