Package leaflet: Information for the user

Daparox 20 mg film-coated tablets

paroxetine (as mesylate)
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, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Daparox is and what it is used for

Paroxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs), which are antidepressant drugs.
Daparox is used to treat:

Depression (major depressive episode)
Obsessive-compulsive disorder (obsessive repetition of thoughts and/or actions)
Panic disorder with or without agoraphobia (e.g. intense fear of leaving home, entering shops, or fear of public places)
Social anxiety disorder/social phobia (intense fear or desire to avoid everyday social situations)
Generalized anxiety disorder (generalized feeling of intense anxiety or excessive nervousness)
Post-traumatic stress disorder (anxiety state related to reliving a traumatic event).

2. What you need to know before taking Daparox

Do not take Daparox:

If you are allergic to paroxetine or to any of the other ingredients of this medicine (listed in section 6).
If you are taking certain medicines used to treat depression or Parkinson’s disease (known as monoamine oxidase inhibitors (MAOIs)).

You may start taking paroxetine only if at least 14 days
have passed since stopping treatment with irreversible MAOIs (such as isocarboxazide and
phenelzine).
If you are taking a reversible MAOI (such as moclobemide, linezolid, methylene blue
(methylthioninium chloride)), you must wait at least 24 hours before starting to take
paroxetine.
Conversely, you must wait at least 7 days after stopping paroxetine before starting to take an MAOI.

If you are taking a specific medicine (thioridazine) used to treat severe mental illnesses, such as psychosis (see also section 2, “Other medicines and Daparox”).
If you are taking a specific antipsychotic medicine (pimozide) (see section 2, “Other medicines and Daparox”).

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

If you are taking certain medicines used to treat severe depression or Parkinson’s disease (MAOIs). You must not take paroxetine at the same time. Your doctor will advise you when to start treatment with paroxetine after stopping these MAOIs (see section 2, “Do not take Daparox” and section 2, “Other medicines and Daparox”).
If you experience restlessness, hyperactivity, or inability to sit still (akathisia). This is more likely to occur within the first few weeks of treatment. If you develop such symptoms, contact your doctor promptly. Increasing the dose may be harmful in such cases.
If you develop a specific syndrome (serotonin syndrome). This syndrome is characterized by a combination of symptoms such as: (extreme) agitation, confusion, irritability, hallucinations (seeing things that are not real), sweating, tremors or shivering, exaggerated reflexes, sudden onset of muscle spasms (myoclonus), increased body temperature, or stiffness. If you experience several of these symptoms simultaneously, contact your doctor immediately and stop treatment with paroxetine.
If you have experienced episodes of extreme euphoria or over-excitement leading to unusual behaviour (mania). If a manic episode occurs, treatment with paroxetine should be discontinued.
If you have liver or severe kidney problems. Your doctor may need to adjust your dose.
If you have cardiovascular disease.
If you have an abnormality in your electrocardiogram (ECG) known as prolonged QT interval.
If you have a family history of QT prolongation, heart conditions such as heart failure, slow heart rate, or low levels of potassium or magnesium.
If you have diabetes. Treatment with paroxetine may alter blood glucose levels, requiring close monitoring. It may be necessary to adjust the dose of insulin and/or other oral antidiabetic medicines.
If you suffer or have previously suffered from epilepsy or seizures. Paroxetine may provoke seizures, so your doctor should exercise particular caution. If you experience seizures, contact your doctor immediately. Discontinuation of paroxetine may be necessary.
If you are undergoing electroconvulsive therapy (ECT). Clinical experience with concomitant administration of paroxetine and ECT is limited, so particular caution is required.
If you suffer or have suffered from elevated intraocular pressure (glaucoma). Paroxetine may cause excessive dilation of the pupils (mydriasis), potentially increasing pressure within the eye. Your doctor should exercise particular caution.
If you are an elderly patient, are taking other medicines, or have liver problems (cirrhosis), as you may be at increased risk of low blood sodium levels. Paroxetine may reduce blood sodium levels, leading to weakness and fatigue. If this occurs, consult your doctor.
If you experience increased tendency to bleeding or are taking medicines that may increase the risk of bleeding, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”). Paroxetine may cause abnormal bleeding, so your doctor should exercise particular caution (see section 2, “Other medicines and Daparox”).
If you wish to stop taking paroxetine. You may experience withdrawal symptoms, especially if stopping abruptly (see section 3, “If you stop taking Daparox”). Consult your doctor before stopping treatment with paroxetine.
Suicidal thoughts and worsening of depression or anxiety disorder. If you are depressed and/or suffer from anxiety disorders, you may occasionally have thoughts of harming yourself or of suicide. These thoughts may be more common when you first start taking antidepressants, as these medicines take time to work—usually about two weeks, but sometimes longer.

You are more likely to have such thoughts if:

You have previously had thoughts of suicide or self-harm
You are a young adult. Clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with antidepressants.

If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go directly to hospital.
You may find it helpful to tell a friend or relative that you suffer from depression or an anxiety disorder and ask them to read this leaflet. You may ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.
Medicines such as Daparox (so-called selective serotonin reuptake inhibitors (SSRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.

Children and adolescents
Paroxetine should normally not be taken by children and adolescents under 18 years of age. It is also important to know that, when taking this class of medicines, patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, oppositional behaviour, and anger). Nevertheless, your doctor may prescribe paroxetine to patients under 18 years of age if they consider it strictly necessary. If your doctor has prescribed paroxetine to a patient under 18 years of age and you wish to obtain further information, please contact your doctor again.
You should inform your doctor if any of the above symptoms appear or worsen during paroxetine treatment in a patient under 18 years of age.
Furthermore, the long-term effects of paroxetine on growth, maturation, and cognitive and behavioural development have not yet been established.

Other medicines and Daparox
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Other medicines may be affected by paroxetine, or may affect the action of paroxetine. Paroxetine may interact with:

Medicines used to treat depression or Parkinson’s disease (MAOIs such as moclobemide or isocarboxazide), certain dietary supplements (L-tryptophan), some medicines used to treat migraine (triptans, such as sumatriptan, almotriptan), certain analgesics (tramadol, buprenorphine, pethidine), medicines used to treat infections (linezolid), a preoperative contrast agent (methylene blue), other selective serotonin reuptake inhibitors (SSRIs, such as fluoxetine, sertraline), certain medicines used to treat psychiatric conditions (lithium, risperidone), a specific medicine used to treat chronic pain or for anaesthesia (fentanyl), and St John’s wort (Hypericum perforatum), a herbal remedy for depression. Concomitant use of these medicines may lead to the development of serotonin syndrome (see section 2, “Do not take Daparox” and “Warnings and precautions”).
Buprenorphine combined with naloxone in opioid dependence replacement therapy.
Certain medicines used to treat psychosis (pimozide). Studies investigating the concomitant use of paroxetine and pimozide have shown that paroxetine may increase blood levels of pimozide. Since pimozide may cause serious adverse effects, such as irregular heartbeat, you must not take paroxetine together with pimozide (see section 2, “Do not take Daparox”).
Enzyme inhibitors, such as medicines used to treat depression (clomipramine). Your doctor may decide to prescribe a lower than usual dose. If you are to take paroxetine together with enzyme inducers (such as carbamazepine, rifampicin, phenobarbital, and phenytoin), a lower starting dose is usually not required, and your doctor will adjust subsequent doses based on the drug’s effects.
Muscle relaxants used in anaesthesia such as mivacurium and suxamethonium may have their muscle-relaxing effects prolonged due to interaction with paroxetine.
The combination of certain medicines used to treat Human Immunodeficiency Virus (HIV) infection (fosamprenavir and ritonavir).
A specific medicine used to treat Parkinson’s disease (procyclidine). The effectiveness and adverse effects of procyclidine may be enhanced. If you experience adverse effects such as dry mouth, blurred vision, constipation, or difficulty emptying the bladder (urinary retention), you may need to consult your doctor for possible dose reduction of procyclidine.
Certain medicines used to treat epilepsy (anticonvulsants, such as sodium valproate). Although no direct effect has been demonstrated, your doctor should exercise particular caution when prescribing paroxetine to epileptic patients.
Medicines that are metabolized by the same liver enzymes as paroxetine. Examples include: certain medicines used to treat depression (tricyclic antidepressants, such as nortriptyline and desipramine), certain medicines used to treat severe mental illnesses such as psychosis (perphenazine, thioridazine, and risperidone), a medicine used to treat ADHD in children (atomoxetine), certain medicines used to treat irregular heartbeat (such as flecainide and propafenone), a medicine used to treat chest pain (angina pectoris) and high blood pressure (metoprolol), a medicine used to treat high cholesterol (pravastatin), and certain medicines used to treat severe mental illness or nausea and vomiting (phenothiazines). The effectiveness and adverse effects of these medicines may be enhanced.
Paroxetine and thioridazine must not be taken together due to the risk of serious adverse effects such as cardiac arrhythmias and sudden death (see section 2, “Do not take Daparox”).
Certain medicines used to prevent blood clotting (anticoagulants, such as acenocoumarol, phenprocoumon). The effectiveness and adverse effects of these medicines may be enhanced, increasing the risk of bleeding. Your doctor will need to monitor you more closely and may need to adjust the dose of anticoagulants (see section 2, “Warnings and precautions”).
A specific medicine used to treat breast cancer or fertility problems (tamoxifen).
Medicines that increase the risk of bleeding. Examples include: certain medicines used to treat severe mental illness or nausea and vomiting (phenothiazines, such as chlorpromazine, perphenazine), a medicine used to treat schizophrenia (clozapine), certain medicines used to treat depression (tricyclic antidepressants), acetylsalicylic acid, medicines that relieve pain and inflammation (NSAIDs, such as ibuprofen or COX-2 inhibitors, such as rofecoxib, celecoxib) (see section 2, “Warnings and precautions”).
Certain medicines used to reduce stomach acid (such as cimetidine or omeprazole).

Daparox with food, drinks and alcohol
Concomitant intake of alcohol and paroxetine should be avoided.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or if you are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. There are insufficient data to determine the safety and efficacy of paroxetine use during pregnancy. Some studies have suggested an increased risk of heart defects in children whose mothers took paroxetine during the first months of pregnancy. In consultation with your doctor, you may decide that it would be best to switch to another treatment or gradually discontinue paroxetine during pregnancy. However, depending on your condition, your doctor may recommend continuing paroxetine as the most appropriate option for you.
Make sure to inform your midwife and/or doctor that you are taking paroxetine. If you take Daparox 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 Daparox so they can advise you on what to do.
When medicines like paroxetine are taken during pregnancy, especially in late pregnancy, newborns may have an increased risk of persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe rapidly and appear cyanotic. This symptom usually appears within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.
If you have taken paroxetine during the last 3 months of pregnancy, the newborn may show other symptoms, usually within the first 24 hours after birth.
Symptoms include difficulty sleeping or feeding, breathing difficulties, cyanosis, unstable body temperature, nausea (vomiting), constant crying, muscle stiffness or weakness, lethargy, tremors, restlessness, or seizures. If your baby shows any of these symptoms at birth and you are concerned, seek advice from your doctor or midwife.
Paroxetine is excreted in breast milk in small amounts. If you are taking paroxetine, consult your doctor before starting breastfeeding. In consultation with your doctor, you may decide that breastfeeding is possible while taking paroxetine.
In animal studies, paroxetine has been shown to reduce sperm quality. In theory, this could affect fertility, but no effect on human fertility has been observed so far.

Driving and using machines
There is no evidence that paroxetine affects the ability to drive or operate machinery. However, this medicine may cause adverse effects (such as blurred vision, dizziness, drowsiness, or confusion). If you experience any of these adverse effects, do not drive, operate machinery, or perform any other activity requiring attention and concentration. This means you should observe your reaction to paroxetine before engaging in such activities.

Daparox contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Daparox

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Paroxetine should preferably be taken in the morning with food. Swallow the tablets whole, without chewing.
The tablet may be divided into equal parts.

Recommended dose:
Major depressive episode
The recommended starting dose is one tablet (20 mg of paroxetine) once daily. Improvement generally begins after one week, but may become evident later (e.g. in the second week). If the response is inadequate, your doctor may decide to increase the dose gradually by increments of ½ tablet (10 mg of paroxetine), up to a maximum of 2½ tablets (50 mg of paroxetina) daily. Your doctor will decide the duration of treatment, which may last for more than 6 months.

Obsessive-compulsive disorder (OCD)
The recommended dose is 2 tablets (40 mg of paroxetine) daily, with a starting dose of 1 tablet (20 mg of paroxetine) daily. If the response is inadequate, your doctor may decide to gradually increase the dose by increments of ½ tablet (10 mg of paroxetine), up to a maximum of 3 tablets (60 mg of paroxetine) daily. Your doctor will decide how long treatment should continue. Treatment duration may extend for several months or longer.

Panic disorder with or without agoraphobia
The recommended dose is 2 tablets (40 mg of paroxetine) daily, with a starting dose of ½ tablet (10 mg of paroxetine) daily. If the response is inadequate, your doctor may decide to gradually increase the dose by increments of ½ tablet (10 mg of paroxetine), up to a maximum of 3 tablets (60 mg of paroxetine) daily. A low initial dose is recommended to avoid potential worsening of panic symptoms at the beginning of treatment. Your doctor will decide how long you need to continue taking the tablets. Treatment duration may extend for several months or longer.

Social anxiety disorder/social phobia
The recommended dose is 1 tablet (20 mg of paroxetine) daily. If the response is inadequate, your doctor may decide to gradually increase the dose by increments of ½ tablet (10 mg of paroxetine), up to a maximum of 2½ tablets (50 mg of paroxetine) daily. Your doctor will decide how long you need to continue taking the tablets. Treatment may last for a long period, during which you will be periodically reassessed.

Generalised anxiety disorder
The recommended dose is 1 tablet (20 mg of paroxetine) daily. If the response is inadequate, your doctor may decide to gradually increase the dose by increments of ½ tablet (10 mg of paroxetine), up to a maximum of 2½ tablets (50 mg of paroxetine) daily. Your doctor will decide how long you need to continue taking the tablets. Treatment may last for a long period, during which you will be periodically reassessed.

Post-traumatic stress disorder
The recommended dose is 1 tablet (20 mg of paroxetine) daily. If the response is inadequate, your doctor may decide to gradually increase the dose by increments of ½ tablet (10 mg of paroxetine), up to a maximum of 2½ tablets (50 mg of paroxetine) daily. Your doctor will decide how long you need to continue taking the tablets. Treatment may last for a long period, during which you will be periodically reassessed.

Elderly patients
The recommended starting dose for elderly patients is the same as the initial dose used in adults; however, the maximum dose must not exceed 2 tablets (40 mg of paroxetine) daily.

Use in children and adolescents
Paroxetine must not be taken by children and adolescents under 18 years of age (see section 2, "Children and adolescents").

Patients with impaired hepatic or renal function
Dosage adjustment is necessary in case of impaired liver or kidney function.

Duration of treatment
Your doctor will tell you how long you should continue taking paroxetine. Depending on your condition, long-term treatment with paroxetine may be necessary. You should continue taking paroxetine for some time after symptoms have disappeared, to ensure they do not return. Never stop treatment with paroxetine without consulting your doctor. Abruptly stopping paroxetine treatment may cause withdrawal symptoms; therefore, the dose should be gradually reduced (see section 3, "If you stop taking Daparox").

If you take more Daparox than you should
In case of overdose, contact your doctor immediately or go to the nearest hospital. Show this leaflet and any remaining tablets to your doctor. In addition to the known adverse effects (see section 4, "Possible side effects"), you may experience the following symptoms: fever and involuntary muscle contractions.

If you forget to take Daparox
Do not take a double dose of paroxetine to make up for a missed dose. Skip the missed dose and take the next tablet at the usual time. If you have any doubts, consult your doctor.

If you stop taking Daparox
Never stop treatment with Daparox without first consulting your doctor, and never stop treatment abruptly, as this may cause withdrawal symptoms. Symptoms that may occur after stopping paroxetine include: dizziness, sensory disturbances (such as tingling, burning, electric shock sensations, or ringing, buzzing, whistling, or other persistent noises in the ears (tinnitus)), anxiety, tinnitus, sleep disturbances (including vivid dreams or nightmares), and headache. Less common effects include: agitation, nausea, tremor, confusion, sweating, emotional instability, visual disturbances, increased or rapid perception of heartbeat (palpitations), diarrhoea, and irritability (see also section 4, "Possible side effects").
These symptoms usually appear within the first few days after stopping treatment, but may also occur in patients who have missed a dose. Withdrawal symptoms usually resolve within two weeks, but in some patients they may be more severe or persist longer (2–3 months or more). If, in agreement with your doctor, you decide to stop paroxetine treatment, the daily dose should be gradually reduced over several weeks or months (starting with gradual reductions of 10 mg per week). You must always consult your doctor before reducing the dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or go to hospital immediately if you experience any of the
following side effects during treatment.
Uncommon side effects (may affect up to 1 in 100 people)

Abnormal bleeding, particularly skin bruising (ecchymoses) and gynaecological bleeding.

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

Convulsive fits, epileptic seizures (convulsions)
Feeling restless and hyperactive with inability to sit still or remain motionless (akathisia)
Low blood sodium levels (hyponatraemia), mainly in elderly patients.

Very rare side effects (may affect up to 1 in 10,000 people)

Allergic reactions to paroxetine which may be severe, accompanied by itching and painful skin rash (urticaria), or a serious reaction causing swelling of the skin, throat or tongue, breathing difficulties and/or itching (angioedema). If you develop a red, granular skin rash, swelling of the eyelids, face, lips, mouth or tongue, if you feel itchy or have difficulty breathing (shortness of breath) or swallowing, or if you feel weak or dizzy leading to collapse or loss of consciousness
The so-called serotonin syndrome (symptoms of which may include agitation, confusion, sweating, seeing things that are not real (hallucinations), hyperreflexia, sudden onset of muscle spasms (myoclonus), shivering, tremor and increased heart rate (tachycardia))
Sudden increase in intraocular pressure (acute glaucoma).

Not known side effects (frequency cannot be estimated from available data)

Aggression; cases of suicidal thoughts or behaviours have been reported during paroxetine treatment or immediately after stopping treatment. However, this symptomatology may be due to the underlying illness.
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 “Pregnancy, breastfeeding and fertility” for further information.

Other side effects
Very common side effects (may affect more than 1 in 10 people)

Feeling unwell (nausea)
Sexual dysfunction, such as problems with ejaculation, reduced libido, male impotence and inability to achieve orgasm.

Common side effects (may affect up to 1 in 10 people)

Increased blood cholesterol levels, decreased appetite
Drowsiness, inability to sleep (insomnia), agitation, abnormal dreams (including nightmares)
Dizziness, feeling of trembling (tremor), headache, loss of concentration (reduced concentration)
Blurred vision
Yawning
Constipation, diarrhoea, vomiting, dry mouth
Sweating
Weight gain, general feeling of tiredness with loss of muscle strength (asthenia).

Uncommon side effects (may affect up to 1 in 100 people)

Decrease in the number of white blood cells
If you are a diabetic patient, you may experience loss of blood sugar control while taking paroxetine. Consult your doctor for adjustment of insulin or antidiabetic medication dosage.
Confusion, seeing things that are not real (hallucinations)
Involuntary movements of the body or face (extrapyramidal disorders)
Enlargement of the pupils (mydriasis)
Acceleration of heart rate (sinus tachycardia)
Feeling dizzy or faint, especially when rising suddenly from a lying or sitting position (postural hypotension)
Skin rash, itching
Difficulty emptying the bladder (urinary retention) and involuntary, uncontrollable leakage of urine (urinary incontinence).

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

Periods of extreme euphoria or overexcitement leading to unusual behaviour (mania, manic episodes), anxiety, panic attacks, depersonalisation
Irresistible urge to move the legs (restless legs syndrome)
Slowing of heart rate (bradycardia)
Increase in liver enzymes
Muscle pain (myalgia), joint pain (arthralgia)
Increased blood concentration of the hormone prolactin (hyperprolactinaemia), which may cause abnormal milk production (galactorrhoea) in both men and women, and disturbances in menstrual periods (including heavy or irregular menstruation, bleeding between periods, or absence or delay of menstruation).

Very rare side effects (may affect up to 1 in 10,000 people)

Decrease in platelets in the blood, increasing the risk of bleeding or bruising (thrombocytopenia)
Fluid retention and low blood sodium levels as a result of syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Gastrointestinal bleeding
Liver disorders, such as hepatitis, sometimes associated with jaundice and/or liver failure
Serious skin reactions (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), urticaria, photosensitivity reactions
Painful erection (priapism)
Swelling of arms and/or legs (peripheral oedema).

Not known side effects (frequency cannot be estimated from available data)

Teeth grinding (bruxism)
Ringing, buzzing, hissing, whistling, or other persistent noises in the ear (tinnitus)
Inflammation of the colon (causing diarrhoea)

An increased risk of bone fractures has been observed in patients taking this type of medicine.
Withdrawal symptoms observed after stopping paroxetine treatment
Common: dizziness, sensory disturbances, sleep disturbances, anxiety and headache.
Uncommon: agitation, nausea, sweating, tremor, confusion, emotional instability, visual disturbances, palpitations, diarrhoea and irritability.
These events are usually mild and self-limiting. Never stop treatment with paroxetine without first consulting your doctor, and never stop treatment abruptly, as you may experience withdrawal symptoms (see section 3, “If you stop taking Daparox”).
Additional side effects in children and adolescents
When paroxetine was given to children and adolescents under 18 years of age, more than 1 in 100 but less than 1 in 10 children/adolescents experienced one of the following side effects: emotional lability (including crying and mood changes), self-harming behaviour, suicide attempts and suicidal thoughts, hostile or aggressive behaviour, loss of appetite, tremor, abnormal sweating, hyperactivity, agitation, nausea, abdominal pain and nervousness.
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 Daparox

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of 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 Daparox contains

The active substance is paroxetine (as mesilate). One tablet contains paroxetine mesilate equivalent to 20 mg of paroxetine.
The other components are:
Core: dibasic calcium phosphate, sodium carboxymethyl starch (type A), magnesium stearate.
Coating: monohydrate lactose, hypromellose, macrogol 4000, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).

Description of the appearance of Daparox and contents of the pack
Daparox tablets are round, yellow, film-coated tablets, with the code "POT 20" embossed on one side and a break line on both sides.
Daparox 20 mg is available in boxes of 10, 12, 14, 20, 28, 30, 50, 56, 60 or 100 tablets in blisters, and in a container of 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Viale Amelia No. 70
00181 Rome, Italy

Manufacturers:

Synthon BV - Microweg 22 - 6545 CM Nijmegen - Netherlands
Synthon Hispania S.L. - Castello No. 1, Poligono Las Salinas - 08830 Sant Boi de Llobregat - Spain
Sanico NV - Veedijk 59, 2300 Turnhout - Belgium
Lannacher Heilmittel GmbH, Schloßplatz 1, 8502 Lannach, Austria
G.L. Pharma GmbH, Schloßplatz 1, A-8502 Lannach, Austria

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Austria: Ennos 20 mg Filmtabletten
Belgium: Paroxetine EG 20 mg, filmomhulde tabletten
Denmark: Euplix, filmovertrukne tabletter 20 mg
Germany: Euplix 20 mg Filmtabletten
Italy: Daparox 20 mg film-coated tablets
Luxembourg: Paroxetine EG 20 mg comprimés pelliculés
Netherlands: Paroxetine 20 mg, filmomhulde tabletten

Patient Information Leaflet: Information for the User

Please read this leaflet carefully before taking this medicine as it contains
important information for you.

This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful. 2. What you need to know before taking Daparox 3. How to take Daparox 4. Possible side effects 5. How to store Daparox 6. Contents of the pack and other information

1. What Daparox is and what it is used for

Depression (major depressive episode)
Obsessive-compulsive disorder (obsessive thoughts or compulsive actions)
Panic disorder with or without agoraphobia (e.g. intense fear of leaving home, entering shops, or fear of public places)
Social anxiety disorder/social phobia (intense fear or desire to avoid everyday social interaction situations)
Generalized anxiety disorder (constant anxiety, with excessive tension and chronic worry)
Post-traumatic stress disorder (anxiety state related to traumatic events).

2. What you should know before taking Daparox

You may start taking paroxetine only if at least 14 days have passed since stopping the use of irreversible MAOIs (such as isocarboxazid and phenelzine).
If you are taking a reversible MAOI (such as moclobemide, linezolid, methylthioninium chloride (methylene blue)), you must wait at least 24 hours before starting to take paroxetine.
Conversely, you must wait at least 7 days after stopping paroxetine before starting to take an MAOI.
- If you are taking certain medicines used to treat severe depression or Parkinson’s disease (MAOIs), do not take paroxetine at the same time (see section 2, “Do not take Daparox” and section 2, “Other medicines and Daparox”).
- If you experience restlessness, hyperactivity, or inability to sit still or remain motionless (akathisia). This is more likely to occur during the first weeks of treatment. If you develop such symptoms, contact your doctor promptly. Increasing the dose in such cases could be harmful.
- If you develop a specific syndrome (serotonin syndrome). This syndrome is characterized by a combination of symptoms such as: (extreme) agitation, confusion, irritability, seeing things that are not real (hallucinations), sweating, tremors or shivering, exaggerated reflexes, sudden onset of muscle spasms (myoclonus), increased body temperature, or muscle stiffness (see section 2, “Other medicines and Daparox”). If you experience several of these symptoms simultaneously, contact your doctor immediately and discontinue paroxetine treatment.
- If you have experienced episodes of extreme euphoria or over-excitement leading to unusual behavior (mania). Paroxetine may cause a shift from a depressive phase to a manic phase. If a manic episode occurs, treatment with paroxetine must be discontinued.
- If you have liver problems or severe kidney problems. Your doctor may need to adjust your dose.
- If you suffer from cardiovascular diseases.
- If you have a known abnormality in your electrocardiogram (ECG) called prolonged QT interval.
- If you have a family history of QT prolongation, heart conditions such as heart failure, slow heart rate, or low levels of potassium or magnesium.
- If you have diabetes. Treatment with paroxetine may alter your blood sugar (glucose) levels, requiring close monitoring. Adjustment of insulin and/or other oral antidiabetic medications may be necessary.
- If you have had or currently suffer from epilepsy or seizures. Paroxetine may provoke seizures (convulsions), so special attention from your doctor is required. If you experience seizures, contact your doctor immediately. Discontinuation of paroxetine treatment may be necessary.
- If you are undergoing or have undergone electroconvulsive therapy (ECT). Clinical experience with concomitant use of paroxetine and ECT is limited, so particular caution from your doctor is required.
If you suffer or have suffered from elevated intraocular pressure (glaucoma). Paroxetine may cause excessive dilation of the pupils (mydriasis), potentially increasing pressure within the eye. Your doctor should exercise particular caution.
.
If you are an elderly patient, are taking other medicines, or have liver problems (cirrhosis), which put you at higher risk of reduced blood sodium levels. Paroxetine may further lower blood sodium levels, leading to weakness and fatigue. If this occurs, consult your doctor.
If you experience increased tendency to bleeding or are taking medicines that may increase the risk of bleeding, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”). Examples include certain medicines used to thin the blood (anticoagulants), certain medicines used to treat serious mental illnesses or nausea and vomiting (phenothiazines), certain medicines used for schizophrenia (clozapine), acetylsalicylic acid, and certain medicines used to treat pain and inflammation (NSAIDs, such as ibuprofen, or COX-2 inhibitors). Paroxetine may cause abnormal bleeding, so your doctor must exercise particular caution (see section 2, “Other medicines and Daparox”).
If you wish to stop taking paroxetine. You may experience withdrawal symptoms, especially if you stop abruptly (see section 3, “If you stop taking Daparox”). Consult your doctor before discontinuing paroxetine treatment.

Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may occasionally have thoughts of harming yourself or committing suicide. 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 are more likely to have such thoughts if:

You have previously had thoughts of suicide or self-harm.
You are a young adult. Clinical studies have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders treated with antidepressants.

Medicines that, like paroxetine, can affect serotonin levels in the brain, such as certain medicines used to treat depression or Parkinson’s disease (MAOIs such as moclobemide or isocarboxazid), certain dietary supplements (L-tryptophan), certain medicines used to treat migraine (triptans, such as sumatriptan, almotriptan), certain painkillers (tramadol, buprenorphine, pethidine), medicines used to treat infections (linezolid), a preoperative contrast agent (methylene blue), other selective serotonin reuptake inhibitors (SSRIs, such as fluoxetine, sertraline), certain medicines used to treat psychiatric conditions (lithium, risperidone), a specific medicine used to treat chronic pain or anesthesia (fentanyl), and St. John’s Wort (Hypericum perforatum), a herbal remedy for depression. Concomitant use of these medicines may lead to the development of serotonin syndrome (see section 2, “Do not take Daparox” and “Warnings and precautions”).
Buprenorphine combined with naloxone for opioid dependence replacement therapy.
Certain medicines used to treat psychosis (pimozide). Studies investigating the concomitant use of paroxetine and pimozide have shown that paroxetine may increase blood levels of pimozide. Since pimozide can prolong the QT interval (an interval detectable on an electrocardiogram, and its prolongation may cause irregular heartbeat), you must not take paroxetine together with pimozide (see section 2, “Do not take Daparox”).
Enzyme inhibitors, such as certain medicines used to treat depression (clomipramine). Your doctor may decide to prescribe a lower than usual dose. If you are to take paroxetine together with enzyme inducers (such as carbamazepine, rifampicin, phenobarbital, and phenytoin), a lower starting dose is usually not required, and your doctor will adjust subsequent doses based on the drug's effects.
Muscle relaxants used in anesthesia such as mivacurium and suxamethonium may have their muscle-relaxing effects prolonged due to interaction with paroxetine.
The combination of certain medicines used to treat HIV infection (fosamprenavir and ritonavir).
A specific medicine used to treat Parkinson’s disease (procyclidine). The effectiveness and side effects of procyclidine may be enhanced. If you experience side effects such as dry mouth, blurred vision, constipation, or difficulty emptying the bladder (urinary retention), you should consult your doctor, who may consider reducing the dose of procyclidine.
Certain medicines used to treat epilepsy (anticonvulsants such as sodium valproate). Although no direct effect has been demonstrated, your doctor must exercise particular caution when prescribing paroxetine to patients with epilepsy.
Medicines that are metabolized by the same liver enzymes that break down paroxetine. Examples include: certain medicines used to treat depression (tricyclic antidepressants, such as nortriptyline and desipramine), certain medicines used to treat serious mental illnesses such as psychosis (perphenazine, thioridazine, and risperidone), a medicine used to treat children with ADHD (atomoxetine), certain medicines used to treat irregular heartbeat (such as flecainide and propafenone), a medicine used to treat chest pain (angina pectoris) and high blood pressure (metoprolol), a medicine used to treat high cholesterol (pravastatin), and certain medicines used to treat serious mental illnesses or nausea and vomiting (phenothiazines). The effectiveness and side effects of these medicines may be enhanced. Paroxetine and thioridazine must not be taken together due to the risk of serious side effects, such as irregular heart rhythm and sudden death (see section 2, “Do not take Daparox”).
Certain medicines that prevent blood clotting (anticoagulants, such as acenocoumarol, phenprocoumon). The effect and side effects of these medicines may be enhanced, increasing the risk of bleeding. In such cases, closer monitoring by your doctor is required, and adjustment of anticoagulant dosage may be necessary (see section 2, “Warnings and precautions”).
A specific medicine used to treat breast cancer or fertility problems (tamoxifen).
Medicines that increase the risk of bleeding. Examples include: certain medicines used to treat serious mental illnesses or nausea and vomiting (phenothiazines, such as chlorpromazine, perphenazine), a medicine used to treat schizophrenia (clozapine), certain medicines used to treat depression (tricyclic antidepressants), acetylsalicylic acid, and medicines used to treat pain and inflammation (NSAIDs, such as ibuprofen or COX-2 inhibitors, such as rofecoxib, celecoxib) (see section 2, “Warnings and precautions”).
Medicines used to reduce stomach acid (such as cimetidine, omeprazole).

Daparox with food, drinks and alcohol

3. How to take Daparox

A hand holds an inverted bottle from which a single drop of liquid is emerging, on a white background

A hand holds a bottle with the cap open while the

4. Possible adverse effects

How to store Daparox

Keep this medicine out of the sight and reach of children.

6. Contents of the pack and other information

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