DAPAROX 20 mg Film-Coated Tablets

Зміст інструкції

1. Daparox 20 mg film-coated tablets
   1. What is Daparox and what is it used for
   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
2. Daparox 20 mg is available in packs of 10, 12, 14, 20, 28, 30, 50, 56, 60 or 100
   1. What is Daparox and what is it used for
   2. What you need to know before taking Daparox
   3. How to take Daparox
   4. Possible side effects
   5. Contents of the pack and other information

Daparox 20 mg film-coated tablets

paroxetine (as mesylate)

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Daparox is and what it is used for
• 2. What you need to know before you take 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 is Daparox and what is it used for

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

• Depression (major depressive episode)
• Obsessive compulsive disorder (repetitive obsessive thoughts and/or actions)
• Panic disorder with or without agoraphobia (e.g. strong fear of leaving home, entering shops, or fear of public places)
• Social anxiety disorder/social phobia (strong fear or desire to avoid everyday social interaction situations)
• Generalized anxiety disorder (generalized feeling of strong anxiety or excessive nervousness)
• Post-traumatic stress disorder (state of anxiety linked 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 any of the other ingredientsof this medicine (listed in section 6).
• If you are taking certain medicines used to treat depression or Parkinson's disease (called monoamine oxidase inhibitors (MAOIs)).

You can only start taking paroxetine at least 14 days after stopping the use of irreversibleMAOIs (such as isocarboxazideand

fenelzine).
If you are taking a reversibleMAOI (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 certain medicine (tioridazine) used to treat severe mental illnesses, such as psychoses (see also section 2, “Other medicines and Daparox”).
• If you are taking a certain 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 tell you when to start treatment with paroxetine once you have finished taking 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 or stay still(akathisia). This is more likely to happen within the first few weeks of treatment. If you experience these symptoms, do not hesitate to contact your doctor. In fact, in such cases, increasing the dose may be harmful.
• If you experience a certain syndrome (serotonin syndrome). This syndrome is characterized by a combination of symptoms, such as: (extreme) agitation, confusion, irritability, seeing things that are not there (hallucinations), sweating, tremors or chills, exaggerated reflexes, sudden onset of muscle spasms (myoclonus), increased body temperature or soreness (see section 2, “Other medicines and Daparox”). If any of these symptoms occur together, contact your doctor immediately and stop taking paroxetine.
• If you have experienced (periods of) extreme euphoria or overexcitement, resulting in unusual behavior (mania). If a manic phase occurs, you must stop treatment with paroxetine.
• If you have liverproblems or severekidneyproblems. An adjustment of the dosage by your doctor is necessary.
• If you have diabetes. Treatment with paroxetine may alter blood glucose levels, so close monitoring is required. It may be necessary to adjust the dose of insulin and/or other oral antidiabetic medicines.
• If you suffer from or have suffered from epilepsy or seizures. Paroxetine can cause seizures, so particular caution is required from your doctor. If you experience seizures, you should contact your doctor immediately. It may be necessary to stop treatment with paroxetine.
• If you have undergone electroconvulsive therapy (ECT). Clinical experience with the concomitant administration of paroxetine with ECT is limited, so particular caution is required from your doctor.
• If you suffer from or have suffered from increased intraocular pressure(glaucoma). Paroxetine can cause excessive dilation of the pupils (mydriasis), with a possible consequent increase in pressure inside the eyeball. Your doctor must exercise particular caution.
• If you have cardiovascular diseases. The safety of using paroxetine has not been studied in patients with these conditions, so particular precautions are necessary from your doctor.
• If you are an elderlypatient, use other medicinesor have liverproblems (cirrhosis) ,as a result of which you are at high risk of a decrease in blood sodium levels. Paroxetine can lower blood sodium levels, resulting in a feeling of weakness and fatigue. If this happens, consult your doctor.
• If you experience an increase in bleeding tendencyor are taking medicines that may increase the risk of bleeding, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”). Paroxetine can cause abnormal bleeding, so particular caution is required from your doctor (see section 2, “Other medicines and Daparox”).
• If you want to stop taking paroxetine. You may experience withdrawal symptoms, especially if you stop suddenly (see section 3, “If you stop taking Daparox”). Consult your doctor before stopping treatment with paroxetine.
• Suicidal thoughts and worsening of your depression or anxiety disorder. If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts may be more frequent the first time you 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 kinds of thoughts if:

• you have had thoughts of committing suicide or harming yourself in the past
• you are a young adult. Information from clinical studies has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders and treated with antidepressants.

At any time you have thoughts of harming yourself or committing suicide, contact your
doctor or go directly to hospital.
You may find it helpful to tell a friend or
relative that you are suffering from depression or anxiety and ask them to read this leaflet. You can ask them to tell you if they think
your depression or anxiety is getting worse, or if they are worried about changes in your behavior.
Medicines such as Daparox (so-called selective serotonin reuptake inhibitors
(SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) can cause symptoms of sexual dysfunction (see section 4). In some cases, persistence of these symptoms has been observed
after discontinuation of treatment.

Children and adolescents
Normally, paroxetine should not be taken by children and adolescents under the age of 18
years. It is also important to know that, if this class of
medicines is taken, patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal ideation and hostility (essentially
aggression, oppositional behavior and anger). Despite the above, 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 want more information, contact your doctor.
It will be appropriate to inform your doctor if any of the above symptoms appear or worsen
during the taking of paroxetine by a patient under 18 years of age.
In addition, the effects on long-term safety of paroxetine relating to growth, maturation and cognitive and behavioral development have not yet been demonstrated.

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

• Medicines used in the treatment of forms of depression or Parkinson's disease ( MAOIssuch as moclobemideor isocarboxazide), some food supplements ( L-tryptophan), some medicines used in the treatment of migraine ( triptans,such as sumatriptan, almotriptan), some painkillers ( tramadol, buprenorphine, pethidine), medicines used in the treatment of infections ( linezolid), a preoperative highlighting agent ( methylene blue), other selective serotonin reuptake inhibitors ( SSRIs,such as fluoxetine, sertraline), some medicines used in the treatment of certain psychiatric conditions ( lithium, risperidone) a certain medicine used in the treatment of chronic pain or in anesthesia ( fentanyl) and St John's Wort or Hypericum perforatum, a natural remedy for depression. The concomitant use of these medicines can lead to the onset of a serotonin syndrome(see paragraph 2, “Do not take Daparox” and “Warnings and precautions”).
• Buprenorphinecombined with naloxonein substitution treatment for opioid dependence.
• Some medicines used in the treatment of psychosis ( pimozide). Studies investigating the concomitant use of paroxetine and pimozide have shown that, in cases of concomitant intake, paroxetine may determine an increase in pimozide blood levels. Because pimozide can cause serious side effects, such as irregular heartbeat, you should not take paroxetine together with pimozide (see paragraph 2, “Do not take Daparox”).
• Enzyme inhibitors, such as medicines used in the treatment of depression ( clomipramine). It is likely that your doctor will decide to prescribe a lower dose than usual. If you are about to take paroxetine together with enzyme inducers (such as carbamazepine, rifampicin, phenobarbital and phenytoin) a lower starting dose is usually not necessary and the doctor will adjust subsequent doses based on the effects of the drug.
• Muscle relaxants used in anesthesia such as mivacurium and suxamethoniummay have their muscle relaxant action prolonged due to interaction with paroxetine.
• The combination of some medicines used for the treatment of Human Immunodeficiency Virus (HIV) infection (fosamprenavir and ritonavir).
• A certain medicine, used in the treatment of Parkinson's disease ( procyclidine). It may determine an enhancement of efficacy, as well as the side effects of procyclidine. If you experience side effects, such as dry mouth, blurred vision, constipation and problems with bladder emptying (urinary retention), you may need to consult your doctor for a possible reduction in the dose of procyclidine.
• Some medicines used in the treatment of epilepsy(anticonvulsants, such as sodium valproate). Although a direct effect has not been demonstrated, it is necessary that your doctor exercise particular caution when prescribing paroxetine to epileptic patients.
• Medicines that are subjected to destruction by the same liver enzymes that metabolize paroxetine. Examples in this sense are: some medicines used in the treatment of depression ( tricyclic antidepressants, such as nortriptylineand desipramine), some medicines used in the treatment of severe mental illnesses, such as

psychoses ( perphenazine, thioridazine and risperidone), a certain medicine
used to treat children with ADHD ( atomoxetine), some medicines
used in the treatment of irregular heartbeat (such as flecainide and
propafenone), a certain medicine used in the treatment of chest pain
(angina pectoris) and high blood pressure ( metoprolol), a certain
medicine used in the treatment of high cholesterol ( pravastatin) and some medicines
useful in the treatment of severe mental illnesses or nausea and vomiting ( phenothiazines). An
enhancement of the efficacy and side effects of these medicines may occur.
Paroxetine and thioridazine should not be taken together, due to the risk of serious
side effects, such as irregular heartbeat and sudden death (see
paragraph 2, “Do not take Daparox”).

• Some medicines for the prevention of blood clotting ( anticoagulants,such as acenocoumarol, phenprocoumon). Enhancement of the efficacy and side effects of these medicines and an increase in the risk of bleeding may occur. The doctor will have to monitor you more closely and it may be necessary to adjust the dose of anticoagulants (see paragraph 2, “Warnings and precautions”).
• A certain medicine used in the treatment of breast cancer or fertility problems ( tamoxifen).
• Medicines that increase the risk of bleeding. Examples in this sense are: some medicines useful in the treatment of severe mental illnesses or nausea and vomiting ( phenothiazines,such as chlorpromazine, perphenazine), a certain medicine used in the treatment of schizophrenia ( clozapine), certain medicines used in the treatment of depression ( tricyclic antidepressants), acetylsalicylic acid, medicines that fight pain and inflammation (NSAIDs, such as ibuprofenor COX-2 inhibitors, such as rofecoxib, celecoxib) (see paragraph 2, “Warnings and precautions”).
• some medicines used to reduce the amount of acid in the stomach (such as cimetidineor omeprazole).

Daparox with food, drinks and alcohol
The simultaneous intake of alcoholand paroxetine should be avoided.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect or are
planning a pregnancy, ask your doctor or pharmacist for advice before taking
this medicine .Sufficient data are not available to determine the safety and
effectiveness of paroxetine use during pregnancy. Some studies have suggested an
increased risk of heart defects in children whose mothers had taken
paroxetine in the first months of pregnancy. In agreement with your doctor, you may decide
that the best thing would be to switch to another treatment or gradually stop
taking paroxetine during pregnancy. However, taking into account your
conditions, the doctor may suggest, as the most appropriate choice for you, to continue
taking paroxetine.

Be 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 a
increased risk of heavy vaginal bleeding shortly after delivery, especially
if you suffer from bleeding disorders (easy bleeding). Inform your attending physician or
midwife/doctor that you are taking Daparox, so that they can advise you on what
to do.
When medicines such as paroxetine are taken during pregnancy, especially the
advanced pregnancy, the risk of persistent pulmonary hypertension of the newborn (PPHN) may increase in children, leading the child to breathe
laboriously and appear cyanotic. This symptomatology usually manifests in the
first 24 hours after birth. If this happens to your child, contact your midwife and/or doctor
immediately.

If you have taken paroxetine in the last 3 months of pregnancy, the newborn may
present other symptoms that usually manifest within the first 24 hours after birth.
The symptoms include difficulty falling asleep or feeding, difficulty
breathing, cyanosis or unstable body temperature, feeling unwell (vomiting), constant crying, stiffness or muscle weakness, lethargy, tremors, nervousness or seizures.
If your child presents any of these symptoms at birth and you are
worried, ask your doctor or midwife for advice.
Paroxetine is excreted in breast milk in small amounts. If you are taking
paroxetine, consult your doctor before starting breastfeeding. In agreement with
your doctor, you may decide that you can breastfeed while using paroxetine.
Paroxetine, in studies on animals, has been shown to reduce sperm quality. In theory,
this could affect fertility, but the impact on human fertility has not yet been
observed.

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

Daparox contains lactose and sodium
If your doctor has diagnosed you with intolerance to certain sugars, contact him 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 always exactly as your doctor or pharmacist has told you.
If you have doubts, consult your doctor or pharmacist.
Paroxetine should preferably be taken in the morning with food. The tablets
should be swallowed whole, without chewing.
The tablet can be divided into equal parts.
The recommended dose is:

Major depressive episode
The recommended starting dose is one tablet (20 mg of paroxetine) once a
day. In general, improvement in patients begins after one week, but may
become evident later (e.g. in the second week). If there is an inadequate
response, your doctor may decide to increase the dose, with gradual increases
of ½ tablet (10 mg of paroxetine), up to a maximum of 2 and ½ tablets (50 mg of
paroxetine) per day. Your doctor will decide the duration of therapy, which may
be prolonged for more than 6 months.

Obsessive-compulsive disorder (OCD)
The recommended dose is 2 tablets (40 mg of paroxetine) per day, with a starting dose of
1 tablet (20 mg of paroxetine) per day. If there is an inadequate response, your doctor may
decide to gradually increase the dosage,
with gradual increases of ½ tablet (10 mg of paroxetine) up to a maximum of 3
tablets (60 mg of paroxetine) per day. Your doctor will decide the duration of therapy,
which may be prolonged for several months or longer.

Panic disorder with or without agoraphobia
The recommended dose is 2 tablets (40 mg of paroxetine) per day, with a starting dose of ½
tablet (10 mg of paroxetine) per day. If there is an inadequate response, your doctor may
decide to gradually increase the dosage,
with gradual increases of ½ tablet (10 mg of paroxetine), up to a maximum of 3
tablets (60 mg of paroxetine) per day. A low initial dosage is recommended, to
avoid potential worsening of panic symptoms at the beginning of
treatment. Your doctor will decide how long you will need to continue to
take the tablets. The duration of therapy may be prolonged for several months or longer.

Social anxiety disorder/social phobia
The recommended dose is 1 tablet (20 mg of paroxetine) per day. If there is an
inadequate response, your doctor may decide to gradually increase the
dosage, with gradual increases of ½ tablet (10 mg of paroxetine), up to a maximum
of 2 and ½ tablets (50 mg of paroxetine) per day. Your doctor will decide how long
you will need to continue to take the tablets. The duration of therapy may
be prolonged for a long period, during which it will be periodically evaluated.

Generalized anxiety disorder
The recommended dose is 1 tablet (20 mg of paroxetine) per day. If there is an
inadequate response, your doctor may decide to gradually increase the
dosage, with gradual increases of ½ tablet (10 mg of paroxetine), up to a maximum
of 2 and ½ tablets (50 mg of paroxetine) per day. Your doctor will decide how long
you will need to continue to take the tablets. The duration of therapy may
be prolonged for a long period, during which it will be periodically evaluated.

Post-traumatic stress disorder
The recommended dose is 1 tablet (20 mg of paroxetine) per day. If there is an
inadequate response, your doctor may decide to gradually increase the
dosage, with gradual increases of ½ tablet (10 mg of paroxetine), up to a maximum
of 2 and ½ tablets (50 mg of paroxetine) per day. Your doctor will decide how long
you will need to continue to take the tablets. The duration of therapy may
be prolonged for a long period, during which it will be periodically evaluated.

Elderly
The recommended initial dose for elderly patients is the same as the initial dose
used in adults, but the maximum dose should not exceed 2 tablets (40 mg of
paroxetine) per day.

Use in children and adolescents
Paroxetine should not be taken by children and adolescents under the age of 18 years
(see section 2, “Children and adolescents”).

Patients with impaired hepatic or renal function
If there is an alteration of hepatic or renal function, a dosage adjustment is necessary.

Duration of treatment
Your doctor will tell you how long you will need to continue taking paroxetine. Based on
your condition, it may be necessary to take paroxetine for a long period.
You should continue to take paroxetine for some time, even once the symptoms have disappeared,
to be sure that they do not recur. Never stop treatment with paroxetine without consulting your doctor.An abrupt interruption
of treatment with paroxetine may cause withdrawal symptoms, therefore the
dosage should be reduced gradually (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
remaining tablets to your doctor. In addition to the known side 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 the 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 consulting your doctor and do not
stop treatment abruptly, as this may cause withdrawal symptoms. The symptoms that may occur once treatment with paroxetine is stopped include: dizziness, sensory disturbances (sensation of pricking, burning, electric shock or buzzing, ringing, whistling, tinkling 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, strong or accelerated perception of
heartbeat (palpitations), diarrhea and irritability (see also section
4, “Possible side effects”).
These symptoms usually appear in the first few days of stopping treatment,
but may also occur in patients who have forgotten to take a dose. Withdrawal symptoms usually disappear within two weeks, but in some patients
may be more severe or persist for a longer period (2-3 months or
longer). If, in agreement with your doctor, you have decided to stop treatment with
paroxetine, the daily dosage must be reduced gradually over several weeks or
months (starting with gradual reductions of 10 mg per week). You should always consult
your doctor before reducing the dosage.
If you have any doubts about using this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Contact your doctor or go to hospital immediately if you experience any of the following side effects during treatment.
Side effects uncommon(may affect up to 1 in 100 people)

• Abnormal bleeding, in particular skin bruising (ecchymosis and gynaecological bleeding).

Side effects rare(may affect up to 1 in 1000 people)

• Convulsions, epileptic seizures
• Feeling of restlessness and hyperactivity with an inability to sit still or remain immobile (akathisia)
• Low blood levels of sodium (hyponatraemia), predominantly in elderly patients.

Side effects very rare(may affect up to 1 in 10000 people)

• Allergic reactions to paroxetine which can be severeaccompanied by itching and painful skin rash (urticaria) or a severe reaction resulting in swelling of the skin, throat or tongue, difficulty breathing 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 and if you feel weak or dizzy with resulting collapse or loss of consciousness
• The so-called serotonin syndrome (whose symptoms may include agitation, confusion, sweating, seeing things that do not exist (hallucinations), hyperreflexia, sudden onset of muscle spasms (myoclonus), chills, tremor and increased heart rate (tachycardia))
• Sudden increase in intraocular pressure (acute glaucoma).

Side effects not known(frequency cannot be estimated from the available data)

• Aggression, cases of self-harming thoughts/behaviour or suicidal thoughts have been reported during therapy with paroxetine or immediately after discontinuation of treatment. However, this symptomatology may be due to the underlying condition.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see “Pregnancy, breastfeeding and fertility” in section 2 for further information.

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

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

Side effects common(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, trembling (tremors), headache, difficulty concentrating
• Blurred vision
• Yawning
• Constipation, diarrhoea, vomiting, dry mouth
• Sweating
• Increased body weight, feeling of general tiredness with loss of muscle strength (asthenia).

Side effects uncommon(may affect up to 1 in 100 people)

• Reduction in the number of white blood cells
• If you are a diabetic patient while taking paroxetine you may have a loss of control of blood sugar levels. Consult your doctor for adjustment of insulin dosage or diabetes medications.
• Confusion, seeing things that do not exist (hallucinations)
• Involuntary movements of the body or face (extrapyramidal disorders)
• Pupil dilation (mydriasis)
• Increased heart rate (sinus tachycardia)
• Feeling of dizziness or fainting, especially when getting up quickly from a lying or sitting position (postural hypotension)
• Skin rash, itching
• Problems emptying the bladder (urinary retention) and involuntary and uncontrolled leakage of urine (urinary incontinence).

Side effects rare(may affect up to 1 in 1000 people)

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

Side effects very rare(may affect up to 1 in 10000 people)

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

Side effects not known(frequency cannot be estimated from the available data)

• Teeth grinding
• Ringing, whistling, hissing, tingling 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 treatment with paroxetine
Common: dizziness, sensory disturbances, sleep disturbances, anxiety and headache.
Uncommon: agitation, nausea, sweating, tremor, confusion, emotional instability, visual disturbances, palpitations, diarrhoea and irritability.
Generally, these events are 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
In cases of administration of paroxetine to children and adolescents under the age of 18 years, more than 1 in 100, but less than 1 in 10 children/adolescents have had one of the following side effects: emotional lability (including crying and mood swings), self-harming behaviour, suicide attempts and suicidal ideation, hostile or aggressive behaviour, loss of appetite, tremor, abnormal sweating, hyperactivity, agitation, nausea, abdominal pain and nervousness.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the blister and on the
pack after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What Daparox contains

• The active ingredient is paroxetine (as mesylate). One tablet contains paroxetine mesylate equivalent to 20 mg of paroxetine.
• The other ingredients are: Core: dibasic calcium phosphate, sodium carboxymethyl starch (Type A), magnesium stearate. Coating: lactose monohydrate, 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, with the code "POT 20" embossed on one
side and with a dividing line on both sides.

Daparox 20 mg is available in packs of 10, 12, 14, 20, 28, 30, 50, 56, 60 or 100

tablets in blisters and in a container of 500 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Viale Amelia n. 70
00181 Rome

Manufacturers:

• Synthon BV - Microweg 22 - 6545 CM Nijmegen - Netherlands
• Synthon Hispania S.L. - Castello n.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 authorised in the Member States of the European Economic Area
under the following denominations:
Austria: Ennos 20 mg Filmtabletten
Belgium: Paroxetine EG 20 mg, film-coated tablets
Denmark: Euplix, film-coated tablets 20 mg
Germany: Euplix 20 mg Filmtabletten
Italy: Daparox 20 mg film-coated tablets
Luxembourg: Paroxetine EG 20 mg film-coated tablets
Netherlands: Paroxetine 20 mg, film-coated tablets

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• This medicine has been prescribed for you only. Do not pass it on to others, even if theirsymptoms are the same as yours, as it may be harmful.
• 2. What you need to know before you take 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 is Daparox and what is it used for

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

2. What you need to know before taking Daparox

• You can only start taking paroxetine if at least 14 days have passed since you stopped taking irreversible MAOIs (such as isocarboxazidand fenelzine).
• If you are taking a reversible MAOI (such as moclobemide, linezolid, methylthioninium chloride(methylene blue), you should 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 medications used to treat severe depression or Parkinson's disease (MAOIs). You should not take paroxetine at the same time(see paragraph 2, “Do not take Daparox” and paragraph 2, “Other medicines and Daparox”).
• If you experience restlessness, hyperactivity or inability to sit or stay still(akathisia). This is more likely to happen within the first few weeks of treatment. If you experience these symptoms, do not hesitate to contact your doctor. In fact, in such cases, increasing the dose may be harmful.
• If you experience a certain syndrome (serotonin syndrome). This syndrome is characterized by a combination of symptoms, such as: (extreme) agitation, confusion, irritability, seeing things that do not exist (hallucinations), sweating, tremors or chills, exaggerated reflexes, sudden onset of muscle spasms (myoclonus), increased body temperature or soreness (see paragraph 2, “Other medicines and Daparox”). If any of these symptoms occur simultaneously, contact your doctor immediately and stop treatment with paroxetine.
• If you have experienced (periods of) extreme euphoria or overexcitement, resulting in unusual behavior (mania). The use of paroxetine may cause a depressive phase to transform into a manic phase. If a manic phase occurs, treatment with paroxetine should be discontinued.
• If you have problems with your liveror severe problems with your kidneys. A dosage adjustment by your doctor is necessary.
• If you have diabetes. Treatment with paroxetine may alter your blood sugar levels (glycemia), so close monitoring is required. It may be necessary to adjust the dose of insulin and/or other oral antidiabetic drugs.
• If you suffer from or have suffered from epilepsy or seizures. Paroxetine can cause seizures (convulsions), so particular attention is needed from your doctor. If seizures (convulsions) occur, you should contact your doctor immediately. It may be necessary to stop treatment with paroxetine.
• If you have undergone electroconvulsive therapy (ECT). Clinical experience with the concomitant administration of paroxetine with ECT is limited, so particular caution is required from your doctor.
• If you suffer from or have suffered from increased intraocular pressure(glaucoma). Paroxetine can cause excessive dilation of the pupils (mydriasis), with a possible consequent increase in pressure inside the eyeball. Your doctor will need to exercise particular caution.
• If you have cardiovascular diseases. The safety of using paroxetine has not been studied in patients with these conditions, so special precautions are needed from your doctor.
• If you are an elderlypatient, use other medicationsor have liverproblems (cirrhosis), as a result of which you are at high risk of a decrease in blood sodium levels. Paroxetine may further lower blood sodium levels, resulting in a feeling of weakness and fatigue. If this happens, consult your doctor.
• If you experience an increase in bleeding tendencyor are taking medications that can cause an increased risk of bleeding, or if a pregnancyis in progress(see “Pregnancy, breastfeeding and fertility”). Examples in this sense are some medications that are used to thin the blood (anticoagulants), some medications used in the treatment of severe mental illness or nausea and vomiting (phenothiazines), certain medications used in the treatment of schizophrenia (clozapine), acetylsalicylic acid and some medications that fight pain and inflammation (NSAIDs, such as ibuprofen or COX-2 inhibitors). Paroxetine may cause abnormal bleeding, so particular caution is required from your doctor (see paragraph 2, “Other medicines and Daparox”).
• If you want to stop taking paroxetine. You may experience withdrawal symptoms, especially if you stop abruptly (see paragraph 3, “If you stop taking Daparox”). Consult your doctor before stopping treatment with paroxetine. Suicidal thoughts and worsening of your depression or anxiety disorderIf 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 frequent the first time you start taking antidepressants, as all these medications take time to work, usually about two weeks but sometimes longer. You may be more likely to have these thoughts if:
• you have previously had thoughts of taking your own life or harming yourself
• you are a young adult. Information from clinical studies has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders and treated with antidepressants.
• Medicines that, like paroxetine, can change the amount of serotonin in the brain, such as some medicines used to treat depression or Parkinson's disease (MAOIssuch as moclobemideor isocarboxazid), some dietary supplements (L-tryptophan), some medicines used to treat migraine (triptans, such as sumatriptan, almotriptan), some painkillers (tramadol, buprenorphine, pethidine), medicines used to treat infections (linezolid), a preoperative highlighting agent (methylene blue), other selective serotonin reuptake inhibitors (SSRIs, such as fluoxetine, sertraline), some medicines used to treat certain psychiatric conditions (lithium, risperidone), a specific medicine used to treat chronic pain or in anesthesia (fentanyl) and St. John's Wort (Hypericum perforatum), a natural remedy for depression. The concomitant use of these medicines can lead to the onset of a serotonin syndrome(see paragraph 2, “Do not take Daparox” and “Warnings and precautions”).
• Buprenorphinecombined with naloxonein opioid substitution treatment.
• Some medicines used to treat psychosis (pimozide). Studies investigating the concomitant use of paroxetine and pimozide have shown that, in cases of concomitant intake, paroxetine may cause an increase in pimozide blood levels. Because pimozide can prolong the QT interval (a QT interval is detectable on an electrocardiogram and its prolongation can cause irregular heartbeat) you should not take paroxetine together with pimozide (see paragraph 2, “Do not take Daparox”).
• Enzyme inhibitors, such as some medicines used to treat depression (clomipramine). It is likely that the doctor will decide to prescribe a lower dose than usual. If you are about to take paroxetine together with enzyme inducers (such as carbamazepine, rifampicin, phenobarbital and phenytoin) a lower starting dose is usually not necessary and the doctor will adjust the subsequent doses based on the effects of the drug.
• Muscle relaxants used in anesthesia such as mivacurium and suxamethoniummay have their muscle relaxant action prolonged due to interaction with paroxetine.
• The combination of some medicines used in the treatment of Human Immunodeficiency Virus (HIV) infection (fosamprenavirand ritonavir).
• A specific medicine used to treat Parkinson's disease (procyclidine). An enhancement of efficacy, as well as side effects, of procyclidine may occur. If you experience side effects such as dry mouth, blurred vision, constipation and problems with bladder emptying (urinary retention), you may need to consult your doctor for a possible reduction in the dose of procyclidine.
• Some medicines used to treat epilepsy(anticonvulsants such as sodium valproate). Although a direct effect has not been demonstrated, it is necessary for your doctor to exercise particular caution when prescribing paroxetine to epileptic patients.
• Medicines that are subjected to destruction by the same liver enzymes that metabolize paroxetine. Examples in this sense are: some medicines used to treat depression (tricyclic antidepressants, such as nortriptylineand desipramine), some medicines used to treat severe mental illness, such as psychoses (perphenazine, thioridazine and risperidone), a specific medicine used to treat children with ADHD (atomoxetine), some medicines used to treat irregular heartbeat (such as flecainide and propafenone), a specific medicine used to treat chest pain (angina pectoris) and high blood pressure (metoprolol), a specific medicine used to treat high cholesterol (pravastatin) and some medicines useful in the treatment of severe mental illness, or nausea and vomiting (phenothiazines). The efficacy and side effects of these drugs may be enhanced. Paroxetine and thioridazine should not be taken together due to the risk of serious side effects, such as irregular heartbeat and sudden death (see paragraph 2, “Do not take Daparox”).

Daparox with food, drinks and alcohol

3. How to take Daparox

4. Possible side effects

• 5. 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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