Arketis tablets 20 mg

Package leaflet: information for the patient

ARKETIS 20 mg tablets, tablets
Paroxetinum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What ARKETIS 20 mg tablets are and what they are used for
2. Important information before taking ARKETIS 20 mg tablets
3. How to take ARKETIS 20 mg tablets
4. Possible side effects
5. How to store ARKETIS 20 mg tablets
6. Contents of the pack and other information

1. What ARKETIS 20 mg tablets are and what they are used for

ARKETIS 20 mg tablets are indicated for the treatment of depression and (or) anxiety disorders in adults.
Anxiety disorders treated with ARKETIS 20 mg tablets include:
obsessive-compulsive disorder (repetitive, intrusive thoughts with uncontrollable behaviour),
panic disorder with or without agoraphobia (panic attacks, including those caused by agoraphobia, i.e. fear of open spaces),
social phobia (fear or avoidance of social situations),
post-traumatic stress disorder (anxiety caused by a traumatic event), and
generalized anxiety disorder (general feeling of intense anxiety or nervousness).
ARKETIS 20 mg tablets belong to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). The mechanism of action of ARKETIS 20 mg tablets and other SSRIs is not fully understood, but they may increase serotonin levels in the brain. Proper treatment of depression or anxiety disorders is important for improving the patient's well-being.

2. Important information before taking ARKETIS 20 mg tablets

When not to take ARKETIS 20 mg tablets:

• if the patient is taking medicines known as monoamine oxidase inhibitors (MAO inhibitors, including moclobemide and methylthioninium chloride (methylene blue)) or has taken them at any time within the last two weeks. The doctor will advise the patient on how to start taking ARKETIS 20 mg tablets after stopping MAO inhibitors;
• if the patient is taking antipsychotic medicines containing thioridazine or pimozide;
• if the patient is allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6).

If any of the above situations apply to the patient, the patient should contact their
treating doctor and not take ARKETIS 20 mg tablets.
Warnings and precautions
Before starting treatment with ARKETIS 20 mg tablets, discuss the following with your doctor or
pharmacist:

• Is the patient taking any other medicines? (See section ARKETIS 20 mg tablets and other medicines later in this leaflet)?
• Is the patient taking tamoxifen for the treatment of breast cancer or fertility problems? ARKETIS 20 mg tablets may reduce the effectiveness of tamoxifen, so the doctor may recommend that the patient use another antidepressant.
• Does the patient have problems with the kidneys, liver, or heart?
• Does the patient have abnormal heart conduction on electrocardiogram (ECG), known as QT interval prolongation?
• Does the patient have a family history of QT interval prolongation, heart disease such as heart failure, slow heart rate, or low potassium or low magnesium levels?
• Does the patient have epilepsy or a history of seizures?
• Has the patient previously experienced episodes of mania (excessively active behaviour or racing thoughts)?
• Is the patient receiving electroconvulsive therapy (ECT)?
• Has the patient previously experienced bleeding episodes or is the patient taking other medicines that may increase the risk of bleeding (blood thinners such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, painkillers and anti-inflammatory medicines, so-called NSAIDs (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)?
• Does the patient have diabetes?
• Is the patient on a low-sodium diet?
• Does the patient have glaucoma (increased pressure in the eye)?
• Is the patient pregnant or planning to become pregnant? (See Pregnancy, breastfeeding and fertility later in this leaflet)
• Is the patient under 18 years of age? (See Use in children and adolescents under 18 years of age later in this leaflet)

If the answer to any of the above questions is YES and the patient has not yet consulted
their doctor, the patient should see their treating doctor again to discuss how to take ARKETIS
20 mg tablets.
Children and adolescents
ARKETIS 20 mg tablets must not be used in the treatment of children and adolescents
under 18 years of age. In patients under 18 years of age, taking ARKETIS 20 mg tablets increases
the risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (particularly
aggression, oppositional behaviours, and anger). If a doctor has prescribed ARKETIS 20 mg tablets
for a patient under 18 years of age, any doubts should be discussed again with the treating doctor.
If any of the listed symptoms occur or worsen during treatment with ARKETIS 20 mg tablets, the
doctor should be informed. In addition, there is currently no data on the long-term safety of
paroxetine use in this age group regarding growth, puberty, cognitive development, and behavioural
development.
In clinical trials in patients under 18 years of age taking paroxetine, common adverse reactions
occurring in less than 1 in 10 patients were: worsening of suicidal thoughts and attempts, deliberate
self-harm, hostility, aggressive or hostile behaviours, loss of appetite, tremor, sweating,
hyperactivity (excess energy), agitation, emotional lability (including tearfulness and mood swings),
and unusual bruising or bleeding (such as nosebleeds) not previously observed.
These studies also showed that the same symptoms, although less frequently, occurred in children
and adolescents receiving placebo (an inactive substance) instead of paroxetine.
In some participants of these studies, withdrawal symptoms occurred after stopping paroxetine.
These symptoms were mostly similar to those observed in adult patients after discontinuation of
paroxetine (see section 3: How to take ARKETIS 20 mg tablets later in this leaflet).
Additionally, in patients under 18 years of age, abdominal pain, nervousness, and emotional lability
(including tearfulness, mood swings, self-harm attempts, suicidal thoughts, and suicidal attempts)
occurred frequently (in less than 1 in 10 patients).
Suicidal thoughts, worsening of depression or anxiety disorders
Patients with depression and/or anxiety disorders may sometimes experience thoughts about
self-harm or suicidal thoughts. These may be intensified at the beginning of treatment with
antidepressants, as it may take some time, usually about two weeks, before the medicines start to
work, and sometimes even longer.
The occurrence of such conditions is more likely:

• if the patient has previously experienced suicidal thoughts or self-harm;
• if the patient is a young adult. Clinical trial data indicate an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who are treated with antidepressants.

If thoughts about self-harm or suicide ever occur, the patient should contact their doctor
immediately or go to a hospital.
Informing family members or friends about the patient's depression or anxiety disorders
may be helpful, and asking them to read this leaflet. The patient may ask them to inform the
patient if they notice that the depression or anxiety disorders worsen or if there are concerning
changes in behaviour.
Important adverse effects observed during paroxetine treatment
In some patients taking ARKETIS 20 mg tablets, symptoms called akathisia may develop,
characterised by a feeling of psychomotor restlessness with inability to sit or stand still. In other
patients, a condition known as serotonin syndrome or neuroleptic malignant syndrome may
develop, in which patients may experience some or all of the following symptoms: intense feeling
of excitement or irritability, confusion (disorientation), anxiety, fever, sweating, tremor, shivering,
hallucinations (seeing or hearing strange things), muscle stiffness, sudden muscle contractions, or
rapid heartbeat. Symptoms may worsen, leading to loss of consciousness. If the patient notices any
of these symptoms, they should contact their doctor. More information about these or other
adverse effects of ARKETIS 20 mg tablets (see section 4 Possible adverse effects).
Medicines such as ARKETIS 20 mg tablets (so-called SSRIs) may cause sexual dysfunction
symptoms (see section 4). In some cases, these symptoms persisted after discontinuation of
treatment.
ARKETIS 20 mg tablets and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently
taken, or plans to take.
Some medicines may affect the action of ARKETIS 20 mg tablets or increase the risk of adverse
effects.
ARKETIS 20 mg tablets may also affect the action of other medicines. These include:

• medicines known as monoamine oxidase inhibitors (MAO inhibitors, including moclobemide and methylthioninium chloride (methylene blue)) – see section When not to take ARKETIS 20 mg tablets;
• medicines known to increase the risk of changes in electrical activity of the heart (e.g. antipsychotics thioridazine or pimozide) – see section When not to take ARKETIS 20 mg tablets;
• acetylsalicylic acid, ibuprofen, or other so-called NSAIDs (non-steroidal anti-inflammatory drugs), such as celecoxib, etodolac, diclofenac, and meloxicam, used for pain and inflammatory conditions;
• tramadol, buprenorphine, and pethidine, which are painkillers;
• buprenorphine in combination with naloxone, used in opioid addiction substitution therapy;
• medicines called triptans, such as sumatriptan, used for the treatment of migraine;
• other antidepressants, including selective serotonin reuptake inhibitors (SSRIs), tryptophan, and tricyclic antidepressants, e.g. clomipramine, nortriptyline, and desipramine;
• a dietary supplement called tryptophan;
• mivacurium and suxamethonium (used in general anaesthesia);
• medicines such as lithium, risperidone, perphenazine, clozapine (so-called antipsychotics), used to treat certain mental disorders;
• fentanyl used in anaesthesia or for the treatment of chronic pain;
• combination of fosamprenavir and ritonavir, used in the treatment of human immunodeficiency virus (HIV) infection;
• St. John’s wort, a herbal preparation used for depression;
• phenobarbital, phenytoin, sodium valproate, or carbamazepine used to treat seizures or epilepsy;
• atomoxetine, a medicine used to treat attention deficit hyperactivity disorder (ADHD);
• procyclidine used to treat tremor, particularly in Parkinson’s disease;
• warfarin or other medicines (anticoagulants) used to thin the blood;
• propafenone, flecainide, and medicines used to treat heart rhythm disorders;
• metoprolol, a beta-blocker used to treat high blood pressure and heart problems;
• pravastatin used to treat high cholesterol levels;
• rifampicin used to treat tuberculosis and acne;
• linezolid, an antibiotic;
• tamoxifen used to treat breast cancer and fertility problems.

If the patient is currently taking or has recently taken any of the listed medicines
and has not yet discussed this with their doctor, the patient should consult their doctor again.
A dose adjustment or change of medicine may be necessary.
Tell your doctor or pharmacist about all medicines currently taken or recently taken,
as well as any medicines the patient plans to take, including medicines available without
a prescription.
Taking ARKETIS 20 mg tablets with food, drink, and alcohol
During treatment with ARKETIS 20 mg tablets, alcohol should not be consumed, as it may worsen
symptoms of the illness or adverse effects. Taking ARKETIS 20 mg tablets in the morning with food
reduces the risk of nausea.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
baby, she should consult her doctor or pharmacist before taking ARKETIS 20 mg tablets.
There are reports of an increased risk of congenital malformations, particularly heart defects, in
children whose mothers took paroxetine during the first months of pregnancy. In the general
population, 1 in 100 children is born with a heart defect. In children whose mothers took
paroxetine, the risk is higher, at 2 in 100 children.
The doctor, in consultation with the patient, may decide whether it is better for the patient to
switch to another medicine or gradually discontinue ARKETIS 20 mg tablets during pregnancy.
However, depending on the patient's condition, the doctor may suggest that it is better for the
patient to continue taking ARKETIS 20 mg tablets.
The patient should inform the midwife and/or doctor that she is taking ARKETIS 20 mg
tablets. Taking ARKETIS 20 mg tablets towards the end of pregnancy may increase the risk of
serious vaginal bleeding occurring shortly after delivery, especially if the patient has a history of
bleeding disorders. If the patient is taking ARKETIS 20 mg tablets, she should inform the doctor or
midwife so they can provide appropriate advice. Medicines such as ARKETIS 20 mg tablets taken
during pregnancy, particularly in the later stages, may increase the risk of serious complications in
the newborn, known as persistent pulmonary hypertension of the newborn (PPHN).
In PPHN, the blood pressure in the blood vessels between the heart and lungs of the baby is too
high. If the patient takes ARKETIS 20 mg tablets during the last three months of pregnancy, other
disorders may also occur in the newborn, usually appearing within the first 24 hours of life. These
include:

• breathing difficulties
• skin cyanosis or increased or decreased body temperature
• bluish lips
• vomiting or feeding difficulties
• extreme fatigue, inability to sleep, or persistent crying
• muscle stiffness or floppiness
• tremor, restlessness, or seizures
• exaggerated reflexes

If any of these symptoms occur in the baby after birth or if there are concerns about the baby's
health, contact the doctor or midwife for advice.
Paroxetine may pass into breast milk in small amounts. If the patient is taking ARKETIS 20 mg
tablets, she should contact her doctor before starting breastfeeding. The doctor, together with the
patient, will decide whether the patient can breastfeed while taking ARKETIS 20 mg tablets.
Animal studies have shown that paroxetine reduces semen quality. This could theoretically affect
fertility, but such an effect has not been observed in humans to date.
Driving and operating machinery
Possible adverse effects caused by ARKETIS 20 mg tablets include dizziness, confusion, drowsiness,
or visual disturbances. If such adverse effects occur, the patient should not drive or operate
machinery.
ARKETIS 20 mg tablets contain sodium
ARKETIS 20 mg tablets contain less than 1 mmol (23 mg) of sodium per tablet, meaning the
medicine is considered "sodium-free".

3. How to use ARKETIS 20 mg Tablets

This medicine should always be taken exactly as prescribed by the doctor. In case of any doubts,
consult the doctor or pharmacist.
Sometimes the prescribed dose requires taking more than one tablet or half a tablet.
The typical dosage regimens for treating various diseases are provided in the table below.

At the beginning of treatment, the doctor will advise the patient on the dose of ARKETIS Tablets 20 mg
to be taken.
For most people, improvement in well-being occurs after several weeks of treatment. If the patient
does not feel better after this time, they should consult their doctor. The doctor may decide to
gradually increase the dose by 10 mg until the maximum daily dose is reached.
ARKETIS Tablets 20 mg should be taken in the morning with a meal.
The tablet should be swallowed whole immediately, with a large amount of water (at least
1 glass of 150 ml). Do not suck, chew, or hold the tablet in the mouth, as this may cause
unpleasant local sensations such as bitter taste, burning in the throat, irritating cough, or a
choking sensation.
If necessary, the tablets may be divided into equal doses.
The doctor will discuss with the patient how long ARKETIS Tablets 20 mg should be taken. Treatment
may last for several months or even longer.
Elderly patients
The maximum dose for patients over 65 years of age is 40 mg per day.
Patients with liver or kidney disease
For patients with liver disease or severe kidney disease, the doctor may prescribe a lower dose of
ARKETIS Tablets 20 mg than the usual dose.
Taking more than the recommended dose of ARKETIS Tablets 20 mg
Never take more tablets than prescribed by the doctor.
If the patient (or another person) has taken too many ARKETIS Tablets 20 mg, seek immediate
medical advice from a doctor or go to hospital. Bring the medicine packaging with you.
In case of overdose with ARKETIS Tablets 20 mg, in addition to the known adverse reactions (see
section 4: Possible side effects), the following symptoms may occur: fever, uncontrolled muscle
spasms.
Missing a dose of ARKETIS Tablets 20 mg
The medicine should be taken daily at the same time.
If a dose of ARKETIS Tablets 20 mg is missed and the patient remembers in the evening before
going to sleep, the dose should be taken as soon as possible. The next day, continue taking the
medicine according to the usual dosing schedule.
If the patient remembers about the missed dose during the night or the next day, the missed dose
should not be taken. The patient may experience withdrawal symptoms, but these should quickly
resolve after taking the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
What to do if there is no improvement
ARKETIS Tablets 20 mg do not relieve symptoms of illness immediately – all antidepressant
medicines take time to start working. In some patients, improvement occurs after several weeks,
while for others it may take longer. Some patients taking antidepressants may feel worse before
they start to feel better. If after several weeks of treatment the patient does not experience
improvement, they should contact their doctor. The doctor should schedule a follow-up visit a few
weeks after starting treatment. Inform the doctor if the patient has not started to feel better.
Stopping treatment with ARKETIS Tablets 20 mg
Do not stop taking ARKETIS Tablets 20 mg unless advised by the doctor.
When discontinuing ARKETIS Tablets 20 mg, the treating doctor will advise on how to gradually
reduce the dose over several weeks or months to minimize the risk of withdrawal symptoms. One
approach is to gradually reduce the patient's dose of ARKETIS Tablets 20 mg by 10 mg per week.
For most patients, withdrawal symptoms are mild and resolve on their own within two weeks. In
some patients, symptoms may be more severe or may last longer.
If the patient experiences withdrawal symptoms after stopping the tablets, the doctor may decide
that the patient should taper the medicine more slowly. In case of severe withdrawal symptoms while
discontinuing ARKETIS Tablets 20 mg, contact the doctor. The doctor may recommend restarting the
tablets and tapering them more gradually.
Even if withdrawal symptoms occur, it is possible to discontinue ARKETIS Tablets 20 mg.
Withdrawal symptoms that may occur after stopping treatment
According to studies, one or more withdrawal symptoms occur in 3 out of 10 patients after
stopping treatment with paroxetine. Some symptoms occur more frequently than others.
Common side effects (may occur in up to 1 in 10 people):

• dizziness, unsteady gait, or balance disturbances;
• tingling sensations, burning sensations, and (less commonly) electric shock-like sensations affecting the head, as well as ringing, buzzing, whistling, or other persistent sounds in the ears (tinnitus);
• sleep disturbances (vivid dreams, nightmares, insomnia);
• feeling of anxiety;
• headache.

Uncommon side effects (may occur in up to 1 in 1,000 people):

• nausea;
• sweating (including night sweats);
• feeling restless or agitated;
• tremor;
• feeling confused or disoriented;
• diarrhea (loose stools);
• emotional lability or irritability;
• visual disturbances;
• palpitations or increased heart rate (heart pounding).

If the patient is concerned about symptoms after stopping ARKETIS Tablets 20 mg,
they should contact their doctor.
If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The likelihood of these reactions is higher during the first few weeks of treatment.
If any of the following adverse reactions occur during treatment, you should
contact your doctor. Going directly to hospital may be necessary.

Uncommon adverse reactions (may occur in up to 1 in 100 people):

• If the patient notices unusual bruising or bleeding, including vomiting blood or blood in the stool, contact a doctor or go to hospital.
• If the patient has difficulty passing urine, contact a doctor or go to hospital.

Rare adverse reactions (may occur in up to 1 in 1,000 people):

• If the patient has a seizure (convulsions), contact a doctor or go immediately to hospital.
• If the patient feels restless and has an inability to sit or stand still, these may be symptoms of a condition called akathisia. Increasing the dose of the medicine may worsen these symptoms. If these symptoms occur, contact a doctor.
• If the patient experiences fatigue, weakness, pain, stiffness or lack of muscle coordination, is disoriented, they may have low blood sodium levels. If such symptoms occur, contact a doctor.

Very rare adverse reactions (may occur in up to 1 in 10,000 people):

• Allergic reactions to paroxetine, which may be severe. If a red, bumpy rash appears on the skin, or swelling of the eyelids, face, lips, mouth or tongue occurs, or itching, difficulty breathing (shortness of breath), difficulty swallowing, or a feeling of weakness or dizziness leading to collapse or loss of consciousness, contact a doctor or go to hospital.
• If the patient experiences some or all of the following symptoms, they may be experiencing serotonin syndrome or neuroleptic malignant syndrome. These symptoms include: feeling highly agitated or irritable, disorientation, anxiety, fever, sweating, tremor, chills, hallucinations (strange visions or hearing strange sounds), muscle stiffness, sudden muscle contractions or rapid heartbeat. Symptoms may worsen, leading to loss of consciousness. If such symptoms occur, contact a doctor.
• Acute angle-closure glaucoma. If the patient experiences eye pain or blurred vision, contact a doctor.

Frequency not known (frequency cannot be determined from available data):

• In some patients, during or shortly after discontinuation of paroxetine treatment, thoughts of self-harm or suicide occurred (see section 2, "Warnings and precautions").
• In some patients, aggression occurred during paroxetine therapy.
• Severe vaginal bleeding shortly after childbirth (postpartum haemorrhage) (see additional information in subsection Pregnancy, breastfeeding and effect on fertility in section 2).

If any of these adverse reactions occur, contact the doctor
in charge.

Other possible adverse reactions occurring during treatment

Very common adverse reactions (may occur in more than 1 in 10 people):

• nausea. Taking the medicine in the morning with food will reduce the likelihood of nausea;
• changes in sexual desire or sexual function, such as difficulty or inability to achieve orgasm, reduced sexual desire, and in men, problems achieving or maintaining erection or ejaculation.

Common adverse reactions (may occur in up to 1 in 10 people):

• increased blood cholesterol levels;
• loss of appetite;
• sleep disturbances (insomnia) or drowsiness;
• unusual dreams (including nightmares);
• dizziness or tremor;
• headache;
• difficulty concentrating;
• feeling of restlessness;
• feeling of excessive tiredness;
• blurred vision;
• yawning, dry mouth;
• diarrhoea or constipation;
• vomiting;
• weight gain;
• sweating.

Uncommon adverse reactions (may occur in up to 1 in 100 people):

• short-term increase in blood pressure or short-term drop in blood pressure when standing up suddenly, which may cause dizziness or fainting;
• faster than usual heartbeat;
• difficulty moving, stiffness, tremor or abnormal movements in the mouth or tongue;
• dilated pupils;
• skin rash;
• itching;
• feeling of disorientation;
• hallucinations (seeing or hearing things that are not there);
• inability to pass urine (urinary retention) or uncontrolled, involuntary passing of urine (urinary incontinence);
• if the patient has diabetes, treatment with ARKETIS tablets 20 mg may lead to worsening of blood sugar control. Discuss with your doctor whether the dose of insulin or antidiabetic medicines needs to be adjusted;
• decreased white blood cell count.

Rare adverse reactions (may occur in up to 1 in 1,000 people):

• abnormal milk production in women and men;
• slow heartbeat;
• changes in liver function (shown in blood test results);
• panic attacks;
• hyperactivity or racing thoughts (mania);
• feeling detached from one's body (depersonalization);
• feeling anxious;
• uncontrollable urge to move the legs (restless legs syndrome);
• joint and muscle pain;
• increased levels of a hormone called prolactin in the blood;
• menstrual disorders (including heavy or irregular bleeding, intermenstrual bleeding, or absence or delay of menstruation).

Very rare adverse reactions (may occur in up to 1 in 10,000 people):

• skin rash with blisters resembling small targets (dark center surrounded by a lighter ring with a dark border), known as erythema multiforme;
• widespread blistering rash with peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome);
• widespread blistering rash with peeling skin over almost the entire body (toxic epidermal necrolysis);
• liver function disorders causing yellowing of the skin or whites of the eyes;
• syndrome of inappropriate antidiuretic hormone secretion (SIADH), resulting in excessive water retention and low sodium (salt) levels. Patients with SIADH may have symptoms of serious illness or may have no symptoms at all;
• fluid or water retention, which may cause swelling of the hands or feet;
• sensitivity to sunlight;
• painful, persistent penile erection;
• decreased platelet count.

Frequency not known (frequency cannot be determined from available data):

• inflammation of the colon (causing diarrhoea);
• teeth grinding.

Some patients may experience ringing, buzzing, whistling, or other persistent sounds in the ears (tinnitus) while taking ARKETIS tablets 20 mg.
Patients taking this type of medicine have shown an increased risk of bone fractures.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store ARKETIS tablets 20 mg

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and the blister. The expiry date refers to the last day of the stated month.
No special storage conditions required.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What ARKETIS 20 mg tablets contain
Each ARKETIS 20 mg tablet contains the active substance 20 mg of paroxetine
(in the form of anhydrous paroxetine hydrochloride).
The other ingredients are: microcrystalline cellulose (E460), calcium hydrogen phosphate dihydrate (E341),
sodium croscarmellose (E468), colloidal anhydrous silica (E551), and magnesium stearate (E470b).

What ARKETIS 20 mg tablets look like and contents of the pack
Tablet.
20 mg: round, flat tablet with bevelled edges, broken white in colour, marked with "20" on one side and a score line allowing division into equal doses.
Pack sizes of 10, 14, 28, 30, 56, 60, 90, 120, 180 or 500 tablets in blister packs are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
e-mail: [email protected]

Manufacturers:
Farmaceutisch Analytisch Laboratorium Duiven BV
Dijkgraaf 30, 6921 RL Duiven
The Netherlands
Medochemie Ltd – Factory AZ
2 Michael Erakleous str., Agios Athanasios Industrial Area
Agios Athanasios 4101 Limassol
Cyprus
Sanico NV
Veedijk 59, Turnhout,
2300, Belgium

This medicinal product is authorised in the member states of the European Economic Area under the following names:
Belgium Paroxetine EG 20 mg tabletten
Cyprus Arketis 20 mg tablets
Czech Republic Arketis 20 mg tablets
Estonia Arketis 20 mg tablets
Greece Paroxia 20 mg
Lithuania Arketis 20 mg tablets
Luxembourg Paroxetine EG 20 mg tabletten
Latvia Arketis 20 mg tablets
Malta Arketis 20 mg tablets
The Netherlands Paroxetine 20 mg tabletten
Poland ARKETIS 20 mg tablets
Slovakia Arketis 20 mg tablets