Arketis tabletki 20 mg

Leaflet accompanying the packaging: patient information

ARKETIS Tablets 20 mg, tablets

Paroxetine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is ARKETIS Tablets 20 mg and what is it used for
• 2. Important information before taking ARKETIS Tablets 20 mg
• 3. How to take ARKETIS Tablets 20 mg
• 4. Possible side effects
• 5. How to store ARKETIS Tablets 20 mg
• 6. Contents of the packaging and other information

1. What is ARKETIS Tablets 20 mg and what is it used for

ARKETIS Tablets 20 mg is indicated for the treatment of adults with depression and/or anxiety disorders.

Anxiety disordersfor which ARKETIS Tablets 20 mg is used include:
obsessive-compulsive disorder (recurring, intrusive thoughts with uncontrollable behavior), panic disorder with or without agoraphobia (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 strong anxiety or nervousness).
ARKETIS Tablets 20 mg belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). The mechanism of action of ARKETIS Tablets 20 mg and other SSRIs is not fully understood, but they may increase the concentration of serotonin in the brain. Proper treatment of depression or anxiety disorders is essential for improving the patient's well-being.

2. Important information before taking ARKETIS Tablets 20 mg

When not to take ARKETIS Tablets 20 mg:

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

If any of the above situations apply to the patient, they should contact their doctor before taking ARKETIS Tablets 20 mg.

Warnings and precautions

Before starting treatment with ARKETIS Tablets 20 mg, the patient should discuss the following with their doctor or pharmacist:

• Is the patient taking any other medicines (see section "ARKETIS Tablets 20 mg and other medicines" later in this leaflet)?
• Is the patient taking tamoxifen for breast cancer or fertility problems? ARKETIS Tablets 20 mg may reduce the effectiveness of tamoxifen, so the doctor may recommend a different antidepressant.
• Does the patient have kidney, liver, or heart problems?
• Does the patient have abnormal heart rhythm (prolonged QT interval) on an electrocardiogram (ECG)?
• Has the patient or their family members had a prolonged QT interval, heart disease such as heart failure, low heart rate, or decreased potassium or magnesium levels?
• Does the patient have epilepsy or has the patient had seizures in the past?
• Has the patient had episodes of mania (excessive activity or racing thoughts) in the past?
• Is the patient being treated with electroconvulsive therapy (ECT)?
• Has the patient had bleeding or is the patient taking other medicines that may increase the risk of bleeding (blood thinners, such as warfarin, antipsychotic drugs, such as perphenazine or clozapine, tricyclic antidepressants, pain and anti-inflammatory drugs, such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, and meloxicam)?
• Does the patient have diabetes?
• Is the patient on a low-sodium diet?
• Does the patient have glaucoma (increased eye pressure)?
• Is the patient pregnant or planning to become pregnant (see "Pregnancy, breastfeeding, and fertility" later in this leaflet)?
• Is the patient under 18 years old (see "Use in children and adolescents under 18 years old" later in this leaflet)?

If the answer to any of the above questions is YESand the patient has not yet consulted their doctor, they should consult their doctor againand ask how to take ARKETIS Tablets 20 mg.

Children and adolescents

ARKETIS Tablets 20 mg should not be used in the treatment of children and adolescents

under 18 years old. In patients under 18 years old, taking ARKETIS Tablets 20 mg increases the risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). If the doctor has prescribed ARKETIS Tablets 20 mg to a patient under 18 years old, in case of any doubts, the patient should consult their doctor again. If the above symptoms occur or worsen during treatment with ARKETIS Tablets 20 mg, the patient should inform their doctor. Additionally, there is currently no data on the long-term safety of paroxetine use in this age group regarding growth, maturation, and cognitive and behavioral development.
In clinical trials in patients under 18 years old taking paroxetine, common side effects that occurred with a frequency of less than 1 in 10 were: increased suicidal thoughts and attempts, intentional self-injury, hostility, aggressive or unfriendly behavior, loss of appetite, tremors, sweating, restlessness (excessive energy), excitement, emotional instability (including tearfulness and mood changes), and unusual bruising or bleeding (such as nosebleeds).
These studies also showed that such symptoms, although less frequent, occurred in children and adolescents taking a placebo (an inactive substance) instead of paroxetine.
Some participants in these studies experienced withdrawal symptoms after stopping paroxetine. These symptoms were mostly similar to those observed in adult patients after stopping paroxetine (see section 3: "How to take ARKETIS Tablets 20 mg" later in this leaflet).
Additionally, in patients under 18 years old, the following side effects occurred frequently (in less than 1 in 10 patients): abdominal pain, nervousness, and emotional instability (including tearfulness, mood changes, self-injury, suicidal thoughts, and suicidal attempts).

Suicidal thoughts, worsening of depression or anxiety disorders

In patients with depression and/or anxiety disorders, suicidal thoughts or self-injury may sometimes occur. They may be more likely to occur at the beginning of treatment with antidepressants, as it may take some time, usually about two weeks, for the medicines to start working, and sometimes even longer.

Such conditions are more likely to occur:

• if the patient has had suicidal thoughts or self-injury in the past;
• if the patient is a young adult. Data from clinical trials indicate an increased risk of suicidal behavior in adults under 25 years old with mental disorders who were treated with antidepressants.

If suicidal thoughts or self-injury occur at any time, the patient should contact their doctor or go to the hospital immediately.
It may be helpful to inform relatives or friendsabout the patient's depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to tell them if they notice that the depression or anxiety disorder is worsening or if there are any worrying changes in the patient's behavior.

Important side effects that have been observed with paroxetine

In some patients taking ARKETIS Tablets 20 mg, symptoms called akathisia may develop, with symptoms such as a feeling of psychomotor restlessness with an inability to sit or stand still. In other patients, a condition called serotonin syndrome or malignant neuroleptic syndrome may develop, with symptoms such as feeling strongly excited or irritated, feeling disoriented, anxious, hot, sweating, trembling, chills, hallucinations (seeing or hearing things that are not there), muscle stiffness, sudden muscle contractions, or rapid heartbeat. The 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 side effects of ARKETIS Tablets 20 mg can be found in section 4 ("Possible side effects").
Medicines like ARKETIS Tablets 20 mg (SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was stopped.

ARKETIS Tablets 20 mg and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may affect the action of ARKETIS Tablets 20 mg or increase the risk of side effects.
ARKETIS Tablets 20 mg may also affect the action of other medicines. These medicines include:

• monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue (methylthioninium chloride)) - see section "When not to take ARKETIS Tablets 20 mg";
• medicines known to affect the heart's electrical activity (e.g., antipsychotic drugs tiordiazine or pimozide) - see section "When not to take ARKETIS Tablets 20 mg";
• acetylsalicylic acid, ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, etodolac, diclofenac, and meloxicam, used to treat pain and inflammation;
• tramadol, buprenorphine, and pethidine, which are painkillers;
• buprenorphine in combination with naloxone, used for opioid substitution treatment;
• triptans, such as sumatriptan, used to treat migraines;
• other antidepressants, including selective serotonin reuptake inhibitors (SSRIs), tryptophan, and tricyclic antidepressants, such as clomipramine, nortriptyline, and desipramine;
• dietary supplement called tryptophan;
• miwakurium and suxamethonium (used in general anesthesia);
• medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotic drugs), used to treat certain mental disorders;
• fentanyl, used in anesthesia or chronic pain treatment;
• the combination of fosamprenavir and ritonavir, used to treat HIV infection;
• St. John's Wort, a herbal preparation used in 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 tremors, especially in Parkinson's disease;
• warfarin or other anticoagulant medicines (blood thinners) used to prevent blood clots;
• 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;
• rifampicin, used to treat tuberculosis and leprosy;
• 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 above medicines

and has not yet discussed this with their doctor, they should consult their doctor again. It may be necessary to change the dose or switch to a different medicine.

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The patient should also tell their doctor or pharmacist about medicines that are available without a prescription.

Taking ARKETIS Tablets 20 mg with food, drink, and alcohol

While taking ARKETIS Tablets 20 mg, the patient should not drink alcohol, as it may worsen the symptoms of the disease or side effects. Taking ARKETIS Tablets 20 mg in the morning, with a meal, reduces the risk of nausea.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a baby, they should consult their doctor or pharmacist before taking ARKETIS Tablets 20 mg.
There are reports of an increased risk of congenital defects, especially 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 and is 2 in 100 children.
The doctor, in agreement with the patient, may decide whether to switch to a different medicine during pregnancy or to gradually stop taking ARKETIS Tablets 20 mg. However, depending on the patient's condition, the doctor may suggest that it is better for the patient to continue taking ARKETIS Tablets 20 mg.

The patient should inform their midwife and/or doctor that they are taking ARKETIS Tablets 20 mg.

Taking ARKETIS Tablets 20 mg at the end of pregnancy may increase the risk of severe vaginal bleedingoccurring shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking ARKETIS Tablets 20 mg, they should inform their doctor or midwife so that they can provide appropriate advice. Medicines like ARKETIS Tablets 20 mg taken during pregnancy, especially in the last trimester, may increase the risk of a condition called persistent pulmonary hypertension of the newborn (PPHN).
In PPHN, the blood pressure in the blood vessels between the heart and lungs is too high. If the patient is taking ARKETIS Tablets 20 mg during the last three months of pregnancy, the newborn may also experience other disorders that usually occur in the first day of life. These symptoms include:

• difficulty breathing
• bluish discoloration of the skin or increased or decreased body temperature
• bluish discoloration of the lips
• vomiting or difficulty sucking
• excessive tiredness, inability to sleep, or persistent crying
• stiffness or limpness of the muscles
• tremors, restlessness, or seizures
• increased reflexes

If the baby experiences any of these symptoms after birth, the patient should contact their doctor or midwife for advice.
Paroxetine may pass into breast milk in small amounts. If the patient is taking ARKETIS Tablets 20 mg, they should consult their doctor before breastfeeding. The doctor, together with the patient, will decide whether to breastfeed while taking ARKETIS Tablets 20 mg.
In animal studies, paroxetine has been shown to reduce sperm quality. This could theoretically affect fertility, but it has not been observed in humans yet.

Driving and using machines

Possible side effects of ARKETIS Tablets 20 mg include dizziness, confusion, drowsiness, or vision disturbances. If these side effects occur, the patient should not drive or operate machinery.

ARKETIS Tablets 20 mg contains sodium

ARKETIS Tablets 20 mg contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take ARKETIS Tablets 20 mg

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should consult their doctor or pharmacist.
Sometimes the recommended dose requires taking more than one tablet or half a tablet.
Typical dosing for the treatment of various diseases is shown in the table below.

At the beginning of treatment, the doctor will indicate the dose of ARKETIS Tablets 20 mg that the patient should take.

In most people, improvement in well-being occurs after a few 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 a bitter taste, burning in the throat, irritating cough, or a feeling of choking.
If necessary, the tablets can be divided into equal doses.
The doctor will discuss with the patient how long to take ARKETIS Tablets 20 mg. Treatment may last several months or even longer.

Elderly patients

The maximum dose for patients over 65 years old is 40 mg per day.

Patients with liver or kidney disease

The doctor may recommend a lower dose of ARKETIS Tablets 20 mg for patients with liver or severe kidney disease.

Taking more than the recommended dose of ARKETIS Tablets 20 mg

Never take more tablets than prescribed by the doctor.

If the patient (or someone else) has taken too many ARKETIS Tablets 20 mg, they should contact their doctor or go to the hospital immediately. They should show the packaging of the medicine.
In addition to the known side effects (see section 4, "Possible side effects"), the following symptoms may occur in case of an overdose of ARKETIS Tablets 20 mg: fever, uncontrolled muscle contractions.

Missing a dose of ARKETIS Tablets 20 mg

The medicine should be taken every day at the same time.

If a dose of ARKETIS Tablets 20 mg is missed and the patient remembers

in the evening before bedtime, they should take the medicine as soon as possible. The next day, they should continue taking the medicine according to the usual dosing schedule.
If the patient remembers to take the medicine at night or the next day, they should not take the missed dose. The patient may experience withdrawal symptoms, but they should resolve quickly after taking the next dose at the usual time.
The patient should not take a double dose to make up for the missed dose.

What to do if there is no improvement

ARKETIS Tablets 20 mg does not relieve symptoms immediately - all antidepressants start working only after some time. In some patients, improvement occurs after a few weeks, in others, it may take a little longer. Some patients taking antidepressants feel worse before they start feeling better. If the patient does not feel better after a few weeks of treatment, they should consult their doctor. The doctor should recommend that the patient have a follow-up visit after a few weeks of starting treatment. The patient should inform their doctor if they have not started feeling better.

Stopping treatment with ARKETIS Tablets 20 mg

The patient should not stop taking ARKETIS Tablets 20 mg unless their doctor advises them to do so.

When stopping ARKETIS Tablets 20 mg, the doctor will inform the patient how to gradually reduce the dose over several weeks or months to minimize the risk of withdrawal symptoms. One way to do this is to gradually decrease the dose of ARKETIS Tablets 20 mg by 10 mg per week. In 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 symptomsafter stopping ARKETIS Tablets 20 mg, the doctor may decide that the patient should stop taking the medicine more slowly. If the withdrawal symptoms are severe, the doctor may recommend restarting the tablets and stopping them more slowly.

Even if withdrawal symptoms occur, it is possible to stop taking ARKETIS Tablets 20 mg.

Withdrawal symptoms that may occur after stopping treatment

According to studies, 3 out of 10 patients who stopped taking paroxetine experienced one or more withdrawal symptoms. 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;
• a feeling of tingling, burning, or (less commonly) electric shock sensations, including the head, and buzzing, hissing, whistling, ringing, or other persistent sounds in the ears (tinnitus);
• sleep disturbances (vivid dreams, nightmares, insomnia);
• a feeling of anxiety;
• headaches.

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

• nausea (nausea);
• sweating (including night sweats);
• a feeling of restlessness or agitation;
• tremors;
• a feeling of disorientation or confusion;
• diarrhea (loose stools);
• emotional instability or irritability;
• visual disturbances;
• palpitations or rapid heartbeat.

If the patient is concerned about withdrawal symptoms from ARKETIS Tablets 20 mg, they should contact their doctor.

In case of further doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, ARKETIS Tablets 20 mg can cause side effects, although not everybody gets them.
The likelihood of side effects is higher in the first few weeks of treatment.

If any of the following side effects occur during treatment, the patient should

contact their doctor. It may be necessary to go to the hospital immediately.

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

• If the patient notices unusual bruising or bleeding, including bloody vomiting or blood in the stool, they should contact their doctor or go to the hospital.
• If the patient has difficulty urinating, they should contact their doctor or go to the hospital.

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

• If the patient has a seizure (convulsions), they should contact their doctor or go to the hospital immediately.
• If the patient feels restless and has a feeling of being unable 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, the patient should contact their doctor.

• If the patient feels tired, weak, painful, stiff, or has difficulty coordinating their muscles, they may have low sodium levels in the blood. If these symptoms occur, the patient should contact their doctor.

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

• Severe allergic reactions to paroxetine, which can be life-threatening. If a red, lumpy rash appears on the skin, swelling of the eyelids, face, lips, mouth, or tongue, itching, difficulty breathing (dyspnea), or a feeling of weakness or fainting occurs, the patient should contact their doctor or go to the hospital.
• If the patient has some or all of the following symptoms, they may have serotonin syndrome or malignant neuroleptic syndrome. These symptoms include: feeling strongly excited or irritated, feeling disoriented, anxious, hot, sweating, trembling, chills, hallucinations (seeing or hearing things that are not there), muscle stiffness, sudden muscle contractions, or rapid heartbeat. The symptoms may worsen, leading to loss of consciousness. If the patient notices any of these symptoms, they should contact their doctor.
• Acute glaucoma. If the patient experiences eye pain or blurred vision, they should contact their doctor.

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

• in some patients taking paroxetine or shortly after stopping treatment, suicidal thoughts or self-injury have occurred (see section 2, "Warnings and precautions").
• in some patients, aggression has occurred during paroxetine treatment.
• severe postpartum hemorrhage (postpartum hemorrhage), (see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2).

If the patient experiences any of these side effects, they should contact their doctor.

Other possible side effects that may occur during treatment

Very common side effects (may occur in more than 1 in 10 people):

• nausea (nausea). Taking the medicine in the morning with a meal reduces the likelihood of nausea;
• changes in sexual desire or sexual function, such as difficulty or inability to achieve orgasm, decreased sexual desire, and, in men, difficulty achieving an erection or ejaculation.

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

• increased cholesterol levels in the blood;
• loss of appetite;
• difficulty sleeping (insomnia) or feeling drowsy;
• unusual dreams (including nightmares);
• dizziness or tremors;
• headaches;
• concentration disorders;
• a feeling of excitement;
• a feeling of excessive weakness;
• visual disturbances;
• yawning, dry mouth;
• diarrhea or constipation;
• vomiting;
• weight gain;
• sweating.

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

• temporary increase in blood pressure or temporary decrease in blood pressure when standing up, which can cause dizziness or fainting;
• rapid heartbeat;
• difficulty moving, stiffness, tremors, or abnormal movements in the mouth or tongue;
• dilated pupils;
• skin rashes;
• itching;
• a feeling of disorientation;
• hallucinations (seeing or hearing things that are not there);
• inability to urinate (urinary retention) or involuntary urination (urinary incontinence);
• if the patient has diabetes, taking ARKETIS Tablets 20 mg may worsen blood sugar control. The patient should discuss with their doctor adjusting the dose of insulin or oral hypoglycemic medicines;
• decreased white blood cell count.

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

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

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

• a skin rash with blisters, which looks like a target (a dark center surrounded by a lighter area with a dark edge), called erythema multiforme;
• a widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome);
• a widespread rash with blisters and peeling skin almost all over the body (toxic epidermal necrolysis);
• liver function disorders, which cause yellowing of the skin or whites of the eyes;
• a syndrome of inappropriate antidiuretic hormone secretion (SIADH), in which there is excessive water retention and decreased sodium levels. Patients with SIADH may have symptoms of severe illness or may not show any symptoms;
• fluid retention or water retention, which can cause swelling of the hands or feet;
• sensitivity to sunlight;
• painful, persistent erection of the penis;
• decreased platelet count.

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

• inflammation of the colon (causing diarrhea);
• grinding of the teeth;

Some patients taking ARKETIS Tablets 20 mg may experience buzzing, hissing, whistling, ringing, or other persistent sounds in the ears (tinnitus) during treatment.
Patient's taking this type of medicine have been observed to have an increased risk of fractures.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store ARKETIS Tablets 20 mg

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the month.
There are no special storage precautions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What ARKETIS Tablets 20 mg contains

Each tablet of ARKETIS Tablets 20 mg contains the active substance paroxetine (in the form of paroxetine hydrochloride anhydrous) at a dose of 20 mg.
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 Tablets 20 mg looks like and contents of the pack

Tablet.
20 mg: round, flat tablet with beveled edges, white, with "20" engraved on one side and a score line allowing for division into equal doses.
Available in packs of 10, 14, 28, 30, 56, 60, 90, 120, 180, or 500 tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:
Vipharm S.A.
A. and F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
e-mail: [email protected]
Manufacturer:
Farmaceutisch Analytisch Laboratorium Duiven BV
Dijkgraaf 30, 6921 RL Duiven
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 authorized in the Member States of the European Economic Area under the following names:

Belgium
Paroxetine EG 20 mg tablets
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 tablets
Latvia
Arketis 20 mg tablets
Malta
Arketis 20 mg tablets
Netherlands
Paroxetine 20 mg tablets
Poland
ARKETIS Tablets 20 mg, tablets
Slovakia
Arketis 20 mg tablets

Date of last revision of the leaflet: November 2024