Paxtin 40

Leaflet accompanying the packaging: patient information

Paxtin 20, 20 mg, coated tablets

Paxtin 40, 40 mg, coated 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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Paxtin and what is it used for

Paxtin is indicated for the treatment of adults with depression and/or anxiety disorders.

Anxiety disorders for which Paxtin is used include: obsessive-compulsive disorder (recurring, intrusive thoughts with uncontrollable behavior); panic disorder (panic attacks, also 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 strong anxiety or nervousness).
Paxtin belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRI). Each person has a substance called serotonin in their brain. In people with depression or anxiety disorders, the concentration of serotonin is lower than in others. The mechanism of action of Paxtin and other SSRI medicines 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 Paxtin

When not to take Paxtin

If the patient is taking medicines called monoamine oxidase inhibitors(so-called MAOIs, including moclobemide and methylthioninium chloride [methylene blue]) or has taken them within the last two weeks. The doctor will provide information on how to start taking Paxtin after stopping MAOI.
If the patient is taking antipsychotic medicinesthioridazine 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 consult a doctor without taking Paxtin.

Warnings and precautions

Before starting Paxtin, the patient should discuss it with their doctor or pharmacist.

Is the patient taking other medicines (see "Paxtin and other medicines" later in the leaflet)?
Is the patient taking tamoxifen for breast cancer treatment [or fertility disorders]? Paxtin may reduce the effectiveness of tamoxifen, so the doctor may recommend using a different antidepressant.
Does the patient have kidney, liver, or heart problems?
Does the patient have a history of epilepsy or seizures?
Has the patient ever had a manic episode (excessively active behavior or racing thoughts)?
Is the patient being treated with electroconvulsive therapy?
Has the patient had bleeding disorders or is taking medicines that increase the risk of bleeding [including medicines used to thin the blood (such as warfarin), antipsychotic medicines (such as perphenazine or clozapine), tricyclic antidepressants, pain and anti-inflammatory medicines with the name non-steroidal anti-inflammatory drugs or NSAIDs (such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)]?
Is the patient pregnant or planning to become pregnant (see "Pregnancy, breastfeeding, and fertility" later in the leaflet)?
Does the patient have diabetes?
Is the patient on a low-sodium diet?
Does the patient have glaucoma (increased eye pressure)?
Is the patient under 18 years old (see "Children and adolescents under 18 years old" later in the leaflet)?
If the answer to any of the above questions is YESand the patient has not discussed it with their doctor, they should consult their doctor again and ask about taking Paxtin.

Children and adolescents under 18 years old

Paxtin should not be used in children and adolescents under 18 years old.In patients under 18 years old, taking Paxtin increases the risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and signs of anger). If a doctor has prescribed Paxtin to a patient under 18 years old and this has caused concerns, the patient should consult the doctor. If the patient experiences or worsens the mentioned symptoms while taking Paxtin, they should inform their doctor. Additionally, there is currently a lack of data on the long-term safety of Paxtin in this age group regarding growth, maturation, and cognitive and behavioral development.
In paroxetine studies in patients under 18 years old, common side effects (occurring in less than 1 in 10 patients) were: increased frequency of suicidal thoughts and attempts; self-harm; hostility; aggressive or unfriendly behavior; loss of appetite; tremors; abnormal sweating; excessive activity (excess energy); excitement; emotional instability (including tearfulness and mood changes) and unusual bruising or bleeding (e.g., nosebleeds). These studies also showed that such symptoms occurred, although less frequently, in children and adolescents taking sugar tablets (placebo) instead of paroxetine.
Some participants in these studies experienced withdrawal symptoms after stopping paroxetine. These symptoms were usually similar to those observed in adult patients after stopping paroxetine (see section 3 "How to take Paxtin" later in the leaflet).
In patients under 18 years old, frequent (less than 1 in 10 people) side effects included abdominal pain, nervousness, and emotional instability (including tearfulness, mood changes, self-harm attempts, suicidal thoughts, and attempts).

Suicidal thoughts, worsening of depression or anxiety disorders

People with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. These thoughts may worsen at the beginning of treatment with antidepressant medicines, as they usually start working after 2 weeks, sometimes later.

The occurrence of suicidal thoughts, self-harm thoughts, or suicide attempts is

more likely if:

• the patient has had suicidal thoughts or self-harm in the past;
• the patient is a young adult; clinical trial data indicate an increased risk of suicidal behavior in people under 25 years old with mental disorders who are being treated with antidepressant medicines.

If the patient experiences suicidal thoughts or self-harm thoughts, they should immediately contact their doctor or go to the hospital.
It may be helpful to inform relatives or friendsabout the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to monitor their condition and inform them if they notice that the depression or anxiety has worsened or if there are worrying changes in behavior.

Important side effects observed during Paxtin treatment

In some patients taking Paxtin, a disorder called "akathisia" may occur, with symptoms such as a feeling of psychomotor agitation with an inability to sit or stand still.
Another condition that may develop is serotonin syndrome or neuroleptic malignant syndromewith some or all of the following symptoms: severe agitation or irritability, confusion, restlessness, feeling of heat, sweating, tremors, shivers, hallucinations (strange images or sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. The severity of these symptoms may increase, leading to loss of consciousness. If any of these symptoms are observed, the patient should consult their doctor. More information on these or other side effects can be found in section 4 "Possible side effects".
Medicines like Paxtin (SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was stopped.

Paxtin and other medicines

Some medicines may affect the action of Paxtin or increase the risk of side effects in the patient. Paxtin may also affect the action of other medicines. These medicines include:
medicines called monoamine oxidase inhibitors(MAOIs, including moclobemide and methylthioninium chloride [methylene blue]) - see "When not to take Paxtin" above
thioridazine or pimozide (antipsychotic medicines) - see "When not to take Paxtin" above
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 (pain relief medicines)
buprenorphine in combination with naloxone, substitution treatment for opioid dependence
triptans (such as sumatriptan), used to treat migraines
other antidepressant medicines, including selective serotonin reuptake inhibitors (SSRIs), tryptophan, and tricyclic antidepressants, e.g., clomipramine, nortriptyline, and desipramine
dietary supplementcalled tryptophan
miwakurium and suxamethonium (used in general anesthesia)
medicines such as lithium, risperidone, perphenazine, clozapine (so-called antipsychotic medicines), used to treat certain mental disorders
fentanyl used in anesthesiaor chronic pain treatment;
the combination of fosamprenavir and ritonavir, used to treat HIV infection
St. John's Wort (a herbal antidepressant)
phenobarbital, phenytoin, sodium valproate, or carbamazepine, medicines used to treat seizuresor epilepsy
atomoxetine, a medicine used to treat attention deficit hyperactivity disorder (ADHD)
procyclidine, a medicine used to relieve Parkinson's disease tremors
warfarin or other blood-thinning medicinesused to prevent blood clots
propafenone, flecainide, and medicines used to treat irregular heart rhythm
metoprolol, a beta-blocker used to treat high blood pressureand heart disease
pravastatin used to treat high cholesterol
rifampicin, a medicine used to treat tuberculosis
linezolid (antibiotic)
tamoxifen, a medicine used to treat breast cancer[or fertility disorders]

If the patient is currently taking or has recently taken any of the above medicines

and has not discussed it with their doctor, they should consult their doctor again. A dose change or a change to a different medicine may be necessary.

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.

Paxtin with food, drink, and alcohol

While taking Paxtin, the patient should not drink alcohol, as it may worsen the symptoms of the disease or side effects. Taking Paxtin in the morning, during breakfast, reduces the risk of nausea.

Pregnancy, breastfeeding, and fertility

Pregnancy

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
There are reports that children whose mothers took paroxetine during the first months of pregnancy have an increased risk of congenital defects, especially heart defects. While the frequency of congenital heart defects in the general population is 1 in 100, in children of mothers treated with paroxetine, it increases to 2 in 100.
The doctor, in agreement with the pregnant patient, may decide that the best solution for her is to change the medicine or gradually stop taking Paxtin. However, depending on the patient's condition, the doctor may consider it better for her to continue taking Paxtin.

The patient should ensure that their midwife or doctor knows that they are taking Paxtin.

Medicines like Paxtin, taken during pregnancy, especially in the later stages, may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the heart and lungs of the newborn is too high. If the patient takes Paxtin in the last 3 months of pregnancy, the newborn may also experience other disorders that usually occur in the first day of life. These include:
breathing difficulties
bluish discoloration of the skin or increased or decreased body temperature
bluish discoloration of the lips
vomiting or difficulty sucking
severe fatigue, inability to sleep, or persistent crying
muscle stiffness or floppiness
tremors or seizures
increased reflexes
If the newborn experiences any of these symptoms or the patient is concerned about the baby's health, they should contact their doctor or midwife, who will provide them with the necessary explanations.
Taking Paxtin at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if the patient has a history of bleeding disorders. If the patient is taking Paxtin, they should inform their doctor or midwife so that they can provide them with the necessary advice.

Breastfeeding

Paxtin may pass into breast milk in very small amounts. Breastfeeding patients should consult their doctor before starting to breastfeed, and they will decide together whether it is possible to breastfeed while taking Paxtin.

Fertility

Animal studies have shown that paroxetine impairs sperm quality. This could theoretically affect fertility, but it has not been observed in humans so far.

Driving and using machines

Possible side effects of Paxtin include dizziness, disorientation, drowsiness, or blurred vision. If the patient experiences these symptoms, they should not drive or operate machinery.

Paxtin contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Paxtin

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Sometimes the recommended dose requires taking more than one tablet or half a tablet.
Recommended doses for different indications are presented in the following table:

The doctor will indicate the dose of Paxtin that the patient should take at the beginning of treatment.
Improvement in well-being usually 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 (each time by 10 mg) until the maximum daily dose is reached.

The tablets should be taken in the morning, during breakfast.

They should be swallowed with water.

They should not be chewed.

If necessary, the tablets can be divided into equal doses.

The doctor will inform the patient how long they should take the tablets. Treatment may last for many 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 problems

Patients with liver or kidney problems may be prescribed a lower dose of Paxtin by their doctor.

Taking a higher dose of Paxtin than recommended

The patient should never take more tablets than recommended by their doctor. If the patient (or another person) has taken a higher dose of Paxtin than recommended, they should consult their doctor or go to the nearest hospital. They should show the packaging of the medicine. Overdose of Paxtin may cause symptoms listed in section 4 "Possible side effects" or fever, involuntary muscle contractions.

Missing a dose of Paxtin

The medicine should be taken every day at the same time.
If the patient forgets to take a dose and remembers before going to bed- they should take the medicine immediately, and the next day take it as usual.
If the patient remembers to take the medicine at night or the next day- they should skip that dose. It is possible that withdrawal symptoms may occur, but they should pass after taking the next dose at the usual time.
The patient should not take a double dose to make up for the missed tablet.

What to do if there is no improvement in well-being

Paxtin does not provide immediate relief from symptoms. The onset of action of all antidepressant medicines requires time. In some people, it occurs within a few weeks, but in others, it may take a little longer. Some patients taking antidepressant medicines experience a worsening of their condition before they start to feel better. If the patient does not feel better after a few weeks of treatment, they should consult their doctor again. The doctor should schedule a follow-up visit a few weeks after starting treatment. The patient should inform their doctor about the lack of improvement in their well-being.

Stopping Paxtin treatment

The patient should not stop taking Paxtin without their doctor's advice.
When stopping Paxtin, the doctor will help gradually reduce the dose over several weeks or months, which should reduce the risk of withdrawal symptoms (withdrawal symptoms - see section "Possible side effects"). One method is to gradually reduce the dose of Paxtin by 10 mg per week. The symptoms that occur when stopping Paxtin are usually mild and go away on their own within two weeks. In some patients, they may be more severe or longer-lasting.
If withdrawal symptomsoccur during stoppingPaxtin, the doctor may recommend a slower dose reduction. If the withdrawal symptoms are severe, the patient should consult their doctor.
The doctor may recommend restarting the medicine and then stopping it much more slowly.

Even if the patient experiences withdrawal symptoms, it is still possible to stop taking Paxtin.

Possible withdrawal symptoms after stopping treatment

Studies have shown that 3 out of 10 patients notice one or more withdrawal symptoms when stopping paroxetine treatment. Some of these symptoms occur more frequently than others.
Common (may occur in less than 1 in 10 people):
dizziness, unsteadiness, or balance problems
feeling of tingling, burning, and (less frequently) electric shock sensations, also in the head
ringing, buzzing, whistling, or other persistent noises in the ears (tinnitus)
sleep disturbances (intense dreams, nightmares, insomnia)
anxiety
headaches
Uncommon (may occur in less than 1 in 100 people):
nausea
sweating (including night sweats)
feeling of anxiety or agitation
tremors
confusion or disorientation
diarrhea (loose stools)
emotional instability or irritability
vision disturbances
feeling of heartbeat or palpitations (palpitations)
If the patient is concerned about withdrawal symptoms after stopping Paxtin, they should consult their doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Paxtin can cause side effects, although not everybody gets them.
The occurrence of side effects is more likely in the first few weeks of taking Paxtin.

If any of the following side effects occur during treatment, the patient should contact their doctor.

It may be necessary to consult a doctor or go to the hospital immediately.
Uncommon side effects(may occur in less than 1 in 100 people)
If the patient experiences unusual bruising or bleeding, including blood in their vomit or stool, they should immediately contact their doctor or go to the hospital.

If the patient is unable to urinate, they should immediately contact their doctor or go to the hospital.

Rare side effects(may occur in less than 1 in 1,000 people)
If the patient experiences a seizure, they should immediately contact their doctor or go to the hospital.
If the patient feels anxious and unable to sit or stand still, these may be symptoms of a disorder called akathisia. Increasing the dose of Paxtin may worsen these symptoms. If they occur, the patient should consult their doctor.

If the patient feels tired, weak, or disoriented and experiences pain, stiffness, or lack of coordination

of movements, the cause may be low sodium levels in the blood. If such symptoms occur, the patient should consult their doctor.
Very rare side effects(may occur in less than 1 in 10,000 people)

Allergic reactions to the medicine, which can be severe.

If the patient experiences a red, raised rash on the skin, swelling of the eyelids, face, lips, mouth, or tongue, starts to feel itchy or has difficulty breathing (shortness of breath) or swallowing and feels weak or faint, leading to collapse or loss of consciousness, they should immediately contact their doctor or go to the hospital.

The occurrence of some or all of the following symptoms may indicate serotonin syndrome or neuroleptic malignant syndrome.

These symptoms include: severe agitation or irritability, confusion, restlessness, feeling of heat, sweating, tremors, shivers, hallucinations (strange images or sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. The severity of these symptoms may increase, leading to loss of consciousness. In this case, the patient should consult their doctor.

Acute glaucoma.

If the patient experiences eye pain or blurred vision, they should consult their doctor.

Side effects with unknown frequency

(frequency cannot be estimated from the available data)
Some people have had thoughts of self-harm or suicide while taking paroxetine or soon after stopping it (see section 2).
Some people have shown aggression while taking paroxetine.
Severe postpartum hemorrhage, occurring shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy" in section 2.

If the patient experiences these side effects, they should consult their doctor.

Other possible side effects during treatment

Very common side effects(may occur in more than 1 in 10 people)
Nausea. Taking Paxtin in the morning, during breakfast, reduces the risk of nausea.
Changes in sex drive or sexual function, e.g., lack of orgasm and erectile dysfunction or ejaculation disorders
Common side effects(may occur in less than 1 in 10 people)
Increased cholesterol levels in the blood
Lack of appetite
Insomnia or drowsiness
Abnormal dreams (including nightmares)
Dizziness or tremors
Headache
Difficulty concentrating
Agitation
Feeling of unusual weakness
Blurred vision
Yawning, dry mouth
Diarrhea or constipation
Vomiting
Weight gain
Sweating
Uncommon side effects(may occur in less than 1 in 100 people)
Rapid increase or decrease in blood pressure, which may cause dizziness or fainting when standing up quickly
Faster than normal heart rate
Lack of movement, stiffness, tremors, or abnormal movements of the mouth and tongue muscles
Pupil dilation
Skin rash
Itching
Feeling of confusion
Hallucinations (strange images or sounds)
Urinary retention (inability to urinate) or involuntary, uncontrollable urination (urinary incontinence)
Decreased white blood cell count
Disorders of blood sugar control in patients with diabetes while taking Paxtin. The patient should discuss adjusting their insulin or other anti-diabetic medicine dose with their doctor.
Rare side effects(may occur in less than 1 in 1,000 people)
Abnormal milk production in men and women
Slow heartbeat
Abnormal liver function tests
Panic attacks
Excessive or manic behavior (manic reactions)
Feeling of being detached from oneself (depersonalization)
Anxiety
Irresistible urge to move their legs (restless legs syndrome)
Joint or muscle pain
High levels of the hormone prolactin in the blood
Menstrual disorders (including heavy or irregular bleeding, spotting, absence, or delay of menstruation)
Very rare side effects(may occur in less than 1 in 10,000 people)
A skin rash with possible blistering, resembling target-like lesions (with dark spots in the center, surrounded by a lighter border and a dark ring on the edge) - so-called erythema multiforme
Widespread rash with blistering and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
Widespread rash with blistering and peeling of the skin on a large area of the body (toxic epidermal necrolysis)
Liver function disorders causing yellowing of the skin and whites of the eyes
Syndrome of inappropriate antidiuretic hormone secretion (SIADH) - a disorder in which the body produces too much water and the sodium (salt) level in the blood decreases due to abnormal chemical signals. SIADH can become a severe disease or be asymptomatic.
Fluid or water retention (which can cause swelling of the hands or feet)
Sensitivity to light
Painful, prolonged erection of the penis
Low platelet count
Side effects with unknown frequency(frequency cannot be estimated from the available data)
Teeth grinding
Ringing, buzzing, whistling, or other persistent noises in the ears (tinnitus)
Colitis (causing diarrhea).
Patients taking this type of medicine have been observed to have an increased risk of bone fractures.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, 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: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +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 Paxtin

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister or container after EXP. The expiry date refers to the last day of the month.
PVC/Aluminum blisters: No special storage precautions.
HDPE container: Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Paxtin contains

The active substance of the medicine is paroxetine.
Paxtin 20
One coated tablet contains 20 mg of paroxetine (in the form of paroxetine hydrochloride).
Paxtin 40
One coated tablet contains 40 mg of paroxetine (in the form of paroxetine hydrochloride).
Other ingredients are: mannitol, microcrystalline cellulose PH 101, microcrystalline cellulose PH 102, copovidone K28, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate.
Tablet coating:hypromellose 5cps, talc, titanium dioxide (E171).

What Paxtin looks like and contents of the pack

Paxtin 20 is a white, round, divisible tablet with a break line, marked with the symbol "PX 20".
Paxtin 40 is a white, round, quadrisectional tablet with a break line, marked with the symbol "PX 40".
The coated tablets are packaged in PVC/Aluminum blisters and placed in a cardboard box or packaged in HDPE containers with an LDPE cap, in a cardboard box.
The packaging contains 30 coated tablets.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia