Paxtin 40

Package leaflet: Information for the patient

Paxtin 20, 20 mg, coated tablets
Paxtin 40, 40 mg, coated tablets
Paroxetinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

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

Leaflet contents:

1. What Paxtin is and what it is 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 pack and other information

1. What Paxtin is and what it is used for

Paxtin is indicated for the treatment of depression and (or) anxiety disorders in adults.
Anxiety disorders treated with Paxtin include: obsessive-compulsive disorder (recurring, intrusive thoughts with uncontrollable behavior); panic disorder with or without agoraphobia (panic attacks, including those triggered 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 (a general feeling of intense anxiety or restlessness).
Paxtin belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). Serotonin is a substance naturally present in the brain. In people with depression or anxiety disorders, serotonin levels are lower than in others. The exact mechanism of action of Paxtin and other SSRIs is not fully understood, but they may increase serotonin levels in the brain. Proper treatment of depression or anxiety disorders is essential for improving the patient's well-being.

2. Important information before using Paxtin

When not to use Paxtin
if the patient is taking medicines known as monoamine oxidase inhibitors (so-called MAOIs, including
moclobemide and methylene blue chloride) or has taken them within the last
two weeks. The doctor will advise when it is safe to start taking Paxtin after stopping
MAOIs.
if the patient is taking the antipsychotic medicines 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, they should consult their doctor and
must not take Paxtin.

Warnings and precautions
Before starting Paxtin, discuss this with your doctor or pharmacist.
Is the patient taking any other medicines? (See "Paxtin with other medicines" later in this leaflet.)
Is the patient taking tamoxifen for the treatment of breast cancer [ or infertility ]? Paxtin may
reduce the effectiveness of tamoxifen, so the doctor may recommend using a different
antidepressant.
Does the patient have impaired kidney, liver, or heart function?
Does the patient have epilepsy or a history of seizures?
Has the patient ever experienced an episode of mania (excessively active behaviour or racing thoughts)?
Is the patient receiving electroconvulsive therapy?
Has the patient previously experienced bleeding disorders or is taking medicines that increase
the risk of bleeding [including medicines used to thin the blood (such as warfarin), antipsychotics (such as perphenazine or clozapine), tricyclic antidepressants, painkillers and anti-inflammatory medicines called 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 this leaflet.)
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 under 18 years of age? (See section "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 discussed this
with their doctor, they should consult their doctor again and ask about using Paxtin.

Children and adolescents under 18 years of age
Paxtin must not be used in children and adolescents under 18 years of age. In patients
under 18 years of age, taking Paxtin increases the risk of adverse effects such as suicide attempts,
suicidal thoughts, and hostility (particularly aggression, oppositional behaviour, and anger). If the doctor has prescribed Paxtin to a patient under 18 years of age and this causes concern, the patient should consult the doctor. If any of these symptoms occur or worsen during treatment with Paxtin, the patient should inform their doctor. Furthermore, there is currently no long-term safety data on the use of Paxtin in this age group regarding growth, puberty, cognitive development, and behavioural development.
In clinical trials of paroxetine in patients under 18 years of age, common adverse reactions (occurring in fewer than 1 in 10 patients) included: increased frequency of suicidal thoughts and suicide attempts; self-harm; hostility; aggressive or hostile behaviour; loss of appetite; tremor; abnormal sweating; excessive activity (hyperactivity); restlessness; emotional lability (including tearfulness and mood swings); and unusual bruising or bleeding (e.g. nosebleeds). These studies also showed that similar symptoms occurred, although less frequently, in children and adolescents receiving sugar tablets (placebo) instead of paroxetine.
In some participants of these trials, withdrawal symptoms occurred after stopping paroxetine. These symptoms were usually similar to those observed in adult patients after discontinuation of paroxetine (see section 3 "How to take Paxtin" later in this leaflet).
Additionally, in patients under 18 years of age, abdominal pain, nervousness, and emotional lability (including tearfulness, mood changes, self-harm attempts, suicidal thoughts and attempts) occurred frequently (in fewer than 1 in 10 individuals).

Suicidal thoughts, worsening 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 antidepressants, as these medicines usually take about 2 weeks, sometimes longer, to start working.
The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely if :

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

If the patient experiences suicidal thoughts or thoughts of self-harm, they should
contact their doctor immediately or go to hospital.
Informing family members or friends about the depression or anxiety disorder and asking them to read this leaflet may be helpful. The patient may ask them to inform them if they notice worsening depression or anxiety, or concerning changes in behaviour.

Important adverse effects observed during treatment with Paxtin
Some patients taking Paxtin may develop a condition called "akathisia," characterised by a feeling of psychomotor agitation with an inability to sit or stand still. In other patients, serotonin syndrome or neuroleptic malignant syndrome may develop, with some or all of the following symptoms: severe agitation or irritability, confusion, restlessness, feeling hot, sweating, tremor, chills, hallucinations (strange images or sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. Symptoms may worsen and lead to loss of consciousness. If any of these symptoms occur, the patient should consult their doctor. More information about these or other adverse effects can be found in section 4 "Possible side effects."
Medicines such as Paxtin (so-called SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment.

Paxtin with other medicines
Some medicines may affect the action of Paxtin or increase the risk of adverse effects. Paxtin may also affect the action of other medicines. These include:
medicines known as monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride – see section "When not to use Paxtin")
thioridazine or pimozide ( antipsychotics ) – see section "When not to use Paxtin"
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 ( painkillers )
buprenorphine in combination with naloxone, used in opioid dependence substitution therapy
triptans (such as sumatriptan), used to treat migraine
other antidepressants, including selective serotonin reuptake inhibitors (SSRIs), tryptophan, and tricyclic antidepressants such as 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 psychiatric disorders
fentanyl, used in anaesthesia or treatment of chronic pain
the combination of fosamprenavir and ritonavir, used to treat infection with human immunodeficiency virus (HIV)
St John’s wort (a herbal antidepressant)
phenobarbital, phenytoin, sodium valproate, or carbamazepine, medicines used to treat seizures or epilepsy
atomoxetine, a medicine used to treat attention deficit hyperactivity disorder (ADHD)
procyclidine, a medicine used to relieve tremors, especially in Parkinson’s disease
warfarin or other medicines (anticoagulants) used to thin the blood
propafenone, flecainide, and medicines used to treat irregular heart rhythm
metoprolol, a beta-blocker used to treat high blood pressure and heart conditions
pravastatin, used to treat high cholesterol levels
rifampicin, a medicine used to treat tuberculosis and acne
linezolid ( antibiotic )
tamoxifen, a medicine used to treat breast cancer [ or infertility ]
If the patient is currently taking or has recently taken any of the listed medicines
and has not yet discussed this with their doctor, they should consult their doctor again. A dose adjustment or change to another medicine may be necessary.
The patient should inform 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
During treatment with Paxtin, alcohol should not be consumed, as it may worsen symptoms of illness or adverse effects. Taking Paxtin in the morning with food may reduce the risk of nausea.

Pregnancy, breastfeeding and fertility
Pregnancy
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 using this medicine.
There are reports that children whose mothers took paroxetine during the first months of pregnancy have an increased risk of congenital malformations, particularly affecting the heart. While in the general population the frequency of congenital heart defects in children is 1 in 100, in children of mothers treated with paroxetine it increases to 2 in 100.
The doctor, in consultation with the pregnant patient, may decide that the best course of action is to switch to another medicine or gradually discontinue Paxtin. However, depending on the patient’s condition, the doctor may consider it better for her to continue taking Paxtin.
It is important to ensure that the midwife or doctor is aware that the patient is taking Paxtin.
Medicines such as Paxtin, when taken during pregnancy, especially in the later stages, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the newborn’s heart and lungs is too high. If the patient takes Paxtin during the last 3 months of pregnancy, the newborn may also experience other problems, usually appearing within the first day of life. These may include:
difficulty breathing
bluish skin or abnormal body temperature (too high or too low)
bluish lips
vomiting or difficulty feeding
excessive tiredness, inability to sleep, or persistent crying
muscle stiffness or floppiness
tremor or seizures
increased reflexes
If any of these symptoms occur in the newborn or if the patient is concerned about the baby’s health, she should contact her doctor or midwife for appropriate advice.
Taking Paxtin towards the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Paxtin, she should inform her doctor or midwife so they can provide appropriate advice.

Breastfeeding
Paxtin may pass into breast milk in very small amounts. Patients taking this medicine should consult their doctor before starting breastfeeding and decide together whether breastfeeding is possible while taking Paxtin.

Fertility
Animal studies have shown that paroxetine impairs sperm quality. This could theoretically affect fertility, but such an effect has not been observed in humans to date.

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

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

3. How to use Paxtin

This medicine should always be used according to the instructions of your doctor or pharmacist. In case of
doubt, consult your doctor or pharmacist.
Sometimes the recommended dose requires taking more than one tablet or half a tablet.
The recommended doses for various indications are shown in the table below:

At the beginning of treatment, the doctor will indicate to the patient the dose of Paxtin to be taken.
For most people, improvement in well-being occurs after several weeks of treatment. If after this time
the patient does not feel better, 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.
Tablets should be taken in the morning, with breakfast.
They should be swallowed with water.
They must not be chewed.
If necessary, tablets may be divided into equal doses.
The doctor will inform the patient how long the tablets should be taken. Treatment may last for
many months, or even longer.

Elderly patients
The maximum dose for patients over 65 years of age is 40 mg per day.

Patients with impaired liver or kidney function
For patients with impaired liver or kidney function, the doctor may prescribe a lower than usual dose of Paxtin.

Taking more Paxtin than prescribed
Never take more tablets than prescribed by the doctor. If the patient (or someone else) has taken more Paxtin than prescribed, they should contact a doctor or go immediately to the nearest hospital. The medicine packaging should be shown. 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 then continue taking it as usual the next day.
If the patient remembers about the dose during the night or the next day – they should skip that dose. Withdrawal symptoms may occur, but they should resolve after taking the next dose at the usual time.
Do not take a double dose to make up for a missed tablet.

What to do if there is no improvement in well-being
Paxtin does not provide immediate symptom relief. It takes time for all antidepressant medicines to start working. In some people, improvement occurs within a few weeks, but for others it may take longer. Some patients taking antidepressants may experience worsening of their condition before improvement in well-being occurs. If the patient does not feel better after several weeks of treatment, they should contact their doctor again. The doctor should schedule a follow-up visit a few weeks after starting treatment. The lack of improvement in well-being should be reported to the doctor.

Stopping treatment with Paxtin
Do not stop taking Paxtin without medical advice.
When discontinuing 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. Withdrawal symptoms occurring during discontinuation of Paxtin are mild in most people and resolve on their own within two weeks. In some individuals, they may be more severe or last longer.
If withdrawal symptoms occur during discontinuation of the medicine, the doctor may recommend a slower dose reduction. If withdrawal symptoms are severe, the patient should contact their doctor. The doctor may recommend resuming treatment and then discontinuing the medicine much more slowly.
Even if withdrawal symptoms occur, it is still possible to discontinue treatment with Paxtin.

Possible withdrawal symptoms after stopping treatment
Studies show that 3 out of 10 patients notice one or more withdrawal symptoms when discontinuing paroxetine therapy. Some of these symptoms occur more frequently than others.

Common (may occur in fewer than 1 in 10 people):
dizziness, unsteadiness or difficulty maintaining balance
tingling, burning sensations, or (less commonly) electric shock-like sensations, including in the head
ringing, buzzing, whistling, or other persistent noise in the ears (tinnitus)
sleep disturbances (vivid dreams, nightmares, insomnia)
anxiety
headache

Uncommon (may occur in fewer than 1 in 100 people):
nausea
sweating (including night sweats)
feeling anxious or agitated
tremor
confusion or disorientation
diarrhea (loose stools)
emotional lability or irritability
visual disturbances
sensation of fluttering or pounding in the chest (palpitations)

If the patient is concerned about withdrawal symptoms after stopping Paxtin, they should contact their doctor.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
The occurrence of adverse reactions is more likely during the first weeks
of treatment with Paxtin.
If any of the adverse reactions listed below occur during treatment, you should
contact your doctor.
It may be necessary to consult a doctor or go immediately to hospital.
Uncommon adverse reactions (may occur in fewer than 1 in 100 people)
If unusual bruising or bleeding occurs , including blood in vomit or stools,
seek immediate medical advice or go to hospital.
If the patient is unable to pass urine, seek immediate medical advice or go to hospital.
Rare adverse reactions (may occur in fewer than 1 in 1,000 people)
If a seizure occurs , seek immediate medical advice or go to hospital.
If the patient feels restless and unable to sit or stand still , these may be symptoms of a condition called akathisia. Increasing the dose of Paxtin may worsen these symptoms. If they occur, consult your doctor.
If the patient experiences fatigue, weakness or disorientation, and pain, stiffness or lack of coordination in movements , this may be due to low sodium levels in the blood. If such symptoms occur, consult your doctor.
Very rare adverse reactions (may occur in fewer than 1 in 10,000 people)
Allergic reactions to the medicine, which may be severe.
If a red, raised skin rash, swelling of the eyelids, face, lips, mouth or tongue occurs, or the patient experiences itching, difficulty breathing (shortness of breath) or swallowing, or weakness or dizziness leading to collapse or loss of consciousness, seek immediate medical advice or go to hospital.
The occurrence of some or all of the following symptoms may indicate serotonin syndrome or neuroleptic malignant syndrome. These symptoms include: intense agitation or irritability, confusion, anxiety, feeling hot, sweating, tremor, chills, hallucinations (strange images or sounds), muscle rigidity, sudden muscle spasms or rapid heartbeat. Symptoms may worsen and lead to loss of consciousness. In such cases, consult your doctor.
Acute glaucoma.
If the patient experiences eye pain or blurred vision, consult your doctor.
Adverse reactions with unknown frequency (frequency cannot be determined from available data)
Some people have had thoughts of harming themselves or of suicide while taking paroxetine or shortly after discontinuation (see section 2).
Some people have shown aggression while taking paroxetine.
Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy" in section 2.
If any of these adverse reactions occur, consult your doctor.
Other possible adverse reactions during treatment
Very common adverse reactions (may occur in more than 1 in 10 people)
Nausea. Taking Paxtin in the morning with food will reduce the risk of nausea.
Changes in sexual desire or sexual function, e.g. lack of orgasm and disturbances in erection and ejaculation
Common adverse reactions (may occur in fewer than 1 in 10 people)
Increased blood cholesterol levels
Loss of appetite
Insomnia or drowsiness
Abnormal dreams (including nightmares)
Dizziness or tremor
Headache
Difficulty concentrating
Agitation
Feeling of unusual weakness
Blurred vision
Yawning, dry mouth
Diarrhoea or constipation
Vomiting
Weight gain
Sweating
Uncommon adverse reactions (may occur in fewer than 1 in 100 people)
Rapid increase or decrease in blood pressure, which may cause dizziness or fainting when standing up suddenly
Faster than normal heart rate
Lack of muscle movement, stiffness, tremor or abnormal movements of the muscles of the mouth and tongue
Pupil dilation
Skin rash
Itching
Feeling confused
Hallucinations (strange images or sounds)
Inability to pass urine (urinary retention) or uncontrolled, involuntary urination (urinary incontinence)
Decreased white blood cell count
Disturbances in blood sugar control in diabetic patients during treatment with Paxtin. Discuss with your doctor possible adjustments to the dose of insulin or other antidiabetic medicine.
Rare adverse reactions (may occur in fewer than 1 in 1,000 people)
Abnormal milk production in women and men
Slow heart rate
Effects on liver function visible in blood tests
Panic attacks
Excessive behaviour or thoughts (manic reactions)
Feeling of detachment from oneself (depersonalization)
Anxiety
Irresistible urge to move the legs (so-called restless legs syndrome)
Joint or muscle pain
High levels of the hormone called prolactin in the blood
Menstrual disturbances (including heavy or irregular bleeding, spotting, absence or delay of menstruation)
Very rare adverse reactions (may occur in fewer than 1 in 10,000 people)
Skin rash with possible blister formation, appearing as small target-like lesions (dark spots in the centre surrounded by a lighter ring and a dark ring at the edge) – so-called erythema multiforme
Widespread rash with blister formation and peeling of the skin, especially around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome)
Widespread rash with blister formation and peeling of the skin over a large area of the body (toxic epidermal necrolysis)
Liver function disturbances 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 sodium (salt) levels in the blood decrease due to abnormal chemical signals. SIADH may become a serious illness or may be asymptomatic.
Fluid or water retention (which may cause swelling of the hands or feet)
Light sensitivity
Painful, prolonged penile erection
Low platelet count
Adverse reactions with unknown frequency (frequency cannot be determined from available data)
Teeth grinding
Ringing, buzzing, whistling, or other persistent noise in the ears (tinnitus)
Inflammation of the colon (causing diarrhoea).
In patients taking this type of medicine, an increased risk of bone fractures has been observed.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products at 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 authorisation holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Paxtin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton, on the blister, and on the container after EXP. The expiry date refers to the last day of the stated month.
PVC/Aluminium blisters: No special storage precautions required.
HDPE bottle: Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

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

What Paxtin looks like and contents of the pack
Paxtin 20 are white, round, biconvex tablets with a score line sensitive to pressure, facilitating breaking, marked with the symbol "PX 20".
Paxtin 40 are white, round, quadrisect tablets with a score line sensitive to pressure, facilitating breaking, marked with the symbol "PX 40".
The coated tablets are packed in blisters made of PVC/Aluminium foil and placed in a cardboard box, or packed in HDPE bottles with a screw cap, inside a cardboard box.
Pack sizes contain 30 coated tablets.

Marketing Authorisation 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, Poland
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia

For further information about the medicinal product and its names in other European Economic Area (EEA) countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
tel. 22 209 70 00