Paxtin 20

Patient Information Leaflet: Information for the Patient

Paxtin 20, 20 mg, Film-Coated Tablets

Paxtin 40, 40 mg, Film-Coated Tablets

Paroxetine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• You should 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Paxtin is and what it is used for
• 2. What you need to know before you take 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 adults with depression and/or anxiety disorders.

Anxiety disorders for which Paxtin is indicated include: obsessive-compulsive disorder (recurring, intrusive thoughts with uncontrollable behavior); panic disorder (panic attacks, which may be 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 (a general feeling of strong anxiety or nervousness).
Paxtin belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). Each person has a substance in the brain called serotonin. In people with depression or anxiety disorders, the level of serotonin is lower than in others. The way Paxtin and other SSRIs work is not fully understood, but they may increase the level of serotonin in the brain. Proper treatment of depression or anxiety disorders is essential for improving the patient's well-being.

2. What you need to know before you take Paxtin

When not to take Paxtin

If you are taking medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue)or have taken them in the last two weeks. Your doctor will tell you when you can start taking Paxtin after stopping your MAOI.
If you are taking antipsychotic medicines called thioridazine or pimozide.
If you are allergicto paroxetine or any of the other ingredients of this medicine (listed in section 6).
If any of the above applies to you, tell your doctor and do not take Paxtin.

Warnings and precautions

Before you start taking Paxtin, talk to your doctor

Are you taking any other medicines (see "Paxtin and other medicines" below)?
Are you taking tamoxifen for breast cancer treatment [or fertility disorders]? Paxtin may reduce the effectiveness of tamoxifen, so your doctor may recommend a different antidepressant.
Do you have kidney, liver, or heart problems?
Do you have a history of epilepsy or have you ever had seizures?
Have you ever had a manic episode (excessive activity or racing thoughts)?
Are you being treated with electroconvulsive therapy?
Have you ever had bleeding disorders or are you taking medicines that increase the risk of bleeding [including anticoagulants (such as warfarin), antipsychotics (such as perphenazine or clozapine), tricyclic antidepressants, or non-steroidal anti-inflammatory drugs (NSAIDs) (such as aspirin, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)]?
Are you pregnant or planning to become pregnant (see "Pregnancy, breastfeeding, and fertility" below)?
Do you have diabetes?
Are you on a low-sodium diet?
Do you have glaucoma (increased eye pressure)?
Are you under 18 years old (see "Children and adolescents under 18 years old" below)?
If the answer to any of the above is yesand you have not discussed this with your doctor, you should consult your 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 your doctor has prescribed Paxtin to a patient under 18 years old and this has caused concerns, you should consult the doctor. If any of these symptoms occur or worsen while taking Paxtin, you should inform your doctor. Additionally, there is currently no 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); restlessness; 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 placebo tablets 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" below).
Furthermore, in patients under 18 years old, common side effects (occurring in less than 1 in 10 patients) 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 harming themselves or committing suicide. These thoughts may worsen when first taking antidepressants, as these medicines start working usually after 2 weeks, sometimes later.

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

more likely:

• if you have had suicidal thoughts or self-harm in the past;
• if you are a young adult; data from clinical trials indicate an increased risk of suicidal behavior in people under 25 years old with mental disorders who are being treated with antidepressants.

If you have suicidal thoughts or thoughts of self-harm, you should contact your doctor or go to the hospital immediately.
It may be helpful to inform your relatives or friendsabout your depression or anxiety disorder and ask them to read this leaflet. You may want to ask them to tell you if they notice that your depression or anxiety is getting worse or if you are acting strangely.

Important side effects seen with Paxtin

In some patients taking Paxtin, a condition called "akathisia" can occur, with symptoms such as a feeling of restlessness with an inability to sit or stand still.
In other patients, a condition called "serotonin syndrome" or "neuroleptic malignant syndrome" can develop, with some or all of the following symptoms: severe agitation or irritability, confusion, restlessness, feeling of heat, sweating, trembling, shivering, hallucinations (strange images or sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. The severity of these symptoms can increase, leading to loss of consciousness. If you notice any of these symptoms, you should contact your doctor. More information about these or other side effects can be found in section 4 "Possible side effects".
Medicines like Paxtin (SSRIs) may cause sexual function disorders (see section 4). In some cases, these disorders have persisted after stopping treatment.

Paxtin and other medicines

Some medicines may affect how Paxtin works or increase the risk of side effects. Paxtin may also affect how other medicines work. These medicines include:
medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue) - see "When not to take Paxtin" above
antipsychotic medicines called thioridazine or pimozide - see "When not to take Paxtin" above
aspirin, 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 to treat opioid dependence
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 supplementcalled tryptophan
miwakurium and suxamethonium (used in general anesthesia)
medicines called lithium, risperidone, perphenazine, clozapine (used to treat certain mental disorders),
fentanyl used in anesthesia or chronic pain treatment;
combination of fosamprenavir and ritonavir, used to treat HIV infection;
St. John's Wort (a herbal antidepressant)
phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizures or epilepsy;
atomoxetine, used to treat attention deficit hyperactivity disorder (ADHD);
procyclidine, used to relieve tremors, especially in Parkinson's disease;
warfarin or other anticoagulants (used to thin the blood);
propafenone, flecainide, and medicines used to treat irregular heartbeat;
metoprolol, a beta-blocker used to treat high blood pressure and heart disease;
pravastatin, used to treat high cholesterol levels;
rifampicin, used to treat tuberculosis;
linezolid (an antibiotic);
tamoxifen, used to treat breast cancer [or fertility disorders];

If you are currently taking or have recently taken any of the above medicines

and have not discussed this with your doctor, you should consult your doctor again. A dose change or a change to a different medicine may be necessary.

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.

Paxtin with food, drink, and alcohol

Do not drink alcohol while taking Paxtin, as it may increase the symptoms of your illness or side effects. Taking Paxtin in the morning with food may reduce the risk of nausea.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There have been reports that babies whose mothers took paroxetine during the first months of pregnancy have an increased risk of congenital defects, especially heart defects. While the overall frequency of congenital heart defects in the general population is 1 in 100, in babies born to mothers treated with paroxetine, this frequency increases to 2 in 100.
Your doctor, in consultation with you, will decide whether the benefits of taking Paxtin outweigh the potential risks to your unborn baby. However, depending on your condition, your doctor may consider it better for you to continue taking Paxtin.

Make sure your midwife or doctor knows you are taking Paxtin.

Medicines like Paxtin, when taken during pregnancy, especially in the last few months, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the heart and lungs of the newborn is too high. If you take Paxtin during the last 3 months of pregnancy, the newborn may also experience other disorders, which usually appear in the first day of life. These include:
breathing difficulties
bluish skin or changes in body temperature
bluish lips
vomiting or difficulty feeding
excessive tiredness, inability to sleep, or persistent crying
stiffness or floppiness of the muscles
tremors or seizures
increased reflexes
If any of these symptoms occur in the newborn or you are concerned about the baby's health, you should contact your doctor or midwife, who will provide you with the necessary explanations.
Taking Paxtin near the end of pregnancy may increase the risk of severe bleeding from the uterus, which can occur shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Paxtin, you should inform your doctor or midwife so that they can provide you with the necessary advice.

Breastfeeding

Paxtin may pass into breast milk in very small amounts. If you are breastfeeding, you should ask your doctor for advice before taking Paxtin. You and your doctor will decide whether you can breastfeed while taking Paxtin.

Fertility

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

Driving and using machines

Paxtin may cause side effects such as dizziness, confusion, drowsiness, or blurred vision. If you experience any of these symptoms, do not drive or operate machinery.

Paxtin contains sodium

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

3. How to take Paxtin

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.
Sometimes the recommended dose requires taking more than one tablet or half a tablet.
The recommended doses for different indications are shown in the table below:

Your doctor will tell you which dose to take.
Improvement in symptoms usually occurs after a few weeks of treatment. If you do not feel better after this time, you should consult your doctor. Your doctor may decide to gradually increase the dose (each time by 10 mg) up to the maximum daily dose.

Take the tablets in the morning with food.

Swallow them with water.

Do not chew them.

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

Your doctor will tell you how long to take the tablets. Treatment may last for several months or 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 more than the recommended dose of Paxtin

Never take more tablets than your doctor has recommended. If you (or someone else) have taken too much Paxtin, you should contact your doctor or go to the hospital immediately. You should take the medicine pack with you. Overdose of Paxtin may cause symptoms listed in section 4 "Possible side effects" or fever, involuntary muscle contractions.

Forgetting to take a dose of Paxtin

Take the medicine every day at the same time.
If you forget to take a dose and remember before going to bed- take the medicine immediately, and the next day take it as usual.
If you remember in the night or the next day- skip the missed dose. You may experience withdrawal symptoms, but they should go away after taking the next dose at the usual time.
Do not take a double dose to make up for a forgotten tablet.

What to do if you do not feel better

Paxtin does not provide immediate relief from symptoms. The onset of action of all antidepressants takes time. In some people, this happens within a few weeks, but in others, it may take a little longer. Some patients taking antidepressants may experience a worsening of their condition before they start to feel better. If you do not feel better after a few weeks of treatment, you should consult your doctor again. Your doctor should schedule a follow-up appointment a few weeks after starting treatment. You should inform your doctor about any lack of improvement.

Stopping treatment with Paxtin

Do not stop taking Paxtin without talking to your doctor.
When stopping Paxtin, your doctor will help you gradually reduce the dose over a few weeks or months, which should reduce the risk of withdrawal symptoms (see "Possible side effects" below). One way to do this is to 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 people, they may be more severe or longer-lasting.
If you experience withdrawal symptomswhen stopping Paxtin, your doctor may recommend a slower dose reduction. If the withdrawal symptoms are severe, you should contact your doctor.
Your doctor may recommend restarting the treatment and then stopping it more slowly.

Even if you experience withdrawal symptoms, it is still possible to stop taking Paxtin.

Possible withdrawal symptoms when 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 are more common than others.
Common (may occur in less than 1 in 10 people):
dizziness, unsteadiness, or difficulty maintaining balance
feeling of tingling, burning, or (less commonly) electric shock sensations, including in the head
ringing, buzzing, whistling, or other persistent noises in the ears (tinnitus)
sleep disturbances (vivid dreams, nightmares, insomnia)
anxiety
headaches
Uncommon (may occur in less than 1 in 100 people):
nausea
sweating (including night sweats)
feeling anxious or agitated
tremors
confusion or disorientation
diarrhea (loose stools)
emotional instability or irritability
visual disturbances
palpitations (pounding heartbeat)
Rare (may occur in less than 1 in 1,000 people):
abnormal bleeding (e.g., nosebleeds)
If you are concerned about withdrawal symptoms after stopping Paxtin, you should talk to your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are more likely to occur during the first few weeks of taking Paxtin.

If you experience any of the following side effects, you should contact your doctor.

You may need to contact your doctor or go to the hospital immediately.
Uncommon side effects(may occur in less than 1 in 100 people)
If you experience unusual bruising or bleeding, including blood in your vomit or stools, you should contact your doctor or go to the hospital immediately.

If you are unable to urinate, you should contact your doctor or go to the hospital immediately.

Rare side effects(may occur in less than 1 in 1,000 people)
If you experience a seizure, you should contact your doctor or go to the hospital immediately.
If you feel anxious 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, you should contact your doctor.

If you feel tired, weak, or disoriented, and experience pain, stiffness, or lack of coordination

these may be symptoms of low sodium levels in the blood. If you experience these symptoms, you should contact your 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 you experience a red, raised rash on the skin, swelling of the eyelids, face, lips, mouth, or tongue, itching, or difficulty breathing (shortness of breath) or swallowing, and weakness or fainting leading to loss of consciousness, you should contact your doctor or go to the hospital immediately.

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, trembling, shivering, hallucinations (strange images or sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. The severity of these symptoms can increase, leading to loss of consciousness. If you experience any of these symptoms, you should contact your doctor.

Acute glaucoma.

If you experience eye pain or blurred vision, you should contact your doctor.
Side effects with unknown frequency(frequency cannot be estimated from the available data)
Some people have had thoughts of harming themselves or committing suicide while taking paroxetine or soon after stopping it (see section 2).
Some people have shown aggression while taking paroxetine.
Severe bleeding from the uterus, which can occur shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy" in section 2.

If you experience any of these side effects, you should contact your 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 with food may reduce the risk of nausea.
Changes in sex drive or sexual function, such as lack of orgasm and erectile dysfunction
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
Restlessness
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
Rapid heartbeat
Lack of movement, stiffness, tremors, or abnormal movements of the mouth and tongue
Dilated pupils
Rash
Itching
Feeling of confusion
Hallucinations (strange images or sounds)
Urinary retention (inability to urinate) or involuntary urination (incontinence)
Decreased white blood cell count
Disorders of blood sugar control in patients with diabetes while taking Paxtin. You should discuss with your doctor the adjustment of the dose of insulin or other antidiabetic medicines.
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 detachment from oneself (depersonalization)
Anxiety
Irresistible urge to move the 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, or absence of menstruation)
Very rare side effects(may occur in less than 1 in 10,000 people)
Rash with possible blistering of the skin, which looks like target-like spots (erythema multiforme)
Widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
Widespread rash with blisters and peeling of the skin on a large area of the body (toxic epidermal necrolysis)
Liver disorders, which can cause yellowing of the skin and whites of the eyes (jaundice)
Syndrome of inappropriate antidiuretic hormone secretion (SIADH) - a disorder in which the body produces too much water and the level of sodium (salt) in the blood decreases due to abnormal chemical signals. SIADH can be a serious condition or have no symptoms.
Fluid retention or water retention (which can cause swelling of the hands or feet)
Sensitivity to sunlight
Prolonged and painful erection of the penis
Low platelet count
Side effects with unknown frequency(frequency cannot be estimated from the available data)
Grinding of the teeth
Ringing, buzzing, whistling, or other persistent noises in the ears (tinnitus)
Colitis (inflammation of the colon)
In patients taking this type of medicine, there is an increased risk of bone fractures.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects directly to the national reporting system (see below). By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paxtin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister or bottle after EXP. The expiry date refers to the last day of that month.
Blisters: No special storage precautions.
Bottles: Do not store above 30°C.
Medicines should 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 film-coated tablet contains 20 mg of paroxetine (as paroxetine hydrochloride).
Paxtin 40
One film-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 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 are white, round, divisible tablets with a score line, marked with "PX 20".
Paxtin 40 are white, round, quadriseptible tablets with a score line, marked with "PX 40".
The tablets are packed in blisters of PVC/Aluminum or in HDPE bottles with a LDPE cap, in a cardboard box.
The pack contains 30 film-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, Poland
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia

For more information about this medicine, including its other names in the European Economic Area

contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
tel. 22 209 70 00
Date of last revision of the leaflet:02/2024
Sandoz logo