Seroxat

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Seroxat, 20 mg, coated tablets

Paroxetine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult your 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 as yours.
• 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 Seroxat and what is it used for
• 2. Important information before taking Seroxat
• 3. How to take Seroxat
• 4. Possible side effects
• 5. How to store Seroxat
• 6. Contents of the packaging and other information

1. What is Seroxat and what is it used for

Seroxat is used to treat adults with depression and/or anxiety disorders.

Anxiety disorders for which Seroxat is used include: obsessive-compulsive disorder (recurring, obsessive thoughts with uncontrolled behavior), panic disorder (panic attacks, including those caused by agoraphobia, which is a fear of open spaces), social phobia (fear or avoidance of social situations), post-traumatic stress disorder (anxiety caused by a traumatic event), generalized anxiety disorder (generalized feeling of anxiety or nervousness). Seroxat belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). It is not fully understood how Seroxat and other SSRIs work, but they may increase the level of serotonin in the brain. Proper treatment of depression and anxiety disorders is important for the patient to feel better.

2. Important information before taking Seroxat

When not to take Seroxat:

• If the patient is taking medicines called monoamine oxidase inhibitors(MAOIs, including moclobemide and methylene blue) or if they have taken them in the last two weeks. The doctor will advise the patient on how to start taking Seroxat after stopping the MAOIs.
• If the patient is taking antipsychotic medicines, such as 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 without taking Seroxat.

Warnings and precautions

Before starting to take Seroxat, the patient should discuss the following with their doctor or pharmacist:

• Is the patient taking any other medicines (see Seroxat and other medicineslater in the leaflet)?
• Is the patient taking tamoxifen for breast cancer treatment? Seroxat may reduce the effectiveness of tamoxifen, and the doctor may recommend a different antidepressant.
• Does the patient have kidney, liver, or heart problems?
• Does the patient have abnormal heart conduction in the electrocardiogram (ECG) known as QT interval prolongation?
• Is there a family history of QT interval prolongation, 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 ever had episodes of mania (excessive activity or racing thoughts)?
• Is the patient being treated with electroconvulsive therapy?
• Has the patient had bleeding or is the patient taking other medicines that may 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, or meloxicam)?
• Does the patient have diabetes?
• Is the patient on a low-sodium diet?
• Does the patient have glaucoma (increased pressure in the eyeball)?
• Is the patient pregnant or planning to become pregnant (see Pregnancy, breastfeeding, and fertilitylater in the leaflet)?
• Is the patient under 18 years old (see Children and adolescents under 18 years oldlater in the leaflet)?

If the answer is YES to any of the above questionsand the patient has not yet consulted their doctor, they should go back to their doctorand ask how to take Seroxat.

Children and adolescents under 18 years old

Seroxat should not be used in children and adolescents under 18 years old.

Patients under 18 years old are at increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and anger). If the doctor has prescribed Seroxat to a patient under 18 years old and there are concerns, the patient should contact their doctor. If these symptoms occur or worsen while taking Seroxat, the patient should inform their doctor. Additionally, there is currently no data on the long-term safety of Seroxat regarding growth, maturation, and cognitive and behavioral development in this age group. In studies of Seroxat in patients under 18 years old, common side effects that occurred with a frequency of less than 1 in 10 were: increased suicidal thoughts and attempts, intentional self-harm, hostility, aggressive behavior, 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 (such as nosebleeds). These studies also showed that such symptoms occurred, although less frequently, in children and adolescents taking placebo tablets instead of Seroxat. Some patients under 18 years old in these studies experienced withdrawal symptoms from Seroxat. These symptoms were very similar to those observed in adults after stopping Seroxat (see section 3). Additionally, in patients under 18 years old, abdominal pain, irritability, and emotional instability (including tearfulness, mood changes, self-harm, suicidal thoughts, and attempts) also occurred frequently (with a frequency of less than 1 in 10).

Suicidal thoughts and worsening of depression or anxiety disorder

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

• if the patient has had suicidal thoughts or self-harm before.
• if the patient is a young adult. Clinical studies have shown 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-harm occur at any time, the patient should contact their doctor or the nearest emergency department immediately. It may be helpful to inform a relative or friend about the patient's depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to tell the doctor if they notice that the depression or anxiety disorder has worsened or if there are worrying changes in the patient's behavior.

Important side effects observed during Seroxat treatment

In some patients taking Seroxat, a condition called akathisia may develop. They feel anxious and cannot sit or stand still. In other patients, a condition called serotonin syndrome or malignant neuroleptic syndrome may occur, in which patients have some or all of the following symptoms: feeling highly agitated or irritated, feeling confused, feeling anxious, fever, sweating, trembling, chills, hallucinations (strange visions or hearing strange sounds), 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 Seroxat can be found in section 4. Medicines like Seroxat (SSRIs) may cause sexual function disorders (see section 4). In some cases, these symptoms persisted after treatment was stopped.

Seroxat and other medicines

Some medicines may affect the action of Seroxat or increase the risk of side effects. Seroxat may also affect the action of other medicines. These medicines include:

• medicines called monoamine oxidase inhibitors(MAOIs, including moclobemide and methylene blue) - see section When not to take Seroxat;
• medicines known to increase the risk of changes in heart electrical activity (e.g., antipsychotic medicines thioridazine or pimozide) - see section When not to take Seroxat;
• 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 for opioid dependence substitution treatment;
• medicines called triptans, such as sumatriptan, used to treat migraines;
• other antidepressant medicines called SSRIs and tricyclic antidepressants, such as clomipramine, nortriptyline, and desipramine;
• dietary supplementcalled tryptophan;
• miwakurium and suxamethonium (used for general anesthesia);
• medicines such as lithium, risperidone, perphenazine, or clozapine (called antipsychotic medicines) used to treat certain mental disorders;
• fentanyl, a medicine used during anesthesiaand to treat chronic pain;
• the combination of fosamprenavir and ritonavir, which is used to treat HIV infections;
• St. John's Wort used as a complementary treatment for depression;
• phenobarbital, phenytoin, sodium valproate, or carbamazepine used to treat seizures or epilepsy;
• atomoxetine, which is used to treat attention deficit hyperactivity disorder (ADHD);
• procyclidine used to treat Parkinson's disease;
• warfarin or other medicines (called 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 problems;
• pravastatin used to treat high cholesterol levels;
• rifampicin used to treat tuberculosis;
• linezolid - an antibiotic;
• tamoxifen, which is used to treat breast cancer.

If the patient is currently taking or has recently taken any of these medicinesand has not yet discussed this with their doctor, they should contact their doctor againand ask how to proceed. The dose of the medicine may need to be changed or a different medicine may need to be taken.

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, including those that are available without a prescription.

Seroxat with food, drink, and alcohol

During Seroxat treatment, the patient should not drink alcohol. Alcohol may increase the symptoms of the disease or side effects. Taking Seroxat in the morning, during a meal, reduces the likelihood of nausea.

Pregnancy, breastfeeding, and fertility

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 suggesting that children whose mothers took Seroxat during the first few months of pregnancy may have congenital malformations, particularly heart defects. In the general population, about 1 in 100 children is born with a heart defect. This number increases to 2 in 100 children if the mother takes Seroxat. The doctor will decide together with the patient whether it is better for the patient to switch to a different medicine or gradually stop taking Seroxat during pregnancy. In some cases, the doctor may also suggest that it is better for the patient to continue taking Seroxat. The patient should ensure that their midwife or doctor is informed that they are taking Seroxat. Taking Seroxat at the end of pregnancy may increase the risk of severe bleeding from the vagina, which occurs shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Seroxat, they should inform their doctor or midwife so that they can provide appropriate advice. Medicines like Seroxat taken during pregnancy, especially in the last few months, may increase the risk of a condition called persistent pulmonary hypertension in the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the heart and lungs is too high. If the patient takes Seroxat during the last 3 months of pregnancy, the newborn may also experience other symptoms, usually within the first 24 hours after birth, including:

• breathing difficulties
• bluish skin or unstable body temperature
• bluish lips
• vomiting or difficulty feeding;
• fatigue, difficulty sleeping, or increased crying
• stiff or floppy muscles
• tremors, jitteriness, or seizures
• increased reflexes. If the newborn experiences any of these symptoms or if there are concerns about the newborn's health, the patient should contact their doctor or midwife for advice.

Seroxat may pass into breast milk in very small amounts. If the patient is taking Seroxat, they should consult their doctor before breastfeeding. The doctor and patient can decide together whether to breastfeed while taking Seroxat. In animal studies, paroxetine has been shown to reduce sperm quality. This could theoretically affect fertility, but the impact on human fertility has not been determined.

Driving and using machines

Possible side effects of Seroxat include dizziness, disorientation, drowsiness, and vision disturbances. If the patient experiences any of these side effects, they should not drive or operate machinery.

Seroxat contains sodium

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

3. How to take Seroxat

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. Sometimes taking one tablet does not ensure that the patient takes the full recommended dose of the medicine. The following table indicates how many Seroxat tablets the patient should take for a given dose.

Dose Number of tablets to take

10 mg half a tablet 20 mg one tablet 30 mg one and a half tablets 40 mg two tablets 50 mg two and a half tablets 60 mg three tablets The usual doses used for different conditions are listed below. The doctor will advise the patient on which dose to start with. Most patients start to feel better after a few weeks. 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.

Tablets should be taken in the morning, during a meal.

Swallow with water.

Do not chew.

The doctor will discuss with the patient how long they should take the tablets. Treatment may last for 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

In patients with liver disease or severe kidney disease, the doctor may recommend a lower dose of Seroxat than usual.

Taking more Seroxat than prescribed

The patient should never take more tablets than prescribed by their doctor. If the patient (or someone else) has taken too many Seroxat tablets, they should immediately inform their doctor or contact the nearest emergency department. They should show them the packaging of the tablets. As a result of overdosing on Seroxat, the patient may experience side effects described in section 4: Possible side effectsor the following symptoms: fever, involuntary muscle contractions.

Missing a dose of Seroxat

The medicine should be taken at the same time every day. If the patient misses a dose and remembers before going to bed, they should take it immediately. The next day, they should take the dose as usual. If the patient remembers in the night or the next day that they missed a dose, 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

Seroxat does not relieve symptoms immediately- all antidepressant medicines start working after some time. Some patients start to feel better after a few weeks, and others later. Some patients taking antidepressants feel worse before they start to feel better. If the patient does not feel better after a few weeks of treatment, they should consult their doctor for advice. The doctor should recommend that the patient have a follow-up visit after a few weeks of starting to take the medicine for the first time. The patient should inform their doctor if they do not start to feel better.

Stopping Seroxat treatment

The patient should not stop taking Seroxat without consulting their doctor.

When stopping Seroxat, the doctor will help the patient gradually reduce the dose over a few weeks or months - this should limit the possibility of withdrawal symptoms. One way to do this is to gradually decrease the dose of Seroxat 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 symptoms after stopping Seroxat, the doctor may decide that the patient should stop taking the medicine more slowly. If the patient experiences severe symptoms during Seroxat withdrawal, they should contact their doctor. The doctor may recommend restarting the tablets and stopping them more slowly.

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

Possible withdrawal symptoms after stopping treatment

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

Common side effects (occurring in up to 1 in 10 patients):

• dizziness, unsteadiness, or difficulty maintaining balance;
• feeling of tingling, burning, or (less commonly) electric shock sensations, including in the head, and ringing, buzzing, whistling, or other persistent noises in the ears (tinnitus);
• sleep disturbances (vivid dreams, nightmares, insomnia);
• feeling of anxiety;
• headaches.

Uncommon side effects (occurring in up to 1 in 100 patients):

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

If the patient is concerned about withdrawal symptoms after stopping Seroxat

they should contact 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, Seroxat can cause side effects, although not everybody gets them. Side effects are more common during the first few weeks of taking Seroxat.

The patient should contact their doctor if they experience any of the following side effects during treatment.

It may be necessary to contact the doctor or the nearest emergency department immediately.

Uncommon side effects (occurring in up to 1 in 100 patients):

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

Rare side effects (occurring in up to 1 in 1,000 patients):

• If the patient has a seizure (convulsions), they should contact their doctor or go to the hospital immediately.
• If the patient feels anxious or cannot sit or stand still, they may be experiencing a condition called akathisia. Increasing the dose of Seroxat may worsen these feelings. If such symptoms occur, the patient should contact their doctor.
• If the patient feels tired, weak, in pain, stiff, or has difficulty coordinating their muscles, they may have low sodium levels in their blood. If such symptoms occur, the patient should contact their doctor.

Very rare side effects (occurring in up to 1 in 10,000 patients):

• Severe allergic reactions to Seroxat, which can be serious. If the patient experiences a red, lumpy rash on the skin, swelling of the eyelids, face, lips, mouth, or tongue, itching, difficulty breathing (dyspnea) or swallowing, feeling of weakness or fainting, they should contact their doctor or go to the hospital immediately.
• If the patient has some or all of the following symptoms, they may be experiencing serotonin syndrome or malignant neuroleptic syndrome: feeling highly agitated or irritated, feeling disoriented, anxious, fever, sweating, trembling, chills, hallucinations (strange visions or hearing strange sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. The symptoms may worsen, leading to loss of consciousness. If such symptoms occur, the patient should contact their doctor.
• Acute glaucoma. If the patient experiences eye pain and vision disturbances, they should contact their doctor.

Side effects with unknown frequency(frequency cannot be estimated from the available data)

• In some patients taking Seroxat or shortly after stopping treatment, suicidal thoughts or self-harm have occurred (see Suicidal thoughts and worsening of depression or anxiety disorderin section 2).
• In some patients taking Seroxat, aggression has occurred.
• Severe bleeding from the vagina, which occurs shortly after delivery (postpartum hemorrhage), see additional information in subsection Pregnancy, breastfeeding, and fertilityin 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 (occurring in more than 1 in 10 patients):

• nausea. Taking Seroxat in the morning, during a meal, reduces the likelihood of nausea;
• change in sexual desire or sexual function. For example, lack of orgasm, or in men, erectile dysfunction and ejaculation disorders.

Common side effects (occurring in up to 1 in 10 patients):

• increased cholesterol levels in the blood;
• loss of appetite;
• sleep disturbances (insomnia) or feeling of drowsiness;
• unusual dreams (nightmares);
• dizziness or tremors;
• headache;
• difficulty concentrating;
• feeling of restlessness;
• feeling of excessive weakness;
• vision disturbances;
• yawning, dry mouth;
• diarrhea or constipation;
• vomiting;
• weight gain;
• sweating.

Uncommon side effects (occurring in up to 1 in 100 patients):

• temporary increase or decrease in blood pressure, which may cause dizziness or fainting when changing position quickly;
• rapid heartbeat;
• difficulty moving, stiffness, tremors, or abnormal movements of the mouth and tongue;
• pupil dilation;
• rash;
• itching;
• feeling of disorientation;
• hallucinations (strange visions or sounds);
• inability to urinate (urinary retention) or involuntary, uncontrollable urination (incontinence);
• in patients with diabetes, Seroxat may worsen blood sugar control. The patient should discuss with their doctor the need to adjust the dose of insulin or diabetes medicines.

Rare side effects (occurring in up to 1 in 1,000 patients):

• abnormal milk production in the breasts in men and women;
• slow heartbeat;
• abnormal liver function shown in blood tests;
• panic attacks;
• excessive activity or racing thoughts (mania);
• feeling of uncertainty about one's own existence (depersonalization);
• feeling of anxiety;
• irresistible urge to move their 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 (occurring in up to 1 in 10,000 patients):

• a skin rash called erythema multiforme, which can occur with blisters and look like small targets (a dark spot in the center surrounded by a lighter ring with a dark ring around the edge);
• a widespread rash on the skin with blisters and peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome);
• a widespread rash on the skin with blisters and peeling of large areas of skin (toxic epidermal necrolysis);
• liver function disorders, which can cause yellowing of the skin or whites of the eyes;
• a condition called syndrome of inappropriate antidiuretic hormone secretion (SIADH), in which the body retains too much water and the sodium level is decreased. 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 light;
• painful, persistent erection of the penis;
• decreased platelet count.

Side effects with unknown frequency(frequency cannot be estimated from the available data);

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

In some patients taking Seroxat, ringing, buzzing, whistling, or other persistent noises in the ears (tinnitus) have occurred during treatment. In patients taking medicines like Seroxat, an increased risk of bone fractures has been observed.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Seroxat

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Do not store above 30°C. Store in the original packaging to protect from light. If the patient is taking half-tablets, they should be careful to store them in the medicine packaging. 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 Seroxat contains

The active substance of Seroxat is paroxetine (20 mg) in the form of paroxetine hydrochloride hemihydrate. The other ingredients of the medicine are: Tablet core: calcium hydrogen phosphate dihydrate, magnesium stearate, sodium carboxymethylcellulose (type A). Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 400, polysorbate 80.

What Seroxat looks like and what the packaging contains

Seroxat, 20 mg, coated tablets - white, oval, biconvex, coated tablets with the inscription "SEROXAT 20" or "20" on one side and a score line on the other side. Each pack of Seroxat, 20 mg, coated tablets contains 30 tablets in child-resistant blisters. For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Croatia, the country of export:

GlaxoSmithKline Trading Services Limited 12 Riverwalk Citywest Business Campus Dublin 24, Ireland

Manufacturer:

Delpharm Poznań Spółka Akcyjna ul. Grunwaldzka 189 60-322 Poznań Poland

Parallel importer:

InPharm Sp. z o.o. ul. Strumykowa 28/11 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k. ul. Chełmżyńska 249 04-458 Warsaw Marketing authorization number in Croatia, the country of export:HR-H-051250245-01 Parallel import authorization number:423/21

It may be helpful for the patient to contact a support group or patient organization, where they can learn more about their condition. The doctor can provide more detailed information. Date of leaflet approval: 01.02.2023[Information about the trademark]