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

Before taking the medicine, you should carefully read the contents of the leaflet, 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 this 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 levels 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 methylthioninium chloride (methylene blue)) or has 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 before 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 rhythm on an 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 blood thinners such as warfarin, antipsychotic medicines such as perphenazine or clozapine, tricyclic antidepressants, non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)?
• 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 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 consult their doctor againand 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 signs of anger) when taking Seroxat. If the doctor has prescribed Seroxat to a patient under 18 years old and there are any doubts, the patient should consult their doctor. If any of 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 included increased suicidal thoughts and attempts, 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 (sugar pills) instead of Seroxat. In some patients under 18 years old in these studies, withdrawal symptoms occurred, which were very similar to the withdrawal symptoms observed in adults after stopping Seroxat (see section 3). Additionally, in patients under 18 years old, abdominal pain, feeling nervous, 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 thoughts may sometimes occur. They may be more common at the start 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 thoughts 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 thoughts occur at any time, the patient should contact their doctor or the nearest emergency department immediately.

It may be helpful for the patient to inform a relative or friendabout their depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to tell them if they notice that their depression or anxiety disorder is getting worse or if they notice any worrying changes in their behavior.

Important side effects seen with Seroxat

In some patients taking Seroxat, a condition called akathisia may develop. They may feel anxious and unable to sit or stand still. In other patients, a condition called serotonin syndrome or neuroleptic malignant syndrome may occur, in which patients have some or all of the following symptoms: feeling highly agitated or irritated, feeling confused, feeling anxious, feeling hot, sweating, shaking, chills, hallucinations (seeing or hearing strange things), muscle stiffness, sudden muscle contractions, or rapid heartbeat. These 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 methylthioninium chloride (methylene blue)) - see section When not to take Seroxat
• Medicines known to increase the risk of changes in heart electrical activity (such as 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 for pain and inflammatory conditions
• Tramadol, buprenorphine, and pethidine, pain relief medicines
• Buprenorphine in combination with naloxone, used for opioid dependence substitution treatment
• Medicines called triptans, such as sumatriptan, used for migraine treatment
• Other antidepressant medicines, called SSRIs and tricyclic antidepressants, such as clomipramine, nortriptyline, and desipramine
• Dietary supplementcalled tryptophan;
• Mivacurium and suxamethonium (used for general anesthesia)
• Medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotic medicines) used for certain mental disorders
• Fentanyl, a medicine used during anesthesiaand for chronic pain treatment
• The combination of fosamprenavir and ritonavir, which is used for HIV infection treatment
• St. John's Wort used as a depression aid
• Phenobarbital, phenytoin, sodium valproate, or carbamazepine used for seizure or epilepsy treatment
• Atomoxetine, which is used for attention deficit hyperactivity disorder (ADHD) treatment
• Procyclidine, used for tremor treatment, especially in Parkinson's disease
• Warfarin or other medicines (called anticoagulants) used for blood thinning
• Propafenone, flecainide, and medicines used for irregular heartbeat treatment
• Metoprolol, a beta-blocker used for high blood pressure and heart problems
• Pravastatin, used for high cholesterol treatment
• Rifampicin, used for tuberculosis treatment
• Linezolid - antibiotic
• Tamoxifen, which is used for breast cancer treatment.

If the patient is currently taking or has recently taken any of the above 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 it may be necessary to take a different medicine.

The patient should tell their doctor or pharmacist about all medicines they are currently taking or

have recently taken, as well as any medicines they plan to take, including those that are available without a prescription.

Seroxat with food, drink, and alcohol

The patient should not drink alcohol while taking Seroxat. Alcohol may increase the symptoms of the disease or side effects. Taking Seroxat in the morning, with food, reduces the likelihood of nausea.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. There are some reports that suggest that children whose mothers took Seroxat during the first few months of pregnancy may have been born with congenital defects, 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 during pregnancy or to gradually stop taking Seroxat. 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 the patient with appropriate advice. Medicines like Seroxat taken during pregnancy, especially in the last trimester, 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 of the baby 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. These include:

• Difficulty breathing;
• Blue discoloration of the skin or unstable body temperature;
• Blue discoloration of the lips;
• Vomiting or difficulty feeding;
• Tiredness, difficulty sleeping, or increased crying;
• Stiff or floppy muscles;
• Tremors, jitteriness, or seizures;
• Increased reflexes. If the baby experiences any of these symptoms after birth or if there are concerns about the baby'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 breastfeeding, they should consult their doctor before starting to take this medicine. The doctor, together with the patient, can decide whether to breastfeed while taking Seroxat. In animal studies, paroxetine has been shown to reduce sperm quality. This could theoretically affect fertility, but the effect on human fertility has not been determined yet.

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 shows how many Seroxat tablets the patient should take for each 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 what dose of Seroxat 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. The patient should take the tablets in the morning, with food. The patient should swallow the tablets with water. The patient should not chew the tablets. The doctor will discuss with the patient how long they should take the tablets. The 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

The doctor may recommend a lower dose of Seroxat for patients with liver or severe kidney disease.

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 an overdose of Seroxat, the patient may experience symptoms described in section 4: Possible side effectsor the following symptoms: fever, involuntary muscle contractions.

Missing a dose of Seroxat

The patient should take the medicine 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 pass 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 take some time to start working. 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 have not started to feel better.

Stopping Seroxat

The patient should not stop taking Seroxat unless their doctor advises them to do so.

When stopping Seroxat, the doctor will help the patient to gradually reduce the dose over a few weeks or months - this should reduce the risk of withdrawal symptoms. One way to do this is to gradually reduce the dose of Seroxat by 10 mg per week. In most patients, withdrawal symptoms are mild and disappear within two weeks. In some patients, symptoms may be more severe or may last longer. If the patient experiences withdrawal symptoms after stopping Seroxat, their doctor may decide that they 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 have shown that 3 in 10 patients notice one or more withdrawal symptoms when stopping Seroxat therapy. 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 anxious
• Headaches

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

• Nausea
• Sweating (including night sweats)
• Feeling anxious or restless
• Tremors
• Feeling disoriented
• Diarrhea (loose stools)
• Emotional instability or irritability
• Vision disturbances
• Palpitations (rapid or irregular 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 1000 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 have a condition called akathisia. Increasing the dose of Seroxat may worsen these feelings. If the patient experiences these symptoms, they should contact their doctor.
• If the patient feels tired, weak, in pain, stiff, or has difficulty moving, they may have low sodium levels in their blood. If the patient experiences these symptoms, they 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 their skin, swelling of their eyelids, face, lips, mouth, or tongue, itching, difficulty breathing (dyspnea) or swallowing, feeling weak 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 have a condition called serotonin syndrome or neuroleptic malignant syndrome: feeling highly agitated or irritated, feeling confused, feeling anxious, feeling hot, sweating, shaking, chills, hallucinations (seeing or hearing strange things), muscle stiffness, sudden muscle contractions, or rapid heartbeat. These symptoms may worsen, leading to loss of consciousness. If the patient experiences these symptoms, they 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 thoughts 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

• Nausea. Taking Seroxat in the morning, with food, reduces the likelihood of nausea.
• Changes in sexual desire or sexual function. For example, lack of orgasm, or in men, erectile dysfunction and ejaculation disorders.

Common side effects(occurring in more than 1 in 10 patients):

• Increased cholesterol levels in the blood
• Lack of appetite
• Sleep disturbances (insomnia) or drowsiness
• Unusual dreams (nightmares)
• Dizziness or tremors
• Headaches
• Difficulty concentrating
• Feeling restless
• Feeling excessively weak
• Vision disturbances
• Yawning, dry mouth
• Diarrhea or constipation
• Vomiting
• Weight gain
• Sweating.

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

• Short-term increases or decreases in blood pressure, which may cause dizziness or fainting when changing position to standing
• Rapid heartbeat
• Difficulty moving, stiffness, tremors, or abnormal movements of the mouth and tongue
• Dilated pupils
• Rashes
• Itching
• Feeling disoriented
• Hallucinations (seeing or hearing strange things)
• Urinary retention (inability to urinate) or involuntary urination (incontinence).
• In patients with diabetes, Seroxat may affect blood sugar control. The patient should discuss this with their doctor to adjust the dose of insulin or diabetes medicines.
• Decreased white blood cell count.

Rare side effects(occurring in up to 1 in 1000 patients):

• Abnormal production of milk in the breasts in men and women
• Slow heartbeat
• Liver function disorders shown in blood tests
• Panic attacks
• Excessive activity or racing thoughts (mania)
• Feeling uncertain about one's own existence (depersonalization)
• Feeling anxious
• Irresistible urge to move the legs (restless legs syndrome)
• Joint or muscle pain
• Increased levels of a hormone called prolactin in the blood
• Menstrual disorders (including heavy or irregular bleeding, intermenstrual bleeding, and absence or delay of menstruation).

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

• A skin rash called erythema multiforme, which may be accompanied by blisters and looks like small targets (a dark spot in the center surrounded by a lighter border with a dark ring around the edge)
• A widespread skin rash with blisters and peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• A widespread skin rash with blisters and peeling of large areas of skin (toxic epidermal necrolysis)
• Liver function disorders that 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 levels are low. Patients with SIADH may have symptoms of severe illness or may not have any symptoms
• Fluid retention or water retention (which may 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)
• Teeth grinding.

Some patients taking Seroxat may experience ringing, buzzing, whistling, or other persistent noises in the ears (tinnitus) during treatment. Patients taking medicines like Seroxat have been observed to have an increased risk of bone fractures.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Seroxat

The medicine should be stored out of sight and reach of children. The patient should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. The patient should not store the medicine above 30°C. The patient should store the medicine in its original packaging to protect it 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, carmellose sodium (type A). Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 400, polysorbate 80.

What Seroxat looks like and contents of the pack

Seroxat, 20 mg, coated tablets - white, coated, oval, biconvex 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 28 tablets in child-resistant blisters.

Marketing authorization holder in Spain, the country of export:

GlaxoSmithKline, S.A. P.T.M. C/ Severo Ochoa, 2 28760 Tres Cantos (Madrid), Spain

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 Spain, the country of export:757195.7

• 760314.6
• 866905.9

Parallel import authorization number: 261/24

This medicine is authorized in the Member States of the European Economic Area under the following names:

It may be helpful for the patient to contact a support group or patient organization, where they can find out more about their condition. The doctor can provide more detailed information.

Translation of day of the week symbols on the packaging:

Lu- Monday

Ma- Tuesday Mi- Wednesday Ju- Thursday Vi- Friday Sa- Saturday Do- Sunday

Date of leaflet approval: 26.06.2024

[Information about the trademark]