Seroxat

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Seroxat, 20 mg, coated tablets
Paroxetinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your physician or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Seroxat is and what it is used for

Seroxat is used in the treatment of adults with depression and (or) anxiety disorders.
Anxiety disorders for which Seroxat is used include: obsessive-compulsive disorder (recurring, obsessive thoughts with uncontrollable behaviour), panic disorder with (or without) agoraphobia (panic attacks, including those caused by agoraphobia, which is 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 (generalized feelings of anxiety or nervousness).
Seroxat belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). The exact mechanism of action of Seroxat and other SSRIs is not fully understood, but they may increase the concentration of serotonin in the brain. Proper treatment of depression and anxiety disorders is important to help the patient feel better.

2. Important information before using Seroxat

When not to use Seroxat:

• If the patient is taking medicines known as monoamine oxidase inhibitors (MAO inhibitors, including moclobemide and methylene blue chloride) or has taken them within the last two weeks. The doctor will advise the patient on how to start taking Seroxat after stopping MAO inhibitors.
• If the patient is taking antipsychotic medicines, such as 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 contact their doctor and must not take Seroxat.

Warnings and precautions
Before starting Seroxat, discuss the following with your doctor or pharmacist:

• Is the patient taking any other medicines? (See Seroxat and other medicines, later in this leaflet)
• Is the patient taking tamoxifen for breast cancer treatment? Seroxat may reduce the effectiveness of tamoxifen, and therefore the doctor may recommend another antidepressant.
• Does the patient have kidney, liver, or heart problems?
• Does the patient have abnormal heart conduction on electrocardiogram (ECG), known as QT interval prolongation?
• Does the patient have a family history of QT interval prolongation, heart disease such as heart failure, slow heartbeat, or low potassium or magnesium levels?
• Does the patient have epilepsy or a history of seizures?
• Has the patient ever experienced episodes of mania (excessively active behaviour or racing thoughts)?
• Is the patient receiving electroconvulsive therapy?
• Has the patient previously experienced bleeding, or is the patient taking other medicines that may increase the risk of bleeding (including blood-thinning medicines such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, pain and anti-inflammatory medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, 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 fertility, later in this leaflet)
• Is the patient under 18 years of age? (See Children and adolescents under 18 years of age, later in this leaflet)

If the answer is YES to any of the above questions and the patient has not yet consulted their doctor, they should see their doctor again to discuss how to use Seroxat.

Children and adolescents under 18 years of age
Seroxat must not be used in children and adolescents under 18 years of age.
Patients under 18 years of age are at increased risk of experiencing adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and anger) while taking Seroxat. If the doctor has prescribed Seroxat for a patient under 18 years of age and there are any concerns, the patient should contact their doctor.
If these symptoms appear or worsen during treatment with Seroxat, the doctor should be informed. In addition, there is currently no long-term data on the safety of Seroxat with regard to growth, maturation, and cognitive and behavioural development in this age group.
In clinical trials of Seroxat in patients under 18 years of age, common adverse effects occurring in less than 1 in 10 patients included: increased frequency of suicidal thoughts and suicide attempts, deliberate self-harm, hostility, aggressive or hostile behaviour, loss of appetite, tremor, abnormal sweating, hyperactivity (excessive energy), agitation, emotional lability (including tearfulness and mood swings), and unusual bruising or bleeding (such as nosebleeds).
These trials also showed that similar symptoms occurred, although less frequently, in children and adolescents taking placebo (sugar pills) instead of Seroxat.
In some patients under 18 years of age in these trials, symptoms related to discontinuation of Seroxat occurred. These symptoms were very similar to those observed in adults after stopping Seroxat (see section 3). In addition, in patients under 18 years of age, abdominal pain, feeling of restlessness, and emotional lability (including tearfulness, mood swings, self-harm attempts, suicidal thoughts, and suicide attempts) were also common (occurring in less than 1 in 10 patients).

Suicidal thoughts and worsening of depression or anxiety symptoms
Patients with depression and (or) anxiety disorders may sometimes experience thoughts of self-harm or suicidal thoughts. These may increase at the beginning of treatment with antidepressants, as it may take some time—usually about two weeks, sometimes longer—before the medicines start to work.
The patient may be more likely to experience such thoughts:

• If they have previously had suicidal thoughts or thoughts of self-harm.
• If they are a young adult. Clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with antidepressants. If thoughts of self-harm or suicide occur at any time, the patient should contact their doctor or the nearest hospital emergency department immediately. It may be helpful to inform a relative or friend about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform them if they notice worsening depression or anxiety or any concerning changes in behaviour.

Important adverse effects observed during treatment with Seroxat
In some patients taking Seroxat, symptoms called akathisia may develop.
They feel restless and unable to sit or stand still. In other patients, a condition called serotonin syndrome or neuroleptic malignant syndrome may develop, in which patients experience some or all of the following symptoms: intense agitation or irritability, confusion (disorientation), anxiety, fever, sweating, tremor, chills, hallucinations (strange visions or hearing strange sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. 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 adverse effects of Seroxat is provided in section 4.
Medicines such as Seroxat (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment.

Seroxat and other medicines
Some medicines may affect how Seroxat works or increase the risk of adverse effects. Seroxat may also affect how other medicines work. These include:

• Medicines known as monoamine oxidase inhibitors (MAO inhibitors, including moclobemide and methylene blue chloride) – see section When not to use Seroxat
• Medicines known to increase the risk of changes in electrical activity of the heart (e.g. antipsychotics thioridazine or pimozide) – see section When not to use Seroxat
• Acetylsalicylic acid, ibuprofen, or other medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), such as celecoxib, etodolac, diclofenac, and meloxicam, used for pain and inflammatory conditions
• Tramadol, buprenorphine, and pethidine, painkillers
• Buprenorphine in combination with naloxone, used in opioid dependence substitution therapy
• Medicines called triptans, such as sumatriptan, used for migraine
• Other antidepressants, known as SSRIs and tricyclic antidepressants, such as clomipramine, nortriptyline, and desipramine
• A dietary supplement called tryptophan
• Mivacurium and suxamethonium (used for general anaesthesia)
• Medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotics) used to treat certain psychiatric disorders
• Fentanyl, a medicine used during anaesthesia and for chronic pain
• The combination of fosamprenavir and ritonavir, used for treatment of human immunodeficiency virus (HIV) infection
• St John’s wort, used as an adjunct in depression
• Phenobarbital, phenytoin, sodium valproate, or carbamazepine used to treat seizures or epilepsy
• Atomoxetine, used to treat attention deficit hyperactivity disorder (ADHD)
• Procyclidine, used to treat tremor, particularly in 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 elevated cholesterol levels
• Rifampicin, used to treat tuberculosis and acne
• Linezolid – an antibiotic
• Tamoxifen, used in breast cancer treatment

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 contact their doctor again to discuss what to do. The dose of medicine may need to be changed, or another 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, including medicines available without a prescription.
Seroxat with food, drink and alcohol
During treatment with Seroxat, alcohol should not be consumed. Alcohol may worsen symptoms of illness or adverse effects. Taking Seroxat in the morning with food reduces the likelihood of nausea.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a baby, she should consult her doctor or pharmacist before using this medicine.
There are some reports suggesting that congenital malformations, particularly heart defects, may occur in babies whose mothers took Seroxat during the first few months of pregnancy. In the general population, about 1 in 100 babies is born with a heart defect. This increases to 2 in 100 babies if the mother took Seroxat. The doctor will decide together with the patient whether it is better to switch to another medicine or gradually discontinue Seroxat during pregnancy. In certain circumstances, the doctor may also suggest that it is better for the patient to continue taking Seroxat.
The patient should ensure that the midwife or doctor is informed that she is taking Seroxat. Taking Seroxat 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 Seroxat, she should inform her doctor or midwife so they can provide appropriate advice. Medicines such as Seroxat taken during pregnancy, especially in the later stages, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN).
In PPHN, blood pressure in the blood vessels between the baby’s heart and lungs is too high. If the patient takes Seroxat during the last three months of pregnancy, other symptoms may also occur in the newborn, usually within the first 24 hours after birth. These include:

• Breathing difficulties
• Bluish skin or unstable body temperature
• Bluish lips
• Vomiting or difficulty feeding properly
• Tiredness, difficulty sleeping, or increased crying
• Stiff or floppy muscles
• Tremors, jitteriness due to agitation, or seizures
• Increased reflexes
  If any of these symptoms occur in the baby 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 taking Seroxat, she should consult her doctor before starting breastfeeding. The doctor and patient may decide together that breastfeeding can continue during treatment with Seroxat.
Animal studies have shown that paroxetine reduces sperm quality. This could theoretically affect fertility, but the effect on human fertility has not yet been established.

Driving and operating machinery
Possible adverse effects caused by Seroxat include dizziness, disorientation, drowsiness, and visual disturbances. If such adverse effects occur, the patient should not drive or operate machinery.

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

3. How to take Seroxat

This medicine should always be taken exactly as prescribed by your doctor. If in doubt,
consult your doctor or pharmacist.
Sometimes taking one tablet does not provide the full recommended dose of the medicine. The table
below indicates how many Seroxat tablets should be taken for each dose.
Dose Number of tablets to be taken
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 given below.

Your doctor will advise you on the starting dose of Seroxat. Most
patients begin to feel better after a few weeks. If there is no improvement by that time,
you should consult your doctor for advice. Your doctor may decide to gradually increase the dose by
10 mg, up to the maximum daily dose.
Tablets should be taken in the morning, during a meal.
Swallow with water.
Do not chew.
Your doctor will discuss with you how long you should continue taking the tablets. Treatment may last
for several months or even longer.
Elderly patients
The maximum dose for patients over 65 years of age is 40 mg per day.
Patients with liver or kidney disease
If you have liver disease or severe kidney disease, your doctor may prescribe a lower dose of Seroxat
than the usual recommended dose.
Taking more Seroxat than prescribed
Never take more tablets than your doctor has prescribed. If you (or someone else) have taken too many Seroxat tablets, contact your doctor immediately or
go to the nearest hospital emergency department. Take the tablet packaging with you.
Symptoms of overdose may include those described in section 4: Possible side effects, or the following symptoms: fever, involuntary muscle contractions.
Missing a dose of Seroxat
Take the medicine at the same time each day.
If you miss a dose and remember before going to bed, take it immediately. The next day, take your usual dose as normal.
If you remember during the night or the following day that you missed a dose, do not take the missed dose. You may experience withdrawal symptoms, but these should quickly resolve after taking the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
What to do if there is no improvement
Seroxat does not relieve symptoms of illness immediately – all antidepressant medicines
take some time to start working. Some patients begin to feel better after a few weeks, while others may take longer. Some patients taking antidepressants may feel worse before they start to feel better. If you do not feel better after a few weeks of treatment, you should consult your doctor for advice. Your doctor should schedule a follow-up visit a few weeks after you first start taking the medicine. Inform your doctor if you have not started to feel better.
Stopping treatment with Seroxat
Do not stop taking Seroxat unless your doctor tells you to.
When discontinuing Seroxat, your doctor will help you gradually reduce the dose over several weeks or months – this should reduce the risk of withdrawal symptoms. One way is to gradually reduce your dose of Seroxat by 10 mg per week. Withdrawal symptoms are usually mild in most patients and resolve on their own within two weeks. However, in some patients, symptoms may be more severe or last longer.
If you experience withdrawal symptoms after stopping the tablets, your doctor may decide that you should taper the dose more slowly. If you experience severe symptoms while discontinuing Seroxat, contact your doctor. They may recommend restarting the tablets and tapering them more gradually.
Even if you experience withdrawal symptoms, it is still possible to stop taking Seroxat.
Possible withdrawal symptoms occurring after stopping treatment
Studies show that 3 out of 10 patients notice one or more withdrawal symptoms when stopping treatment with Seroxat. 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
• Tingling sensations, burning sensations, and (less commonly) electric shock-like sensations, including in the head, and ringing, buzzing, whistling, or other persistent noise in the ears (tinnitus)
• Sleep disturbances (vivid dreams, nightmares, insomnia)
• Feeling of anxiety
• Headache

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

• Nausea
• Sweating (including night sweats)
• Feeling restless or agitated
• Tremor
• Feeling disoriented
• Diarrhea (loose stools)
• Emotional lability or irritability
• Visual disturbances
• Palpitations or increased heart rate (rapid or irregular heartbeat)

If you are concerned about withdrawal symptoms after stopping Seroxat,
you should contact your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions may more commonly occur during the first weeks of taking Seroxat.
You should contact your doctor if any of the following adverse reactions occur during treatment.
It may be necessary to contact your doctor immediately or go to the nearest hospital emergency department.

Uncommon adverse reactions (occurring in up to 1 in 100 patients):

• If the patient experiences unusual bruising or bleeding, including vomiting blood or blood in the stool, they should contact a doctor immediately or go to hospital.
• If the patient experiences difficulty passing urine, they should contact a doctor immediately or go to hospital.

Rare adverse reactions (occurring in up to 1 in 1000 patients):

• If the patient has a seizure (fit), they should contact a doctor immediately or go to hospital.
• If the patient feels restless or unable to 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, contact your doctor.
• If the patient experiences fatigue, weakness, pain, stiffness, or lack of muscle coordination, or is confused, they may have low blood sodium levels. If such symptoms occur, contact your treating doctor.

Very rare adverse reactions (occurring in up to 1 in 10,000 patients):

• Allergic reactions to Seroxat, which may be severe. If the patient develops a red, blotchy rash, swelling of the eyelids, face, lips, mouth or tongue, itching, difficulty breathing (shortness of breath) or swallowing, or a feeling of weakness or dizziness leading to collapse or loss of consciousness, they should contact a doctor immediately or go to hospital.
• If the patient experiences some or all of the symptoms listed below, they may be experiencing serotonin syndrome or neuroleptic malignant syndrome. These symptoms include: a feeling of intense agitation or irritability, confusion, anxiety, fever, sweating, tremors, chills, hallucinations (strange visions or hearing unusual sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. Symptoms may worsen and lead to loss of consciousness. If such symptoms occur, contact your doctor.
• Acute glaucoma. If the patient experiences eye pain and blurred vision, they should contact their treating doctor.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• In some patients, during or shortly after discontinuation of Seroxat treatment, thoughts of self-harm or suicide occurred (see Suicidal thoughts and worsening of depression or anxiety disorder in section 2).
• In some patients, aggression occurred during treatment with Seroxat.
• Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection Pregnancy, breastfeeding and fertility in section 2. If any of these adverse reactions occur, contact your treating doctor.

Other possible adverse reactions occurring during treatment

Very common adverse reactions (occurring in more than 1 in 10 patients):

• 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 and ejaculation disorders.

Common adverse reactions (occurring in up to 1 in 10 patients):

• Increased blood cholesterol levels
• Loss of appetite
• Sleep disturbances (insomnia) or drowsiness
• Unusual dreams (nightmares)
• Dizziness or tremors
• Headache
• Difficulty concentrating
• Feeling of restlessness
• Feeling of excessive fatigue
• Blurred vision
• Yawning, dry mouth
• Diarrhoea or constipation
• Vomiting
• Weight gain
• Sweating

Uncommon adverse reactions (occurring in up to 1 in 100 patients):

• Brief increases or decreases in blood pressure, which may cause dizziness or fainting when standing up suddenly
• Faster than normal heartbeat
• Difficulty moving, stiffness, tremors, or abnormal movements of the mouth and tongue
• Pupil dilation
• Skin rash
• Itching
• Feeling of confusion
• Hallucinations (strange images or sounds)
• Inability to pass urine (urinary retention) or uncontrolled, involuntary urination (urinary incontinence)
• In patients with diabetes, treatment with Seroxat may worsen blood sugar control. Discuss with your doctor whether insulin or antidiabetic medication doses need adjustment.
• Decreased white blood cell count

Rare adverse reactions (occurring in up to 1 in 1000 patients):

• Abnormal milk production in the breast glands in both men and women
• Slow heartbeat
• Liver effects indicated by blood tests assessing liver function
• Panic attacks
• Excessive activity or racing thoughts (mania)
• Feeling of unreality or detachment from oneself (depersonalization)
• Feelings of anxiety
• 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, or absence or delay of menstruation)

Very rare adverse reactions (occurring in up to 1 in 10,000 patients):

• Skin rash called erythema multiforme, which may present with blisters and appear as small targets (a dark spot in the centre surrounded by a lighter ring and a dark ring at the edge)
• Widespread blistering rash with skin peeling, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome)
• Widespread blistering rash with peeling of large areas of skin (toxic epidermal necrolysis)
• Liver function disorders causing yellowing of the skin or whites of the eyes (jaundice)
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH), where due to abnormal chemical signals in the body, excess water is retained and sodium (salt) levels decrease. Patients with SIADH may show symptoms of serious illness or may have no symptoms at all
• Fluid retention (which may lead to swelling of the hands or feet)
• Light sensitivity
• Painful, persistent penile erection (priapism)
• Decreased platelet count

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• Inflammation of the large intestine (causing diarrhoea)
• Teeth grinding (bruxism)

Some patients may experience ringing, buzzing, whistling, or other persistent noise in the ears (tinnitus) while taking Seroxat.
In patients taking this type of medicine, an increased risk of bone fractures has been observed.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of 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.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Seroxat

Keep the medicine out of the 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 stated month.
Do not store above 30°C.
Keep in the original packaging to protect from light.
If the patient is using half tablets, care should be taken to store them in the medicine's packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This practice will help protect the environment.

6. Contents of the pack and other information

What Seroxat contains
The active substance is paroxetine (20 mg) in the form of paroxetine hydrochloride hemihydrate.
Other ingredients are:
Tablet core: calcium hydrogen phosphate dihydrate, magnesium stearate, sodium carboxymethyl starch (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, film-coated tablets – white, oval, biconvex film-coated tablets, with the imprint “SEROXAT 20” or “20” on one side and a central break line on the other side allowing the tablet to be divided.
Each pack of Seroxat 20 mg film-coated tablets contains 30 tablets in child-resistant blister packs.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Portugal, country of export:
GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Rua Dr. António Loureiro Borges, 3
Arquiparque – Miraflores
1495-131 Algés, Portugal

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 Authorisation Number in Portugal, country of export: 5053780
Parallel Import Licence Number: 116/25

This medicinal product is authorised 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 learn more about their condition. Detailed information will be provided by the attending physician.