Seroxat

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Seroxat, 20 mg, coated tablets
Paroxetinum
Please read this leaflet carefully before taking 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 doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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 generalised anxiety disorder (generalised feelings of anxiety or nervousness).
Seroxat belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). The exact way in which Seroxat and other SSRIs work is not fully understood, but they may increase the concentration of serotonin in the brain. Proper treatment of depression and anxiety disorders is important so that the patient feels better.

2. Important information before taking Seroxat

When not to take 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 to take Seroxat, discuss 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 treating doctor may recommend the patient use another antidepressant.
• Does the patient have problems with kidneys, liver, or heart?
• 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 heart rate, or low potassium or low magnesium levels?
• Does the patient have epilepsy or has the patient previously experienced 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 episodes, 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, medicines used for pain and inflammation 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 contacted
their doctor, the patient should go back to their doctor and ask how to take
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 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 to a patient under 18 years of age
and there are any concerns, the patient should contact their doctor.
If the mentioned symptoms occur or worsen during treatment with Seroxat, the doctor should be informed. Additionally, there is currently no long-term data on the safety of Seroxat regarding growth, puberty, and cognitive and behavioural development in this age group.
In clinical studies of Seroxat in patients under 18 years of age, common adverse effects occurring in less than 1 in 10 patients were: increased frequency of suicidal thoughts and suicide attempts, self-harm, hostility, aggressive or hostile behaviour, loss of appetite, tremor, abnormal sweating, excessive activity (displaying excess energy), restlessness, emotional lability (including tearfulness and mood changes), and unusual bruising or bleeding (such as nosebleeds).
These studies also showed that such effects occurred, although less frequently, in children and adolescents receiving placebo (dummy tablets) instead of Seroxat.
In some patients under 18 years of age in these studies, symptoms related to discontinuation of Seroxat occurred. These symptoms were very similar to those observed in adults after stopping Seroxat (see section 3). Additionally, in patients under 18 years of age, abdominal pain, feeling restless, and emotional lability (including tearfulness, mood changes, 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, before the medicines start to work, and sometimes even longer.
The patient may be more likely to have such thoughts:

• if the patient previously had suicidal thoughts or thoughts of self-harm.
• if the patient is 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 ever occur, the patient must contact their doctor or the nearest hospital emergency department immediately. Informing a relative or friend about the patient's depression or anxiety disorder and asking them to read this leaflet may be helpful. The patient may ask them to inform the patient if they notice worsening of depression or anxiety, or concerning changes in behaviour.

Important adverse effects observed during treatment with Seroxat
In some patients taking Seroxat, symptoms called akathisia may develop.
They then feel restless and unable to sit or stand still. In other patients, a condition known as serotonin syndrome or neuroleptic malignant syndrome may develop, in which patients experience some or all of the following symptoms: feeling highly agitated or irritable, confusion, 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 sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment.

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

• medicines known as monoamine oxidase inhibitors (MAO inhibitors, including moclobemide and methylene blue chloride) – see section When not to take Seroxat;
• medicines known to increase the risk of changes in heart electrical activity (e.g. antipsychotics thioridazine or pimozide) – see section When not to take 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 combined with naloxone, used in opioid 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 (known as antipsychotics) used for treating certain psychiatric disorders;
• fentanyl, a medicine used during anaesthesia and for chronic pain;
• the combination of fosamprenavir and ritonavir, used for treating human immunodeficiency virus (HIV) infection;
• St. John’s wort, used as an adjunct in depression;
• phenobarbital, phenytoin, sodium valproate, or carbamazepine used for seizures or epilepsy;
• atomoxetine, used for attention deficit hyperactivity disorder (ADHD);
• procyclidine used for tremor, particularly in Parkinson’s disease;
• warfarin or other medicines (known as anticoagulants) used to thin the blood;
• propafenone, flecainide, and medicines used for irregular heartbeat;
• metoprolol, a beta-blocker used for high blood pressure and heart problems;
• pravastatin used for high cholesterol levels;
• rifampicin used for tuberculosis and acne;
• linezolid – an antibiotic;
• tamoxifen, used for breast cancer treatment.

If the patient is currently taking or has recently taken any of these medicines, and has not yet discussed this with their doctor, they should contact their doctor again to ask 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, as well as any medicines they plan to take, including those available without a prescription.

Seroxat with food, drink and alcohol
While taking Seroxat, alcohol must 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, breastfeeding, thinks she may be pregnant, or plans to have a baby, she should consult her doctor or pharmacist before taking this medicine.
There are some reports suggesting that children whose mothers took Seroxat during the first few months of pregnancy may have congenital developmental abnormalities, particularly heart defects. In the general population, about 1 in 100 children are born with a heart defect. This number increases to 2 in 100 children 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 must 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
• skin blueness 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 the patient may decide that breastfeeding is acceptable while taking 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 must not drive or operate machinery.

Seroxat contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning 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 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 after this time,
you should consult your doctor. Your doctor may decide to gradually increase the dose by
10 mg up to the maximum daily dose.
Take tablets in the morning, with food.
Swallow with water.
Do not chew.
Your doctor will discuss with you how long you should take 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
For patients with liver disease or severe kidney disease, your doctor may prescribe a lower dose of
Seroxat than usually used.
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.
Overdose of Seroxat may cause symptoms 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. Take your next dose the next day as usual.
If you remember during the night or the next 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
begin to work only after some time. Some patients begin to feel better after a few weeks, others later. 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 stopping Seroxat, your doctor will help you gradually reduce the dose over several weeks or months – this should help reduce the possibility of withdrawal symptoms. One way is to gradually reduce the patient's dose of Seroxat by 10 mg weekly. In most patients, withdrawal symptoms are mild 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 Seroxat tablets, your doctor may decide that you should taper the medicine more slowly. If you experience severe symptoms while stopping Seroxat, contact your doctor. Your doctor may recommend restarting the tablets and tapering them more slowly.
Even if you experience 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 in maintaining balance;
• tingling sensation, burning sensation and (less commonly) electric shock-like sensations, including in the head, and ringing, buzzing, whistling, hissing 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 of restlessness or agitation;
• tremor;
• feeling of disorientation;
• diarrhoea (loose stools);
• emotional lability or irritability;
• visual disturbances;
• palpitations or increased heart rate (pounding or racing heart).

If you are concerned about withdrawal symptoms after stopping Seroxat,
contact your doctor.
If you have any further questions about the use of this medicine, contact 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 occur more frequently during the first weeks of treatment with Seroxat.
Contact a doctor if any of the following adverse reactions occur during treatment.
It may be necessary to contact a doctor immediately or go to the nearest hospital emergency department.

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

• If the patient develops 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 urinating, they should contact a doctor immediately or go to hospital.

Rare adverse reactions (occurring in up to 1 in 1,000 patients):

• If the patient has a seizure (convulsions), 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 a 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 the 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, raised skin rash, swelling of the eyelids, face, lips, mouth, or tongue, itching, difficulty breathing (shortness of breath) or swallowing, a feeling of weakness or dizziness leading to falling 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 a condition known as serotonin syndrome or neuroleptic malignant syndrome. These symptoms include: a feeling of intense agitation or irritability, confusion, restlessness, feeling hot, sweating, tremors, 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 such symptoms occur, contact a doctor.
• Acute glaucoma. If the patient experiences eye pain and develops blurred vision, they should contact the treating doctor.

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

• In some patients, thoughts of self-harm or suicide have occurred during treatment with Seroxat or shortly after stopping treatment (see Suicidal thoughts and worsening of depression or anxiety disorder symptoms in section 2).
• In some patients, aggression has 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 such adverse reactions occur, contact the 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, and in men, disturbances of erection and ejaculation.

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 tiredness;
• blurred vision;
• yawning, dry mouth;
• diarrhoea or constipation;
• vomiting;
• weight gain;
• sweating.

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

• temporary increase or decrease in blood pressure, which may cause dizziness or fainting when changing position to standing up suddenly;
• faster than usual heartbeat;
• difficulty moving, stiffness, tremors, or abnormal movements of the mouth and tongue;
• pupil dilation;
• skin rash;
• itching;
• feeling of disorientation;
• hallucinations (strange images or sounds);
• inability to urinate (urinary retention) or uncontrolled, involuntary urination (urinary incontinence);
• in patients with diabetes, treatment with Seroxat may lead to worsening of blood sugar control. Discuss with a doctor about adjusting the dose of insulin or antidiabetic medicines.

Rare adverse reactions (occurring in up to 1 in 1,000 patients):

• abnormal milk production in the breast glands in men and women;
• slow heartbeat;
• liver effects shown in blood tests assessing liver function;
• panic attacks;
• excessive mental or physical activity or racing thoughts (mania);
• feeling of unreality about oneself (depersonalization);
• feeling 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, and absence or delay of menstruation).

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

• a skin rash called erythema multiforme, which may present with blisters and appear as small targets (a dark spot in the center surrounded by a lighter ring with a dark ring around the edge);
• widespread blistering skin rash with peeling of the skin, especially around the mouth, nose, eyes, and genital organs (Stevens-Johnson syndrome);
• widespread blistering skin rash with peeling of a large area of skin (toxic epidermal necrolysis);
• liver function disorders causing yellowing of the skin or whites of the eyes;
• syndrome of inappropriate antidiuretic hormone secretion (SIADH), in which, due to improper 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 or water retention (which may lead to swelling of the hands or feet);
• light sensitivity;
• painful, persistent penile erection;
• decreased platelet count.

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

• inflammation of the large intestine (causing diarrhoea);
• teeth grinding.

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 adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 to provide more information on the safety of the medicine.

5. How to store Seroxat

Keep this 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. Store in the original packaging to protect from light.
If the patient uses 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 in use. This 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 of the medicine 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 breakline on the other side allowing for tablet splitting.
Each pack of Seroxat 20 mg, film-coated tablets contains 30 tablets in child-resistant blisters.

For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Croatia, 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 Warszawa
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warszawa
Poland

Marketing Authorisation number in Croatia, country of export: HR-H-051250245-01
Parallel import licence 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. Detailed information will be provided by the attending physician.