Seroxat

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Seroxat, 20 mg, film-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 give it to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of Contents

1. What Seroxat is and what it is used for
2. What you need to know 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 treated with Seroxat include: obsessive-compulsive disorder (recurring, obsessive thoughts with uncontrollable behaviour), panic disorder (panic attacks, including those associated with 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 known as 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 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 must contact their doctor and must not take Seroxat.

Warnings and precautions
Before starting to take Seroxat, discuss this 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 that the patient use 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 heart rate, or low potassium or low magnesium levels?
• Does the patient have epilepsy or has the patient had seizures in the past?
• Has the patient ever experienced episodes of mania (excessively active behaviour or racing thoughts)?
• Is the patient receiving electroconvulsive therapy (ECT)?
• Has the patient had bleeding problems in the past 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, and medicines used for pain and inflammation called 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 effect on 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, 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 behaviours, and anger) while taking Seroxat. If the doctor has prescribed Seroxat for a patient under 18 years of age and there are any doubts, the patient should contact their doctor. If any of the mentioned symptoms occur or worsen during treatment with Seroxat, the doctor must be informed. Furthermore, 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, deliberate self-harm, hostility, aggressive or hostile behaviour, loss of appetite, tremor, abnormal sweating, increased activity (displaying excess energy), restlessness, emotional lability (including tearfulness and mood swings), and unusual bruising or bleeding (such as nosebleeds).

These studies also showed that the same symptoms occurred, although less frequently, in children and adolescents taking 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). In addition, in patients under 18 years of age, abdominal pain, feeling of agitation, 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 disorder symptoms
Patients with depression and (or) anxiety disorders may sometimes experience thoughts of self-harm or suicidal thoughts. These may be intensified 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.

Such thoughts may be more frequent in the patient if:

• the patient previously had suicidal thoughts or thoughts of self-harm,
• the patient is a young adult. Clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with antidepressants. If the patient ever experiences thoughts of self-harm or suicide, they must contact their doctor or the nearest hospital 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 inform the patient if they notice that the depression or anxiety disorder worsens or if there are worrying changes in their behaviour.

Important adverse effects observed during treatment with Seroxat
In some patients taking Seroxat, symptoms called akathisia may develop.
The patient then feels 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: intense restlessness 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 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 electrical activity of the heart (e.g. antipsychotics such as thioridazine or pimozide) – see section: When not to take Seroxat;
• acetylsalicylic acid, ibuprofen, or other medicines called 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;
• dietary supplement called tryptophan;
• mivacurium and suxamethonium (used for general anaesthesia);
• medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotics) used for 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 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 (called anticoagulants) used for blood thinning;
• 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 the listed medicines
and has not yet discussed this with their doctor, they should contact their doctor again and ask what to do. The dose of the medicine may need to be adjusted or another medicine may need to be taken.

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including medicines available without a prescription.

Seroxat with food, drink, and alcohol
Do not consume alcohol while taking Seroxat. Alcohol may worsen symptoms of the illness or adverse effects. Taking Seroxat in the morning with food reduces the likelihood of nausea.

Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine. There are some reports indicating that children whose mothers took Seroxat during the first few months of pregnancy had congenital developmental abnormalities, 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 took Seroxat. The doctor, together with the patient, will decide whether it is better for the patient during pregnancy to switch to another medicine or to gradually discontinue Seroxat. In certain circumstances, the doctor may also suggest that it is better for the patient to continue taking Seroxat.

Ensure that the midwife or doctor is informed that the patient is taking Seroxat. Taking Seroxat towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting 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 heart and lungs of the baby 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 temperature instability;
• blueness of the lips;
• vomiting or difficulty feeding properly;
• fatigue, 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, contact the 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, together with the patient, may decide that the patient can breastfeed 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 using machines
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, which means the medicine is considered "sodium-free".

3. How to take Seroxat

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should
consult your doctor or pharmacist.
Sometimes taking one tablet does not provide the entire recommended dose of the medicine. The table
below indicates how many Seroxat tablets should be taken 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 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, 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 aged over 65 years 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 normally 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. Show them the tablet packaging.
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 forget to take a dose and remember before going to bed,
take it immediately. Take your next dose the following 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 forgotten 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 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. 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 advises you to do so. When
discontinuing Seroxat, your doctor will help you gradually reduce the dose over several
weeks or months – this should reduce the likelihood of withdrawal symptoms. One
way is to gradually reduce your dose of Seroxat by 10 mg per week. 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 the tablets, your doctor may
decide that you should taper off the medicine more slowly. If you experience severe symptoms while discontinuing Seroxat, contact your doctor. Your doctor 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 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 in the head, as well as ringing, buzzing, whistling, or other persistent noises in the ears (tinnitus);
• sleep disturbances (vivid dreams, nightmares, insomnia);
• feelings of anxiety;
• headaches.

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

• nausea;
• sweating (including night sweats);
• feelings of restlessness or agitation;
• tremors;
• feelings 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 using 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 occur more frequently during the first weeks of treatment with 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 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 passing urine, 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 (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 the doctor.
• If the patient experiences fatigue, weakness, pain, stiffness or lack of muscle coordination, or is disoriented, they may have low sodium levels in the blood. 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, blotchy rash on the skin, swelling of the eyelids, face, lips, mouth or tongue, itching, difficulty breathing (shortness of breath) or swallowing, or feels weak or dizzy leading to collapse or loss of consciousness, they should contact a doctor immediately or go to hospital;
• If the patient has 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, disorientation, anxiety, fever, sweating, tremors, chills, hallucinations (strange visions or hearing strange sounds), muscle stiffness, sudden muscle contractions or rapid heartbeat. Symptoms may worsen and lead to loss of consciousness. If such symptoms occur, contact the doctor;
• Acute glaucoma. If the patient experiences eye pain and blurred vision, they should contact the treating doctor.

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

• In some patients, thoughts of self-harm or suicide occurred during or shortly after discontinuation of treatment with Seroxat (see Suicidal thoughts and worsening of depression or anxiety symptoms 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 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, or in men, erectile and ejaculatory 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 tiredness;
• blurred vision;
• yawning, dry mouth;
• diarrhoea or constipation;
• vomiting;
• weight gain;
• sweating.

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

• transient increase or decrease in blood pressure, which may cause dizziness or fainting upon sudden standing;
• 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 pass urine (urinary retention) or uncontrolled, involuntary passing of urine (urinary incontinence);
• in patients with diabetes, treatment with Seroxat may lead to worsening of blood sugar control. Discuss with your doctor adjustments to insulin or antidiabetic medication dosage.
• decreased white blood cell count.

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 indicated by blood tests assessing liver function;
• panic attacks;
• excessive mental activity or racing thoughts (mania);
• feeling of unreality or detachment from oneself (depersonalization);
• feeling of anxiety;
• irresistible urge to move the legs (restless legs syndrome);
• joint or muscle pain;
• increased blood levels of a hormone called prolactin;
• 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):

• a skin rash called erythema multiforme, which may present with blisters and resemble small targets (a dark spot in the center surrounded by a lighter ring with a dark edge);
• widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome);
• widespread skin rash with blisters and peeling of large areas 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), where due to abnormal chemical signals in the body, excess water is retained and sodium (salt) levels decrease. Patients with SIADH may experience 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 determined from available data)

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

Some patients may experience ringing, buzzing, whistling, or other persistent noises 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, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 the 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.
Store in the original packaging to protect from light.
If patients are using half tablets, they should take care 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 will help protect the environment.

6. Contents of the package 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 (E 341), magnesium stearate (E 470b),
sodium carboxymethyl starch (type A).
Tablet coating: hypromellose (E 464), titanium dioxide (E 171), macrogol 400, polysorbate 80.

What Seroxat looks like and contents of the pack
Seroxat 20 mg, coated tablets – white, oval, biconvex coated tablets, printed with "20" or "Seroxat 20" on one side and a division line on the other side.
Each pack of Seroxat 20 mg coated tablets contains 30 coated tablets in blisters.

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

Marketing Authorisation Holder in the Republic of 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation Number in the Republic of Croatia, the country of export: HR-H-051250245-01
Parallel Import Licence Number: 410/16

This medicine is authorised in the European Economic Area member states 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 illness. Detailed information will be provided by the treating physician.