Seroxat

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

• Keep this leaflet for possible future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse effects, including any 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 depression and (or) anxiety disorders in adults.
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 generalised anxiety disorder (generalised 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 so that the patient feels 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, contact the doctor in charge and do 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 the treatment of breast cancer? Seroxat may reduce the effectiveness of tamoxifen, and therefore the 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 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 anticoagulants such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, and 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 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 contacted their doctor, the patient should see their doctor again and ask how to take Seroxat.

Children and adolescents under 18 years of age
Seroxat should 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 manifestations of anger) while taking Seroxat. If the doctor has prescribed Seroxat to a patient under 18 years of age and there are any doubts, contact the doctor. If any of the above symptoms appear or worsen during treatment with Seroxat, inform the doctor. Furthermore, there is currently no long-term data on the safety of Seroxat regarding growth, maturation, cognitive development, and behavioural development in this age group.

In clinical trials of Seroxat in patients under 18 years of age, common adverse events 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, excessive activity (displaying excess energy), restlessness, emotional lability (including tearfulness and mood changes), and unusual bruising or bleeding (such as nosebleeds).

These trials 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 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 agitated, 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 be intensified at the beginning of treatment with antidepressants, as it may take some time, usually about two weeks, before antidepressants start to work, and sometimes even longer.

Such thoughts may be more common 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 young 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, contact the 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 worsening 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: intense restlessness or agitation, 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 discontinuation of 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 use 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 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 substitution therapy;
• medicines known as triptans, such as sumatriptan, used for the treatment of migraine;
• other antidepressants, known as SSRIs and tricyclic antidepressants, such as clomipramine, nortriptyline, and desipramine;
• the dietary supplement tryptophan;
• mivacurium and suxamethonium (used for general anaesthesia);
• medicines such as lithium, risperidone, perphenazine, clozapine (known as antipsychotics) used to treat certain psychiatric disorders;
• fentanyl, a medicine used during anaesthesia and for the treatment of chronic pain;
• the combination of fosamprenavir and ritonavir, used for the 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 for the treatment of attention deficit hyperactivity disorder (ADHD);
• procyclidine, used to treat tremor, especially in Parkinson’s disease;
• warfarin or other medicines (known as anticoagulants) used to thin the blood;
• propafenone, flecainide, and medicines used to treat irregular heartbeat;
• metoprolol, a beta-blocker used to treat high blood pressure and heart problems;
• pravastatin, used to treat high cholesterol levels;
• rifampicin, used to treat tuberculosis and acne;
• linezolid – an antibiotic;
• tamoxifen, used in the treatment of breast cancer.

If the patient is currently taking or has recently taken any of the listed medicines and has not discussed this with their doctor, the patient should contact their doctor again and ask what to do. The dose of the medicine may need to be changed, or it may be necessary to take another medicine.

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 those available without a prescription.

Seroxat with food, drink and alcohol
During treatment with Seroxat, alcohol should not be consumed. 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 using this medicine.

There are some reports indicating that infants whose mothers took Seroxat during the first few months of pregnancy had congenital developmental defects, particularly heart defects. In the general population, about 1 in 100 babies is born with a heart defect. This number increases to 2 in 100 babies if the mother took Seroxat. The doctor, together with the patient, will decide whether it is better for the patient 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.

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 that appropriate advice can be provided. Medicines such as Seroxat taken during pregnancy, particularly 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 cyanosis or unstable body temperature
• cyanosis 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
• exaggerated 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 may 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, 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 taking one tablet may not provide the full 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 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 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.
Tablets should be taken in the morning, with food.
Swallow them 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
In patients with liver disease or severe kidney disease, your doctor may recommend a lower dose of
Seroxat than is usually prescribed.
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
packaging of the tablets.
As a result of an overdose of Seroxat, you may experience symptoms described in section 4:
Possible side effects, or the following symptoms: fever, involuntary muscle contractions.
If you miss 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 following day that you missed a dose, do not
take the missed dose. You may experience withdrawal symptoms, but these should
quickly subside 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. 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 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 help reduce the possibility of withdrawal symptoms.
One way is to gradually reduce the patient's 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 may persist 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 during
discontinuation of 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
discontinuing 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;
• tingling sensations, burning sensations and (less commonly) electric shock-like sensations, including in the head, and ringing, buzzing, whistling, humming 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;
• diarrhoea (loose stools);
• emotional lability or irritability;
• visual disturbances;
• palpitations or increased heart rate (tachycardia).

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

4. Possible adverse effects

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

Uncommon adverse effects (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 effects (occurring in up to 1 in 1,000 patients):

• If the patient has a seizure (convulsion), 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, is disoriented, they may have low sodium levels in the blood. If such symptoms occur, contact the treating doctor.

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

• Allergic reactions to Seroxat, which may be severe. If the patient develops a red, lumpy rash on the skin, 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 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, 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 the doctor;
• Acute glaucoma. If the patient experiences eye pain and develops blurred vision, they should contact the treating doctor.

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

• In some patients, thoughts of self-harm or suicide occurred during or shortly after stopping 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 effect on fertility in section 2.

If any of these adverse effects occur, contact the treating doctor.

Other possible adverse effects occurring during treatment

Very common adverse effects (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, disturbances of erection and ejaculation.

Common adverse effects (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 effects (occurring in up to 1 in 100 patients):

• brief increases or decreases in blood pressure, which may cause dizziness or fainting when changing position suddenly to standing;
• faster than usual heartbeat;
• difficulty moving, stiffness, tremors or abnormal movements of the mouth and tongue;
• dilated pupils;
• 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 diabetic patients, treatment with Seroxat may lead to worsening control of blood sugar levels. Discuss with your doctor adjustments to insulin or diabetes medication dosage.
• decreased white blood cell count.

Rare adverse effects (occurring in up to 1 in 1,000 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 uncertainty about one's own identity (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 disturbances (including heavy or irregular bleeding, intermenstrual bleeding, or absence or delay of menstruation).

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

• skin rash called erythema multiforme, which may include blisters and appear as target-like lesions (a dark spot in the centre surrounded by a lighter ring with a dark edge);
• widespread skin rash with blisters and peeling of the skin, especially 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 are reduced. Patients with SIADH may have symptoms of serious illness or may show no symptoms at all;
• fluid or water retention (which may lead to swelling of the hands or feet);
• sensitivity to light;
• painful, persistent penile erection;
• decreased platelet count.

Adverse effects 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to 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 the patient is using tablet halves, 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. Such practices 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 components of the medicine are:
Tablet core: calcium hydrogen phosphate dihydrate, magnesium stearate, sodium carboxymethyl starch (type A).
Tablet coating: Opadry White YS-1R-7003: hypromellose, titanium dioxide (E 171), polyethylene glycol 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 number "20" embossed on one side and a 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 Romania, country of export:
GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus
Dublin 24
Ireland

Manufacturer:
DELPHARM POZNAŃ SPÓŁKA AKCYJNA
ul. Grunwaldzka 189
60-322 Poznań
Poland

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in Romania, country of export: 601/2008/02
Parallel Import Licence Number: 319/19

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) 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.