Seroxat 20 mg film-coated tablets: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Seroxat 20 mg film-coated tablets

paroxetine (as hydrochloride hemihydrate)

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Seroxat is and what it is used for
What you need to know before taking Seroxat
How to take Seroxat
Possible adverse effects
How to store Seroxat
Contents of the pack and other information

1. What Seroxat is and what it is used for

Seroxat is used for the treatment of depression and/or anxiety disorders in adults. The anxiety disorders for which Seroxat is indicated are: obsessive-compulsive disorder (obsessive, repetitive thoughts with uncontrollable behaviour), panic disorder (panic attacks, including those caused by agoraphobia, which is fear of open spaces), social anxiety disorder (fear of or avoidance of social situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (persistently feeling very anxious and nervous).

Seroxat belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). The precise mechanism of action of Seroxat and other SSRIs is not fully understood, but they act by increasing the level of serotonin in the brain. Proper treatment of depression or anxiety disorders is important to help you feel better.

2. What you need to know before taking Seroxat

Do not take Seroxat

if you are being treated with medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride (methylene blue)), or if you have been treated with any of these medicines within the last two weeks. Your doctor will advise you on how to start taking Seroxat after stopping the MAOI
if you are taking an antipsychotic medicine called thioridazine or the antipsychotic called pimozide
if you are allergic to paroxetine or to any of the other ingredients of this medicine (listed in section 6).

If you are in any of these situations, tell your doctor and do not take Seroxat.

Warnings and precautions

Talk to your doctor or pharmacist before taking Seroxat

if you are taking other medicines (see the section Other medicines and Seroxat)
if you are taking tamoxifen for the treatment of breast cancer (or fertility problems). Seroxat may make tamoxifen less effective, so your doctor should recommend that you take another antidepressant
if you have any kidney, liver, or heart problems
if you have an abnormality in your heart rhythm seen on an electrocardiogram (ECG) known as QT interval prolongation
if you have a family history of QT interval prolongation, heart conditions such as heart failure, slow heart rate, or low levels of potassium or magnesium
if you have epilepsy or experience seizures or epileptic fits
if you have had manic episodes (excessively active thoughts or behavior)
if you are receiving electroconvulsive therapy (ECT)
if you are prone to bleeding or bruising, or are taking any medicine that may increase the risk of bleeding (including medicines such as warfarin (acenocoumarol), antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines for pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)
if you have diabetes
if you are on a low-sodium diet
if you have glaucoma (high eye pressure)
if you are pregnant or planning to become pregnant (see the section Pregnancy, breastfeeding and fertility)
if you are under 18 years of age (see the section Children and adolescents under 18 years of age).

If you are in any of these situations and have not yet consulted your doctor**, ask your doctor about how to take Seroxat**.

Children and adolescents under 18 years of age

Seroxat should not be used to treat children and adolescents under 18 years of age. You should also be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking Seroxat. Nevertheless, your doctor may prescribe Seroxat to patients under 18 years of age if they decide it is the most appropriate treatment. If your doctor has prescribed Seroxat to you or your child under 18 years of age and you wish to discuss this decision, speak to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while you or your child under 18 years of age are taking Seroxat. The long-term effects of Seroxat on safety with regard to growth, maturation, and cognitive and behavioral development in this age group have not yet been established.

In clinical studies of Seroxat in patients under 18 years of age, the common adverse effects, affecting fewer than 1 in 10 children or adolescents, were: increased suicidal thoughts and suicide attempts, self-harm attempts, hostile, aggressive, or uncooperative behavior, loss of appetite, tremors, abnormal sweating, hyperactivity (excessive energy), agitation, emotional lability (including crying and mood swings), and unexpected bruising or bleeding (such as nosebleeds). These effects were also observed, though less frequently, in patients in these studies who did not take Seroxat.

When stopping treatment with Seroxat, some patients under 18 years of age in these studies reported withdrawal effects. These effects were very similar to those observed in adults who stopped taking Seroxat (see section 3). In addition, patients under 18 years of age frequently experienced (affecting fewer than 1 in 10) stomach pain, nervousness, and emotional lability (including crying, mood swings, self-harm attempts, suicidal thoughts, and suicide attempts).

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. These may increase at the beginning of treatment with antidepressants, as all these medicines take time to work—usually about two weeks, but sometimes longer.

You are more likely to experience this

If you have previously had thoughts of suicide or self-harm.
If you are a young adult. Clinical trial data show an increased risk of suicidal behavior in psychiatric patients under 25 years of age being treated with an antidepressant.

If you have thoughts of harming yourself or committing suicide at any time, contact your doctor or go to the hospital immediately.

It may be helpful for you to tell a family member or close friend that you are depressed or have anxiety disorders, and ask them to read this leaflet. You may also ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behavior.

Important adverse effects observed with Seroxat

Some patients taking Seroxat develop a condition called akathisia and feel restless and unable to sit still. Other patients develop a condition called serotonin syndrome or neuroleptic malignant syndrome, and may experience one or more of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremor, chills, hallucinations (strange visions or sounds), muscle rigidity, sudden jerky movements, or increased heart rate. Symptoms may worsen and lead to loss of consciousness. Contact your doctor if you experience any of these symptoms. For more information about this or other adverse effects of Seroxat, see section 4.

Some medicines in the same class as Seroxat (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Other medicines and Seroxat

Some medicines may alter the effect of Seroxat or make it more likely that certain adverse effects occur. Seroxat may also alter the effect of some medicines. For example:

Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride (methylene blue)). See the section Do not take Seroxat.
Medicines known to increase the risk of changes in the heart's electrical activity (e.g., the antipsychotics thioridazine or pimozide). See the section Do not take Seroxat.
Acetylsalicylic acid, ibuprofen, and other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, etodolac, diclofenac, and meloxicam, used to treat pain and inflammation.
Tramadol, buprenorphine, and meperidine, analgesics.
Buprenorphine combined with naloxone, used as opioid addiction replacement therapy.
Medicines called triptans, such as sumatriptan, used to treat migraine.
Other antidepressants, including other selective serotonin reuptake inhibitors and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
A dietary supplement called tryptophan.
Mivacurium and suxamethonium (used in anesthesia).
Medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat certain psychiatric disorders.
Fentanyl, used in anesthesia or to treat chronic pain.
A combination of fosamprenavir and ritonavir, used to treat human immunodeficiency virus (HIV) infection.
St. John’s wort, a herbal remedy used to treat depression.
Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizures or epilepsy.
Atomoxetine, a medicine used to treat attention deficit hyperactivity disorder (ADHD).
Procyclidine, used to relieve tremors, especially in Parkinson’s disease.
Warfarin and other medicines (called anticoagulants) used to thin the blood.
Propafenone, flecainide, and medicines used to treat cardiac rhythm disorders.
Metoprolol, a beta-blocker used to treat high blood pressure and heart conditions.
Pravastatin, used to treat high cholesterol.
Rifampicin, used to treat tuberculosis (TB) and leprosy.
Linezolid, an antibiotic.
Tamoxifen, used to treat breast cancer (or fertility problems).

If you are taking or have recently taken any of these medicines, tell your doctor and ask what you should do. Your doctor may decide to adjust your dose or prescribe a different medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Taking Seroxat with food, drinks, and alcohol

Do not consume alcohol while taking Seroxat. Alcohol may worsen your symptoms or side effects.

Taking Seroxat in the morning with food may reduce the likelihood of nausea.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Some studies have shown an increased risk of birth defects, particularly those affecting the heart, in newborns whose mothers took Seroxat during the first months of pregnancy. In the general population, approximately 1 in 100 newborns is born with a heart defect. This rate increased to 2 in 100 newborns in mothers who took Seroxat. Your doctor, in consultation with you, may switch you to another treatment or gradually discontinue Seroxat during pregnancy. However, depending on your circumstances, your doctor may recommend continuing Seroxat.

Ensure your doctor or midwife knows that you are taking Seroxat. If you take Seroxat in late pregnancy, there is an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Seroxat so they can advise you. Medicines like Seroxat may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy, particularly in the later stages. In newborns with persistent pulmonary hypertension (PPHN), the pressure in the blood vessels between the heart and lungs is very high.

If you take Seroxat during the third trimester of pregnancy, your newborn may also experience other symptoms, usually beginning within the first 24 hours after birth. These symptoms may include:

difficulty breathing
bluish skin or appearing too hot or too cold
blue lips
vomiting or feeding difficulties
extreme tiredness, difficulty sleeping, or frequent crying
muscle stiffness or floppiness
tremors, localized tremors, or seizures
exaggerated reflexes.

If your baby shows any of these symptoms at birth, or if you are concerned about your newborn’s health, contact your doctor or midwife, who will advise you.

Seroxat passes into breast milk in very small amounts. Consult your doctor if you are taking Seroxat before starting breastfeeding. Your doctor, in consultation with you, may advise continuing breastfeeding while taking Seroxat.

Animal studies have shown that paroxetine reduces sperm quality. This could theoretically affect fertility in humans, but this effect has not yet been observed in people.

Driving and using machines

Some of the adverse effects caused by Seroxat include dizziness, confusion, drowsiness, or blurred vision. If you experience any of these effects, do not drive or operate machinery.

Seroxat contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.

3. How to take Seroxat

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Sometimes you may need to take more than one tablet or half a tablet. The following table will show you how many tablets you should take:

Dosage	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 normal doses for the different indications are detailed in the following table:

	Initial daily dose	Recommended daily dose	Maximum daily dose
Depression	20 mg	20 mg	50 mg
Obsessive-compulsive disorder	20 mg	40 mg	60 mg
Panic disorder	10 mg	40 mg	60 mg
Social anxiety disorder	20 mg	20 mg	50 mg
Post-traumatic stress disorder	20 mg	20 mg	50 mg
Generalized anxiety disorder	20 mg	20 mg	50 mg

Your doctor will tell you what dose to take when starting treatment with Seroxat. Most people begin to feel better after a couple of weeks. If you do not start to feel better after this time, consult your doctor, who will advise you on what to do. Your doctor may decide to gradually increase the dose in 10 mg increments up to the maximum daily dose.

Take the tablets in the morning with food.

Swallow the tablets with water.

Do not chew the tablets.

Your doctor will determine how long your treatment should last. This period may extend for several months or even longer.

Elderly patients

The maximum dose for people over 65 years of age is 40 mg per day.

Patients with kidney or liver problems

If you have severe hepatic or renal impairment, your doctor may advise you to take lower doses of Seroxat than usual.

If you take more Seroxat than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medication and the amount ingested.

Never take more tablets than your doctor has prescribed.

A person who has taken an overdose of Seroxat may experience some of the symptoms listed in section 4, Possible side effects, or one of the following symptoms: fever, involuntary muscle contractions.

If you forget to take Seroxat

Take your medication at the same time each day.

If you forget a dose and remember before going to bed, take it immediately. Take the next dose at your usual time.

If you remember during the night or the following day, skip the missed dose. You may experience some withdrawal symptoms, but these should disappear after taking the next dose at your usual time.

Do not take a double dose to make up for missed doses.

What to do if you do not feel better

Seroxat will not improve your symptoms immediately; all antidepressants take time to work. Some people begin to feel better after a couple of weeks, but others may require more time. Some people taking antidepressants may feel worse before they start to feel better. If you do not begin to feel better after a couple of weeks, inform your doctor, who will advise you on what to do. Your doctor may have scheduled a follow-up appointment two weeks after starting your treatment.

If you stop taking Seroxat

Do not stop treatment until your doctor tells you to do so.

When stopping treatment with Seroxat, your doctor will advise you on how to gradually reduce the dose over a period of several weeks or months, which will help reduce the risk of withdrawal symptoms. One way to do this is to gradually reduce your Seroxat dose by 10 mg each week. Most people find that any withdrawal symptoms that occur when stopping Seroxat are mild and disappear on their own within two weeks. For others, these symptoms may be more severe or last longer.

If you experience withdrawal symptoms while stopping treatment, your doctor may decide to discontinue treatment more slowly. If you experience severe withdrawal symptoms, please consult your doctor. Your doctor may recommend restarting treatment and then stopping it more gradually.

Even if you experience withdrawal symptoms, you may still be able to discontinue treatment with Seroxat.

Possible withdrawal effects when stopping treatment

Studies have shown that 3 out of every 10 patients experience one or more symptoms when stopping treatment with Seroxat. Some of these effects occur more frequently than others.

Common adverse effects

May affect up to 1 in 10 people

Dizziness, unsteadiness, or balance disturbances.
Tingling, burning sensations, and less frequently, electric shock-like sensations, even in the head; ringing, buzzing, hissing, or other persistent noises in the ears (tinnitus).
Sleep disturbances (very vivid dreams, nightmares, inability to sleep).
Anxiety.
Headaches.

Uncommon adverse effects

May affect up to 1 in 100 people

Nausea (vomiting).
Sweating (including night sweats).
Restlessness or agitation.
Tremor.
Confusion or disorientation.
Diarrhea (loose stools).
Feeling overly sensitive or irritable.
Visual disturbances.
Rapid or very strong heartbeats (palpitations).

Consult your doctor if you are concerned about withdrawal effects from Seroxat.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them. Adverse effects are more likely to occur during the first weeks of treatment with Seroxat.

Tell your doctor if you experience any of the adverse effects listed below while taking Seroxat.

You may need to consult your doctor or go to hospital immediately.

Uncommon adverse effects

May affect up to 1 in 100 people

If you have unusual bruising or bleeding, such as blood in vomit or stools, contact your doctor or go to hospital immediately.
If you are unable to urinate, contact your doctor or go to hospital immediately.

Rare adverse effects

May affect up to 1 in 1,000 people

If you experience seizures (epileptic fits), contact your doctor or go to hospital immediately.
Feeling restless, unable to sit still or remain motionless, known as akathisia. Increasing the dose of Seroxat may worsen your symptoms. If you feel this way, consult your doctor.
Tiredness, weakness, confusion, and muscle pain, stiffness, or lack of coordination. This may be due to low sodium levels in the blood. If you have these symptoms, consult your doctor.

Very rare adverse effects

May affect up to 1 in 10,000 people

Allergic reactions to Seroxat, which may be severe.

If you develop a rash with redness and lumps, swelling of the face, eyelids, lips, mouth or tongue, itching, difficulty breathing (shortness of breath) or swallowing, and feeling weak or faint, which may lead to collapse or loss of consciousness, contact your doctor or go to hospital immediately.

If you notice any or all of the following symptoms, you may be experiencing serotonin syndrome or neuroleptic malignant syndrome. Symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremor, chills, hallucinations (strange sounds or visions), muscle rigidity, sudden jerky movements, or rapid heartbeat. Severity may increase and lead to loss of consciousness. If you feel this way, consult your doctor.
Acute angle-closure glaucoma.

If you develop eye pain and blurred vision, consult your doctor.

Frequency not known

Frequency cannot be estimated from the available data

Some people have experienced thoughts of harming themselves or of suicide while taking Seroxat or shortly after stopping treatment (see Suicidal thoughts and worsening of depression or anxiety disorder in section 2).
Some people have experienced aggression while taking Seroxat.
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see Pregnancy, breastfeeding and fertility in section 2 for more information.

If you experience these adverse effects, contact your doctor.

Other possible adverse effects during treatment:

Very common adverse effects

May affect more than 1 in 10 people

Feeling unwell (nausea). This effect may be reduced by taking your medication in the morning after breakfast.
Changes in sexual desire or function, for example, lack of orgasm, and in men, abnormal erection and ejaculation.

Common adverse effects

May affect up to 1 in 10 people

Increased blood cholesterol levels.
Decreased appetite.
Difficulty sleeping (insomnia) or drowsiness.
Abnormal dreams (including nightmares).
Dizziness, tremors.
Headache.
Difficulty concentrating.
Agitation.
Unusual weakness.
Blurred vision.
Yawning, dry mouth.
Diarrhoea or constipation.
Vomiting.
Weight gain.
Sweating.

Uncommon adverse effects

May affect up to 1 in 100 people

Temporary increases in blood pressure, or temporary decreases in blood pressure that may cause dizziness or fainting when standing up quickly.
Faster than normal heartbeat.
Lack of movement, stiffness, tremor, or abnormal movements of the mouth and tongue.
Dilated pupils.
Skin rash.
Itching.
Confusion.
Hallucinations (strange sounds or visions).
Inability to urinate (urinary retention) or urinary incontinence (uncontrolled and involuntary urination).
If you are a diabetic patient, you may notice loss of control of blood sugar levels while taking Seroxat. Consult your doctor about adjusting your insulin or diabetes medication dosage.
Decreased white blood cell count.

Rare adverse effects

May affect up to 1 in 1,000 people

Abnormal breast milk secretion in men and women.
Slowed heart rate.
Liver effects seen in laboratory tests indicating liver function.
Panic attacks.
Excessively active behaviour or thoughts (mania).
Feeling detached from oneself (depersonalisation).
Anxiety.
Irresistible urge to move the legs (Restless Legs Syndrome).
Joint or muscle pain.
Increased blood levels of a hormone called prolactin.
Menstrual cycle disturbances (including heavy or irregular periods, bleeding between periods, or absence or delay of periods).

Very rare adverse effects

May affect up to 1 in 10,000 people

Skin rash, in which blisters may appear with a target-like appearance (dark central spots surrounded by a pale area, with a dark ring around it), called erythema multiforme.
Widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
Widespread rash affecting a large body surface with blisters and skin peeling (toxic epidermal necrolysis).
Liver disorders causing yellowing of the skin or whites of the eyes.
Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body retains excess water and sodium (salt) concentration decreases, due to inappropriate chemical signals. Patients with SIADH may feel severely ill or may have no symptoms at all.
Fluid or water retention (causing swelling of arms or legs).
Sensitivity to sunlight.
Painful and prolonged penile erection.
Decreased platelet count in blood.

Frequency not known

Frequency cannot be estimated from the available data

Inflammation of the colon (causing diarrhoea).
Teeth grinding.

Some patients have experienced ringing, whistling, buzzing, tinkling or other persistent noises in the ears (tinnitus) while taking Seroxat.

It has been observed that people taking medicines like Seroxat have an increased risk of bone fractures.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Seroxat

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect from light.

If you are taking half a tablet, take care to store it safely in the container.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and other information

Composition of Seroxat

The active substance is paroxetine (20 mg) as hydrochloride hemihydrate.

The other components are:

In the tablet core: calcium hydrogen phosphate dihydrate (E341), magnesium stearate (E470b), and sodium carboxymethyl starch (type A) from potato.

In the tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol 400, and polysorbate 80 (E433).

Appearance of the product and contents of the container

Seroxat 20 mg film-coated tablets are presented as white, oval tablets, marked with "20" on one side and a break line on the other. Each Seroxat pack contains child-resistant blisters of 4, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 250 or 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer responsible:

Delpharm Poznan Spólka Akcyjna
ul. Grunwaldzka 189
60-322 Poznan
Poland

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany, Austria, Belgium, Cyprus, Denmark

Slovakia, Slovenia, Spain, Estonia, Finland, Greece, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Netherlands, Poland, Portugal, Czech Republic, Sweden

Seroxat

France

Deroxat

You can request further information about your condition by contacting a patient organization. Please consult your doctor.

Date of the most recent review of this leaflet: December 2023.

Detailed and up-to-date information about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/