Seroxat

Package leaflet: Information for the user

SEROXAT 20 mg film-coated tablets

paroxetine (as hemihydrate hydrochloride)
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Never give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 a treatment for adults with depression and/or anxiety disorders. The anxiety disorders for which
treatment with SEROXAT is indicated are: obsessive-compulsive disorder (repetitive, obsessive thoughts
with uncontrollable behaviours), panic disorder (panic attacks, including those caused by agoraphobia,
i.e. 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 (feeling excessively anxious or nervous in general).
SEROXAT belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). It is not fully known how SEROXAT and other SSRIs work, but they may help increase the level of serotonin in the brain.
Treating depression or anxiety disorders appropriately is important to help you feel better.

2. What you should know before taking SEROXAT

Do not take SEROXAT

• If you are taking other medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)), or if you have taken them at any time within the last two weeks. Your doctor will advise you on how to start taking SEROXAT after you have stopped taking MAOIs.
• If you are taking an antipsychotic called thioridazine or an antipsychotic called pimozide.
• If you are allergic to paroxetine or to any of the other ingredients of this medicine (listed in section 6). If any of these situations apply to you, speak to your doctor before taking SEROXAT.

Warnings and precautions
Talk to your doctor or pharmacist before taking SEROXAT

• Are you taking any other medicine? (See inside this leaflet, Other medicines and SEROXAT)
• Are you taking tamoxifen for the treatment of breast cancer or for fertility problems? SEROXAT may make tamoxifen less effective, so your doctor may recommend that you take another antidepressant.
• Do you have problems with your kidneys, liver, or heart?
• Do you suffer from epilepsy or have you previously had seizures?
• Have you ever experienced episodes of mania (overactive behaviour or thoughts)?
• Have you received electroconvulsive therapy?
• Have you previously had bleeding episodes, or are you taking other medicines that may increase the risk of bleeding (these include blood-thinning medicines such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines used for pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)?
• Do you have diabetes?
• Are you on a low-sodium diet?
• Do you have glaucoma (high pressure in the eye)?
• Are you pregnant or planning to become pregnant? (See inside this leaflet Pregnancy, breast-feeding and fertility)
• Are you under 18 years of age? (See inside this leaflet Children and adolescents under 18 years)

If you answered YES to any of these questions, and have not already discussed this with your doctor, go back to your doctor and ask what you should do about taking SEROXAT.

Children and adolescents under 18 years
SEROXAT must not be used in children and adolescents under 18 years of age.
Furthermore, patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) when taking SEROXAT. If your doctor has prescribed SEROXAT for you (or for your child) and you wish to discuss this, go back to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while you (or your child) are taking SEROXAT. In addition, in this age group, the long-term effects of SEROXAT on growth, maturation, and cognitive and behavioural development have not yet been established.

In studies with SEROXAT in patients under 18 years of age, the common adverse effects occurring in fewer than 1 in 10 children/adolescents were: increased suicidal thoughts and suicide attempts, deliberate self-harm, hostile behaviour, aggressive or unfriendly behaviour, loss of appetite, tremors, unusual sweating, hyperactivity (having too much energy), restlessness, changes in emotions (including crying and mood changes), and unusual bruising or bleeding (such as nosebleeds). These studies also showed that the same symptoms occurred in children and adolescents taking sugar pills (placebo) instead of SEROXAT, although less frequently.

In these studies conducted in patients under 18 years of age, some patients experienced withdrawal symptoms after stopping SEROXAT. These symptoms were mostly similar to those observed in adults after stopping SEROXAT (see section 3). In addition, patients under 18 years of age commonly experienced (in fewer than 1 in 10 cases) stomach pain, nervousness, and changes in emotions (including crying, mood changes, self-harm, suicidal thoughts, and suicide attempts).

Suicidal thoughts and worsening of depression or anxiety disorders
If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of harming yourself or taking your life. These thoughts may be more common when you first start taking antidepressants, as all these medicines take time to work—usually about two weeks, but sometimes longer.

You may be more likely to have these types of thoughts:

• If you have previously had thoughts of harming yourself or taking your life.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who are being treated with an antidepressant.

If at any time you have thoughts of harming yourself or taking your life, contact your doctor or go directly to hospital.

You may find it helpful to tell a relative or friend that you suffer from depression or anxiety disorders, and ask them to read this leaflet. You may ask them to inform you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour.

Important adverse effects observed with SEROXAT
Some patients taking SEROXAT experience a condition called akathisia, meaning they feel restless and unable to sit or stand still. Other patients may experience what is called serotonin syndrome or neuroleptic malignant syndrome, which may include some or all of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. The condition may worsen and lead to loss of consciousness. If you experience any of these symptoms, contact your doctor. For more information on these or other adverse effects of SEROXAT, see section 4.

Medicines such as SEROXAT (so-called selective serotonin reuptake inhibitors, SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have been observed to persist after discontinuation of treatment.

Other medicines and SEROXAT
Some medicines may interfere with the action of SEROXAT or may make adverse effects more likely. SEROXAT may also interfere with the action of other medicines. These include:

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)) – see inside this leaflet Do not take SEROXAT.
• Thioridazine or pimozide, which are antipsychotics – see inside this leaflet Do not take SEROXAT.
• Acetylsalicylic acid, ibuprofen, or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib, etodolac, diclofenac, and meloxicam, used for pain and inflammation
• Tramadol, buprenorphine, and pethidine, painkillers
• Buprenorphine in combination with naloxone, opioid dependence treatment
• Medicines called triptans, such as sumatriptan, used to treat migraine
• Other antidepressants, including other SSRIs, tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine
• A dietary supplement called tryptophan
• Mivacurium and succinylcholine (used in anaesthesia)
• Medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotics) used to treat certain psychiatric conditions
• Fentanyl, used in anaesthesia or for treating chronic pain
• A combination of fosamprenavir and ritonavir, used to treat Human Immunodeficiency Virus (HIV) infection
• St John’s wort (Hypericum perforatum), a herbal remedy for depression
• Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizures or epilepsy
• Atomoxetine, used to treat attention deficit hyperactivity disorder (ADHD)
• Procyclidine, used to treat tremor, especially in Parkinson’s disease
• Warfarin or other medicines (called anticoagulants) used to thin the blood
• Propafenone, flecainide, and medicines used to treat irregular heartbeat
• Metoprolol, a beta-blocker used to treat high blood pressure and heart problems
• Pravastatin, used to treat high cholesterol
• Rifampicin, used to treat tuberculosis and leprosy
• Linezolid, an antibiotic
• Tamoxifen, used for the treatment of breast cancer or fertility problems

If you are taking or have recently taken any of the medicines listed above, and have not yet discussed this with your doctor, go back to your doctor and ask what you should do. It may be necessary to adjust your dose or you may need to take a different medicine.

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

SEROXAT with food, drinks, and alcohol
Do not drink alcohol while taking SEROXAT. Alcohol may worsen your symptoms and adverse effects. Taking SEROXAT in the morning with food will reduce the likelihood of feeling unwell (nausea).

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.

In children of mothers who took SEROXAT during the first months of pregnancy, there have been some reports indicating an increased risk of birth defects, particularly heart defects. In the general population, about 1 in 100 children is born with a heart defect. This rate increases to 2 in 100 children in mothers who took SEROXAT. You and your doctor may decide whether it is better for you to switch to another treatment or gradually discontinue SEROXAT during pregnancy. However, depending on the circumstances, your doctor may advise you that it is better for you to continue taking SEROXAT.

Make sure your midwife or doctor knows that you are taking SEROXAT. If you take SEROXAT near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (a tendency to bleed easily). Inform your doctor or midwife that you are taking SEROXAT so they can advise you accordingly. When medicines such as SEROXAT are taken during pregnancy, particularly in late pregnancy, they may increase the risk in the newborn of a serious condition called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the pressure in the blood vessels between the baby’s heart and lungs is too high. If you take SEROXAT during the last three months of pregnancy, your newborn may also experience other conditions, which usually begin within the first 24 hours after birth. Symptoms include:

• Breathing difficulties
• Bluish skin colour, or being too hot or too cold
• Blue lips
• Vomiting or feeding poorly
• Being very tired, inability to sleep, or excessive crying
• Stiff or floppy muscles
• Tremors, restlessness, or seizures
• Exaggerated reflexes

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

SEROXAT may pass into breast milk in very small amounts. If you are taking SEROXAT, go back to your doctor and discuss this before starting breastfeeding. You and your doctor can decide whether you can breastfeed while taking SEROXAT.

Paroxetine has been shown to reduce sperm quality in animal studies. Theoretically, this could affect fertility, but no impact on human fertility has been observed so far.

Driving and using machines
Possible adverse effects of SEROXAT include dizziness, confusion, drowsiness, or blurred vision. If you experience these adverse effects, do not drive or operate machinery.

SEROXAT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take SEROXAT

Always take this medicine exactly as your doctor or pharmacist has told you. If you are
in any doubt, consult your doctor or pharmacist.
Sometimes you may need to take more than one tablet or half a tablet. This table will show you
how many tablets to take.

The usual doses for the different conditions are reported in the table below.

Your doctor will tell you what dose to take when you start taking SEROXAT. Most
people begin to feel better after a couple of weeks. If you do not start to feel better after this time,
discuss it with your doctor, who will advise you. Your doctor may decide to gradually increase your dose,
by 10 mg at a time, up to the maximum daily dose.
Take the tablets in the morning with food.
Swallow them with water.
Do not chew them.
Your doctor will tell you how long you will need to take your tablets. This may be for many months or even
longer.
Elderly patients
The maximum dose for patients over 65 years of age is 40 mg per day.
Patients with liver or kidney disease
If you have liver problems or severe kidney disease, your doctor may decide to reduce your dose of SEROXAT
from the usual dose.
If you take more SEROXAT than you should
Do not take more tablets than your doctor recommends. If you take more SEROXAT tablets than you
should (or someone else has done so), contact your doctor or hospital immediately. Show them the tablet
pack.
People who have taken an overdose of SEROXAT may experience one of the symptoms listed in Section 4, Possible
side effects, or one of the following symptoms: fever, uncontrollable muscle stiffness.
If you forget to take SEROXAT
Take your medicine every day at the same time.
If you forget to take a dose and remember before going to bed, take it immediately. Then continue as
usual the next day.
If you only remember during the night, or the following day, do not take the missed dose. You may
experience withdrawal effects, but these should disappear once you take your next dose at the usual time.
Do not take a double dose to make up for a forgotten tablet.
What to do if you do not feel better
SEROXAT does not improve your symptoms immediately – all antidepressants need time to work.
Some people will start to feel better within a couple of weeks, but for others it may take a little longer. Some
people taking antidepressants feel worse before they start to feel better. If you do not start to feel better after
a couple of weeks, go back to your doctor for advice. Your doctor should ask to see you again a couple of
weeks after you start treatment. Tell your doctor that you have not started to feel better.
If you stop taking SEROXAT
Do not stop taking SEROXAT unless your doctor tells you to do so.
When stopping SEROXAT, your doctor will help you gradually reduce the dose over a number of weeks or
months – this should help reduce the possibility of withdrawal effects. One way to do this is to gradually
reduce your dose of SEROXAT by 10 mg per week.
Most people find that any withdrawal symptoms from SEROXAT are mild and disappear on their own within
two weeks. For some people, these symptoms may be more severe or last longer.
If you experience withdrawal effects while stopping the tablets, your doctor may decide to stop them more
slowly. If you have severe withdrawal effects when stopping SEROXAT, contact your doctor. They may ask
you to start taking the tablets again and then stop them more slowly.
If you have withdrawal effects, you will still be able to stop SEROXAT.
Possible withdrawal effects when stopping treatment
Studies show that 3 out of 10 patients notice one or more symptoms when stopping SEROXAT.
Some withdrawal effects occur more frequently than others when treatment is stopped.
Common side effects
These may affect up to 1 in 10 patients

• Dizziness, feeling unsteady, or loss of balance
• Prickling sensations, burning sensations, (less commonly) electric shock sensations, even in the head, and ringing, buzzing, hissing, or other persistent noises in the ear (tinnitus)
• Sleep disturbances (vivid dreams, nightmares, inability to sleep)
• Feeling anxious
• Headache

Uncommon side effects
These may affect up to 1 in 100 patients

• Feeling unwell (nausea)
• Sweating (including night sweats)
• Feeling restless or agitated
• Tremor
• Feeling confused or disoriented
• Diarrhoea (loose stools)
• Feeling emotional or irritable
• Visual disturbances
• Increased or stronger heartbeat (palpitations).

Talk to your doctor if you are concerned about withdrawal effects when stopping SEROXAT.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are more likely to occur during the first weeks of treatment with SEROXAT.
Contact your doctor if you experience any of the following side effects during treatment.
You may need to contact your doctor or go directly to hospital.

Uncommon side effects
These may affect up to 1 in 100 patients

• If you have unusual bruising or bleeding, including blood in your vomit or stools, contact your doctor or go directly to hospital.
• If you are unable to urinate, contact your doctor or go directly to hospital.

Rare side effects
These may affect up to 1 in 1,000 patients

• If you have seizures (fits), contact your doctor or go directly to hospital.
• If you feel restless and feel as though you cannot sit or stand still, you may have a condition called akathisia. Increasing the dose of SEROXAT may worsen these feelings. If you feel this way, contact your doctor.
• If you feel tired, weak, or confused and have sore, stiff, or uncoordinated muscles, this may be due to low levels of sodium in your blood. If you have these symptoms, contact your doctor.

Very rare side effects
These may affect up to 1 in 10,000 patients

• Allergic reactions, which may be severe, to SEROXAT. If you develop a skin rash with red raised areas, swelling of the eyelids, face, lips, mouth and tongue, sudden onset of itching, and have difficulty breathing (shortness of breath) or swallowing, or feel weak or dizzy and collapse or lose consciousness, contact your doctor or go directly to hospital.
• If you have some or all of the following symptoms, you may have a condition called serotonin syndrome or neuroleptic malignant syndrome. Symptoms include: feeling very restless or irritable, feeling confused, feeling agitated, feeling hot, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. Severity may increase, leading to loss of consciousness. If you feel this way, contact your doctor.
• Acute glaucoma. If you start to feel eye pain and your vision becomes blurred, contact your doctor.

Not known
Frequency cannot be estimated from the available data

• Some people have had thoughts of harming themselves or of suicide while taking SEROXAT or immediately after stopping treatment (see Suicidal thoughts and worsening of depression or anxiety disorders in section 2).
• Some people have shown aggression while taking SEROXAT.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, Pregnancy, breastfeeding and fertility, for further information. If you experience these side effects, consult your doctor.

Other possible side effects during treatment

Very common side effects
These may affect more than 1 in 10 patients

• Feeling unwell (nausea). Taking the medicine in the morning with food will reduce the likelihood of this occurring.
• Changes in sexual behaviour or sexual function. For example, lack of orgasm and, in men, abnormalities of erection and ejaculation.

Common side effects
These may affect up to 1 in 10 patients

• Increased level of cholesterol in the blood
• Loss of appetite
• Poor sleep (insomnia) or feeling drowsy
• Abnormal dreams (including nightmares)
• Dizziness or tremors
• Headache
• Difficulty concentrating
• Feeling restless
• Unusually weak feeling
• Blurred vision
• Yawning, dry mouth
• Diarrhoea or constipation
• Vomiting
• Weight gain
• Sweating

Uncommon side effects
These may affect up to 1 in 100 patients

• Short-term increase or decrease in blood pressure, which may cause dizziness or fainting when standing up suddenly
• Faster than normal heartbeat
• Lack of movement, stiffness, tremor, or abnormal movements of the mouth and tongue
• Dilated pupils
• Skin rash
• Itching
• Feeling confused
• Hallucinations (strange visions or sounds)
• Inability to urinate (urinary retention) or involuntary and uncontrollable loss of urine (urinary incontinence)
• If you are a diabetic patient, you may notice a loss of control of your blood sugar levels while taking SEROXAT. Consult your doctor for adjustment of insulin or diabetes medication dosage.

Rare side effects
These may affect up to 1 in 1,000 patients

• Abnormal production of milk from the breast in men and women
• Slower heartbeat
• Liver effects detectable by liver function blood tests
• Panic attacks
• Hyperactive behaviour and thoughts (mania)
• Feeling detached from yourself (depersonalisation)
• Feeling anxious
• Irresistible urge to move the legs (Restless Legs Syndrome)
• Joint or muscle pain
• Increased blood levels of a hormone called prolactin
• Menstrual cycle disorders (including heavy or irregular periods, bleeding between periods, or absence or delay of periods)

Very rare side effects
These may affect up to 1 in 10,000 patients

• Skin rash, which may appear as blisters and resemble small targets (dark central spots surrounded by a paler area, with a dark ring around the edge), known as erythema multiforme
• Widespread blistering rash with peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• Widespread blistering rash with peeling of the skin over most of the body surface (toxic epidermal necrolysis)
• Liver problems causing yellowing of the skin and whites of the eyes
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body retains too much water and sodium levels (a salt) decrease, as a result of improper chemical signals. Patients with SIADH may become seriously ill or may have no symptoms at all.
• Fluid or water retention, which may cause swelling of the arms or legs
• Sensitivity to sunlight
• Painful erection of the penis that does not go away
• Low platelet count

Not known
Frequency cannot be estimated from the available data

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

Some patients have experienced ringing, whooshing, whistling, buzzing or other persistent noises in the ear (tinnitus) while taking SEROXAT.
An increased risk of bone fractures has been observed in patients taking this type of medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this 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 (exp) stated on the blister pack, bottle, and carton. The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from light.
If you use split tablets, store them carefully in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What SEROXAT contains
Film-coated tablets 20 mg
The active substance is paroxetine (20 mg), as hemihydrochloride.
The excipients are:
Tablet core: dibasic calcium phosphate dihydrate (E341), magnesium stearate (E470b),
sodium carboxymethylstarch (Type A)
Film coating: hypromellose (E464), titanium dioxide (E171), macrogol 400,
polysorbate 80 (E433)
Description of the appearance of SEROXAT and package contents
The SEROXAT 20 mg film-coated tablets are white, oval-shaped, engraved with "20" on one side and a break line on the other side. Each SEROXAT package contains child-resistant blisters of 50x1, 4, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 250 or 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura 7 - 37135 Verona - Italy
Manufacturer:
GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka 189, 60-322 Poznań (Poland)
or
Famar Italia S.p.A. – Via Zambeletti, 25 - Baranzate (MI)
This medicinal product is authorized in the European Economic Area Member States under the following
names:
Authorization number 566/01 film-coated tablets 20 mg
Austria Seroxat 20 mg - Filmtabletten
Belgium Seroxat
Cyprus Seroxat
Czech Republic Seroxat 20 mg
Denmark Seroxat
Estonia Seroxat
Finland Seroxat
France Deroxat
Germany Seroxat 20 mg Filmtabletten
Greece Seroxat
Hungary Seroxat 20 mg filmtabletta
Iceland Seroxat
Ireland Seroxat 20 mg film-coated tablets
Italy Seroxat
Latvia Seroxat 20 mg film-coated tablets
Lithuania Seroxat
Luxembourg Seroxat
Malta Seroxat
Netherlands Seroxat 20 mg tablet
Norway Seroxat 20 mg
Poland Seroxat
Portugal Seroxat
Slovakia Seroxat 20 mg
Slovenia Seroxat 20 mg
Spain Seroxat
United Kingdom Seroxat
You may find it helpful to contact a support group or patient association to learn more about your condition. Your doctor can provide further details.

Package leaflet: information for the user

SEROXAT 2 mg/ml oral suspension

paroxetine (as hydrochloride hemihydrate)
Please read this entire leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

7. What SEROXAT is and what it is used for
8. What you need to know before taking SEROXAT
9. How to take SEROXAT
10. Possible side effects
11. How to store SEROXAT
12. Contents of the pack and other information

1. What SEROXAT is and what it is used for

SEROXAT is a treatment for adults with depression and/or anxiety disorders. The anxiety disorders for which
treatment with SEROXAT is indicated are: obsessive-compulsive disorder (repetitive, obsessive thoughts
with uncontrollable behaviours), panic disorder (panic attacks, including those caused by agoraphobia, i.e. 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 or nervous).
SEROXAT belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). It is not fully understood how SEROXAT and other SSRIs work, but they may help increase the level of serotonin in the brain.
Appropriately treating depression or anxiety disorders is important to help you feel better.

2. What you should know before taking SEROXAT

Do not take SEROXAT

• If you are taking other medicines called monoamine oxidase inhibitors (MAOIs), including moclobemide and methylene blue (methylthioninium chloride), or if you have taken them at any time within the past two weeks. Your doctor will advise you on how to start taking SEROXAT after you have stopped taking MAOIs.
• If you are taking an antipsychotic medicine called thioridazine or an antipsychotic called pimozide.
• If you are allergic to paroxetine or to any of the other ingredients of this medicine (listed in section 6).

If any of the above apply to you, speak to your doctor before taking SEROXAT.
Warnings and precautions
Talk to your doctor or pharmacist before taking SEROXAT.

• Are you taking any other medicines? (See inside this leaflet, Other medicines and SEROXAT?)
• Are you taking tamoxifen for the treatment of breast cancer or fertility problems? SEROXAT may make tamoxifen less effective, so your doctor may recommend that you take another antidepressant.
• Do you have kidney, liver, or heart problems?
• Do you have epilepsy or have you previously had seizures?
• Have you ever experienced episodes of mania (hyperactive behaviour or thoughts)?
• Are you receiving electroconvulsive therapy?
• Have you previously had bleeding episodes, or are you taking other medicines that may increase the risk of bleeding? (These include blood-thinning medicines such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines used for pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam?)
• Do you have diabetes?
• Are you on a low-sodium diet?
• Do you have glaucoma (increased pressure in the eye)?
• Are you pregnant or planning to become pregnant? (See inside this leaflet Pregnancy, breastfeeding and fertility.)
• Are you under 18 years of age? (See inside this leaflet Children and adolescents under 18 years.))

If you answered YES to any of these questions and have not already discussed this with your doctor, return to your doctor and ask what you should do about taking SEROXAT.
Children and adolescents under 18 years
SEROXAT must not be used in children and adolescents under 18 years of age.
Furthermore, patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) when taking SEROXAT. If your doctor has prescribed SEROXAT for you (or your child) and you wish to discuss this, return to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while you (or your child) are taking SEROXAT. In addition, in this age group, the long-term effects of SEROXAT on growth, maturation, and cognitive and behavioural development have not yet been established.
In clinical studies with SEROXAT in patients under 18 years of age, the common adverse effects occurring in less than 1 in 10 children/adolescents were: increased suicidal thoughts and suicide attempts, deliberate self-harm, hostile, aggressive or unfriendly behaviour, loss of appetite, tremors, unusual sweating, hyperactivity (excessive energy), restlessness, emotional changes (including crying and mood changes), and unusual bruising or bleeding (such as nosebleeds). These studies also showed that the same symptoms occurred in children and adolescents taking sugar pills (placebo) instead of SEROXAT, although less frequently.
In these studies conducted in patients under 18 years of age, some patients experienced withdrawal symptoms after stopping SEROXAT. These symptoms were mostly similar to those observed in adults after stopping SEROXAT (see section 3). In addition, patients under 18 years of age commonly (in less than 1 in 10) also experienced stomach pain, nervousness, and emotional changes (including crying, mood changes, self-harm attempts, suicidal thoughts, and suicide attempts).
Suicidal thoughts and worsening of depression or anxiety disorders
If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide.
These thoughts may be more common when you first start taking antidepressants, as all these medicines take time to work—usually about two weeks, but sometimes longer.
You may be more likely to have these types of thoughts:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. Data from clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with an antidepressant.

If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go directly to hospital.
You may find it helpful to tell a relative or friend that you suffer from depression or anxiety disorders and ask them to read this leaflet. You may ask them to let you know if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour.
Important adverse effects observed with SEROXAT
Some patients taking SEROXAT experience a condition called akathisia, meaning they feel restless and feel unable to sit or stand still. Other patients may experience what is called serotonin syndrome or neuroleptic malignant syndrome, which may include some or all of the following symptoms: feeling very restless or irritable, confusion, restlessness, feeling hot, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. The condition may worsen, leading to loss of consciousness. If you experience any of these symptoms, contact your doctor. For more information on these or other adverse effects of SEROXAT, see section 4.
Medicines such as SEROXAT (so-called selective serotonin reuptake inhibitors, SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.
Other medicines and SEROXAT
Some medicines may interfere with the action of SEROXAT or may make adverse effects more likely. SEROXAT may also interfere with the action of other medicines. These include:

• Medicines called monoamine oxidase inhibitors (MAOIs) (including moclobemide and methylene blue (methylthioninium chloride)) – see inside this leaflet Do not take SEROXAT.
• Thioridazine or pimozide, which are antipsychotics – see inside this leaflet Do not take SEROXAT.
• Acetylsalicylic acid, ibuprofen, or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib, etodolac, diclofenac, and meloxicam, used for pain and inflammation
• Tramadol, buprenorphine, and pethidine, painkillers
• Buprenorphine in combination with naloxone, opioid dependence replacement therapy
• Medicines called triptans, such as sumatriptan, used to treat migraine
• Other antidepressants, including other SSRIs, tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine
• A dietary supplement called tryptophan
• Mivacurium and succinylcholine (used in anaesthesia)
• Medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotics) used to treat certain psychiatric conditions
• Fentanyl, used in anaesthesia or for treating chronic pain
• A combination of fosamprenavir and ritonavir, used to treat Human Immunodeficiency Virus (HIV) infection
• St. John’s wort (Hypericum perforatum), a herbal remedy for depression
• Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizures or epilepsy
• Atomoxetine, used to treat attention deficit hyperactivity disorder (ADHD)
• Procyclidine, used to treat tremor, especially in Parkinson’s disease
• Warfarin or other medicines (called anticoagulants) used to thin the blood
• Propafenone, flecainide, and medicines used to treat irregular heartbeat
• Metoprolol, a beta-blocker used to treat high blood pressure and heart problems
• Pravastatin, used to treat high cholesterol
• Rifampicin, used to treat tuberculosis and leprosy
• Linezolid, an antibiotic
• Tamoxifen, used for the treatment of breast cancer or fertility problems
• Medicines such as cimetidine and omeprazole, used to reduce stomach acid production

If you are taking or have recently taken any of the medicines listed above, and have not yet discussed this with your doctor, return to your doctor and ask what you should do. It may be necessary to adjust your dose, or you may need to take a different medicine.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
SEROXAT with food, drinks, and alcohol
Do not drink alcohol while taking SEROXAT. Alcohol may worsen your symptoms and adverse effects. Taking SEROXAT in the morning with food will reduce the likelihood of feeling unwell (nausea).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
In babies of mothers who took SEROXAT during the first months of pregnancy, there have been some reports indicating an increased risk of birth defects, particularly heart defects.
In the general population, about 1 in 100 babies is born with a heart defect.
This rate increases to 2 in 100 babies in mothers taking SEROXAT. You and your doctor may decide whether it is better for you to switch to another treatment or gradually discontinue SEROXAT during pregnancy. However, depending on the circumstances, your doctor may advise that it is better for you to continue taking SEROXAT.
Make sure your midwife or doctor knows that you are taking SEROXAT. If you take SEROXAT near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (a tendency to bleed easily). Inform your doctor or midwife that you are taking SEROXAT so they can advise you on what to do. When medicines like SEROXAT are taken during pregnancy, particularly in late pregnancy, they may increase the risk in the baby of a serious condition called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the pressure in the blood vessels between the baby’s heart and lungs is too high. If you take SEROXAT during the last three months of pregnancy, your newborn may also experience other conditions, which usually begin within the first 24 hours after birth. Symptoms include:

• breathing difficulties
• bluish skin colour or feeling too hot or too cold
• blue lips
• vomiting or feeding problems
• extreme tiredness, inability to sleep, or excessive crying
• stiff or floppy muscles
• tremors, restlessness, or seizures
• exaggerated reflexes.

If your baby shows any of these symptoms at birth, or if you are concerned about your baby’s health, contact your doctor or midwife, who will be able to advise you.
SEROXAT may pass into breast milk in very small amounts. If you are taking SEROXAT, return to your doctor and discuss this before starting breastfeeding. You and your doctor can decide whether you can breastfeed while taking SEROXAT.
Paroxetine has been shown to reduce sperm quality in animal studies. In theory, this could affect fertility, but no impact on human fertility has been observed so far.
Driving and using machines
Possible adverse effects of SEROXAT include dizziness, confusion, drowsiness, or blurred vision. If you experience these adverse effects, do not drive or operate machinery.
SEROXAT contains

• Parabens: Methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216), which may cause allergic reactions (including delayed reactions).
• Orange Yellow FCF (E110): a colouring agent, which may cause allergic reactions.
• Sorbitol (E420) and maltitol (E965): this medicine contains (up to) 2.7 g of sorbitol and (typically) 283 mg of maltitol per 10 ml. Sorbitol and maltitol are sources of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolise fructose, speak to your doctor before taking this medicine.
• Propylene glycol (E1520): This medicine contains 500 mg of propylene glycol per 10 ml.
• Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per 10 ml, i.e., essentially “sodium-free”.

3. How to take SEROXAT

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The usual doses for different conditions are shown in the table below.

Your doctor will tell you what dose to take when you start taking SEROXAT. Most
people begin to feel better after a couple of weeks. If you do not start to feel better after this time,
discuss it with your doctor, who will advise you. Your doctor may decide to gradually increase your dose,
5 ml (10 mg of paroxetine) at a time, up to the maximum daily dose.
Shake the bottle before use.
Take SEROXAT in the morning with food.
Your doctor will tell you how long you need to take your medicine. This may be for many
months or even longer.
Elderly patients
The maximum dose for patients over 65 years of age is 20 ml (40 mg of paroxetine) per day.
Patients with liver or kidney disease
If you have liver problems or severe kidney disease, your doctor may decide to reduce your dose of SEROXAT
compared to the usual dose.
If you take more SEROXAT than you should
Do not take more medicine than your doctor has recommended. If you take more SEROXAT than you
should (or if someone else is doing so), contact your doctor or go to a hospital immediately. Show them the
packaging.
People who have taken an overdose of SEROXAT may experience one of the symptoms listed in Section 4, Possible
side effects, or one of the following symptoms: fever, uncontrollable muscle stiffness.
If you forget to take SEROXAT
Take your medicine every day at the same time.
If you forget to take a dose and remember before going to bed, take it immediately.
Continue as usual the next day.
If you only remember during the night or the following day, do not take the missed dose. You may experience
withdrawal symptoms, but these should disappear once you take your next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
What to do if you do not feel better
SEROXAT does not improve your symptoms immediately – all antidepressants take time to work.
Some people begin to feel better within a couple of weeks, but for others it may take a little longer. Some people
taking antidepressants feel worse before they start to feel better. If you do not begin to feel better after a couple
of weeks, return to your doctor, who will advise you. Your doctor should arrange to see you again a couple of
weeks after starting treatment. Inform your doctor that you have not started to feel better.
If you stop taking SEROXAT
Do not stop taking SEROXAT unless your doctor tells you to do so.
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 effects. One way to do this is to gradually reduce your
current dose of SEROXAT by 5 ml (10 mg of paroxetine) per week. Most people find that any withdrawal
symptoms from SEROXAT are mild and disappear on their own within two weeks. For some people, these
symptoms may be more severe or last longer.
If you experience withdrawal effects while stopping the medicine, your doctor may decide to taper the dose
more slowly. If you have severe withdrawal effects when stopping SEROXAT, contact your doctor. They may
ask you to start taking the medicine again and then stop more gradually.
Even if you experience withdrawal effects, you will still be able to stop taking SEROXAT.
Possible withdrawal effects when stopping treatment
Studies show that 3 out of 10 patients notice one or more symptoms when stopping SEROXAT.
Some withdrawal effects occur more frequently than others when stopping treatment.
Common side effects
These may affect up to 1 in 10 patients

• Dizziness, feeling unsteady, or loss of balance
• Prickling sensations, burning sensations, and (less commonly) electric shock-like sensations, even in the head, and ringing, buzzing, hissing, or other persistent noises in the ear (tinnitus)
• Sleep disturbances (vivid dreams, nightmares, inability to sleep)
• Feeling anxious
• Headache

Uncommon side effects
These may affect up to 1 in 100 patients

• Feeling unwell (nausea)
• Sweating (including night sweats)
• Feeling restless or agitated
• Tremor
• Feeling confused or disoriented
• Diarrhoea (loose stools)
• Feeling emotional or irritable
• Visual disturbances
• Increased or stronger heartbeat (palpitations)

Talk to your doctor if you are concerned about withdrawal effects when stopping SEROXAT.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are more likely to occur during the first few weeks of treatment with SEROXAT.
Contact your doctor if you experience any of the following side effects during treatment.
You may need to contact your doctor or go directly to hospital.

Uncommon side effects
These may affect up to 1 in 100 patients

• If you have unusual bruising or bleeding, including blood in your vomit or stools, contact your doctor or go directly to hospital.
• If you are unable to pass urine, contact your doctor or go directly to hospital.

Rare side effects
These may affect up to 1 in 1,000 patients

• If you have seizures (fits), contact your doctor or go directly to hospital.
• If you feel restless and have an inability to sit or stand still, you may be experiencing a condition called akathisia. Increasing the dose of SEROXAT may worsen these feelings. If you feel this way, contact your doctor.
• If you feel tired, weak, or confused and have sore, stiff, or uncoordinated muscles, this may be due to low levels of sodium in the blood. If you have these symptoms, contact your doctor.

Very rare side effects
These may affect up to 1 in 10,000 patients

• Allergic reactions to SEROXAT, which may be severe. If you develop a skin rash with red raised areas, swelling of the eyelids, face, lips, mouth and tongue, onset of itching, difficulty breathing (shortness of breath) or swallowing, or feel weak or dizzy to the point of collapsing or losing consciousness, contact your doctor or go directly to hospital.
• If you have some or all of the following symptoms, you may be experiencing serotonin syndrome or neuroleptic malignant syndrome. Symptoms include: feeling very restless or irritable, feeling confused, feeling agitated, feeling hot, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. The condition may worsen, leading to loss of consciousness. If you feel this way, contact your doctor.
• Acute glaucoma. If you begin to experience eye pain and blurred vision, contact your doctor.

Not known
Frequency cannot be estimated from the available data

• Some people have had thoughts of harming themselves or of suicide while taking SEROXAT or immediately after stopping treatment (see Suicidal thoughts and worsening of depression or anxiety disorders in section 2).
• Some people have shown aggression while taking SEROXAT.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, Pregnancy, breastfeeding and fertility, for further information. If you experience these side effects, consult your doctor.

Other possible side effects during treatment

Very common side effects
These may affect more than 1 in 10 patients

• Feeling unwell (nausea). Taking the medicine in the morning with food will reduce the likelihood of this occurring.
• Changes in sexual behaviour or sexual function. For example, lack of orgasm, and in men, abnormalities of erection and ejaculation.

Common side effects
These may affect up to 1 in 10 patients

• Increased level of cholesterol in the blood
• Loss of appetite
• Poor sleep (insomnia) or feeling drowsy
• Abnormal dreams (including nightmares)
• Dizziness or tremors
• Headache
• Difficulty concentrating
• Feeling restless
• Unusually weak feeling
• Blurred vision
• Yawning, dry mouth
• Diarrhoea or constipation
• Vomiting
• Weight gain
• Sweating

Uncommon side effects
These may affect up to 1 in 100 patients

• Short-term increase or decrease in blood pressure, which may cause dizziness or fainting when standing up suddenly
• Faster than normal heartbeat
• Lack of movement, stiffness, tremor, or abnormal movements of the mouth and tongue
• Dilated pupils
• Skin rash
• Itching
• Feeling confused
• Hallucinations (strange visions or sounds)
• Inability to pass urine (urinary retention) or uncontrolled and involuntary loss of urine (urinary incontinence)
• If you are a diabetic patient, you may notice a loss of control of your blood sugar levels while taking SEROXAT. Consult your doctor for adjustment of insulin or diabetes medication dosage.

Rare side effects
These may affect up to 1 in 1,000 patients

• Abnormal production of milk from the breast in men and women
• Slower heartbeat
• Liver effects detectable by liver function blood tests
• Panic attacks
• Hyperactive behaviour and thoughts (mania)
• Feeling detached from yourself (depersonalisation)
• Feeling anxious
• 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 side effects
These may affect up to 1 in 10,000 patients

• Skin rash, which may appear as blisters and resemble small targets (dark central spots surrounded by a paler area with a dark ring around the edge), known as erythema multiforme
• Widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• Widespread skin rash with blisters and peeling of the skin over most of the body surface (toxic epidermal necrolysis)
• Liver problems causing yellowing of the skin and whites of the eyes
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body retains too much water and sodium levels (a salt) decrease, as a result of improper chemical signals. Patients with SIADH may become seriously ill or may have no symptoms at all.
• Fluid or water retention, which may cause swelling of the arms or legs
• Sensitivity to sunlight
• Painful erection of the penis that does not go away
• Low platelet count

Not known
Frequency cannot be estimated from the available data

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

Some patients have experienced ringing, buzzing, hissing, whistling, or other persistent noises in the ear (tinnitus) while taking SEROXAT.
An increased risk of bone fractures has been observed in patients taking this type of medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this 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 (exp) stated on the bottle and carton. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep in the original bottle.
Discard the contents of the bottle one month after opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SEROXAT contains

• The active substance is paroxetine (20 mg/10 ml) as hemihydrate hydrochloride.
• The excipients are: Polacrilin potassium, microcrystalline cellulose and sodium carmellose, propylene glycol (E1520), glycerol (E422), sorbitol (E420), maltitol (E965), mannitol (E421), methyl p-hydroxybenzoate (E218), propyl p-hydroxybenzoate (E216), disodium citrate dihydrate (E331), anhydrous citric acid (E330), sodium saccharin (E954), natural orange flavour, natural lemon flavour, orange yellow FCF colour (E110), simethicone emulsion, purified water.

Description of the appearance of SEROXAT and contents of the pack
SEROXAT 2 mg/ml oral suspension is an orange-coloured liquid with an orange odour and a sweet taste. It is available in 150 ml bottles, supplied with a dosing glass.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura 7 - 37135 Verona - Italy
Manufacturer:
Aspen Bad Oldesloe GmbH - Bad Oldesloe (Germany)

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Authorisation number 566/03:
Austria Seroxat 2 mg/ml -Suspension
France Deroxat
Germany Seroxat 2 mg/ml –Suspension zum Einnehmen
Greece Seroxat
Ireland Seroxat 20 mg/10 ml oral suspension
Italy Seroxat
Netherlands Seroxat suspension 2 mg/ml
Portugal Seroxat
United Kingdom Seroxat

You may find it helpful to contact a support group or patient organisation to learn more about your condition. Your doctor will be able to provide you with further details.