Sereupin

Package leaflet: Information for the user

SEREUPIN 20 mg film-coated tablets

Paroxetine (as hydrochloride hemihydrate)
Please read this leaflet carefully before you take 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. Do not give it to other people, 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What SEREUPIN is and what it is used for
2. What you need to know before taking SEREUPIN
3. How to take SEREUPIN
4. Possible side effects
5. How to store SEREUPIN
6. Contents of the pack and other information

1. What Sereupin is and what it is used for

Sereupin is a treatment for adults with depression and/or anxiety disorders. The anxiety disorders for which treatment with Sereupin is indicated are: obsessive-compulsive disorder (repetitive, obsessive thoughts with uncontrollable behaviors), panic disorder (panic attacks, including those caused by agoraphobia, i.e. fear of open spaces), social anxiety disorders (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).
Sereupin belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). A substance called serotonin is commonly present in the brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Sereupin and other SSRIs work, but they may help increase serotonin levels in the brain.
Treating depression or anxiety disorders appropriately is important to help you feel better.

2. What you need to know before taking Sereupin

Do not take SEREUPIN

• 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 past two weeks. Your doctor will advise you on how to start taking SEREUPIN after stopping 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 SEREUPIN.

Warnings and precautions
Talk to your doctor or pharmacist before taking SEREUPIN if:

• you are taking any other medicine (see inside this leaflet Other medicines and SEREUPIN)?
• you are taking tamoxifen for the treatment of breast cancer or fertility problems? SEREUPIN may reduce the effectiveness of tamoxifen, so your doctor may recommend that you take another antidepressant.
• you have kidney, liver, or heart problems?
• you suffer from epilepsy or have previously had seizures?
• you have ever experienced episodes of mania (hyperactive behaviour or thoughts)?
• you are receiving electroconvulsive therapy?
• you have previously had bleeding episodes, or are 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)?
• you have diabetes?
• you are on a low-sodium diet?
• you have glaucoma (high pressure in the eye)?
• you are pregnant or planning to become pregnant (see inside this leaflet Pregnancy, breastfeeding, and fertility)?
• you are 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 SEREUPIN.

Children and adolescents under 18 years
SEREUPIN 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 SEREUPIN. If your doctor has prescribed SEREUPIN for you (or for 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 SEREUPIN. In addition, in this age group, the long-term effects of SEREUPIN on growth, maturation, and cognitive and behavioural development have not yet been established. In clinical studies of SEREUPIN in patients under 18 years of age, the common adverse effects affecting fewer than 1 in 10 children/adolescents were: increased suicidal thoughts and suicide attempts, deliberate self-harm, hostile, aggressive, or unfriendly behaviour, loss of appetite, tremor, unusual sweating, hyperactivity (excessive 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 SEREUPIN, although less frequently. In these studies conducted in patients under 18 years of age, some patients experienced withdrawal symptoms after stopping SEREUPIN. These symptoms were mostly similar to those observed in adults after discontinuation of SEREUPIN (see section 3, inside this leaflet). In addition, patients under 18 years of age commonly experienced (in fewer than 1 in 10 cases) stomach pain, feeling nervous, and changes in emotions (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 ending 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 ending your life or harming yourself
• if you are a young adult. Clinical study data 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 ending 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 worsening, or if they are concerned about changes in your behaviour.

Important adverse effects observed with SEREUPIN
Some patients taking SEREUPIN 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 restless or irritable, confusion, agitation, 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 notice any of these symptoms, contact your doctor. For more information on these or other side effects of SEREUPIN, see section 4, inside this leaflet.
Medicines such as SEREUPIN (so-called selective serotonin reuptake inhibitors, SSRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Other medicines and SEREUPIN
Some medicines may interfere with the action of SEREUPIN or may make adverse effects more likely. SEREUPIN 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 SEREUPIN”.
• Thioridazine or pimozide, which are antipsychotics – see inside this leaflet “Do not take SEREUPIN”.
• 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 and pethidine, painkillers
• 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 to treat 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, 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.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those without a prescription.

SEREUPIN with food, drinks, and alcohol
Do not drink alcohol while taking SEREUPIN. Alcohol may worsen your symptoms and side effects. Taking SEREUPIN 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 before taking this medicine. In infants whose mothers took SEREUPIN during the first months of pregnancy, there have been some reports suggesting 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 SEREUPIN.

You and your doctor may decide whether it is better for you to switch to another treatment or gradually discontinue SEREUPIN during pregnancy. However, depending on the circumstances, your doctor may advise you that it is better for you to continue taking SEREUPIN.

Make sure your midwife or doctor knows that you are taking SEREUPIN. When medicines like SEREUPIN 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 SEREUPIN 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 poor feeding
• being very tired, 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.

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

Paroxetine, in animal studies, has been shown to reduce sperm quality. In theory, this could affect fertility, but no impact on human fertility has been observed to date.

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

3. How to take Sereupin

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Sometimes it may be necessary 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 SEREUPIN. Most people feel better after a couple of weeks. If you do not start to feel better after this time, talk to 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 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 SEREUPIN compared to the usual dose.

If you take more SEREUPIN than you should
Do not take more tablets than your doctor has recommended. If you take more SEREUPIN tablets than you should (or if someone else is doing so), contact your doctor immediately or go to the nearest hospital. Show them the tablet pack.
People who have taken an overdose of SEREUPIN 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 SEREUPIN
Take your medicine at the same time every day.
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 effects, but these should disappear once you take the 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
SEREUPIN does not improve your symptoms immediately – all antidepressants need time to work.
Some people 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 arrange to see you again a couple of weeks after starting treatment. Tell your doctor that you have not started to feel better.

If you stop treatment with SEREUPIN
Do not stop taking SEREUPIN unless your doctor tells you to do so.
When stopping SEREUPIN, your doctor will help you to 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 dose of SEREUPIN by 10 mg per week.
Most people find that any withdrawal symptoms from SEREUPIN 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 when stopping the tablets, your doctor may decide to stop them more slowly. If you have severe withdrawal effects when stopping SEREUPIN, contact your doctor. They may ask you to start taking the tablets again and then stop more slowly.
If you experience withdrawal effects, you will still be able to stop SEREUPIN.

Possible withdrawal effects when stopping treatment
Studies show that 3 out of 10 patients notice one or more symptoms when stopping SEREUPIN. Some withdrawal effects occur more frequently than others when stopping treatment.

Common side effects, which may affect up to 1 in 10 people

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

Uncommon side effects, which may affect up to 1 in 100 people

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

Talk to your doctor if you are concerned about withdrawal effects when stopping SEREUPIN.
If you have any 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 everyone gets them. Side effects are more likely to occur during the first weeks of treatment with SEREUPIN.
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, which may affect up to 1 in 100 people

• If you have unusual bruising or bleeding, including blood in 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, which may affect up to 1 in 1,000 people

• If you have seizures (convulsive 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 be experiencing a condition called akathisia. Increasing the dose of SEREUPIN may worsen these sensations. 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, which may affect up to 1 in 10,000 people

• Allergic reactions, which can be severe, to SEREUPIN. If you develop a skin rash with red, raised areas, swelling of the eyelids, face, lips, mouth, or tongue, sudden onset of itching, difficulty breathing (shortness of breath) or swallowing, and feel weak or dizzy, leading to collapse or loss of consciousness, contact your doctor or go directly to hospital.
• If you have some or all of the following symptoms, you may be experiencing what is 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 begin to experience eye pain and blurred vision, contact your doctor.

Frequency not known
Some people have had thoughts of harming themselves or of suicide while taking SEREUPIN or immediately after stopping treatment (see section 2). Some people have shown aggression while taking SEREUPIN.
If you experience these side effects, consult your doctor.

Other possible side effects during treatment

Very common side effects, which may affect more than 1 in 10 people

• 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, absence of orgasm and, in men, abnormalities of erection and ejaculation.

Common side effects, which may affect up to 1 in 10 people

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

Uncommon side effects, which may affect up to 1 in 100 people

• 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 loss of control of blood sugar levels while taking SEREUPIN. Consult your doctor for adjustment of insulin or diabetes medication dosage.

Rare side effects, which may affect up to 1 in 1,000 people

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

• 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), called 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 excess water and sodium concentration decreases (a salt), 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 arms or legs
• Sensitivity to sunlight
• Painful erection of the penis that does not go away
• Low platelet count

Frequency not known

• Teeth grinding

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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the carton. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What SEREUPIN contains
Film-coated tablets 20 mg
The active substance is paroxetine (20 mg), as hemihydrochloride.
The excipients are:
Film-coated tablets 20 mg
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 SEREUPIN and contents of the pack
The 20 mg film-coated tablets of SEREUPIN are white, oval-shaped, engraved with "20" on one side and a break line on the other side. Each SEREUPIN pack contains 28 tablets in child-resistant blisters.
Marketing Authorization Holder
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 - 37135 Verona
Manufacturer:
Famar Italia S.p.A. – Via Zambeletti, 25 - Baranzate (MI)
AbbVie S.r.l. – S.R. 148 Pontina km 52 snc – 04011 Campoverde di Aprilia (LT)
GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka 189, 60-322 Poznań, Poland

PACKAGE LEAFLET: INFORMATION FOR THE USER

SEREUPIN 20 mg/10 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 could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Sereupin is and what it is used for

Sereupin is a treatment for adults with depression and/or anxiety disorders. The anxiety disorders for which treatment with Sereupin is indicated are: obsessive-compulsive disorder (repetitive, obsessive thoughts with uncontrollable behaviors), panic disorder (panic attacks, including those caused by agoraphobia, i.e. fear of open spaces), social anxiety disorders (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).
Sereupin belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). A substance called serotonin is commonly present in the brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Sereupin and other SSRIs work, but they may help increase serotonin levels in the brain.
Appropriately treating depression or anxiety disorders is important to help you feel better.

2. What you need to know before taking Sereupin

Do not take SEREUPIN

• If you are taking other medicines called monoamine oxidase inhibitors (MAOIs), including moclobemide and methylene blue chloride (methylene blue), or if you have taken them at any time within the past two weeks. Your doctor will advise you on how to start taking SEREUPIN 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 these cases apply to you, talk to your doctor before taking SEREUPIN.
Warnings and precautions
Talk to your doctor or pharmacist before taking Sereupin.

• Are you taking any other medicine? (See inside this leaflet “Other medicines and SEREUPIN”)
• Are you taking tamoxifen for the treatment of breast cancer or fertility problems? SEREUPIN 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 suffer from epilepsy or have you previously had seizures?
• Have you ever experienced episodes of mania (overactive behaviour or thoughts)?
• Are you receiving electroconvulsive therapy (ECT)?
• 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, 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, go back to your doctor and ask what to do about taking SEREUPIN.

Children and adolescents under 18 years of age
SEREUPIN must not be used in children and adolescents under 18 years of age. In addition, 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 SEREUPIN. If your doctor has prescribed SEREUPIN 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 SEREUPIN. Furthermore, in this age group, the long-term effects of SEREUPIN on growth, maturation, and cognitive and behavioural development have not yet been established. In clinical studies of SEREUPIN in patients under 18 years of age, 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, tremor, unusual sweating, hyperactivity (excess 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 SEREUPIN, although less frequently. In these studies conducted in patients under 18 years of age, some patients experienced withdrawal symptoms after stopping SEREUPIN. These symptoms were mostly similar to those observed in adults after discontinuation of SEREUPIN (see section 3, inside this leaflet). In addition, patients under 18 years of age commonly experienced (in less than 1 in 10 cases) stomach pain, nervousness, and changes in emotions (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 ending 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 ending your life or harming yourself
• 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 ending 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 worsening, or if they are concerned about changes in your behaviour.

Important adverse effects observed with SEREUPIN
Some patients taking SEREUPIN 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 restless or irritable, confusion, agitation, feeling hot, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle rigidity, sudden muscle contractions, or rapid heartbeat. The condition may worsen, leading to loss of consciousness. If you notice any of these symptoms, contact your doctor. For more information on these or other side effects of SEREUPIN, see section 4, inside this leaflet.
Medicines such as SEREUPIN (so-called selective serotonin reuptake inhibitors, SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.

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

• Medicines called monoamine oxidase inhibitors (MAOIs), including moclobemide and methylene blue chloride (methylene blue) – see inside this leaflet “Do not take SEREUPIN”.
• Thioridazine or pimozide, which are antipsychotics – see inside this leaflet “Do not take SEREUPIN”.
• 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 and pethidine, painkillers
• 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, which are 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, go back to your doctor and ask what to 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 available without a prescription.

SEREUPIN with food, drinks, and alcohol
Do not drink alcohol while taking SEREUPIN. Alcohol may worsen your symptoms and side effects. Taking SEREUPIN 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 before taking this medicine.
In babies born to mothers who took SEREUPIN 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 SEREUPIN.
You and your doctor may decide whether it is better for you to switch to another treatment or gradually discontinue SEREUPIN during pregnancy. However, depending on the circumstances, your doctor may advise you that it is better for you to continue taking SEREUPIN.
Make sure your midwife or doctor knows that you are taking SEREUPIN. When medicines such as SEREUPIN are taken during pregnancy, especially during late pregnancy, they may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the baby’s heart and lungs is too high. If you take SEREUPIN 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
• Bluish lips
• Vomiting or feeding problems
• Being very tired, inability to sleep, or excessive crying
• Stiff or floppy muscles
• Tremors, agitation, 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.
SEREUPIN can pass into breast milk in very small amounts. If you are taking SEREUPIN, go back to your doctor and discuss this before starting breastfeeding. You and your doctor can decide whether you can breastfeed while taking SEREUPIN. Paroxetine, in animal studies, has been shown to reduce sperm quality. In theory, this could affect fertility, but the impact on human fertility has not yet been observed.

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

SEREUPIN contains

• This medicine contains a sugar called sorbitol (E420). If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking SEREUPIN.
• Methyl 4-hydroxybenzoate (E218) and propyl 4-hydroxybenzoate (E216) may cause allergic reactions (including delayed reactions).
• Orange Yellow FCF (E110) is used as a colouring agent and may cause allergic reactions.

3. How to take Sereupin

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:
Recommended Daily Maximum
Initial Dose Daily Dose Dose
Depression 10 ml 10 ml 25 ml
Obsessive-compulsive disorder 10 ml 20 ml 30 ml
Panic disorder 5 ml 20 ml 30 ml
Social anxiety disorder 10 ml 10 ml 25 ml
Post-traumatic stress disorder 10 ml 10 ml 25 ml
Generalised anxiety disorder 10 ml 10 ml 25 ml
Your doctor will tell you what dose to take when you start taking SEREUPIN. Most
people begin to feel better after a couple of weeks. If you do not start to feel better after this time, speak to your doctor, who will advise you. Your doctor may decide to gradually increase your dose by 5 ml (10 mg of paroxetine) at a time, up to the maximum daily dose.
Shake the bottle before use.
Take SEREUPIN in the morning with food.
Your doctor will tell you how long you need to take this medicine. This may be for several 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 SEREUPIN compared to the usual dose.

If you take more SEREUPIN than you should
Do not take more medicine than your doctor has recommended. If you take more SEREUPIN than you should (or if someone else does), contact your doctor immediately or go to the nearest hospital. Show them the packaging.
People who have taken an overdose of SEREUPIN 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 SEREUPIN
Take your medicine at the same time every day.
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 remember only 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 dose.

What to do if you do not feel better
SEREUPIN does not improve your symptoms immediately – all antidepressants require time to take effect.
Some people begin to feel better within a couple of weeks, but for others it may take longer. 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, return to your doctor for advice. 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 SEREUPIN
Do not stop taking SEREUPIN unless your doctor tells you to do so.
When stopping SEREUPIN, your doctor will help you gradually reduce the dose over several weeks or months – this should help reduce the risk of withdrawal effects. One way to do this is to gradually reduce your dose of SEREUPIN by 5 ml (10 mg of paroxetine) per week. Most people find that any withdrawal symptoms from SEREUPIN 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 stop the treatment more slowly. If you have severe withdrawal effects when stopping SEREUPIN, 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 SEREUPIN eventually.

Possible withdrawal effects when stopping treatment
Studies show that 3 out of 10 patients notice one or more symptoms when stopping SEREUPIN. Some withdrawal effects occur more frequently than others when stopping treatment.

Common side effects, likely to affect up to 1 in 10 patients

• Dizziness, feeling unsteady, or loss of balance
• Prickling sensations, burning sensations, and (less commonly) electric shock sensations, including 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, likely to 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
• Vision disturbances
• Increased or stronger heartbeat (palpitations)

Speak to your doctor if you are concerned about withdrawal effects when stopping SEREUPIN.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Side effects are more likely to occur during the first weeks of treatment with SEREUPIN.
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, which may affect up to 1 in 100 people

• If you have unusual bruising or bleeding, including blood in your vomit or faeces, 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, which may affect up to 1 in 1,000 people

• If you have seizures (convulsive 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 be experiencing a condition called akathisia. Increasing the dose of SEREUPIN may worsen these sensations. 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, which may affect up to 1 in 10,000 people

• Allergic reactions to SEREUPIN, which can be severe. If you develop a skin rash with red, raised areas, swelling of the eyelids, face, lips, mouth, or tongue, onset of itching, difficulty breathing (shortness of breath) or swallowing, and feel weak or dizzy leading to collapse or loss of 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, confusion, restlessness, 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 begin to experience eye pain and blurred vision, contact your doctor.

Frequency not known
Some people have had thoughts of harming themselves or of suicide while taking SEREUPIN or immediately after stopping treatment (see section 2).
Some people have shown aggression while taking SEREUPIN.
If you experience these side effects, consult your doctor.

Other possible side effects during treatment

Very common side effects, which may affect more than 1 in 10 people

• Feeling sick (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, which may affect up to 1 in 10 people

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

Uncommon side effects, which may affect up to 1 in 100 people

• 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 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 SEREUPIN. Consult your doctor for adjustment of insulin or diabetes medication dosage.

Rare side effects, which may affect up to 1 in 1,000 people

• Abnormal production of milk from the breast in both men and women
• Slower than normal heartbeat
• Liver effects detectable by liver function blood tests
• Panic attacks
• Hyperactive behaviour and thoughts (mania)
• Feeling detached from oneself (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, which may affect up to 1 in 10,000 people

• Skin rash, which may appear as blisters and resemble small targets (dark spots in the centre 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 accumulates excess water and has reduced sodium concentration (a salt), 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 penile erection that does not stop
• Low platelet count

Frequency not known

• Teeth grinding

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

Keep out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the blister pack, bottle, and outer carton. The
expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the medicinal product in the original packaging to protect it from light.
The medicinal product must be used within one month after first opening the bottle. Any remaining product
should be discarded.
Do not dispose of any medicinal product 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 SEREUPIN contains
The active substance is paroxetine (20 mg/10 ml) as hydrochloride hemihydrate.
The excipients are:
Polacrilin potassium, dispersible cellulose (E460), propylene glycol, glycerol (E422), sorbitol (E420),
methyl 4-hydroxybenzoate (E218), propyl 4-hydroxybenzoate (E216), sodium dihydrate citrate (E331), anhydrous
citric acid (E330), sodium saccharin (E954), natural orange flavour, natural lemon flavour, colouring
Orange Yellow FCF (E110), simethicone emulsion, purified water.
Description of the appearance of SEREUPIN and the contents of the pack
SEREUPIN 20 mg/10 ml oral suspension is an orange-coloured liquid with an orange odour and a sweet taste. It is available in 150 ml bottles, with a dosing cup.
Marketing Authorization Holder
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 - 37135 Verona
Manufacturer:
Farmaclair - Hérouville-Saint-Clair (France)
Aspen Bad Oldesloe GmbH - Bad Oldesloe (Germany)