Paroxetine Zentiva

Patient Information Leaflet: Information for the User

Paroxetina Zentiva 20 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, as 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. Never give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Paroxetina Zentiva is and what it is used for

Paroxetina Zentiva is a treatment for adults with depression and/or anxiety disorders. The anxiety disorders for which treatment with Paroxetina Zentiva 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 generalised anxiety disorder (feeling excessively anxious or nervous in general).
Paroxetina Zentiva belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). All of us have a substance called serotonin in our brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Paroxetina Zentiva 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 Paroxetina Zentiva

Do not take Paroxetina Zentiva

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

pimozide.
If any of these apply to you, talk to your doctor before taking Paroxetina Zentiva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Paroxetina Zentiva

• Are you taking any other medicines? (See inside this leaflet, Other medicines and Paroxetina Zentiva)
• Are you taking tamoxifen for the treatment of breast cancer or fertility problems? Paroxetina Zentiva 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 or convulsions?
• Have you ever experienced episodes of mania (hyperactive behaviour or thoughts)?
• Have you received 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 or 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 eye pressure)?
• 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 of age)

If you answered YES to any of these questions and have not already discussed them with your doctor,
contact your doctor and ask what to do about taking Paroxetina Zentiva.
Children and adolescents under 18 years of age
Paroxetina Zentiva 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 Paroxetina Zentiva. If your doctor has
prescribed Paroxetina Zentiva for you (or for your child) and you wish to discuss this, contact your
doctor. You must inform your doctor if any of the symptoms listed above appear or
worsen while you (or your child) are taking Paroxetina Zentiva. Furthermore, in this age group
the long-term effects of Paroxetina Zentiva on growth, maturation and cognitive and behavioural
development have not yet been established.
In clinical studies with paroxetine in patients under 18 years of age, common adverse reactions
affecting less than 1 in 10 children/adolescents were: increased suicidal thoughts and suicide attempts,
deliberate self-harm, hostile attitude, aggressive or unfriendly behaviour, loss of appetite, tremor,
abnormal sweating, hyperactivity (excess energy), agitation, 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 paroxetine, although less frequently.
In these studies conducted in patients under 18 years of age, some patients experienced withdrawal symptoms after discontinuation of paroxetine. These symptoms were mostly similar to those observed in adults after stopping paroxetine (see inside this leaflet section 3, How to take Paroxetina Zentiva). In addition, patients under 18 years of age commonly experienced (in less 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 taking your life. These thoughts may be more frequent 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 such thoughts:

• If you have previously had thoughts of taking 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.
• 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 worsening, or if they are concerned about changes in your behaviour.

Important adverse effects observed with Paroxetina Zentiva
Some patients taking Paroxetina Zentiva experience a condition called akathisia,
i.e. they feel restless and unable to sit or stand still. Other patients may experience a condition 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. 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 Paroxetina Zentiva, see inside this leaflet Section 4, Possible side effects.
Other medicines and Paroxetina Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may interfere with the action of Paroxetina Zentiva, or may make it more likely that adverse effects occur. Paroxetina Zentiva may also interfere with the action of other medicines. These include:

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride) – see inside this leaflet Do not take Paroxetina Zentiva
• Thioridazine or pimozide, which are antipsychotics – see inside this leaflet Do not take Paroxetina Zentiva.
• Aspirin (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, tryptophan and 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, 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 (TB) 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, contact your doctor and ask what to do. It may be necessary to adjust the dose or you may need to take a different medicine.
Paroxetina Zentiva with food, drinks and alcohol
Do not drink alcohol while taking Paroxetina Zentiva. Alcohol may worsen your symptoms and side effects. Taking Paroxetina Zentiva in the morning with food will reduce the likelihood of feeling unwell (nausea).
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
In children of mothers who took Paroxetina Zentiva during the first months of pregnancy, there have been some reports showing 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 take Paroxetina Zentiva. You and your doctor may decide whether it is better for you to switch to another treatment or gradually discontinue Paroxetina Zentiva during pregnancy. However, depending on the circumstances, your doctor may advise you that it is better for you to continue taking Paroxetina Zentiva.
Make sure your midwife or doctor knows that you are taking Paroxetina Zentiva.
When medicines such as Paroxetina Zentiva are taken during pregnancy, particularly during 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 Paroxetina Zentiva 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 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.

Paroxetina Zentiva may pass into breast milk in very small amounts. If you are taking
Paroxetina Zentiva, contact your doctor and discuss this with them before starting breastfeeding.
You and your doctor can decide whether you can breastfeed while taking Paroxetina
Zentiva.
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 side effects of Paroxetina Zentiva include dizziness, confusion, drowsiness or blurred vision. If you experience these side effects, do not drive or operate machinery.

3. How to take Paroxetine Zentiva

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, 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 shown in the table below.

Your doctor will tell you what dose to take when you start taking Paroxetina Zentiva. Most people begin to 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. He or she 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.
The tablets can be divided into equal doses.
Do not chew them.
Your doctor will tell you how long you need to take your tablets. This may be for several 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 problems with your liver or kidneys, your doctor may decide to reduce your dose of Paroxetina Zentiva compared to the usual dose. If you have severe liver or kidney disease, the maximum dose is 20 mg per day.

If you take more Paroxetina Zentiva than you should
Do not take more tablets than your doctor recommends. If you take more Paroxetina Zentiva tablets than you should (or if someone else has done so), contact your doctor or go to a hospital immediately. Show them the tablet packaging.
People who have taken an overdose of Paroxetina Zentiva 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 Paroxetina Zentiva
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 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 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
Paroxetina Zentiva does not improve your symptoms immediately – all antidepressants take time to work.
Some people begin to feel better within a couple of weeks, but others may need 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 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 Paroxetina Zentiva
Do not stop taking Paroxetina Zentiva unless your doctor tells you to do so.
When stopping Paroxetina Zentiva, 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 dose of Paroxetina Zentiva by 10 mg per week. Most people find that any withdrawal symptoms from Paroxetina Zentiva 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 Paroxetina Zentiva, contact your doctor. He or she may ask you to start taking the tablets again and then stop more slowly.
Even if you experience withdrawal effects, you will still be able to stop Paroxetina Zentiva.

Possible withdrawal effects when stopping treatment
Studies show that 3 out of 10 patients notice one or more symptoms when stopping paroxetine. 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, and (less commonly) electric shock sensations, including in the head
• Some patients have developed ringing, buzzing, hissing, tinnitus, or other persistent noises in the ear (tinnitus) while taking Paroxetina Zentiva
• 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 (shaking)
• 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 Paroxetina Zentiva. If you have any further questions about using 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 few weeks of treatment with Paroxetina Zentiva.
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 bruises and unusual 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, which may affect up to 1 in 1,000 people:

• If you have seizures (fits), contact your doctor or go directly to hospital.
• If you feel restless and as though you cannot sit or stand still, you may be experiencing a condition called akathisia. Increasing the dose of Paroxetina Zentiva 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 sodium levels 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 Paroxetina Zentiva. If you develop a skin rash with red raised areas, swelling of the eyelids, face, lips, mouth, and tongue, sudden onset of itching, have 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 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.

Frequency not known

• Some people have had thoughts of harming themselves or of suicide while taking Paroxetina Zentiva or immediately after stopping treatment (see Section 2, What you need to know before taking Paroxetina Zentiva).
• Some people have shown aggression while taking Paroxetina Zentiva.
• Teeth grinding. 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, 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
• Difficulty concentrating
• Feeling restless
• 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 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 Paroxetina Zentiva. 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
• Slowed heartbeat
• Liver effects detectable by liver function blood tests
• Panic attacks
• Hyperactive behaviour and thoughts (mania)
• Feeling detached from yourself (depersonalization)
• 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, and 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), 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 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 erection of the penis that does not go away
• Low platelet count

Some patients have experienced ringing, buzzing, hissing, whistling, or other persistent noises in the ear (tinnitus) while taking Paroxetina Zentiva. 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, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the website:
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 Paroxetina Zentiva

This medicine does not require any special storage conditions.
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 after
EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Paroxetina Zentiva contains

• The active substance is paroxetine. Each tablet contains 20 mg of paroxetine as anhydrous hydrochloride.
• The other excipients are magnesium stearate, sodium starch glycolate, mannitol (E421), microcrystalline cellulose, polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), soybean lecithin (E322) and xanthan gum (E415).

Description of the appearance of Paroxetina Zentiva and contents of the pack
Paroxetina Zentiva 20 mg film-coated tablets are white or almost white, round, film-coated, biconvex tablets, engraved on one side.
Each pack of Paroxetina Zentiva contains blisters of 10, 14, 20, 28, 30, 56, 60, 90, 100 and 500 tablets.
Marketing Authorization Holder
Zentiva Italia S.r.l. - Viale Bodio, 37/b - 20158 Milan
Manufacturer
Bluepharma Indústria Farmacêutica, S.A.
S. Martinho do Bispo
3045-016 Coimbra
Portugal