Paroxetine Bluepharma 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paroxetina Bluepharma 20 mg film-coated tablets EFG

Paroxetine

Read all of 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

Paroxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). In the brain, all of us have a substance called serotonin. People who are depressed or have anxiety have lower levels of this substance. The precise mechanism of action of paroxetine and other SSRIs is not fully understood, but they exert their effect by increasing the level of serotonin in the brain.

Treating depression or anxiety disorder appropriately is important to help you feel better.

2. What you need to know before taking Paroxetina Bluepharma

Do not take Paroxetina Bluepharma:

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

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

Warnings and precautions

Talk to your doctor or pharmacist before starting paroxetine

• if you are taking other medicines (see section "Taking Paroxetina Bluepharma with other medicines")
• if you are taking tamoxifen for the treatment of breast cancer (or fertility problems). Paroxetine may make tamoxifen less effective, so your doctor should recommend you take another antidepressant.
• if you have any kidney, liver, or heart problems
• if you have epilepsy or experience seizures or epileptic fits
• if you have had manic episodes (excessively active thoughts or behaviors)
• if you are receiving electroconvulsive therapy (ECT)
• if you are prone to bleeding or bruising, or are being treated with any medicine that may increase the risk of bleeding (including medicines such as warfarin (acenocoumarol), antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines used to treat pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam), or if you are pregnant (see "Pregnancy, breastfeeding and fertility").
• if you have diabetes
• if you are on a low-sodium diet
• if you have glaucoma (increased eye pressure)
• if you are pregnant or planning to become pregnant (see section "Pregnancy, breastfeeding and fertility")
• if you are under 18 years of age (see section "Children and adolescents under 18 years of age").

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

Children and adolescents under 18 years of age

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

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

When discontinuing treatment with paroxetine, some patients under 18 years of age in these studies reported withdrawal-related adverse effects. These effects were very similar to those observed in adults discontinuing paroxetine treatment (see section How to take Paroxetina Bluepharma). In addition, patients under 18 years of age frequently experienced (affecting fewer than 1 in 10) stomach pain, nervousness, and emotional instability (including crying, mood changes, self-harm attempts, suicidal thoughts, and suicide attempts).

Suicidal thoughts and worsening of depression or anxiety disorder

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

This is more likely to happen if:

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

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

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

Important adverse effects observed with Paroxetina Bluepharma

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

Taking Paroxetina Bluepharma with other medicines

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

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

• medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride (methylene blue)). See section "Do not take Paroxetina Bluepharma."
• medicines called thioridazine or pimozide, which are antipsychotics. See section "Do not take Paroxetina Bluepharma."
• acetylsalicylic acid, ibuprofen, and other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, etodolac, diclofenac, and meloxicam, used to treat pain and inflammation.
• tramadol and pethidine, analgesics.
• medicines called triptans, such as sumatriptan, used to treat migraine.
• other antidepressants, including other selective serotonin reuptake inhibitors and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
• a dietary supplement called tryptophan.
• mivacurium and suxamethonium (used in anesthesia).
• medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat certain psychiatric conditions.
• fentanyl, used in anesthesia or to treat chronic pain.
• a combination of fosamprenavir and ritonavir, used to treat human immunodeficiency virus (HIV) infection.
• St. John’s wort, a herbal remedy used to treat depression.
• phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizures or epilepsy.
• atomoxetine, a medicine used to treat attention deficit hyperactivity disorder (ADHD).
• procyclidine, used to relieve tremors, especially in Parkinson’s disease.
• warfarin and other medicines (called anticoagulants) used to thin the blood.
• propafenone, flecainide, and medicines used to treat cardiac rhythm disorders.
• metoprolol, a beta-blocker used to treat high blood pressure and heart conditions.
• pravastatin, used to treat high cholesterol.
• rifampicin, used to treat tuberculosis (TB) and leprosy.
• linezolid, an antibiotic.
• tamoxifen, used to treat breast cancer (or fertility problems).

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

Taking Paroxetina Bluepharma with food, drinks, and alcohol

Do not consume alcohol while taking paroxetine. Alcohol may worsen your symptoms or side effects. Taking paroxetine in the morning with food may reduce the likelihood of nausea.

Pregnancy, breastfeeding and fertility

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

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

If you take Paroxetina Bluepharma in the late stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Paroxetina Bluepharma so they can advise you.

Ensure your doctor or midwife knows you are taking paroxetine. Medicines like paroxetine may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy, particularly in the later stages. In newborns with persistent pulmonary hypertension (PPHN), the pressure in the blood vessels between the heart and lungs is very high. If you take paroxetine during the third trimester, your newborn may also experience other symptoms, usually beginning within the first 24 hours after birth. These symptoms include:

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

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

Paroxetine passes into breast milk in very small amounts. Consult your doctor if you are taking paroxetine before starting breastfeeding. Your doctor, in agreement with you, may advise you to continue breastfeeding while taking paroxetine.

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

Driving and using machines

During treatment with paroxetine, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how paroxetine affects you.

3. How to take Paroxetine Bluepharma

Follow exactly the dosage instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Sometimes you may need to take more than one tablet or half a tablet. The following table will show you how many tablets you should take:

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

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

Take the tablets in the morning, with food.

The tablets should be swallowed with water.

The tablet may be divided into equal doses.

The tablets must not be chewed.

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

Elderly patients

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

Patients with kidney or liver problems

If you have severe hepatic or renal impairment, your doctor may recommend that you take smaller doses of paroxetine than usual.

If you take more Paroxetina Bluepharma than you should

Never take more tablets than your doctor has prescribed.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. A person who has taken an overdose of paroxetine may experience some of the symptoms listed in section 4, Possible side effects, or any of the following symptoms: fever, involuntary muscle contractions.

If you forget to take Paroxetina Bluepharma

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. Take the next dose at the usual time.

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

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

What to do if you do not feel better

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

If you stop taking Paroxetina Bluepharma

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

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

If you experience withdrawal effects while stopping treatment, your doctor may decide to taper the dose more slowly. If you experience severe withdrawal symptoms, please consult your doctor. They may advise you to restart treatment and then stop more gradually.

Even if you experience withdrawal effects, you should still be able to stop treatment with paroxetine.

Possible withdrawal effects when stopping treatment

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

Common adverse effects, which may affect up to 1 in 10 patients:

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

Uncommon adverse effects, which may affect up to 1 in 100 patients:

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

Consult your doctor if you are concerned about withdrawal effects from this medicine. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects are more likely to occur during the first weeks of treatment with paroxetine.

Inform your doctor if you experience any of the adverse effects listed below while taking paroxetine. It may be necessary for you to contact your doctor or go to hospital immediately.

Uncommon adverse effects, which may affect up to 1 in 100 patients:

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

Rare adverse effects, which may affect up to 1 in 1,000 patients:

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

Very rare adverse effects, which may affect up to 1 in 10,000 patients:

• Allergic reactions to paroxetine, which can be severe.
• If you develop a rash with redness and lumps, swelling of the face, eyelids, lips, mouth or tongue, itching, or difficulty breathing (shortness of breath) or swallowing, and a feeling of weakness or dizziness that may lead to collapse or loss of consciousness, contact your doctor or go to hospital immediately.
• If you notice any or all of the following symptoms, you may be experiencing serotonin syndrome or neuroleptic malignant syndrome. Symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremor, chills, hallucinations (strange sounds or visions), muscle rigidity, sudden jerky movements, or rapid heartbeat. Severity may increase and lead to loss of consciousness. If you feel this way, consult your doctor.
• Acute glaucoma. If you develop eye pain and blurred vision, consult your doctor.

Frequency not known

• Teeth grinding
• Some people have experienced thoughts of harming themselves or suicide while taking paroxetine or shortly after stopping treatment (see section 2, Before taking Paroxetina Bluepharma).
• Aggressiveness.

-.Inflammation of the colon (causing diarrhoea).

-.Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see Pregnancy, breastfeeding and fertility in section 2 for more information.

Other possible adverse effects during treatment:

Very common adverse effects, which may affect more than 1 in 10 patients:

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

Common adverse effects, which may affect up to 1 in 10 patients:

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

Uncommon adverse effects, which may affect up to 1 in 100 patients:

• Transient increases in blood pressure, or transient decreases in blood pressure that may cause dizziness or fainting when standing up quickly.
• Faster than normal heartbeat.
• Lack of movement, stiffness, tremor, or abnormal movements of the mouth and tongue.
• Pupil dilation.
• Skin rash.
• Itching.
• Confusion.
• Hallucinations (strange sounds or visions).
• Inability to urinate (urinary retention) or urinary incontinence (uncontrolled and involuntary urination).
• If you are a diabetic patient, you may notice loss of control of blood sugar levels while taking paroxetine. Consult your doctor about how to adjust your insulin dose or diabetes medication.

Rare adverse effects, which may affect up to 1 in 1,000 patients:

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

Very rare adverse effects, which may affect up to 1 in 10,000 patients:

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

Some patients have experienced ringing, buzzing, hissing, tinnitus, or other persistent noises in the ears (tinnitus) while taking paroxetine. People taking medicines such as paroxetine have been observed to have an increased risk of bone fractures.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paroxetine Bluepharma

No special storage conditions are required.

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

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

If you are taking half a tablet, take care to store it safely in its original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paroxetina Bluepharma

• Each film-coated tablet contains 20 mg of paroxetine, as anhydrous hydrochloride.
• The other components are magnesium stearate, sodium carboxymethyl starch (type A) (from potato), mannitol (E421), microcrystalline cellulose, polyvinyl alcohol (partially hydrolysed) (E1203), titanium dioxide (E171), talc (E553b), soya lecithin (E322) and xanthan gum (E415).

Appearance of the product and contents of the pack

Paroxetina Bluepharma 20 mg film-coated tablets are presented as white to off-white, round, coated, biconvex tablets, scored on one side. Each pack of Paroxetina Bluepharma contains blisters of 14, 28, 56 or 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bluepharma - Indústria Farmacêutica, S.A.

São Martinho do Bispo

3045-016 Coimbra

Portugal

Date of the most recent revision of this leaflet: January 2011

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/