PAROXETINE BLUEPHARMA 20 mg FILM-COATED TABLETS

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 further 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 signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What is Paroxetina Bluepharma and what is it 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 thoughts, repetitive behavior), panic disorder (panic attacks, including those caused by agoraphobia, which is the fear of open spaces), social anxiety disorder (fear or avoidance of social contact), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (feeling normally very anxious and nervous).

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

Properly treating depression or anxiety disorder is important to help you feel better.

2. What you need to know before you take 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 methylthioninium chloride (methylene blue)), or if you have been under treatment with any of these medicines in the last two weeks. Your doctor will advise you how to start taking paroxetine once you have stopped taking the MAOI.
• if you are taking an 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

Consult your doctor or pharmacist before starting to take paroxetine

• if you are taking other medicines (see the section on "Using other medicines and Paroxetina Bluepharma")
• 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 taking another antidepressant
• if you have any kidney, liver, or heart problems
• if you have epilepsy or have had seizures or epileptic fits
• if you have had manic episodes (thoughts or behaviors that are excessively active)
• if you are being treated with electroconvulsive therapy (ECT)
• if you have a tendency to bleed or bruise, or are being treated with a medicine that may increase the risk of bleeding (including medicines such as warfarin (acenocoumarol), antipsychotics like 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, breast-feeding, and fertility").
• if you have diabetes
• if you are on a low-sodium diet
• if you have glaucoma (high eye pressure)
• if you are pregnant or think you may be pregnant (see the section on "Pregnancy, breast-feeding, and fertility")
• if you are under 18 years of age (see the section on "Children and adolescents under 18 years of age").

If you are in any of these situations and have not yet consulted your doctor, ask him 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. Also, you should know that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking paroxetine. Nevertheless, your doctor may prescribe paroxetine to patients under 18 years of age when he decides it is most convenient for the patient. If your doctor has prescribed paroxetine to you or your child under 18 years of age and you want to discuss this decision, consult your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen when you or your child under 18 years of age are taking paroxetine. The long-term effects of paroxetine on safety, related to growth, maturity, and cognitive and behavioral development in this age group, have not yet been demonstrated.

In studies conducted with paroxetine in patients under 18 years of age, frequent adverse effects, which affected less than 1 in 10 children or adolescents, were: an increase in suicidal thoughts and attempts, self-harm behaviors, hostile, aggressive, or unfriendly behaviors, loss of appetite, tremors, abnormal sweating, hyperactivity (having too much energy), agitation, unstable emotions (including crying and mood changes), and the appearance of bruises or bleeding (such as nosebleeds). These effects were also observed in patients included in these studies who did not take paroxetine, although with less frequency.

When stopping treatment with paroxetine, in these studies, some of the patients under 18 years of age reported having withdrawal effects. These effects were very similar to those observed in adults who stopped treatment with paroxetine (see the section "How to take Paroxetina Bluepharma"). Additionally, patients under 18 years of age frequently experienced (affecting less than 1 in 10) stomach pain, nervousness, and unstable emotions (including crying, mood changes, self-harm behaviors, suicidal thoughts, and attempts).

Suicidal thoughts and worsening of your 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, which is usually a few weeks but can be longer.

This is more likely to happen

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. There is information from clinical trials that shows an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were being treated with an antidepressant.

If you have thoughts of self-harm or suicide at any time, consult your doctor or go to the hospital immediately.

It may be helpful for you to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

Important side effects observed with Paroxetina Bluepharma

Some patients who take paroxetine develop a disorder called akathisia, and they feel restless and cannot sit or stay still. Other patients develop a condition called serotonin syndrome or neuroleptic malignant syndrome, and they may have some or all of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, trembling, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden jerky movements, or increased heart rate. The severity can increase and lead to loss of consciousness. Consult your doctor if you have any of these symptoms. For more information on this or other side effects of paroxetine, see the section 4, "Possible side effects," in this leaflet.

Taking Paroxetina Bluepharma with other medicines

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

Some medicines may change the effect of paroxetine or make some side effects more likely. Paroxetine may also change the effect of some medicines. For example:

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)). See the section "Do not take Paroxetina Bluepharma."
• Medicines called thioridazine or pimozide, which are antipsychotics. See the 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, painkillers.
• Medicines called triptans, such as sumatriptan, used to treat migraines.
• 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 some psychiatric disorders.
• Fentanyl, used in anesthesia or to treat chronic pain.
• A combination of fosamprenavir and ritonavir, used to treat human immunodeficiency virus (HIV) infection.
• St. John's Wort, a herbal remedy for 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 make the blood more fluid.
• Propafenone, flecainide, and medicines used to treat heart rhythm disorders.
• Metoprolol, a beta-blocker used to treat high blood pressure and heart disorders.
• Pravastatin, used to treat high cholesterol.
• Rifampicin, used to treat tuberculosis (TB) and leprosy.
• Linezolid, an antibiotic.
• Tamoxifen, used to treat breast cancer (or fertility problems).

If you are taking or have recently taken any of these medicines, tell your doctor and consult what you should do. Your doctor may decide to change the dose or prescribe another 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, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

In some studies, an increased risk of malformations, particularly those affecting the heart, has been observed 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 malformation. This proportion increased to 2 in 100 newborns in mothers who took paroxetine. Your doctor, in agreement with you, may change you to another treatment or gradually stop the treatment with paroxetine while you are pregnant. However, depending on your circumstances, your doctor may recommend continuing to take paroxetine.

If you take Paroxetina Bluepharma in the final stage of pregnancy, there may be a greater risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Paroxetina Bluepharma to advise you.

Make sure your doctor or midwife knows that you are taking paroxetine. Medicines like paroxetine may increase the risk of a serious disease called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy, particularly at the end of it. The pressure in the blood vessels that go between the heart and lungs is very high in newborns with persistent pulmonary hypertension (PPHN). If you are taking paroxetine in the last trimester of pregnancy, your newborn may also have other symptoms that usually start during the first 24 hours after birth. These symptoms include:

• Difficulty breathing.
• Blue-tinged skin or looking too hot or cold.
• Blue lips.
• Vomiting or difficulty feeding.
• Feeling very tired, difficulty sleeping, or frequent crying.
• Stiffness or floppiness of the muscles.
• Tremors, localized tremors, or seizures.
• Exaggerated reflexes.

If your baby has 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 you start breast-feeding. Your doctor, in agreement with you, may advise you to continue breast-feeding while taking paroxetine.

Studies in animals have shown that paroxetine reduces sperm quality. This may theoretically affect fertility in humans, but it 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 machines until you know how the treatment with paroxetine affects you.

3. How to take Paroxetina Bluepharma

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Sometimes it may be necessary 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 indicate what dose you should take when starting treatment with this medication. Most people start to feel better after a couple of weeks. If after this time you do not start to feel better, consult your doctor, who will indicate what to do. Your doctor may decide to gradually increase the dose, in increments of 10 mg, up to the maximum daily dose.

Take the tablets in the morning, with food.

The tablets should be swallowed with water.

The tablet can be divided into equal doses.

The tablets should not be chewed.

Your doctor will indicate the duration of the treatment. This period may be extended for several months or even longer.

Elderly patients

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

Patients with kidney or liver problems

If you have severe liver or kidney failure, your doctor may advise you to take smaller doses of paroxetine than usual.

If you take more Paroxetina Bluepharma than you should

Never take more tablets than your doctor has recommended.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. A person who has taken an overdose of paroxetine may experience some of the symptoms that appear in section 4, Possible adverse effects,or some of the following symptoms: fever, involuntary muscle contraction.

If you forget to take Paroxetina Bluepharma

Take your medication 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 next 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 missed doses.

What to do if you do not feel better

Paroxetine will not improve your symptoms immediately, all antidepressants take time to work. Some people start to feel better after a couple of weeks, but others may require more time. Some people who take antidepressants feel worse before starting to notice improvement. If you do not start to feel better after a couple of weeks, inform your doctor, who will indicate what to do. It is possible that your doctor has scheduled a follow-up appointment after 2 weeks of starting your treatment.

If you interrupt treatment with Paroxetina Bluepharma

Do not interrupt treatment until your doctor indicates it.

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

If you experience withdrawal effects while interrupting your treatment, your doctor may decide to interrupt it more slowly. If you experience severe withdrawal symptoms, please consult your doctor. Your doctor may advise you to start treatment again and then interrupt it more slowly.

Although you may experience some withdrawal effect, you may be able to interrupt your treatment with paroxetine.

Possible withdrawal effects when interrupting treatment

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

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

• Feeling dizzy, with instability or balance disturbances.
• Tingling, burning sensations, and less frequently, electric shock sensation, even in the head, buzzing, whistling, ringing, or other persistent noises in the ears (tinnitus).
• Sleep disturbances (very vivid dreams, nightmares, inability to sleep).
• Anxiety.
• Headaches.

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

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

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

It is more likely that adverse effects will appear during the first few weeks of treatment with paroxetine.

Inform your doctor if you experience any of the adverse effects described below during treatment with paroxetine. You may need to consult your doctor or go to the hospital immediately.

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

• If you have bruising or unusual bleeding, such as blood in your vomit or stools, contact your doctor or go to the hospital immediately.
• If you experience inability to urinate, contact your doctor or go to the 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 the hospital immediately.
• If you have a feeling of restlessness, inability to stay seated or stay still, called akathisia. Increasing the dose of paroxetine may worsen your symptoms. If you feel this way, consult your doctor.
• 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 that can be severe.
• If you develop a skin rash with redness and bumps, swelling of the face, eyelids, lips, mouth, or tongue, itching, or difficulty breathing (difficult breathing) or swallowing, and a feeling of weakness or fainting that can cause collapse or loss of consciousness, contact your doctor or go to the hospital immediately.
• If you notice any or all of the following symptoms, you may be experiencing serotonin syndrome or neuroleptic malignant syndrome. The symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, trembling, chills, hallucinations (strange sounds or visions), muscle stiffness, sudden movements, or rapid heartbeats. The severity can increase and lead to loss of consciousness. If you feel this way, consult your doctor.
• Acute glaucoma. If you experience eye pain and blurred vision, consult your doctor.

Frequency not known

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

- Inflammation of the colon (which causes diarrhea).

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

Other possible adverse effects during treatment:

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

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

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

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

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

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

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

• Abnormal milk secretion in men and women.
• Decreased heart rate.
• Liver effects that appear in laboratory tests that indicate liver function.
• Panic attacks.
• Very active behaviors or thoughts (mania).
• Feeling detached from oneself (depersonalization).
• Anxiety.
• Irresistible need to move the legs (Restless Legs Syndrome).
• Pain in joints or muscles.
• Increased levels of a hormone called prolactin in the blood.
• Menstrual disorders (including heavy or irregular periods, bleeding between periods, and absence or delay of period).

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

• Skin rash, in which blisters appear with a target-like appearance (dark central spots surrounded by a pale area, with a dark ring around) called erythema multiforme.
• Widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Widespread rash over a large body surface with blisters and skin peeling (toxic epidermal necrolysis).
• Liver disorders that turn the skin or the whites of the eyes yellow.
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH) which is a condition in which the body develops an excess of water and a decrease in sodium (salt) concentration as a result of inappropriate chemical signals. Patients with SIADH may feel severely ill or may have no symptoms.
• Water or fluid retention (which causes swelling of arms or legs).
• Sensitivity to sunlight.
• Painful and prolonged erection of the penis.
• Decreased platelet count in the blood.

Some patients have experienced buzzing, whistling, ringing, or other persistent noises in the ears (tinnitus) when taking paroxetine. It has been observed that people taking medications like paroxetine have a higher risk of bone fractures.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Paroxetina Bluepharma

It does not require special storage conditions.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

If you are taking half a tablet, be careful to store it safely in the packaging.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Paroxetina Bluepharma

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

Appearance of the product and package contents

Paroxetina Bluepharma 20 mg film-coated tablets are presented in the form of white or off-white, round, film-coated, and biconvex tablets, scored on one side. Each package of Paroxetina Bluepharma contains blisters of 14, 28, 56, or 500 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Bluepharma - Indústria Farmacêutica, S.A.

São Martinho do Bispo

3045-016 Coimbra

Portugal

Date of the last revision of this prospectus: January 2011

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/