Leaflet: information for the user

Paroxetina Bluepharma 20 mg film-coated tablets EFG

Paroxetina

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

- Keep this leaflet, as 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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Paroxetina Bluepharma

3. How to take Paroxetina Bluepharma

4. Possible side effects

5. Storage of Paroxetina Bluepharma

6. Contents of the pack and additional information

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

Paroxetina belongs to a group of medications called selective serotonin reuptake inhibitors (SSRIs). We all have a substance called serotonin in the brain. People who are depressed or have anxiety have lower levels of this substance. The exact mechanism of action of paroxetina and other SSRIs is not precisely known, but they exert their action by increasing the level of serotonin in the brain.

Treating depression or anxiety disorders properly is important to help you feel better.

Do not take Paroxetina Bluepharma:

- if you are allergic to paroxetine or to 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 methionine chloride (methylen blue)), or if you have been treated 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, inform 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 sectionUse of 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 you take another antidepressant

- if you have any kidney, liver or heart problems

- if you have epilepsy or if you have seizures or convulsions

- if you have had manic episodes (excessively active thoughts or behaviors)

- if you are being treated with electroconvulsive therapy (ECT)

- if you have a tendency to bleed or bruise, or if you 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, pain and inflammation medicines called non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, 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 (high eye pressure)

- if you are pregnant or if you think you may become pregnant (see the sectionPregnancy, breastfeeding and fertility)

- if you are under 18 years of age (see the sectionChildren and adolescents under 18 years of age).

If you are in any of these situationsand have not yet consulted your doctor, ask your doctor 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 higher risk of adverse effects such as suicidal thoughts, suicidal ideation and hostility (predominantly aggression, confrontational behavior and irritability) when taking paroxetine. Despite this, your doctor may prescribe paroxetine to patients under 18 years of age when they decide it is best for the patient. 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 should inform your doctor if any of the symptoms listed above appear or worsen when you or your child under 18 years of age are taking paroxetine. The long-term safety of paroxetine in relation to growth, maturation and cognitive and behavioral development in this age group has not yet been demonstrated.

In studies conducted with paroxetine in patients under 18 years of age, the most common adverse effects, which affected less than 1 in 10 children or adolescents, were: an increase in thoughts and attempts of suicide, self-harm, 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 fortuitous cardinals or bleeding (such as nasal bleeding). These effects were also observed in patients included in these studies who did not take paroxetine, although less frequently.

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

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, sometimes you may 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 take effect, which is usually two weeks but sometimes longer.

It is more likely to happen

- If you have previously had thoughts of suicide or self-harm.

- If you are ayoung adult. There is information from clinical trials that shows an increased risk of suicidal behavior in young adults under 25 years of age with psychiatric illnesses being treated with some antidepressant.

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

It may be helpful for you to explain to a family member or close friendthat you are depressed or have anxiety disorders, 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 concerned about changes in your behavior.

Important adverse effects observed with Paroxetina Bluepharma

Some patients taking paroxetine develop a disorder called akathisia, andfeel restless and unable to sit or stay still. Other patients develop the so-calledserotonin syndrome or malignant neuroleptic syndrome, and may have any or all of the following symptoms: feeling very agitated or irritable, confusion, restlessness, sensation of heat, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle rigidity, sudden, brief movements or increased heart rate. The severity can increase and lead to loss of consciousness.Consult your doctorif you have any of these symptoms. For more information on this or other adverse effects of paroxetine, see section 4,Possible adverse effects,in this leaflet.

Paroxetina Bluepharma with other medicines

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

Some medicines may modify the effect of paroxetine or make it more likely for some adverse effects to occur. Paroxetine may also modify the effect of some medicines. For example:

- Medicines calledmonoamine oxidase inhibitors(MAOIs, including moclobemide and methionine chloride (methylen blue)). See the sectionDo not take Paroxetina Bluepharma.

- The medicines called thioridazine or pimozide, which areantipsychotics. See the sectionDo not take Paroxetina Bluepharma.

- Aspirin, ibuprofen and other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, etodolac, diclofenac and meloxicam, used to treatpain and inflammation.

- Tramadol and petidina,analgesics.

- Medicines called triptans, such as sumatriptan, used to treatmigraine.

- Otherantidepressants, including other selective serotonin reuptake inhibitors and tricyclic antidepressants such as clomipramine, nortriptyline and desipramine.

- Adietary supplementcalled tryptophan.

- Mivacurio and suxamethonium (used in anesthesia).

- Medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat somepsychiatric illnesses.

- Fentanyl, used inanesthesiaor to treatchronic pain.

- A combination of fosamprenavir and ritonavir, used to treathuman immunodeficiency virus (HIV) infection.

- St. John's Wort, a medicinal herb to treatdepression.

- Phenobarbital, phenytoin, sodium valproate or carbamazepine, used to treatconvulsionsorepilepsy.

- Atomoxetine, a medicine used to treatattention deficit hyperactivity disorder (ADHD).

- Procyclidine, used to alleviate tremor, especially inparkinson's disease.

- Warfarin and other medicines (called anticoagulants) used tothin the blood.

- Propafenone, flecainide and medicines used to treatheart rhythm disorders.

- Metoprolol, a beta-blocker used to treathigh blood pressure and heart disorders.

- Pravastatin, used to treathigh cholesterol.

- Rifampicin, used to treattuberculosis (TB)andleprosy.

- Linezolid, anantibiotic.

- Tamoxifen, used totreating breast cancer(orfertility problems).

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

Paroxetina Bluepharma with food, drinks and alcohol

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may become pregnant, consult your doctor or pharmacist before using 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 are born with a heart malformation. This proportion increased to 2 in 100 newborns in mothers who took paroxetine. Your doctor, in consultation with you, may change your treatment or stop taking paroxetine gradually 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 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 know that you are taking Paroxetina Bluepharma to be able 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 and particularly in the last stages of it. The pressure in the blood vessels 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 present other symptoms that normally begin during the first 24 hours after birth. Among these symptoms are:

- Difficulty breathing.

- Blue skin or appearance of being very hot or cold.

- Blue lips.

- Vomiting or difficulty feeding.

- Feeling very tired, difficulty sleeping or frequent crying.

- Muscle stiffness or flaccidity.

- Tremors, localized tremors or convulsions.

- 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 starting to breastfeed. Your doctor, in consultation with you, may advise you to continue breastfeeding while taking paroxetine.

Studies in animals have shown that paroxetine reduces the quality of sperm. Theoretically, this may affect human fertility, but this impact has not yet been observed in people.

Driving and operating machinery

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.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.In case of 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 to take:

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

Your doctor will tell you what dose to take when you start treatment with this medication.Most people start to feel better after a couple of weeks. If you don't start to feel better after this time, consult your doctor who will tell you 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 split into equal doses.

The tablets should not be chewed.

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

Patients over 65 years old

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.

If you have taken too much of this medication or have accidentally ingested it, 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 have some of the symptoms listed in the section "Possible side 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 it before bedtime, take it immediately. Take the next dose at the usual time.

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

Do not take a double dose to compensate for the missed doses.

What to do if you don't 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 need more time. Some people who take antidepressants may feel worse before they start to notice an improvement. If you don't start to feel better after a couple of weeks, tell your doctor, who will tell you what to do. Your doctor may have scheduled a follow-up appointment for you after two weeks of starting treatment.

What to do if you interrupt treatment with Paroxetina Bluepharma

Do not interrupt treatment until your doctor tells you to.

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

If you experience withdrawal symptoms while interrupting treatment, your doctor may decide to interrupt treatment 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 symptoms, you can still interrupt treatment with paroxetine.

Withdrawal symptoms when treatment is interrupted

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

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

-Feeling dizzy, unstable, or experiencing balance problems.

-Tickling, burning sensations, and, less frequently, a feeling of electric discharge, even in the head, ringing, buzzing, beeping, or other persistent sounds in the ears (tinnitus).

-Sleep disturbances (vivid dreams, nightmares, inability to sleep).

-Anxiety.

-Headaches.

Rare side effects, which may affect up to 1 in 100 patients:

-Nausea (vomiting).

-Sweating (including night sweats).

-Restlessness or agitation.

-Tremors.

-Confusion or disorientation.

-Diarrhea (soft stools).

-Feeling extremely sensitive or irritable.

-Visual disturbances.

-Palpitations (rapid or strong heartbeats).

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

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

It is more likely that side effects will occur during the first weeks of treatment with paroxetine.

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

Rare side 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 the hospital immediately.

-If you experience difficulty urinating, contact your doctor or go to the hospital immediately.

Very rare side 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 sit or stay still,known as akathisia. Increasing the dose of paroxetine may worsen your symptoms. If you feel this way,see your doctor.

-Fatigue, 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,see your doctor.

Very rare side 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 blisters, swelling of the face, eyelids, lips, mouth, or tongue, itching, or difficulty breathing (difficult breathing) or swallowing, and a feeling of weakness or dizziness that may cause a collapse or loss of consciousness,contact your doctor or go to the hospital immediately.

-If you notice any of the following symptomsyou may be suffering from aserotonin syndrome or malignant neuroleptic syndrome. The symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling of heat, sweating, tremors, chills, hallucinations (strange sounds or visions), muscle rigidity, sudden, rapid movements, or rapid heartbeat. The severity may increase and lead to loss of consciousness. If you feel this way,see your doctor.

-Acute glaucoma.If you experience eye pain and blurred vision,see your doctor.

Unknown frequency

- Tics

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

-Aggression.

-Colitis (which causes diarrhea).

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

Other possible side effects during treatment:

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

-Feeling sick (nausea). This effect may be reduced by taking your medication in the morning after breakfast.

-Change in sex drive or sexual function, for example, lack of orgasm and, in men, abnormal erection and ejaculation.

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

-Increased levels of cholesterol in the blood.

-Loss of appetite.

- Difficulty sleeping (insomnia) or drowsiness.

-Abnormal dreams (including nightmares).

-Dizziness, tremors.

-Headache.

-Difficulty concentrating.

-Restlessness.

-Unusual weakness.

-Blurred vision.

-Yawning, dry mouth.

-Diarrhea or constipation.

-Vomiting.

-Weight gain.

-Sweating.

Rare side 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.

-Abnormal heart rhythms.

-Lack of movement, stiffness, tremors, 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 involuntary urination (incontinence).

-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 side effects,which may affect up to 1 in 1,000 patients:

-Abnormal milk secretion in men and women.

-Decreased heart rate.

-Liver effects that are seen in laboratory tests that indicate liver function.

-Panic attacks.

-Manic behavior or thoughts.

-Feeling disconnected from oneself (derealization).

-Anxiety.

-Irresistible need to move the legs (Restless Legs Syndrome).

-Muscle or joint pain.

-Increased levels of a hormone called prolactin in the blood.

-Changes in menstrual cycle (including heavy or irregular periods, bleeding between periods, and absence or delay of period).

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

-Skin rash, in which may appear blisters with a central dark spot surrounded by a pale area, with a dark ring around it, called erythema multiforme.

-Widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).

-Widespread rash with blisters and skin peeling over a large body surface (toxic epidermal necrolysis).

-Liver changes that turn the skin or the white of the eyes yellow.

-Syndrome of inappropriate antidiuretic hormone secretion (SIADH) that is a state in which the body develops an excess of water and a decrease in sodium concentration as a result of inappropriate chemical signals. SIADH patients may feel severely ill or have no symptoms.

-Water retention or fluid (which causes swelling of arms or legs).

-Sensitivity to sunlight.

-Prolonged and painful erection of the penis.

-Decreased platelet count in the blood.

Some patients have experienced ringing, buzzing, beeping, or other persistent noises in the ears (tinnitus) when taking paroxetine. People taking medications like paroxetine have a higher risk of bone fractures.

Reporting of side effects

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

By reporting side effects, you can contribute to providing more information about the safety of this medicine.

No requires special conditions for conservation.

Keep this medication out of the 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 drains or in the trash. Deposit the packaging and medications that you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

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, carboxymethylcellulose sodium (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 content of the packaging

Paroxetina Bluepharma 20 mg film-coated tablets are presented in the form of white to off-white, round, 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 commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Bluepharma - Indústria Farmacêutica, S.A.

São Martinho do Bispo

3045-016 Coimbra

Portugal

Last review date of this leaflet: January 2011

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