Paroxetine Aurovitas 30 mg film-coated tablets: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Paroxetine Aurovitas 30 mg film-coated tablets

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

Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

What Paroxetine Aurovitas is and what it is used for
What you need to know before taking Paroxetine Aurovitas
How to take Paroxetine Aurovitas
Possible side effects
How to store Paroxetine Aurovitas
Contents of the pack and other information

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

Paroxetina Aurovitas 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 very anxious and nervous).

Paroxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). The precise 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 taking Paroxetina Aurovitas

Do not take Paroxetina Aurovitas

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Paroxetina Aurovitas.

If you are taking other medicines (see section "Other medicines and Paroxetina Aurovitas").
If you are taking tamoxifen for the treatment of breast cancer or fertility problems. Paroxetine may make tamoxifen less effective, so your doctor may recommend taking another antidepressant.
If you have any kidney, liver, or heart problems.
- If you have an abnormality in your heart rhythm seen on an electrocardiogram (ECG) known as QT interval prolongation.
- If you have a family history of QT interval prolongation, heart conditions such as heart failure, slow heart rate, or low levels of potassium or magnesium.
If you have epilepsy or a history of seizures or epileptic fits.
If you have had manic episodes (excessively active thoughts or behaviors).
If you are receiving electroconvulsive therapy (ECT).
If you have a history of bleeding disorders or if you are pregnant (see "Pregnancy, breastfeeding, and fertility") or are taking other medicines that may increase the risk of bleeding (these include medicines used to thin the blood such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines for pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam).
If you have diabetes.
If you are on a low-sodium diet.
If you have glaucoma (increased pressure in the eye).
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").
- If you are taking medicines containing buprenorphine. Using these medicines together with Paroxetina Aurovitas may lead to serotonin syndrome, a potentially life-threatening condition (see "Taking Paroxetina Aurovitas with other medicines").

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

Paroxetine must not be used to treat children and adolescents under 18 years of age. In patients under 18 years, there is also an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking paroxetine. If your doctor has prescribed paroxetine for you (or your child) and you wish to discuss this decision, speak to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while you (or your child) are taking paroxetine. In addition, the long-term safety effects of paroxetine on growth, maturation, and cognitive and behavioral development in this age group have not yet been established.

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

In these studies, some patients under 18 years reported withdrawal effects when stopping paroxetine treatment. These effects were very similar to those observed in adults who discontinued paroxetine (see section 3). Additionally, patients under 18 years frequently experienced (affecting less 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 of 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.

You are more likely to experience this if:

You have previously had thoughts of suicide or 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 an antidepressant.

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

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

Important adverse effects observed with paroxetine

Some patients taking paroxetine develop a condition called akathisia, and feel restless and unable to sit still or remain motionless. Other patients develop a condition called 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. Symptoms may worsen and lead to loss of consciousness. Contact your doctor if you experience any of these symptoms. For more information about this or other adverse effects of paroxetine, see section 4.

Some medicines in the same class as paroxetine (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Other medicines and Paroxetina Aurovitas

Some medicines may alter the effect of paroxetine or make certain adverse effects more likely. Paroxetine may also alter the effect of some medicines. These include:

Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride). See section "Do not take Paroxetina Aurovitas."
Medicines known to increase the risk of changes in the heart's electrical activity (e.g., the antipsychotics thioridazine or pimozide). See section "Do not take Paroxetina Aurovitas."
Acetylsalicylic acid, ibuprofen, and other medicines called non-steroidal anti-inflammatory drugs (NSAIDs), such as celecoxib, diclofenac, etodolac, and meloxicam, used to treat pain and inflammation.
Tramadol, buprenorphine, and pethidine, painkillers.
- Buprenorphine combined with naloxone, opioid addiction replacement therapy.
Medicines called triptans, such as sumatriptan, used to treat migraine.
Other antidepressants, including other SSRIs 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, and clozapine (antipsychotics) used to treat certain psychiatric conditions.
Fentanyl, used in anesthesia 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 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 heart 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.
Some medicines may increase the side effects of Paroxetina Aurovitas and, in some cases, may cause very serious reactions. Do not take any other medicine while taking Paroxetina Aurovitas without first consulting your doctor, especially:
- Medicines containing buprenorphine. These medicines may interact with Paroxetina Aurovitas and you may experience symptoms such as involuntary rhythmic muscle contractions, including in the muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience these symptoms.

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.

Tell 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.

Taking Paroxetina Aurovitas with food, drinks, and alcohol

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

An increased risk of birth defects, 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 defect. This rate increased to 2 in 100 newborns in mothers who took paroxetine. Your doctor, in consultation 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.

Ensure your midwife or doctor knows you are taking paroxetine.

If you take Paroxetina during 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 you are taking Paroxetina so they can advise you. Medicines like paroxetine may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy, particularly near the end. 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 of pregnancy, 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 cold.
Bluish lips.
Vomiting or difficulty feeding.
Extreme tiredness, trouble 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 consultation with you, may advise continuing breastfeeding while taking paroxetine.

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

Driving and using machines

Some of the adverse effects paroxetine may cause include dizziness, confusion, drowsiness, or blurred vision. If you experience any of these effects, do not drive or operate machinery.

Paroxetina Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult them before taking this medicine.

Paroxetina Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free."

3. How to take Paroxetine Aurovitas

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Sometimes it may be necessary for you to take more than one tablet or half a tablet. The following table will show you how many tablets you should take:

Dosage	Number of tablets to take
10 mg	Half a white tablet
20 mg	One white tablet
30 mg	One blue tablet or one and a half white tablets
40 mg	Two white tablets
50 mg	One blue tablet + one white tablet or two and a half white tablets
60 mg	Two blue tablets or three white tablets

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

	Initial dose	Recommended daily dose	Maximum daily dose
Depression	20 mg	20 mg	50 mg
Obsessive-compulsive disorder	20 mg	40 mg	60 mg
Panic disorder	10 mg	40 mg	60 mg
Social phobia disorder	20 mg	20 mg	50 mg
Post-traumatic stress disorder	20 mg	20 mg	50 mg
Generalized anxiety disorder	20 mg	20 mg	50 mg

Your doctor will tell you what dose to take when you start treatment with paroxetine. 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.

Swallow the tablets with water.

Do not chew the tablets.

Your doctor will determine how long your treatment should last. This period may last 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 liver problems or severe kidney disease, your doctor may decide that you should take lower doses of paroxetine than usual.

If you take more Paroxetina Aurovitas 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 medication 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 the following symptoms: fever, involuntary muscle contractions.

If you forget to take Paroxetina Aurovitas

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 your 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 your 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 require more time. 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, inform your doctor, who will advise you on what to do. Your doctor may have scheduled a follow-up appointment approximately 2 weeks after you started treatment. Inform your doctor if you have not started to feel better.

If you stop taking Paroxetina Aurovitas

Do not stop taking paroxetine unless your doctor tells you to.

When stopping paroxetine treatment, your doctor will instruct you on how to gradually reduce the dose over a period of several weeks or months; this 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 occurring when stopping paroxetine are mild and resolve on their own within two weeks. For others, these symptoms may be more severe or last longer.

If you experience withdrawal effects while stopping your treatment, your doctor may decide that you should stop more slowly. If you experience severe withdrawal symptoms, consult your doctor. Your doctor may advise you to restart treatment and then stop again more gradually.

Even if you experience withdrawal effects, you may still be able to discontinue paroxetine treatment successfully.

Possible withdrawal effects when stopping treatment

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

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

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

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

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 paroxetine.

If you have any other 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 gets 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. You may need to consult your doctor or go to hospital immediately.

Uncommon: may affect up to 1 in 100 people

If you have bruising or unusual bleeding, such as blood in 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: may affect up to 1 in 1,000 people

If you experience seizures (epileptic fits), contact your doctor or go to hospital immediately.
If you feel restless, unable to sit still or remain motionless, you may have a condition called akathisia. Increasing the dose of paroxetine may worsen your symptoms. If you feel this way, consult your doctor.
Tiredness, weakness, or confusion, and you have 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: may affect up to 1 in 10,000 people

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 feel weak or faint, possibly leading to collapse or loss of consciousness, contact your doctor or go to hospital immediately.
If you notice one or more 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 (cannot be estimated from available data)

Some people have experienced thoughts of harming themselves or of suicide while taking paroxetine or shortly after stopping treatment (see Suicidal thoughts and worsening of depression or anxiety disorder in section 2).
Some people have experienced aggression while taking paroxetine.
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see Pregnancy, breastfeeding and fertility in section 2 for more information.

If you experience these adverse effects, contact your doctor.

Other possible adverse effects during treatment:

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

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: may affect up to 1 in 100 people

Transient increases in blood pressure, or transient decreases in blood pressure which 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 uncontrolled and involuntary urination (urinary 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.
- Decreased white blood cell count.

Rare: may affect up to 1 in 1,000 people

Abnormal milk secretion in men and women.
Slowed heart rate.
Liver effects seen in laboratory tests indicating liver function.
Panic attacks.
Very active behaviour or thoughts (mania).
Feeling detached from oneself (depersonalisation).
Anxiety.
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: may affect up to 1 in 10,000 people

Skin rash, in which blisters with a target-like appearance (dark central spots surrounded by a pale area, with a dark ring around it) may appear, known as 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 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) concentration decreases, due to inappropriate chemical signals. Patients with SIADH may feel severely ill or may have no symptoms.
Water or fluid retention (causing swelling of arms or legs).
Sensitivity to sunlight.
Painful and prolonged penile erection.
Decreased platelet count in blood.

Frequency not known (cannot be estimated from available data)

Inflammation of the colon (causing diarrhoea).
Teeth grinding.

Some patients have experienced ringing, buzzing, hissing, tinkling or other persistent noises in the ears (tinnitus) when taking paroxetine.

It has been observed that people taking medicines like paroxetine have an increased risk of bone fractures.

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Aurovitas

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

Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paroxetina Aurovitas

The active substance is paroxetine. Each film-coated tablet contains 30 mg of paroxetine (as paroxetine hydrochloride hemihydrate).
The other components are:

Tablet core: calcium hydrogen phosphate dihydrate, calcium hydrogen phosphate, lactose monohydrate, sodium carboxymethylstarch (Type A) from potato, magnesium stearate.

Tablet coating: titanium dioxide (E171), hypromellose (E464), macrogol 400, indigo carmine aluminium lake (E132), polysorbate 80 (E433).

Appearance of the product and contents of the container

Film-coated blue tablets, modified capsule-shaped, biconvex, marked with “F” on one side and “12” on the other.

Paroxetina Aurovitas film-coated tablets are available in blister packs containing 7, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100 and 250 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in EEA Member States under the following names:

Belgium:	Paroxetine Aurobindo 30 mg film-coated tablets
Spain:	Paroxetine Aurovitas 30 mg film-coated tablets
Malta:	Paroxetine Aurobindo 30 mg film-coated tablets
Portugal:	Paroxetine Aurovitas

Date of the most recent review of this leaflet: March 2024

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