Prospect: Information for the user

Paroxetina Aurovitas 20 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

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

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

2.What you need to know before starting to take Paroxetina Aurovitas

3.How to take Paroxetina Aurovitas

4.Possible adverse effects

5.Storage of Paroxetina Aurovitas

6.Contents of the package and additional information

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 (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).

Paroxetine belongs to a group of medications called selective serotonin reuptake inhibitors (SSRIs). The exact mechanism of action of paroxetine and other SSRIs is not precisely known, but they exert their action by increasing the level of serotonin in the brain. Properly treating depression or anxiety is important to help you feel better.

Do not take Paroxetina Aurovitas

•If you are allergic to paroxetine or any of the other components of this medication (listed in section 6).

•Ifyou are taking medications called monoamine oxidase inhibitors (MAOIs, including moclobemide and methionine chloride (methylen blue)), or have taken them in the last two weeks. Your doctor will advise you on how to start taking paroxetine once you have stopped taking the MAOI.

•Ifyou are taking a psychiatric medication 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

Consult your doctor or pharmacist before starting to take Paroxetina Aurovitas.

•If you are taking other medications (see the sectionOther medications and Paroxetina Aurovitas).

•If you are taking tamoxifen for breast cancer treatment or fertility problems. Paroxetine may make tamoxifen less effective, so your doctor may recommend taking another antidepressant.

• If you have a heart rhythm abnormality known as QT interval prolongation after an electrocardiogram (ECG).
• If you have a family history of QT interval prolongation, heart disease such as heart failure, low heart rate, or low levels of potassium or magnesium.

•If you have any kidney, liver, or heart problems.

•If you have epilepsy or a history of 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 history of bleeding disordersor if you are pregnant (see “Pregnancy, breastfeeding, and fertility”)or taking other medications that may increase the risk of bleeding (these include medications used to make blood thinner such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, pain and inflammation medications called nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam).

•If you have diabetes.

•If you are on a low-sodium diet.

•If you have glaucoma (elevated eye pressure).

•If you are pregnant or think you may become pregnant (see the sectionPregnancy, breastfeeding, and fertility).

•If you are under 18 years old (see the sectionChildren and adolescents under 18 years).

• If you are taking medications that contain buprenorphine. The use of these medications with Paroxetina Aurovitas may lead to serotonin syndrome, a potentially fatal condition (see “Taking Paroxetina Aurovitas with other medications”).

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

Children and adolescents under 18 years

Paroxetine should not be used in the treatment of children and adolescents under 18 years.Furthermore, in patients under 18 years, there is a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking paroxetine. If your doctor has prescribed paroxetine to you (or your child) and you wish to discuss this decision, consult your doctor. Inform your doctor if any of the symptoms mentioned above appear or worsen when you (or your child) are taking paroxetine. Additionally, the long-term safety effects of paroxetine on growth, maturation, and cognitive and behavioral development in this age group have not yet been demonstrated.

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

In these studies, some patients under 18 years reported experiencing withdrawal effects when stopping paroxetine treatment. These effects were very similar to those observed in adults who stopped taking paroxetine (see section 3). Additionally, patients under 18 years frequently experienced (affecting less than 1 in 10), stomach pain, nervousness, and unstable emotions (including crying, mood changes, self-harm, suicidal thoughts and attempts).

Suicidal thoughts and worsening of depression or anxiety

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 medications take time to become effective, which is usually two weeks but can be longer in some cases.

This 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 adults under 25 years with psychiatric disorders being treated with some antidepressants.

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 friend that 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 paroxetine

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 neuroleptic malignant syndrome, and may have one or more 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, involuntary 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.

Some medications in the group to which paroxetine belongs (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Other medications and Paroxetina Aurovitas

Some medications may modify the effect of paroxetine or make some adverse effects more likely. Paroxetine may also modify the effect of some medications. These include:

•Medications calledmonoamine oxidase inhibitors(MAOIs, including moclobemide and methionine chloride (methylen blue)). See the sectionDo not take Paroxetina Aurovitas.

•Medications known to increase the risk of changes in heart rhythm activity (e.g. theantipsychoticsthioridazine or pimozide). See the sectionDo not take Paroxetina Aurovitas.

•Aspirin, ibuprofen, and other medications called nonsteroidal anti-inflammatory drugs, such as celecoxib, diclofenac, etodolac, and meloxicam, used to treatpain and inflammation.

•Tramadol, buprenorphine, and pentazocine,analgesics.

• Buprenorphine combined with naloxone, treatment for opioid addiction.

•Medications called triptans, such as sumatriptan, used to treatmigraine.

•Otherantidepressants, including other SSRIs and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.

•Adietary supplementcalled tryptophan.

•Mivacurium and suxamethonium (used in anesthesia).

•Medications such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat somepsychiatric disorders.

•Fentanyl, used inanesthesiaor to treatchronic pain.

•A combination of fosamprenavir and ritonavir, used to treatHIV infection.

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

•Phenobarbital, phenytoin,valproate sodium, or carbamazepine, used to treatseizuresorepilepsy.

•Atomoxetine, a medication used to treatattention deficit hyperactivity disorder (ADHD)(ADHD).

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

•Warfarin and other medications (called anticoagulants) used tothin the blood.

•Propafenone, flecainide, and medications used to treatheart rhythm disorders.

•Metoprolol, a beta-blocker used to treathigh blood pressure andheart disorders.

•Pravastatin, used to treathigh cholesterol.

•Rifampicin, used to treattuberculosis (TB)(TB)andleprosy.

•Linezolid, anantibiotic.

•Tamoxifen, used to treatbreast cancerorfertility problems.

•Some medications may increase the adverse effects ofParoxetina Aurovitasand in some cases may cause severe reactions. Do not take any other medication while takingParoxetina Aurovitaswithout first consulting your doctor, especially:

• medications that contain buprenorphine. These medications may interact with Paroxetina Aurovitas and you may experience symptoms such as involuntary muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, temperature above 38 °C. Contact your doctor if you experience these symptoms.

?If you are taking or have recently taken any of these medications, inform your doctor and consult what to do.You may need to change the dose or have your doctor prescribe another medication.

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

Taking Paroxetina Aurovitas with food, drinks, and alcohol

Do not consume alcohol while taking Paroxetina. Alcohol may worsen your symptoms or adverse effects. Taking Paroxetina 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 medication.

There has been an observed increase in the risk of malformations, particularly those affecting the heart, 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 gradually discontinue paroxetine while pregnant. However, depending on your circumstances, your doctor may recommend continuing to take paroxetine.

Make sure your midwife or doctor knows that you are taking paroxetine.

If you take Paroxetina in the final stages of pregnancy, there may be an increased risk of excessive vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Paroxetina to advise you. Medications like paroxetine may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy and particularly in the final stages. The pressure in the blood vessels between the heart and lungs is very high in newborns with persistent pulmonary hypertension (PPHN).

If you take paroxetine in the last trimester of pregnancy,your newborn may also experience other symptoms that usually begin within the first 24 hours after birth. These symptoms include:

-Difficulty breathing.

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

-Blue lips.

-Vomiting or difficulty feeding.

-Feeling extremely 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 sperm quality. Theoretically, this may affect fertility, but this impact on fertility has not yet been observed in humans.

Driving and operating machinery

Some of the adverse effects that paroxetine may cause are dizziness, confusion, feeling drowsy, or blurred vision. If you experience any of these effects, do not drive vehicles or operate machinery.

Paroxetina Aurovitas contains lactose

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

Paroxetina Aurovitas contains sodium

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

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

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

Swallow the tablets with water.

Do not chew the tablets.

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

Older people

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

Patients with kidney or liver problems

If you have liver problems or a severe kidney disease, your doctor may decide that you take lower doses of paroxetine than usual.

If you take more Paroxetina Aurovitas than you should

Never take more tablets than your doctor has recommended.If you have taken an overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone91 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 section 4,Adverse reactions,or the following symptoms: fever, involuntary muscle contraction.

If you forget to take Paroxetina Aurovitas

Take your medication at the same time every day.

If you remember to take a dose and it is before bedtime, take it immediately. Take the next dose at the usual time.

If you remember to take a dose during the night or the next day, omit 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 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 act. Some people start to feel better after a couple of weeks, but others may need more time. Some people who take antidepressants feel worse before they start to notice 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 2 weeks of starting treatment. Inform your doctor if you haven't started to feel better.

If you interrupt treatment with Paroxetina Aurovitas

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

When you stop treatment with paroxetine, your doctor will tell you how to gradually reduce the dose over a period of several weeks or months; this will help reduce the risk of withdrawal symptoms. One way to do this is to gradually reduce the dose ofparoxetineyou are taking by 10 mg each week. Most people consider the possible symptoms that occur when stopping treatment withparoxetineto 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 stopping treatment, your doctor may decide to stop treatment more slowly. If you experience severe withdrawal symptoms, consult your doctor. Your doctor may advise you to start treatment again and then stop it more slowly.

You can still stop treatment with paroxetine even if you experience withdrawal symptoms.

Withdrawal symptoms when stopping treatment

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

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

•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 (very vivid dreams, nightmares, inability to sleep).

•Anxiety.

•Headaches.

Rare adverse effects, which can affect up to 1 in 100 people:

•Nausea.

•Sweating (including night sweats).

•Restlessness or agitation.

•Trembling.

•Confusion or disorientation.

•Diarrhea (soft stools).

•Feeling very sensitive or irritable.

•Visual disturbances.

•Palpitations.

Consult your doctor if you are concerned about withdrawal symptoms from paroxetine.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications,this medicationmay 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 listed below. You may need to see your doctor or go to the hospital immediately.

Rare: may affect up to 1 in 100 people

•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 have difficulty urinating, contact your doctor or go to the hospital immediately..

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

•If you experience seizures (epileptic crises), contact your doctor or go to the hospital immediately..

•If you have restlessness, inability to sit or stay still,you may have something called akathisia. Increasing the dose of paroxetine may worsen your symptoms. If you feel this way, see your doctor.

•Fatigue, weakness, or confusion and have 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: may affect up to 1 in 10,000 people

•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 or all of the following symptoms,you may be experiencing aserotonin syndrome or malignant neuroleptic syndrome.The symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremors, chills, hallucinations (strange sounds or visions), muscle rigidity, sudden, rapid movements, or rapid heartbeats. 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..

Frequency not known (cannot be estimated from available data)

•Some people have experienced thoughts of self-harm or suicide while taking paroxetine or shortly after stopping treatment (seeThoughts of suicide and worsening of depression or anxiety disorderin section 2).

•Some people have experienced aggression while taking paroxetine.

• Excessive vaginal bleeding shortly after delivery (postpartum hemorrhage), seePregnancy, lactation, and fertilityin section 2 for more information.

If you experience these side effects, contact your doctor.

Other possible side effects during treatment:

Very common: may affect more than 1 in 10 people

•Unpleasant feeling (nausea). This side effect may decrease 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.

Common: may affect up to 1 in 10 people

•Increased levels of cholesterol in the blood.

•Decreased 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.

Uncommon: may affect up to 1 in 100 people

•Transient increases in blood pressure, or transient decreases that may cause dizziness or fainting when standing up quickly.

•Abnormal heartbeats.

•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 and uncontrollable 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 adjusting 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.

•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 urge to move the legs (Restless Legs Syndrome).

•Muscle or joint pain.

•Increased levels of a hormone called prolactin.

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

Very rare: may affect up to 1 in 10,000 people

•Skin rash, in which small, round, red spots (petechiae) may appear, called erythema multiforme.

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

•Widespread rash over a large area of the body with blisters and peeling of the skin (toxic epidermal necrolysis).

•Liver damage that turns the skin or the white of the eyes yellow.

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

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

•Sensitivity to sunlight.

•Prolonged and painful erection of the penis.

•Decreased platelet count in the blood.

Frequency not known (cannot be estimated from available data)

•Inflammation of the colon (which causes diarrhea).

•Grinding of teeth.

Some patients have experienced persistent ringing, buzzing, hissing, or other sounds 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 of side effects

If you experience any type of side effect, consult 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 Vigilance of Medicinal Products for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Paroxetina Aurovitas

-The active ingredient is paroxetine. Each film-coated tablet contains 20 mg of paroxetine (as paroxetine hydrochloride hemihydrate).

-The other components are:

Tablet core:calcium dihydrogen phosphate, calcium hydrogen phosphate, lactose monohydrate, sodium carboxymethyl starch (Type A) from potato, magnesium stearate.

Film coating:titanium dioxide (E171), hypromellose (E464), macrogol 400, polysorbate 80 (E433).

Appearance of the product and contents of the package

Film-coated tablets of white or off-white color, in the form of modified capsule-shaped, biconvex tablets, with the mark “56” on one face and “C” and a notch on the other. The tablet can be divided into equal doses.

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the EEA member states under the following names:

Last review date of this leaflet: March 2024

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