Package Insert: Information for the User

Paroxetine Hydrochloride 20 mg Film-Coated Tablets

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

• Keep this package insert, 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 should not be given 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 package insert. See section 4.

Paroxetina pensa is used for the treatment of depression and/or anxiety disorders in adults.The anxiety disorders for which Paroxetina pensa is indicated are:

• Obsessive-compulsive disorder (repetitive, obsessive thoughts with uncontrolled behavior)
• Panic disorder (including panic attacks 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)
• Generalized anxiety disorder (feeling excessively anxious and nervous)

Paroxetina belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). We all have a substance called serotonin in our brain. People who are depressed or anxious have lower levels of this substance. The exact mechanism of action of Paroxetina pensa 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 Pensa:

• if you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6).
• This medicine contains soy oil. Do not use it if you are allergic to peanuts or soy.

• 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 Paroxetina once you have stopped taking the MAOI.
• if you aretaking an antipsychotic medicinecalled thioridazine or the antipsychotic called pimozide.

if you are in any of these situations, inform your doctor and do not take Paroxetina Pensa.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paroxetina Pensa

• if you are taking other medicines (see the sectionUse of other medicines and Paroxetina Pensa)
• if you are taking tamoxifen for the treatment of breast cancer (or fertility problems). Paroxetina Pensa may make tamoxifen less effective, so your doctor should recommend 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 are being treated with a 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 nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam) or if you are pregnant (see the sectionPregnancy, 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 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 of age)

if you are in any of these situationsand have not yet consulted your doctor, ask your doctor how to take Paroxetina Pensa.

Children and adolescents under 18 years of age

Paroxetina should not be used in the treatment of children and adolescents under 18 years of age. Furthermore, it should be noted that in patients under 18 years of age, there is a higher risk of adverse effects such as suicidal thoughts, suicidal attempts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking paroxetine. However, your doctor may prescribe Paroxetina Pensa to patients under 18 years of age when they decide it is the most appropriate for the patient. If your doctor has prescribed Paroxetina Pensa 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 below appear or worsen when you or your child under 18 years of age is taking paroxetine. The long-term safety of paroxetine in terms of 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-mutilation, 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 discontinuing paroxetine treatment 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 discontinued paroxetine treatment (see the section 3How to take Paroxetina Pensa). 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-mutilation, thoughts and attempts of suicide).

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 take effect, which is usually two weeks but can be longer.

This is more likely to happen

• if you have had thoughts of suicide or self-harm before.
• if you are anadult young person. There is information from clinical trials that shows an increased risk of suicidal behavior in adults under 25 years of age with psychiatric illnesses 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 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 Pensa

Some patients taking Paroxetina Pensa 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 may 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 Paroxetina Pensa, see the section 4Adverse effects,in this leaflet.

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

Other medicines and Paroxetina Pensa

Some medicines may modify the effect of Paroxetina Pensa or make it more likely for adverse effects to occur. Paroxetina Pensa 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 Pensa.
• Medicines called thioridazine or pimozide, which areantipsychotics. See the sectionDo not take Paroxetina Pensa.
• Aspirin, ibuprofen, and other medicines called nonsteroidal 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.
• Fentanil, 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 treatseizures or epilepsy.
• Atomoxetine, a medicine used to treatattention deficit hyperactivity disorder (ADHD).
• Procyclidine, used to relieve 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 totreat breast cancer(orfertility problems).

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

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

Taking Paroxetina Pensa with food, drinks, and alcohol

Do not consume alcohol while taking paroxetine. Alcohol may worsen your symptoms or side effects.

Take your medicine in the morning, preferably with food, which may reduce the likelihood of nausea.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

In some studies, there was an increased risk of malformations, particularly those affecting the heart, in newborns whose mothers took Paroxetina Pensa 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 Paroxetina Pensa. Your doctor, in consultation with you, may change you to another treatment or discontinue Paroxetina Pensa gradually while you are pregnant. However, depending on your circumstances, your doctor may recommend continuing to take Paroxetina Pensa.

Ensure that your doctor or midwife knows that you are taking Paroxetina Pensa. Medicines like Paroxetina Pensa may increase the risk of a serious disease called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy and particularly towards the end 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 Paroxetina Pensa 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 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 baby's health,contact your doctor or midwife, who will advise you.

If you take Paroxetina Pensa in the final stages of pregnancy, there may be a higher risk of excessive 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 Pensa to advise you.

Paroxetina Pensa passes into breast milk in very small amounts.Consult your doctor if you are taking Paroxetina Pensa before starting to breastfeed. Your doctor, in consultation with you, may advise you to continue breastfeeding while taking Paroxetina Pensa.

Animal studieshave shown that paroxetine reduces sperm quality. Theoretically, this may affect human fertility, but this impact has not yet been observed in humans.

Driving and operating machinerySome of the adverse effects that Paroxetina Pensa 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 Pensa 20 mg tablets contain soy.

If you are allergic to peanuts or soy, do not take this medicine.

Paroxetina Pensa 20 mg tablets contain sodium.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Sometimes you may need to take more than one tablet or half a tablet. The following table will show you how many tablets to take:

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

Your doctor will tell you what dose to take when starting treatment with Paroxetine pensa.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 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 tablets should not be chewed.

The tablet can be divided into equal halves.

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 any kidney or liver disease, your doctor may advise you to take smaller doses of paroxetine than usual.

If you take more Paroxetine pensa than you should

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.

Do not take more tablets than your doctor has recommended.

A person who has taken an overdose of Paroxetine pensa may have some of the symptoms listed in section 4, Possible side effects, or some of the following symptoms: fever, involuntary muscle contraction.

If you forgot to take Paroxetine pensa

Take your medication at the same time every day.

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

If you remember 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 pensa 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 do not 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 after 2 weeks of starting treatment.

If you interrupt treatment with Paroxetine pensa

Do not interrupt treatment until your doctor tells you to.

When interrupting 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 dose of Paroxetine pensa you are taking by 10 mg each week. Most people consider the possible symptoms that occur when treatment with Paroxetine pensa 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 will be able to interrupt treatment with Paroxetine pensa.

Withdrawal symptoms when interrupting treatment

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

Common side effects (may affect up to 1 in 10 people)

- Feeling dizzy, unstable, or experiencing balance disturbances

• 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.
• Anxiety.

- Headaches.

Uncommon side effects (may affect up to 1 in 100 people)

• Nausea (vomiting).
• Sweating (including excessive sweating)
• Restlessness or agitation.
• Tremors.
• Confusion or disorientation.
• Diarrhea (soft stools).
• Feeling very sensitive or irritable.
• Visual disturbances.
• Palpitations (rapid or strong heartbeats).

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

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.

Side effects that are not common (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 experience difficulty urinating, contact your doctor or go to the hospital immediately.

Side effects that are rare (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 feel restless, unable to sit or stay still, known as akathisia. Increasing the dose of Paroxetine may worsen your symptoms. If you feel this way, consult your doctor.
• Feeling tired, weak, confused, and painful, stiff, and lack of muscle coordination. This may be due to low sodium levels in the blood. If you have these symptoms, consult your doctor.

Side effects that are 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 feeling weak or having a dizziness that can cause a collapse or loss of consciousness, contact your doctor or go to the hospital immediately.

• If you notice any of the following symptoms, you may be experiencing a serotonin syndrome or malignant neuroleptic syndrome. Symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, trembling, chills, hallucinations (strange sounds or visions), muscle rigidity, sudden and rapid movements, or rapid heartbeat. 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 (cannot be estimated from available data)

• Some people have experienced thoughts of self-harm or suicide while taking Paroxetine or shortly after stopping treatment (see section 2 What you need to know before starting to take Paroxetine).
• Aggression.

Other possible side effects during treatment:

Side effects that are very common (may affect more than 1 in 10 people)

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

Side effects that are common (may affect up to 1 in 10 people)

• 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.

Side effects that are not common (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).
• Difficulty urinating (urinary retention) or 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.
• Decreased white blood cell count.

Side effects that are rare (may affect up to 1 in 1,000 people)

• Abnormal secretion of breast milk in men and women.
• Decreased heart rate.
• Liver damage that is seen in laboratory tests that indicate liver function.
• Panic attacks.
• Very active behaviors or thoughts (mania).
• 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).

Side effects that are very rare (may affect up to 1 in 10,000 people)

• Skin rash, with small, round, red spots (petechiae) or small, round, red spots with a white center (urticaria), or widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Widespread rash with blisters and peeling of the skin (toxic epidermal necrolysis). Yellowing of the skin or white of the eyes due to liver damage.

• Water retention or fluid accumulation that causes swelling of the arms or legs.
• Sensitivity to sunlight.

• Decreased platelet count in the blood.
• Prolonged and painful erection of the penis.

Frequency not known (cannot be estimated from available data)

• Grinding of teeth.
• Inflammation of the colon (causing diarrhea).
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see section “Pregnancy, breastfeeding, and fertility” for more information.

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

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 Medicines for Human Use:https://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 out of sight and reach of children.

Do not use Paroxetina Pensa after the expiration date CAD that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines that you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Paroxetina Pensa 20 mg tablets

• The active ingredient is paroxetine anhydrous (as hydrochloride). Each tablet contains 20 mg of paroxetine.
• The other components are: magnesium stearate, sodium starch glycolate (from potato), mannitol (E-421), microcrystalline cellulose, polymethacrylate, partially hydrogenated polyvinyl alcohol, titanium dioxide (E-171), talc, soy lecithin (E-322), xanthan gum (E-415).

Appearance of the product and content of the packaging

Paroxetina Pensa 20 mg is presented in the form of coated tablets, oblong, biconvex, white or grayish-white, and scored. Each package contains 14, 28, 56 or 500 tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Labiana Pharmaceuticals, S.L.U.

Casanova 27-31

08757 Corbera de Llobregat (Spain)

or

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses, 2 (Alcobendas)

28108 Madrid (Spain)

Last review date of this leaflet: November 2023

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