Paroxetine Pensa 20 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paroxetina Pensa 20 mg film-coated tablets EFG

Read the entire 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 must not be given 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 or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

What Paroxetina Pensa 20 mg tablets are and what they are used for
What you need to know before taking Paroxetina Pensa 20 mg tablets
How to take Paroxetina Pensa 20 mg tablets
Possible side effects
How to store Paroxetina Pensa 20 mg tablets
Contents of the pack and other information

1. What PAROXETINE PENSA 20 mg TABLETS is and what it is used for

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

Obsessive-compulsive disorder (obsessive, repetitive thoughts with uncontrollable behavior)
Panic disorder (panic attacks, including those caused by agoraphobia, which is fear of open spaces)
Social anxiety disorder (fear of or avoidance of social contact situations)
Post-traumatic stress disorder (anxiety caused by a traumatic event)
Generalized anxiety disorder (persistently feeling excessive anxiety and nervousness).

Paroxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). In the brain, all of us have a substance called serotonin. People who are depressed or have anxiety have lower levels of this substance. The precise mechanism of action of Paroxetine pensa and other SSRIs is not fully understood, but they work by increasing the level of serotonin in the brain. Proper treatment of depression or anxiety disorders is important to help you feel better.

2. What you need to know before taking PAROXETINE PENSA 20 mg TABLETS

Do not take Paroxetine Pensa:

If you are allergic to paroxetine or to any of the other ingredients of this medicine (listed in section 6).
This medicine contains soya oil. It should not be used if you are allergic to peanuts or soya.
If you are being treated with medicines called monoamine oxidase inhibitors (MAOIs), including moclobemide and methylene blue chloride (methylene blue), or if you have been treated with any of these medicines within the last two weeks. Your doctor will advise you on how to start taking Paroxetine after stopping the MAOI.
If you are taking the 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 Pensa.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Paroxetine Pensa:

if you are taking other medicines (see section Other medicines and Paroxetine Pensa)
if you are taking tamoxifen for the treatment of breast cancer (or fertility problems). Paroxetine Pensa may make tamoxifen less effective, so your doctor should recommend taking another antidepressant
if you have any kidney, liver, or heart problems
if you have epilepsy or experience seizures or epileptic fits
if you have had manic episodes (excessively active thoughts or behavior)
if you are receiving electroconvulsive therapy (ECT)
if you are prone to bleeding or bruising, or are taking any medicine that may increase the risk of bleeding (including medicines such as warfarin (acenocoumarol), antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines used to treat pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam), or if you are pregnant (see section 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 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 of age)

If you are in any of these situations and have not yet consulted your doctor**, ask them about how to take Paroxetine Pensa.**

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. Furthermore, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking paroxetine. Nevertheless, your doctor may prescribe Paroxetine Pensa to patients under 18 years of age if they consider it appropriate. If your doctor has prescribed Paroxetine Pensa for you or your child under 18 years of age and you wish to discuss this decision, consult your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while you or your child under 18 years of age is taking paroxetine. The long-term effects of paroxetine on safety regarding growth, maturation, and cognitive and behavioral development in this age group have not yet been established.

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

When discontinuing treatment with paroxetine, some patients under 18 years of age reported withdrawal symptoms in these studies. These symptoms were very similar to those observed in adults discontinuing paroxetine treatment (see section 3 How to take Paroxetine Pensa). In addition, patients under 18 years of age frequently experienced (affecting fewer than 1 in 10) stomach pain, nervousness, and emotional instability (including crying, mood swings, 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 suicidal thoughts or thoughts of self-harm.
If you are a young adult. Clinical trial data show an increased risk of suicidal behavior in psychiatric patients under 25 years of age who are being treated with an antidepressant.

If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go to 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 may also ask them to inform you 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 Pensa

Some patients taking Paroxetine Pensa develop a condition called akathisia and feel restless and unable to sit still or remain still. 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. The condition 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 Pensa, see section 4 Possible adverse effects in this leaflet.

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

Other medicines and Paroxetine Pensa

Some medicines may alter the effect of Paroxetine Pensa or make certain adverse effects more likely. Paroxetine Pensa may also alter the effect of some medicines. For example:

Medicines called monoamine oxidase inhibitors (MAOIs), including moclobemide and methylene blue chloride (methylene blue). See section Do not take Paroxetine Pensa.
The medicines called thioridazine or pimozide, which are antipsychotics. See section Do not take Paroxetine Pensa.
Acetylsalicylic acid, ibuprofen, and other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, etodolac, diclofenac, and meloxicam, used to treat pain and inflammation.
Tramadol and pethidine, analgesics.
Medicines called triptans, such as sumatriptan, used to treat migraine.
Other antidepressants, including other selective serotonin reuptake inhibitors and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
A dietary supplement called tryptophan.
Mivacurium and suxamethonium (used in anesthesia).
Medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat certain psychiatric disorders.
Fentanyl, used in anesthesia or to treat chronic pain.
A combination of fosamprenavir and ritonavir, used to treat human immunodeficiency virus (HIV) infection.
St. John's wort, a herbal remedy 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 tremor, especially in Parkinson's disease.
Warfarin and other medicines (called anticoagulants) used to thin the blood.
Propafenone, flecainide, and medicines used to treat cardiac rhythm disorders.
Metoprolol, a beta-blocker used to treat high blood pressure and heart disorders.
Pravastatin, used to treat high cholesterol.
Rifampicin, used to treat tuberculosis (TB) and leprosy.
Linezolid, an antibiotic.
Tamoxifen, used to treat breast cancer (or fertility problems).

If you are taking or have recently taken any of these medicines, 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 Paroxetine Pensa with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Some studies have shown an increased risk of birth defects, particularly those affecting the heart, in newborns whose mothers took Paroxetine Pensa during the first months of pregnancy. In the general population, approximately 1 in every 100 newborns is born with a heart defect. This rate increased to 2 in every 100 newborns in mothers who took Paroxetine Pensa. Your doctor, in agreement with you, may switch you to another treatment or gradually discontinue Paroxetine Pensa during pregnancy. However, depending on your circumstances, your doctor may recommend continuing Paroxetine Pensa.

Ensure that your doctor or midwife knows you are taking Paroxetine Pensa. Medicines such as Paroxetine Pensa may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy, particularly towards 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 are taking Paroxetine Pensa 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 too cold.
Bluish lips.
Vomiting or feeding difficulties.
Extreme tiredness, difficulty 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 for advice.

Taking Paroxetine Pensa late in pregnancy may increase the risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Paroxetine Pensa so they can advise you.

Paroxetine Pensa passes into breast milk in very small amounts. Consult your doctor if you are taking Paroxetine Pensa before starting breastfeeding. Your doctor, in agreement with you, may advise continuing breastfeeding while taking Paroxetine Pensa.

Animal studies have shown that paroxetine reduces sperm quality. Theoretically, this may affect fertility in humans, but this effect has not yet been observed in people.

Driving and use of machines Some of the adverse effects that Paroxetine Pensa may cause include dizziness, confusion, drowsiness, or blurred vision. If you experience any of these effects, do not drive or operate machinery.

Paroxetine Pensa 20 mg tablets contain soya.

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

Paroxetine Pensa 20 mg tablets contain sodium.

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

3. HOW TO TAKE PAROXETINE PENSA 20 mg TABLETS

Follow exactly the dosing instructions for this medicine as prescribed 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:

Dosage	Number of tablets to take
10 mg	Half a tablet
20 mg	One tablet
30 mg	One and a half tablets
40 mg	Two tablets
50 mg	Two and a half tablets
60 mg	Three tablets

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

	Initial daily 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 Paroxetina Pensa. 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.

The tablet may be divided into equal halves.

Your doctor will determine how long your treatment should last. This period may extend 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 a kidney or liver disease, your doctor may advise you to take lower doses of paroxetine than usual.

If you take more Paroxetina Pensa than you should

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.

Never take more tablets than your doctor has recommended.

A person who has taken an overdose of Paroxetina Pensa may experience some of the symptoms listed in section 4, Possible side effects, or any of the following symptoms: fever, involuntary muscle contractions.

If you forget to take Paroxetina Pensa

Take your medication at the same time each day.

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

Do not take a double dose to make up for a missed dose.

What to do if you do not feel better

Paroxetina Pensa will not improve your symptoms immediately; all antidepressants take some time to work. Some people begin to feel better after a couple of weeks, but others may require more time. Some people taking antidepressants may feel worse before they start to feel better. If you do not start 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 two weeks after you started treatment.

If you stop treatment with Paroxetina Pensa

Do not stop treatment until your doctor tells you to do so.

When stopping treatment with paroxetine, your doctor will advise you on how to gradually reduce the dose over several weeks or months. This will help reduce the risk of experiencing withdrawal symptoms. One way to do this is to gradually reduce your dose of Paroxetina Pensa by 10 mg each week. Most people find that any withdrawal symptoms they experience are mild and disappear on their own within two weeks. For others, these symptoms may be more severe or last longer.

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

Even if you experience withdrawal symptoms, you may still be able to stop treatment with Paroxetina Pensa.

Possible withdrawal symptoms when stopping treatment

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

Frequent adverse effects (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, hissing, or other persistent noises in the ears (tinnitus)
- Sleep disturbances
- Anxiety
Headaches

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

Nausea (vomiting)
Sweating (including excessive sweating)
Restlessness or agitation
Tremor
Confusion or disorientation
Diarrhea (loose stools)
Feeling overly sensitive or irritable
Visual disturbances
Rapid or strong heartbeats (palpitations)

Consult your doctor if you are concerned about withdrawal effects from Paroxetina Pensa.

If you have any further 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 will experience 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 following adverse effects during treatment with paroxetine

You may need to consult your doctor or go to hospital immediately.

Uncommon adverse effects (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 adverse effects (may affect up to 1 in 1,000 people):

If you experience seizures (epileptic fits), contact your doctor or go to hospital immediately.
Feeling restless, unable to sit still or remain motionless, known as akathisia. Increasing the dose of Paroxetina pensa may worsen your symptoms. If you feel this way, consult your doctor.
Tiredness, weakness, confusion, and pain, stiffness, and lack of muscle coordination. This may be due to low sodium levels in the blood. If you have these symptoms, consult your doctor.

Very rare adverse effects (may affect up to 1 in 10,000 people)

Allergic reactions to Paroxetina pensa which may be severe.

If you develop a skin rash with redness and lumps, swelling of the face, eyelids, lips, mouth or tongue, itching, difficulty breathing (shortness of breath) or swallowing, and feeling weak or faint, which may lead to collapse or loss of consciousness, contact your doctor or go to hospital immediately.

If you notice any or all 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 self-harm or suicide while taking Paroxetina pensa or shortly after stopping treatment (see section 2 What you need to know before taking Paroxetina pensa).
Aggressiveness.

Other possible adverse effects during treatment:

Very common adverse effects (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 adverse effects (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 adverse effects (may affect up to 1 in 100 people)

Transient increases or decreases in blood pressure, which may cause dizziness or fainting when standing up quickly.
Faster than normal heartbeats.
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 urinary incontinence (uncontrolled and involuntary urination).
If you are a diabetic patient, you may notice loss of control of blood sugar levels while taking paroxetine. Consult your doctor about how to adjust your insulin or diabetes medication dose.
Decreased white blood cell count.

Rare adverse effects (may affect up to 1 in 1,000 people)

Abnormal breast milk secretion in men and women.
Slowed heart rate.
Liver effects seen in laboratory tests indicating liver function.
Panic attacks.
Excessively active behaviours 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 adverse effects (may affect up to 1 in 10,000 people)

Skin rash, in which blisters may appear with a target-like appearance (dark central spots surrounded by a pale area, with a dark ring around it), known as 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 body surface with blisters and skin peeling (toxic epidermal necrolysis). Liver disturbances causing yellowing of the skin or whites of the eyes.
Fluid retention causing swelling of arms or legs. Sensitivity to sunlight.
Decreased platelet count in blood.
Painful and prolonged penile erection.

Frequency not known (cannot be estimated from available data)

Teeth grinding (bruxism)
Inflammation of the colon (causing diarrhoea)
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section “Pregnancy, breastfeeding and fertility” for more information.

Some patients have experienced ringing, buzzing, whistling, tinkling or other persistent noises in the ears (tinnitus) while taking Paroxetina.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of PAROXETINE PENSA 20 mg TABLETS

No special storage conditions required.

Keep out of the sight and reach of children.

Do not use Paroxetine Pensa after the expiry date (EXP) shown on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paroxetina Pensa 20 mg tablets

The active substance is anhydrous paroxetine (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 contents of the pack

Paroxetina Pensa 20 mg is presented as film-coated tablets, oblong, biconvex, white or greyish-white, and scored. Each pack contains 14, 28, 56 or 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Labiana Pharmaceuticals, S.L.U.

Casanova 27-31

08757 Corbera de Llobregat (Spain)

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses, 2 (Alcobendas)

28108 Madrid (Spain)

Date of the most recent revision of this leaflet: November 2023

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