Paroxetine Kern Pharma 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Paroxetina Kern Pharma 20 mg film-coated tablets EFG

Paroxetine (as hemihydrochloride)

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

• Keep this leaflet. 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 they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Paroxetina Kern Pharma is and what it is used for
2. What you need to know before taking Paroxetina Kern Pharma
3. How to take Paroxetina Kern Pharma
4. Possible side effects
5. How to store Paroxetina Kern Pharma
6. Contents of the pack and other information

1. What Paroxetina Kern Pharma is and what it is used for

Paroxetina Kern Pharma 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 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 situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (persistently feeling excessive anxiety and nervousness).

Paroxetina Kern Pharma 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 starting to take Paroxetina Kern Pharma

Do not take Paroxetina Kern Pharma

• if you are being treated with medicines called monoamine oxidase enzyme 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 an antipsychotic medicine called thioridazine or the antipsychotic called pimozide
• if you are allergic to paroxetine or to any of the other components of this medicine (listed in section 6)

If you are in any of these situations, inform your doctor and do not take Paroxetina Kern Pharma.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Paroxetina Kern Pharma:

• if you are taking other medicines (see section Other medicines and Paroxetina Kern Pharma)

• if you are taking tamoxifen for the treatment of breast cancer (or fertility problems). Paroxetine may make tamoxifen less effective, so your doctor should recommend 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, low heart rate, or low levels of potassium or magnesium

• if you have epilepsy or experience seizures or epileptic fits

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

• 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 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 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 Paroxetina Kern Pharma.

Children and adolescents

Paroxetine should not be used to treat children and adolescents under 18 years of age. You should also be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking paroxetine. Nevertheless, your doctor may prescribe paroxetine to patients under 18 years of age if they consider it the most appropriate treatment. If your doctor has prescribed paroxetine to you or to 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 described above appear or worsen while you or your child under 18 years of age are 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 of paroxetine in patients under 18 years of age, the following common adverse effects (affecting less than 1 in 10 children or adolescents) were reported: increased suicidal thoughts and attempts, self-harm attempts, hostile, aggressive, or unfriendly behaviors, loss of appetite, tremors, abnormal sweating, hyperactivity (excessive energy), agitation, emotional instability (including crying and mood changes), and unexplained bruising or bleeding (such as nosebleeds). These effects were also observed, although less frequently, in patients in these studies who did not take paroxetine.

When stopping treatment with paroxetine, some patients under 18 years of age in these studies reported withdrawal-related adverse effects. These effects were very similar to those observed in adults who stopped taking paroxetine (see section 3). In addition, patients under 18 years of age frequently experienced (affecting less than 1 in 10) stomach pain, nervousness, and emotional instability (including crying, mood changes, self-harm attempts, and suicidal thoughts and attempts).

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 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.
• If 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 antidepressants.

If at any time you have thoughts of harming yourself or committing suicide, contact 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 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

Some patients taking paroxetine develop a condition called akathisia, feeling restless and unable to sit still or remain seated. Other patients develop 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 jerking movements, or increased heart rate. Severity may increase and lead to loss of consciousness. Contact your doctor if you experience any of these symptoms. For more information on this or other adverse effects of Paroxetina Kern Pharma, see section 4.

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

Other medicines and Paroxetina Kern Pharma

Some medicines may alter the effect of Paroxetina or make certain adverse effects more likely. Paroxetine 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 Paroxetina Kern Pharma.
• Medicines known to increase the risk of changes in the electrical activity of the heart (e.g., the antipsychotics thioridazine or pimozide). See section Do not take Paroxetina Kern Pharma.
• 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, buprenorphine, and pethidine, analgesics.
• Buprenorphine combined with naloxone, a substitution treatment for opioid addiction.
• 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 conditions.
• 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 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).

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 Kern Pharma with food, drink 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 occurring.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 Paroxetina during the first months of pregnancy. In the general population, approximately 1 out of every 100 newborns is born with a heart malformation. This rate increased to 2 out of every 100 newborns in mothers who took Paroxetina. Your doctor, in agreement with you, might switch you to another treatment or gradually discontinue Paroxetina treatment during pregnancy. However, depending on your individual circumstances, your doctor may recommend continuing Paroxetina.

Make sure your doctor or midwife knows that you are taking Paroxetine. If you take Paroxetine in 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 that you are taking Paroxetine so they can advise you accordingly. Medicines such as Paroxetine may increase the risk of developing a serious condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy, particularly in the later stages. The pressure in the blood vessels going between the heart and the lungs is very high in newborns with persistent pulmonary hypertension (PPHN).

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

• difficulty breathing

- blue-colored skin or appearance of being too hot or too cold

• blue lips

• vomiting or difficulties with food intake

• feeling very tired, difficulty sleeping, or frequent crying

- muscle stiffness or weakness

• tremors, localized shaking 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 breastfeeding. Your doctor, together with you, may advise you to continue breastfeeding while taking Paroxetine.

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

Driving and use of machinery

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

Paroxetine Kern Pharma contains sodium

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

3. How to take Paroxetine Kern Pharma

Follow exactly the instructions for taking Paroxetine Kern Pharma as given by your doctor. If you have any doubts, 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 you should take:

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

Your doctor will tell you what dose to take when you start treatment with Paroxetina Kern Pharma. 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.

The tablets should be swallowed with water.

The tablets must not be chewed.

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 renal or hepatic impairment

If you have severe liver or kidney impairment, your doctor may advise you to take lower doses of Paroxetina than usual.

If you take more Paroxetina Kern Pharma 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 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 Kern Pharma

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 the usual time.

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

What to do if you do not feel better

Paroxetina 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 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 Kern Pharma

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

When stopping treatment with Paroxetina, your doctor will instruct you on 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 your current dose of Paroxetina by 10 mg each week. Most people find that any potential symptoms occurring when stopping Paroxetina 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 effects while stopping treatment, your doctor may decide that you should stop more slowly. If you experience severe withdrawal symptoms, please consult your doctor. They may advise you to restart treatment and then stop more gradually.

Even if you experience withdrawal effects, you may still be able to discontinue treatment with Paroxetina.

Possible withdrawal effects when stopping treatment

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

Frequent adverse effects

May affect up to 1 in 10 people

• Feeling dizzy, unsteady, or having 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 (very vivid dreams, nightmares, inability to sleep).
• Anxiety.
• Headaches.

Uncommon adverse effects

May affect up to 1 in 100 people

• Nausea (vomiting).
• 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 Paroxetina Kern Pharma

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

4. Possible adverse effects

Like all medicines, Paroxetine Kern Pharma may produce adverse effects, although not everyone experiences 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 during treatment with Paroxetine Kern Pharma.

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 unusual bruising or 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.
• If you feel restlessness or an inability to sit still or remain motionless, known as akathisia. Increasing the dose of Paroxetine may worsen your symptoms. If you feel this way, consult your doctor.
• Tiredness, weakness, confusion, and pain, stiffness, or lack of coordination in muscles. 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 Paroxetine, which can be serious. If you develop a rash with redness and lumps, swelling of the face, eyelids, lips, mouth or tongue, itching, difficulty breathing (shortness of breath) or swallowing, or feel weak or faint, possibly leading 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, trembling, chills, hallucinations (strange sounds or visions), muscle stiffness, 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 (frequency 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 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 adverse effects (may affect more than 1 in 10 people)

• Feeling unwell (nausea). This effect may be reduced by taking your medication 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 cholesterol levels in blood.
• 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 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.
• 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 adjusting your insulin or diabetes medication dosage.
• Decreased white blood cell count.

Rare adverse effects (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.
• Changes in menstrual periods (including heavy or irregular periods, bleeding between periods, or absence or delay of periods).

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

• Rash, in which blisters resembling small targets (dark central spots surrounded by a pale area, with a dark ring around) 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 abnormalities 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 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 (frequency 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) while 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 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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paroxetine Kern Pharma

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Paroxetine Kern Pharma after the expiry date stated on the packaging after EXP. 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 are unsure, 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 Paroxetine Kern Pharma:

• The active substance is paroxetine in the form of hemihydrochloride. Each tablet contains 20 mg of paroxetine.

• The other components are: anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate, hypromellose, titanium dioxide (E171) and macrogol 400.

Appearance of the product and contents of the pack

Paroxetine Kern Pharma is presented as white, film-coated, round, scored tablets. The score line is intended to facilitate breaking the tablet for ease of swallowing, but not to divide it into equal doses.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent review of this leaflet: December 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.