PAROXETINE VIATRIS 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Paroxetina Viatris 20 mg film-coated tablets EFG

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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Paroxetina Viatris and what is it used for
2. What you need to know before you take Paroxetina Viatris
3. How to take Paroxetina Viatris
4. Possible side effects
5. Storage of Paroxetina Viatris

1. Contents of the pack and further information

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

Paroxetine is a treatment for adults with depression (major depressive episode) and/or anxiety disorders.The anxiety disorders that are treated with paroxetine are: obsessive-compulsive disorder (obsessive thoughts, repetitive behavior), panic disorder (panic attacks, including those caused by agoraphobia - fear of open spaces), social anxiety disorder (fear or rejection of social situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (general feeling of anxiety or nervousness).

Paroxetine belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). Everyone has a substance in the brain called serotonin. People who suffer from depression or anxiety have lower levels of serotonin than the rest of the population. It is not known exactly how paroxetine and other SSRIs work, but they can help increase serotonin levels in the brain. It is essential to treat depression and anxiety disorders properly, as they will help you recover.

2. What you need to know before you take Paroxetina Viatris

Do not take Paroxetina Viatris

• If you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6).
• If you are being treated with a type of medicine called monoamine oxidase inhibitors (MAOIs, including moclobemide, linezolid, and methylthioninium chloride (methylene blue)), or if you have been under such treatment in the last two weeks. Your doctor will inform you how to start taking paroxetine once you have stopped taking MAOIs.
• If you are taking antipsychotic medicines called thioridazine or pimozide.

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

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you start taking paroxetine.

• If you have any kidney, liver, or heart problems.
• If you have epilepsy or a history of seizures or convulsions.
• If you have ever had manic episodes (hyperactive thoughts or behavior).
• If you are being treated for severe depression with electroconvulsive therapy (ECT).
• If you are diabetic.
• If you have an abnormal heart tracing on an electrocardiogram (ECG) known as QT interval prolongation.
• If you have a family history of QT interval prolongation, heart diseases such as heart failure, low heart rate, or low potassium or magnesium levels.
• If you have low sodium levels in your blood.
• If you have glaucoma (high pressure in the eye).
• If you are taking tamoxifen to treat breast cancer or fertility problems. Paroxetine may decrease the effectiveness of tamoxifen, and your doctor may recommend taking another antidepressant.
• If you have a history of bleeding disorders, if you are pregnant (see "Pregnancy, breastfeeding, and fertility") or are taking other medicines that may increase the risk of bleeding (including medicines used to thin the blood, such as warfarin, antipsychotics like perphenazine or clozapine, tricyclic antidepressants like clomipramine, medicines used to treat pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam).
• If you are under 18 years old (see section "Use in children and adolescents under 18 years").

Please confirm with your doctor if any of the above applies to you, or if you are unsure.

Use in children and adolescents under 18 years

Paroxetine should not be used in the treatment of children and adolescents under 18 years.In patients under 18 years, there is a greater risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this class of medicines. However, the doctor may prescribe paroxetine to patients under 18 years when they decide what is best for the patient. If your doctor has prescribed paroxetine to you (or your child) and you want to discuss this decision, please go back to your doctor. You must inform your doctor if any of the symptoms mentioned above appear or worsen when you (or your child) are taking paroxetine. Also, the long-term effects on safety, growth, maturity, and cognitive and behavioral development in this age group have not yet been demonstrated.

Some patients who participated in studies of minors under 18 years had withdrawal effects when stopping treatment with paroxetine. These effects were very similar to those observed in adults after stopping treatment with paroxetine (see section 3, "How to take Paroxetina Viatris").

Suicidal thoughts and worsening of depression or anxiety disorders

If you are depressed and/or have anxiety disorders, you may have some thoughts of harming yourself or committing suicide. These thoughts can increase at the start of treatment with antidepressants, as these medicines take time to be effective, usually around two weeks, but sometimes longer.

You may have these thoughts more likely:

• If you have previously had thoughts of suicide or self-harm.

• If you are a young adult. Information from clinical trials has shown a greater risk of suicidal behavior in adults under 25 years with psychiatric disorders who were being treated with an antidepressant.

If you have suicidal thoughts or self-harm at any time , contact your doctor or go to the nearest hospital immediately.

It may be helpful to explain to a close relative or friendthat you suffer from depression or anxiety disorder, and ask them to read this leaflet. You can ask them if they think your depression or anxiety is getting worse, or if they are concerned about possible changes in behavior that you may suffer.

Consult your doctor if you have any doubts.

Important adverse effects observed with Paroxetina Viatris

Some patients who take paroxetine develop akathisia, which consists of a feeling of restlessness at the body level that is accompanied by an inability to remain still.Other patients develop the serotonin syndrome, which is characterized by the presence of some or all of the following symptoms: confusion, restlessness, sweating, tremors, chills, hallucinations (strange visions or sounds), sudden muscle jerks or rapid heartbeat. If you notice any of these symptoms, contact your doctor. For more information on these adverse reactions or others related to paroxetine, see section 4, "Possible side effects".

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

Other medicines and Paroxetina Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may change the effect of paroxetine or make it more likely to have side effects. Paroxetine may also change the effect of other medicines. These include:

• Medicines called monoamine oxidase inhibitors(MAOIs, including moclobemide, for treating depression, and methylthioninium chloride (methylene blue)), see "Do not take Paroxetina Viatris" in this section. Medicines known to increase the risk of changes in heart electrical activity (such as antipsychotics thioridazine or pimozide) - see "Do not take Paroxetina", inside this leaflet.
• Aspirin (acetylsalicylic acid), ibuprofen, or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs), such as celecoxib or rofecoxib, etodolac, diclofenac, and meloxicam (used to treat pain and inflammation).
• Medicines used to reduce the risk of blood clot formation (antiplatelet agents) such as clopidogrel.
• Pain relievers like buprenorphine, tramadol, pethidine.
• Medicines called triptans, such as sumatriptan (used to treat migraine).
• Other medicines for treating depression, including other SSRIs and tricyclic antidepressants like clomipramine, nortriptyline, and desipramine.
• A dietary supplementcalled tryptophan.
• Medicines like lithium, risperidone, perphenazine, clozapine (called antipsychotics).
• Fentanyl, used in anesthesiaor 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 for treating depression).
• Phenobarbital, phenytoin, or carbamazepine (used to treat seizuresor epilepsy).
• Atomoxetine (used to treat Attention Deficit Hyperactivity Disorder (ADHD)).
• Procyclidine (for treating tremors, especially Parkinson's disease).
• Warfarin or other medicines (called anticoagulants), which are used to thin the blood.
• Medicines used to treat irregular heartbeatssuch as propafenone and flecainide.
• Metoprolol, a beta-blocker (for treating high blood pressureand heart problems).
• Pravastatin, used to treat high cholesterol levels.
• Rifampicin (used to treat tuberculosis (TB)and leprosy).
• Linezolid (an antibioticused to treat infections).
• Tamoxifen, used to treat breast canceror fertility problems.
• Mivacurium or suxamethonium (medicines used to relax muscles).

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking Paroxetina Viatris with food and alcohol

Do not drink alcohol while taking paroxetine. Alcohol may worsen your symptoms or side effects. Taking paroxetine in the morning with food will reduce the likelihood of having a general feeling of discomfort (nausea).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Paroxetine is not recommended during pregnancy because it may harm the baby. Your doctor must decide whether it is better for you to change to another treatment or gradually stop taking paroxetine while you are pregnant. However, depending on your circumstances, your doctor may recommend continuing to take paroxetine.

Make sure your doctor or midwife knows you are taking paroxetina. When taken during pregnancy, especially in the last 3 months, medicines like paroxetine may increase the risk of a serious condition in newborns called persistent pulmonary hypertension (PPHN), making the baby breathe faster and have blue-tinged skin. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, you must contact your midwife and/or doctor immediately.

The symptoms include:

• Difficulty breathing.
• Blue-tinged skin or looking too hot or cold.
• Blue lips.
• Vomiting or difficulty feeding.
• Feeling very tired, difficulty sleeping, or frequent crying.
• Stiffness or floppiness.
• Tremors, irritability, 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.

If you take paroxetine in the final stages of pregnancy, there may be a greater risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife must know that you are taking paroxetine to advise you.

Paroxetine may pass into breast milk in very small amounts. If you are taking paroxetine, inform your doctor before starting breastfeeding.

Studies in animals have shown that paroxetine reduces sperm quality. Theoretically, this could affect fertility, but it has not yet been observed in human fertility.

Driving and using machines

The possible side effects of paroxetine include dizziness, confusion, drowsiness, or blurred vision. If you experience these side effects, do not drive or use machines.

Paroxetina Viatris contains sodium

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

3. How to take Paroxetina Viatris

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended doses for the different diseases are set out below in the following table:

Your doctor will indicate what dose to take when starting treatment with Paroxetina Viatris.Most people start to feel better after a couple of weeks of treatment. If you don't improve after this time, inform your doctor, he will advise you what to do. He or she may decide to gradually increase the dose, 10 mg at a time, up to a maximum daily dose.

Take your tablets in the morning with food. The tablets should not be chewed, but swallowed whole with water.

The score line is only for breaking and facilitating swallowing and not for dividing into equal doses.

Your doctor will indicate how long you need to keep taking your tablets. This can be for several months or even longer.

Use in elderly people

The maximum daily dose for elderly people (over 65 years) is 40 mg per day.

Use in children and adolescents

Children and adolescents under 18 yearsshould not normally take paroxetine, unless their doctor has decided that it is beneficial for them.

Patients with kidney or liver problems

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

If you take more Paroxetina Viatristhan 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. Never take more tablets than your doctor has recommended. Show them the medicine package.

Someone who has taken an overdose of paroxetine may present some of the symptoms described in section 4, “Possible Adverse Effects”, or the following symptoms: vomiting, pupil dilation, fever, headache, uncontrolled muscle stiffness, and increased heart rate.

If you forget to take Paroxetina Viatris

Take your medicine at the same time every day.

If you forget to take a dose and remember before going to bed at night, take it immediately. The next day, continue treatment normally. If you remember during the night or the next day, do not take the missed dose. You will probably suffer from withdrawal effects, but they usually 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 don't improve

Paroxetine will not relieve your symptoms immediately - all antidepressants take time to start working. Some people will start to feel better in a couple of weeks, but others may take a little longer to improve. Some people taking antidepressants feel worse before experiencing improvement. Your doctor should ask you to come back after two weeks of starting treatment. Inform your doctor if you haven't started to feel better.

If you stop treatment with Paroxetina Viatris

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

When you need to stop treatment with paroxetine, your doctor will help you gradually reduce the dose you take over several weeks or months - this should help reduce the possibility of suffering from withdrawal symptoms. One way to do this is to gradually reduce the dose of paroxetine you take by 10 mg per week. Most people find that any symptoms they experience when stopping paroxetine are mild and disappear on their own within two weeks. For some people, these symptoms can be more severe or last longer.

If you suffer from withdrawal symptomswhen stopping your tablets, your doctor may decide that you should stop your treatment more slowly. If you experience severe withdrawal symptoms when stopping paroxetine, please go see your doctor. He or she may ask you to start taking your tablets again and stop taking them more progressively.

Although you may suffer from some withdrawal effects, you will be able to stop your treatment with paroxetine.

Possible withdrawal symptoms when stopping treatment

Studies show that 3 out of 10 patients notice one or more symptoms when stopping paroxetine. Some withdrawal effects when stopping treatment occur more frequently than others.

Frequent(may affect up to 1 in 10 people)

• Dizziness, with instability or balance disturbances.
• Tingling, burning sensation, and (less frequently) electric shock sensation, even in the head, and buzzing, whistling, hissing, ringing, or other persistent noises in the ears (tinnitus).
• Sleep disturbances (very vivid dreams, nightmares, inability to sleep).
• Anxiety.
• Headache.

Uncommon(may affect up to 1 in 100 people)

• Vomiting (nausea).
• Sweating (including night sweats).
• Restlessness or agitation.
• Tremors.
• Confusion or disorientation.
• Diarrhea (soft stools).
• Feeling of sensitivity or irritability.
• Visual disturbances.
• Fast or very frequent heartbeats (palpitations).

Please consult your doctor if you are concerned about withdrawal symptoms when stopping treatment with paroxetine.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

These adverse effects are more likely to occur during the first few weeks of treatment with paroxetine.

Tell your doctor if you experience any of the following adverse reactions during treatment or go to the nearest hospital immediately:

Uncommon(may affect up to 1 in 100 people)

• If you have bruising or unusual bleeding, including blood in your vomit or stools.
• If you are unable to urinate.

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

• Seizures (epileptic fits).
• A feeling of restlessness, inability to stay seated or standing, may have a serious symptom called akathisia. Increasing the dose you take of paroxetine may make this symptom worse.
• Fatigue, feeling weak or confused, and having painful, stiff, or uncoordinated muscles, this may be due to low sodium levels in the blood.

Very Rare(may affect up to 1 in 10,000 people)

• Allergic reactions, which can be severe.

If you develop a skin rash with redness and bumps, swelling of the eyelids, face, lips, mouth, or tongue, itching, or difficulty breathing (shortness of breath) or swallowing, and a feeling of weakness or dizziness, which can cause collapse or loss of consciousness.

• Skin rash, which can lead to blisters, and appear like small targets (dark central spot surrounded by a paler area, with a dark ring around the edge), called erythema multiforme.
• A widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• A widespread rash with blisters and peeling of the skin over much of the body surface (toxic epidermal necrolysis).
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH), which is a condition in which the body develops an excess of water and a decrease in sodium levels, as a result of inadequate chemical signals. Patients with SIADH may worsen or may have no symptoms.
• If you have all or some of the following symptoms, you may have a serious condition called serotonin syndrome: confusion, restlessness, sweating, tremors, chills, hallucinations (strange visions or noises), sudden jerks of the muscles, or rapid heartbeat.
• If your eyes become painful and you develop blurred vision. This can be a symptom of glaucoma.
• If your skin or the white part of your eyes turns yellow, they can be signs of liver problems.

Frequency not known(cannot be estimated from available data)

• You have thoughts of harming yourself or committing suicide. Suicidal behavior has been reported during treatment with paroxetine or shortly after stopping treatment.

Other possible adverse effects during treatment

Very common(may affect more than 1 in 10 people)

• Dizziness (nausea). Taking your medicine in the morning with food will reduce the likelihood of you experiencing these effects.
• Change in libido or sexual function. For example, lack of orgasm, and in men, abnormal erection and ejaculation.

Common(may affect up to 1 in 10 people)

• Decreased appetite.
• Insomnia or drowsiness.
• Abnormal dreams (including nightmares).
• Dizziness or tremors.
• Headache.
• Agitation.
• Feeling of unusual weakness.
• Yawning, dry mouth.
• Diarrhea or constipation.
• Weight gain.
• Sweating.
• Increased cholesterol levels.
• Nausea (vomiting).
• Inability to concentrate properly.

Uncommon(may affect up to 1 in 100 people)

• Faster than normal heartbeats.
• Mild increase or decrease in blood pressure, which can make you feel dizzy or faint when standing up suddenly.
• Lack of movement, stiffness, tremors, or abnormal movements in the mouth and tongue.
• Dilated pupils.
• Uncontrolled and involuntary urination (urinary incontinence).
• If you are a diabetic patient, you may observe uncontrolled blood sugar levels while taking paroxetine. Consult your doctor about how to adjust your insulin or diabetes medication dose.
• Decreased white blood cell count.

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

• Abnormal milk production in men and women.
• Decreased heart rate.
• Increased liver enzymes, which can be seen in a blood test.
• Panic attacks.
• Obsessive behaviors or thoughts (mania).
• Feeling distant from oneself (depersonalization).
• Anxiety.
• Pain in muscles and joints.
• Uncontrollable urge to move the legs (restless legs syndrome).
• Increased levels of a hormone called prolactin in the blood.
• Menstrual disorders (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)

• Water or fluid retention, which can cause swelling of the arms or legs.
• Sensitivity to sunlight.
• Painful and persistent erection of the penis.
• Unexplained or unusual bleeding or bruising. These can be signs of having a low platelet count in the blood.

Frequency not known(cannot be estimated from available data)

• Teeth grinding.
• Aggression.
• Buzzing, whistling, hissing, ringing, or other persistent noises in the ears (tinnitus).
• Inflammation of the colon (which causes diarrhea).
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see “Pregnancy, breastfeeding, and fertility” in section 2 for more information.

An increased risk of bone fractures has been observed in patients taking this type of medication.

In studies of paroxetine in people under 18, common adverse effects that affected less than 1 in 10 children/adolescents were: increased suicidal thoughts and attempts, self-harm, hostility, aggression, or unfriendly attitude, lack of appetite, tremors, abnormal sweating, hyperactivity (having too much energy), agitation, emotional instability (including crying and mood changes). These studies also showed that these symptoms also affected children and adolescents who took sugar pills (placebo) instead of paroxetine, although in these, the symptoms occurred less frequently.

Additionally, patients under 18 also frequently experienced (affecting less than 1 in 10 patients) stomach pain, nervousness, and emotional instability (including crying, mood changes, self-harm attempts, suicidal thoughts, and attempts).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) https://www.aemps.gob.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Paroxetina Viatris

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the bottle, blister, or box, after CAD or EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Keep in the original package to protect it from light.

Medicines should not be thrown down the drain or into the trash. Deposit the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Paroxetina Viatris

The active ingredient is paroxetine.

Each film-coated tablet contains 20 mg of paroxetine as anhydrous hydrochloride.

The other ingredients are:

Core of the tablet: calcium hydrogen phosphate, colloidal anhydrous silica, sodium carboxymethyl starch type A (derived from potato starch), and magnesium stearate (E-470b). See section 2 “Paroxetina Viatris contains sodium”.

Coating of the tablet:talc (E-553b), titanium dioxide (E-171), and basic butyl methacrylate copolymer.

Appearance of the product and package contents

Paroxetina Viatris film-coated tablets are white, marked with “P2” on one side and “G” on the other side, and approximately 8 mm in diameter. The tablets have a score line on one face.

Paroxetina Viatris is available in polyethylene bottles and blisters containing 10, 12, 14, 20, 28, 30, 50, 56, 58, 60, 98, 100, 200, 250, or 500 tablets, or perforated unit-dose blisters containing 28 tablets. The bottles contain a desiccant. Do not eat the desiccant.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

or

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1

Hungary

or

Generics (UK) Ltd.

Station Close Potters Bar

EN6 1TL Hertfordshire

United Kingdom

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine has been authorized in the EEA Member States under the following names:

Germany Paroxedura

Austria Paroxetin “Arcana”

Belgium Paroxetine Mylan

Denmark Paroxetin Mylan

Spain Paroxetina Viatris 20 mg film-coated tablets EFG

Italy Paroxetina Mylan Generics

Luxembourg Paroxetine Mylan

Netherlands Paroxetine Mylan

Portugal Paroxetina Mylan

United Kingdom Paroxetine

You may find it useful to contact patient support groups or organizations for more information about your condition. Your doctor can provide you with more details.

Date of last revision of this leaflet:March 2025

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