Paroxetine Viatris 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Paroxetina Viatris 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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, pharmacist or nurse.
• 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, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Paroxetina Viatris

3. How to take Paroxetina Viatris

4. Possible adverse effects

5. How to store Paroxetina Viatris

6. Contents of the pack and other information

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

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

Paroxetine belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). Serotonin is a substance found in the brain of all people. People who suffer from depression or anxiety have lower levels of serotonin than the general population. While the exact way in which paroxetine and other SSRIs work is not fully understood, it is known that they can help increase serotonin levels in the brain. It is important to properly treat depression and anxiety disorders as this will help you recover.

2. What you need to know before taking 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 methylene blue chloride (methylene blue)), or if you have been treated with such medicines within the last two weeks. Your doctor will advise you on how to start taking paroxetine after stopping 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 starting to take 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 a known heart rhythm abnormality on electrocardiogram (ECG) called QT interval prolongation.
• If you have a family history of QT interval prolongation, heart diseases such as heart failure, slow heart rate, or low levels of potassium or magnesium.
• If you have low sodium levels in the blood.
• If you have glaucoma (increased pressure in the eye).
• If you are taking tamoxifen to treat breast cancer or fertility problems. Paroxetine may reduce 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 if you are taking other medicines that may increase the risk of bleeding (including medicines used to thin the blood, such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants such as clomipramine, medicines used to treat pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam).
• If you have a history of bleeding disorders, if you are pregnant (see “Pregnancy, breastfeeding, and fertility”), or if you are taking other medicines that may increase the risk of bleeding (including medicines used to thin the blood, such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants such as clomipramine, medicines used to treat pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam).
• If you are under 18 years of age (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 to treat children and adolescents under 18 years of age. In patients under 18 years, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe paroxetine to patients under 18 years if they decide it is in the patient’s best interest. If your doctor has prescribed paroxetine to you (or your child) and you wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen while you (or your child) are taking paroxetine. In addition, the long-term effects on safety regarding growth, maturation, and cognitive and behavioral development in this age group have not yet been established.

Some patients in clinical trials of under-18s experienced withdrawal symptoms when stopping treatment with paroxetine. These symptoms were very similar to those observed in adults when stopping 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 sometimes have thoughts about harming yourself or committing suicide. These thoughts may increase at the beginning of treatment with antidepressants, as these medicines take time to become effective, usually around two weeks, but sometimes longer.

You may be more likely to have thoughts like these:

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

• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in psychiatric patients under 25 years of age who were being treated with an antidepressant.

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

It may be helpful to tell a close family member or friend that you suffer from depression or an anxiety disorder, and ask them to read this leaflet. You may ask them whether they think your depression or anxiety is worsening, or if they are concerned about possible behavioral changes you may experience.

Consult your doctor if you have any doubts.

Important adverse effects observed with Paroxetina Viatris

Some patients taking paroxetine develop akathisia, which consists of a feeling of inner restlessness accompanied by an inability to remain still. Other patients develop serotonin syndrome, 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 experience 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 same class as paroxetine (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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Some medicines may alter the effect of paroxetine or make adverse effects more likely. Paroxetine may also alter the effect of other medicines. These include:

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide, used to treat depression, and methylene blue chloride (methylene blue)), see “Do not take Paroxetina Viatris” in this section. Medicines known to increase the risk of disturbances in the heart's electrical activity (e.g., the antipsychotics thioridazine or pimozide) – see "Do not take Paroxetina", in 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 clots (antiplatelets) such as clopidogrel.
• Painkillers such as buprenorphine, tramadol, and meperidine.
• Medicines called triptans such as sumatriptan (used to treat migraine).
• Other medicines to treat depression, including other SSRIs and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
• A dietary supplement called tryptophan.
• Medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotics).
• 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, or carbamazepine (used to treat seizures or epilepsy).
• Atomoxetine (used to treat Attention Deficit Hyperactivity Disorder (ADHD)).
• Procyclidine (to treat tremor, especially in Parkinson’s disease).
• Warfarin or other medicines (called anticoagulants) used to thin the blood.
• Medicines used to treat irregular heartbeats such as propafenone and flecainide.
• Metoprolol, a beta-blocker (used to treat high blood pressure and heart problems).
• Pravastatin, used to treat high cholesterol levels.
• Rifampicin (used to treat tuberculosis (TB) and leprosy).
• Linezolid (an antibiotic used to treat infections).
• Tamoxifen, used to treat breast cancer or fertility problems.
• Mivacurium or suxamethonium (medicines used to relax muscles).

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

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 feeling generally unwell (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. Paroxetine is not recommended during pregnancy because it may harm the baby. Your doctor must decide whether it is better for you to switch to another treatment or gradually stop taking paroxetine during pregnancy. However, depending on your circumstances, your doctor may recommend continuing paroxetine.

Ensure your doctor or midwife knows that you are taking paroxetine. When taken during pregnancy, especially during the last three months, medicines like paroxetine may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and have bluish skin. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, you must contact your midwife and/or doctor immediately.

Symptoms include:

• Difficulty breathing.
• Bluish skin or appearance of being too hot or too cold.
• Bluish lips.
• Vomiting or difficulty feeding.
• Feeling very tired, trouble sleeping, or frequent crying.
• Muscle stiffness or floppiness.
• Tremors, irritability, or seizures.
• 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 late 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 know you are taking paroxetine so they can advise you.

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

Animal studies have shown that paroxetine reduces sperm quality. Theoretically, this could affect fertility, but the impact on human fertility has not yet been observed.

Driving and using machines

Possible side effects of paroxetine include dizziness, confusion, drowsiness, or blurred vision. If you experience these side effects, do not drive or operate machinery.

Paroxetina Viatris contains sodium

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

3. How to take Paroxetine Viatris

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended doses for the different conditions are specified below in the following table:

	Initial 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 anxiety 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 Paroxetine Viatris. Most people begin to feel better after a couple of weeks of treatment. If you do not improve within this time, inform your doctor, who will advise you on what to do. He or she may decide to gradually increase your dose by 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 intended solely for ease of swallowing and breaking the tablet, and not for dividing into equal doses.

Your doctor will tell you how long you need to continue taking your tablets. This may be for several months or even longer.

Use in elderly patients

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

Use in children and adolescents

Children and adolescents under 18 years of age should generally not take paroxetine unless your doctor has decided it is beneficial for them.

Patients with kidney or liver problems

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

If you take more Paroxetine Viatris than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 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 experience some of the symptoms described in section 4, “Possible Side Effects,” or the following symptoms: vomiting, dilated pupils, fever, headache, uncontrollable muscle stiffness, and increased heart rate.

If you forget to take Paroxetine Viatris

Take your medication at the same time each day.

If you forget to take a dose and remember before going to bed at night, take it immediately. The next day, continue treatment as usual. If you remember during the night or the following day, do not take the missed dose. You may experience withdrawal effects, but these usually disappear after taking the 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 improve

Paroxetine will not relieve your symptoms immediately—like all antidepressants, it takes time to start working. Some people begin to feel better within a couple of weeks, but others may take a little longer. Some people taking antidepressants feel worse before they start to improve. Your doctor should ask you to come in for a check-up about two weeks after starting treatment. Inform your doctor if you have not started to feel better.

If you stop treatment with Paroxetine 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 your dose over several weeks or months—this should help reduce the likelihood of experiencing withdrawal symptoms. One way to do this is to gradually reduce your paroxetine dose by 10 mg per week. Most people find that any symptoms they experience when stopping paroxetine are mild and disappear on their own within about two weeks. For some people, these symptoms may be more severe or last longer.

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

Even if you experience some withdrawal effects, you may still be able to stop treatment with paroxetine.

Possible withdrawal symptoms when stopping treatment

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

Common (may affect up to 1 in 10 people)

• Dizziness, with unsteadiness or balance disturbances.
• Tingling, burning sensations, and (less frequently) electric shock-like sensations, even in the head, and ringing, buzzing, whistling, 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)

• Nausea (vomiting).
• Sweating (including night sweats).
• Restlessness or agitation.
• Tremor.
• Confusion or disorientation.
• Diarrhea (loose stools).
• Feeling of sensitivity or irritability.
• Visual disturbances.
• Rapid or very frequent heartbeat (palpitations).

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

If you have any further 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 experiences them.

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

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

Uncommon (may affect up to 1 in 100 people)

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

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

• Seizures (epileptic fits).
• Feeling restless, inability to sit or stand still; you may have a serious condition called akathisia. Increasing your dose of paroxetine may worsen this symptom.
• Tiredness, feeling weak or confused, and having sore, stiff, or uncoordinated muscles, which 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 serious.

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

• Skin rash, which may blister and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge), known as erythema multiforme.
• Widespread blistering rash with peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
• Widespread blistering rash with peeling of the skin over a large part of the body (toxic epidermal necrolysis).
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body retains excess water and sodium (salt) levels decrease, due to inappropriate chemical signals. Patients with SIADH may worsen or may have no symptoms at all.
• 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 (seeing or hearing strange things), sudden muscle jerks, or rapid heartbeat.
• If your eyes become painful and you develop blurred vision. This may be a sign of glaucoma.
• If your skin or the whites of your eyes turn yellow, these may be signs of liver problems.

Frequency not known (cannot be estimated from available data)

• You have thoughts of harming yourself or of suicide. Suicidal behaviour 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)

• Nausea. Taking your medicine in the morning with food will reduce the likelihood of these effects.
• Changes 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.
• Poor sleep (insomnia) or drowsiness.
• Abnormal dreams (including nightmares).
• Dizziness or tremors.
• Headache.
• Agitation.
• Unusual feeling of weakness.
• Yawning, dry mouth.
• Diarrhoea or constipation.
• Weight gain.
• Sweating.
• Increased cholesterol levels.
• Malaise (vomiting).
• Inability to concentrate properly.

Uncommon (may affect up to 1 in 100 people)

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

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

• Abnormal milk production in men and women.
• Slowing of the heart rate.
• Increased liver enzymes, which may be seen in a blood test.
• Panic attacks.
• Obsessive thoughts or behaviours (mania).
• Feeling detached from yourself (depersonalisation).
• Anxiety.
• Pain in muscles and joints.
• Irresistible urge to move the legs (restless legs syndrome).
• Increase in a hormone called prolactin in the blood.
• Changes in menstrual cycle (including heavy or irregular periods, bleeding between periods, and absence or delay of periods).

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

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

Frequency not known (cannot be estimated from available data)

• Grinding of teeth.
• Aggression.
• Ringing, buzzing, hissing, whistling, or other persistent noises in the ears (tinnitus).
• Inflammation of the colon (causing diarrhoea).
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); 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 medicine.

In studies of paroxetine in patients under 18 years of age, the common adverse effects affecting less than 1 in 10 children/adolescents were: increased suicidal thoughts and suicide attempts, self-harm, hostility, aggression or uncooperative attitude, loss of appetite, tremors, abnormal sweating, hyperactivity (excess energy), agitation, and emotional instability (including crying and mood swings). These studies also showed that these symptoms occurred in children and adolescents who took sugar tablets (placebo) instead of paroxetine, although less frequently.

In addition, patients under 18 years of age 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 suicide attempts).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, 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 Viatris

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle, blister pack, or box, after EXP or CAD. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paroxetina Viatris

The active substance is paroxetine.

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

The other components are:

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

Tablet coating: talc (E-553b), titanium dioxide (E-171), and butyl methacrylate copolymer.

Appearance of the product and contents of the container

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

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 unit-dose perforated blisters containing 28 tablets. The bottles contain a desiccant. Do not eat the desiccant.

Paroxetina Viatris is also available in Duma Twist-off polyethylene bottles containing 250 tablets. These bottles contain a desiccant.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1
Hungary

or

Generics (UK) Ltd.
Station Close
Potters Bar
EN6 1TL Hertfordshire
United Kingdom

More information about this medicinal product can be requested from the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product has been authorized in the Member States of the EEA 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 helpful to contact patient support groups or patient organizations to learn more about your condition. Your doctor can provide further details.

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

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