Paroxetine Vir 20 mg film-coated tablets EFG

Paroxetine

Read this leaflet carefully before you start taking this medicine.

• 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

Paroxetina Vir belongs to a group of medications called antidepressants and acts on the central nervous system.

Paroxetina Vir is indicated for:

• Treatment of depression.
• Treatment of obsessive-compulsive disorders.
• Treatment of anxiety disorder.
• Treatment of social phobia.
• Treatment of generalized anxiety disorder.

Do not take Paroxetina Vir:

• If you are allergic to paroxetine or any of the components of this medication included in section 6.
• If you are being treated with a medication called thioridazine or with a type of medication for the treatment of depression called MAO inhibitors (IMAO) or if you have been under this treatment in the last two weeks.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paroxetina Vir:

Be especially careful with Paroxetina Vir if you are over 65 years old because this medication may reduce the amount of sodium in your blood and cause drowsiness and muscle weakness. If you experience these symptoms, please consult your doctor as soon as possible.

Some medications in the group to which Paroxetina Vir belongs (called ISRS/IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

The relief of your symptoms will not occur immediately. Generally, improvement begins to be noticeable in a few weeks. In some cases, symptoms of depression or other psychiatric conditions may include thoughts of self-harm or suicide. It is possible that these symptoms will continue or increase until the antidepressant effect is achieved with the medication. Inform your doctor immediately or go to the nearest hospital if you have thoughts or feelings that are dangerous during the initial period of treatment or at any other time during treatment.

Children and adolescents

Paroxetina should not be used in the treatment of children and adolescents under 18 years old.

Also, be aware that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking paroxetine. Despite this, your doctor may prescribe paroxetine to patients under 18 years old when they decide it is the best option for the patient. If your doctor has prescribed paroxetine to you or your child under 18 years old and you want to discuss this decision, consult your doctor. Inform your doctor if any of the symptoms listed above appear or start when you or your child under 18 years old are taking paroxetine. The long-term effects of paroxetine on safety, related to growth, maturity, and cognitive and behavioral development in this age group have not yet been demonstrated.

In studies conducted with paroxetine in patients under 18 years old, the most common adverse effects, which affected less than 1 in 10 children or adolescents, were: an increase in thoughts and attempts of suicide, self-harm, hostile, aggressive, or unfriendly behaviors, loss of appetite, tremors, abnormal sweating, hyperactivity (having too much energy), agitation, unstable emotions (including crying and mood changes), and the appearance of unexpected bruises or bleeding (such as nosebleeds). These effects were also observed in patients included in these studies who did not take paroxetine, although less frequently.

When stopping treatment with paroxetine, some of the patients under 18 years old reported 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 old frequently experienced (affecting less than 1 in 10) stomach pain, nervousness, and unstable emotions (including crying, mood changes, self-harm, thoughts and attempts of suicide).

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 committing suicide. These may increase at the beginning of treatment with antidepressants, as all these medications take time to take effect, which is usually two weeks but can be longer.

It is more likely to happen:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. There is information from clinical trials that shows an increase in the risk of suicidal behavior in adults under 25 years old with psychiatric illnesses who were being treated with an antidepressant.
• If you have thoughts of harming yourself or committing suicide at any time, consult your doctor or go to the hospital immediately.

It may be helpful for you to explain to a family member or close friend that you are depressed or have anxiety disorders, and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Important adverse effects observed with paroxetine

Some patients taking paroxetine develop a disorder called akathisia, and feel restless and unable to sit or stay still. Other patients develop the so-called "serotonin syndrome," and may have one or more of the following symptoms: confusion, restlessness, sweating, tremors, chills, hallucinations (strange visions or sounds), sudden, abrupt movements, or an increase in heart rate. Consult your doctor if you have any of these symptoms. For more information on this or other adverse effects of paroxetine, see section 4.

Other medications and Paroxetina Vir

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

Especially Paroxetina Vir may modify the effect of the following medications:

• Other antidepressants.
• Those for treating mental illnesses (neuroleptics).
• Those for treating epilepsy.
• Lithium, used for the treatment of manias.
• Cimetidine (for the treatment of stomach discomfort).
• Procyclidine, for the treatment of Parkinson's disease.
• Those containing tryptophan.
• Those that may increase the risk of bleeding or alter blood coagulation (e.g. oral anticoagulants, aspirin, and others).
• Some medications used for the treatment of patients with irregular heartbeats (arrhythmias).
• Metoprolol, used for the treatment of high blood pressure, irregular heartbeats (arrhythmias), and angina.
• Migraine medications
• Tramadol (used for pain)
• Antibiotics (lizenolid)

Paroxetina Vir and food and beverages

As with all medications of this type, it is recommended to avoid consuming alcohol while taking Paroxetina Vir.

Take your medication in the morning, preferably with breakfast. The tablets should be swallowed whole, with water, and preferably with food. The tablets should not be chewed.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking a medication. Do not take Paroxetina Vir while pregnant or breastfeeding, unless your doctor advises you to.

Pregnancy

Inform your doctor immediately if you discover you are pregnant, or if you think you may become pregnant. Your doctor may recommend gradually stopping treatment with Paroxetina Vir or continuing with it. Some studies have suggested a possible increase in the risk of heart defects in newborns whose mothers received Paroxetina Vir in the first months of pregnancy. These studies showed that less than 2% of children whose mothers received paroxetine at the beginning of their pregnancy had some heart problem, compared to the 1% observed in the general population.

If you take Paroxetina Vir in the final stages of pregnancy, there may be an increased risk of excessive vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Paroxetina Vir to be able to advise you.

Driving and operating machinery

During treatment with Paroxetina Vir, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how the treatment with Paroxetina Vir affects you.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Do not forget to take your medication.

Your doctor will inform you if you should increase or decrease the medication dose during the treatment period, as well as the duration of the treatment.

It is recommended to administer Paroxetina Vir once a day, in the morning, with breakfast. The tablets should be swallowed whole, with water, and preferably with food. The tablets should not be chewed.

You should continue taking your medication even if you do not notice an improvement, as it may take several weeks for the medication to start acting.

Adults

Depression

The recommended dose is 1 tablet (20 milligrams) per day in adults, which can be increased to 50 milligrams per day.

Obsessive-compulsive disorder

The recommended dose is 2 tablets (40 milligrams) per day, starting with 20 milligrams per day, up to a maximum of 60 milligrams per day.

Anxiety disorder

The recommended dose is 2 tablets (40 milligrams) per day, starting with 10 milligrams per day, up to a maximum of 60 milligrams per day.

Social phobia

The recommended dose is 1 tablet (20 milligrams) per day in adults, which can be increased to 50 milligrams per day.

Generalized anxiety disorder

The recommended dose is 1 tablet (20 milligrams) per day, which can be increased to 50 milligrams per day.

Older adults

The initial recommended doses are the same as for adults. In this group of patients, the maximum dose is 40 milligrams per day.

Children and adolescents

Paroxetina Vir is not recommended for use in children under 18 years old (see section 2).

Patients with renal or hepatic insufficiency

If you have renal or hepatic insufficiency, you should take smaller doses than usual. Inform your doctor if you have any kidney or liver alterations before starting treatment.

If you estimate that the action of Paroxetina Vir is too strong or too weak, inform your doctor or pharmacist.

If you take more Paroxetina Vir than you should

If you have taken more Paroxetina Vir than you should, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone: 915 620 420, indicating the medication and the amount used.

Follow the prescribed dosage schedule set by your doctor. It is unlikely that taking more than one dose will be hazardous, even if you consume the entire contents of a package. If this occurs, see your doctor as soon as possible, or contact the nearest hospital emergency service.

The treatment includes the usual general measures used in case of overdose with any antidepressant. Gastric evacuation will be performed by inducing vomiting, gastric lavage, or both. After gastric evacuation, 20 to 30 grams of activated charcoal will be administered every 4 to 6 hours for the first 24 hours after ingestion. Conservative treatment with vital sign monitoring and observation of the patient is also recommended.

If you forget to take Paroxetina Vir

Do not take a double dose to compensate for the missed doses.

If you forget to take Paroxetina Vir, take it as soon as you remember and, the next day, take your usual dose at the scheduled time.

If you forgot to take Paroxetina Vir all day, do not take a double dose the next day.

If you interrupt treatment with Paroxetina Vir

If treatment with Paroxetina Vir is interrupted abruptly, some withdrawal symptoms may appear, such as dizziness, sensory disturbances, headache, sleep disturbances, agitation or anxiety, nausea, and sweating, which are mild to moderate in nature and decrease spontaneously. Your doctor will advise you on how to stop treatment gradually to avoid these symptoms.

Children may experience additional symptoms when treatment is interrupted, such as abdominal pain, nervousness, and mood changes.

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

Some patients may experience these side effects during treatment or when stopping it.

Possible side effects during treatment

Some people may be allergic to some medicines, although this occurs in very rare occasions (less than 1 person in 10,000). If you experience any of the following symptoms while taking Paroxetina Vir, inform your doctor immediately or go to the nearest hospital:

• Swelling of the face, eyelids, lips, mouth, or tongue.
• Skin rashes or urticaria (itching on the skin) anywhere on the body.
• Difficulty breathing or swallowing.

If you notice any adverse reaction described below, which may or may not be related to Paroxetina Vir, consult your doctor or pharmacist.

The side effects that may appear very frequently (more than 1 person in 10) while taking Paroxetina Vir are:

• Nausea. This side effect may decrease by taking your medication in the morning after breakfast.
• Sexual dysfunction (lack of orgasm, and in men, abnormal erection and ejaculation).

The following side effects may be frequent (more than 1 person in 100 and less than 1 person in 10):

• Loss of appetite.
• Insomnia (lack of sleep) or drowsiness.
• Dizziness, tremor.
• Blurred vision.
• Yawning.
• Dry mouth, diarrhea, constipation.
• Sweating, weakness.
• Weight gain.

The side effects that may appear infrequently (more than 1 person in 1,000 and less than 1 person in 100) during treatment with Paroxetina Vir include:

• Ecchymosis (purple discoloration that occurs due to blood accumulation under the skin, bleeding of mucous membranes).
• Confusion.
• Hallucinations.
• Extrapyramidal effects (disorders of movement and coordination).
• Sinus tachycardia (alteration of heart rhythm).
• Transient increases or decreases in blood pressure, usually in patients with high blood pressure or anxiety.
• Skin rashes (spots on the skin), itching on the skin.
• Urinary retention.
• Decreased white blood cell count.

The side effects that may appear rarely (more than 1 person in 10,000 and less than 1 person in 1,000) during treatment with Paroxetina Vir include:

• Hypontremia (decrease in the amount of sodium in the blood), especially in older people, which may lead to symptoms such as weakness and drowsiness (sensation of sleep).
• Seizures.
• Manic reactions (euphoria).
• Vaginal bleeding, bleeding of the stomach mucosa. Agitation.
• Anxiety.
• Panic attacks.
• Bradycardia (decrease in heart rhythm). Increase in liver enzymes.
• Milk secretion (excessive or abundant secretion of breast milk). Involuntary body movements, including the face.
• Muscle and joint pain.

The side effects that may appear very rarely (less than 1 person in 10,000) are:

• Serotonin syndrome; symptoms may include agitation, confusion, diaphoresis (abnormal sweating), hallucinations, hyperreflexia (increased response of reflexes), myoclonia (involuntary movements), chills, tachycardia, and tremor.
• Liver effects such as hepatitis (inflammation of the liver), sometimes related to jaundice (yellow discoloration of skin and mucous membranes) and/or liver insufficiency.
• Photosensitivity (sensitivity to sunlight).
• SIHAD (a hormone that produces.
• Retention of liquids and water, leading to fatigue, weakness, or confusion).
• Acute glaucoma (high pressure inside the eye).
• Peripheral edema (retention of liquids in the extremities).
• Bleeding of the stomach mucosa.
• Thrombocytopenia (decrease in the number of platelets in the blood).
• Priapism (abnormal and prolonged erection of the penis).

Side effects of unknown frequency:

• Grinding of teeth
• Inflammation of the colon (causing diarrhea)
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Possible side effects when stopping treatment

Studies have shown that 3 out of 10 people have reported symptoms when stopping treatment with Paroxetina Vir, compared to 2 out of 10 patients when stopping treatment with a placebo. It is more likely that these symptoms will appear if you have taken Paroxetina Vir for a long time, are in a phase of dose increase, or if the dose is reduced very quickly. In most cases, the symptoms disappear on their own within two weeks.

When stopping treatment with Paroxetina Vir, your doctor will instruct you to do it gradually, thus reducing the likelihood of side effects. Consult your doctor if you experience severe side effects when stopping treatment with Paroxetina Vir, your doctor may recommend continuing your treatment and reducing it later. If you experience any side effect, it does not mean that you will not be able to stop your treatment.

The side effects that may appear frequently (more than 1 person in 100 and less than 1 person in 10) when stopping treatment with Paroxetina Vir are:

• Dizziness, instability.
• Sensory alterations, including prickling, burning, and, less frequently, sensations of electroshock (even in the head).
• Sleep disturbances (including very vivid dreams, nightmares, insomnia). Anxiety.
• Headache.

The side effects that may appear infrequently (more than 1 person in 1,000 and less than 1 person in 100) when stopping treatment with Paroxetina Vir are:

• Nausea.
• Sweating (including nocturnal sweating).
• Agitation.
• Tremor.
• Confusion.
• Emotional instability.
• Visual disturbances.
• Palpitations.
• Diarrhea.
• Irritability.

The side effects that most frequently (more than 1 person in 100 and less than 1 person in 10) are observed in children and adolescents under 18 years old are:

• Loss of appetite.
• Tremor (involuntary shaking).
• Abnormal sweating.
• Hypervigilance.
• Hostile or unfriendly behavior (mainly in children under 12 years old with obsessions and compulsive disorders).
• Agitation.
• Unstable emotions, including crying, mood changes, self-harm attempts, thoughts, and attempts of suicide (mainly in studies in adolescents with major depression).

The additional side effects observed frequently in children and adolescents under 18 years old who stop treatment with Paroxetina Vir are: unstable emotions (including crying, mood changes, self-harm attempts, thoughts, and attempts of suicide), abdominal pain, and nervousness.

If any of these symptoms start to be bothersome or worsen, inform your doctor.

If you notice any other adverse reaction not described in this prospectus, consult your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano. Website:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the reach and sight of children.

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medicines at the SIGRE collection pointof the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Paroxetina Vir

• Core: sodium glycolate starch, microcrystalline cellulose, magnesium stearate, and mannitol.
• Coating: white opadry (partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), xanthan gum (E 415), soy lecithin (E 322), talc) and polymethacrylate

Appearance of the product and contents of the packaging

Paroxetina Vir is presented in coated tablets with a film in containers containing 14, 28, and 56 tablets.

Holder of the marketing authorization and responsible for manufacturing

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

This prospectus has been reviewed in December 2020

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