PAROXETINE ALMUS 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Paroxetina Almus20 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 or pharmacist.
• 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 or pharmacist. 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 Almus 20 mg tablets and what is it used for
2. What you need to know before you take Paroxetina Almus 20 mg tablets
3. How to take Paroxetina Almus 20 mg tablets
4. Possible side effects
5. Storage of Paroxetina Almus 20 mg tablets
6. Pack contents and further information

1. What is Paroxetina Almus 20 mg tablets and what is it used for

Paroxetina Almus is used for the treatment of depression and/or anxiety disorders in adults.

The anxiety disorders for which Paroxetina Almus is indicated are:

• obsessive-compulsive disorder (obsessive thoughts, repetitive, uncontrolled behavior),
• panic disorder (panic attacks, including those caused by agoraphobia, which is the fear of open spaces)
• social phobia (fear or avoidance of social contact situations)
• post-traumatic stress disorder (anxiety caused by a traumatic event)
• generalized anxiety disorder (feeling normally very anxious or nervous).

Paroxetina Almus belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). We all have a substance in the brain called serotonin.

People who are depressed or have anxiety have lower serotonin levels than others. The precise mechanism of action of Paroxetina Almus and other SSRIs is not fully known, but they work by increasing serotonin levels in the brain. Properly treating depression or anxiety disorder is important to help you feel better.

2. What you need to know before you take Paroxetina Almus 20 mg tablets

Do not take Paroxetina Almus

• if you are allergicto paroxetine, peanuts, soy, or any of the other ingredients of Paroxetina Almus (listed in section 6).
• if you are being treated with medicines called monoamine oxidase inhibitors(MAOIs, including moclobemide and methylthioninium chloride (methylene blue)), or if you have been under such treatment in the last two weeks. Your doctor will advise you how to start taking Paroxetina Almus once you have stopped taking the MAOI.
• if you are taking an antipsychotic medicinecalled thioridazine or the antipsychotic called pimozide.

If you are in any of these situations, tell your doctor and do not take Paroxetina Almus.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paroxetina Almus.

• if you are taking other medicines (see the section on "Using other medicines and Paroxetina Almus")
• if you are taking tamoxifen for the treatment of breast cancer (or fertility problems). Paroxetina Almus may make tamoxifen less effective, so your doctor should recommend taking another antidepressant
• if you have kidney, liver, or heart problems
• if you have epilepsy or have seizures or epileptic fits
• if you have had manic episodes (excessively active thoughts or behavior)
• if you are being treated with electroconvulsive therapy (ECT)
• if you have a tendency to bleed or bruise, or are being treated with a medicine that may increase the risk of bleeding (including medicines such as warfarin (acenocoumarol), antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines for treating pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam) or if you are pregnant (see "Pregnancy, breastfeeding, and fertility")
• if you have diabetes
• if you are on a low-sodium diet
• if you have glaucoma (high eye pressure)
• if you are pregnant or think you may be pregnant (see the section on "Pregnancy, breastfeeding, and fertility")
• if you are under 18 years of age (see the section on "Children and adolescents under 18 years of age").

If you are in any of these situationsand have not yet consulted your doctor, ask your doctor how to take Paroxetina Almus

Children and adolescents under 18 years of age

Paroxetina Almus should not be used in the treatment of children and adolescents under 18 years of age.Also, you should know that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritation) when taking Paroxetina Almus. Nevertheless, your doctor may prescribe Paroxetina Almus to patients under 18 years of age when they decide it is most convenient for the patient. If your doctor has prescribed Paroxetina Almus to your child under 18 years of age and you want to discuss this decision, consult your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen when you or your child under 18 years of age are taking Paroxetina Almus. The long-term effects of Paroxetina Almus 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 of age, frequent adverse effects, which affected less than 1 in 10 children or adolescents, were: an increase in suicidal thoughts and attempts, self-harm, hostile, aggressive, or unfriendly behavior, loss of appetite, tremors, abnormal sweating, hyperactivity (having too much energy), agitation, unstable emotions (including crying and mood changes), and the appearance of bruises or bleeding (such as nosebleeds). These effects were also observed in patients included in these studies who did not take paroxetine, although with less frequency.

When interrupting treatment with paroxetine, in these studies, some patients under 18 years of age reported having withdrawal effects. These effects were very similar to those observed in adults who interrupted treatment with paroxetine (see section 3 "How to take Paroxetina Almus"). Additionally, patients under 18 years of age frequently experienced (affecting 1 in 10) stomach pain, nervousness, and unstable emotions (including crying, mood changes, self-harm, 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 can increase at the beginning of treatment with antidepressants, as all these medicines take time to work, which is usually a few weeks but can sometimes be longer.

• This is more likely to happen to youif 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 increased risk of suicidal behavior in young adults under 25 years of age with psychiatric disorders who are being treated with an antidepressant.

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

It may be useful for you to explain toa family member or close friendthat 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 side effects seen with Paroxetina Almus

Some patients taking Paroxetina Almus develop a disorder called akathisia, and feel restless and unable to sit or stay still. Other patients develop a condition called serotonin syndrome or neuroleptic malignant syndrome, and may have some or all of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, trembling, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden jerky movements, or increased heart rate. The severity can increase and lead to loss of consciousness. Consult your doctorif you have any of these symptoms. For more information on this or other side effects of Paroxetina Almus, see section 4 Possible side effectsin this leaflet.

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

Other medicines and Paroxetina Almus

Some medicines may change the effect of Paroxetina Almus or make it more likely that certain side effects will appear. Paroxetina Almus may also change the effect of some medicines. For example:

• Medicines called monoamine oxidase inhibitors(MAOIs, including moclobemide and methylthioninium chloride (methylene blue)). See the section "Do not take Paroxetina Almus".
• The medicines called thioridazine or pimozide, which are antipsychotics. See the section "Do not take Paroxetina Almus".
• Acetylsalicylic acid, ibuprofen, and other medicines called non-steroidal anti-inflammatory drugs, such as celecoxib, etodolac, diclofenac, and meloxicam, used to treat pain and inflammation.
• Tramadol and pethidine, analgesics.
• Medicines called triptans, such as sumatriptan, used for migraines.
• Other antidepressants, including other selective serotonin reuptake inhibitors and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
• A dietary supplementcalled tryptophan.
• Mivacurium and suxamethonium (used in anesthesia).
• Medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat some psychiatric disorders.
• 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, sodium valproate, or carbamazepine, used to treat seizuresor 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 make the blood more fluid.
• Propafenone, flecainide, and medicines used to treat heart rhythm disorders.
• Metoprolol, a beta-blocker used to treat high blood pressureand heart disorders.
• Pravastatin, used to treat high cholesterol.
• Rifampicin, used to treat tuberculosis (TB)and leprosy.
• Linezolid, an antibiotic.
• Tamoxifen, used to treat breast cancer (or fertility problems).

If you are taking or have recently taken any of these medicines, tell your doctor and ask what you should do.Your doctor may decide to change the dose or prescribe another medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines,including those obtained without a prescription.

Taking Paroxetina Almus with food, drinks, and alcohol

Do not consume alcohol while taking Paroxetina Almus. Alcohol may worsen your symptoms or side effects.

Taking Paroxetina Almus in the morning with food may reduce the likelihood of nausea.

Pregnancy, breastfeeding, and fertility

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

In some studies, an increased risk of malformations, particularly those affecting the heart, has been observed in newborns whose mothers took Paroxetina Almus during the first months of pregnancy. In the general population, approximately 1 in 100 newborns is born with a heart malformation. This proportion increased to 2 in 100 newborns in mothers who took Paroxetina Almus. Your doctor, in agreement with you, may change your treatment to another or gradually stop the treatment with Paroxetina Almus while you are pregnant. However, depending on your circumstances, your doctor may recommend continuing to take Paroxetina Almus.

If you take Paroxetina Almus in the final stage 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 should know that you are taking Paroxetina Almus to advise you.

Make sure your doctor or midwife knows that you are taking Paroxetina Almus. Medicines like Paroxetina Almus may increase the risk of a serious disease called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy, particularly at the end of it. The pressure in the blood vessels that go between the heart and lungs is very high in newborns with persistent pulmonary hypertension (PPHN).

If you are taking Paroxetina Almus in the last trimester of pregnancy, your newborn may also have other symptoms that usually start during the first 24 hours after birth. These symptoms include:

• Difficulty breathing.
• Bluish skin or appearance of being too hot or cold.
• Bluish lips.
• Vomiting or difficulty feeding.
• Feeling very tired, difficulty sleeping, or frequent crying.
• Muscle stiffness or floppiness.
• Tremors, localized tremors, 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.

Paroxetina Almuspasses into breast milk in very small amounts.Consult your doctor if you are taking Paroxetina Almus before starting to breastfeed. Your doctor, in agreement with you, may advise you to continue breastfeeding while taking Paroxetina Almus.

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

Driving and using machines

Some of the side effects that Paroxetina Almus can cause are dizziness, confusion, drowsiness, or blurred vision. If you experience any of these effects, do not drive or use machines.

Paroxetina Almus 20 mg tablets contain soy.

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

Paroxetina Almus 20 mg tablets contain sodium.

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

3. How to take Paroxetine Almus 20 mg tablets

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

Sometimes it may be necessary to take more than one tablet or half a tablet. The following table will show you how many tablets you should take:

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

Your doctor will indicate what dose you should take when starting treatment with Paroxetine Almus.Most people start to feel better after a couple of weeks. If after this time you do not start to feel better, consult your doctor, who will indicate how to proceed. Your doctor may decide to gradually increase the dose, in increments of 10 mg, up to the maximum daily dose.

Take the tablets in the morning, with food.The tablets should be swallowed with water.

The tablets should not be chewed.

The tablet can be divided into equal doses.

Your doctor will indicate the duration of the treatment. This period may be extended for several months or even longer.

Elderly patients

The maximum dose for people over 65 years old is 40 mg per day.

Patients with kidney or liver problems

If you have severe hepatic or renal insufficiency, your doctor may advise you to take smaller doses of Paroxetine Almus than usual.

If you take more Paroxetine Almus than you should

Never take more tablets than your doctor has recommended.

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.

A person who has taken an overdose of Paroxetine Almus may experience some of the symptoms that appear in section 4, Possible adverse effects,or some of the following symptoms: fever, involuntary muscle contraction.

If you forget to take Paroxetine Almus

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 the usual time.

If you remember during the night or the next day, omit the forgotten dose. You may suffer 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 forgotten doses.

What to do if you do not feel better

Paroxetine Almus will not improve your symptoms immediately, all antidepressants take time to work. Some people start to feel better after a couple of weeks, but others may require more time. Some people who take antidepressants feel worse before starting to notice improvement. If you do not start to feel better after a couple of weeks, inform your doctor, who will indicate what to do. It is possible that your doctor has scheduled a follow-up appointment after 2 weeks of starting your treatment.

If you interrupt treatment with Paroxetine Almus

Do not interrupt treatment until your doctor indicates it.

When interrupting treatment with Paroxetine Almus, your doctor will indicate how to gradually reduce the doses over a period of several weeks or months, which will help reduce the risk of suffering from withdrawal symptoms. One way to do this is to gradually reduce the dose of Paroxetine Almus you are taking by 10 mg each week. Most people consider the possible symptoms that occur when interrupting treatment with Paroxetine Almus to be mild and disappear on their own within two weeks. For others, these symptoms can be more severe or last longer.

If you suffer from withdrawal effectswhile interrupting your treatment, the doctor may decide to interrupt it more slowly. If you experience severe withdrawal symptoms, please consult your doctor. Your doctor may advise you to start treatment again and then interrupt it more slowly.

Although you may suffer from some withdrawal effect, you will be able to interrupt your treatment with Paroxetine Almus.

Possible withdrawal effects when interrupting treatment

Studies have shown that 3 out of 10 patients experience one or more symptoms when interrupting their treatment with Paroxetine Almus. Some of these effects occur more frequently than others.

Common adverse effects

May affect up to 1 in 10 people

• • Feeling dizzy, unstable, or having balance disturbances.
• Tingling, burning sensations, and, less frequently, electric shock sensation, even in the head, buzzing, whistling, ringing, or other noises.
• Persistent 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

• Vomiting (nausea).
• Sweating (including night sweats).
• Restlessness or agitation.
• Tremors.
• Confusion or disorientation.
• Diarrhea (soft stools).
• Feeling very sensitive or irritable.
• Visual disturbances.
• Rapid or very strong heart palpitations.

Consult your doctor if you are concerned about the withdrawal effects of Paroxetine Almus.

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

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them. It is more likely that adverse effects will appear during the first weeks of treatment with Paroxetine Almus.

Inform your doctor if you suffer from any of the adverse effects described during treatment with Paroxetine Almus:

It may be necessary to consult your doctor or go to the hospital immediately.

Uncommon adverse effects

May affect up to 1 in 100 people:

• If you have bruises or unusual bleeding, such as blood in vomit or stools, contact your doctor or go to the hospital immediately.
• If you experience inability to urinate, contact your doctor or go to the hospital immediately.

Rare adverse effects

May affect up to 1 in 1,000 people:

• If you experience seizures(epileptic crises), contact your doctor or go to the hospital immediately.
• If you have a feeling of restlessness, inability to stay seated or stay still, called akathisia. Increasing the dose of Paroxetine Almus may worsen your symptoms. If you feel this way, consult your doctor.
• Fatigue, weakness, confusion, and pain, stiffness, and lack of muscle coordination. This may be due to low sodium levels in the blood. If you have these symptoms, consult your doctor.

Very rare adverse effects

May affect up to 1 in 10,000 people:

• Severe allergic reactions to Paroxetine Almus

If you develop a skin rash with redness and bumps, swelling of the face, eyelids, lips, mouth, or tongue, itching, or difficulty breathing (shortness of breath) or swallowing, and you feel weak or dizzy followed by collapse or loss of consciousness, contact your doctor or go to the hospital immediately.

• If you notice any or all of the following symptoms, you may be suffering from serotonin syndrome or neuroleptic malignant syndrome. The symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, trembling, chills, hallucinations (strange sounds or visions), muscle stiffness, sudden involuntary movements, or rapid heartbeats. The severity can increase and lead to loss of consciousness. If you feel this way, consult your doctor.
• Acute glaucoma.

If you experience eye pain and blurred vision, consult your doctor.

Frequency not known

The frequency cannot be estimatedfrom the available data

• Some people have experienced thoughts of self-harm or suicide while taking Paroxetine Almus or shortly after stopping treatment (see section 2 What you need to know before starting to take Paroxetine Almus).
• Aggression.
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Other possible adverse effects during treatment

Very common adverse effects

May affect more than 1 in 10 people:

• Feeling sick (nausea). This effect may be reduced by taking your medication in the morning after breakfast.
• Change 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 the blood.
• Decreased appetite.
• Difficulty sleeping (insomnia) or drowsiness.
• Abnormal dreams (including nightmares).
• Dizziness, tremors.
• Agitation.
• Unusual weakness.
• Blurred vision.
• Diarrhea 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 that can cause dizziness or fainting when standing up quickly.
• Faster than normal heartbeats.
• Lack of movement, stiffness, tremors, or abnormal movements of the mouth and tongue.
• Pupil dilation.
• Skin rash.
• Itching.
• Confusion.
• Hallucinations (strange sounds or visions).
• Inability to urinate (urinary retention) or urinary incontinence (uncontrolled and involuntary urination).
• If you are a diabetic patient, you may notice a loss of control over your sugar levels while taking Paroxetine Almus. Consult your doctor about how to adjust your insulin or diabetes medication dose.
• Decreased white blood cell count.

Rare adverse effects

May affect up to 1 in 1,000 people:

• Abnormal milk secretion in men and women.
• Decreased heart rate.
• Liver effects that appear in laboratory tests that indicate liver function.
• Panic attacks.
• Very active behavior or thoughts (mania).
• Feeling detached from oneself (depersonalization).
• Anxiety.
• Irresistible need to move the legs (Restless Legs Syndrome).
• Pain in joints or muscles.
• 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 adverse effects

May affect up to 1 in 10,000 people:

• Skin rash, which can appear with blisters that look like small targets (dark central spots surrounded by a pale area, with a dark ring around) called 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 disorders that turn the skin or the whites of the eyes yellow.
• Decreased platelet count in the blood.
• 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 (salt) concentration as a result of 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 erection of the penis.
• Decreased platelet count in the blood.

Frequency not known

The frequency cannot be estimatedfrom the available data

• Inflammation of the colon (causing diarrhea)
• Teeth grinding

Some patients have experienced buzzing, whistling, ringing, or other persistent noises in the ears (tinnitus) when taking Paroxetine Almus.

It has been observed that people taking medications like Paroxetine Almus have a higher risk of bone fractures.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Paroxetine Almus 20 mg tablets

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the blister, tablet container, or outer container. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

6. Package contents and additional information

Composition of Paroxetine Almus 20 mg tablets

The active ingredient is paroxetine hydrochloride. Each film-coated tablet contains anhydrous paroxetine hydrochloride equivalent to 20 mg of paroxetine.

• The other components (excipients) are:

Core of the tablet: magnesium stearate, sodium glycolate starch (Type A) of potato, mannitol, microcrystalline cellulose.

Coating of the tablet: methacrylic acid-methyl methacrylate copolymer (Eudragit E100), polyvinyl alcohol (partially hydrolyzed), titanium dioxide (E-171), talc, soy lecithin (E-322), xanthan gum (E-415).

Appearance of the product and package contents

Paroxetine Almus 20 mg: film-coated tablets, round and biconvex, white to off-white, 10 mm in diameter, scored on the edges and on both sides, and marked with P20 on one side.

The tablet can be divided into equal doses.

Package sizes:

Blister: 10, 12, 14, 28, 30, and 56 film-coated tablets.

Cylindrical white tablet container with white cap and desiccant (silica gel) containing: 20, 30, 60, and 100 film-coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80 Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer

Actavis Ltd.

BLB 015-016, Bulebel Industrial Estate

ZTN 3000 Zejtun

Malta

Balkanpharma – Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

This medication is authorized in the member states of the European Economic Area with the following names:

Italy: Paroxetine Almus 20 mg film-coated tablets

Date of the last revision of this leaflet:January 2024