Paroxetine Almus 20 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paroxetine Almus 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

What Paroxetine Almus 20 mg film-coated tablets are and what they are used for
What you need to know before taking Paroxetine Almus 20 mg film-coated tablets
How to take Paroxetine Almus 20 mg film-coated tablets
Possible side effects
How to store Paroxetine Almus 20 mg film-coated tablets
Contents of the pack and other 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, repetitive thoughts with uncontrollable behaviour),
panic disorder (panic attacks, including those caused by agoraphobia, which is fear of open spaces),
social phobia (fear of or avoidance of social situations),
post-traumatic stress disorder (anxiety caused by a traumatic event),
generalized anxiety disorder (persistently feeling very anxious or nervous).

Paroxetina Almus belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). All of us have a substance in the brain called serotonin.

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

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

Do not take Paroxetina Almus

if you are allergic to paroxetine, peanuts, soy, or any of the other components of Paroxetina Almus (listed in section 6).
if you are being treated with medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide 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 Paroxetina Almus after stopping the MAOI.
if you are taking the antipsychotic medicine called thioridazine or the antipsychotic called pimozide.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Paroxetina Almus:

if you are taking other medicines (see section "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 any kidney, liver, or heart problems
if you have epilepsy or experience seizures or epileptic fits
if you have had manic episodes (excessively active thoughts or behaviors)
if you are receiving electroconvulsive therapy (ECT)
if you are prone to bleeding or bruising, or are taking any medicine that may increase the risk of bleeding (including medicines such as warfarin (acenocoumarol), antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, pain and inflammation medicines 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 become pregnant (see section "Pregnancy, breastfeeding and fertility")
if you are under 18 years of age (see section "Children and adolescents under 18 years of age").

If you are in any of these situations and have not yet consulted your doctor**, ask them about how to take Paroxetina Almus**

Children and adolescents under 18 years of age

Paroxetina Almus should not be used to treat children and adolescents under 18 years of age. You should also be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking Paroxetina Almus. Nevertheless, your doctor may prescribe Paroxetina Almus to patients under 18 years of age if they decide it is the most appropriate treatment for the patient. If your doctor has prescribed Paroxetina Almus for your child under 18 years of age and you wish to discuss this decision, consult your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while you or your child under 18 years of age are taking Paroxetina Almus. The long-term effects of Paroxetina Almus on safety regarding growth, maturation, and cognitive and behavioral development in this age group have not yet been established.

In clinical studies with paroxetine in patients under 18 years of age, the following common adverse effects (affecting less than 1 in 10 children or adolescents) were observed: increased suicidal thoughts and attempts, self-harm attempts, hostile, aggressive, or unfriendly behaviors, loss of appetite, tremors, abnormal sweating, hyperactivity (excessive energy), restlessness, emotional instability (including crying and mood swings), and unexpected bruising or bleeding (such as nosebleeds). These effects were also observed, although less frequently, in patients included in these studies who did not take paroxetine.

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

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 thoughts may increase at the beginning of treatment with antidepressants, as all these medicines take time to work—usually about two weeks, but sometimes longer.

You are more likely to experience this if you have previously had suicidal thoughts or thoughts of self-harm.
If you are a young adult. Clinical trial data show an increased risk of suicidal behavior in psychiatric patients under 25 years of age treated with antidepressants.

If you have thoughts of harming yourself or committing suicide at any time, contact your doctor or go to the hospital immediately.

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

Important adverse effects observed with Paroxetina Almus

Some patients taking Paroxetina Almus develop a condition called akathisia, and feel restless and unable to sit still or remain motionless. Other patients develop a condition called serotonin syndrome or neuroleptic malignant syndrome, and may experience one or more of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden jerking movements, or increased heart rate. The condition may worsen and lead to loss of consciousness. Contact your doctor if you experience any of these symptoms. For more information about this or other adverse effects of Paroxetina Almus, see section 4 Possible adverse effects in this leaflet.

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

Other medicines and Paroxetina Almus

Some medicines may alter the effect of Paroxetina Almus or make it more likely that certain adverse effects will occur. Paroxetina Almus may also alter the effect of some medicines. For example:

Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride (methylene blue)). See section "Do not take Paroxetina Almus".
The medicines called thioridazine or pimozide, which are antipsychotics. See 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 migraine.
Other antidepressants, including other selective serotonin reuptake inhibitors and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
A dietary supplement called tryptophan.
Mivacurium and suxamethonium (used in anesthesia).
Medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat certain psychiatric disorders.
Fentanyl, used in anesthesia or to treat chronic pain.
A combination of fosamprenavir and ritonavir, used to treat human immunodeficiency virus (HIV) infection.
St. John’s wort, a herbal remedy used to treat depression.
Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizures or epilepsy.
Atomoxetine, a medicine used to treat attention deficit disorder and hyperactivity (ADHD).
Procyclidine, used to relieve tremors, especially in Parkinson’s disease.
Warfarin and other medicines (called anticoagulants) used to thin the blood.
Propafenone, flecainide, and medicines used to treat heart rhythm disorders.
Metoprolol, a beta-blocker used to treat high blood pressure and heart 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, inform your doctor and ask what you should do. Your doctor may decide to change the dose or prescribe a different medicine.

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

Taking Paroxetina Almus with food, drinks, and alcohol

Do not consume alcohol while taking Paroxetina Almus. Alcohol may worsen your symptoms or adverse 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 birth defects, 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 defect. This rate increased to 2 in 100 newborns in mothers who took Paroxetina Almus. Your doctor, in agreement with you, may switch you to another treatment or gradually discontinue Paroxetina Almus during pregnancy. However, depending on your circumstances, your doctor may recommend continuing Paroxetina Almus.

If you take Paroxetina Almus in the late stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Paroxetina Almus so they can advise you.

Ensure your doctor or midwife knows you are taking Paroxetina Almus. Medicines like Paroxetina Almus may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy, particularly in the later stages. In newborns with persistent pulmonary hypertension (PPHN), the pressure in the blood vessels between the heart and lungs is very high.

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

Difficulty breathing.
Bluish skin or appearance of being too hot or too cold.
Bluish lips.
Vomiting or feeding difficulties.
Extreme tiredness, trouble sleeping, or frequent crying.
Muscle stiffness or floppiness.
Tremors, localized tremors, or seizures.
Exaggerated reflexes.

If your baby shows 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 Almus passes into breast milk in very small amounts. Consult your doctor if you are taking Paroxetina Almus before starting breastfeeding. Your doctor, in agreement with you, may advise continuing breastfeeding while taking Paroxetina Almus.

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

Driving and using machines

Some of the adverse effects caused by Paroxetina Almus include dizziness, confusion, drowsiness, or blurred vision. If you experience any of these effects, do not drive or operate machinery.

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

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

Dosage	Number of tablets to take
10 mg	Half a tablet
20 mg	One tablet
30 mg	One and a half tablets
40 mg	Two tablets
50 mg	Two and a half tablets
60 mg	Three tablets

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

	Initial daily 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 starting treatment with Paroxetina Almus. Most people begin to feel better after a couple of weeks. If you do not start to feel better after this time, consult your doctor, who will advise you on what to do. Your doctor may decide to gradually increase your dose in 10 mg increments up to the maximum daily dose.

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

The tablets must not be chewed.

The tablet may be divided into equal doses.

Your doctor will tell you how long your treatment should last. This period may extend for several months or even longer.

Elderly patients

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

Patients with kidney or liver problems

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

If you take more Paroxetina Almus than you should

Never take more tablets than your doctor has prescribed.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

A person who has taken an overdose of Paroxetina Almus may experience some of the symptoms listed in section 4, Possible side effects, or any of the following symptoms: fever, involuntary muscle contractions.

If you forget to take Paroxetina Almus

Take your medication at the same time each 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 following day, skip the missed dose. You may experience some withdrawal symptoms, but these should disappear after taking the next dose at the usual time.

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

What to do if you do not feel better

Paroxetina Almus will not improve your symptoms immediately; all antidepressants take time to work. Some people begin to feel better after a couple of weeks, but others may require more time. Some people taking antidepressants feel worse before they start to feel better. If you do not begin to feel better after a couple of weeks, inform your doctor, who will advise you on what to do. Your doctor may have scheduled a follow-up appointment two weeks after starting your treatment.

If you stop treatment with Paroxetina Almus

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

When stopping treatment with Paroxetina Almus, your doctor will instruct you on how to gradually reduce the dose over a period of several weeks or months, which will help reduce the risk of experiencing withdrawal symptoms. One way to do this is to gradually reduce your current dose of Paroxetina Almus by 10 mg each week. Most people find that any possible symptoms occurring when stopping treatment with Paroxetina Almus are mild and resolve on their own within two weeks. For others, these symptoms may be more severe or last longer.

If you experience withdrawal symptoms while stopping your treatment, your doctor may decide to discontinue treatment more slowly. If you experience severe withdrawal symptoms, please consult your doctor. Your doctor may advise you to restart treatment and then discontinue it more gradually.

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

Possible withdrawal effects when stopping treatment

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

Frequent adverse effects

May affect up to 1 in 10 people

- Dizziness, unsteadiness, or balance disturbances.
Tingling, burning sensations, and less frequently, electric shock-like sensations, even in the head; ringing, buzzing, hissing, 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

Nausea (vomiting).
Sweating (including night sweats).
Restlessness or agitation.
Tremor.
Confusion or disorientation.
Diarrhea (loose stools).
Feeling overly sensitive or irritable.
Visual disturbances.
Rapid or very strong heartbeats (palpitations).

Consult your doctor if you are concerned about withdrawal effects from Paroxetina Almus.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Adverse effects are more likely to occur during the first weeks of treatment with Paroxetina Almus.

Inform your doctor if you experience any of the adverse effects described during treatment with Paroxetina Almus:

You may need to consult your doctor or go to hospital immediately.

Uncommon adverse effects

May affect up to 1 in 100 people:

If you have unusual bruising or bleeding, such as blood in vomit or stools, contact your doctor or go to hospital immediately.
If you are unable to urinate, contact your doctor or go to hospital immediately.

Rare adverse effects

May affect up to 1 in 1,000 people:

If you experience seizures (epileptic fits), contact your doctor or go to hospital immediately.
If you feel restless, unable to sit still or remain motionless, known as akathisia. Increasing the dose of Paroxetina Almus may worsen your symptoms. If you feel this way, consult your doctor.
Tiredness, weakness, confusion, and muscle pain, stiffness, and lack of 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:

Allergic reactions to Paroxetina Almus that can be severe

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

If you notice any or all of the following symptoms, you may be experiencing serotonin syndrome or neuroleptic malignant syndrome. Symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremor, chills, hallucinations (strange sounds or visions), muscle rigidity, sudden jerky movements, or rapid heartbeat. Severity may increase and lead to loss of consciousness. If you feel this way, consult your doctor.
Acute glaucoma

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

Frequency not known

Frequency cannot be estimated from the available data

Some people have experienced thoughts of self-harm or suicide while taking Paroxetina Almus or shortly after stopping treatment (see section 2 What you need to know before starting to take Paroxetina Almus).
Aggressiveness.
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); 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 unwell (nausea). This effect may be reduced by taking your medication in the morning after breakfast.
Changes in sexual desire or function, for example, lack of orgasm and, in men, abnormal erection or ejaculation.

Common adverse effects

May affect up to 1 in 10 people:

Increased levels of cholesterol in the blood.
Decreased appetite.
Difficulty sleeping (insomnia) or drowsiness.
Abnormal dreams (including nightmares).
Dizziness, tremors.
Agitation.
Unusual weakness.
Blurred vision.
Yawning, dry mouth.
Diarrhoea or constipation.
Vomiting.
Weight gain.
Sweating.

Uncommon adverse effects

May affect up to 1 in 100 people:

Transient increases or decreases in blood pressure, which may cause dizziness or fainting when standing up quickly.
Faster than normal heartbeat.
Lack of movement, stiffness, tremor, or abnormal movements of the mouth and tongue.
Pupil dilation.
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 of your blood sugar levels while taking Paroxetina Almus. Consult your doctor about adjusting your insulin or diabetes medication dosage.
Decreased white blood cell count.

Rare adverse effects

May affect up to 1 in 1,000 people:

Abnormal milk secretion in men and women.
Slowed heart rate.
Liver effects seen in laboratory tests indicating liver function abnormalities.
Panic attacks.
Very active behaviour or thoughts (mania).
Feeling detached from oneself (depersonalization).
Anxiety.
Irresistible urge to move the legs (Restless Legs Syndrome).
Joint or muscle pain.
Increased blood levels of a hormone called prolactin.
Menstrual cycle disturbances (including heavy or irregular periods, bleeding between periods, and absence or delay of periods).

Very rare adverse effects

May affect up to 1 in 10,000 people:

Skin rash with blisters appearing as small target-like spots (dark central spots surrounded by a pale area, with a dark ring around it), known as erythema multiforme.
Widespread blistering rash with peeling skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
Widespread rash affecting large areas of the body with blisters and skin peeling (toxic epidermal necrolysis).
Liver problems causing yellowing of the skin or whites of the eyes.
Decreased platelet count in blood.
Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body retains excess water and sodium (salt) concentration decreases due to inappropriate chemical signals. Patients with SIADH may feel severely unwell or may have no symptoms.
Water or fluid retention (causing swelling of arms or legs).
Sensitivity to sunlight.
Painful and prolonged penile erection.
Decreased platelet count in blood.

Frequency not known

Frequency cannot be estimated from the available data

Inflammation of the colon (causing diarrhoea)
Teeth grinding

Some patients have experienced ringing, buzzing, hissing, tinkling or other persistent noises in the ears (tinnitus) while taking Paroxetina Almus.

It has been observed that people taking medicines like Paroxetina Almus have an increased risk of bone fractures.

Reporting of adverse effects

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

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paroxetine Almus 20 mg Tablets

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

Do not use this medicine after the expiry date stated on the blister pack, tablet container, or outer packaging. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Instead, return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure how to dispose of unused medicines or packaging, ask your pharmacist. This will help protect the environment.

6. Contents of the container and other information

Composition of Paroxetina Almus 20 mg tablets

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

Other components (excipients) are:

Tablet core: magnesium stearate, sodium glycolate starch (Type A) from potato, mannitol, microcrystalline cellulose.

Tablet coating: methacrylic acid-methyl methacrylate copolymer (Eudragit E100), polyvinyl alcohol (partially hydrolyzed), titanium dioxide (E-171), talc, soybean lecithin (E-322), xanthan gum (E-415).

Appearance of the product and contents of the container

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

The tablet can be divided into equal doses.

Container sizes:

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

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

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80
Email: [email protected]

Manufacturer:

Actavis Ltd.

BLB 015-016, Bulebel Industrial Estate

ZTN 3000 Zejtun

Malta

Balkanpharma – Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Italy: Paroxetina Almus 20 mg compresse rivestite con film

Date of the most recent revision of this leaflet: January 2024