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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paroxetina AlmusPharma 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. 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, and you should not give it to other people, even if they have the same symptoms as you, because it could 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 Paroxetina AlmusPharma 20 mg film-coated tablets are and what they are used for
What you need to know before taking Paroxetina AlmusPharma 20 mg film-coated tablets
How to take Paroxetina AlmusPharma 20 mg film-coated tablets
Possible side effects
How to store Paroxetina AlmusPharma 20 mg film-coated tablets
Contents of the pack and other information

1. What Paroxetina Almus Pharma is and what it is used for

Paroxetine is used for the treatment of depression and/or anxiety disorders in adults. The anxiety disorders for which this medicine 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), and generalized anxiety disorder (feeling excessively anxious or nervous most of the time).

Paroxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). The precise mechanism of action of this medicine and other SSRIs is not fully understood, but they work by increasing the level of serotonin in the brain. Proper treatment of depression or anxiety disorders is important to help you feel better.

2. What you need to know before taking Paroxetina Almus Pharma

Do not take Paroxetina Almus Pharma

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 paroxetine after stopping the MAOI.
If you are taking an antipsychotic medicine called thioridazine or the antipsychotic called pimozide.
If you are allergic to paroxetine, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6).

If any of these situations apply to you, tell your doctor and do not take this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking paroxetine

If you are taking other medicines (see section "Other medicines and Paroxetina Almus Pharma").
If you are taking tamoxifen for the treatment of breast cancer (or fertility problems). Paroxetine may make tamoxifen less effective, so your doctor should recommend that you take another antidepressant.
If you have any kidney, liver, or heart problems.
If you have an abnormality in your heart rhythm seen on an electrocardiogram (ECG), known as QT interval prolongation.
If you have a family history of QT interval prolongation, heart disease such as heart failure, slow heart rate, or low levels of potassium or magnesium.
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).
If you have diabetes.
If you are on a low-sodium diet.
If you have glaucoma (high eye pressure).
If you are pregnant or planning to 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 the answer is YES to any of these situations and you have not yet consulted your doctor**, ask your doctor about how to take paroxetine.**

Children and adolescents under 18 years of age

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

You should also know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking paroxetine. If your doctor has prescribed paroxetine for you (or your child) and you wish to discuss this decision, speak to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while you (or your child) are taking this medicine. 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/adolescents) were observed: increased suicidal thoughts and suicide attempts, self-harm attempts, hostile, aggressive, or unfriendly behavior, loss of appetite, tremors, abnormal sweating, hyperactivity (excessive energy), agitation, emotional lability (including crying and mood swings), and unexpected bruising or bleeding (such as nosebleeds). These effects were also observed, although less frequently, in patients in these studies who did not take paroxetine.

When stopping treatment with paroxetine, some patients under 18 years of age in these studies reported withdrawal symptoms. These symptoms were very similar to those observed in adults who stopped taking paroxetine (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 lability (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 of suicide. These 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 being treated with an antidepressant.

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

It may be helpful for you to tell 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 inform 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 paroxetine

Some patients taking paroxetine 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, tremor, chills, hallucinations (strange visions or sounds), muscle rigidity, sudden jerking movements, or increased heart rate. Symptoms may worsen and lead to loss of consciousness. Contact your doctor if you experience any of these symptoms. For more information on this or other adverse effects of Paroxetina Almus, see section 4.

Some medicines in the same class as paroxetine (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 Pharma

Some medicines may alter the effect of paroxetine or make it more likely that certain adverse effects occur. Paroxetine 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 Pharma.
Medicines known to increase the risk of changes in the heart's electrical activity (e.g., the antipsychotics thioridazine or pimozide). See section Do not take Paroxetina Almus Pharma.
Acetylsalicylic acid, ibuprofen, and other medicines called non-steroidal anti-inflammatory drugs (NSAIDs), such as celecoxib, etodolac, diclofenac, and meloxicam, used to treat pain and inflammation.
Tramadol, buprenorphine, and pethidine, analgesics.
Buprenorphine combined with naloxone, a substitution treatment for opioid addiction.
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 hyperactivity disorder (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, and have not discussed this with your doctor, inform your doctor and ask what you should do. Your doctor may decide to adjust 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 Pharma with food, drinks, and alcohol

Do not consume alcohol while taking Paroxetina Almus. Alcohol may worsen your symptoms or side effects. Taking this medicine 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. Some studies have shown an increased risk of birth defects, particularly those affecting the heart, in newborns whose mothers took paroxetine 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 paroxetine. Your doctor, in consultation with you, may switch you to another treatment or gradually discontinue this medicine during pregnancy. However, depending on your individual circumstances, your doctor may recommend continuing this medicine.

Ensure your doctor or midwife knows that you are taking paroxetine. If you take this medicine 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 this medicine so they can provide appropriate advice. Medicines like paroxetine may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN) when taken during pregnancy, particularly in the later stages. In newborns with PPHN, the pressure in the blood vessels between the heart and lungs is very high. If you take this medicine during the third trimester, your newborn may also experience other symptoms, usually beginning within the first 24 hours after birth. These symptoms include:

Difficulty breathing.
Bluish skin or appearing too hot or too cold.
Bluish lips.
Vomiting or feeding difficulties.
Extreme tiredness, difficulty sleeping, or frequent crying.
Muscle stiffness or floppiness.
Tremors, localized shaking, 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 for advice.

Paroxetine passes into breast milk in very small amounts. Consult your doctor if you are taking this medicine before starting breastfeeding. Your doctor, in consultation with you, may advise continuing breastfeeding while taking this medicine.

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 this medicine may cause include dizziness, confusion, drowsiness, or blurred vision. If you experience any of these effects, do not drive or operate machinery.

Paroxetina Almus Pharma contains sodium

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

Paroxetina Almus Pharma contains soya lecithin

This medicine contains soya lecithin. If you are allergic to peanuts or soya, do not take this medicine.

3. How to take Paroxetina Almus Pharma

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

Sometimes you may need 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	One 10 mg tablet (yellow) or half a 20 mg tablet (white)
20 mg	One 20 mg tablet (white) or two 10 mg tablets (yellow)
30 mg	One 30 mg tablet (blue) or one and a half 20 mg tablets (white) or one 20 mg tablet (white) + one 10 mg tablet (yellow) or three 10 mg tablets (yellow)
40 mg	Two 20 mg tablets (white) or one 30 mg tablet (blue) + one 10 mg tablet (yellow) or four 10 mg tablets (yellow)
50 mg	One 30 mg tablet (blue) + one 20 mg tablet (white) or two and a half 20 mg tablets (white) or two 20 mg tablets (white) + one 10 mg tablet (yellow) or five 10 mg tablets (yellow)
60 mg	Two 30 mg tablets (blue) or three 20 mg tablets (white) or six 10 mg tablets (yellow)

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 phobia 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. Most people start 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 increments of 10 mg, up to the maximum daily dose.

Take the tablets in the morning, with food.

Swallow the tablets with water.

Do not chew the tablets.

The tablet may be divided into equal doses.

Your doctor will tell you how long your treatment should last. This period may last 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 smaller doses of this medicine than usual.

If you take more Paroxetina Almus Pharma than you should

Never take more tablets than your doctor has recommended. If you take too many paroxetine tablets (or someone else does), consult your doctor or go to hospital immediately. Show them the medicine packaging.

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 medicine and the amount ingested.

A person who has taken an overdose of Paroxetina Almus Pharma 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 Pharma

Take your medicine 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 your usual time.

If you remember during the night or the following day, skip the missed dose. You may experience some withdrawal symptoms, but they should disappear after taking the next dose at your usual time.

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

What to do if you do not feel better

Paroxetine 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 taking antidepressants feel worse before they start to feel better. If you do not start 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. Inform your doctor if you have not started to feel better.

If you stop treatment with paroxetine

Do not stop treatment with Paroxetina Almus Pharma until your doctor tells you to do so.

When stopping treatment with paroxetine, your doctor will advise you on how to gradually reduce the dose over a period of several weeks or months. This will help reduce the risk of experiencing withdrawal symptoms. One way to do this is to gradually reduce your current dose by 10 mg each week. Most people find that the possible symptoms that occur when stopping this medicine are mild and disappear 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 stop the treatment more slowly. If you experience severe withdrawal symptoms, please consult your doctor. They may advise you to restart treatment and then stop it again more gradually.

Even if you experience withdrawal symptoms, you may still be able to stop your treatment with Paroxetina Almus Pharma.

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 paroxetine. 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, whistling, or other persistent noises 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 paroxetine.

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 will experience them. Adverse effects are more likely to occur during the first weeks of treatment with this medicine.

Inform your doctor if you experience any of the adverse effects described during treatment.

It may be necessary for you 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 this medicine may worsen your symptoms. If you feel this way, consult your doctor.
Tiredness, weakness, confusion, and muscle pain, stiffness, or lack of coordination, which 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 Pharma, which may be severe.

If you develop a skin rash with redness and lumps, swelling of the face, eyelids, lips, mouth or tongue, itching, or difficulty breathing (shortness of breath) or swallowing, and a feeling of weakness or dizziness that may lead to 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, trembling, chills, hallucinations (strange sounds or visions), muscle rigidity, sudden jerky movements, or rapid heartbeat. The condition may worsen 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 taking Paroxetina Almus Pharma).
Some people have experienced aggression while taking this medicine.
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see Pregnancy, breastfeeding and fertility in section 2 for more information.

If you experience these adverse effects, contact your doctor.

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 medicine 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 blood cholesterol levels.
Decreased appetite.
Difficulty sleeping (insomnia) or drowsiness.
Abnormal dreams (including nightmares).
Dizziness, tremors.
Headache.
Difficulty concentrating.
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 in blood pressure, or transient decreases in blood pressure that 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).
Reduced white blood cell count.
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 Pharma. Consult your doctor about how to adjust your insulin or diabetes medication dose.

Rare adverse effects

May affect up to 1 in 1,000 people:

Abnormal breast milk secretion in men and women.
Slowing of the heart rate.
Liver effects seen in laboratory tests indicating liver function.
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, in which blisters may appear resembling small targets (dark central spots surrounded by a pale area, with a dark ring around it), known as 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 abnormalities causing yellowing of the skin or whites of the eyes.
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 feel severely ill or may have no symptoms at all.
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) when taking paroxetine.

It has been observed that people taking this type of medicine have an increased risk of bone fractures.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a side 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 Pharma

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

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

If you are using scored tablets, take care to keep them safely stored in their original container.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you are unsure, please consult your pharmacist on how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paroxetina Almus Pharma

The active substance is paroxetine.

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

The other components are: mannitol, microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium stearate.
The film coating contains: basic butylated methacrylate copolymer, partially hydrolyzed poly(vinyl alcohol) (E1203), titanium dioxide (E171), talc (E553b), soybean lecithin (E322), and xanthan gum (E415).

Nature of the product and contents of the container

The tablets are white, round, film-coated, biconvex, 10 mm in diameter, with a score line on one side and marked with "P20" on the other.

The tablet can be divided into equal doses.

Pack sizes:

Paroxetina Almus Pharma 20 mg is available in blisters of 14, 28, and 56 film-coated tablets, and in perforated unit-dose blisters of 14, 28, and 56 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona),

Spain

Manufacturer:

Teva Pharma S.L.U.

C/C, n° 4, Polígono Industrial Malpica

50016 Zaragoza,

Spain

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

Denmark: Zakkinter

Spain: Paroxetina Almus Pharma 20 mg, 30 mg film-coated tablets EFG

France: Paroxetine Almus Pharma 20 mg, comprimé pelliculé sécable

Italy: Paroxetina Almus Pharma

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

Other sources of information

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