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

Patient Information Leaflet

Introduction

Patient Information Leaflet

Paroxetina Davurgama 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor 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 may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

What Paroxetina Davurgama is and what it is used for
What you need to know before taking Paroxetina Davurgama
How to take Paroxetina Davurgama
Possible side effects
How to store Paroxetina Davurgama
Contents of the pack and other information

1. What Paroxetina Davurgama 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 the fear of open spaces), social anxiety disorder (fear of or avoidance of social situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (persistently feeling excessive anxiety and worry).

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 Davurgama

Do not take Paroxetina Davurgama

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 any of these 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, soy, or peanuts, or to any of the other ingredients of this medicine (listed in section 6).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take paroxetine

If you are taking other medicines (see section "Other medicines and Paroxetina Davurgama"),
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 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 conditions 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 behavior)
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, medicines for pain and inflammation 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 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 your answer is YES to any of these situations and you have not yet consulted your doctor**, go to your doctor and ask about how to take paroxetine**.

Children and adolescents under 18 years of age

Paroxetine 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 (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, consult 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 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, common adverse effects, affecting fewer than 1 in 10 children/adolescents, included: increased suicidal thoughts and attempts, self-harm attempts, hostile, aggressive, or unfriendly behavior, loss of appetite, tremors, abnormal sweating, hyperactivity (excessive energy), agitation, emotional instability (including crying and mood swings), and occurrence of unexplained bruising or bleeding (such as nosebleeds). These effects were also observed, although less frequently, in children/adolescents in these studies who were taking placebo instead of paroxetine.

When discontinuing treatment with paroxetine, some patients under 18 years of age in these studies reported withdrawal-related adverse effects. These effects were very similar to those observed in adults discontinuing paroxetine (see section 3). In addition, patients under 18 years of age frequently experienced (affecting fewer than 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 may increase at the beginning of treatment with antidepressants, as all these medicines take time to work—usually about two weeks, but sometimes longer.

This is more likely to happen if:

You have previously had suicidal thoughts or thoughts of self-harm.
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 explain to 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, 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 paroxetine, 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 Davurgama

Some medicines may alter the effect of paroxetine or increase the likelihood of adverse effects. 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 Davurgama
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 Davurgama.
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, used as opioid addiction replacement therapy.
Medicines called triptans, such as sumatriptan, used to treat 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 conditions.
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 for advice on what to do. Your doctor may decide to change your dose or prescribe a different medicine.

Inform 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 Davurgama with food, drinks, and alcohol

Do not consume alcohol while taking this medicine. Alcohol may worsen your symptoms or adverse 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.

In some studies, an increased risk of birth defects, particularly those affecting the heart, has been observed 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 paroxetine 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 you are taking this medicine so they can advise you. Medicines like paroxetine 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 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 appearance of being too hot or too cold
Bluish lips
Vomiting or feeding difficulties
Extreme tiredness, difficulty 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.

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. Theoretically, this could affect fertility in humans, but this effect has not yet been observed in people.

Driving and use of 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 Davurgama contains sodium

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

Paroxetina Davurgama contains soya lecithin

This medicine contains soya lecithin (derived from soya oil). Do not take this medicine if you are allergic to peanuts or soya.

3. How to take Paroxetine Davurgama

Follow exactly the dosage instructions given to you by your doctor. If in doubt, 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 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 starting treatment with paroxetine. 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 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 must not be chewed.

The score line is intended to divide the tablet into equal doses.

Your doctor will determine 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 paroxetine than usual.

If you take more paroxetine than you should

Never take more tablets than your doctor has prescribed. If you take too many paroxetine tablets (or someone else does), contact 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 paroxetine may experience some of the symptoms listed in section 4, Possible adverse effects, or any of the following symptoms: fever, involuntary muscle contractions.

If you forget to take Paroxetina Davurgama

Take your medicine at the same time every day.

If you forget to take a dose but remember before going to bed, take it immediately. Then take your 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 they should disappear after taking your 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

Paroxetine 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. Consult your doctor if you have not started to feel better.

If you stop treatment with paroxetine

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

When stopping treatment with paroxetine, your doctor will instruct 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 paroxetine dose by 10 mg each week. Most people find that any 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 that you should stop more slowly. If you experience severe withdrawal symptoms, please consult your doctor. They may advise you to restart treatment and then stop again more gradually.

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

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 using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Tell your doctor if you experience any of the following adverse effects during treatment

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.
Feeling restless, unable to sit still or remain still, 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, 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 paroxetine that may be serious.

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 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, 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 harming themselves or suicide while taking this medicine or shortly after stopping treatment (see Suicidal thoughts and worsening of depression or anxiety disorder in section 2).
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 and 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 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).
Decreased 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 loss of control of blood sugar levels while taking this medicine. 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 milk production in men and women.
Slower than normal heart rate.
Liver effects seen in laboratory tests indicating liver function.
Panic attacks.
Very active behaviour or thoughts (mania).
Feeling detached from oneself (depersonalisation).
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 with a target-like appearance (dark central spots surrounded by a pale area, with a dark ring around it), called erythema multiforme.
Widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
Widespread rash over a large area of the body with blisters and peeling of the skin (toxic epidermal necrolysis).
Liver disturbances 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 has reduced 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 number of platelets in the 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 possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paroxetine Davurgama

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

Do not use this medicine after the expiry date shown on the blister, bottle, or packaging, following EXP. The expiry date refers to the last day of the month indicated.

If you are taking half a tablet, take care to store it safely in the original packaging.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist 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 Davurgama

The active substance is paroxetine.

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

The other components are mannitol, microcrystalline cellulose, sodium carboxymethyl starch Type A (from potato), magnesium stearate.
The coating contains: basic butyl methacrylate copolymer, partially hydrolysed polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), soya lecithin (E322) and xanthan gum (E415).

Appearance of the product and contents of the pack

The tablets are white, round, coated, biconvex, 10 mm in diameter, scored on one side and printed on the other with P20.

The score mark is intended to facilitate breaking the tablet into equal doses.

It is presented in blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 98 or 100 film-coated tablets and in pre-cut single-dose blister packs of 10x1, 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 98x1 or 100x1 film-coated tablets, and in bottles containing 28, 56, 100 or 250 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

The Netherlands

Local representative

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 - Madrid

Spain

Manufacturer:

Teva Pharma, S.L.U.

Polígono Malpica C/ C, 4.

50016 Zaragoza

Spain

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

Denmark: Paroxetin Teva B.V.

Spain: Paroxetina Davurgama 20 mg film-coated tablets EFG

Portugal: Paroxetina Refta

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

Other sources of information

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