Daparox 20 mg film-coated tablets: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Daparox 20 mg film-coated tablets

paroxetine (mesilate)

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 must not be given to other people, even if they have the same symptoms as you. It could harm them.
If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Daparox is and what it is used for

Paroxetine belongs to a group of antidepressant medicines known as selective serotonin reuptake inhibitors (SSRIs).

Daparox is indicated for:

Major depressive episode (periods of depression).
Obsessive-compulsive disorder (obsessive repetition of thoughts and/or actions).
Panic disorder with and without agoraphobia (abnormal fear of leaving home, entering shops, or fear of open spaces).
Social anxiety disorder/social phobia (excessive fear or avoidance of any social situation).
Generalized anxiety disorder (generalized fear accompanied by significant anxiety or nervousness).

2. What you need to know before taking Daparox

Do not take Daparox

if you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6).
if you are taking medicines for the treatment of depression or Parkinson’s disease [the so-called monoamine oxidase inhibitors (MAOIs) ].
You may only use paroxetine if you have stopped taking irreversible MAOIs at least 14 days earlier (e.g. isocarbazide and phenelzine).
if you are using a reversible MAOI (e.g. moclobemide, linezolid, methylene blue (methylthioninium chloride)), you must wait at least 24 hours before taking paroxetine.
Conversely, when stopping paroxetine, you must wait at least 7 days before starting MAOIs.
if you are receiving treatment with thioridazine, used to treat serious mental illnesses such as psychosis (see also section 2 “Other medicines and Daparox”).
if you are taking medicines used to treat psychosis, such as pimozide (see section 2 “Other medicines and Daparox”).

Warnings and precautions

Talk to your doctor or pharmacist before starting Daparox:

if you are taking certain medicines used in the treatment of depression or Parkinson’s disease (MAOIs). You must not take paroxetine together with these medicines. Your doctor will advise you when to start treatment with paroxetine after stopping these MAOIs (see section 2, “Do not take Daparox”, and section 2, “Other medicines and Daparox”).
if you experience symptoms such as restlessness, hyperactivity, inability to sit still, or inability to remain still (akathisia). This may occur during the first weeks of treatment. If so, contact your doctor. Increasing the dose may be harmful.
if you start experiencing symptoms of serotonin syndrome. This syndrome presents as a combination of some of the following symptoms: agitation (extreme), confusion, irritability, delirium (hallucinations), sweating, tremors or chills, increased reflexes, sudden muscle contractions (myoclonus), high fever or rigidity (see section 2, “Other medicines and Daparox”). If you experience any of these symptoms together, contact your doctor immediately and stop taking paroxetine.
if you have or have had episodes of extreme euphoria or overexcitement causing unusual behavior (mania). If you enter a manic phase, it may be necessary to discontinue treatment with paroxetine.
if you have liver problems or severe kidney problems. Your doctor may need to adjust your dose.
if you have diabetes. Treatment with paroxetine may alter blood sugar levels, which should therefore be monitored. It may be necessary to adjust the dose of insulin or oral antidiabetic agents.
if you have or have had epilepsy or seizures. Paroxetine may cause seizures (stroke), so your doctor must pay close attention to this. If you experience seizures (stroke), contact your doctor immediately. It may be necessary to discontinue treatment with paroxetine.
if you are receiving electroconvulsive therapy (ECT). Experience with the use of paroxetine during ECT is limited, so your doctor must pay close attention to this.
if you have or have had increased intraocular pressure (glaucoma). Paroxetine may dilate the pupils (mydriasis), which could lead to increased eye pressure, so your doctor must monitor this carefully.
if you have cardiovascular disorders. The safety of paroxetine use has not been investigated in patients with this condition, so your doctor should take extra precautions.
if you are an elderly person, are taking other medication, or have liver problems (cirrhosis), and as a result are at high risk of having low levels of sodium (salt) in the blood. Paroxetine may decrease blood sodium concentration, causing weakness and fatigue. If this occurs, contact your doctor.
if you have an increased tendency to bleed, if you are taking medicines that may increase the risk of bleeding, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”). Paroxetine may increase the risk of bleeding, so your doctor must pay close attention to this (see section 2 “Other medicines and Daparox”).
if you wish to stop taking paroxetine, you may experience withdrawal symptoms, especially if treatment is stopped abruptly (see section 3 “If you stop taking Daparox”). Consult your doctor before stopping treatment with paroxetine.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or of suicide. This risk may increase when you first start taking antidepressants, because 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 thoughts of suicide or self-harm.
you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in psychiatric patients under 25 years of age treated with an antidepressant.

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

It may be helpful for you to explain to a close family member or 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.

Some medicines in the same group as Daparox (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Paroxetine should not be used in children or adolescents under 18 years of age. You should 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 (especially aggression, confrontational behavior, and anger) when taking this type of medicine. Nevertheless, your doctor may prescribe paroxetine to patients under 18 years of age if they decide it is in their best interest. If your doctor has prescribed paroxetine to a patient under 18 years of age and you wish to discuss this decision, speak to them. You must inform your doctor if any of the symptoms listed above appear or worsen in patients under 18 years of age treated with paroxetine. In addition, it has not been definitively established whether this medicine affects growth, maturation, or cognitive or behavioral development in this age group.

Other medicines and Daparox

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

There are other medicines whose effects may be affected by paroxetine. In turn, these medicines may affect the effectiveness of paroxetine. Paroxetine may interact with the following medicines:

Medicines used to treat depression or Parkinson’s disease (MAOIs such as moclobemide or isocarboxazid), a dietary supplement (L-tryptophan), migraine medicines (triptans such as sumatriptan, almotriptan), certain painkillers (tramadol, buprenorphine, meperidine), an antibiotic (linezolid), a preoperative visualizing agent (methylene blue), other selective serotonin reuptake inhibitors (SSRIs such as fluoxetine, sertraline), medicines used to treat psychiatric disorders (lithium, risperidone), certain medicines used to treat chronic pain or anesthesia (fentanyl), and St. John’s wort (Hypericum perforatum), a herbal remedy for depression. Concurrent use of these medicines may cause serotonin syndrome (see section 2 “Do not take Daparox” and section 2 “Warnings and precautions”).
Buprenorphine combined with naloxone, opioid addiction replacement therapy.
Treatment for psychosis (pimozide). Studies on the concomitant use of paroxetine and pimozide show that paroxetine may increase blood levels of pimozide. Since pimozide can cause serious adverse effects such as cardiac rhythm disorders, you must not use paroxetine at the same time as pimozide (see section 2, “Do not take Daparox”).
Medicines that are enzyme inhibitors, such as certain medicines used to treat depression (clomipramine). Your doctor may prescribe a lower than usual dose. If you are to use paroxetine together with enzyme inducers (e.g.: carbamazepine, rifampicin, phenobarbital and phenytoin), a lower initial dose is generally not required, and your doctor will adjust subsequent doses according to the medicine’s effect.
Due to interaction with paroxetine, there may be a prolonged muscle-relaxing effect of muscle relaxants used in anesthesia such as mivacurium and suxamethonium.
Combination of medicines to treat Acquired Immunodeficiency Syndrome (AIDS) (fosamprenavir and ritonavir).
Medicines used to treat Parkinson’s disease (procyclidine). The effect and adverse effects of procyclidine may be increased. If you start experiencing adverse effects such as dry mouth, blurred vision, constipation, and urinary retention due to voiding dysfunction, it may be necessary to reduce the dose of procyclidine, after consulting your doctor.
Medicines used to treat epilepsy (anticonvulsants such as sodium valproate). Although no direct effect has been demonstrated, your doctor must prescribe paroxetine very carefully in patients with epilepsy.
Medicines that are metabolized by the same liver enzymes as paroxetine, such as some antidepressants (tricyclic antidepressants like nortriptyline and desipramine), certain medicines for severe mental illnesses such as antipsychotics (perphenazine, thioridazine, and risperidone), a medicine used to treat children with attention deficit hyperactivity disorder (ADHD) (atomoxetine), certain medicines for cardiac rhythm disorders (such as flecainide and propafenone), certain medicines for chest tightness (angina) and high blood pressure (metoprolol), a medicine used to treat high cholesterol (pravastatin), and certain medicines for severe mental illness or nausea and vomiting (phenothiazines). The effect and adverse effects of these medicines may increase. Paroxetine and thioridazine must not be used together due to the risk of serious adverse effects such as cardiac rhythm disorders (serious ventricular arrhythmia) and sudden death (see section 2 “Do not take Daparox”).
Oral anticoagulant tablets (anticoagulants such as acenocoumarol, phenprocoumon). The effect and adverse effects of these medicines may be increased, as well as the risk of bleeding. Your doctor should monitor you more closely and it may be necessary to adjust the anticoagulant dose (see section 2, “Warnings and precautions”).
Medicines used to treat breast cancer or fertility problems (tamoxifen).
Medicines that increase the risk of bleeding. Certain medicines used to treat severe mental illness or nausea and vomiting (phenothiazines such as chlorpromazine, perphenazine), a medicine used to treat schizophrenia (clozapine), certain medicines used to treat depression (tricyclic antidepressants), acetylsalicylic acid, medicines used for pain and inflammation (NSAIDs such as ibuprofen, or COX-2 inhibitors such as rofecoxib, celecoxib) (see section 2, “Warnings and precautions”).
Medicines used to reduce stomach acidity (cimetidine, omeprazole).

Taking Daparox with food, drinks and alcohol

You should avoid consuming alcohol while taking this medicine.

Pregnancy, breastfeeding and fertility

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

There are not sufficient data to determine the safety and efficacy of paroxetine use during pregnancy. Some studies have shown an increased risk of cardiac effects in newborns of mothers who received paroxetine during the first months of pregnancy. You and your doctor may decide whether it is better to switch to another treatment or gradually discontinue paroxetine treatment. However, depending on the circumstances, your doctor may advise continuing treatment.

Make sure your midwife or doctor knows that you are taking paroxetine. If you take Daparox 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 must know you are taking Daparox so they can advise you.

Medicines like paroxetine may increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy, particularly towards the end of pregnancy, causing the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours of life. If this happens to your baby, contact your midwife and/or doctor immediately. If you take paroxetine during the last three months of pregnancy, your newborn baby may also have other conditions, which usually begin within the first 24 hours after birth. These include difficulty sleeping or feeding, breathing problems, bluish skin color, temperature fluctuations, vomiting, persistent crying, muscle stiffness or floppiness, lethargy, tremors, restlessness, or irritability. If you notice any of these symptoms in your newborn, contact your doctor or midwife for advice.

Paroxetine is excreted in small amounts in breast milk. If you are taking paroxetine, consult your doctor about whether you should start breastfeeding. Therefore, you should not take it while breastfeeding unless your doctor tells you to.

In animal studies, paroxetine has been shown to reduce sperm quality. In theory, this could affect fertility, although its impact on human fertility is not yet known.

Driving and using machines

Paroxetine does not affect the ability to drive or use machines. However, this medicine may cause adverse effects (such as blurred vision, dizziness, drowsiness, or confusion). If you experience any of these adverse effects, do not drive or operate machinery, or do any other activity requiring alertness or concentration. This means that before performing such activities, you should observe your reaction to paroxetine.

Daparox contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Daparox

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

Paroxetine should preferably be taken in the morning with food. Swallow the tablets whole, without chewing.

The tablet may be divided into equal doses.

The recommended dose is:

Major Depressive Episode

The recommended dose is 1 tablet (20 mg paroxetine) daily. Improvement usually begins within one week, but you may not notice the effect until the second week. If the effect is not satisfactory, your doctor may decide to gradually increase the dose in increments of half a tablet (10 mg paroxetine) up to a maximum of two and a half tablets (50 mg paroxetine) daily. Your doctor will determine the duration of treatment, which may be longer than 6 months.

Obsessive-Compulsive Disorder (OCD)

The recommended dose is 2 tablets (40 mg paroxetine) daily, with an initial dose of 1 tablet (20 mg paroxetine) daily. If the effect is not satisfactory, your doctor may decide to gradually increase the dose in increments of half a tablet (10 mg paroxetine). The maximum dose is 3 tablets (60 mg paroxetine) daily. Your doctor will determine the duration of treatment, which may last for several months or even longer.

Panic Disorder with or without Agoraphobia

The recommended dose is 2 tablets (40 mg paroxetine) daily, with an initial dose of half a tablet (10 mg paroxetine) daily. If the effect is not satisfactory, your doctor may decide to gradually increase the dose in increments of half a tablet (10 mg paroxetine). The maximum dose is 3 tablets (60 mg paroxetine) daily. The initial dose is low to avoid worsening of panic disorder symptoms during the initial phase of treatment. Your doctor will determine the duration of treatment, which may last for several months or even longer.

Social Anxiety Disorder / Social Phobia

The recommended dose is 1 tablet (20 mg paroxetine) daily. If the effect is not satisfactory, your doctor may decide to gradually increase the dose in increments of half a tablet (10 mg paroxetine). The maximum dose is two and a half tablets (50 mg paroxetine) daily. Your doctor will determine the duration of treatment. This may be prolonged and should be regularly reviewed.

Generalized Anxiety Disorder

Elderly patients

The recommended initial dose for elderly patients is the same as for adults, although the maximum dose should not exceed 2 tablets (40 mg paroxetine) daily.

Use in children and adolescents

Paroxetine must not be used in children or adolescents under 18 years of age (see section 2, “Children and adolescents”).

Patients with renal or hepatic impairment

If you have liver problems or severe kidney disease, your doctor will need to adjust your dose.

Duration of treatment

Your doctor will determine how long you should continue taking paroxetine. Depending on your condition, you may need to take paroxetine for a long time. You should continue taking paroxetine for a certain period even after your symptoms have subsided, to prevent them from returning. Do not stop treatment with paroxetine without consulting your doctor. If you stop treatment with paroxetine suddenly, you may experience withdrawal symptoms; therefore, the dose should be gradually reduced (see section 3, “If you stop taking Daparox”).

If you take more Daparox than you should

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). In addition to the known side effects (see section 4, “Possible adverse effects”), you may experience the following symptoms: fever and involuntary muscle contractions.

If you forget to take Daparox

Do not take a double dose to make up for a missed dose. Skip the missed dose and continue taking the medicine as usual. If you have any doubts, always consult your doctor.

If you stop taking Daparox

Do not stop treatment with Daparox without consulting your doctor, and never stop treatment suddenly, as this may cause withdrawal symptoms. The effects you may experience if you stop taking paroxetine include: dizziness, sensory disturbances (tingling or burning sensations, feeling of electric shocks, or ringing, buzzing, whistling, hissing, or other persistent noises in the ears (tinnitus)), anxiety, sleep disturbances (such as vivid dreams or nightmares), and headache. Less common effects include: agitation, nausea, tremor, confusion, sweating, emotional instability, visual disturbances, strong heartbeats (palpitations), diarrhea, and irritability (see section 4 “Possible adverse effects”).

These symptoms usually begin in the first few days after stopping treatment, but may also occur in patients who miss a dose. Withdrawal effects usually disappear within two weeks. In some patients, they may be more severe or may last longer (2–3 months or more). If you and your doctor decide to discontinue treatment with paroxetine, the daily dose should be gradually reduced over several weeks or months (starting with weekly reductions of 10 mg).

Always consult your doctor before reducing the dose.

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.

Contact your doctor or go to hospital immediately if you experience any of the following adverse effects during treatment.

Uncommon adverse effects (may affect up to 1 in 100 people):

Abnormal bleeding, predominantly bruising on the skin (ecchymosis) and gynecological bleeding.

Rare adverse effects (may affect up to 1 in 1,000 people):

Seizures and convulsions.
Feeling restless and hyperactive with inability to sit still or remain still (akathisia).
Low levels of sodium in the blood (hyponatremia), predominantly in elderly patients.

Very rare adverse effects (may affect up to 1 in 10,000 people):

Allergic reactions, which can be severe with paroxetine, including itching and painful skin rash (urticaria) or serious reactions causing swelling of the skin, throat or tongue, difficulty breathing and/or itching (angioedema). If you develop a red, bumpy rash, swelling of the eyelids, face, lips, mouth or tongue, start itching or have difficulty breathing (shortness of breath) or swallowing, and feel weak or dizzy and consequently fall or lose consciousness.
Serotonin syndrome (symptoms may include agitation, confusion, sweating, hallucinations, hyperreflexia, sudden muscle contractions (myoclonus), tremors, and increased heart rate (tachycardia)).
Sudden increase in eye pressure (acute glaucoma).

Adverse effects with frequency not known (cannot be estimated from available data):

Aggression, and cases of suicidal thoughts/behaviour or suicide, have been reported during treatment with paroxetine or immediately after discontinuation.

However, these symptoms may also be due to the underlying illness.

Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.

Other adverse effects

Very common adverse effects (may affect more than 1 in 10 people):

Nausea
Sexual dysfunction such as ejaculation problems, decreased libido, impotence in men, and inability to achieve orgasm.

Common adverse effects (may affect up to 1 in 10 people):

Increased blood cholesterol levels, reduced appetite.
Drowsiness, inability to sleep (insomnia), agitation, abnormal dreams (including nightmares).
Dizziness, tremor, headache, loss of concentration (decreased concentration).
Blurred vision.
Yawning.
Constipation, diarrhoea, vomiting, dry mouth.
Sweating.
Increase in body weight, general feeling of weakness with loss of muscle strength (asthenia).

Uncommon adverse effects (may affect up to 1 in 100 people):

Decrease in white blood cell count.
If you are a diabetic patient, you may notice loss of control of your blood sugar levels while taking paroxetine. Consult your doctor about adjusting the dose of insulin or diabetes medications.
Confusion, imagining things that are not really there (hallucinations).
Involuntary movements of the body or face (extrapyramidal disorders).
Pupil dilation (mydriasis).
Fast heart rate (sinus tachycardia).
Feeling of weakness or dizziness when standing up suddenly (postural hypotension).
Skin rash, itching (pruritus).
Problems emptying the bladder (urinary retention) and urinary incontinence.

Rare adverse effects (may affect up to 1 in 1,000 people):

Euphoria or overexcitement causing abnormal behaviour (mania, manic episodes), anxiety, panic attacks, loss of personality.
Irresistible urge to move the legs (Restless Legs Syndrome).
Slow heart rate (bradycardia).
Elevation of liver enzymes.
Muscle pain (myalgia), joint pain (arthralgia).
Elevated blood levels of the hormone prolactin (hyperprolactinaemia), which may cause abnormal milk production from the breast in men and women (galactorrhoea) and menstrual disorders (including heavy or irregular periods, bleeding between periods, and absence or delay of menstruation).

Very rare adverse effects (may affect up to 1 in 10,000 people):

Reduction in blood platelets, with increased risk of bleeding or bruising (thrombocytopenia).
Fluid retention and low sodium levels in the blood as a result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Gastrointestinal bleeding.
Liver disorders (such as hepatitis, sometimes associated with jaundice and/or liver failure).
Serious skin reactions (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), photosensitivity.
Pain during erection (priapism).
Swelling of arms and/or legs (peripheral oedema).

Adverse effects with frequency not known (cannot be estimated from available data):

Teeth grinding.
Ringing, buzzing, hissing or other persistent noises in the ears (tinnitus).
Inflammation of the colon causing diarrhoea.

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

Withdrawal symptoms observed upon discontinuation of paroxetine treatment

Common: dizziness, sensory disturbances, sleep disturbances, anxiety, and headache.

Uncommon: excitement, nausea, sweating, tremors, confusion, emotional instability, visual disturbances, palpitations, diarrhoea, and irritability.

These symptoms are usually mild and resolve on their own. Do not stop treatment with paroxetine without consulting your doctor and never abruptly, as you may experience withdrawal symptoms (see section 3, “If you stop treatment with Daparox”).

Other adverse effects in children and adolescents

When children and adolescents under 18 years of age were given paroxetine, at least 1 in 100 but fewer than 1 in 10 children/adolescents experienced one of the following adverse effects: emotional changes (crying and mood changes), self-harm, suicidal thoughts and attempts, hostile and unfriendly behaviour, loss of appetite, tremors, abnormal sweating, hyperactivity, excitement, nausea, stomach pain and restlessness.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Daparox

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

Do not use this medicine after the expiry date stated on the carton and blister after “EXP”. 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. Dispose of empty containers and any unused medicines at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Package contents and other information

Composition of Daparox

The active substance is paroxetine (as mesylate). Each tablet contains paroxetine mesylate, equivalent to 20 mg of paroxetine.
The other components (excipients) are:
Core: anhydrous calcium hydrogen phosphate, sodium carboxymethyl starch from potato (Type A), magnesium stearate.
Film coating: lactose monohydrate, hypromellose, Macrogol 4000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the medicinal product and contents of the container

Daparox tablets are round, yellow, film-coated tablets. They are marked with the inscription "POT 20" on one side and are scored on both sides.

Daparox is available in packs containing 10, 12, 14, 20, 28, 30, 50, 56, 60 or 100 tablets in blister packs, and one pack containing 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A - Edificio Australia

08840 Viladecans, Barcelona (Spain)

Telephone: 932 534 500

Manufacturer:

Synthon BV

Microweg 22

6545 CM Nijmegen

The Netherlands

Synthon Hispania, S.L.

C/Castelló, 1.

Polígono Industrial Las Salinas

08030 Sant Boi de Llobregat (Spain)

This medicinal product is authorised in the European Economic Area member states under the following names:

Spain: Daparox 20 mg film-coated tablets

Date of the most recent review of this leaflet: July 2023

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