DAPAROX 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Daparox 20 mg Film-Coated Tablets

paroxetine (mesilate)

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Daparox and what is it used for
2. What you need to know before you take Daparox
3. How to take Daparox
4. Possible side effects
5. Storing Daparox
6. Package Contents and Additional Information

1. What is Daparox and what is it used for

Paroxetine belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs).

Daparox is indicated for:

• Major depressive episode (periods of depression).
• Obsessive-compulsive disorder (repetitive obsessive thoughts and/or acts).
• Anxiety disorder with and without agoraphobia (abnormal fear of leaving home, entering stores, or fear of open spaces).
• Social anxiety disorder/social phobia (exaggerated or avoidance fear of any social situation).
• Generalized anxiety disorder (general fear with much 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 ingredientsof this medicine (listed in section 6).
• if you are taking medicines for the treatment of depression or Parkinson's disease [so-called monoamine oxidase inhibitors (MAOIs)].

• You may only use paroxetine if you stop taking irreversible MAOIs at least 14 days in advance (e.g., isocarboxazidand phenelzine).
moclobemide, linezolid, methylthioninium chloride (methylene blue)), you should wait at least 24 hours before taking paroxetine.
• Conversely, when you stop taking paroxetine, you should wait at least 7 days before starting to take an MAOI.

• if you are receiving treatment with thioridazine, used to treat severe 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

Consult your doctor or pharmacist before starting to take Daparox:

• if you take certain medicines used in the treatment of depression or Parkinson's disease (MAOIs). You should not take paroxetine with these medicines. Your doctor will tell you when you can start taking paroxetine after you have stopped taking these MAOIs (see section 2, "Do not take Daparox", and section 2, "Other medicines and Daparox").
• if you have symptoms such as restlessness, hyperactivity, or inability to sit or stand still(akathisia). This can occur during the first few weeks of treatment. If this is the case, contact your doctor. An increase in dose may be harmful.
• if you start to suffer from symptoms of serotonin syndrome. This syndrome is characterized by a combination of some of the following symptoms: extreme restlessness, confusion, irritability, delirium (hallucinations), sweating, tremors or shivering, increased reflexes, sudden muscle contractions (myoclonus), high fever, or stiffness (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 (periods of) extreme euphoria or overexcitement that causes unusual behavior (mania). If you enter a manic phase, it may be necessary to discontinue treatment with paroxetine.
• if you have liver 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 be monitored. It may be necessary to adjust the dose of insulin or oral antidiabetics.
• if you have or have had epilepsy or seizures. Paroxetine can cause seizures (apoplexy), so your doctor will need to pay close attention to this. If you have seizures (apoplexy), contact your doctor immediately. It may be necessary to discontinue treatment with paroxetine.
• if you are receiving treatment with electroconvulsive therapy (ECT). So far, experience with the use of paroxetine during ECT is limited, so your doctor will need to pay close attention to this.
• if you have or have had an increase in intraocular pressure(glaucoma). Paroxetine can dilate the pupils (mydriasis), which can lead to an increase in eye pressure, so your doctor will need to pay close attention to this.
• if you have cardiovascular disorders. The safety of using paroxetine has not been investigated in patients with this disease, so your doctor will need to take extra precautions.
• if you are an elderly person, use other medication, or have liver problems (cirrhosis), and as a result, you are at high risk of having low sodium levels in your blood. Paroxetine can decrease sodium levels in the blood, which can cause weakness and fatigue. If this happens, contact your doctor.
• if you have an increased tendency to bleed, if you are taking medicines that can increase the risk of bleeding, or if you are pregnant(see "Pregnancy, breastfeeding, and fertility"). Paroxetine can increase the risk of bleeding, so your doctor will need to pay close attention to this (see section 2 "Warnings and precautions").
• if you want to stop taking paroxetine, you may experience withdrawal symptoms, particularly 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 your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or committing suicide. This can increase when you start taking antidepressants, because 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.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders who were treated with an antidepressant.

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

It may be helpful for you to tell a relative or close friendthat you are depressed or have an anxiety disorder and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

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

Children and adolescents

Paroxetine should not be used in children and adolescents under 18 years of age. You should know that in patients under 18 years, there is an increased risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and anger) when taking this type of medicine. Nevertheless, your doctor may prescribe paroxetine to patients under 18 years when they decide what is best for them. If your doctor has prescribed paroxetine to a patient under 18 years and you want to discuss this decision, go see them. You should inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years treated with paroxetine. Additionally, it is not yet known whether this medicine affects growth, maturity, and cognitive or behavioral development in this age group.

Other medicines and Daparox

Tell your doctor or pharmacistif you are taking, have recently taken, or might take any other medicines.

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

• Medicines used to treat depression or Parkinson's disease (MAOIssuch as moclobemideor isocarboxazid), a dietary supplement (L-tryptophan), medicines for migraine (triptans, such as sumatriptan, almotriptan), certain painkillers (tramadol, buprenorphine, pethidine), a medicine used to treat infections (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), a certain medicine used to treat chronic pain or in anesthesia (fentanyl), and St. John's Wort(Hypericum perforatum), a herbal remedy for depression. The simultaneous use of these medicines can produce serotonin syndrome (see section 2 "Do not take Daparox" and section 2 "Warnings and precautions").
• Buprenorphinecombined with naloxone, substitution treatment for opioid addiction.
• Treatment of psychosis (pimozide). Studies on the concomitant use of paroxetine and pimozide show that paroxetine can increase the amount of pimozide in the blood. Since pimozide can cause serious adverse effects such as cardiac arrhythmias, you should 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 will probably prescribe a lower dose than usual. If you are going to use paroxetine with enzyme inducers (e.g., carbamazepine, rifampicin, phenobarbital, and phenytoin), you usually do not need a lower initial dose, and your doctor will adjust the following doses according to the effect of the medicine.
• Due to the interaction with paroxetine, there may be a prolongation of the muscle relaxant effect of muscle relaxants used in anesthesia, such as mivacurium and suxamethonium.
• Combination of medicines to treat AIDS (Acquired Immune Deficiency Syndrome)(fosamprenavirand ritonavir).
• Medicines used to treat Parkinson's disease (procyclidine). The effect and adverse effects of procyclidine may be increased. If you start to notice adverse effects such as dry mouth, blurred vision, constipation, and urinary retention in the bladder due to a voiding disorder, it may be necessary to reduce the dose of procyclidine, after consulting your doctor.
• Medicines for the treatment of epilepsy, (anticonvulsants such as sodium valproate). Although it has not been shown to have a direct effect, your doctor will need to prescribe paroxetine very carefully in patients with epilepsy.
• Medicines that are broken down by the same liver enzymes as paroxetine, such as certain medicines for depression (tricyclic antidepressants, such as nortriptylineand 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 heart rhythm disorders (such as flecainideand propafenone), certain medicines for the treatment of chest tightness (angina pectoris) and high blood pressure (metoprolol), a medicine used to treat high cholesterol levels (pravastatin), and certain medicines for the treatment of severe mental illnesses or nausea and vomiting (phenothiazines). The effect and adverse effects of these medicines may be increased. You should not use paroxetine and thioridazinetogether, due to the risk of serious adverse effects such as cardiac arrhythmias (severe ventricular arrhythmia) and sudden death (see section 2 "Do not take Daparox").
• Anticoagulant tablets (anticoagulantssuch as acenocoumarol, phenprocoumon). The effect and adverse effects of these medicines may be increased, as well as the risk of bleeding. Your doctor will need to monitor you more closely and may need to adjust the dose of anticoagulants (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 illnesses 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 (NSAIDssuch as ibuprofenor 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is not enough data to determine the safety and efficacy of using paroxetine during pregnancy. Some studies have shown an increased risk of cardiac effects in newborns of mothers who received paroxetine in the first months of pregnancy. You and your doctor can decide whether it is better to change to another treatment or gradually stop treatment with paroxetine. However, depending on the circumstances, your doctor may advise you to continue treatment.

Make sure your midwife or doctor knows that you are taking paroxetine.If you take Daparox in the final stages of pregnancy, there may be a higher risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Daparox to advise you.

Medicines like paroxetine may increase the risk of a serious disease in babies, called persistent pulmonary hypertension of the newborn (PPHN), when taken during pregnancy, particularly in the last months of pregnancy, making the baby breathe faster and appear blue. These symptoms usually start within the first 24 hours of life. If this happens to your baby, you should contact your midwife and/or doctor immediately. If you take paroxetine during the last 3 months of pregnancy, your newborn baby may also have other conditions, which usually start within the first 24 hours after birth. These include problems sleeping or feeding properly, respiratory problems, blue discoloration, temperature changes, vomiting, persistent crying, muscle stiffness or flexibility, apathy, tremors, nervousness, or irritability. If you notice that your child has any of these symptoms when born, contact your doctor or midwife, who will advise you.

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

In animal studies, it has been shown that paroxetine reduces sperm quality. In theory, this could affect fertility, although it is not yet known what impact it has on human fertility.

Driving and using machines

Paroxetine does not affect your ability to drive or use machines. However, this medicine can cause adverse effects (such as blurred vision, dizziness, drowsiness, or confusion). If you notice any of these adverse effects, do not drive or use machinery or do any other activity that requires you to be alert or concentrated. 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 told you that you have an intolerance to some sugars, consult 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 administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

The tablet can be divided into equal doses.

The recommended dose is:

• Major Depressive Episode

The recommended dose is 1 tablet (20 mg paroxetine) per day. Improvement usually starts after one week, but it is possible that you will only notice the effect from the second week onwards. If the effect is not satisfactory, your doctor may decide to gradually increase the dose in half-tablet increments (10 mg paroxetine) up to a maximum of 2 and a half tablets (50 mg paroxetine) per day. Your doctor will determine the duration of treatment, which may be more than 6 months.

• Obsessive-Compulsive Disorder (OCD)

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

• Panic Disorder with or without Agoraphobia

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

• Social Anxiety Disorder / Social Phobia

The recommended dose is 1 tablet (20 mg paroxetine) per day. If the effect is not satisfactory, your doctor may decide to gradually increase the dose in half-tablet increments (10 mg paroxetine). The maximum dose is 2 and a half tablets (50 mg paroxetine) per day. Your doctor will determine the duration of treatment. This may be prolonged over time and should be regularly evaluated.

• Generalized Anxiety Disorder

The recommended dose is 1 tablet (20 mg paroxetine) per day. If the effect is not satisfactory, your doctor may decide to gradually increase the dose in half-tablet increments (10 mg paroxetine). The maximum dose is 2 and a half tablets (50 mg paroxetine) per day. Your doctor will determine the duration of treatment. This may be prolonged over time and should be regularly evaluated.

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) per day.

Use in Children and Adolescents

Paroxetine should 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 or severe kidney problems, your doctor will adjust your dose.

Duration of Treatment

Your doctor will determine the period during which you must continue taking paroxetine. Depending on your illness, you may need to take paroxetine for a long time. You should continue taking paroxetine for some time, even when your symptoms have subsided, to prevent them from returning. Do not stop treatment with paroxetine without consulting your doctor.If you suddenly stop treatment with paroxetine, you may experience withdrawal symptoms, so the dose should be gradually reduced (see section 3, "If you stop treatment with Daparox").

If you take more Daparox than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested). In addition to the known side effects (see section 4, "Possible side 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 forgotten doses. Omit the forgotten dose and continue taking the medication normally. If you have doubts, always consult your doctor.

If you stop treatment with 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 are: dizziness, sensory disturbances (tingling or prickling sensation, sensation of electric shocks or 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: excitement, nausea, tremors, confusion, sweating, emotional instability, visual disturbances, strong heartbeats (palpitations), diarrhea, and irritability (see section 4 "Possible side effects").

These symptoms usually start in the first few days after stopping treatment, but they can also occur in patients who forget to take a dose. Normally, the withdrawal effects disappear within two weeks. In some patients, they can be more severe or can last longer (2-3 months or more). If you and your doctor decide to stop treatment with paroxetine, the daily dose should be gradually reduced over a few weeks or months (starting with 10 mg per week).

You should always consult your doctor before reducing the dose.

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

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone will experience them.

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

Side effects are uncommon(may affect up to 1 in 100 people):

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

Side effects are rare(may affect up to 1 in 1,000 people):

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

Side effects are very rare(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 severe reactions that cause swelling of the skin, throat, or tongue, difficulty breathing and/or itching (angioedema). If you develop a red and 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).

Side effects with unknown frequency(cannot be estimated from the available data):

• Aggression, cases of self-harm or suicidal thoughts/behavior have been reported during treatment with paroxetine or immediately after its discontinuation.

However, these symptoms can also be due to the underlying disease.

• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Other side effects

Side effects are very common(may affect more than 1 in 10 people)

• Nausea
• Sexual dysfunction such as ejaculation problems, decreased sexual desire, impotence in men, and inability to orgasm.

Side effects are common(may affect up to 1 in 10 people)

• Increased cholesterol levels in the blood, reduced appetite.
• Drowsiness, inability to sleep (insomnia), agitation, abnormal dreams (including nightmares).
• Dizziness, tremors, headaches, loss of concentration (decreased concentration)
• Blurred vision
• Constipation, diarrhea, vomiting, dry mouth
• Sweating
• Weight gain, feeling of general weakness with loss of muscle strength (asthenia).

Side effects are uncommon(may affect up to 1 in 100 people)

• Decreased white blood cell count
• If you are a diabetic patient, you may observe a 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)
• Uncontrolled body or face movements (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)
• Urinary retention and urinary incontinence

Side effects are rare(may affect up to 1 in 1,000 people)

• Euphoria or overexcitement, causing abnormal behavior (mania, manic episodes), anxiety, panic attacks, loss of personality
• Irritable leg syndrome
• Slow heart rate (bradycardia)
• Elevated liver enzymes
• Muscle pain (myalgia), joint pain (arthralgia)
• High levels of prolactin in the blood (hyperprolactinemia), which can cause abnormal milk production in men and women (galactorrhea) and menstrual disorders (including heavy or irregular periods, bleeding between periods, and absence or delay of menstruation).

Side effects are very rare(may affect up to 1 in 10,000 people)

• Decrease 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 inadequate antidiuretic hormone secretion (SIADH).
• Gastrointestinal bleeding.
• Liver disorders (such as hepatitis, sometimes associated with jaundice and/or liver failure).
• Severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), sensitivity to sunlight.
• Painful erection (priapism).
• Swelling of the arms and/or legs (peripheral edema).

Side effects with unknown frequency(cannot be estimated from the available data)

• Teeth grinding
• Ringing, buzzing, whistling, and other persistent noises in the ears (tinnitus)
• Inflammation of the colon that causes diarrhea

It has been observed that patients taking this type of medication have a higher risk of bone fractures.

Withdrawal symptoms observed when discontinuing treatment with paroxetine

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

Uncommon: excitement, nausea, sweating, tremors, confusion, emotional instability, visual disturbance, palpitations, diarrhea, and irritability.

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

Other side effects in children and adolescents

When children and adolescents under 18 years of age received paroxetine, at least 1 in 100, but less than 1 in 10 children/adolescents experienced one of the following side effects: emotional changes (crying and mood changes), self-harm, suicidal thoughts and behaviors, hostile and unfriendly behavior, loss of appetite, tremors, abnormal sweating, hyperactivity, excitement, nausea, stomach pain, and nervousness.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use www.notificaRAM.es By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Daparox

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

Do not use this medication after the expiration date shown on the box and blister after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

6. Package contents and additional information

Composition of Daparox

• The active ingredient is paroxetine (as mesylate). Each tablet contains paroxetine mesylate, equivalent to 20 mg of paroxetine.

• The other ingredients (excipients) are:

• Core: anhydrous calcium hydrogen phosphate, sodium starch glycolate (Type A), magnesium stearate.
• Coating: hydrated lactose, hypromellose, Macrogol 4000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Appearance and package contents

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

Daparox is available in boxes containing 10, 12, 14, 20, 28, 30, 50, 56, 60, or 100 tablets in blisters, and a container with 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Holder:

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Australia Building

08840 Viladecans, Barcelona (Spain)

Phone: 932 534 500

Manufacturer:

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

Synthon Hispania, S.L.

C/Castelló, 1.

Polígono Industrial Las Salinas

08030 Sant Boi de Llobregat (Spain)

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

Spain: Daparox 20 mg film-coated tablets

Date of last revision of this leaflet: July 2023

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