Leaflet: information for the user

Daparox 33 mg/ml oral drops in solution

paroxetine (mesylate)

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects,inform your doctor or pharmacist. Also, any side effects not mentioned in this leaflet are included. See section 4.

1.What isDaparox33 mg/ml oral drops in solutionand what it is used for

2.What you need to knowbefore starting to takeDaparox 33 mg/ml oral drops in solution

3.How to takeDaparox 33 mg/ml oral drops in solution

4.Possible side effects

5.Storage ofDaparox 33 mg/mloral drops in solution

6.Contents of the pack and additional information

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

Daparox is indicated for:

• Major depressive episode (periods of depression)
• Obsessive-compulsive disorder (repetitive obsessive thoughts and/or actions)
• Anxiety disorder with and without agoraphobia (abnormal fear of leaving the house, entering stores, or fear of open spaces)

anxiety disorder

• Social anxiety disorder/social phobia (exaggerated or avoidance of any social situation)

• Generalized anxiety disorder (general fear with much anxiety or nervousness)

Do not take Daparox if

• you are allergic to paroxetine or any of the other ingredients of this medicine (see section 6).
• you are taking medicines for the treatment of depression or Parkinson's disease (so-called monoamine oxidase inhibitors [MAOIs]).

• You can only use paroxetine if you stop taking irreversible MAOIs at least 14 days before (e.g. isocarboxazid and phenelzine).

• If you receive a reversible MAOI (e.g. moclobemide, linezolid, chlorpromazine – 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 MAOIs.

• If you take a certain medicine (thioridazine) used to treat severe mental illnesses, such as psychosis.Paroxetine may cause an increase in thioridazine blood levels, thereby increasing the risk of thioridazine side effects.One of the possible side effects are irregular heartbeats (severe ventricular arrhythmia) and sudden death (see also section 2, “Other medicines and Daparox”).
• If you take a certain medicine used to treat psychosis (pimozide).Paroxetine may cause an increase in pimozide blood levels, thereby increasing the risk of pimozide side effects (see section 2, “Other medicines and Daparox”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Daparox.

Be especially careful with Daparox

• If you are taking certain medicines used in the treatment of depression or Parkinson's disease (MAOIs).You must not take paroxetine with these medicines.Your doctor will indicate when you should start treatment with paroxetine after stopping the administration of these MAOIs (see section 2, “Do not take Daparox”, and section 2, “Other medicines and Daparox”).

• If you experience symptoms such as restlessness, hyperactivity or inability to sit or inability to remain still (akathisia). If this is the case, contact your doctor. An increase in dose may be harmful.
• If you start to experience symptoms of serotonin syndrome.This syndrome is presented as a combination of any of the following symptoms: extreme restlessness, confusion, irritability, delirium (hallucinations), sweating, tremors or chills, increased reflexes and sudden muscle contractions (myoclonus), high fever, 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 (periods of) extreme euphoria or overexcitement that causes unusual behavior (mania). If you have a manic episode, 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.The treatment with paroxetine may alter blood sugar levels, which must be controlled accordingly.You may need to adjust the dose of insulin or oral antidiabetic drugs.
• If you have or have had epilepsy or convulsions.Paroxetine may cause convulsions (apoplexy), so your doctor should pay close attention to this.If you experience convulsions (apoplexy), contact your doctor immediately.It may be necessary to discontinue treatment with paroxetine.
• If you are receiving electroconvulsive therapy (ECT).So far, the experience with the use of paroxetine during ECT treatment is limited, so your doctor should pay close attention to this.
• If you have or have had an increase in intraocular pressure (glaucoma).Paroxetine may dilate the pupils (mydriasis), which may lead to an increase in ocular pressure, so your doctor should pay close attention to this.
• If you have cardiovascular problems.The safety of using paroxetine has not been investigated in patients with this disease, so your doctor should take extra precautions.
• If you are an elderly person, use other medication or have liver problems (cirrhosis), and as a result, you have a high risk of having low sodium levels in the blood.Paroxetine may decrease sodium levels in the blood, which causes weakness and fatigue.If this occurs, contact your doctor.
• If you experience an increase in the tendency to bleed or if you are taking other medicines that may increase the risk of bleeding, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”).Several examples of these medicines are those used to thin the blood (anticoagulants), certain medicines used to treat severe mental illnesses or nausea and vomiting (phenothiazines), a specific medicine used to treat schizophrenia (clozapine), aspirin and certain medicines used to reduce pain and inflammation (NSAIDs, such as ibuprofen or COX-2 inhibitors, such as rofecoxib or celecoxib).Paroxetine may cause abnormal bleeding, so your doctor may need to pay special attention to this (see section 2, “Taking other medicines”).
• If you have visual problems.Your doctor will tell you that it is not advisable for you to administer this medicine yourself if you have visual problems.Ask your caregiver or a friend to control the dose you need.
• If you want to stop taking paroxetine, you may experience withdrawal symptoms, particularly if treatment is stopped suddenly (see section 3, If you stop taking Daparox).

Thoughts of suicide 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 is more likely to happen:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult.The information from clinical trials has shown an increase in the risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were treated with an antidepressant.

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 close family member or friend that you are depressed or have anxiety disorders, 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 concerned about changes in your behavior.

Some medicines in the group to which Daparox belongs (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4).

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 suicidal behavior, suicidal thoughts and hostility (especially aggression, confrontational behavior and anger) when taking this class of medicines.However, your doctor may prescribe paroxetine to patients under 18 years of age when they decide that it is the best option for them.If your doctor has prescribed paroxetine to a patient under 18 years of age and wants to discuss this decision, see them.You should inform your doctor if any of the symptoms listed above appear or worsen in patients under 18 years of age treated with paroxetine.Furthermore, it has not been shown with certainty whether this medicine affects growth, maturation and cognitive or behavioral development in this age group.

Other medicines and Daparox

Inform your doctor or pharmacistif you are taking, have taken recently or may need to take any other medicine.

There are other medicines whose effects may be affected by paroxetine.At the same time, these medicines may affect the efficacy 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), medicines for migraines (triptans such as sumatriptan, almotriptan), analgesics (tramadol, buprenorphine, petidina), a medicine used to treat infections (linezolid), reversible non-selective MAOIs that act as preoperative visualizing agents (methylene blue), other selective serotonin reuptake inhibitors (SSRIs) (such as fluoxetine, sertraline), medicines used to treat psychiatric disorders (lithium, risperidone), a medicine used to treat chronic pain or in anesthesia (fentanyl) and St. John's Wort (Hypericum perforatum), herbal remedy for depression.The simultaneous use of these medicines may produce serotonin syndrome (see section 2, “Do not take Daparox” and section 2, “Warnings and precautions”).
• Buprenorphinecombined with naloxone, treatment for opioid addiction.
• Treatment of psychosis (pimozide).Studies have been conducted on the concomitant use of paroxetine and pimozide, which show that paroxetine may increase the amount of pimozide in the blood.Since pimozide may cause serious side effects such as heart rhythm disorders, you should not use paroxetine at the same time as pimozide (see section 2, “Do not take Daparox”).
• Enzyme inhibitors, such as certain medicines used to treat depression (tricyclic antidepressants such as clomipramine).Your doctor will probably prescribe a lower dose than usual.If you are going to use paroxetine together 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 subsequent 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 the muscle relaxants used in anesthesia such as mivacurium and suxamethonium.
• Combination of medicines to treat HIV infection (fosamprenavir and ritonavir).
• Medicines used to treat Parkinson's disease (procyclidine).The effects and side effects of procyclidine may be increased.If you start to experience side effects such as dry mouth, blurred vision, constipation and urinary retention due to a bladder emptying disorder, you may need to reduce the dose of procyclidine, after consulting your doctor.
• Determined medicines for the treatment of epilepsy (anticonvulsants such as valproate sodium).Although it has not been shown to have a direct effect, your doctor should make a very careful prescription of paroxetine in patients with epilepsy.
• Medicines that are metabolized by the same liver enzymes as paroxetine, such as certain medicines for depression (tricyclic antidepressants such as nortriptyline and desipramine), certain medicines for severe mental illnesses, such as antipsychotics (perphenazine, thioridazine and risperidone), a medicine used to treat attention deficit hyperactivity disorder (ADHD) (atomoxetine), certain medicines for heart rhythm disorders (such as flecainide and propafenone), certain medicines for chest pain and high blood pressure (metoprolol), a medicine used to treat high cholesterol (pravastatin) and certain medicines for severe mental illnesses or nausea and vomiting (phenothiazines).Paroxetine may increase the effect and side effects of these medicines.Paroxetine and thioridazine should not be used together, as the risk of serious side effects such as heart rhythm disorders and sudden death (see section 2, “Do not take Daparox”).
• Anticoagulant tablets (acenocoumarol, phenprocoumon).The effect and side effects of these medicines may be increased, as well as the risk of bleeding.Your doctor should monitor you more closely and may need to adjust the dose of anticoagulants (see section 2, “Warnings and precautions”).
• Medicines used in lung 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, such as clomipramine, desipramine), aspirin, medicines used to reduce pain and inflammation (NSAIDs, such as ibuprofen or COX-2 inhibitors, such as rofecoxib or celecoxib).
• Medicines used to reduce stomach acid (cimetidine, omeprazole).

Use of Daparox with food, drinks and alcohol

Alcohol and paroxetine should not be taken at the same time.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using 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 heart defects in newborns of mothers who received paroxetine in the first months of pregnancy.You and your doctor may decide whether it is better to change to another treatment or to discontinue paroxetine gradually.However, depending on the circumstances, your doctor may advise you to continue treatment.

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

Medicines like paroxetine may increase the risk of a serious disease in newborns, called persistent pulmonary hypertension of the newborn (PPHN), when taken during pregnancy, particularly towards the end of pregnancy, making the baby breathe faster and appear blue.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 that start during the first 24 hours after birth.These include problems with sleeping and feeding, respiratory problems, blue color, temperature variations, vomiting, persistent crying, rigidity or flexibility of the muscles, apathy, tremors, nervousness or irritability.If the baby has any of these symptoms when born, contact your doctor or midwife who will advise you.

Paroxetine passes in small amounts into breast milk.Before starting breastfeeding, talk to your doctor about taking paroxetine.You and your doctor may decide that you can breastfeed while taking paroxetine.

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

Driving and operating machines

Paroxetine does not affect your ability to drive or operate machines.However, this medicine may cause side effects (such as blurred vision, dizziness, drowsiness or confusion).If you experience any of these side effects, do not drive or operate tools or machines, or any other activity that requires being alert or concentrated.This means that, before performing these activities, you should observe your reaction to paroxetine.

Daparox contains ethanol (alcohol), propylene glycol and sodium

This medicine contains 67 mg of ethanol in each 20 drops, which corresponds to 111 mg/ml (11% v/v).The amount in 20 drops is less than 2 ml of beer or 1 ml of wine.The small amount of alcohol in this medicine will have no perceptible effect.

This medicine contains 490 mg of propylene glycol in each 20 drops, which corresponds to 811 mg/ml.

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

Follow exactly the administration instructions of this medication as indicated by your doctor.Consult your doctor or pharmacist if you have any doubts.

Paroxetineshould be taken preferably in the morning accompanied by food.

Take paroxetine with water, never with any other type of drink.

Paroxetine can be administered using a dropper (dose of 10 mg to 30 mg) or a syringe (dose of 40 mg to 60 mg).

If your doctor recommends using the dropper, pour the necessary amount of drops into a full glass of water (200 ml), mix well and drink the entire contents of the glass.

To avoid errors when counting 40 drops or more, your doctor may consider prescribing this medication in the form of tablets or using the syringe to administer the oral suspension (the dose is expressed in ml).

If your doctor recommends using an oral syringe, insert the tip of the syringe into the plastic dropper of the bottle, turn the bottle upside down and load the number of ml prescribed into the syringe. Discharge the contents of the syringe into a full glass of water (200 ml), mix well and drink the entire glass.

After each use, rinse the syringe with water and let it air dry.

The recommended dose is as follows:

• Major depressive episode

The recommended dose is 20 mg (20 drops) per day.In normal conditions, you should start feeling better within a week, although the effects may manifest later (such as two weeks).If the effects are insufficient, your doctor may gradually increase the dose by 10 mg (10 drops) to a maximum of 50 mg (1.5 ml) per day.Your doctor will determine the period during which you must continue taking the drops,which may last more than 6 months.

• Obsessive-compulsive disorder (OCD)

The recommended dose is 40 mg (1.2 ml) per day, with an initial dose of 20 mg (20 drops) per day.If the effects are insufficient, your doctor may gradually increase the dose by 10 mg (10 drops).The maximum daily dose is 60 mg (1.8 ml).Your doctor will determine the period during which you must continue taking the drops,which may last a few months or more.

• Anxiety disorder with or without agoraphobia

The recommended dose is 40 mg (1.2 ml) per day, with an initial dose of 10 mg (10 drops) per day.If the effects are insufficient, your doctor may gradually increase the dose by 10 mg (10 drops).The maximum daily dose is 60 mg (1.8 ml).The initial dose is low to avoid worsening of anxiety symptoms at the beginning of treatment.Your doctor will determine the period during which you must continue taking the drops,which may last a few months or more.

• Social anxiety disorder/social phobia

The recommended dose is 20 mg (20 drops) per day.If the effects are insufficient, your doctor may gradually increase the dose by 10 mg (10 drops).The maximum daily dose is 50 mg (1.5 ml).Your doctor will determine the period during which you must continue taking the drops,which may last a long time, and during this interval, the treatment should be evaluated periodically.

• Generalized anxiety disorder

The recommended dose is 20 mg (20 drops) per day.If the effects are insufficient, your doctor may gradually increase the dose by 10 mg (10 drops).The maximum daily dose is 50 mg (1.5 ml).Your doctor will determine the period during which you must continue taking the drops,which may last a long time, and during this interval, the treatment should be evaluated periodically.

Older patients

The recommended initial dose for older patients is the same as the initial dose in other adult patients, but the maximum daily dose cannot exceed 40 mg (1.2 ml).

Use in children and adolescents

Paroxetine should not be used in children or adolescents under 18 years old (see section 2, "Children and adolescents").

Patients with renal or hepatic insufficiency

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

Duration of treatment

Your doctor will determine the period during which you must continue taking paroxetine.In accordance with your disease, you may need to take paroxetine for a long time.You should continue taking paroxetine for a certain period, even when your symptoms have improved, to prevent them from recurring.Do not stop taking paroxetine without consulting your doctor.If you suddenly stop taking paroxetine, you may experience withdrawal symptoms, so 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, 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 forgot to take Daparox

Do not take a double dose to compensate for the missed doses.Omit the missed dose and take the next one when due.Consult your doctor if you have any doubts.

If you stop taking Daparox

Do not stop taking Daparox without consulting your doctor, and never stop taking it suddenly, as this may cause withdrawal symptoms.

The effects you may experience if you stop taking paroxetine are:dizziness, sensory disturbances [tingling or prickling, feeling of electric shocks, buzzing, hissing, whistling, ringing or other persistent sounds 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 can also occur in patients who forget to take a dose. Normally, withdrawal symptoms disappear within two weeks. In some patients, they may be more severe or last longer (2-3 months or more). If you and your doctor decide to stop taking 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.

Like all medicines, this medicine can cause 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 effectsinfrequent(may affect up to1 in 100 people)

• abnormal bleeding, predominantly skin bruising (ecchymosis) and gynecological bleeding.

Side effectsrare(may affect up to 1in 1,000 people)

• seizures and convulsions
• feeling restless and hyperactive with inability to sit or remain still (akathisia)
• low sodium levels in the blood (hyponatremia), predominantly in elderly patients.

Side effectsvery rare(may affect up to1 in 10,000 people)

• allergic reactions,which can be severewith paroxetine, including itching and painful skin rash (urticaria) or severe reactions that cause skin swelling, throat or tongue swelling, difficulty breathing and/or itching (angioedema). If you develop a red itchy rash, swelling of the eyelids, face, lips, mouth or tongue, start to feel itchy or have difficulty breathing (shortness of breath) or swallowing, and feel weak or dizzy and, consequently, fall or lose consciousness,contact your doctor or go to the hospital immediately.
• serotonin syndrome (symptoms may include agitation, confusion, sweating, hallucinations, hyperreflexia, muscle spasms (myoclonus), tremors and increased heart rate (tachycardia).
• acute glaucoma (sudden increase in eye pressure)

Side effects withunknown frequency(cannot be estimated from available data)

• aggression, cases of self-harm or suicidal thoughts, have been reported during treatment with paroxetine or immediately after treatment discontinuation. However, these symptoms may also be due to the underlying disease.
• excessive vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy, lactation and fertility” in section 2 for more information.

Otherside effects

Side effectsvery common(may affect more than 1 in 10 people)

• nausea
• sexual dysfunction such as ejaculation problems, decreased libido, impotence in men and inability to orgasm.

Side effectscommon (may affect up to1 in 10 people)

• increased cholesterol levels in the blood, reduced appetite.
• drowsiness, insomnia, agitation, abnormal dreams (including nightmares).
• dizziness, tremor, headache, loss of concentration (diminished concentration)
• blurred vision
• yawns
• constipation, diarrhea, vomiting, dry mouth
• sweating
• weight gain, feeling of general weakness with loss of muscle strength (asthenia).

Side effectsinfrequent(may affect up to1 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, hallucinations
• uncontrolled body or facial movements (extrapyramidal disorders)
• pupil dilation (mydriasis)
• rapid heart rate (sinus tachycardia)
• feeling weak or dizzy when standing up (postural hypotension)
• skin rash, itching (pruritus)
• urinary retention and incontinence

Side effectsrare(may affect up to 1in 1,000 people)

• euphoria or overexcitement, causing abnormal behavior (mania, manic episodes), anxiety, panic attacks, loss of personality
• irresistible urge to move the legs (Restless Legs Syndrome)
• slow heart rate (bradycardia)
• elevated liver enzymes
• muscle pain (myalgia), joint pain (arthralgia)
• high levels of prolactin in the blood (hyperprolactinemia), which may cause abnormal milk production by the breast in men and women (galactorrhea) and menstrual disorders (including heavy or irregular periods, bleeding between periods and absence or delay of menstruation).

Side effectsvery rare(may affect up to1 in 10,000 people)

• reduced platelet count, with increased risk of bleeding or hematoma formation (thrombocytopenia)
• fluid retention and low sodium levels in the blood due to the syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• gastrointestinal bleeding
• liver disorderssuch as inflammation (hepatitis), sometimes associated with jaundice and/or liver failure
• severe skin effects (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), urticaria, photosensitivity.
• erection pain (priapism)
• swelling of the arms and/or legs (peripheral edema)

Side effects withunknown frequency(cannot be estimated from available data)

• grinding of teeth
• tinnitus (ringing, buzzing, hissing or other persistent sounds in the ears)
• inflammation of the colon (causing diarrhea)

Patients taking this medicine have a higher risk of bone fractures.

Withdrawal symptoms observed when discontinuing treatment with paroxetine

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

Infrequent: excitement, nausea, sweating, tremors, confusion, emotional instability, visual disorder, palpitations, irritability and diarrhea.

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

Additional side effects in children and adolescents

When children and adolescents under 18 years 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 attempts, antisocial and unfriendly behavior, loss of appetite, tremors, abnormal sweating, hyperactivity, excitement, nausea, stomach pain and nervousness.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date indicated on the packaging after “CAD.”The expiration date is the last day of the month indicated.

This medication does not require any special storage conditions.

After opening, the solution must be used within a period of 56 days.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Daparox 33 mg/ml oral drops in solution

• The active principle is paroxetine (in the form of mesilate).

1 ml of Daparox contains 33.1 mg of paroxetine (in the form of mesilate).

One drop contains 1 mg of paroxetine (in the form of mesilate).

• The other components (excipients) are as follows:

Sodium saccharin (E954)

Acesulfame K (E950)

Spearmint flavor (spearmint essential oil, menthol, eucalyptol, ethanol, water)

Polysorbate 80 (E433)

Ethanol (111 mg/ml)

Propylene glycol (E1520).

Appearance of Daparox and contents of the package

Daparox is a transparent, light reddish-brown to light brown solution packaged in an amber-colored glass vial of 20 ml containing at least 18.5 ml of solution.

The vial is packaged in a cardboard box and contains a dropper and a child-resistant closure. It may also include an oral syringe.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80.

3rd floor, module A-Edificio Australia

08840 Viladecans, Barcelona (Spain)

Phone: 932 534 500

Manufacturer:

Synthon BV

Microweg 22

6545 CMNijmegen

Netherlands

Synthon Hispania, S.L.

C. Castelló, 1

Polígono Industrial Las Salinas

08830 Sant Boi de Llobregat (Barcelona) - Spain

Hormosan Pharma GmbH

Hanauer Landstrasse 139 - 143

60314 Frankfurt am Main- Germany

This medicine is authorized in the member states of the European Economic Area with the following names

Austria: Ennos 33.1 mg/ml, Lösung zum Einnehmen

Germany:Paroxetine-Hormosan 33.1 mg/ml.

Italy: Dapagut 33.1 mg/ml, gocce orali, soluzione

Netherlands:Parmite

Spain: Daparox 33 mg/ml gotas orales en solución

Last review date of this leaflet: December 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es