Daparox 33 mg/ml oral solution drops

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Daparox 33 mg/ml oral solution drops

paroxetine (mesilate)

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if their symptoms are the same as yours, as it may harm them.
• If you experience any adverse reactions, inform your doctor or pharmacist. This includes any possible adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Daparox 33 mg/ml oral solution drops is and what it is used for
2. What you need to know before taking Daparox 33 mg/ml oral solution drops
3. How to take Daparox 33 mg/ml oral solution drops
4. Possible adverse effects
5. How to store Daparox 33 mg/ml oral solution drops
6. Contents of the pack and other information

1. What Daparox 33 mg/ml oral drops in solution is and what it is used for

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 (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 worry, accompanied by marked anxiety or nervousness)

2. What you need to know before taking Daparox 33 mg/ml oral solution drops

Do not take Daparox if

• you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6).

• you are taking medicines for the treatment of depression or Parkinson’s disease (known as monoamine oxidase inhibitors [MAOIs]).

• You may only start paroxetine at least 14 days after stopping irreversible MAOIs (e.g. isocarboxazide and phenelzine).

• if you are receiving a reversible MAOI (e.g. moclobemide, linezolid, methylene blue chloride – methylene blue), 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 taking a certain medicine (thioridazine) used to treat serious mental illnesses, such as psychosis. Paroxetine may increase the blood concentration of thioridazine, thereby increasing the risk of thioridazine-related side effects. One possible side effect is irregular heartbeat (serious ventricular arrhythmia) and sudden death (see also section 2, “Other medicines and Daparox”).

• if you are taking a certain medicine used to treat psychosis (pimozide). Paroxetine may increase the blood concentration of pimozide, thereby increasing the risk of experiencing one of pimozide’s side effects (see section 2, “Other medicines and Daparox”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Daparox.

Take special care with Daparox

• If you are taking certain medicines used to treat depression or Parkinson’s disease (MAOIs). You must not take paroxetine together with these medicines. Your doctor will advise you when to start paroxetine treatment 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 motionless (akathisia). If this occurs, contact your doctor. Increasing the dose may be harmful.

• If you begin to experience symptoms of serotonin syndrome. This syndrome presents as a combination of some of the following symptoms: extreme restlessness, confusion, irritability, delirium (hallucinations), sweating, tremors or chills, increased reflexes and sudden muscle contractions (myoclonus), high fever, and 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 leading to unusual behavior (mania). If you experience a manic episode, treatment with paroxetine may need to be discontinued.

• 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 medicines.

• If you have or have had epilepsy or seizures. Paroxetine may cause seizures (stroke), so your doctor must monitor this closely. 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 paroxetine use during ECT is limited, so your doctor must monitor this closely.

• If you have or have had increased intraocular pressure (glaucoma). Paroxetine may cause pupil dilation (mydriasis), which could lead to increased eye pressure, so your doctor must monitor this closely.

• If you are an elderly person, are taking other medications, or have liver problems (cirrhosis), and as a result are at high risk of low blood sodium (salt) levels. Paroxetine may reduce blood sodium concentration, leading to weakness and fatigue. If this occurs, contact your doctor.

• If you experience an increased tendency to bleed, or are taking other medicines that may increase bleeding risk, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”). Examples of such medicines include blood thinners (anticoagulants), certain medicines used to treat serious mental illness or nausea and vomiting (phenothiazines), a specific medicine used to treat schizophrenia (clozapine), acetylsalicylic acid, and certain medicines used to relieve pain and inflammation (NSAIDs, such as ibuprofen or COX-2 inhibitors). 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 vision problems. Your doctor will advise that you should not self-administer this medicine if you have vision problems. Ask your caregiver or a friend to control your required dose.

• 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 paroxetine treatment.

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 starting antidepressants, as these medicines take time to work—usually about two weeks, but sometimes longer.

This is more likely to occur:

• 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 psychiatric patients under 25 years of age treated with an antidepressant.

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

It may be helpful 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 inform 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 the most appropriate treatment. If your doctor has prescribed paroxetine to a patient under 18 and you wish to discuss this decision, speak to them. 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 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 (MAOIs such as moclobemide or isocarboxazida), a dietary supplement (L-tryptophan), migraine medicines (triptans such as sumatriptan, almotriptan), painkillers (tramadol, buprenorphine, pethidine), a medicine used for infections (linezolid), a non-selective reversible MAOI used as 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 medicine used for 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 substitution therapy.
• Treatment for psychosis (pimozide). Studies on the concomitant use of paroxetine and pimozide show that paroxetine may increase pimozide blood levels. Since pimozide may cause serious adverse effects such as cardiac rhythm disorders, you must not use paroxetine together with 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 based on the medicine’s effect.
• Due to interaction with paroxetine, a prolonged muscle-relaxing effect of muscle relaxants used in anesthesia such as mivacurium and suxamethonium may occur.
• Combination of medicines to treat Acquired Immunodeficiency Syndrome (AIDS) (fosamprenavir and ritonavir).
• Medicines used to treat Parkinson’s disease (procyclidine). The effects and side effects of procyclidine may be increased. If you experience side effects such as dry mouth, blurred vision, constipation, and urinary retention due to voiding disorders, it may be necessary to reduce the procyclidine dose, after consulting your doctor.
• Certain medicines for the treatment of epilepsy (anticonvulsants such as sodium valproate). Although no direct effect has been demonstrated, your doctor should prescribe paroxetine with great care in patients with epilepsy.
• Medicines metabolized by the same liver enzymes as paroxetine, such as some antidepressants (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 tightness (angina) 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). The effect and side 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”).
• 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 in lung cancer or fertility problems (tamoxifen).
• Medicines that increase bleeding risk. Certain medicines used to treat serious 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), acetylsalicylic acid, and 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).

Use of Daparox with food, drinks, and alcohol

Alcohol consumption should be avoided while taking paroxetine.

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 insufficient data to determine the safety and efficacy of paroxetine use during pregnancy.

Some studies have shown an increased risk of cardiac defects in newborns whose mothers 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. However, depending on the circumstances, your doctor may advise continuing treatment.

Ensure your midwife and/or doctor know 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 newborns called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy, particularly towards the end, causing the baby to breathe faster and appear blue. 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 may also experience other conditions beginning within the first 24 hours after birth. These include sleep and feeding difficulties, breathing problems, bluish skin color, temperature fluctuations, vomiting, persistent crying, muscle stiffness or floppiness, lethargy, tremors, nervousness, or irritability. If your baby has any of these symptoms at birth, contact your doctor or midwife for advice.

Paroxetine passes into breast milk in small amounts. If you are taking paroxetine, discuss it with your doctor before starting breastfeeding. You and your doctor may decide that breastfeeding is acceptable while taking paroxetine.

Animal studies have shown that paroxetine reduces sperm quality. In theory, this may 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 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 machinery, or engage in any activity requiring alertness or concentration. This means you should observe your reaction to paroxetine before performing such activities.

Daparox contains ethanol (alcohol), propylene glycol, and sodium

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

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

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

3. How to take Daparox 33 mg/ml oral solution drops

Follow exactly the instructions for use of this medicine as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Paroxetine should preferably be taken in the morning with food.

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

Paroxetine may be administered using a dropper (doses from 10 mg to 30 mg) or an oral syringe (doses from 40 mg to 60 mg).

If your doctor recommends using the dropper, pour the required number of drops into a glass filled with water (200 ml), stir the mixture well, and drink the entire contents of the glass.

To avoid errors when counting 40 drops or more, your doctor may consider prescribing this medicine in tablet form or using an oral syringe to administer the oral solution (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 draw into the syringe the number of ml prescribed. Empty the syringe into a glass filled with water (200 ml), mix well, and drink the entire contents of the glass.

After each use, rinse the syringe with water and allow it to dry in the air.

The recommended dose is as follows:

• Major depressive episode

The recommended dose is 20 mg (20 drops) daily. Under normal conditions, you should begin to feel better within one week, although effects may appear later (for example, after two weeks). If the effects are insufficient, your doctor may gradually increase the dose in 10 mg (10 drops) increments up to a maximum of 50 mg (1.5 ml) daily. Your doctor will determine how long you need to continue taking the drops, which may last longer than 6 months.

• Obsessive-compulsive disorder (OCD)

The recommended dose is 40 mg (1.2 ml) daily, with an initial dose of 20 mg (20 drops) daily. If the effects are insufficient, your doctor may gradually increase the dose in 10 mg (10 drops) increments. The maximum daily dose is 60 mg (1.8 ml). Your doctor will determine how long you need to continue taking the drops, which may last several months or longer.

• Panic disorder with or without agoraphobia

The recommended dose is 40 mg (1.2 ml) daily, with an initial dose of 10 mg (10 drops) daily. If the effects are insufficient, your doctor may gradually increase the dose in 10 mg (10 drops) increments. The maximum daily dose is 60 mg (1.8 ml). The initial dose is low to avoid worsening panic disorder symptoms at the beginning of treatment. Your doctor will determine how long you need to continue taking the drops, which may last several months or longer.

• Social anxiety disorder/social phobia

The recommended dose is 20 mg (20 drops) daily. If the effects are insufficient, your doctor may gradually increase the dose in 10 mg (10 drops) increments. The maximum daily dose is 50 mg (1.5 ml). Your doctor will determine how long you need to continue taking the drops, which may be for a long duration, and treatment should be periodically reviewed during this time.

• Generalized anxiety disorder

The recommended dose is 20 mg (20 drops) daily. If the effects are insufficient, your doctor may gradually increase the dose in 10 mg (10 drops) increments. The maximum daily dose is 50 mg (1.5 ml). Your doctor will determine how long you need to continue taking the drops, which may be for a long duration, and treatment should be periodically reviewed during this time.

Elderly patients

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

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 need to continue taking paroxetine. Depending on your condition, you may need to take paroxetine for a long time. You should continue taking paroxetine for some time even after your symptoms have improved, to prevent them from returning. Do not stop treatment with paroxetine without consulting your doctor. If you stop treatment abruptly, 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 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 missed doses. Skip the missed dose and take the next dose at the scheduled time. 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 are: dizziness, sensory disturbances [tingling or burning sensations, electric shock-like sensations, tinnitus (ringing, buzzing, whistling, or other persistent noises in the ears)], 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. Typically, withdrawal effects resolve 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 discontinue paroxetine treatment, the daily dose should be gradually reduced over several weeks or months (starting with 10 mg weekly reductions). 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 a 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, mainly bruising (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 or remain still (akathisia)
• Low levels of sodium in the blood (hyponatremia), mainly in elderly patients.

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

• Allergic reactions, which can be serious with paroxetine, including itching and painful skin rash (urticaria) or severe reactions causing swelling of the skin, throat, or tongue, difficulty breathing and/or itching (angioedema). If you develop a red, raised rash, swelling of the eyelids, face, lips, mouth, or tongue, start feeling itchy or have difficulty breathing (shortness of breath) or swallowing, feel weak or dizzy, and consequently fall or lose consciousness, contact your doctor or go to a hospital immediately.
• 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, cases of suicidal thoughts/behaviors or suicide have been reported during treatment with paroxetine or immediately after discontinuation of treatment. However, these symptoms may also be due to the underlying illness.
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); 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 problems with ejaculation, 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, difficulty concentrating (decreased concentration).
• Blurred vision
• Yawning
• Constipation, diarrhea, 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 a loss of control of your blood sugar levels while taking paroxetine. Consult your doctor about adjusting your insulin or diabetes medication dosage.
• Confusion, imagining things that are not really there (hallucinations)
• Uncontrolled movements of the body or face (extrapyramidal disorders)
• Pupil dilation (mydriasis)
• Fast heart rate (sinus tachycardia)
• Feeling weak or dizzy 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 behavior (mania, manic episodes), anxiety, panic attacks, loss of personality
• Irresistible urge to move the legs (Restless Legs Syndrome)
• Slow heart rate (bradycardia)
• Increase in liver enzymes
• Muscle pain (myalgia), joint pain (arthralgia)
• Elevated blood levels of the hormone prolactin (hyperprolactinemia), which may cause abnormal milk production from the breast in men and women (galactorrhea) 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 blood sodium levels as a result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• Gastrointestinal bleeding
• Liver disorders such as inflammation (hepatitis), sometimes associated with jaundice and/or liver failure
• Serious skin adverse effects (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), urticaria, photosensitivity.
• Pain during erection (priapism)
• Swelling of arms and/or legs (peripheral edema)

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 diarrhea)

Patients taking this medicine have an increased risk of bone fractures.

Withdrawal symptoms observed when discontinuing treatment with paroxetine

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

Uncommon: agitation, nausea, sweating, tremors, confusion, emotional instability, visual disturbances, palpitations, irritability, and diarrhea.

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

Additional 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, unfriendly and hostile behavior, loss of appetite, tremors, abnormal sweating, hyperactivity, excitement, nausea, stomach pain, and nervousness.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Daparox 33 mg/ml oral drops solution

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

Do not use this medicine after the expiry date stated on the container after "EXP". The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

After opening, the solution should be used within 56 days.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Daparox 33 mg/ml oral drops solution

• The active substance is paroxetine (as mesilate).

1 ml of Daparox contains 33.1 mg of paroxetine (as mesilate).

One drop contains 1 mg of paroxetine (as mesilate).

• The other components (excipients) are:

Sodium saccharin (E954)

Acesulfame K (E950)

Peppermint flavour (peppermint essential oil, menthol, eucalyptol, ethanol, water)

Polysorbate 80 (E433)

Ethanol (111 mg/ml)

Propylene glycol (E1520).

Appearance of Daparox and contents of the pack

Daparox is a clear, reddish-brown to light brown solution, supplied in a 20 ml amber glass bottle containing at least 18.5 ml of solution.

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

Only certain pack 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)
Telephone: 932 534 500

Manufacturer:

Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands

Synthon Hispania, S.L.

• 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 medicinal product is authorized in the Member States of the European Economic Area under 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 oral drops solution

Date of the most recent revision of this leaflet: December 2023

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