Package Insert: Information for the User

Daparox 20 mg Film-Coated Tablets

paroxetine (mesylate)

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.What is Daparox and for what it is used

2.What you need to know before starting to take Daparox

3.How to take Daparox

4.Possible adverse effects

5.Storage of Daparox

6.Contents of the package and additional information

Paroxetine belongs to a group of medications 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).
• Panic disorder with and without agoraphobia (abnormal fear of leaving the house, entering stores, or fear of open spaces).
• 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 areallergic 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 [calledmonoamine oxidase inhibitors (MAOIs)].

• You will only be able to use paroxetine if you stop taking irreversible MAOIs at least 14 days before (e.g.isocarboxazidandphenelzine).
• if you use a reversible MAOI (e.g.moclobemide, linezolid, methylene blue(chloride of methionine), you should wait at least 24 hours before taking paroxetine.
• when you stop taking paroxetine, you should wait at least 7 days before starting to take MAOIs.

• if you are receiving treatment withthioridazine, 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 aspimozide(see section 2 “Other medicines and Daparox”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Daparox:

• if you are taking certain medicines used in the treatment of depression or Parkinson's disease (MAOIs). Do not take paroxetine with these medicines. Your doctor will tell you when to 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 asrestlessness, hyperactivity, or inability to sit or remain still (akathisia). This may occur during the first weeks of treatment. If this is the case, contact your doctor. An increase in dose may be harmful.
• if you start to experience symptoms ofserotonin syndrome. This syndrome presents as a combination of some of the following symptoms: restlessness (extreme), confusion, irritability, delirium (hallucinations), sweating, tremors or chills, increased reflexes, sudden muscle contractions (myoclonus), high fever, or rigidity (see section 2, “Other medicines and Daparox”). If you experience any of these symptoms together, contact your doctor immediately and stop taking paroxetine.
• if you have or have had (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 problems with yourliverorsevere problems with your kidneys. Your doctor may need to adjust your dose.
• if you havediabetes. Treatment with paroxetine may alter blood sugar levels, which must be controlled. You may need to adjust your dose of insulin or oral antidiabetic medicines.
• if you have or have hadepilepsy or seizures. Paroxetine may cause seizures (apoplexy), so your doctor will 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 withelectroconvulsive therapy (ECT). So far, the experience with the use of paroxetine during ECT treatment islimited, so your doctor will pay close attention to this.
• if you have or have had anincrease in intraocular pressure (glaucoma). Paroxetine may dilate the pupils (mydriasis), which may lead to an increase in ocular pressure, so your doctor will pay close attention to this.
• if you havecardiovascular disorders. The safety of using paroxetine has not been investigated in patients with this disease, so your doctor will take extra precautions.
• if you are anolder person, takingother medicationor have problems with yourliver(cirrhosis), and as a result, you have a high risk of having low levels of sodium (salt) in your blood. Paroxetine may decrease sodium levels in the blood, which causes weakness and fatigue. If this occurs, contact your doctor.
• if you have an increasedtendency 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 may increase the risk of bleeding, so your doctor will pay close attention to this (see section 2 “Other medicines and Daparox”).
• if you want tostop taking paroxetine, you may experience withdrawal symptoms, particularly if treatment is stopped suddenly (see section 3 “If you stop taking Daparox”). Consult your doctor before discontinuing treatment with paroxetine.

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 may be more likely:

• if you have had thoughts of suicide or self-harm before.
• if you are a young adult.The clinical trials have shown an increased 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 to explain to a close family member or friendthat 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). 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 suicidal thoughts, suicidal behavior, 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 if they decide 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. In addition, 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 (MAOIssuch asmoclobemideorisocarboxazid), a dietary supplement (L-tryptophan), medicines for migraine (triptans, such assumatriptan,almotriptan), certain analgesics (tramadol, buprenorphine, pethidine), a medicine used to treat infections (linezolid), a preoperative visualizing agent (methylene blue), other selective serotonin reuptake inhibitors (SSRIs, such asfluoxetine, sertraline), medicines used to treat psychiatric disorders (lithium, risperidone), a medicine used to treat chronic pain or in anesthesia (fentanyl) andSt. John's Wort(Hypericum perforatum), a 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 withnaloxone, a treatment for opioid addiction.
• Psychosis treatment (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 can cause severe adverse effects such as cardiac arrhythmias, 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 asnortriptylineanddesipramine), psychiatric disorders (perphenazine, thioridazineandrisperidone), a medicine used to treat attention deficit hyperactivity disorder (ADHD) in children (atomoxetine), certain medicines used to treat cardiac rhythm disorders (such asflecainideandpropafenone), certain medicines used to treat chest pain and high blood pressure (metoprolol), a medicine used to treat high cholesterol (pravastatin) and certain medicines used to treat psychiatric disorders or nausea and vomiting (phenothiazines). Paroxetine may increase the effect and adverse effects of these medicines. Paroxetine andthioridazineshould not be used together, as there is a risk of severe adverse effects such as cardiac arrhythmias and sudden death (see section 2 “Do not take Daparox”).
• Anticoagulants (acenocoumarol,fenprocoumon), which may increase the effect and adverse effects of these medicines, as well as the risk of bleeding.Your doctor will 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 psychiatric disorders or nausea and vomiting (phenothiazines, such aschlorpromazine, perphenazine), a medicine used to treat schizophrenia (clozapine), certain medicines used to treat depression (tricyclic antidepressants),aspirin, medicines used to treat pain and inflammation (NSAIDssuch asibuprofenor,Cox-2 inhibitors, such as therofecoxib,celecoxib) (see section 2, “Warnings and precautions”).
• Medicines used to reduce stomach acid (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, 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 cardiac effects 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 discontinue paroxetine gradually. 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 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 so they can 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, causing the baby to breathe faster and appear blue. These symptoms usually start within the first 24 hours of life. If this happens to your baby, contact your midwife and/or doctor immediately. If you take paroxetine during the last 3 months of pregnancy, your newborn baby may also experience other conditions that usually start within the first 24 hours after birth. These include problems with sleeping or feeding, respiratory problems, blue color, temperature variations, 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 before starting to breastfeed. Therefore, do not take it if you are breastfeeding, unless your doctor tells you to.

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 machinery

Paroxetine does not affect your ability to drive or operate machinery. However, this medicine may cause adverse effects (such as blurred vision, dizziness, sleepiness, or confusion). If you experience any of these adverse effects, do not drive or operate machinery or perform any other activity that requires you to be alert or focused.This means that, before performing these 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 certain 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”.

Follow exactly the administration instructions of this medication as 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 crushing 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 within a week, but you may only notice the effect from the second week. If the effect is not satisfactory, your doctor may decide to gradually increase the dose in half-tablet (10 mg paroxetine) increments 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 longer than 6 months.

• Obsessive-Compulsive Disorder (OCD)

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

• Anxiety Disorder with or without Agoraphobia

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

• Social Anxiety Disorder / Social Phobia

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

Older patients

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

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 need to 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 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 compensate for the missed doses. Omit the missed dose and continue taking the medication as usual. If you are unsure, consult your doctor always.

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, ringing, hissing, or other persistent sounds in the ears (tinnitus)), anxiety, sleep disturbances (such as vivid dreams or nightmares), and headache.Less common effects such as: excitement, nausea, tremors, confusion, sweating, emotional instability, visual disturbances, strong heartbeats (palpitations), diarrhea, and irritability (see section 4 “Possible adverse effects”).

These symptoms usually start within the first few days after stopping treatment, but may 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).

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 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 effectsinfrequent(may affect up to 1 in 100 people):

• Abnormal bleeding, predominantly skin bruises (ecchymosis and gynecological bleeding).

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

• Seizures and convulsions.
• Restlessness and hyperactivity 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 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 skin swelling, throat or tongue swelling, difficulty breathing and/or itching (angioedema). If you develop a red itchy rash with blisters, facial swelling, lips, mouth or tongue swelling, start itching or have difficulty breathing 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 withunknown frequency(cannot be estimated from available data):

• Aggression, cases of self-harm or suicidal thoughts, during paroxetine treatment or immediately after its discontinuation.

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

• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy, lactation and fertility” in section 2 for more information.

Otherside effects

Side effectsvery frequent(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, decreased concentration (diminished concentration)
• Blurred vision
• Yawning
• Constipation, diarrhea, vomiting, dry mouth
• Sweating
• Weight gain, general feeling of weakness with muscle weakness (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, imagination of things that are not really there (hallucinations)
• Uncontrolled body or facial movements (extrapyramidal disorders)
• Pupil dilation (mydriasis)
• Fast heart rate (sinus tachycardia)
• Feeling weak or dizzy when standing up suddenly (postural hypotension)
• Itching, skin rash (pruritus)
• Urinary retention and incontinence problems

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)
• Elevated blood levels of the prolactin hormone (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 inadequate secretion of antidiuretic hormone (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), photosensitivity.
• Erectile 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, and other persistent noises in the ears
• Colitis inflammation causing diarrhea

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

Symptoms of withdrawal observed upon discontinuing paroxetine treatment

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

Infrequent: excitement, nausea, sweating, tremors, confusion, emotional instability,

vision disorder, palpitations, diarrhea, and irritability.

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

Other side effects in children and adolescents

When children and adolescents under 18 years old 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, hostile 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 Pharmacovigilance of Medicines for Human Use www.notificaRAM.esBy 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 that appears on the box and on the blister after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Daparox

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

• The other components (excipients) are:

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

Appearance of the product and contents of the packaging

Daparox tablets are round, yellow in color, and coated with a film. They show the inscription "POT 20" on one side and are scored on both sides.

Daparox is presented in boxes containing 10, 12, 14, 20, 28, 30, 50, 56, 60, or 100 tablets available in blister packaging and a pack of 500 tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible manufacturer

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

Responsible manufacturer:

Synthon BV

Microweg 22

6545 CM Nijmegen

Holland

Synthon Hispania, S.L.

C/Castelló, 1.

Polígono Industrial Las Salinas

08030 Sant Boi de Llobregat (Spain)

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

Spain: Daparox 20 mg film-coated tablets

Last review date of this leaflet: July 2023

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es