Package Insert: Information for the User

Paroxetina Mabo 10 mg Tablets EFG

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 for you, and you should not give it to others who may 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.

6. Contents of the pack and additional information

Paroxetina is used for the treatment of depression and/or anxiety disorders in adults. The anxiety disorders for which this medication is indicated are: obsessive-compulsive disorder (repetitive, obsessive thoughts with uncontrolled behavior), anxiety disorder (panic crises, including those caused by agoraphobia, which is the fear of open spaces), social anxiety disorder (fear or avoidance of social contact situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (feeling normally a lot of anxiety and nervousness).

Paroxetina belongs to a group of medications called selective serotonin reuptake inhibitors (SSRIs). The exact mechanism of action of paroxetina and other SSRIs is not precisely known, but they exert their action by increasing the level of serotonin in the brain. Treating depression or anxiety disorders properly is important to help you feel better.

Do not take Paroxetina Mabo:

-if you are being treated with medications called monoamine oxidase inhibitors(MAOIs, including moclobemide and methionine chloride (methylen blue)), or if you have been treated with any of these medications in the last two weeks. Your doctor will advise you how to start taking paroxetina once you have stopped taking the MAOI

-if you are taking an antipsychotic medicationcalled thioridazine or the antipsychotic called pimozide

-if you are allergicto paroxetina or to any of the other components of this medication (including those listed in section 6).

If you are in any of these situations, inform your doctor and do not take paroxetina.

Warnings and precautions

Consult your doctor or pharmacist before starting to take paroxetina

- if you are taking other medications (see the sectionOther medications and paroxetina)

- if you are taking tamoxifen for the treatment of breast cancer (or fertility problems). Paroxetina may make tamoxifen less effective, so your doctor should recommend another antidepressant

- if you have any kidney, liver, or heart problems

- if you have a heart condition known as prolonged QT interval

- if you have a family history of prolonged QT interval, heart diseases such as heart failure, low heart rate, or low levels of potassium or magnesium

- if you have epilepsy or if you experience seizures or convulsions

- if you have had manic episodes (excessively active thoughts or behaviors)

- if you are being treated with electroconvulsive therapy (ECT)

- if you have a tendency to bleed or bruise, or if you are being treated with any medication that may increase the risk of bleeding (including medications such as warfarin (acenocoumarol), antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, pain and inflammation medications called nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)

- if you have diabetes

- if you are on a low-sodium diet

- if you have glaucoma (elevated eye pressure)

- if you are pregnant or if you think you may become pregnant (see the sectionPregnancy, breastfeeding, and fertility)

- if you are under 18 years of age (see this leafletChildren and adolescents under 18 years of age).

If you are in any of these situationsand have not yet consulted your doctor, ask your doctor how to take paroxetina.

Children and adolescents under 18 years of age

Paroxetina should not be usedin the treatment of children and adolescents under 18 years of age. Additionally, you should know that in patients under 18 years of age, there is a higher risk of adverse effects such as suicidal thoughts, suicidal attempts, and hostility (primarily aggression, confrontational behavior, and irritability) when taking paroxetina. Despite this, your doctor may prescribe paroxetina to patients under 18 years of age when they decide it is the best option for the patient. If your doctor has prescribed paroxetina to you or your child under 18 years of age and you wish to discuss this decision, consult your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen when you or your child under 18 years of age are taking paroxetina. The long-term safety of paroxetina in terms of growth, maturation, and cognitive and behavioral development in this age group has not yet been demonstrated.

In studies conducted with paroxetina in patients under 18 years of age, the most common adverse effects, which affected less than 1 in 10 children or adolescents, were: an increase in suicidal thoughts and attempts, self-harm, hostile behaviors, aggressive or uncooperative behaviors, loss of appetite, tremors, abnormal sweating, hyperactivity (excessive energy), agitation, unstable emotions (including crying and mood changes), and the appearance of petechiae or bleeding (such as nosebleeds). These effects were also observed in patients included in these studies who did not take paroxetina, although less frequently.

When stopping treatment with paroxetina, some of the patients under 18 years of age reported adverse effects of withdrawal. These effects were very similar to those observed in adults who stopped taking paroxetina (see the sectionHow to take paroxetina). In addition, patients under 18 years of age frequently experienced (affecting less than 1 in 10) stomach pain, nervousness, and unstable emotions (including crying, mood changes, self-harm, suicidal thoughts and attempts).

Suicidal thoughts and worsening of depression or anxiety

Ifyou are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. These may increase at the beginning of treatment with antidepressants, as all these medications take time to take effect, which is usually two weeks but can be longer.

This is more likely to happen

• if you have had suicidal thoughts or self-harm previously.
• if you are anadult young person. There is information from clinical trials that shows an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were being treated with some antidepressants.

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

It may be helpful for you to explain to a family member or close friendwho is depressed or has 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.

Important adverse effects observed with paroxetina

Some patients taking paroxetina develop a condition called akathisia,and feel restless and unable to sit or stay still. Other patients develop the so-calledserotonin syndrome ormalignant neuroleptic syndrome, and may have one or more of the following symptoms:feel very agitated or irritable, confusion, restlessness, sensation of heat, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle rigidity, sudden, involuntary movements, or increased heart rate. The severity can increase and lead to loss of consciousness.

Consult your doctorif you have any of these symptoms. For more information about this or other adverse effects of paroxetina, see section 4.

Some medications in the group to which paroxetina belongs (called SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Other medications and paroxetina

Some medications may modify the effect of paroxetina or make it more likely for adverse effects to occur. Paroxetina may also modify the effect of some medications. For example:

- Medications calledmonoamine oxidase inhibitors(MAOIs, including

moclobemide and methionine chloride (methylen blue)). See the sectionDo not take paroxetina.

- Medications known to increase the risk of changes in heart activity (e.g. theantipsychoticstioridazine or pimozide). See the sectionDo not take paroxetina.

- Medications called tioridazine or pimozide, which areantipsychotics. See the sectionDo not take paroxetina.

- Aspirin, ibuprofen, and other medications called nonsteroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, etodolac, diclofenac, and meloxicam, used to treatpain and inflammation.

- Tramadol, buprenorphine, and petidina,analgesics.

-Buprenorphine combined with naloxone, treatment for opioid addiction.

- Medications called triptans, such as sumatriptan, used to treatmigraines.

- Otherantidepressants, including other selective serotonin reuptake inhibitors and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.

- A dietary supplement called tryptophan.

- Mivacurio and suxamethonium (used in anesthesia).

- Medications such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat somepsychiatric disorders.

- Fentanyl, used inanesthesiaor to treatchronic pain.

- A combination of fosamprenavir and ritonavir, used to treatHIV infection.

- St. John's Wort, a medicinal herb used to treatdepression.

- Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treatseizuresorepilepsy.

- Atomoxetine, a medication used to treatattention deficit hyperactivity disorder (ADHD).

- Procyclidine, used to relieve tremors, especially inparkinson's disease.

- Warfarin and other medications (called anticoagulants) used tothin the blood.

- Propafenone, flecainide, and medications used to treatheart rhythm disorders.

- Metoprolol, a beta-blocker used to treathigh blood pressureandheart disorders.

- Pravastatin, used to treathigh cholesterol.

- Rifampicin, used to treattuberculosis (TB)andleprosy.

- Linezolid, anantibiotic.

- Tamoxifen, used to treatbreast cancer(orfertility problems).

If you are taking or have taken recently any of these medications, inform your doctor and consult what to do.Your doctor may decide to change the dose or prescribe another medication.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication,including those acquired without a prescription.

Taking paroxetina with food, drinks, and alcohol

Do not consume alcohol while taking paroxetina.Alcohol may worsen your symptoms or adverse effects.

Taking paroxetina in the morning with food may reduce the likelihood of nausea.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

In some studies, an increased risk of malformations, particularly those affecting the heart, was observed in newborns whose mothers took paroxetina during the first months of pregnancy.In the general population, approximately 1 in 100 newborns are born with a heart defect. This proportion increased to 2 in 100 newborns in mothers who took paroxetina. Your doctor, in consultation with you, may change your medication or gradually discontinue paroxetina while you are pregnant. However, depending on your circumstances, your doctor may recommend continuing to take paroxetina.

Ensure that your doctor or midwife knows that you are taking paroxetina.

If you take paroxetina in the final stages of pregnancy, there may be an increased risk of excessive vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking paroxetina to advise you.

Paroxetina may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy and particularly in the last stages of pregnancy. The pressure in the blood vessels between the heart and lungs is very high in newborns with PPHN.

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If you are taking paroxetina in the last trimester of pregnancy,your newborn may also experience other symptoms that normally begin within the first 24 hours after birth. These symptoms include:

- Difficulty breathing.

- Blue-tinged skin or appearance of being too hot or cold.

- Blue lips.

- Vomiting or difficulty feeding.

- Feeling extremely tired, difficulty sleeping, or frequent crying.

- Muscle stiffness or flaccidity

- Tremors, localized tremors, or seizures.

- Exaggerated reflexes.

If your baby has any of these symptoms at birth, or if you are concerned about your baby's health,contact your doctor or midwife, who will advise you.

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Paroxetina passes into breast milk in very small amounts.Consult your doctor if you are taking Paroxetina before starting to breastfeed. Your doctor, in consultation with you, may advise you to continue breastfeeding while taking paroxetina.

Studies in animals have shown that paroxetina reduces sperm quality. Theoretically, this may affect human fertility, but this has not yet been observed in humans.

Driving and operating machinery

Some of the adverse effects that paroxetina may cause are dizziness, confusion, feeling drowsy, or blurred vision. If you experience any of these effects, do not drive vehicles or operate machinery.

Paroxetina Mabo 10/20/30/40 mg tablets

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.If in doubt, consult your doctor or pharmacist again.

The normal doses for different indications are detailed in the table below:

Your doctor will tell you what dose to take when starting treatment with paroxetine.Most people start to feel better after a couple of weeks. If after this time you do not start to feel better, consult your doctor who will tell you what to do. Your doctor may decide to gradually increase the dose, in increments of 10 mg, up to the maximum daily dose.

Take the tablets in the morning, with food.

The tablets should be swallowed whole, immediately, with plenty of water (at least 1 glass of 150 ml). Do not suck, chew, or keep the tablet in the mouth, as this can cause an unpleasant local sensation such as bitter taste, burning in the throat, irritating cough, or sensation of asphyxia.

Your doctor will tell you the duration of treatment. This period may be prolonged for several months or even longer.

Patients over 65 years old

The maximum dose for people over 65 years old is 40 mg per day.

Patients with kidney or liver problems

If you have severe liver or kidney failure, your doctor may advise you to take smaller doses of paroxetine than usual.

If you take more paroxetine 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.

Never take more tablets than your doctor has recommended.

A person who has taken an overdose of paroxetine may have some of the symptoms listed in the section 4, Possible side effects, or some of the following symptoms: fever, involuntary muscle contraction.

If you forget to take paroxetine

Take your medication at the same time every day.

If you forget to take a dose and remember before going to bed,take it immediately. Take the next dose at the usual time.

If you remember during the night or the next day, omit the missed dose. You may experience some withdrawal symptoms, but they should disappear after taking the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

What to do if you don't feel better

Paroxetine will not improve your symptoms immediately, all antidepressants take time to act. Some people start to feel better after a couple of weeks, but others may need more time. Some people who take antidepressants feel worse before they start to notice improvement. If you do not start to feel better after a couple of weeks, tell your doctor, who will tell you what to do. Your doctor may have scheduled an appointment for you after 2 weeks of starting treatment.

If you interrupt treatment with paroxetine

Do not interrupt treatment until your doctor tells you to.

When interrupting treatment with paroxetine, your doctor will tell you how to gradually reduce the dose over a period of several weeks or months, which will help reduce the risk of withdrawal symptoms. One way to do this is to gradually reduce the dose of paroxetine you are taking by 10 mg each week. Most people consider the possible symptoms that occur when interrupting treatment with paroxetine to be mild and disappear on their own in two weeks. For other people, these symptoms may be more severe or last longer.

If you experience withdrawal symptoms while interrupting treatment, your doctor may decide to interrupt treatment more slowly. If you experience severe withdrawal symptoms, please consult your doctor. Your doctor may advise you to start treatment again and then interrupt it more slowly.

You can interrupt treatment with paroxetine even if you experience some withdrawal symptoms.

Possible withdrawal effects when interrupting treatment

Studies have shown that 3 out of 10 patients experience one or more symptoms when they interrupt their treatment with paroxetine. Some of these effects occur more frequently than others.

Frequent side effects, which can affect up to 1 in 10 patients:

- Feeling dizzy, unstable, or experiencing balance disturbances.

- Tingling, burning sensations, and, less frequently, a sensation of electric discharge, even in the head, buzzing, ringing, beeping, or other persistent sounds in the ears (tinnitus).

- Sleep disturbances (vivid dreams, nightmares, inability to sleep).

- Anxiety.

- Headaches.

Rare side effects, which can affect up to 1 in 100 patients:

- Vomiting (nausea).

- Sweating (including night sweats).

- Restlessness or agitation.

- Tremors.

- Confusion or disorientation.

- Diarrhea (soft stools).

- Feeling extremely sensitive or irritable.

- Visual disturbances.

- Rapid or strong heart palpitations.

Consult your doctor if you are concerned about withdrawal effects from paroxetine.

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. It is more likely that side effects will occur during the first weeks of treatment with paroxetine.

Inform your doctor if you experience any of the side effects listed below during treatment with paroxetine.

You may need to consult your doctor or go to the hospital immediately.

Side effects that are uncommon, affecting up to 1 in 100 patients:

-If you have unusual bruising or bleeding, such as blood in your vomit or stools,contact your doctor or go to the hospital immediately.

-If you experience difficulty urinating, contact your doctor or go to the hospital immediately.

Side effects that are rare, affecting up to 1 in 1,000 patients:

-If you experience seizures(epileptic fits),contact your doctor or go to the hospital immediately.

-If you have a feeling of restlessness, inability to sit or stay still,known as akathisia. Increasing the dose of paroxetine may worsen your symptoms. If you feel this way,consult your doctor.

-Feeling tired, weak, confused, and pain, stiffness, and lack of muscle coordination.This may be due to low sodium levels in the blood. If you have these symptoms,consult your doctor.

Side effects that are very rare, affecting up to 1 in 10,000 patients:

• Allergic reactions to paroxetine that can be severe.

If you develop a skin rash with redness and blisters, swelling of the face, eyelids, lips, mouth, or tongue, itching, or difficulty breathing (difficult breathing) or swallowing, and feeling weak or having a dizziness that can cause a collapse or loss of consciousness,consult your doctor or go to the hospital immediately.

If you notice any of the following symptomsyou may be experiencing aserotonin syndrome or malignant neuroleptic syndrome.The symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, trembling, chills, hallucinations (strange sounds or visions), muscle rigidity, sudden, rapid movements, or rapid heartbeat. The severity can increase and lead to loss of consciousness. If you feel this way,consult your doctor.

• Acute glaucoma.

If you suddenly experience eye pain and blurred vision,consult your doctor.

Unknown frequency,The frequency cannot be estimatedfrom the available data

-Some people have experienced thoughts of self-harm or suicide while taking paroxetine or shortly after stopping treatment (see Thoughts of suicide and worsening of depression or anxiety disorder in section 2).

-Some people have experienced aggression while taking paroxetine.

-Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage),see Pregnancy, breastfeeding, and fertilityin section 2 for more information,

Other possible side effects during treatment:

Very common side effects, affecting more than 1 in 10 patients:

-Feeling sick (nausea). This effect can be reduced by taking your medication in the morning after breakfast.

-Change in sexual desire or function. For example, lack of orgasm and, in men, abnormal erection and ejaculation.

Common side effects, affecting up to 1 in 10 patients:

-Increase in blood cholesterol levels.

-Loss of appetite.

-Difficulty sleeping (insomnia) or drowsiness.

-Abnormal dreams (including nightmares).

-Dizziness, tremors.

-Headache.

-Difficulty concentrating.

-Restlessness.

-Unusual weakness.

-Blurred vision.

-Yawning, dry mouth.

-Diarrhea or constipation.

-Vomiting.

-Weight gain.

-Sweating.

Uncommon side effects, affecting up to 1 in 100 patients:

-Transient increases in blood pressure, or transient decreases that may cause dizziness or fainting when standing up quickly.

-Rapid heartbeat.

-Lack of movement, stiffness, tremor, or abnormal movements of the mouth and tongue.

-Pupil dilation.

-Skin rash.

-Itching.

-Confusion.

-Hallucinations (strange sounds or visions).

-Inability to urinate (urinary retention) or involuntary urination (incontinence).

-If you are a diabetic patient, you may notice a loss of control of blood sugar levels while taking paroxetine. Consult your doctor about how to adjust the dose of your insulin or diabetes medication.

-Decreased white blood cell count.

Rare side effects, affecting up to 1 in 1,000 patients:

-Abnormal milk secretion in men and women.

-Decreased heart rate.

-Liver effects that are seen in laboratory tests that indicate liver function.

-Panic attacks.

-Very active behaviors or thoughts (mania).

-Feeling detached from oneself (derealization).

-Anxiety.

-Irresistible need to move the legs (Restless Legs Syndrome).

-Joint or muscle pain.

-Increased blood levels of a hormone called prolactin.

-Alterations in menstrual cycle (including heavy or irregular periods, bleeding between periods, and absence or delay of period).

Very rare side effects, affecting up to 1 in 10,000 patients:

-Skin rash, in which small, round, red spots (target lesions) may appear, called erythema multiforme.

-Widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).

-Widespread rash over a large area of the body with blisters and peeling of the skin (toxic epidermal necrolysis).

-Liver changes that turn the skin or the white of the eyes yellow.

-Syndrome of inappropriate antidiuretic hormone secretion (SIADH) that is a state in which the body develops an excess of water and a decrease in sodium concentration as a result of inappropriate chemical signals. SIADH patients may feel severely ill or have no symptoms.

-Water retention or fluid (which causes swelling of arms or legs).

-Sensitivity to sunlight.

-Painful and prolonged erection of the penis.

-Decreased platelet count in the blood.

Some patients have experienced persistent ringing, buzzing, beeping, or other sounds in the ears (tinnitus) when taking paroxetine.

It has been observed that people taking this type of medication, such as paroxetine, have a higher risk of bone fractures.

Side effects of unknown frequency, the frequency cannot be estimatedfrom the available data

-Inflammation of the colon (which causes diarrhea).

-Grinding of teeth.

Some patients have experienced persistent ringing, buzzing, beeping, or other sounds in the ears (tinnitus) when taking this medication. It has been observed that people taking medications like paroxetine have a higher risk of bone fractures

Reporting of side effects

If you experience any type of side effect, consult your doctor, 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 Vigilance of Medicines for Human Use, website:www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

This medication does not require any special storage conditions.

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

Composition of Paroxetina Mabo 10 mg tablets

The active ingredientis: paroxetine, each tablet contains 10 mg of paroxetine as anhydrous paroxetine hydrochloride.

The other components are:microcrystalline cellulose (E 460), calcium dihydrogen phosphate dihydrate (E 341), croscarmellose sodium (E 468), anhydrous colloidal silica (E 551) and magnesium stearate (E 470b).

Appearance of the product and contents of the package

Paroxetina Mabo is presented in the form of almost white, biconvex, and round tablets with 10 inscribed on one side.

This medication is presented in blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 120, 180, or 500 tablets available in blister packs.

Only some package sizes may be commercially available.

Holder of the marketing authorization and Responsible for the manufacture:

Holder of the marketing authorization:

MABO-FARMA S.A.

Calle Rejas 2, planta 1

28821. Coslada. Madrid

Spain

Responsible for the Manufacture:

Farmaceutisch Analytisch Laboratorium Duiven BV

Dijkgraaf 30, Duiven

Netherlands

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

Last review date of this leaflet:August 2024

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