Package Leaflet: Information for the User

Paroxetina Normon 40 mg Film-Coated Tablets

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Paroxetina Normon is and what it is used for

2. What you need to know before you start taking Paroxetina Normon

3. How to take Paroxetina Normon

4. Possible side effects

5. Storage of Paroxetina Normon

6. Contents of the pack and additional information

Paroxetina Normon is used for the treatment of depression and/or anxiety disorders in adults.The anxiety disorders for which Paroxetina Normon 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 excessively anxious and nervous).

Paroxetina Normon belongs to a group of medications known as selective serotonin reuptake inhibitors (SSRIs).Everyone has a substance called serotonin in the brain. People who are depressed or anxious have lower levels of this substance.The exact mechanism of action of Paroxetina Normon 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 Normon

• 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 on 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 with your doctor or pharmacist before starting to takeParoxetina Normon

• If you are taking other medications (see the sectionOther medications and Paroxetina Normon).
• 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 prolongation of the QT interval
• If you have a family history of prolongation of the 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, antidepressants such as 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 have a history of bleeding disorders
• 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 the sectionChildren and adolescents).

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

Children and adolescents

Paroxetina Normon should not be used in 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 ideation, and hostility (predominantly 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 effects of paroxetina on safety, related to growth, maturation, and cognitive and behavioral development in this age group have 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 thoughts and attempts of suicide, self-mutilation, hostile, aggressive, or unfriendly behaviors, loss of appetite, tremors, abnormal sweating, hyperactivity (excessive energy), agitation, unstable emotions (including crying and mood changes), and the appearance of fortuitous cardinals or bleeding (such as nasal bleeding). These effects were also observed in patients included in these studies who did not take paroxetina, although less frequently.

When discontinuing paroxetina treatment in these studies, 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 discontinued paroxetina treatment (see section 3). Additionally, patients under 18 years of age frequently (affecting less than 1 in 10) experienced stomach pain, nervousness, and unstable emotions (including crying, mood changes, self-mutilation, thoughts and attempts of suicide).

Thoughts of suicide and worsening of depression or anxiety disorder

If you 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 previously had thoughts of suicide or self-harm.
• 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 antidepressant.

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 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.

Important adverse effects observed with Paroxetina Normon

Some patients who take paroxetina develop a condition called akathisia, andfeel restless and unable to sit or stay still. Other patients develop the so-calledserotonin syndromeor malignant neuroleptic syndrome, and may have any or all of the following symptoms: feeling very agitated or irritable, confusion, restlessness,sensation of heat, sweating, tremors, chills, hallucinations (strange visions or sounds),muscle rigidity, sudden and violent movements, or an increase in heart rate. The severity can increase and lead to loss of consciousness.Consult your doctorif you have any of these symptoms. For more information on this or other adverse effects of paroxetina, see section 4.

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

Other medications andParoxetina Normon

Some medications may modify the effect of paroxetina or make it more likely for some 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 Normon.
• The medications called thioridazine or pimozide, which areantipsychotics. See the sectionDo not take Paroxetina Normon.
• 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.
• Adietary supplementcalled 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 treathuman immunodeficiency virus (HIV) infection.
• St. John's Wort, a medicinal herb used to treatdepression.
• Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treatseizures or epilepsy.
• Atomoxetine, a medication used to treatattention deficit hyperactivity disorder (ADHD).
• Procyclidine, used to alleviate tremor, especially inParkinson's disease.
• Warfarin and other medications (called anticoagulants) used tothin the blood.
• Propafenone, flecainide, and medications used to treatcardiac arrhythmias.
• Metoprolol, a beta-blocker used to treathigh blood pressure and cardiac disorders.
• Pravastatin, used to treathigh cholesterol.
• Rifampicin, used to treattuberculosis (TB)andleprosy.
• Linezolid, anantibiotic.
• Tamoxifen, used totreat breast 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.

Paroxetina Normon 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 malformation. 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 treatment while 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 Normon.

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, particularly in the final stages. The pressure in the blood vessels between the heart and lungs is very high in newborns with PPHN.

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

These symptoms include:

• Difficulty breathing.
• Blue skin or appearance of being very hot or cold.
• Blue lips.
• Vomiting or difficulty feeding.
• Feeling very 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.

Paroxetina Normon 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 the quality of sperm. Theoretically, this may affect human fertility, but this has not yet been observed in people.

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 Normon contains sodium

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 indicated by your doctoror pharmacist.In case of doubt, consult your doctor or pharmacist again.

Sometimes you may need to take more than one tablet or half a tablet. The following table will show you how many tablets to take:

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

Your doctor will indicate 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 indicate 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 with water.

The tablets should not be chewed.

The tablet can be divided into equal doses.

Your doctor will indicate the duration of treatment. This period may be extended 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 Paroxetina Normon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Do not take more tablets than your doctor has recommended.

A person who has taken an overdose of paroxetine may have some of the symptoms listed insection4,Possible side effects, or some of the following symptoms: fever, involuntary muscle contraction.

If you forgot to take Paroxetina Normon

Take your medication at the same time every day.

If you remember to take it before bedtime, 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

Paroxetina Normon will not improve your symptoms immediately, all antidepressants take time to act. Somepeople 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 indicate what to do. Your doctor may have scheduled a follow-up appointment after 2 weeks of starting treatment.

If you interrupt treatment with Paroxetina Normon

Do not interrupt treatment until your doctor tells you to.

When interrupting treatment with Paroxetina Normon, your doctor will indicate 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 withdrawal symptoms that occur when treatment with paroxetine is interrupted to be mild and disappear on their own in two weeks. For others, 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.

Although you may experience some withdrawal symptoms, you can still interrupt treatment with Paroxetina Normon.

Withdrawal symptoms 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.

Common side effects

May affect up to 1 in 10 people

• Feeling dizzy, unstable, or experiencing balance problems.
• Tickling, burning sensations, and, less frequently, a feeling of electric discharge, even in the head, ringing, buzzing, beeping, or other persistent sounds in the ears (tinnitus).
• Sleep disturbances (vivid dreams, nightmares, inability to sleep).
• Anxiety.
• Headaches.

Less common side effects

May affect up to 1 in 100 people

• Nausea (vomiting).
• Sweating (including night sweats).
• Restlessness or agitation.
• Tremors.
• Confusion or disorientation.
• Diarrhea (soft stools).
• Feeling very sensitive or irritable.
• Visual disturbances.
• Palpitations (rapid or strong heartbeats).

Consult your doctor if you are concerned about withdrawal symptoms from Paroxetina Normon.

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

Like all medicines, this medicine may 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 described below during treatment with Paroxetina Normon.

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

Rare side effects

May affect up to 1 in 100 people

• 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.

Very rare side effects

May affect up to 1 in 1,000 people

• If you experience seizures (epileptic fits), contact your doctor or go to the hospital immediately.
• If you experience 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 painful, stiff, and lack of muscle coordination. This may be due to low sodium levels in the blood. If you have these symptoms, consult your doctor.

Very rare side effects

May affect up to 1 in 10,000 people

• Severe allergic reactions to paroxetine.

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 may cause a collapse or loss of consciousness, contact your doctor or go to the hospital immediately.

• If you experience any of the following symptoms, you may be experiencing a serotonin syndrome. Symptoms include: confusion, restlessness, sweating, tremors, chills, hallucinations (strange sounds or visions), sudden or rapid heartbeats. If you feel this way, consult your doctor.
• Acute glaucoma.

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

Unknown frequency

The frequency cannot be estimated from 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 fertility in section 2 for more information.

Other possible side effects during treatment:

Very common side effects

May affect more than 1 in 10 people

• Feeling sick (nausea). This effect may be reduced by taking your medication in the morning after breakfast.
• Change in sex drive or sexual function, for example, lack of orgasm and, in men, abnormal erection and ejaculation.

Common side effects

May affect up to 1 in 10 people

• Increased levels of cholesterol in the blood.
• 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.

Rare side effects

May affect up to 1 in 1,000 people

• Transient increases in blood pressure, or transient decreases in blood pressure that may cause dizziness or fainting when standing up quickly.
• Abnormal heartbeats.
• Lack of movement, stiffness, tremors, 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 loss of control of blood sugar levels while taking paroxetine. Consult your doctor about how to adjust your insulin or diabetes medication dose.
• Decreased white blood cell count.

Rare side effects

May affect up to 1 in 1,000 people

• Abnormal secretion of breast milk in men and women.
• Decreased heart rate.
• Liver effects that are seen in laboratory tests that indicate liver function.
• Panic attacks.
• Manic behavior or thoughts.
• Feeling disconnected from oneself (derealization).
• Anxiety.
• Irresistible need to move legs (Restless Legs Syndrome).
• Muscle or joint pain.
• Increased levels of a hormone called prolactin.
• Changes in menstrual period (including heavy or irregular periods, bleeding between periods, and absence or delay of period).

Very rare side effects

May affect up to 1 in 10,000 people

Skin rash, in which small blisters with a central dark spot surrounded by a pale area, with a dark ring around it, called erythema multiforme may appear.

• Widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Widespread rash over a large body surface with blisters and skin peeling (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. Patients with SIADH may feel severely ill or have no symptoms.
• Water retention or fluid (which causes swelling of arms or legs).
• Sensitivity to sunlight.
• Prolonged and painful erection of the penis.
• Decreased platelet count in the blood.

Unknown frequency

The frequency cannot be estimated from the available data

• Colitis (inflammation of the colon that causes diarrhea).
• Grinding of teeth.

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

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 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 Vigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not usethis medicationafter the expiration date (EXP) that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C.

If you are taking half a tablet, be careful to store it safely in the packaging.

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

Composition ofParoxetina Normon

The active ingredient is paroxetine (40 mg), as hydrochloride, hemihydrate.

The other components are:

• In the core of the tablet: calcium dihydrogen phosphate, carboxymethylcellulose sodium Type A (from potato) and magnesium stearate.
• In the coating of the tablet: hypromellose, macrogol, polysorbate 80 and titanium dioxide (E171).

Appearance of the product and content of the packaging

Paroxetina Normon 40 mg film-coated tablets are white, elliptical and biconvex, with a diameter of 14.1 mm, marked with “40” on one face and a dividing line on the other. They are presented in packs of28tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

You can request more information about your disease by contacting a patient organization. Consult your doctor.

Date of the last review of this leaflet: December 2023

Other sources of information

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