Package Insert: Information for the User

Paroxetina Qualigen Farma 20 mg Film-Coated 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 only for you and should not be given 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.

Paroxetina is used for the treatment of depression and/or anxiety disorders in adults.

Anxiety disorders for which paroxetina 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 Qualigen Farma belongs to a group of medications called selective serotonin reuptake inhibitors (SSRIs). The precise mechanism of action of paroxetina and other SSRIs is not 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 Qualigen Farma:

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paroxetina Qualigen Farma:

• if you are taking other medications (see the sectionOther medications and Paroxetina Qualigen Farma)
• if you are taking tamoxifen for the treatment of breast cancer (or fertility problems). Paroxetina Qualigen Farma may make tamoxifen less effective, so your doctor should recommend you take an antidepressant
• if you have any kidney, liver, or heart problems
• if you have a heart condition known as prolongation of the QT interval, as detected by an electrocardiogram (ECG)
• if you have a family history of prolongation of the QT interval, heart disease such as heart failure, low heart rate, or low levels of potassium or magnesium
• if you have epilepsy or 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 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

• if you are pregnant or think you may be pregnant (see the sectionPregnancy, breastfeeding, and fertility)
• if you are under 18 years of age (see the sectionChildren and adolescents under 18 years of age)

If you are in any of these situations and have not yet consulted your doctor, ask them how to take Paroxetina Qualigen Farma.

Children and adolescents

Paroxetine should not be used normally in the treatment of children and adolescents under 18 years of age. Also, be aware 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 Qualigen Farma. Despite this, your doctor may prescribe this medicationto patients under 18 years of age when they decide it is best for the patient. If your doctor has prescribed Paroxetina Qualigen Farma to you or your child under 18 years of age and you want to discuss this decision, consult your doctor. 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 Qualigen Farma. The long-term effects of Paroxetina Qualigen Farma on safety, related to growth, maturity, and cognitive and behavioral development in this age group have not yet been demonstrated.

In studies conducted with Paroxetina Qualigen Farma 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 (having too much 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 Qualigen Farma, although less frequently.

When discontinuing treatment with Paroxetina Qualigen Farma, some patients under 18 years of age reported adverse effects of withdrawal. These effects were very similar to those observed in adults who discontinued treatment with Paroxetina Qualigen Farma (see section 3). In addition, 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).

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of self-harm or suicide. These may increase when taking antidepressants for the first time, as all these medications require a time to start working, usually around two weeks, although in some cases it may be longer.

It is more likely to happen:

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

- If you are a young adult. 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 an 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 friend that you are depressed or have anxiety disorders, and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Important adverse effects observed with Paroxetina Qualigen Farma

Some patients taking Paroxetina Qualigen Farma develop a disorder called akathisia, and feel restless and unable to sit or stay still. Other patients develop the so-called serotonin syndrome or 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, abrupt movements, or increased heart rate. The severity may increase and lead to loss of consciousness. Consult your doctor if you have any of these symptoms. For more information on this or other adverse effects of Paroxetina Qualigen Farma, see section 4.

Some medications in the group to which Paroxetina Qualigen Farma belongs (called ISRS/IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Other medications and Paroxetina Qualigen Farma

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

Some medications may modify the effect of Paroxetina Qualigen Farma or make it more likely for adverse effects to appear. Paroxetina Qualigen Farma may modify the effect of some medications. For example:

• Medications called monoamine oxidase inhibitors (MAOIs, including moclobemide and methionine chloride (methylen blue)). See the sectionDo not take Paroxetina Qualigen Farma.
• Medications known to increase the risk of changes in heart activity (e.g. antipsychotics thioridazine or pimozide). See the sectionDo not take Paroxetina Qualigen Farma.
• Aspirin, ibuprofen, and other medications called nonsteroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, etodolac, ibuprofen, and meloxicam, used to treat pain and inflammation.
• Tramadol, buprenorphine, and petidina, analgesics.
• Buprenorphine combined with naloxone, treatment for opioid addiction.
• Medications called triptans, such as sumatriptan, used to treat migraines.
• Other antidepressants, including other selective serotonin reuptake inhibitors and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
• A dietary supplement called tryptophan.
• Mivacurium and suxamethonium (used in anesthesia).
• Medications such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat some psychiatric disorders.
• Fentanyl, used in anesthesia or to treat chronic pain.
• A combination of fosamprenavir and ritonavir, used to treat HIV infection.
• St. John's Wort, a medicinal herb to treat depression.
• Phenobarbital, phenytoin, valproate sodium, or carbamazepine, used to treat seizures or epilepsy.
• Atomoxetine, a medication used to treat attention deficit hyperactivity disorder (ADHD).
• Procyclidine, used to relieve tremors, especially in Parkinson's disease.
• Warfarin and other medications (called anticoagulants) used to make blood thinner.
• Propafenone, flecainide, and medications used to treat high blood pressure and heart disorders.

• Metoprolol, a beta-blocker used to treat heart rhythm disorders. Pravastatin, used to treat high cholesterol.
• Rifampicin, used to treat tuberculosis (TB) and leprosy.
• Linezolid, an antibiotic.
• Tamoxifen, used to treat breast cancer (or fertility 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, even those purchased without a prescription.

Paroxetina Qualigen Farma with food, drinks, and alcohol:

Do not consume alcohol while taking paroxetine. Alcohol may worsen your symptoms or side effects.

Taking paroxetine 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, there was an increased risk of malformations, particularly those affecting the heart, in newborns whose mothers took paroxetine 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 paroxetine. Your doctor, in consultation with you, may change your medication or gradually discontinue paroxetine while pregnant. However, depending on your circumstances, your doctor may recommend continuing to take paroxetine.

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

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

If you are taking Paroxetina Qualigen Farma 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 skin or appearance of being too 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.

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

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

Driving and operating machinery

Some of the adverse effects that Paroxetina Qualigen Farma 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 Qualigen Farma contains lecithin from soy and sodium

This medication contains lecithin from soy, which may contain soy oil. Do not use in case of allergy to peanuts or soy.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

It may be necessary to take more than one tablet or half a tablet at times.

The following table shows how many tablets you should take:

The recommended dose for different indications is detailed in the following table:

Your doctor will indicate what dose you should take when starting treatment with paroxetine. Most people start to feel better after a couple of weeks. If you don't start to feel better after this time, 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.

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 starting 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 Qualigen Farma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 5620420, indicating the medication and the amount ingested.

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

If you forgot to take Paroxetina Qualigen Farma

Take your medication at the same time every day.

If you forget to take a dose and remember 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

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 don't 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 Qualigen Farma

Do not stop treatment until your doctor tells you to.

When you stop treatment with paroxetine, your doctor will indicate how to gradually reduce the dose over 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 stopping treatment with paroxetine 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 stopping treatment, your doctor may decide to stop treatment more gradually. If you experience severe withdrawal symptoms, please consult your doctor. Your doctor may advise you to start treatment again and then stop it more gradually.

Although you may experience some withdrawal symptoms, you may still be able to stop treatment with paroxetine.

Withdrawal symptoms when stopping treatment

Studies have shown that 3 out of 10 patients experience one or more symptoms when stopping 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 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

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.
• Fast or strong heart palpitations.

Consult your doctor if you are concerned about withdrawal symptoms 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 Paroxetina Qualigen Farma.

Inform your doctor if you experience any of the side effects described below during treatment with Paroxetina Qualigen Farma.

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

Less common 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.

Rare side effects

May affect up to 1 in 1,000 people

• If you experience seizures (epileptic crises), 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 Paroxetina Qualigen Farma may worsen your symptoms. If you feel this way, see your doctor.
• Fatigue, weakness, confusion, and pain, stiffness, and lack of muscle coordination. This may be due to low sodium levels in the blood. If you have these symptoms, see your doctor.

Very rare side effects

May affect up to 1 in 10,000 people

• Allergic reactions to Paroxetina Qualigen Farma that can be severe.

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

• If you notice any of the following symptoms, you may be experiencing a serotonin syndrome or neuroleptic malignant syndrome.

The symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremors, 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, see your doctor.

• Acute glaucoma.

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

Frequency not known

The frequency cannot be estimated from the available data

• Some people have experienced thoughts of self-harm or suicide while taking Paroxetina Qualigen Farma or shortly after stopping treatment (seeThoughts of suicide and worsening of depression or anxiety disorderin section 2).
• Some people have experienced aggression while taking Paroxetina Qualigen Farma.
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), seePregnancy, breastfeeding, and fertilityin section 2 for more information.

If you experience these side effects, contact your doctor.

Other possible side effects during treatment:

Very common side effects

May affect more than 1 in 10 people

• Feeling sick (nausea). This effect can 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.

Less common side effects

May affect up to 1 in 100 people

Rare side effects

May affect up to 1 in 1,000 people

Very rare side effects

May affect up to 1 in 10,000 people

Frequency not known

• 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 Paroxetina Qualigen Farma.

It has been observed that people taking medications like Paroxetina Qualigen Farma have a higher risk of bone fractures.

Reporting of side effects

If you experience any type of side effect, see 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:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children. No special conditions for conservation are required.

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

Medications should not be disposed of through drains or in the trash. Deposit 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 Paroxetina Qualigen Farma 20mg tablets:

The active ingredient is paroxetine in the form of hydrochloride. Each tablet contains 20 mg of paroxetine.

The other components (excipients) are: magnesium stearate (E-572), sodium carboxymethyl potato starch (type A), mannitol (E-421), microcrystalline cellulose (E-460i), hydrolyzed polyvinyl alcohol metacrylate, titanium dioxide (E-171), talc, soy lecithin (E-322), xanthan gum (E-415).

Appearance of the product and contents of the packaging

Paroxetina Qualigen Farma 20 mg is presented in the form of coated tablets, oblong, biconvex, scored, white or grayish-white in color.

Each package contains 14, 28, 56, and 500 coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Av. Barcelona, 69

08970 – Sant Joan Despí, Barcelona

Spain

Responsible for manufacturing:

Toll Manufacturing Services, S.L.

C/Aragoneses, 2

28108 Alcobendas, Madrid

Spain

Last review date of this leaflet:july 2024

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