Package Insert: Information for the Patient

Paroxetina Stada 40 mg Tablets

Read this entire 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 only 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.

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

2.What you need to know before starting to take Paroxetina Stada

3.How to take Paroxetina Stada

4.Possible adverse effects

5.Storage of Paroxetina Stada

6. Contents of the package and additional information

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

The 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 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. Properly treating depression or anxiety is important to help you feel better.

Do not take Paroxetina Stada

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

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

•if you are taking an antipsychotic medication called thioridazine or the antipsychotic called pimozide.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take paroxetine:

-if you are taking other medications (see sectionOther Medications and Paroxetina Stada)

-if you are taking tamoxifen for the treatment of breast cancer (or fertility problems)

Paroxetine may make tamoxifen less effective, so your doctor should recommend another antidepressant for you to take.

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

-if you have a heart condition known as prolonged QT interval after an electrocardiogram (ECG)

-if you have a family history of prolonged 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 like 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 (high eye pressure)

-if you are pregnant or think you may become pregnant (see sectionPregnancy, Breastfeeding, and Fertility)

-if you are under 18 years of age (see sectionChildren 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 paroxetine.

Children and Adolescents under 18 years of age

Paroxetine should not be used 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 paroxetine. However, your doctor may prescribe paroxetine to patients under 18 years of age when they decide what is best for the patient. If your doctor has prescribed paroxetine 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 mentioned above appear or worsen when you or your child under 18 years of age are taking paroxetine. The long-term effects of paroxetine on safety, related to growth, maturation, and cognitive and behavioral development in this age group have not yet been demonstrated.

In studies conducted with paroxetine 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 paroxetine, although less frequently.

When discontinuing paroxetine treatment in these studies, some patients under 18 years of age reported adverse effects of withdrawal. These effects were very similar to those observed in adults who discontinued paroxetine 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).

Suicidal thoughts and worsening of depression or anxiety:

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.

It 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 close family member or 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 paroxetine

Some patients taking paroxetine develop a condition called akathisia, andfeel restless and unable to sit or stay still.Other patients develop the so-calledserotonin syndrome or malignant neuroleptic syndrome, and may have some 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, rapid 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 on this or other adverse effects of paroxetine, see section 4.

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

Other Medications and Paroxetina Stada

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

-Medications called monoamine oxidase inhibitors (MAOIs, including moclobemide and methionine chloride (methylen blue)). See sectionDo not take Paroxetina Stada.

-Medications known to increase the risk of changes in heart activity (e.g. antipsychotics thioridazine or pimozide). See sectionDo not take Paroxetina Stada.

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

-Tramadol, buprenorphine, and petidin, 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.

-Mivacurio and suxamethonium (used in anesthesia).

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

-Fentanil, 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 used to treat depression.

-Fenobarbital, 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 heart rhythm disorders.

-Metoprolol, a beta-blocker used to treat high blood pressure and heart 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,including those purchased without a prescription.

Taking Paroxetina Stada with food, drinks, and alcohol

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

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

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or think you may become pregnant, 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 malformation. This proportion increased to 2 in 100 newborns in mothers who took paroxetine. Your doctor, in consultation with you, may change your medication or discontinue paroxetine gradually while you are pregnant. However, depending on your circumstances, your doctor may recommend continuing to take paroxetine.

Ensure that your doctor or midwife knows that you are taking paroxetine. If you take paroxetine in the final stages of pregnancy, there may be a higher 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 paroxetine to advise you.

Paroxetine may pass into breast milk in 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 paroxetine.

Animal studies 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

During treatment with paroxetine, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how paroxetine affects you.

Paroxetina Stada contains sodium

This medication contains less than 23 mg of sodium (1 mmol) 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.

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

To administer doses of 10, 30, or 50 mg, other presentations of paroxetine must be used.

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

Your doctor will tell you what dose to take when you start 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 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 with water. The tablets should not be chewed.

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

Older patients

The maximum dose for people over 65 years 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 Stada 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 section4.Possible side effects, or some of the following symptoms: fever, involuntary muscle contraction.

If you forgot to take Paroxetina Stada

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 tell you what to do. Your doctor may have scheduled a follow-up appointment after 2 weeks of starting treatment.

If you interrupt treatment with Paroxetina Stada

Do not stop treatment until your doctor tells you to.

When you stop treatment with paroxetine, your doctor will tell you 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 treatment with paroxetine is stopped to be mild and disappear on their own in 2 weeks. For some people, 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 slowly. If you experience severe withdrawal symptoms, please consult your doctor. Your doctor may advise you to start treatment again and then stop it more slowly.

Although you may experience some withdrawal symptoms, you will 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 they stop treatment with paroxetine. Some of these effects occur more frequently than others.

Frequent side effects, which may affect up to 1 in 10 people:

-Feeling dizzy, unstable, or experiencing balance disturbances.

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

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

-Anxiety.

-Headaches.

Rare side effects, which may affect up to 1 in 100 people:

-Nausea (vomiting).

-Sweating (including night sweats).

-Restlessness or agitation.

-Trembling.

-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 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 listed below during treatment with paroxetine.

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

Uncommon side effects, which 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, which 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, see your doctor.

-Feeling tired, 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, which may affect up to 1 in 10,000 people:

-Allergic reactions to paroxetine, which 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 may cause a collapse or loss of consciousness, contact your doctor or go to the hospital immediately.

-If you notice any or all of the following symptoms, you may be experiencing a serotonin syndrome or malignant neuroleptic syndrome. 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 heartbeats. The severity may 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.

Unknown frequency (frequency cannot be estimated from available data):

• Some people have experienced thoughts of self-harm or suicide while taking paroxetine or shortly after stopping treatment (seeThoughts of suicide and worsening of depression or anxiety disorderin 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.

If you experience these side effects, contact your doctor.

Other possible side effects during treatment:

Very common side effects, which may affect more than 1 in 10 people:

-Feeling sick (nausea). This side effect may decrease 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, which may affect up to 1 in 10 people:

-Increased levels of cholesterol in the blood.

-Decreased 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, which may affect up to 1 in 100 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.

-Dilated pupils.

-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 adjusting the dose of insulin or diabetes medications.

-Decreased white blood cell count.

Rare side effects, which may affect up to 1 in 1,000 people:

-Abnormal milk secretion in men and women.

-Decreased heart rate.

-Liver damage that is seen in laboratory tests that indicate liver function.

-Panic attacks.

-Active or excessive thoughts (mania).

-Feeling disconnected from oneself (derealization).

-Anxiety.

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

-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, which may affect up to 1 in 10,000 people:

-Skin rash, in which may appear blisters with a small, dark center surrounded by a pale area, with a dark ring around it, 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 body surface with blisters and peeling of the skin (toxic epidermal necrolysis).

-Liver damage that turns the skin or the white of the eyes yellow.

-SIADH (Syndrome of Inappropriate Antidiuretic Hormone Secretion) which 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.

- Fluid retention or edema (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 (frequency cannot be estimated from 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, 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 Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of the medicine.

This medication does not require special storage conditions.

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

Keep this medication out of sight and reach of children.

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

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. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Paroxetina Stada

-The active ingredient is paroxetine. Each tablet contains 40 mg of paroxetine (anhydrous hydrochloride).

-The other components are: microcrystalline cellulose (E460), calcium hydrogen phosphate, croscarmellose sodium (E468), anhydrous colloidal silica (E551) and magnesium stearate (E470b). See section 2Paroxetina Stada contains sodium.

Appearance of the product and content of the container

Paroxetina Stada is presented in the form of scored, capsule-shaped, almost white tablets, 15.5-15.8 mm in length and 7.0-7.3 mm in width. The tablet can be divided into equal doses.

This medication is presented in a container holding 14 or 28 tablets available in blisters.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Farmaceutisch Analytisch Laboratorium Duiven BV

Dijkgraaf 30, Duiven

Netherlands

or

Sanico NV

Veedijk 59

BE-2300 Turnhout

Belgium

Date of the last review of this leaflet:August 2024

The detailed information of this medication is available on the website of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es/