Package Insert: Information for the User

Paroxetine Hydrochloride Alter 20 mg Film-Coated Tablets

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

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

Paroxetina Alter 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 the group of medications known as 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 Alter

• 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 Alter once you have stopped taking the MAOI.
• if you are taking an antipsychotic medicationcalled thioridazine or the antipsychotic called pimozide
• if you are allergicto paroxetine or to any of the other components of this medication (listed in section 6).
• This medication contains soy oil. Do not use it in case of an allergy to peanuts or soy.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paroxetina Alter

• if you are taking other medications (see thesection Other medications and Paroxetina Alter)
• if you are taking tamoxifen for breast cancer (or fertility problems). Paroxetina Alter may make tamoxifen less effective, so your doctor should recommend another antidepressant
• if you have any kidney, liver, or heart problems
• 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 develop hematomas, or if you are being treated with any medication that may increasethe risk of hemorrhage (including medications such as warfarin (acenocoumarol), antipsychotics like perphenazine or clozapine, antidepressants like tricyclic antidepressants, medications for pain and inflammation 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 pregnantor 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 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 Alter.

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. Furthermore, you should 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 Alter. However, your doctor may prescribe Paroxetine Alter to patients under 18 years of age when they decide it is the most appropriate for the patient. If your doctor has prescribed Paroxetine Alter 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 mentioned above appear or worsen when you or your child under 18 years of age are taking Paroxetine Alter. The long-term safety of Paroxetine Alter in terms of growth, maturation, and cognitive and behavioral development in this age group has not yet been demonstrated.

In studies conducted with Paroxetine Alter 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, aggressive, or unfriendly behavior, loss of appetite, tremors, abnormal sweating, hyperactivity (excessive energy), agitation, unstable emotions (including crying and mood changes), and the appearance of bruises or bleeding (such as nosebleeds). These effects were also observed in patients included in these studies who did not take Paroxetine Alter, although less frequently.

When discontinuing treatment with Paroxetine Alter, 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 Paroxetine Alter (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-harm, suicidal thoughts and attempts).

Suicidal thoughts and worsening of your 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 had previous 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 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 Paroxetine Alter

Some patients taking Paroxetine Alter develop a disorder 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 any or all of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle rigidity, sudden, brief 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 Paroxetine Alter, see section 4.

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

Other medications and Paroxetine Alter

Some medications may modify the effect of Paroxetine Alter or make some adverse effects more likely. Paroxetine Alter 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 Paroxetine Alter.
• The medications called thioridazine or pimozide, which areantipsychotics. See the sectionDo not take Paroxetine Alter.
• 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 petidin,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 (SSRIs) 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 for treatingdepression.
• 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) and leprosy.
• Linezolid, anantibiotic.
• Tamoxifen, used totreat 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 Paroxetine Alter with food, drinks, and alcohol

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

Taking Paroxetine Alterin the morning with food may reduce the likelihood of nausea.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you 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 Alter 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 Alter. Your doctor, in consultation with you, may change your medication or gradually discontinue Paroxetine Alter while you are pregnant. However, depending on your circumstances, your doctor may recommend continuing to take Paroxetine Alter.

Ensure that your doctor or midwife knows that you are taking Paroxetine Alter.If you take Paroxetine Alter 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 be aware that you are taking Paroxetine Alter to advise you. Paroxetine Alter 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 blood pressure in the blood vessels between the heart and lungs is very high in newborns with PPHN.

If you are taking Paroxetine Alter 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:

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

Animal studies have shown that paroxetine reduces sperm quality. 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 Paroxetine Alter may cause are dizziness, confusion, feeling drowsy, or blurred vision. If you experience any of these effects, do not drive vehicles or operate machinery.

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 indicated by your doctor or pharmacist. If in 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 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.

The tablet can be split into equal doses.

Your doctor will tell you 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 Alter than you should

Consult your doctor or pharmacist immediately if you have taken an overdose or accidentally ingested the medication, or call the Toxicology 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 experience some of the symptoms listed in section 4, Possible side effects, or some of the following symptoms: fever, involuntary muscle contractions.

If you forgot to take Paroxetina Alter

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

Paroxetine will not improve your symptoms immediately, all antidepressants take time to work. Some people start to feel better after a couple of weeks, but others may need more time. Some people who take antidepressants may feel worse before they start to notice an 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 Alter

Do not interrupt treatment until your doctor tells you to.When you interruptparoxetine treatment, 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 withdrawal symptoms that occur when paroxetine treatment is interrupted to be mild and disappear on their own in two weeks. For other people, these symptomsmaybe 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 withdrawal symptoms, you may still be able to interrupt paroxetine treatment

Withdrawal symptoms that may occur when treatment is interrupted

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

Common side effects

May affectup 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, buzzing, ringing, beeping, or other persistent sounds in the ears (tinnitus).
• Sleep disturbances (vivid dreams, nightmares, inability to sleep).
• Anxiety.
• Headaches.

Uncommon side effects

May affectup to 1 in 100 people

• Vomiting (nausea).
• Sweating (including night sweats).
• Restlessness or agitation.
• Tremors.
• Confusion or disorientation.
• Diarrhea (soft stools).
• Feeling extremely sensitive or irritable.
• Visual disturbances.
• 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 few weeks of treatment or when stopping Paroxetina Alter.

Inform your doctor if you experience any of the side effects described below during treatment with Paroxetina Alter.You may need to see your doctor or go to the hospital immediately.

Rare side effects

May affectup 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 affectup 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 Paroxetina Alter may worsen your symptoms. If you feel this way,see 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,see your doctor.

Very rare side effects

May affectup to 1 in 10,000 people

-Severe allergic reactions to Paroxetina Alter.

If you develop a skin rash with redness and blisters, swelling of the face, eyelids, lips, mouth, or tongue, itching, or difficulty breathing (respiratory distress) 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 of the following symptoms, you may be experiencing serotonin syndrome or neuroleptic malignant syndrome.The symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, trembling, chills, hallucinations (strange sounds or visions), muscle rigidity, sudden, involuntary movements, or rapid heartbeat. 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

The frequency cannot be estimatedfrom the available data

• Some people have experienced thoughts of self-harm or suicide while taking Paroxetina Alter 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 Alter.
• 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 affectmore 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 affectup 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 affectup to 1 in 100 people

• Transient increases in blood pressure, or transient decreases 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 Paroxetina Alter. Consult your doctor about how to adjust your insulin or diabetes medication dose.
• Decreased white blood cell count.

Rare side effects

May affectup to 1 in 1,000 people

• Abnormal milk secretion in men and women.
• Decreased heart rate.
• Liver effects seen in laboratory tests indicating liver function.
• Panic attacks.
• Manic behavior or thoughts.
• Feeling disconnected from oneself (derealization).
• Anxiety.
• Irresistible need to move legs (Restless Legs Syndrome).
• Joint or muscle pain.
• Increased levels of a hormone called prolactin in the blood.
• Menstrual cycle changes (including heavy or irregular periods, bleeding between periods, and absence or delay of periods).

Very rare side effects

May affectup 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 with blisters and skin peeling over a large body surface (toxic epidermal necrolysis).
• Liver changes that turn the skin or the white of the eyes yellow.
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH), which is a condition 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 or fluid retention (causing 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 estimatedfrom 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 Paroxetina Alter.

It has been observed that people taking medications like Paroxetina Alter 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: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.

No special storage conditions are required.

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. By doing so, you will help protect the environment.

Composition of Paroxetina Alter 20 mg 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, sodium carboxymethylcellulose from potato, mannitol (E421), microcrystalline cellulose, polymethacrylate, partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), talc, soy lecithin (E322), xanthan gum (E415).

Appearance of the product and content of the packaging

Coated tablets, oblong, biconvex, white or grayish-white in color, and scored, divisible into two equal halves.

Aluminum-Aluminum blisters.

Packages containing 14, 28, 56, and 500 (clinical package) tablets.

Only some package sizes may be commercially marketed.

Marketing authorization holder

Laboratorios Alter S.A

C/ Mateo Inurria, 30

28036 Madrid-Spain

Responsible for manufacturing

Labiana Pharmaceuticals, S.L.U.

C/ Casanova 27-31

08757 Corbera de Llobregat, Barcelona

Spain

or

Toll Manufacturing Services, S.L.

Aragoneses, 2(Alcobendas)

28108

Spain

Last review date of this leaflet: December 2023

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/