PAROXETINE ALTER 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Paroxetine Alter 20 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Paroxetine Alter and what is it used for
2. What you need to know before you take Paroxetine Alter
3. How to take Paroxetine Alter
4. Possible side effects
5. Storing Paroxetine Alter
6. Contents of the pack and other information

1. What is Paroxetine Alter and what is it used for

Paroxetine Alter is used for the treatment of depression and/or anxiety disorders in adults. The anxiety disorders for which paroxetine is indicated are: obsessive-compulsive disorder (obsessive thoughts, repetitive behavior), panic disorder (panic attacks, including those caused by agoraphobia, which is the fear of open spaces), social anxiety disorder (fear or avoidance of social contact), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (feeling normally very anxious and nervous).

Paroxetine belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). The mechanism of action of paroxetine and other SSRIs is not fully understood, but they exert their effect by increasing the level of serotonin in the brain. Properly treating depression or anxiety disorder is important to help you feel better.

2. What you need to know before you take Paroxetine Alter

Do not take Paroxetine Alter

• . Your doctor will advise you how to start taking Paroxetine Alter once you have stopped taking the MAOI.
• to paroxetine or any of the other ingredients of this medicine (listed in section 6).
• This medicine contains soybean oil. It should not be used in case of peanut or soy allergy.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paroxetine Alter

• (see the section Other medicines and Paroxetine Alter)
• . Paroxetine Alter may make tamoxifen less effective, so your doctor should recommend taking another antidepressant
• (including medicines such as warfarin (acenocoumarol), antipsychotics like perphenazine or clozapine, tricyclic antidepressants, medicines used to treat pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)
• Pregnancy, breastfeeding, and fertility)
• Children 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 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. You should also know that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritation) when taking Paroxetine Alter. Nevertheless, your doctor may prescribe Paroxetine Alter to patients under 18 years of age when they decide it is most convenient 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 effects of Paroxetine Alter on safety, related to growth, maturity, and cognitive and behavioral development in this age group, have not yet been demonstrated.

In studies conducted with Paroxetine Alter in patients under 18 years of age, frequent adverse effects, which affected less than 1 in 10 children or adolescents, were: an increase in suicidal thoughts and attempts, self-harm behaviors, 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 bruises or bleeding (such as nosebleeds). These effects were also observed in patients included in these studies who did not take Paroxetine Alter, although with less frequency.

When discontinuing treatment with Paroxetine Alter, in these studies, some of the patients under 18 years of age reported having withdrawal effects. These effects were very similar to those observed in adults who discontinued treatment with Paroxetine Alter (see section 3). Additionally, patients under 18 years of age frequently experienced (affecting less than 1 in 10) stomach pain, nervousness, and unstable emotions (including crying, mood changes, self-harm behaviors, suicidal thoughts, and attempts).

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or committing suicide. These may increase at the beginning of treatment with antidepressants, as all these medicines take time to work, which is usually a few weeks but can sometimes be longer.

This is more likely to happen

• .
• . 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 self-harm or 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 an anxiety disorder 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 worried about changes in your behavior.

Important side effects seen with Paroxetine Alter

Some patients who take Paroxetine Alter develop a disorder called akathisia, and feel restless and unable to sit or stay still. Other patients develop a condition called serotonin syndrome or neuroleptic malignant syndrome, and may have some or all of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, trembling, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden jerky 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 side effects of Paroxetine Alter, see section 4.

Some medicines of the same group as Paroxetine Alter (called SSRIs) may cause symptoms of sexual dysfunction(see section 4). In some cases, these symptoms persist after stopping treatment.

Other medicines and Paroxetine Alter

Some medicines may change the effect of Paroxetine Alter or make some side effects more likely. Paroxetine Alter may also change the effect of some medicines. For example:

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)). See the section Do not take Paroxetine Alter.
• Medicines called thioridazine or pimozide, which are antipsychotics. See the section Do not take Paroxetine Alter.
• Acetylsalicylic acid, ibuprofen, and other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, etodolac, diclofenac, and meloxicam, used to treat pain and inflammation.
• Tramadol, buprenorphine, and pethidine, painkillers.
• Buprenorphine combined with naloxone, substitution treatment for opiate addiction.
• Medicines called triptans, such as sumatriptan, used to treat migraine.
• 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).
• Medicines 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 human immunodeficiency virus (HIV) infection.
• St. John's Wort, a herbal remedy for depression.
• Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizures or epilepsy.
• Atomoxetine, a medicine used to treat attention deficit hyperactivity disorder (ADHD).
• Procyclidine, used to relieve tremors, especially in Parkinson's disease.
• Warfarin and other medicines (called anticoagulants) used to make the blood more fluid.
• Propafenone, flecainide, and medicines 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 recently taken any of these medicines, tell your doctor and ask what you should do. Your doctor may decide to change the dose or prescribe another medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Taking Paroxetine Alter with food, drinks, and alcohol

Do not drink alcohol while taking Paroxetine Alter. Alcohol can worsen your symptoms or side effects.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

In some studies, an increased risk of malformations, particularly those affecting the heart, has been observed in newborns whose mothers took Paroxetine Alter during the first months of pregnancy. In the general population, approximately 1 in 100 newborns is born with a heart malformation. This proportion increased to 2 in 100 newborns in mothers who took Paroxetine Alter. Your doctor, in agreement with you, may change your treatment to another or gradually stop treatment with Paroxetine Alter while you are pregnant. However, depending on your circumstances, your doctor may recommend continuing to take Paroxetine Alter.

Make sure your doctor or midwife knows you are taking Paroxetine Alter. If you take Paroxetine Alter in the final stage of pregnancy, there may be a greater risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Paroxetine Alter to advise you. Medicines like Paroxetine Alter may increase the risk of a serious disease called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy, particularly at the end of it. The pressure in the blood vessels that go between the heart and lungs is very high in newborns with persistent pulmonary hypertension (PPHN).

If you are taking Paroxetine Alter in the last trimester of pregnancy, your newborn may also have other symptoms that usually start during the first 24 hours after birth. These symptoms include:

• difficulty breathing
• blue-tinged skin or looking too hot or cold
• blue lips
• vomiting or difficulty feeding
• feeling very tired, difficulty sleeping, or frequent crying
• muscle stiffness or floppiness
• tremors, localized tremors, or seizures
• exaggerated reflexes.

If your baby has any of these symptoms at birth, or if you are concerned about your newborn'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 agreement with you, may advise you to continue breastfeeding while taking Paroxetine Alter.

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

Driving and using machines:

Some of the side effects that Paroxetine Alter can cause are dizziness, confusion, drowsiness, or blurred vision. If you experience any of these effects, do not drive vehicles or use machines.

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

3. How to take Paroxetine Alter

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

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

The normal doses for the different indications are 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 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 the treatment. This period may be extended for several months or even longer.

Elderly patients

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

Patients with kidney or liver problems

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

If you take more Paroxetine Alter 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 experience some of the symptoms that appear in section 4, Possible adverse effects, or some of the following symptoms: fever, involuntary muscle contraction.

If you forget to take Paroxetine Alter

Take your medication at the same time every day.

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

If you remember during the night or the next day, skip 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 make up for missed doses.

Q

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 require more time. Some people who take antidepressants feel worse before starting 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. It is possible that your doctor has scheduled a follow-up appointment after 2 weeks of starting your treatment.

If you interrupt treatment with Paroxetine Alter

Do not interrupt treatment until your doctor indicates it. When you interrupttreatment with paroxetineyour doctor will indicate how to gradually reduce the doses over a period of several weeks or months, this will help reduce the risk of experiencing 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 that the possible symptoms that occur when interrupting treatment with paroxetine are mild and disappear on their own within two weeks. For other people, these symptoms can be more severe or last longer.

If you experience withdrawal effectswhile interrupting your treatment, your doctor may decide to interrupt it 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 effect, you may be able to interrupt your treatment with paroxetine

Possible withdrawal effects when interrupting treatment

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

E

May affect up to 1 in 10 people

• Feeling dizzy, unsteady, or having balance problems.
• Tingling, burning sensations, and less frequently, electric shock sensations, even in the head, buzzing, whistling, ringing, or other persistent noises in the ears (tinnitus).
• Sleep disturbances (very vivid dreams, nightmares, inability to sleep).
• Anxiety.
• Headaches.

E

May affect up to 1 in 100 people

• Vomiting (nausea).
• Sweating (including night sweats).
• Restlessness or agitation.
• Tremors.
• Confusion or disorientation.
• Diarrhea (soft stools).
• Feeling very sensitive or irritable.
• Visual disturbances.
• Rapid or very strong heartbeats.

C

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

Adverse effects are more likely to appear during the first few weeks of treatment or when interrupting treatment with Paroxetine Alter.

Tell your doctor if you experience any of the adverse effects described below during treatment with Paroxetine Alter. You may need to consult your doctor or go to the hospital immediately.

Uncommon adverse effects

May affect up to 1 in 100 people

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

-

Rare adverse 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 have a feeling of restlessness, inability to sit or stay still, called akathisia. Increasing the dose of Paroxetine Alter may worsen your symptoms. If you feel this way, consult 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, consult your doctor.

Very rare adverse effects

May affect up to 1 in 10,000 people

-

If you develop a skin rash with redness and bumps, swelling of the face, eyelids, lips, mouth, or tongue, itching, or difficulty breathing (difficulty breathing) or swallowing, and a feeling of weakness or dizziness that can cause 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 stiffness, sudden jerky movements, or rapid heartbeats. The severity can increase and lead to loss of consciousness. If you feel this way, consult your doctor.

-

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

Frequency not known

The frequency cannot be estimatedfrom the available data

• Some people have experienced thoughts of self-harm or suicide while taking Paroxetine Alter or shortly after stopping treatment (see Thoughts of suicide and worsening of depression or anxiety disorderin section 2).
• Some people have experienced aggression while taking Paroxetine Alter.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see Pregnancy, breastfeeding, and fertilityin section 2 for more information.

If you experience these adverse effects, contact your doctor

Other possible adverse effects during treatment:

Very common adverse 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 sexual desire or function, for example, lack of orgasm, and in men, abnormal erection and ejaculation.

Common adverse effects

May affect up to 1 in 10 people

• Increased cholesterol levels in the blood.
• Decreased appetite.
• Difficulty sleeping (insomnia) or drowsiness.
• Abnormal dreams (including nightmares).
• Dizziness, tremors.
• Headaches.
• Difficulty concentrating.
• Agitation.
• Unusual weakness.
• Blurred vision.
• Diarrhea or constipation.
• Vomiting.
• Weight gain.
• Sweating.

Uncommon adverse effects

May affect up to 1 in 100 people

• Transient increases in blood pressure, or transient decreases in blood pressure that can cause dizziness or fainting when standing up quickly.
• Faster than normal 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 urinary incontinence (uncontrolled and involuntary urination).
• If you are a diabetic patient, you may notice loss of control of blood sugar levels while taking Paroxetine Alter. Consult your doctor about how to adjust your insulin or diabetes medication dose.
• Decreased white blood cell count.

Rare adverse effects

May affect up to 1 in 1,000 people

• Abnormal milk secretion in men and women.
• Decreased heart rate.
• Liver effects that appear in laboratory tests that indicate liver function.
• Panic attacks.
• Very active behavior or thoughts (mania).
• Feeling detached from oneself (depersonalization).
• Anxiety.
• Irresistible urge to move the legs (Restless Legs Syndrome).
• Pain in joints or muscles.
• Increased levels of a hormone called prolactin in the blood.
• Menstrual disorders (including heavy or irregular periods, bleeding between periods, and absence or delay of period).

Very rare adverse effects

May affect up to 1 in 10,000 people

• Skin rash, which can appear with blisters and a target-like appearance (erythema multiforme).
• Widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Widespread rash over a large area of the body with blisters and peeling of the skin (toxic epidermal necrolysis).
• Liver disorders that cause yellowing of the skin or the whites of the eyes.
• 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 (salt) concentration as a result of inappropriate chemical signals. Patients with SIADH may feel severely ill or may have no symptoms.
• Water or fluid retention (causing swelling of arms or legs).
• Sensitivity to sunlight.
• Painful and prolonged erection of the penis.
• Decreased platelet count in the blood.

Frequency not known

The frequency cannot be estimatedfrom the available data

• Inflammation of the colon (causing diarrhea).
• Teeth grinding.

Some patients have experienced ringing, whistling, ringing, or other persistent noises in the ears (tinnitus) when taking Paroxetine Alter.

It has been observed that people taking medications like Paroxetine Alter have a higher risk of bone fractures.

Reporting adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Paroxetine Alter

Keep this medication out of 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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofParoxetine Alter 20 mg tablets

• The active ingredient is paroxetine in the form of hydrochloride. Each tablet contains 20 mg of paroxetine.
• The other ingredients (excipients) are: magnesium stearate, sodium starch glycolate, mannitol (E421), microcrystalline cellulose, polymethacrylate, partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), talc, soy lecithin (E322), xanthan gum (E415).

Appearance of the product and package contents

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

Aluminum-Aluminum blisters.

Packaging containing 14, 28, 56, and 500 (clinical packaging) tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Laboratorios Alter S.A.

C/ Mateo Inurria, 30

28036 Madrid-Spain

Manufacturer

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

Date of the last revision of this leaflet: December 2023

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