Paroxetine Alter 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Paroxetina Alter 20 mg Film-coated Tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Leaflet Contents

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

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

Paroxetina 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, repetitive thoughts with uncontrollable behaviour), panic disorder (panic attacks, including those caused by agoraphobia, which is fear of open spaces), social anxiety disorder (fear of or avoidance of social situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (persistently feeling very anxious and nervous).

Paroxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). The precise mechanism of action of paroxetine and other SSRIs is not fully understood, but they work 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 starting to take Paroxetina Alter

Do not take Paroxetina Alter

• if you are being treated with medicines known as monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)) or if you have been treated with any of these medicines within the last two weeks. Your doctor will advise you on how to start taking Paroxetina Alter after stopping the MAOI.
• if you are taking an antipsychotic medicine called thioridazine or the antipsychotic called pimozide
• if you are allergic to paroxetine or to any of the other ingredients of this medicine (listed in section 6).
• This medicine contains soya oil. It should not be used if you are allergic to peanuts or soya.

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 medicines (see the section Other medicines and Paroxetina Alter)
• if you are taking tamoxifen for the treatment of breast cancer (or fertility problems). Paroxetina Alter may make tamoxifen less effective, so your doctor should recommend taking another antidepressant
• if you have any kidney, liver, or heart problems
• if you have epilepsy or experience seizures or epileptic fits
• if you have had manic episodes (excessively active thoughts or behavior)
• if you are receiving electroconvulsive therapy (ECT)
• if you are prone to bleeding or bruising, or are being treated with any medicine that may increase the risk of bleeding (including medicines such as warfarin (acenocoumarol), antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines for pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, 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 planning to become pregnant (see section Pregnancy, breastfeeding and fertility)
• if you are under 18 years of age (see section Children and adolescents under 18 years of age)

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

Children and adolescents under 18 years of age

Paroxetine should not be used to treat children and adolescents under 18 years of age. You should also be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking Paroxetina Alter. Nevertheless, your doctor may prescribe Paroxetina Alter to patients under 18 years of age if they decide it is the most appropriate treatment. If your doctor has prescribed Paroxetina Alter to you or to your child under 18 years of age and you wish to discuss this decision, please consult your doctor. You must inform your doctor if any of the symptoms described above appear or worsen while you or your child under 18 years of age are taking Paroxetina Alter. The long-term effects of Paroxetina Alter on safety with regard to growth, maturation, and cognitive and behavioral development in this age group have not yet been established.

In clinical studies of Paroxetina Alter in patients under 18 years of age, the following common adverse effects (affecting less than 1 in 10 children or adolescents) were observed: increased suicidal thoughts and suicide attempts, self-harm attempts, hostile, aggressive, or uncooperative behavior, loss of appetite, tremors, abnormal sweating, hyperactivity (excessive energy), agitation, emotional instability (including crying and mood swings), and occurrence of unexpected bruising or bleeding (such as nosebleeds). These effects were also observed, though less frequently, in patients included in these studies who did not take Paroxetina Alter.

When discontinuing treatment with Paroxetina Alter, some patients under 18 years of age reported withdrawal symptoms in these studies. These symptoms were very similar to those observed in adults who stopped treatment with Paroxetina Alter (see section 3). In addition, patients under 18 years of age frequently experienced (affecting less than 1 in 10) stomach pain, nervousness, and emotional instability (including crying, mood swings, self-harm attempts, suicidal thoughts, and suicide attempts).

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide. These may increase at the beginning of treatment with antidepressants, as all these medicines take some time to take effect, usually about two weeks, but sometimes longer.

This is more likely to happen to you

• If you have previously had thoughts of suicide or of harming yourself.
• If you are a young adult. Clinical trial data show an increased risk of suicidal behavior in psychiatric patients under 25 years of age being treated with an antidepressant.

If at any time you have thoughts of harming yourself or of suicide, contact 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 may also ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behavior.

Important adverse effects observed with Paroxetina Alter

Some patients taking Paroxetina Alter develop a condition called akathisia, and feel restless and unable to sit still or remain motionless. Other patients may develop a condition known as serotonin syndrome or neuroleptic malignant syndrome, and may experience one or more of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle rigidity, sudden jerking movements, or increased heart rate. The severity may increase and lead to loss of consciousness.

Contact your doctor if you experience any of these symptoms. For further information about this or other adverse effects of Paroxetina Alter, see section 4.

Some medicines in the same class as Paroxetina Alter (known as SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Other medicines and Paroxetina Alter

Some medicines may alter the effect of Paroxetina Alter or make it more likely that certain adverse effects will occur. Paroxetina Alter may also alter the effect of some medicines. For example:

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)). See section Do not take Paroxetina Alter.
• Medicines known as thioridazine or pimozide, which are antipsychotics. See section Do not take Paroxetina Alter.
• Acetylsalicylic acid, ibuprofen, and other medicines called non-steroidal anti-inflammatory drugs such as celecoxib, etodolac, diclofenac, and meloxicam, used to treat pain and inflammation.
• Tramadol, buprenorphine, and meperidine (pethidine), analgesics.
• Buprenorphine combined with naloxone, a substitution treatment for opioid 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 anaesthesia).
• Medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat certain psychiatric disorders.
• Fentanyl, used in anaesthesia 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 used to treat 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 tremor, especially in Parkinson's disease.
• Warfarin and other medicines (called anticoagulants) used to thin the blood.
• Propafenone, flecainide, and medicines used to treat cardiac rhythm disorders.
• Metoprolol, a beta-blocker used to treat high blood pressure and heart conditions.
• 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, inform your doctor and ask what you should do. Your doctor may decide to adjust the dose or prescribe a different medicine.

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

Taking Paroxetina Alter with food, drinks, and alcohol

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

Taking Paroxetina 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

In some studies, an increased risk of birth defects, particularly those affecting the heart, has been observed in newborns whose mothers took Paroxetina Alter during the first months of pregnancy. In the general population, approximately 1 out of every 100 newborns is born with a heart defect. This rate increased to 2 out of every 100 newborns in mothers who took Paroxetina Alter. Your doctor, in consultation with you, may switch you to another treatment or gradually discontinue treatment with Paroxetina Alter during pregnancy. However, depending on your individual circumstances, your doctor may recommend continuing treatment with Paroxetina Alter.

Ensure that your doctor or midwife knows that you are taking Paroxetina Alter. If you take Paroxetina Alter in the later stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Paroxetina Alter so they can provide appropriate advice. Medicines such as Paroxetina Alter may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy, particularly in the later stages. In newborns with persistent pulmonary hypertension (PPHN), the pressure in the blood vessels between the heart and lungs is very high.

If you take Paroxetina Alter during the third trimester of pregnancy, your newborn may also experience other symptoms, which usually begin within the first 24 hours after birth. These symptoms may include:

• difficulty breathing
• bluish skin or appearance of being too hot or too cold
• blue lips
• vomiting or difficulty feeding
• extreme tiredness, difficulty sleeping, or frequent crying
• muscle stiffness or floppiness
• tremors, localized shaking, or seizures
• exaggerated reflexes.

If your baby shows 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.

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

Animal studies have shown that paroxetine reduces sperm quality. This could theoretically affect fertility in humans, but this effect has not yet been observed in people.

Driving and use of machinery:

Some of the adverse effects that Paroxetina Alter may cause include dizziness, confusion, drowsiness, or blurred vision. If you experience any of these effects, do not drive or operate machinery.

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

3. How to take Paroxetine Alter

Follow exactly the instructions for use of this medicine given 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 you should take:

Dosage	Number of tablets to take
10 mg	Half a tablet
20 mg	One tablet
30 mg	One and a half tablets
40 mg	Two tablets
50 mg	Two and a half tablets
60 mg	Three tablets

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

	Initial daily dose	Recommended daily dose	Maximum daily dose
Depression	20 mg	20 mg	50 mg
Obsessive-compulsive disorder	20 mg	40 mg	60 mg
Panic disorder	10 mg	40 mg	60 mg
Social anxiety disorder	20 mg	20 mg	50 mg
Post-traumatic stress disorder	20 mg	20 mg	50 mg
Generalized anxiety disorder	20 mg	20 mg	50 mg

Your doctor will tell you what dose to take when you start treatment with paroxetine. Most people begin to feel better after a couple of weeks. If you do not start to feel better after this time, consult your doctor, who will advise you on what to do. Your doctor may decide to gradually increase the dose in 10 mg increments up to the maximum daily dose.

Take the tablets in the morning, with food. The tablets should be swallowed with water. The tablets must not be chewed.

The tablet may be divided into equal doses.

Your doctor will determine how long the treatment should last. This period may extend for several months or even longer.

Elderly patients

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

Patients with kidney or liver problems

If you have severe hepatic or renal insufficiency, your doctor may advise you to take lower doses of paroxetine than usual.

If you take more Paroxetina Alter than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 listed in section 4, Possible side effects, or any of the following symptoms: fever, involuntary muscle contractions.

If you forget to take Paroxetina Alter

Take your medicine at the same time each day.

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

If you remember during the night or the following day, skip the missed dose. You may experience some withdrawal symptoms, but these should disappear after taking the next dose at your usual time.

Do not take a double dose to make up for missed doses.

What to do if you do not feel better

Paroxetine will not improve your symptoms immediately; all antidepressants take time to work. Some people begin to feel better after a couple of weeks, but others may require more time. Some individuals taking antidepressants feel worse before they start to notice improvement. If you do not begin to feel better after a couple of weeks, inform your doctor, who will advise you on what to do. Your doctor may have already scheduled a follow-up appointment approximately 2 weeks after you started treatment.

If you stop treatment with Paroxetina Alter

Do not stop treatment unless your doctor tells you to do so. When stopping treatment with paroxetine, your doctor will instruct you on how to gradually reduce the dose over a period of several weeks or months, which will help reduce the risk of experiencing withdrawal symptoms. One way to do this is by gradually decreasing your paroxetine dose by 10 mg each week. Most people find that potential symptoms occurring when stopping paroxetine are mild and resolve on their own within two weeks. However, for some individuals, these symptoms may be more severe or last longer.

If you experience withdrawal-related effects while discontinuing treatment, your doctor may decide that you should stop more slowly. If you experience severe withdrawal symptoms, please consult your doctor. They may advise you to restart treatment and then discontinue it more gradually.

Although you may experience some effects due to withdrawal, you may still be able to discontinue your treatment with paroxetine.

Possible withdrawal effects when stopping treatment

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

Frequent adverse effects

May affect up to 1 in 10 people

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

Uncommon adverse effects

May affect up to 1 in 100 people

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

Consult your doctor if you are concerned about effects due to paroxetine withdrawal

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Adverse effects are more likely to occur during the first weeks of treatment or when discontinuing treatment with Paroxetina Alter.

Inform your doctor if you experience any of the adverse effects listed below during treatment with Paroxetina 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 unusual bruising or bleeding, such as blood in vomit or stools, contact your doctor or go to the hospital immediately.

-If you experience inability to urinate, 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 feel restless, unable to sit still or remain motionless, known as akathisia. Increasing the dose of Paroxetina Alter may worsen your symptoms. If you feel this way, consult your doctor.
• Fatigue, weakness, confusion, and muscle pain, stiffness, and lack of 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

-Allergic reactions to Paroxetina Alter that may be serious.

If you develop a skin rash with redness and lumps, swelling of the face, eyelids, lips, mouth or tongue, itching or difficulty breathing (shortness of breath) or swallowing, and a feeling of weakness or dizziness that may lead to 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 serotonin syndrome or neuroleptic malignant syndrome. Symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremor, chills, hallucinations (strange sounds or visions), muscle stiffness, sudden jerky movements, or rapid heartbeat. The condition may worsen and lead to loss of consciousness. If you feel this way, consult your doctor.

-Acute glaucoma.

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

Frequency not known

Frequency cannot be estimated from the available data

• Some people have had thoughts of harming themselves or suicide while taking Paroxetina Alter or shortly after stopping treatment (see Suicidal thoughts and worsening of depression or anxiety disorder in section 2).
• Some people have experienced aggressiveness while taking Paroxetina Alter.
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage). See Pregnancy, breastfeeding and fertility in 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 unwell (nausea). This effect may be reduced by taking your medication in the morning after breakfast.
• Changes 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 levels of cholesterol in the blood.
• Decreased appetite.
• Difficulty sleeping (insomnia) or drowsiness.
• Abnormal dreams (including nightmares).
• Dizziness, tremors.
• Headache.
• Difficulty concentrating.
• Agitation.
• Unusual weakness.
• Blurred vision.
• Yawning, dry mouth.
• 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 may cause dizziness or fainting when standing up quickly.
• Faster than normal heartbeats.
• Lack of movement, stiffness, tremor, 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 urinary incontinence (uncontrolled and involuntary urination).
• If you are a diabetic patient, you may notice loss of control of blood sugar levels while taking Paroxetina Alter. Consult your doctor on how to adjust your insulin dose or diabetes medication.
• Decreased white blood cell count.

Rare adverse effects

May affect up to 1 in 1,000 people

• Abnormal breast milk secretion in men and women.
• Decreased heart rate.
• Liver effects observed in laboratory tests indicating liver function.
• Panic attacks.
• Excessively active behaviors or thoughts (mania).
• Feeling detached from oneself (depersonalization).
• Anxiety.
• Irresistible urge to move the legs (Restless Legs Syndrome).
• Joint or muscle pain.
• Increased blood levels of a hormone called prolactin.
• Menstrual cycle disturbances (including heavy or irregular periods, bleeding between periods, and absence or delay of periods).

Very rare adverse effects

May affect up to 1 in 10,000 people

• Skin rash, in which blisters may appear with a target-like appearance (dark central spots surrounded by a pale area, with a dark ring around it), known as erythema multiforme.
• Widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Widespread rash affecting a large body surface area, with blisters and skin peeling (toxic epidermal necrolysis).
• Liver problems causing yellowing of the skin or whites of the eyes.
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body retains excess water and has reduced sodium (salt) concentration due to inappropriate chemical signals. Patients with SIADH may feel seriously ill or may have no symptoms at all.
• Fluid retention (causing swelling of arms or legs).
• Sensitivity to sunlight.
• Painful and prolonged penile erection.
• Decrease in the number of platelets in the blood.

Frequency not known

Frequency cannot be estimated from the available data

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

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

It has been observed that people taking medications such as Paroxetina Alter have an increased risk of bone fractures.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Paroxetine Alter

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paroxetine Alter 20 mg tablets

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

Appearance of the medicine and contents of the pack

Film-coated tablets, oblong, biconvex, white or off-white, with a score line allowing division into equal halves.

Aluminum-aluminum blisters.

Packs containing 14, 28, 56 and 500 (hospital pack) tablets.

Only certain pack sizes may be commercially available.

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 most recent revision of this leaflet: December 2023

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