Paroxetine Mabo 30 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paroxetina Mabo 30 mg tablets

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

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

Leaflet contents

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

2. What you need to know before taking Paroxetina Mabo

3. How to take Paroxetina Mabo

4. Possible adverse effects

5. How to store Paroxetina Mabo

6. Contents of the pack and other information

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

Paroxetine is used for the treatment of depression and/or anxiety disorders in adults. The anxiety disorders for which this medicine 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 act 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 taking Paroxetina Mabo

Do not take Paroxetina Mabo:

• if you are being treated with medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue 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 paroxetine 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).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take paroxetine

• if you are taking other medicines (see section Other medicines and paroxetine)
• 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 that you take another antidepressant
• if you have any kidney, liver, or heart problems
• if you have an abnormality in your heart rhythm seen on an electrocardiogram (ECG) known as QT interval prolongation
• if you have a family history of QT interval prolongation, heart diseases such as heart failure, low heart rate, or low levels of potassium or magnesium
• 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 taking any medicine that may increase the risk of bleeding (including medicines such as warfarin (acenocoumarol), antipsychotics such as 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
• if you are on a low-sodium diet
• if you have glaucoma (increased 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 your doctor about 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. Furthermore, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking paroxetine. Nevertheless, your doctor may prescribe paroxetine to patients under 18 years of age if they decide it is the most appropriate treatment. If your doctor has prescribed paroxetine to you or your child under 18 years of age and you wish to discuss this decision, speak to your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen while you or your child under 18 years of age are taking paroxetine. The long-term effects of paroxetine on safety regarding growth, maturation, and cognitive and behavioral development in this age group have not yet been established.

In clinical studies with paroxetine in patients under 18 years of age, common adverse effects, affecting less than 1 in 10 children or adolescents, included: 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 lability (including crying and mood changes), and occurrence of unexplained bruising or bleeding (such as nosebleeds). These effects were also observed, though less frequently, in patients in these studies who did not take paroxetine.

When discontinuing treatment with paroxetine, some patients under 18 years of age in these studies reported withdrawal-related adverse effects. These effects were very similar to those observed in adults who discontinued paroxetine treatment (see section How to take paroxetine). In addition, patients under 18 years of age frequently experienced (affecting less than 1 in 10) stomach pain, nervousness, and emotional lability (including crying, mood changes, 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 time to work, usually about two weeks, but sometimes longer.

You are more likely to experience this

• if you have previously had thoughts of suicide or self-harm.
• if you are a young adult. Clinical trial data show an increased risk of suicidal behavior in psychiatric patients under 25 years of age who are being treated with antidepressants.

If you have thoughts of harming yourself or of suicide at any time, contact your doctor or go to the hospital immediately.

It may be helpful for you to inform 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 paroxetine

Some patients taking paroxetine develop a condition called akathisia, and feel restless and unable to sit still. Other patients develop what is 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, tremor, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden jerky 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 more information about this or other adverse effects of paroxetine, see section 4.

Some medicines in the same class as paroxetine (called SSRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Other medicines and paroxetine

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

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride (methylene blue)). See section Do not take paroxetine.
• Medicines known to increase the risk of changes in the heart's electrical activity (e.g., the antipsychotics thioridazine or pimozide). See section Do not take paroxetine.
• 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 meperidine, analgesics.
• Buprenorphine combined with naloxone, used as opioid addiction replacement therapy.
• 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 certain psychiatric conditions.
• Fentanyl, used in anesthesia or for treating 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 tremors, especially in Parkinson’s disease.
• Warfarin and other medicines (called anticoagulants) used to thin the blood.
• Propafenone, flecainide, and medicines used to treat heart 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 change your 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 medicines, including those obtained without a prescription.

Taking paroxetine 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, 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 malformations, particularly those affecting the heart, has been observed in newborns whose mothers took paroxetine during the first months of pregnancy. In the general population, approximately 1 in 100 newborns is born with a heart defect. This rate increased to 2 in 100 newborns in mothers who took paroxetine. Your doctor, in agreement with you, may switch you to another treatment or gradually discontinue paroxetine during pregnancy. However, depending on your circumstances, your doctor may recommend continuing paroxetine.

Ensure your doctor or midwife knows that you are taking paroxetine. If you take paroxetine in the late 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 paroxetine so they can advise you. Medicines like paroxetine 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 are taking paroxetine during the third trimester of pregnancy, your newborn may also experience other symptoms, usually beginning within the first 24 hours after birth. These symptoms may include:

• Difficulty breathing.
• Bluish skin or appearance of being too hot or too cold.
• Bluish lips.
• Vomiting or difficulty feeding.
• Extreme tiredness, difficulty sleeping, or frequent crying.
• Muscle stiffness or floppiness.
• Tremors, localized tremors, 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.

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

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 using machines

Some of the adverse effects caused by paroxetine include dizziness, confusion, drowsiness, or blurred vision. If you experience any of these effects, do not drive or operate machinery.

Paroxetina Mabo 10/20/30/40 mg tablets

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially “sodium-free.”

3. How to take Paroxetine Mabo

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Your doctor will tell you what dose to take when starting treatment with paroxetine. Most people begin to feel better after a couple of weeks. If you do not start to feel better by then, 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 whole and immediately with plenty of water (at least one 150 ml glass). Do not suck, chew, or hold the tablet in your mouth, as this may cause an unpleasant local sensation such as a bitter taste, burning in the throat, irritating cough, or choking sensation.

Your doctor will determine how long your 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 recommend that you take lower doses of paroxetine than usual.

If you take more paroxetine 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 prescribed.

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 paroxetine

Take your medication at the same time every day.

If you forget to take a dose but 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 a missed dose.

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 people taking antidepressants feel worse before they start to feel better. If you do not start to feel better after a couple of weeks, inform your doctor, who will advise you on what to do. Your doctor may have scheduled a follow-up appointment approximately 2 weeks after you started treatment.

If you stop treatment with paroxetine

Do not stop treatment until 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 to gradually reduce your current dose of paroxetine by 10 mg each week. Most people find that any possible symptoms that occur when stopping paroxetine are mild and disappear on their own within two weeks. For others, these symptoms may be more severe or last longer.

If you experience withdrawal symptoms while stopping your treatment, your doctor may decide to taper the dose more slowly. If you experience severe withdrawal symptoms, please consult your doctor. They may advise you to restart treatment and then stop it again more gradually.

Even if you experience withdrawal symptoms, you may still be able to discontinue treatment with paroxetine.

Possible withdrawal symptoms when stopping treatment

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

Frequent adverse effects, which may affect up to 1 in 10 patients:

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

Uncommon adverse effects, which may affect up to 1 in 100 patients:

• Nausea (vomiting).
• Sweating (including night sweats).
• Restlessness or agitation.
• Tremor.
• Confusion or disorientation.
• Diarrhea (loose stools).
• Increased sensitivity or irritability.
• Visual disturbances.
• Rapid or very strong heartbeats (palpitations).

Consult your doctor if you are concerned about withdrawal effects from paroxetine.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Adverse effects are more likely to occur during the first weeks of treatment with paroxetine.

Inform your doctor if you experience any of the adverse effects listed below while taking paroxetine.

It may be necessary for you to consult your doctor or go to hospital immediately.

Uncommon adverse effects, which may affect up to 1 in 100 patients:

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

Rare adverse effects, which may affect up to 1 in 1,000 patients:

• If you experience seizures (epileptic fits), contact your doctor or go to hospital immediately.
• If you feel restless or unable to sit still or remain motionless, a condition known as akathisia. Increasing the dose of paroxetine may worsen your symptoms. If you feel this way, consult your doctor.
• Tiredness, 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, which may affect up to 1 in 10,000 patients:

• Allergic reactions to paroxetine that may be serious.

If you develop a 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 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 rigidity, sudden jerky movements, or rapid heartbeat. The condition may worsen and lead to loss of consciousness. If you feel this way, contact your doctor.

• Acute angle-closure glaucoma.

If you suddenly develop eye pain and blurred vision, contact your doctor.

Frequency not known, frequency cannot be estimated from the available data

• Some people have had thoughts of harming themselves or of suicide while taking paroxetine or shortly after stopping treatment (see Suicidal thoughts and worsening of depression or anxiety disorder in section 2).

• Some people have experienced aggression while taking paroxetine.

• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage). See Pregnancy, breastfeeding and fertility in section 2 for more information.

Other possible adverse effects during treatment:

Very common adverse effects, which may affect more than 1 in 10 patients:

• Feeling unwell (nausea). This effect may be reduced by taking your medicine 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, which may affect up to 1 in 10 patients:

• Increased blood cholesterol levels.
• Decreased appetite.
• Difficulty sleeping (insomnia) or drowsiness.
• Abnormal dreams (including nightmares).
• Dizziness, tremors.
• Headache.
• Difficulty concentrating.
• Agitation.
• Unusual weakness.
• Blurred vision.
• Yawning, dry mouth.
• Diarrhoea or constipation.
• Vomiting.
• Weight gain.
• Sweating.

Uncommon adverse effects, which may affect up to 1 in 100 patients:

• Transient increases in blood pressure, or transient decreases in blood pressure that may cause dizziness or fainting when standing up quickly.
• Faster than normal heartbeat.
• 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 a loss of control of your blood sugar levels while taking paroxetine. Consult your doctor about how to adjust your insulin or diabetes medication dose.
• Decreased white blood cell count.

Rare adverse effects, which may affect up to 1 in 1,000 patients:

• Abnormal milk secretion in men and women.
• Slowing of the heart rate.
• Liver effects seen in laboratory tests indicating liver function.
• Panic attacks.
• Very active behaviour or thoughts (mania).
• Feeling detached from oneself (depersonalisation).
• 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, or absence or delay of periods).

Very rare adverse effects, which may affect up to 1 in 10,000 patients:

• 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 peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
• Widespread rash affecting a large body surface area with blisters and peeling of the skin (toxic epidermal necrolysis).
• Liver disturbances 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 sodium (salt) levels decrease as a result of inappropriate chemical signals. Patients with SIADH may feel severely ill or may have no symptoms at all.
• Water or fluid retention (causing swelling of arms or legs).
• Sensitivity to sunlight.
• Painful and prolonged erection of the penis.
• Decreased number of platelets in the blood.

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

It has been observed that people taking this type of medicine such as paroxetine have an increased risk of bone fractures.

Adverse effects with unknown frequency, frequency cannot be estimated from the available data

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

Some patients have experienced ringing, whistling, buzzing, tinkling or other persistent noises in the ears (tinnitus) while taking this medicine. It has been observed that people taking medicines such as paroxetine have an increased risk of bone fractures.

Reporting of adverse effects

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

5. Storage of Paroxetine Mabo

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

Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.

This medicine requires no special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paroxetina Mabo 30 mg tablets

The active substance is: paroxetine; each tablet contains 30 mg of paroxetine as anhydrous paroxetine hydrochloride.

The other components are: microcrystalline cellulose (E 460), calcium hydrogen phosphate dihydrate (E 341), sodium croscarmellose (E 468), colloidal anhydrous silica (E 551), and magnesium stearate (E 470b).

Appearance of the product and contents of the pack

Paroxetina Mabo is presented as almost white, round tablets with flat faces, bevelled edges and a score line. The tablet can be divided into two equal doses.

This medicine is available in blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 120, 180, or 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

MABO-FARMA S.A.
Calle Vía de los Poblados 3,
Edificio 6, 28033, Madrid,
Spain.

Manufacturer:

Farmaceutisch Analytisch Laboratorium Duiven BV
Dijkgraaf 30, Duiven
The Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last review of this leaflet: August 2024

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