PAROXETINE MABO 10 mg TABLETS

2. What you need to know before you take Paroxetina Mabo

Do not take Paroxetina Mabo:

• if you are being treated with medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)), or if you have been under treatment with any of these medicines in the last two weeks. Your doctor will advise you how to start taking paroxetine once you have stopped taking the MAOI.
• if you are taking an antipsychotic medicine called thioridazine or the antipsychotic called pimozide.
• if you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6).

If you are in any of these situations, tell 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 the 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 taking another antidepressant.
• if you have any kidney, liver, or heart problems.
• if you have an abnormality in your heart tracing after 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 potassium or magnesium levels.
• if you have epilepsy or have had seizures or epileptic fits.
• if you have had manic episodes (excessively active thoughts or behavior).
• if you are being treated with electro-convulsive therapy (ECT).
• if you have a tendency to bleed or bruise easily, or are being treated with any medicine that may increase the risk of bleeding (including medicines such as warfarin (acenocoumarol), antipsychotics like perphenazine or clozapine, tricyclic antidepressants, medicines for treating 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 think you may be pregnant (see the section "Pregnancy, breastfeeding, and fertility").
• if you are under 18 years of age (see the section "Children and adolescents under 18 years of age" in this leaflet).

If you are in any of these situationsand have not yet consulted your doctor, ask your doctor how to take paroxetine.

Children and adolescents under 18 years of age

Paroxetine should not be used in the treatment of children and adolescents under 18 years of age. Also, you should 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 irritability) when taking paroxetine. Nevertheless, your doctor may prescribe paroxetine to patients under 18 years of age when they decide it is most convenient for the patient. If your doctor has prescribed paroxetine 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. The long-term effects of paroxetine 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 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 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, although with less frequency.

When stopping treatment with paroxetine, 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 stopped treatment with paroxetine (see the section "How to take paroxetine"). 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 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 medicines take time to work, which is normally a few weeks but can sometimes be longer.

This is more likely to happen

• If you have previously had 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 illnesses who were being treated with some antidepressants.

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 tella relative 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 side effects seen with paroxetine

Some patients who take paroxetine develop a disorder called akathisia, and feel restless and unable to sit or stay still. Other patients develop what is 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, see section 4.

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

Other medicines and paroxetine

Some medicines may change the effect of paroxetine or make it more likely that some side effects will appear. Paroxetine 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".

Medicines known to increase the risk of changes in heart activity (e.g., antipsychotics thioridazine or pimozide). See the section "Do not take paroxetine".

• Medicines called thioridazine or pimozide, which are antipsychotics. See the 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 pethidine, painkillers.
• Buprenorphine combined with naloxone, substitution treatment for opioid addiction.
• Medicines called triptans, such as sumatriptan, used to treat migraines.
• Other antidepressants, including other selective serotonin reuptake inhibitors and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
• A dietary supplement called tryptophan.
• Mivacurium and suxamethonium (used in anesthesia).
• Medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat some psychiatric illnesses.
• 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 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 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,even 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 side 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 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 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. Your doctor, in agreement with you, may change your treatment to another or gradually stop treatment with paroxetine while you are pregnant. However, depending on your circumstances, your doctor may recommend continuing to take paroxetine.

Make sure your doctor or midwife knows that you are taking paroxetine.

If you take paroxetine 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 to advise you. Medicines like paroxetine 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 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:

• Breathing difficulties.
• Bluish skin or appearance of being too hot or cold.
• Bluish lips.
• Vomiting or difficulties with feedings.
• Feeling very tired, difficulty sleeping, or frequent crying.
• Muscle stiffness or flaccidity.
• 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 passes into breast milk in very small amounts. Consult your doctor if you are taking Paroxetine before starting to breastfeed. Your doctor, in agreement with you, may advise you to continue breastfeeding while taking paroxetine.

Studies with 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 can cause are dizziness, confusion, drowsiness, or blurred vision. If you experience any of these effects, do not drive vehicles or use machines.

Paroxetina Mabo 10/20/30/40 mg Tablets

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

3. How to Take Paroxetine Mabo

Follow your doctor's or pharmacist's administration instructions for this medication exactly.If in doubt, consult your doctor or pharmacist again.

The normal doses for 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 how to proceed. 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 whole, immediately, with plenty of water (at least 1 glass of 150 ml). Do not suck, chew, or keep the tablet in your mouth, as this can cause a local unpleasant sensation such as a bitter taste, throat irritation, cough, or feeling of suffocation.

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 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

Take your medication at the same time every day.

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

If you remember during the night or the next day, omit the forgotten 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 the 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 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

Do not interrupt treatment until your doctor indicates it.

When You Interrupt Treatment with Paroxetine, your 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 others, 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 Will 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.

Common Adverse Effects, Which May Affect Up to 1 in 10 Patients:

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

Uncommon Adverse Effects, Which May Affect Up to 1 in 100 Patients:

• 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.

Consult Your Doctor If You Are Concerned About the Withdrawal Effects of Paroxetine.

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. It is more likely that adverse effects will appear during the first weeks of treatment with paroxetine.

Tell Your Doctor If You Experience Any of the Adverse Effects Described Below During Treatment with Paroxetine.

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

Uncommon Adverse Effects, Which May Affect Up to 1 in 100 Patients:

• If you have bruises or unusual bleeding, such as blood in your 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, Which May Affect Up to 1 in 1,000 Patients:

• If you experience seizures (epileptic fits), contact your doctor or go to the hospital immediately.
• If you feel restless, unable to stay seated or stay still, called akathisia. Increasing the dose of paroxetine may worsen your symptoms. If you feel this way, consult your doctor.
• 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, Which May Affect Up to 1 in 10,000 Patients:

• Severe allergic reactions to paroxetine.

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, consult your doctor or go to the hospital immediately.

If You Notice Any of the Following Symptomsyou may be experiencing serotonin syndrome or neuroleptic malignant syndrome. The symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremors, 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.

• Acute Glaucoma.

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

Frequency Not Known, The Frequency Cannot Be Estimatedfrom the available data

-Some patients have experienced thoughts of self-harm or suicide while taking paroxetine or shortly after stopping treatment (see Suicidal Thoughts and Worsening of Your Depression or Anxiety Disorder in section 2).

• Some patients have experienced aggression while taking paroxetine.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), 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 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, Which May Affect Up to 1 in 10 Patients:

• Increased cholesterol levels 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, Which May Affect Up to 1 in 100 Patients:

• 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 a loss of control of blood sugar levels while taking paroxetine. Consult your doctor about how to adjust the dose of your insulin or diabetes medication.
• 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.
• 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, Which May Affect Up to 1 in 10,000 Patients:

• Skin rash, which can appear with blisters that look like small targets (dark central spots surrounded by a pale area, with a dark ring around) called erythema multiforme.
• Widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Widespread rash over a large body surface with blisters and skin peeling (toxic epidermal necrolysis).
• Liver disorders that turn the skin or the whites 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 (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 (which causes swelling of arms or legs).
• Sensitivity to sunlight.
• Painful and prolonged erection of the penis.
• Decreased platelet count in the blood.

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

It has been observed that people who take this type of medication, such as paroxetine, have a higher risk of bone fractures.

Adverse Effects of Unknown Frequency, The Frequency Cannot Be Estimatedfrom the available data

• Colon inflammation (which causes diarrhea).
• Teeth grinding.

Some patients have experienced buzzing, whistling, ringing, or other persistent noises in the ears (tinnitus) when taking this medication. It has been observed that people who take medications like paroxetine have a higher risk of bone fractures.

Reporting Adverse Effects

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

5. Conservation of Paroxetine Mabo

Keep this medication out of sight and reach of children.

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

This medication does not require any special storage conditions.

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 way, you will help protect the environment.

6. Container Content and Additional Information

Composition of Paroxetina Mabo 10 mg tablets

The active ingredient is: paroxetine, each tablet contains 10 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), anhydrous colloidal silica (E 551), and magnesium stearate (E 470b).

Appearance of the Product and Container Content

Paroxetina Mabo is presented in the form of almost white, biconvex, and round tablets with 10 inscribed on one side.

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

MABO-FARMA S.A.

Rejas Street 2, 1st floor

1. Coslada, Madrid

Spain

Manufacturer:

Farmaceutisch Analytisch Laboratorium Duiven BV

Dijkgraaf 30, Duiven

Netherlands

This medication is authorized in the member states of the European Economic Area under the following names

Date of the Last Revision of this Prospectus:August 2024

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