PAROXETINE AUROVITAS 20 mg FILM-COATED TABLETS

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

Do not take Paroxetine Aurovitas

• If you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue).
• If you are taking an antipsychotic called thioridazine or the antipsychotic called pimozida.

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

Warnings and precautions

Consult your doctor or pharmacist before taking Paroxetine Aurovitas.

• If you are taking other medicines (see the section "Other medicines and Paroxetine Aurovitas").
• If you are taking tamoxifen for breast cancer or fertility problems. Paroxetine may make tamoxifen less effective, so your doctor may recommend taking a different antidepressant.
• If you have a heart condition, such as a prolongation of the QT interval.
• If you have a family history of QT interval prolongation, heart disease, or low potassium or magnesium levels.

• If you have kidney, liver, or heart problems.
• If you have epilepsy or a history of seizures or convulsions.
• If you have had manic episodes (excessive activity or behavior).
• If you are being treated with electroconvulsive therapy (ECT).
• If you have a history of bleeding disorders or are pregnant (see "Pregnancy, breastfeeding, and fertility") or are taking other medicines that may increase the risk of bleeding (including anticoagulants, antiplatelet agents, or nonsteroidal anti-inflammatory drugs (NSAIDs)).
• 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 "Pregnancy, breastfeeding, and fertility").
• If you are under 18 years old (see "Children and adolescents under 18 years old").

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

Children and adolescents under 18 years old

Paroxetine should not be used in the treatment of children and adolescents under 18 years old. In patients under 18 years old, an increased risk of suicidal thoughts, suicidal attempts, and hostility (mainly aggression, oppositional behavior, and anger) has been observed when taking paroxetine. If your doctor has prescribed paroxetine for you (or your child) and you want to discuss this decision, consult your doctor. You should inform your doctor if any of the above symptoms appear or worsen when you (or your child) are taking paroxetine.

In studies with paroxetine in patients under 18 years old, common side effects (affecting less than 1 in 10 children or adolescents) included increased suicidal thoughts and attempts, self-harm, hostility, aggression, or unfriendly behavior, loss of appetite, tremors, sweating, hyperactivity (having too much energy), agitation, unstable emotions (including crying and mood swings), and unusual bruising or bleeding.

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 or killing yourself. These may increase at the start of treatment with antidepressants, as these medicines take time to work, usually about 2 weeks, but sometimes longer.

It is more likely to happen

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

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

Important side effects seen with paroxetine

Some patients taking paroxetine develop a condition called akathisia, and feel restless and unable to sit or stand still. Others 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, shaking, shivering, hallucinations (seeing or hearing things that are not there), stiff muscles, sudden jerky movements, or a fast heart rate. The severity can increase, leading to loss of consciousness. Consult your doctorif you have any of these symptoms.

Other medicines and Paroxetine Aurovitas

Some medicines may affect the way paroxetine works, or may increase the risk of side effects. Paroxetine may also affect the way some other medicines work.

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue). See the section "Do not take Paroxetine Aurovitas".
• Medicines known to increase the risk of changes in heart activity (e.g., antipsychotics thioridazine or pimozida). See the section "Do not take Paroxetine Aurovitas".
• Aspirin, ibuprofen, and other nonsteroidal anti-inflammatory drugs (NSAIDs) used to treat pain and inflammation.
• Tramadol, buprenorphine, and pethidine, painkillers.

• Medicines called triptans, such as sumatriptan, used to treat migraines.
• Other antidepressants, including other SSRIs 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, and clozapine (antipsychotics) used to treat some psychiatric conditions.
• Fentanyl, used in anesthesia or to treat chronic pain.
• A combination of fosamprenavir and ritonavir, used to treat 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, tell your doctor and consult what to do. Your doctor may decide to change the dose or prescribe a different 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 Aurovitas with food, drinks, and alcohol

Do not drink alcohol while taking Paroxetine Aurovitas. Alcohol may worsen your symptoms or side effects. Taking Paroxetine Aurovitas 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

An increased risk of malformations, in particular 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 decide to change your treatment or gradually stop paroxetine while you are pregnant. However, depending on your circumstances, your doctor may recommend continuing to take paroxetine.

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

If you take Paroxetine Aurovitas in the last 3 months of pregnancy, there may be an increased risk of heavy bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Paroxetine Aurovitas to 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 last months.

If you take paroxetine in the last trimester of pregnancy, your newborn may also have other symptoms, usually starting in the first 24 hours after birth. These symptoms include:

• Difficulty breathing.
• Blue-tinged skin or looking too hot or cold.
• Blue-tinged lips.
• Vomiting or difficulty feeding.
• Feeling very tired, difficulty sleeping, or crying frequently.
• Stiff or floppy muscles.
• Shakiness, tremors, or seizures.
• Exaggerated reflexes.

If your baby has any of these symptoms, 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 before breastfeeding while taking paroxetine. 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 may theoretically affect fertility, but this effect on human fertility has not been observed.

Driving and using machines

Some of the side effects of paroxetine, such as dizziness, confusion, drowsiness, or blurred vision, may impair your ability to drive or operate machinery. If you experience any of these effects, do not drive or use machines.

Paroxetine Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Paroxetine Aurovitas contains sodium

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

3. How to Take Paroxetine Aurovitas

Follow the administration instructions for 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 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.

Swallow the tablets with water.

Do not chew the tablets.

Your doctor will indicate the duration of the treatment. This period may be extended for several months or even longer.

Elderly People

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

Patients with Kidney or Liver Problems

If you have liver problems or severe kidney disease, your doctor may decide that you take lower doses of paroxetine than usual.

If You Take More Paroxetine Aurovitas Than You Should

Never take more tablets than your doctor has recommended.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.

A person who has taken an overdose of paroxetine may experience some of the symptoms that appear in section 4, Possible Adverse Effects,or the following symptoms: fever, involuntary muscle contraction.

If You Forget to Take Paroxetine Aurovitas

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 suffer 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 forgotten 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. Inform your doctor if you have not started to feel better.

If You Stop Treatment with Paroxetine Aurovitas

Do not stop taking paroxetine until your doctor tells you to.

When you stop 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 suffering from 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 stopping 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 effects while stopping your treatment, your doctor may decide to stop it more slowly. If you experience severe withdrawal symptoms, consult your doctor. He or she may advise you to start treatment again and then stop it more slowly.

Even if You Experience Withdrawal Effects, You May Still Be Able to Stop Your Treatment with Paroxetine.

Possible Withdrawal Effects When Stopping Treatment

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

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

• Feeling dizzy, with instability or balance disturbances.
• Tingling, 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 (very vivid dreams, nightmares, inability to sleep).
• Anxiety.
• Headaches.

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

• 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 produce adverse effects, although not all people experience them. It is more likely that adverse effects will appear during the first few weeks of treatment with paroxetine.

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

Uncommon: May Affect Up to 1 in 100 People

• 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: May Affect Up to 1 in 1,000 People

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

• Allergic reactions to paroxetine that can be severe. If you develop a skin rash with redness and bumps, swelling of the face, eyelids, lips, mouth, or tongue, itching, or difficulty breathing (difficult breathing) or swallowing, and feeling weak or having a fainting spell that can cause 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 suffering from 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 involuntary 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 experience eye pain and blurred vision, consult your doctor.

Frequency Not Known (Cannot Be Estimated from Available Data)

• Some people have experienced thoughts of self-harm or 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.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see Pregnancy, Breastfeeding, and Fertilityin section 2 for more information.

If you experience these adverse effects, consult your doctor.

Other Possible Adverse Effects During Treatment:

Very Common: 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.
• Change in sexual desire or function, for example, lack of orgasm, and in men, abnormal erection and ejaculation.

Common: 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: 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 uncontrolled and involuntary urination (urinary incontinence).
• If you are a diabetic patient, you may notice loss of control of 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: 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: May Affect Up to 1 in 10,000 People

• Skin rash, in which blisters appear with a target-like appearance (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 disease 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 (Cannot Be Estimated from Available Data)

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

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 medications like paroxetine 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 does not appear in this prospectus. 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 Aurovitas

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be thrown down the drain or into the trash. Deposit the containers and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Paroxetine Aurovitas

• The active ingredient is paroxetine. Each film-coated tablet contains 20 mg of paroxetine (as paroxetine hydrochloride hemihydrate).
• The other ingredients are:

Core of the tablet:calcium hydrogen phosphate dihydrate, calcium hydrogen phosphate, lactose monohydrate, sodium carboxymethyl starch (Type A) potato, magnesium stearate.

Coating of the tablet:titanium dioxide (E171), hypromellose (E464), macrogol 400, polysorbate 80 (E433).

Appearance of the Product and Package Contents

Film-coated tablets, white or almost white in color, capsule-shaped, biconvex, with the mark "56" on one side and "C" and a score line on the other. The tablet can be divided into equal doses.

Paroxetine Aurovitas film-coated tablets are available in blister packs of 7, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100, and 250 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This Medication is Authorized in the EEA Member States Under the Following Names:

Date of Last Revision of This Prospectus: March 2024

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/).