PAROXETINE AUROVITAS 30 mg FILM-COATED TABLETS

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

Do not take Paroxetina 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 pimozide.

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 starting treatment with Paroxetina Aurovitas.

• if you are taking other medicines (see the section "Other medicines and Paroxetina Aurovitas").
• if you are taking tamoxifen for breast cancer treatment or fertility problems. Paroxetine may make tamoxifen less effective, so your doctor may recommend taking another antidepressant.
• if you have any kidney, liver, or heart problems.
  • if you have an abnormal heart rhythm (seen on an electrocardiogram, ECG) called QT interval prolongation.
  • if you have a family history of QT interval prolongation, heart disease such as heart failure, low heart rate, or low potassium or magnesium levels.

• if you have epilepsy or a history of seizures or convulsions.
• if you have had manic episodes (excessively active thoughts or behaviors).
• if you are being treated with electroconvulsive therapy (ECT).
• if you have a history of bleeding disorders or if you are pregnant (see "Pregnancy, breastfeeding, and fertility") or are taking other medicines that may increase the risk of bleeding (these include medicines used to make the blood more fluid, such as warfarin, antipsychotics like perphenazine or clozapine, tricyclic antidepressants, pain and inflammation medicines called non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, 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 might be pregnant (see the section "Pregnancy, breastfeeding, and fertility").
• if you are under 18 years old (see the section "Children and adolescents under 18 years old").
  • if you are taking medicines containing buprenorphine. The use of these medicines with Paroxetina Aurovitas may lead to serotonin syndrome, a potentially life-threatening condition (see "Taking Paroxetina Aurovitas with other medicines").

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 old

Paroxetine should not be used in the treatment of children and adolescents under 18 years old. Also, in patients under 18 years old, there is a greater risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking paroxetine. If your doctor has prescribed paroxetine for you (or your child) and you wish to discuss this decision, consult your doctor. You must inform your doctor if any of the above symptoms appear or worsen when you (or your child) are taking paroxetine. Additionally, the long-term safety effects of paroxetine on 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 old, common side effects that affected less than 1 in 10 children or adolescents were: increased thoughts and attempts of suicide, self-harm behaviors, hostile, aggressive, or unfriendly behaviors, loss of appetite, tremors, abnormal sweating, hyperactivity (having too much energy), agitation, unstable emotions (including crying and mood changes), and unusual bruising or bleeding (such as nosebleeds). These effects were also observed in patients included in these studies who did not take paroxetine, although with lower frequency.

In these studies, some patients under 18 years old reported having withdrawal effects when stopping treatment with paroxetine. These effects were very similar to those observed in adults who stopped treatment with paroxetine (see section 3). Additionally, patients under 18 years old 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 suicide. These may increase at the beginning of treatment with antidepressants, as all these medicines take time to work, which is usually a few weeks but sometimes may 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 old with psychiatric disorders who were being treated with some antidepressants.

If you have thoughts of self-harm or suicide at any time, consult your doctor or go to the hospital immediately.

It may be helpful for you to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

Important side effects seen with paroxetine

Some patients who take paroxetine develop a disorder called akathisia, and feel restless and cannot sit or stand still. Other patients develop a condition called serotonin syndrome or neuroleptic malignant syndrome, and may have some or all of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, trembling, chills, hallucinations (unusual 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 in the same group as paroxetine (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Other medicines and Paroxetina Aurovitas

Some medicines may change the effect of paroxetine or make some side effects more likely. Paroxetine may also change the effect of some medicines. These include:

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue). See the section "Do not take Paroxetina Aurovitas".
• Medicines known to increase the risk of changes in heart electrical activity (e.g., antipsychotics thioridazine or pimozide). See the section "Do not take Paroxetina Aurovitas".
• Aspirin, ibuprofen, and other medicines called non-steroidal anti-inflammatory drugs (NSAIDs), such as celecoxib, diclofenac, etodolac, 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 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, clozapine (antipsychotics) used to treat some psychiatric disorders.
• Fentanyl, used in anesthesia or to treat chronic pain.
• A combination of fosamprenavir and ritonavir, used to treat human immunodeficiency virus (HIV) infection.
• St. John's Wort, a herbal remedy for depression.
• Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizures or epilepsy.
• Atomoxetine, a medicine used to treat attention deficit hyperactivity disorder (ADHD).
• Procyclidine, used to relieve tremors, especially in Parkinson's disease.
• Warfarin and other medicines (called anticoagulants) used to make the blood more fluid.
• Propafenone, flecainide, and medicines used to treat heart rhythm disorders.
• Metoprolol, a beta-blocker used to treat high blood pressure and heart disorders.
• Pravastatin, used to treat high cholesterol.
• Rifampicin, used to treat tuberculosis (TB) and leprosy.
• Linezolid, an antibiotic.
• Tamoxifen, used to treat breast cancer or fertility problems.
• Some medicines may increase the side effects of Paroxetina Aurovitas and may occasionally cause very serious reactions. Do not take any other medicine while taking Paroxetina Aurovitas without consulting your doctor first, especially:
  • medicines containing buprenorphine. These medicines may interact with Paroxetina Aurovitas and you may experience symptoms such as involuntary muscle contractions, including the muscles that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38 °C. Contact your doctor if you experience these symptoms.

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 bought without a prescription.

Taking Paroxetina Aurovitas with food, drinks, and alcohol

Do not drink alcohol while taking Paroxetina Aurovitas. Alcohol may worsen your symptoms or side effects. Taking Paroxetina Aurovitas in the morning with food may reduce the likelihood of nausea.

Pregnancy, breastfeeding, and fertility

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

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 switch you to another treatment or gradually stop paroxetine treatment 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 Paroxetina Aurovitas in the final 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 know that you are taking Paroxetina 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 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 take 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:

• Difficulty breathing.
• Blue-tinged skin or looking too hot or cold.
• Blue lips.
• Vomiting or difficulty feeding.
• Feeling very tired, difficulty sleeping, or frequent crying.
• Muscle stiffness or floppiness.
• Tremors, localized tremors, or convulsions.
• 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.

Animal studies have shown that paroxetine reduces sperm quality. Theoretically, this could affect fertility, but this impact on human fertility has not yet been observed.

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 or use machinery.

Paroxetina Aurovitas contains lactose

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

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

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

Take the tablets in the morning, with food.

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 should 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, skip the missed dose. You may experience some withdrawal symptoms, but they should disappear after taking the next dose at the usual time. Do not take a double dose to make up for missed doses.

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 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 the possible symptoms that occur when stopping treatment with paroxetine to be mild and to 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. Your doctor 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, unsteady, or having balance problems.
• Tingling, burning sensations, and, less frequently, electric shock sensations, even in the head, buzzing, whistling, ringing, or other persistent noises in the ears (tinnitus).
• Sleep disturbances (very vivid dreams, nightmares, inability to sleep).
• Anxiety.
• Headaches.

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

Rare: 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 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.
• Feeling tired, weak, or confused and having 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

• Severe allergic reactions to paroxetine that can be serious. If you develop a rash with redness and bumps, swelling of the face, eyelids, lips, mouth, or tongue, itching, or difficulty breathing (difficulty 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 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 experience eye pain and blurred vision, consult your doctor.

Frequency Not Known (Cannot Be Estimated from Available Data)

• Some people have experienced thoughts of harming themselves or suicidal thoughts 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 Fertility in Section 2 for more information.

If you experience these adverse effects, contact your doctor.

Other Possible Adverse Effects During Treatment:

Very Common: May Affect More than 1 in 10 People

• Feeling unwell (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: 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.
• 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

• Rash 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 peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Widespread rash over a large area of the body with blisters and peeling of the skin (toxic epidermal necrolysis).
• Liver disorders that turn the skin or 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.
• Fluid retention or swelling (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 taking 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 is not listed 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 away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Paroxetine Aurovitas

• The active ingredient is paroxetine. Each film-coated tablet contains 30 mg of paroxetine (as paroxetine hydrochloride hemihydrate).
• The other components are:

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

Coating of the tablet:titanium dioxide (E171), hypromellose (E464), macrogol 400, aluminum lake of carmine (E132), polysorbate 80 (E433).

Appearance of the Product and Package Contents

Blue film-coated tablets, modified capsule-shaped, biconvex, with the mark "F" on one face and "12" on the other.

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 the 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/).