PAROXETINE PENSA 20 mg FILM-COATED TABLETS

2. What you need to know before you take PAROXETINE PENSA 20 mg film-coated tablets

Do not take Paroxetine Pensa:

• If you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6).
• This medicine contains soybean oil. It should not be used in case of peanut or soy allergy.

• If you are being treated with medicines called monoamine oxidase inhibitors (MAOIs), including moclobemide and methylene blue (methylthioninium chloride),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 in any of these situations, tell your doctor and do not take Paroxetine Pensa.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paroxetine Pensa

• if you are taking other medicines (see the section Use of other medicines and Paroxetine Pensa)
• if you are taking tamoxifen for breast cancer treatment (or fertility problems). Paroxetine Pensa may make tamoxifen less effective, so your doctor should recommend taking another antidepressant
• if you have kidney, liver, or heart problems

• if you have epilepsy or if you have seizures or epileptic fits

• if you have had manic episodes (excessively active thoughts or behavior)
• if you are being treated with electroconvulsive therapy (ECT)
• if you have a tendency to bleed or bruise, or are being treated with a medicine that may increase the risk of bleeding (including medicines such as warfarin (acenocoumarol), antipsychotics like perphenazine or clozapine, tricyclic antidepressants, medicines to treat pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam) or if you are pregnant (see the section Pregnancy, breast-feeding, and fertility)

• 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, breast-feeding, and fertility
• if you are under 18 years old (see the 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 how to take Paroxetine Pensa.

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.It should also be known 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 irritation) when taking paroxetine. Nevertheless, the doctor may prescribe Paroxetine Pensa to patients under 18 years of age when he decides it is most convenient for the patient. If the doctor has prescribed Paroxetine Pensa 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 (having too much 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 discontinuing treatment with paroxetine, in these studies, some patients under 18 years of age reported having withdrawal effects. These effects were very similar to those observed in adults who discontinued treatment with paroxetine (see section 3 How to take Paroxetine Pensa). 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 attempts, 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 can increase at the beginning of treatment with antidepressants, as all these medicines take time to work, which is usually 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 there is an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who are being treated with any antidepressant.

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

It may be useful for you to explain to a family member 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 Pensa

Some patients who take Paroxetine Pensa develop a disorder called akathisia, and feel restless and unable to sit or stay still. Other patients develop the so-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 Pensa, see section 4 Possible side effectsin this leaflet.

Some medicines in the group to which Paroxetine Pensa 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 Pensa

Some medicines can change the effect of Paroxetine Pensa or make it more likely that some side effects will appear. Paroxetine Pensa can also change the effect of some medicines. For example:

• Medicines called monoamine oxidase inhibitors (MAOIs),including moclobemide and methylene blue (methylthioninium chloride). See the section Do not take Paroxetine Pensa.
• The medicines called thioridazine or pimozide, which are antipsychotics. See the section Do not take Paroxetine Pensa.
• 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 and pethidine, analgesics.
• 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 supplementcalled tryptophan.
• Mivacurium and suxamethonium (used in anesthesia).
• Medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat some psychiatric disorders.
• Fentanyl, used in anesthesiaor 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 treating depression.
• Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizuresor 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)

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 Pensa with food, drinks, and alcohol

Do not consume alcohol while taking paroxetine. Alcohol can worsen your symptoms or side effects.

Take your medicine in the morning, preferably with food, as this can reduce the likelihood of nausea.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

In some studies, an increased risk of malformations, particularly those affecting the heart, has been observed in newborns whose mothers took Paroxetine Pensa 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 Pensa. Your doctor, in agreement with you, may change your treatment to another or gradually stop treatment with Paroxetine Pensa while you are pregnant. However, depending on your circumstances, your doctor may recommend continuing to take Paroxetine Pensa.

Make sure your doctor or midwife knows that you are taking Paroxetine Pensa. Medicines like Paroxetine Pensa 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 Pensa 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.
• Bluish skin or looking too hot or cold.
• Bluish lips.
• Vomiting or difficulty feeding.
• Feeling very tired, difficulty sleeping, or frequent crying.
• Muscle stiffness or floppiness.
• 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.

If you take Paroxetine Pensa in the final stages 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 Pensa to be able to advise you.

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

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

Paroxetine Pensa 20 mg film-coated tablets contain soybean oil.

If you are allergic to peanuts or soy, do not take this medicine.

Paroxetine Pensa 20 mg film-coated tablets contain sodium.

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

3. How to TAKE PAROXETINE PENSA 20 mg TABLETS

Follow the administration instructions of 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 Pensa. 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.

The tablets should be swallowed with water.

The tablets should not be chewed.

The tablet can be divided into two equal halves.

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 any kidney or liver disease, your doctor may advise you to take smaller doses of paroxetine than usual.

If you take more Paroxetine Pensa 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 Pensa 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 Pensa

Take your medication at the same time every day.

If you forget to take a dose and remember before going to bed, 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 forgotten doses.

What to do if you do not feel better

Paroxetine Pensa 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, inform 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 Pensa

Do not interrupt treatment until your doctor indicates it.

When interrupting 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 Pensa you are taking by 10 mg each week. Most people consider that the possible symptoms that occur when interrupting treatment with Paroxetine Pensa 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 effectswhile interrupting your treatment, the 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 Pensa.

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 Pensa. Some of these effects occur more frequently than others.

Common adverse effects (may affect up to 1 in 10 people)

• Feeling dizzy, unstable, or having balance problems
  • 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.
  • Anxiety.

• Headaches.

Uncommon adverse effects (may affect up to 1 in 100 people)

• Vomiting (nausea).
• Sweating (including sweating)
• Restlessness or agitation.
• Tremors.
• Confusion or disorientation.
• Diarrhea (soft stools).
• Feeling very sensitive or irritable.
• Visual disturbances.
• Rapid or very strong heart palpitations.

Consult your doctor if you are concerned about the withdrawal effects of Paroxetine Pensa.

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 everyone will 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 during treatment with paroxetine

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

Uncommon adverse effects (may affect up to 1 in 100 people):

• If you have 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 adverse effects (may affect up to 1 in 1,000 people):

• If you experience seizures(epileptic fits), contact your doctor or go to the hospital immediately.
• If you have a feeling of restlessness, inability to sit still or stay still, called akathisia. Increasing the dose of Paroxetine Pensa 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 (may affect up to 1 in 10,000 people)

• Severe allergic reactions to Paroxetine Pensa.

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, contact your doctor or go to the hospital immediately.

• If you notice any of the following symptoms, you may be experiencing 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 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 patients have experienced thoughts of self-harm or suicide while taking Paroxetine Pensa or shortly after stopping treatment (see section 2 What you need to know before taking Paroxetine Pensa).
• Aggression.

Other possible adverse effects during treatment:

Very common adverse effects (may affect more than 1 in 10 people)

• 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 (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.
• Headache.
• Difficulty concentrating.
• Agitation.
• Unusual weakness.
• Blurred vision.
• Yawning, dry mouth.
• Diarrhea or constipation.
• Vomiting.
• Weight gain.
• Sweating.

Uncommon adverse effects (may affect up to 1 in 100 people)

• Transient increases in blood pressure, or 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.
• Pupil dilation.
• Skin rash.
• Itching.
• Confusion.
• Hallucinations (strange sounds or visions).
• Urinary retention (inability to urinate) or urinary incontinence (uncontrolled and involuntary urination).
• If you are a diabetic patient, you may notice loss of control of blood sugar levels while taking paroxetine. Consult your doctor about how to adjust your insulin or diabetes medication dose.
• Decreased white blood cell count.

Rare adverse effects (may affect up to 1 in 1,000 people)

• Abnormal milk secretion in men and women.
• Decreased heart rate.
• Liver function test abnormalities.
• Panic attacks.
• Manic behavior or thoughts.
• Feeling detached from oneself (depersonalization).
• Anxiety.
• Irresistible need 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(may affect up to 1 in 10,000 people)

• Skin rash with blisters that have a target-like appearance (erythema multiforme).
• Widespread skin rash with blisters and peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Widespread skin rash with blisters and peeling over a large body surface area (toxic epidermal necrolysis). Liver disorders that turn the skin or whites of the eyes yellow.

• Water or fluid retention that causes swelling of the arms or legs. Sensitivity to sunlight.

• Decreased platelet count in the blood.
• Painful and prolonged erection of the penis.

Frequency not known(cannot be estimated from available data)

• Teeth grinding
• Colitis (which causes diarrhea)
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see section "Pregnancy, breastfeeding, and fertility" for more information.

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

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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of PAROXETINE PENSA 20 mg TABLETS

No special storage conditions are required.

Keep out of sight and reach of children.

Do not use Paroxetine Pensa after the expiration date CAD that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofParoxetine Pensa 20 mg tablets

• The active ingredient is anhydrous paroxetine (as hydrochloride). Each tablet contains 20 mg of paroxetine.
• The other ingredients are: magnesium stearate, sodium glycolate starch (from potato), mannitol (E-421), microcrystalline cellulose, polymethacrylate, partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), talc, soy lecithin (E-322), xanthan gum (E-415).

Appearance of the product and package contents

Paroxetine Pensa 20 mg is presented in the form of film-coated tablets, oblong, biconvex, white or grayish-white, and scored. Each package contains 14, 28, 56, or 500 tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Labiana Pharmaceuticals, S.L.U.

Casanova 27-31

08757 Corbera de Llobregat (Spain)

or

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses, 2 (Alcobendas)

28108 Madrid (Spain)

Date of the last revision of this leaflet: November 2023

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/