PAROXETINE QUALIGEN FARMA 20 mg FILM-COATED TABLETS

2. What you need to know before you take Paroxetine Qualigen Farma

Do not take Paroxetine Qualigen Farma:

• if you are being treated with medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue), or if you have been treated with any of these medicines in the last two weeks. Your doctor will advise you how to start taking Paroxetine Qualigen Farma 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).
• this medicine contains soya lecithin, which may contain soya oil. It should not be used in case of peanut or soya allergy.
• if you are in any of these situations, tell your doctor and do not take Paroxetine Qualigen Farma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paroxetine Qualigen Farma:

• if you are taking other medicines (see the section Other medicines and Paroxetine Qualigen Farma)
• if you are taking tamoxifen for the treatment of breast cancer (or fertility problems). Paroxetine Qualigen Farma may make tamoxifen less effective, so your doctor should recommend taking an antidepressant
• if you have any kidney, liver, or heart problems
• if you have an abnormality in your heart rhythm 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 low 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, or are being treated with any medicine that may increase the risk of bleeding (including medicines such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines for treating pain and inflammation 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

• if you are pregnant or think you may be pregnant (see the section Pregnancy, breast-feeding and fertility)
• if you are under 18 years of age (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 him how to take Paroxetine Qualigen Farma.

Children and adolescents

Paroxetine should not normally 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 (predominantly aggression, confrontational behavior, and irritation) when taking Paroxetine Qualigen Farma. Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age when he decides it is most convenient for the patient. If your doctor has prescribed Paroxetine Qualigen Farma to you or your child under 18 years of age and you want to discuss this decision, consult your doctor. You should inform your doctor if any of the symptoms detailed above appear or worsen when you or your child under 18 years of age are taking Paroxetine Qualigen Farma. The long-term effects of Paroxetine Qualigen Farma 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 Qualigen Farma in patients under 18 years of age, the frequent adverse effects, which affected less than 1 in 10 children or adolescents, were: an increase in suicidal thoughts and attempts, self-harm, 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 Qualigen Farma, although with lower frequency.

When stopping treatment with Paroxetine Qualigen Farma, 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 Qualigen Farma (see section 3). 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, suicidal thoughts, and attempts).

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may sometimes have thoughts of self-harm or suicide. These may increase when taking antidepressants for the first time, as all these medicines require time to start taking effect, usually around two weeks, although in some cases it may take longer.

It is more likely to happen to you:

• 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 disorders who were being treated with an 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 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 concerned about changes in your behavior.

Important side effects observed with Paroxetine Qualigen Farma

Some patients taking Paroxetine Qualigen Farma develop a disorder called akathisia, and they feel restless and unable to sit or stay still. Other patients develop a condition called serotonin syndrome or neuroleptic malignant syndrome, and they may have some or all of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremors, 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 doctor if you have any of these symptoms. For more information on this or other side effects of Paroxetine Qualigen Farma, see section 4.

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

Other medicines and Paroxetine Qualigen Farma

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

Some medicines may modify the effect of Paroxetine Qualigen Farma or make it more likely that some side effects will appear. Paroxetine Qualigen Farma may modify the effect of some medicines. For example:

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue). See the section Do not take Paroxetine Qualigen Farma.
• Medicines known to increase the risk of changes in heart electrical activity (e.g., antipsychotics thioridazine or pimozide). See the section Do not take Paroxetine Qualigen Farma.
• Aspirin, ibuprofen, and other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, etodolac, ibuprofen, 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 migraine.
• Other antidepressants, including other selective serotonin reuptake inhibitors and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
• A dietary supplement called tryptophan.
• Mivacurium and suxamethonium (used in anesthesia).
• Medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat 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 treating 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 high blood pressure and heart disorders.

• Metoprolol, a beta-blocker used to treat heart rhythm 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, including those obtained without a prescription.

Taking Paroxetine Qualigen Farma 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, breast-feeding, and fertility

If you are pregnant or breast-feeding, 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 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 this medicine 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 Qualigen Farma 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 between the heart and lungs is very high in newborns with persistent pulmonary hypertension (PPHN).

If you are taking Paroxetine Qualigen Farma in the last trimester of pregnancy, your newborn may also present with 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 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.

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

Paroxetine Qualigen Farma contains soya lecithin and sodium

This medicine contains soya lecithin, which may contain soya oil. It should not be used in case of peanut or soya allergy.

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

3. How to Take Paroxetine Qualigen Farma

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 shows how many tablets you should take:

The recommended dose for different indications is 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.

The tablets should be swallowed with water.

The tablets should not be chewed.

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

Elderly Patients

The initial 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 Qualigen Farma Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 5620420, 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 some of the following symptoms: fever, involuntary muscle contraction.

If You Forget to Take Paroxetine Qualigen Farma

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 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, 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 Qualigen Farma

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, which 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 treatment with paroxetine is interrupted are mild and disappear on their own within two weeks. For other people, these symptoms can be more severe or last longer.

If you suffer from withdrawal effects while 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 suffer from some withdrawal effect, you may be able to interrupt your treatment with paroxetine.

Possible Withdrawal Effects When Treatment is Interrupted

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

Common Adverse Effects

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 (vivid dreams, nightmares, inability to sleep).
• Anxiety.
• Headaches.

Uncommon Adverse Effects

May affect up to 1 in 100 people

• 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 everyone will experience them. It is more likely that adverse effects will appear during the first few weeks of treatment with Paroxetine Qualigen Farma.

Inform your doctor if you suffer from any of the adverse effects described below during treatment with Paroxetine Qualigen Farma.

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 are unable to urinate, 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 stay seated or stay still, called akathisia. Increasing the dose of Paroxetine Qualigen Farma 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

• Allergic reactions to Paroxetine Qualigen Farma that can be severe.

If you develop a skin rash with redness and bumps, swelling of the face, lips, mouth, or tongue, itching, or difficulty breathing (difficult 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 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

The frequency cannot be estimated from the available data

• Some people have experienced thoughts of self-harm or suicide while taking Paroxetine Qualigen Farma or shortly after stopping treatment (see Thoughts of Suicide and Worsening of Depression or Anxiety Disorderin section 2).
• Some people have experienced aggression while taking Paroxetine Qualigen Farma.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see Pregnancy, Breastfeeding, and Fertilityin section 2 for more information.

If You Experience These Adverse Effects, Contact Your Doctor.

Other Possible Adverse Effects During Treatment:

Very Common Adverse Effects

May affect more than 1 in 10 people

• Feeling sick (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 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.
• 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 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 urination (involuntary urination).
• If you are a diabetic patient, you may notice loss of control of blood sugar levels while taking Paroxetine Qualigen Farma. 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 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 need to move the legs (Restless Legs Syndrome).
• Pain in the 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 periods).

Very Rare Adverse Effects

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 peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Widespread rash over a large body surface with blisters and peeling of the skin (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 (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

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

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

It has been observed that people taking medications like Paroxetine Qualigen Farma have a higher risk of bone fractures.

Reporting Adverse Effects

If you experience any of these adverse effects, 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 PAROXETINA QUALIGEN FARMA

Keep this medication out of sight and reach of children. It does not require special storage conditions.

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

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. 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 Qualigen Farma 20mg Tablets:

The active ingredient is paroxetine in the form of hydrochloride. Each tablet contains 20 mg of paroxetine.

The other components (excipients) are: magnesium stearate (E-572), sodium carboxymethyl potato starch (type A), mannitol (E-421), microcrystalline cellulose (E-460i), hydrolyzed polyvinyl alcohol polymethacrylate, titanium dioxide (E-171), talc, soy lecithin (E-322), xanthan gum (E-415).

Appearance of the Product and Package Contents

Paroxetine Qualigen Farma 20 mg is presented in the form of film-coated tablets, oblong, biconvex, scored, white or grayish-white in color.

Each package contains 14, 28, 56, and 500 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Av. Barcelona, 69

08970 – Sant Joan Despí, Barcelona

Spain

Manufacturer:

Toll Manufacturing Services, S.L.

C/Aragoneses, 2

28108 Alcobendas, Madrid

Spain

Date of the Last Revision of this Leaflet:July 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/