PAROXETINE STADA 20 mg TABLETS

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

Do not take Paroxetina Stada

• if you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6).
• 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 once you have stopped taking the MAOI.
• if you are taking an antipsychotic medicine called thioridazine or the antipsychotic pimozide.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting paroxetine:

• if you are taking other medicines (see section Other medicines and Paroxetina Stada)
• if you are taking tamoxifen for breast cancer treatment (or fertility problems)

Paroxetine may make tamoxifen less effective, so your doctor should recommend taking another antidepressant

• if you have kidney, liver, or heart problems
• if you have an abnormal heart rhythm (seen on an electrocardiogram, ECG) known as 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 have seizures or epileptic fits
• if you have had manic episodes (excessively active thoughts or behaviors)
• if you are being treated with electroconvulsive therapy (ECT)
• if you have a tendency to bleed or bruise easily or are being treated with a medicine that may increase the risk of bleeding (including medicines such as warfarin, antipsychotics like perphenazine or clozapine, tricyclic antidepressants, medicines to treat 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 (high eye pressure)
• if you are pregnant or think you may be pregnant (see section Pregnancy, breast-feeding, and fertility)
• if you are under 18 years of age (see section Children and adolescents under 18 years of age)

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

Children and adolescents under 18 years of age

Paroxetine should not be used in the treatment of children and adolescents under 18 years of age.

Also, you should know that in patients under 18 years of age, there is a greater risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking paroxetine. Nevertheless, your doctor may prescribe paroxetine to patients under 18 years of age when they decide what is best for the patient. If your doctor has prescribed paroxetine to you or your child under 18 years of age and you want to discuss this decision, talk to 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, common side effects that affected less than 1 in 10 children or adolescents were: increased thoughts and attempts of suicide, 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 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.

When stopping 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 stopped treatment with paroxetine (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:

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming or killing yourself. These may increase at the start of treatment with antidepressants, as all these medicines take time to work, usually about two weeks, but sometimes longer.

It is more likely to happen:

• If you have previously had thoughts of killing or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric conditions who were treated with an antidepressant.

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

It may be helpful for you to tell a relative or close friendthat you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might 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 condition called akathisia, and feel restless and unable to 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, shaking, shivering, hallucinations (seeing or hearing things that are not there), muscle stiffness, sudden jerky movements, or increased heart rate. The severity can increase and lead to loss of consciousness.

Talk to your doctorif you have any of these symptoms. For more information on this or other side effects of paroxetine, see section 4.

Some medicines of the same group as Paroxetina Stada (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Other medicines and Paroxetina Stada

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

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue). See section Do not take Paroxetina Stada.
• Medicines known to increase the risk of changes in heart activity (e.g., antipsychotics thioridazine or pimozide). See section Do not take Paroxetina Stada.
• Aspirin, ibuprofen, and other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, etodolac, diclofenac, and meloxicam, used to treat pain and inflammation.
• Tramadol, buprenorphine, and pethidine, painkillers.
• Buprenorphine combined with naloxone, substitution treatment for opioid addiction.
• Medicines called triptans, such as sumatriptan, used to treat 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 diseases.
• 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 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 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 to 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 not prescribed.

Taking Paroxetina Stada with food, drinks, and alcohol

Do not drink 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 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 during the first months of pregnancy. In the general population, about 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 medicine 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 doctor or midwife knows you are taking paroxetine. If you take paroxetine in the late stage 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 you are taking paroxetine 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 between the heart and lungs is very high in newborns with PPHN.

If you are taking paroxetine in the last trimester of pregnancy, your newborn may also have other symptoms that usually start during the first 24 hours after birth. These symptoms include:

• 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. Ask your doctor if you can breast-feed while taking paroxetine. Your doctor, in agreement with you, may advise you to continue breast-feeding while taking paroxetine.

Animal studies have shown that paroxetine reduces sperm quality. This may theoretically affect fertility in humans, but this effect has not been observed in people yet.

Driving and using machines

During treatment with paroxetine, you may feel drowsy or dizzy. Do not drive or use tools or machines until you know how paroxetine affects you.

Paroxetina Stada contains sodium

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

3. How to Take Paroxetine Stada

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

Patients with Kidney or Liver Problems

If you have severe hepatic or renal insufficiency, your doctor may advise you to take smaller doses of paroxetine than usual.

If You Take More Paroxetine Stada Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Never take more tablets than your doctor has recommended.

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

If You Forget to Take Paroxetine Stada

Take your medication at the same time every day.

If you forget to take a dose, and you 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 Stada

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 interrupting 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 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.

Even if you suffer from some withdrawal effect, you will be able to interrupt your treatment with paroxetine.

Possible withdrawal effects when interrupting treatment

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

Frequent 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.

Infrequent adverse effects, which 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 all people experience them.

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

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

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

Infrequent adverse effects, which may affect up to 1 in 100 people:

• If you have bruises or unusual bleeding, such as blood in vomit or stools, contact your doctor or go to the hospital immediately.
• If you experience inability to urinate, contact your doctor or go to the hospital immediately.

Rare adverse effects, which may affect up to 1 in 1,000 people:

• If you experience seizures (epileptic crises), 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 may worsen your symptoms. If you feel this way, consult your doctor.
• Fatigue, weakness, confusion, and pain, stiffness, and lack of muscle coordination.

This may be due to low sodium levels in the blood. If you have these symptoms, consult your doctor.

Very rare adverse effects, which may affect up to 1 in 10,000 people:

• Allergic reactions to paroxetine, which 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 a feeling of weakness 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 of heat, sweating, tremors, 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 (frequency 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 Thoughts of Suicide and Worsening of Depression or Anxiety Disorderin 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 frequent adverse effects, which 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.

Frequent adverse effects, which 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.
• Diarrhea or constipation.
• Vomiting.
• Weight gain.
• Sweating.

Infrequent adverse effects, which 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 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 the dose of insulin or diabetes medications.
• Decreased white blood cell count.

Rare adverse effects, which may affect up to 1 in 1,000 people:

• Abnormal milk secretion in men and women.
• Decreased heart rate.
• Liver effects that are seen 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 joints or muscles.
• Increased levels of a hormone called prolactin in the blood.
• Menstrual disorders (including heavy or irregular periods, bleeding between periods, and absence or delay of period).

Very rare adverse effects, which may affect up to 1 in 10,000 people:

• Skin rash, in which blisters with a target-like appearance (dark central spots surrounded by a pale area, with a dark ring around) called erythema multiforme may appear.
• 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 (which causes swelling of arms or legs).
• Sensitivity to sunlight.
• Painful and prolonged erection of the penis.
• Decreased platelet count in the blood.

Frequency not known (frequency cannot be estimated from available data):

• Inflammation of the colon (which causes 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 is not listed in this prospectus. 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 the medication.

5. Conservation of Paroxetine Stada

This medication does not require special storage conditions.

If you are taking half a tablet, be careful to store it safely in the container.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the container, after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be thrown away through the sewers or in the trash. Deposit the containers and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Container Contents and Additional Information

Composition of Paroxetine Stada

• The active ingredient is paroxetine. Each tablet contains 20 mg of paroxetine (anhydrous hydrochloride).
• The other components are: microcrystalline cellulose (E460), calcium hydrogen phosphate, sodium croscarmellose (E468), anhydrous colloidal silica (E551), and magnesium stearate (E470b). See section 2 Paroxetine Stada contains sodium.

Product Appearance and Container Contents

Paroxetine Stada is presented in the form of a round, scored, almost white tablet, with flat faces, beveled edge, with a diameter between 9.0-9.2 mm, and with the inscription “20” on one of the faces. The tablet can be divided into equal doses.

This medication is presented in a container containing 14, 28, and 56 tablets, available in blister packs.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Farmaceutisch Analytisch Laboratorium Duiven BV

Dijkgraaf 30, Duiven

Netherlands

or

Sanico NV

Veedijk 59

BE-2300 Turnhout

Belgium

Date of the Last Revision of this Prospectus:August 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/