PAROXETINE TARBIS 20 mg FILM-COATED TABLETS

1. What Paroxetina TARBIS is and what it is used for

Paroxetina TARBIS 20 mg belongs to a group of medicines called antidepressants and acts on the central nervous system.

Paroxetina TARBIS is indicated for:

Treatment of depression

Treatment of obsessive-compulsive disorders

Treatment of anxiety disorders

Treatment of social phobia

Treatment of generalized anxiety disorder.

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

Do not take Paroxetina TARBIS

• if you are allergic to the active substance paroxetine or any of the other ingredients of this medicine (listed in section 6).
• if you are being treated with a medicine called thioridazine or with pimozide or with a type of medicine for the treatment of depression called monoamine oxidase inhibitors (MAOIs) or if you have been under such treatment in the last two weeks.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paroxetina TARBIS

• If you have any kidney, liver, or heart problems
• If you have had manic episodes
• If you have epilepsy or if you have seizures
• If you have diabetes
• If you have any disease that causes high eye pressure (glaucoma)
• If you have bruising or bleeding easily or are being treated with any medicine that may increase bleeding, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility")
• If you are taking neuroleptics (for the treatment of mental illnesses)
• If you are taking any product that contains St. John's Wort.
• If you are pregnant, think you may be pregnant, or are planning to become pregnant, as well as if you are breastfeeding.

There has been an observed increase in the risk of bone fractures in patients treated with this type of medicine.

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

Be careful with paroxetine if you are over 65 years old because this medicine may reduce the amount of sodium in your blood and cause drowsiness and muscle weakness. If you experience these symptoms, please consult your doctor as soon as possible.

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 working, usually around two weeks, although in some cases it may take longer.

You are more likely to have these thoughts:

• If you have previously had thoughts of self-harm or suicide.
• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric disorders who were treated with an antidepressant.

If at any time you have thoughts of self-harm or suicide, contact your doctor or go directly to a hospital.

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

Children and adolescents under 18 years of age

Paroxetine should not normally be used in the treatment of children and adolescents under 18 years of age. At the same time, you should know that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this class of medicines. Nevertheless, the doctor may prescribe paroxetine to patients under 18 years of age when they decide it is most convenient for the patient. If the doctor prescribes paroxetine to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed below progress or experience complications when patients under 18 years of age are taking paroxetine. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of paroxetine in this age group have not yet been demonstrated.

Using Paroxetina TARBIS with other medicines

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

Especially Paroxetina TARBIS may modify the effect of the following medicines:

• other antidepressants
• those for treating mental illnesses (neuroleptics)
• those for treating epilepsy
• lithium, which is used for the treatment of manias
• cimetidine (for the treatment of stomach discomfort)
• procyclidine, for the treatment of Parkinson's disease
• those that contain tryptophan
• those that may increase the risk of bleeding or alter blood coagulation (e.g., oral anticoagulants, acetylsalicylic acid, and others)
• some medicines used for the treatment of patients with irregular heartbeats (arrhythmias)
• metoprolol, which is used for the treatment of high blood pressure, irregular heartbeats (arrhythmias), and angina.
• Migraine treatments
• Tramadol (used for pain)
• Antibiotics (linezolid)
• Metabolism inhibitors

Taking Paroxetina TARBIS with food, drinks, and alcohol:

As with all medicines of this type, it is advisable to avoid consuming alcohol while taking paroxetine.

Take your medicine in the morning, preferably with breakfast. The tablets should be swallowed whole, with water, and preferably with food. The tablets should not be chewed.

Pregnancy, breastfeeding, and fertility

If you take paroxetine 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 to advise you.

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

Consult your doctor or pharmacist before taking a medicine. Do not take paroxetine while pregnant or breastfeeding, unless advised by your doctor. Inform your doctor immediately if you discover you are pregnant or think you may become pregnant. Your doctor may recommend gradually stopping treatment with Paroxetina TARBIS or continuing with it. Some studies have suggested a possible increase in the risk of heart defects in newborns whose mothers received Paroxetina TARBIS in the first months of pregnancy. These studies showed that less than 2% of children whose mothers received paroxetine at the start of their pregnancy had some heart problems, compared to 1% observed in the general population.

Make sure your midwife and/or doctor knows that you are taking Paroxetina TARBIS. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Paroxetina TARBIS may increase the risk of a serious disease in babies called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

It has been shown that paroxetine reduces sperm quality in animal studies. This could theoretically affect fertility, but the impact on human fertility has not been observed yet.

Driving and using machines

During treatment with Paroxetina TARBIS, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with Paroxetina Tarbis affects you.

Paroxetina TARBIS contains soybean lecithin.

This medicine contains soybean lecithin. It should not be used in case of peanut or soy allergy.

3. How to take Paroxetina TARBIS

Follow exactly the administration instructions of this medicine indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate if you should increase or reduce the dose of the medicine during the treatment period, as well as the duration of the treatment.

It is recommended to administer Paroxetina TARBIS 20 mg once a day, in the morning, with breakfast. The tablets should be swallowed whole, with water, and preferably with food. The tablets should not be chewed.

You should continue taking your medicine even if you do not notice improvement, as it may take several weeks for the medicine to start working.

Adults:

Depression

The recommended dose is 1 tablet (20 mg) per day in adults, and the dose may be increased up to 50 mg per day.

Obsessive-compulsive disorder

The recommended dose is 2 tablets (40 mg) per day, starting with 20 mg per day, up to a maximum of 60 mg per day.

Anxiety disorder

The recommended dose is 2 tablets (40 mg) per day, starting with 10 mg per day, up to a maximum of 60 mg per day.

Social phobia

The recommended dose is 1 tablet (20 mg) per day in adults, and the dose may be increased up to 50 mg per day.

Generalized anxiety disorder

The recommended dose is 1 tablet (20 mg) per day, and the dose may be increased up to 50 mg per day.

Elderly patients

The initial recommended doses are the same as for adults. In this group of patients, the maximum dose is 40 mg per day.

Children

Paroxetine is not recommended for use in children under 18 years of age (see section 2: Before taking Paroxetina TARBIS).

Patients with renal or hepatic impairment

If you have kidney or liver problems, you should take smaller doses than usual. Inform your doctor if you have any kidney or liver problems before starting treatment.

If you think the effect of Paroxetina TARBIS is too strong or too weak, tell your doctor or pharmacist.

The tablet can be divided into equal doses.

If you take more Paroxetina TARBIS 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 medicine and the amount used.

Follow the dosage regimen set by your doctor. It is unlikely that taking more than one dose will be dangerous, even if the entire contents of a pack are consumed. If this happens, go to your doctor without delay or contact the emergency department of the nearest hospital.

Treatment includes the general measures usually used in case of overdose with any antidepressant. Gastric content will be emptied by inducing vomiting, gastric lavage, or both. After gastric evacuation, 20 to 30 grams of activated charcoal will be administered every 4-6 hours during the first 24 hours after ingestion. Conservative treatment with monitoring of vital signs and observation of the patient is also recommended.

If you forget to take Paroxetina TARBIS

Do not take a double dose to make up for forgotten doses.

If you forget to take Paroxetina TARBIS, take it as soon as you remember, and the next day, take your usual dose at the usual time.

If you forget to take Paroxetina TARBIS throughout the day, DO NOT take a double dose the next day.

If you stop taking Paroxetina TARBIS

If you suddenly stop taking paroxetine, you may experience some disorders due to withdrawal, such as dizziness, sensory disturbances, headache, sleep disturbances, agitation, or anxiety, nausea, and sweating, which are mild to moderate and decrease spontaneously. Your doctor will advise you on how to gradually stop treatment to avoid these symptoms.

Children may have additional symptoms when stopping treatment, such as abdominal pain, nervousness, and mood changes.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, paroxetine can have adverse effects, although not all people suffer from them.

Some patients may experience these effects during treatment or when stopping it.

Possible adverse effects during treatment:

Some people may be allergic to some medications, although this occurs very rarely (it can affect less than 1 in 10,000 patients). If you experience any of the following symptoms while taking paroxetine, inform your doctor immediately or go to the nearest hospital:

1. - swelling of the face, eyelids, lips, mouth, or tongue
2. - skin rash or hives (itching on the skin) anywhere on the body
3. - difficulty breathing or swallowing

If you observe any adverse effect described below, which may or may not be related to paroxetine, consult your doctor or pharmacist.

The adverse effects that may appear very frequently (can affect more than 1 in 10 patients) when taking Paroxetine TARBIS are:

• nausea. This effect can be reduced by taking your medication in the morning after breakfast
• sexual dysfunction (lack of orgasm, and in men, abnormal erection and ejaculation)

The following adverse effects may be frequent (can affect between 1 and 10 out of 100 patients):

1. - decreased appetite
2. - insomnia (lack of sleep) or drowsiness
3. - dizziness, tremor
4. - agitation
5. - blurred vision
6. - yawning
7. - dry mouth, diarrhea, constipation
8. - sweating, weakness
9. - weight gain

The adverse effects that may appear infrequently (can affect between 1 and 10 out of 1,000 patients) during treatment with Paroxetine TARBIS include:

• bruising (purple discoloration caused by blood accumulation under the skin), bleeding from mucous membranes
• confusion
• hallucinations
• extrapyramidal effects (movement and coordination disorders)
• sinus tachycardia (alteration of heart rhythm)
• transient increases or decreases in blood pressure, usually in patients with high blood pressure or anxiety
• skin rash (spots on the skin), itching on the skin
• urinary retention
• decrease in white blood cell count

The adverse effects that may appear rarely (can affect between 1 and 10 out of 10,000 patients) during treatment with Paroxetine TARBIS include:

• hyponatremia (decrease in sodium levels in the blood), especially in elderly people or those with the syndrome of inadequate antidiuretic hormone secretion (SIADH), which can lead to symptoms such as weakness and drowsiness (feeling of sleep).
• seizures
• manic reactions (euphoria)
• anxiety
• panic attacks
• loss of personality
• bradycardia (decrease in heart rate)
• increase in liver enzymes
• galactorrhea (excessive milk secretion)
• muscle and joint pain, sensation of restlessness and need to move called akathisia (inability to remain seated, need to walk back and forth, to alternate foot support).

The adverse effects that may appear very rarely (can affect less than 1 in 10,000 patients) are:

• serotonin syndrome; symptoms may include agitation, confusion, diaphoresis (abnormal sweating), hallucinations, hyperreflexia (increased reflex response), myoclonus (involuntary movements), chills, tachycardia, and tremor
• liver effects such as hepatitis (inflammation of the liver), sometimes related to jaundice (yellowing of skin and mucous membranes) and/or liver failure
• photosensitivity (sensitivity to sunlight)
• syndrome of inadequate antidiuretic hormone secretion (SIADH) (a hormone whose excess can cause fluid and water retention, leading to fatigue, weakness, or confusion)
• acute glaucoma (high pressure inside the eye)
• peripheral edema (fluid retention in the limbs)
• stomach mucosa bleeding
• thrombocytopenia (decrease in platelet count in blood)
• allergic reactions (including hives and angioedema)
• priapism (abnormal and prolonged erection of the penis)

The adverse effects that can occur with an unknown frequency are:

• aggression
• teeth grinding
• colon inflammation (causing diarrhea)
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Possible adverse effects when stopping treatment:

Studies have shown that 3 out of 10 people have reported having symptoms when stopping treatment with paroxetine, compared to 2 out of 10 patients when stopping treatment with a placebo. It is more likely that these symptoms will appear if you have been taking paroxetine for a long time, are in a dose increase phase, or if the dose is decreased very quickly. In most cases, the symptoms disappear on their own within two weeks.

When stopping treatment with paroxetine, your doctor will indicate that you should do it gradually, which will reduce the possibility of having adverse effects. Consult your doctor if you experience severe adverse effects when stopping treatment with paroxetine; your doctor may recommend continuing treatment and reducing it later in a slower manner. If you experience any adverse effect, it does not mean that you will not be able to stop your treatment.

Among the adverse effects that may appear more frequently when stopping treatment are:

• dizziness, emotional instability
• sensory alterations, including sensation of pins and needles, burning, and, less frequently, sensations of the type of electric shock (even in the head)
• sleep alterations (including very vivid dreams, nightmares, insomnia)
• anxiety
• headache

Among the adverse effects that may appear less frequently when stopping treatment are:

1. - nausea
2. - sweating (including night sweats)
3. - agitation
4. - tremor
5. - confusion
6. - emotional instability
7. - visual alterations
8. - palpitations
9. - diarrhea
10. - irritability

The adverse effects that are most frequently observed in children and adolescents under 18 years of age are:

• Decreased appetite
• Tremor (uncontrollable shaking)
• Abnormal sweating
• Hyperactivity
• Hostile/unfriendly behavior (mainly in children under 12 years with obsessive and compulsive disorders)
• Agitation
• Unstable emotions, including crying, mood changes, self-harm attempts, suicidal thoughts, and attempts (occurred mainly in studies in adolescents with major depression).

The additional adverse effects that are frequently observed in children and adolescents under 18 years of age who stop treatment with paroxetine are: unstable emotions (including crying, mood changes, self-harm attempts, suicidal thoughts, and attempts), dizziness, nausea, abdominal pain, and nervousness.

If any of these symptoms start to become bothersome or worsen, inform your doctor.

Reporting Adverse Effects

If you experience any type of adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear 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 this medication.

5. Conservation of Paroxetine TARBIS

Keep this medication out of sight and reach of children.

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

No special storage conditions are required.

Medicines 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. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Paroxetine TARBIS

• The active ingredient is paroxetine in the form of hydrochloride. Each tablet contains 20 mg of paroxetine.
• The other components (excipients) 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 TARBIS 20 mg is presented in the form of film-coated tablets, circular, biconvex, scored on one side, white or grayish-white in color.

It is presented in packages containing 14, 28, 56, and 500 (clinical package) tablets.

Only some package sizes may be commercialized.

Marketing Authorization Holder and Manufacturer

Holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer:

FERRER INTERNACIONAL, S.A.

Joan Buscallà, 1-9

08173 Sant Cugat del Vallès (Barcelona)

Spain

Date of the Last Revision of this Prospectus:October 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/