Prospecto: information for thepatient

Paroxetina Tarbis 20 mg film-coated tablets EFG

Paroxetina (hydrochloride)

Read this prospectus carefully before starting to takethis medication, because it contains important information for you.

- Keep this prospectus, as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

- If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.See section 4.

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

2. What you need to know before starting to take Paroxetina Tarbis

3. How to take Paroxetina Tarbis

4. Possible adverse effects

5. Storage of Paroxetina Tarbis

6. Contents of the package and additional information

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

ParoxetinaTARBIS is indicated for:

Treatment of depression

Treatment of obsessive-compulsive disorders

Treatment of anxiety disorder

Treatment of social phobia

Treatment of generalized anxiety disorder.

Do not take Paroxetina TARBIS

- if you are allergic to the active ingredient paroxetina or to any of the other components of this medication (listed in section 6).

- if you are being treated with a medication called tioridazina or with pimozida or with a type of medication for the treatment of depression called MAO inhibitors (IMAO) 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 bleed easily or are being treated with any medication 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, if you think you are pregnant or if you plan to become pregnant, as well as if you are breastfeeding.

A higher risk of bone fractures has been observed in patients treated with this type of medication.

Some medications in the group to which Paroxetina TARBIS belongs (called ISRS/IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

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

Thoughts of suicide and worsening of depression or anxiety disorder

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

You would be more prone to having these types of 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 old) with psychiatric illnesses treated with an antidepressant.

If you ever 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 family member 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

Paroxetina should not be used normally 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 higher risk of adverse effects such as attempts at suicide, suicidal thoughts and hostility (mainly aggression, confrontational behavior and irritability) when taking this type of medication. However, the doctor who corresponds to you may prescribe paroxetina to patients under 18 years of age when they decide that it is the most convenient for the patient. If the doctor who corresponds to you has prescribed paroxetina to a patient under 18 years of age and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed below progress or if you experience complications when patients under 18 years of age are taking paroxetina. At the same time, the long-term effects on safety and related to growth, maturity and cognitive and behavioral development of paroxetina in this age group have not yet been demonstrated.

Use of Paroxetina TARBIS with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

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

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

Taking Paroxetina TARBIS with food, drinks and alcohol:

As with all medications of this type, it is recommended to avoid consuming alcohol while taking paroxetina.

Take your medication 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 paroxetina in the final stage of pregnancy, there may be a higher risk of excessive vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking paroxetina so they can advise you.

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

Inform your doctor or pharmacist before taking any medication. Do not take paroxetina while pregnant or breastfeeding, unless your doctor advises you to. Inform your doctor immediately if you discover you are pregnant, or if you think you may become pregnant. Your doctor may recommend that you gradually discontinue treatment with Paroxetina TARBIS or continue 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 paroxetina at the beginning of their pregnancy had some heart problem, compared to the 1% observed in the general population.

Make sure your midwife and/or doctor know that you are taking Paroxetina TARBIS. When taken during pregnancy, particularly in the last three months of pregnancy, medications like Paroxetina TARBIS may increase the risk of a serious disease in newborns, called persistent pulmonary hypertension of the newborn (HPPN), 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.

Paroxetina has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but the impact on human fertility has not been observed so far.

Driving and operating 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 soy lecithin.

This medication contains soy lecithin. It should not be used in case of allergy to peanuts or soy.

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

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

Remember to take your medication.

Your doctor will inform you if you should increase or decrease the medication dosage 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 medication even if you do not notice an improvement, as it may take several weeks for the medication to start acting.

Adults:

Depression

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

Generalized anxiety disorder

The recommended dose is 1 tablet (20 mg) per day, which may be increased 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 old (see section 2: Before taking Paroxetina TARBIS).

Patients with renal or hepatic insufficiency

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

If you estimate that the action of Paroxetina TARBIS is too strong or too weak, inform 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

Follow the prescribed dosage schedule set by your doctor. It is unlikely that taking more than one dose will be hazardous, even if you consume the entire contents of a package. If this occurs, visit your doctor as soon as possible, or contact the emergency department of the nearest hospital.

The treatment includes the usual general measures used in case of overdose with any antidepressant. Gastric evacuation will be performed by inducing vomiting, gastric lavage, or both. After gastric evacuation, 20 to 30 grams of activated charcoal will be administered every 4 to 6 hours for the first 24 hours after ingestion. Additionally, conservative treatment with vital sign monitoring and observation of the patient is recommended.

If you forget to take Paroxetina TARBIS

Do not take a double dose to compensate for the missed 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 scheduled time.

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

If you interrupt treatment with Paroxetina TARBIS

If treatment with paroxetine is interrupted abruptly, some withdrawal symptoms may appear, such as dizziness, sensory disturbances, headache, sleep disturbances, agitation or anxiety, nausea, and sweating, which are of mild to moderate severity and decrease spontaneously. Your doctor will advise you on how to stop treatment gradually, to avoid these symptoms.

Children may experience additional symptoms when treatment is interrupted, such as abdominal pain, nervousness, and mood changes.

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

Like all medications, paroxetine may have side effects, although not everyone will experience them.

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

Possible side effects during treatment:

Some people may be allergic to certain medications, although this occurs in very rare instances (may affect fewer 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 rashes or urticaria (itching on the skin) anywhere on the body
3. - Difficulty breathing or swallowing

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

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

• Nausea. This side 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 side effects may be frequent (may affect between 1 and 10 in every 100 patients):

1. - Decreased appetite
2. - Insomnia (lack of sleep) or drowsiness
3. - Dizziness, tremor
4. - Restlessness
5. - Blurred vision
6. - Yawning
7. - Dry mouth, diarrhea, constipation
8. - Sweating, weakness
9. - Weight gain

The side effects that may appear infrequently (may affect between 1 and 10 in every 1,000 patients) during treatment with Paroxetine TARBIS include:

• Ecchymosis (purple discoloration caused by blood accumulation under the skin), mucosal bleeding
• 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 rashes (skin spots), itching on the skin
• Urinary retention
• Decreased white blood cell count

The side effects that may appear rarely (may affect between 1 and 10 in every 10,000 patients) during treatment with Paroxetine TARBIS include:

• Hypontremia (decreased sodium levels in the blood), especially in older adults or those with the syndrome of inappropriate antidiuretic hormone secretion (SIADH), which may cause symptoms such as weakness and drowsiness (sensation of sleep).
• Seizures
• Manic reactions (euphoria)
• Anxiety
• Panic attacks
• Loss of personality
• Bradycardia (decreased heart rate)
• Increased liver enzymes
• Milk galactorrhea (excessive milk secretion)
• Muscle and joint pain, sensation of restlessness and need to move, known as akathisia (inability to sit still, need to walk back and forth, alternate foot support).

The side effects that may appear very rarely (may affect fewer 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 (yellow discoloration of skin and mucous membranes) and/or liver insufficiency
• Photosensitivity (sensitivity to sunlight)
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH) (a hormone whose excess may cause fluid and water retention, leading to fatigue, weakness, or confusion)
• Acute glaucoma (high pressure inside the eye)
• Peripheral edema (fluid retention in the extremities)
• Gastric mucosal bleeding
• Thrombocytopenia (decreased platelet count in the blood)
• Allergic reactions (including urticaria and angioedema)
• Priapism (prolonged and abnormal erection of the penis)

The side effects that may appear with unknown frequency are:

• Aggression
• Teeth grinding
• Colitis (inflammation of the colon, causing diarrhea)
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Possible side effects when stopping treatment:

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

When stopping paroxetine treatment, your doctor will instruct you to do so gradually, reducing the likelihood of side effects. Consult your doctor if you experience severe side effects when stopping paroxetine treatment. Your doctor may recommend continuing your treatment and reducing it gradually. If you experience any side effects, it does not mean you will not be able to stop your treatment.

The side effects that may appear more frequently when stopping treatment are:

• Dizziness, emotional instability
• Sensory alterations, including feeling pinched, burned, and, less frequently, sensations of electroshock (even in the head)
• Sleep disturbances (including vivid dreams, nightmares, insomnia)
• Anxiety
• Headache

The side effects that may appear less frequently when stopping treatment are:

1. Nausea
2. Sweating (including nocturnal sweating)
3. Restlessness
4. Tremor
5. Confusion
6. Emotional instability
7. Visual disturbances
8. Palpitations
9. Diarhea
10. Irritability

The side effects that are most frequently observed in children and adolescents under 18 years old are:

• Decreased appetite
• Tremor (involuntary shaking)
• Abnormal sweating
• Hypervigilance
• Hostile or unfriendly behavior (mainly in children under 12 years old with obsessions and compulsive disorders)
• Restlessness
• Unstable emotions, including crying, mood changes, self-harm attempts, thoughts, and suicide attempts (mainly in adolescent depression studies).

The additional side effects that are frequently observed in children and adolescents under 18 years old when stopping paroxetine treatment are: unstable emotions (including crying, mood changes, self-harm attempts, thoughts, and suicide attempts), dizziness, nausea, abdominal pain, and nervousness.

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

Reporting side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the 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 disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of 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.

Composition of Paroxetina 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, potato starch glycolate sodium, 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 contents of the packaging

Paroxetina 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 packaging containing 14, 28, 56, and 500 (clinical packaging) tablets.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible manufacturer:

FERRRER INTERNACIONAL, S.A.

Joan Buscallà, 1-9

08173 Sant Cugat del Vallès (Barcelona)

Spain

Last review date of this leaflet:October 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/