Paroxetine Tarbis 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Paroxetine Tarbis 20 mg film-coated tablets EFG

Paroxetine (hydrochloride)

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What Paroxetine TARBIS is and what it is used for
2. What you need to know before taking Paroxetine TARBIS
3. How to take Paroxetine TARBIS
4. Possible adverse effects
5. How to store Paroxetine TARBIS
6. Contents of the pack and other information

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 the:

Treatment of depression

Treatment of obsessive-compulsive disorder

Treatment of panic disorder

Treatment of social phobia

Treatment of generalized anxiety disorder.

2. What you need to know before taking Paroxetina TARBIS

Do not take Paroxetina TARBIS

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Paroxetina TARBIS

• If you have any kidney, liver, or heart problems
• If you have had manic episodes
• If you have epilepsy or seizures
• If you have diabetes
• If you have a condition causing increased eye pressure (glaucoma)
• If you bruise easily or bleed easily, or are being treated with a medicine that may increase bleeding, or if you are pregnant (see "Pregnancy, breastfeeding and fertility")
• If you are taking antipsychotics (for the treatment of mental illnesses)
• If you are taking any product containing St. John's wort.
• If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding.

An increased risk of bone fractures has been observed in patients treated with this type of medicine.

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

Take special care with paroxetine if you are over 65 years of age, because this medicine may reduce sodium levels in the 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 depression or anxiety disorder

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

You are more likely to have such thoughts:

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

If at any time you have thoughts of self-harm or suicide, contact your doctor immediately 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 may ask them whether 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 to treat children and adolescents under 18 years of age. In addition, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe paroxetine to patients under 18 years of age if they decide it is the most appropriate treatment for the patient. If your doctor has prescribed paroxetine to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You must inform your doctor if any of the symptoms listed below worsen or become complicated while patients under 18 years of age are taking paroxetine. In addition, the long-term effects on safety, as well as on growth, maturation, and cognitive and behavioral development of paroxetine in this age group, have not yet been established.

Taking Paroxetina TARBIS with other medicines

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

In particular, Paroxetina TARBIS may alter the effect of the following medicines:

• other antidepressants
• medicines used to treat mental illnesses (antipsychotics)
• medicines used to treat epilepsy
• lithium, used to treat mania
• cimetidine (used to treat gastric discomfort)
• procyclidine, used to treat Parkinson's disease
• medicines containing tryptophan
• medicines that may increase the risk of bleeding or affect blood clotting (e.g. oral anticoagulants, acetylsalicylic acid, and others)
• certain medicines used to treat patients with irregular heartbeats (arrhythmias)
• metoprolol, used to treat high blood pressure, irregular heartbeats (arrhythmias), and angina
• antimigraine medicines
• tramadol (used for pain)
• antibacterial agents (oxazolidinones)
• inhibitors of metabolism

Taking Paroxetina TARBIS with food, drinks, and alcohol:

As with all medicines of this type, it is advisable to avoid 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 must not be chewed.

Pregnancy, breastfeeding and fertility

If you take paroxetine during the later stages 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 be aware that you are taking paroxetine so they can advise you accordingly.

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 any medication. Do not take paroxetina while pregnant or breastfeeding unless advised by your doctor. Inform your doctor immediately if you find out you are pregnant, or if you are planning to become pregnant. Your doctor may recommend gradually discontinuing treatment with Paroxetina TARBIS or continuing treatment. Some studies have suggested a possible increased risk of heart defects in newborns whose mothers took Paroxetina TARBIS during the first months of pregnancy. These studies showed that less than 2% of infants whose mothers received paroxetine early in pregnancy had heart problems, compared to 1% in the general population.

Ensure that your midwife and/or doctor knows you are taking Paroxetina TARBIS. Medications such as Paroxetina TARBIS, when taken during pregnancy—particularly during the last three months—may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish in colour. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.

Animal studies have shown that paroxetine may reduce sperm quality. Theoretically, this could affect fertility, but no impact on human fertility has been observed to date.

Driving and use of machinery

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

Paroxetina TARBIS contains soya lecithin.

This medicine contains soya lecithin. It must not be used if you are allergic to peanuts or soya.

3. How to take Paroxetine TARBIS

Follow exactly the dosing instructions for this medicine as given by your doctor.

If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will advise you whether the dose of the medicine should be increased or reduced during the treatment period, as well as the duration of treatment.

Paroxetine TARBIS 20 mg is recommended to be taken once daily in the morning with breakfast. The tablets should be swallowed whole with water and preferably with food. The tablets must not be chewed.

You should continue taking your medication 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) daily in adults, with the possibility of increasing the dose up to 50 mg daily.

Obsessive-compulsive disorder

The recommended dose is 2 tablets (40 mg) daily, starting treatment at 20 mg daily, up to a maximum of 60 mg daily.

Panic disorder

The recommended dose is 2 tablets (40 mg) daily, starting treatment at 10 mg daily, up to a maximum of 60 mg daily.

Social phobia

The recommended dose is 1 tablet (20 mg) daily in adults, with the possibility of increasing the dose up to 50 mg daily.

Generalized anxiety disorder

The recommended dose is 1 tablet (20 mg) daily, with the possibility of increasing the dose up to 50 mg daily.

Elderly patients

The recommended starting doses are the same as for adults. In this patient group, the maximum dose is 40 mg daily.

Children

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

Patients with renal or hepatic impairment

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

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

The tablet may be divided into equal doses.

If you take more Paroxetine TARBIS than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount taken.

Follow the dosing schedule prescribed by your doctor. It is unlikely that taking more than one dose will be dangerous, even if the entire contents of a package are consumed. However, if this occurs, go to your doctor without delay or contact the nearest hospital emergency service.

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

If you forget to take Paroxetine TARBIS

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

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

If you forget to take Paroxetine TARBIS for the entire day, DO NOT take a double dose the next day.

If you stop taking Paroxetine TARBIS

If treatment with paroxetine is stopped abruptly, withdrawal symptoms may occur, such as dizziness, sensory disturbances, headache, sleep disturbances, agitation or anxiety, nausea, and sweating, which are generally mild to moderate in severity and decrease spontaneously. Your doctor will advise you on how to gradually discontinue the treatment to avoid these symptoms.

Children may experience additional symptoms when treatment is discontinued, such as abdominal pain, restlessness, 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 everyone will experience them.

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

Possible adverse effects during treatment:

Some people may be allergic to certain medicines, although this is very rare (may 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 of the skin) anywhere on the body
3. • difficulty breathing or swallowing

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

Adverse effects that may occur very commonly (may affect more than 1 in 10 patients) with Paroxetina TARBIS are:

• nausea. This effect may 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 occur commonly (may affect between 1 and 10 out of 100 patients):

1. • decreased appetite
2. • insomnia (difficulty sleeping) or drowsiness
3. • dizziness, tremor
4. • agitation
5. • blurred vision
6. • yawning
7. • dry mouth, diarrhoea, constipation
8. • sweating, weakness
9. • weight gain

Adverse effects that may occur uncommonly (may affect between 1 and 10 out of 1,000 patients) during treatment with Paroxetina TARBIS include:

• bruising (purple discoloration due to blood accumulation under the skin), mucosal bleeding
• confusion
• hallucinations
• extrapyramidal effects (movement and coordination disorders)
• sinus tachycardia (abnormal heart rhythm)
• transient increases or decreases in blood pressure, usually in patients with high blood pressure or anxiety
• skin rashes (skin spots), skin itching
• urinary retention
• decreased white blood cell count

Adverse effects that may occur rarely (may affect between 1 and 10 out of 10,000 patients) during treatment with Paroxetina TARBIS include:

• hyponatraemia (reduced sodium levels in the blood), especially in elderly patients or those with syndrome of inappropriate antidiuretic hormone secretion (SIADH), which may cause symptoms such as weakness and drowsiness (feeling sleepy).
• seizures
• manic reactions (euphoria)
• anxiety
• panic attacks
• loss of personality
• bradycardia (slowed heart rate)
• increased liver enzymes
• galactorrhoea (excessive or abundant milk secretion)
• muscle and joint pain, sensation of restlessness and need to move, known as akathisia (inability to remain seated, need to pace back and forth, shifting weight from one foot to the other).

Adverse effects that may occur 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 muscle jerks), chills, tachycardia and tremor
• liver effects such as hepatitis (inflammation of the liver), sometimes associated with jaundice (yellowing of the skin and mucous membranes) and/or liver failure
• photosensitivity (sensitivity to sunlight)
• syndrome of inappropriate 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 oedema (fluid retention in the limbs)
• bleeding from the stomach mucosa
• thrombocytopenia (reduced platelet count in the blood)
• allergic reactions (including urticaria and angioedema)
• priapism (abnormal and prolonged penile erection)

Adverse effects with unknown frequency are:

• aggression
• teeth grinding
• inflammation of the colon (causing diarrhoea)
• heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see «Pregnancy»1 in section 2 for more information.

Possible adverse effects when stopping treatment:

Studies have shown that 3 out of 10 people reported experiencing symptoms when stopping treatment with paroxetine, compared to 2 out of 10 patients stopping placebo treatment. These symptoms are more likely to occur if you have been taking paroxetine for a long time, are in a dose-increase phase, or if the dose is reduced too quickly. In most cases, symptoms resolve on their own within two weeks.

When stopping treatment with paroxetine, your doctor will advise you to do so gradually, thereby reducing the likelihood of adverse effects. Consult your doctor if you experience serious adverse effects when stopping paroxetine treatment; your doctor may recommend continuing your treatment and reducing the dose more slowly. If you experience any adverse effect, this does not mean you cannot stop your treatment.

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

• dizziness, emotional instability
• sensory disturbances, including tingling sensations, burning sensations, and less frequently, electric shock-like sensations (even in the head)
• sleep disturbances (including vivid dreams, nightmares, insomnia)
• anxiety
• headache

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

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

Adverse effects most frequently observed in children and adolescents under 18 years of age are:

• decreased appetite
• tremor (involuntary shaking)
• abnormal sweating
• hyperactivity
• hostile/unfriendly behaviour (mainly in children under 12 years with obsessions and compulsive disorders)
• agitation
• emotional instability including crying, mood swings, self-harm attempts, suicidal thoughts and suicide attempts (occurred mainly in studies in adolescents with major depression).

Additional adverse effects frequently observed in children and adolescents under 18 years of age who discontinue paroxetine treatment are: emotional instability (including crying, mood swings, self-harm attempts, suicidal thoughts and suicide attempts), dizziness, nausea, abdominal pain and nervousness.

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

Reporting of adverse effects

If you experience any type of adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paroxetine TARBIS

Keep this medicine out of sight and reach of children.

Do not use Paroxetine TARBIS after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paroxetina TARBIS

• The active substance is paroxetine in the form of hydrochloride. Each tablet contains 20 mg of paroxetine.
• The other components (excipients) are: magnesium stearate, sodium starch glycolate 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 contents of the pack

Paroxetina TARBIS 20 mg is presented as film-coated, circular, biconvex tablets, scored on one side, white or whitish in color.

It is available in packs containing 14, 28, 56 and 500 tablets (hospital pack).

Only some pack sizes may be commercially available.

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 latest revision of this leaflet: October 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/