Package Insert: Information for the User

Paroxetina Davur 20 mg Film-Coated Tablets EFG

paroxetine

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Paroxetina Davur belongs to a group of medications called antidepressants and acts on the central nervous system.

Paroxetina Davur 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 Davur:

• if you are allergic (hypersensitive) to paroxetine active or to any of the other components of this medication.
• if you are being treated with a medication called thioridazine or with pimozide or with a type of medication for the treatment of depression called MAO inhibitors (IMAO, including moclobemide and methionine chloride (methylen blue)) or if you have been treated with the aforementioned in the last two weeks.
• This medication contains soy lecithin (derived from soy oil). It should not be used in case of allergy to peanuts or soy.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Paroxetina Davur.

Be especially careful with Paroxetina Davur:

• if you have any kidney, liver, or heart problems
• if you have had manic episodes
• if you have epilepsy or if you experience seizures
• if you have diabetes, your doctor may need to adjust your insulin or other antidiabetic treatment dose
• if you have any disease that causes elevated eye pressure (glaucoma)

• if you have bleeding tendencies or are being treated with a medication that may increase the risk of bleeding
• if you are taking neuroleptics (for the treatment of mental illnesses)
• if you are taking a product containing St. John's Wort
• if you are pregnant, think you may be pregnant, or plan to become pregnant, as well as if you are breastfeeding
• if you are taking tamoxifen for breast cancer (or fertility problems). Paroxetina Davur may make tamoxifen less effective, so your doctor should recommend taking another antidepressant.
• if you have a history of bleeding disorders or if you are pregnant (see "Pregnancy")

Be especially careful with paroxetine if you are over 65 years old because this medication 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.

Like other medications of this type, relief of your symptoms will not occur immediately. Generally, improvement begins to be noticeable in a few weeks. In some cases, symptoms of depression or other psychiatric conditions may include thoughts of self-harm or suicide. These symptoms may continue or worsen until the full antidepressant effect of the medication is achieved. Inform your doctor immediately or visit the nearest hospital if you have dangerous thoughts or feelings during the initial treatment period or at any other time during treatment, or if you notice a worsening of symptoms or the appearance of new symptoms of your disease..

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

Children and adolescents:

Paroxetine should not be used normally in the treatment of children and adolescents under 18 years old. However, you should know that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (primarily aggression, confrontational behavior, and irritability) when taking this type of medication. Nevertheless, the doctor who prescribes your medication may prescribe Paroxetina Davur to patients under 18 years old when they decide it is the best option for the patient. If your doctor has prescribed Paroxetina Davur to a patient under 18 years old and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above progress or if you experience complications when patients under 18 years old are taking paroxetine. Additionally, the long-term effects of paroxetine on safety and related to growth, maturity, and cognitive and behavioral development in this age group have not yet been demonstrated.

Other medications and Paroxetina Davur:

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

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

• other antidepressants
• those for treating mental illnesses (neuroleptics)
• those for treating epilepsy
• lithium, used for treating manias
• cimetidine (for treating gastrointestinal discomfort)
• procyclidine, for treating Parkinson's disease
• those containing tryptophan
• those that may increase the risk of bleeding or alter coagulation
• blood (e.g. oral anticoagulants, aspirin, and others)
• some medications used to treat patients with irregular heartbeats (arrhythmias)
• metoprolol, used for treating high blood pressure, irregular heartbeats (arrhythmias), and angina
• antimigraine medications
• tramadol and pethidine (used for pain)
• antibiotics (linezolid)
• metabolism inhibitors
• tamoxifen, used for treating breast cancer (or fertility problems)
• medications called monoamine oxidase inhibitors (IMAO, including moclobemide and methionine chloride (methylen blue)). See the "Do not take Paroxetina Davur" section
• fentanyl, used in anesthesia or for chronic pain
• a combination of fosamprenavir and ritonavir, used to treat HIV infection
• pravastatin, a medication used to regulate blood cholesterol levels.
• buprenorphine, used for pain

Paroxetina Davur with food and drinks:

Like all medications of this type, it is recommended to avoid consuming alcohol while taking paroxetine.

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

Do not take paroxetine 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 gradually stopping treatment with Paroxetina Davur or continuing with it.

Some studies have suggested a possible increase in the risk of malformations, particularly those affecting the heart, in newborns whose mothers received Paroxetina Davur in the first months of pregnancy. In the general population, approximately 1 in 100 newborns are born with a heart malformation. This proportion increased to 2 in 100 newborns in mothers who took paroxetine. Your doctor, in consultation with you, may change your treatment or gradually stop treatment with paroxetine while pregnant. However, depending on your circumstances, your doctor may recommend continuing to take paroxetine.

Make sure your midwife and/or doctor know that you are taking Paroxetina Davur. Medications like Paroxetina Davur may increase the risk of a serious disease called persistent pulmonary hypertension in newborns (HPPN) when taken during pregnancy and particularly towards the end of it. The pressure in the blood vessels between the heart and lungs is very high in newborns with persistent pulmonary hypertension (HPPN).

If you take paroxetine in the final stages of pregnancy, there may be a higher risk of excessive vaginal bleeding 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.

Driving and using machines:

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

Paroxetina Davur contains:

Sodium

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

Soy lecithin

This medication contains soy lecithin (derived from soy oil). It should not be used in case of allergy to peanuts or soy.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

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

It is recommended to administer Paroxetina Davur 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 improvement, as it may take several weeks for the medication to start acting.

Adults

Depression

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

Obsessive-compulsive disorder

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

Anxiety disorder

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

Social phobia

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

Generalized anxiety disorder

The recommended dose is 1 tablet (20 milligrams) per day, which can be increased up to 50 milligrams per day.

Older patients

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

Use in children and adolescents

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

Patients with liver or kidney disease

If you have liver or kidney 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 Davur is too strong or too weak, inform your doctor or pharmacist.

If you take more Paroxetina Davur than you should

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

Follow the established dosing 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. In case of this occurring, go to your doctor without delay, 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, 20-30 grams of activated charcoal will be administered every 4-6 hours for the first 24 hours after ingestion. Additionally, conservative treatment with monitoring of vital signs and observation of the patient is recommended.

If you forgot to take Paroxetina Davur

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

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

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

If you interrupt treatment with Paroxetina Davur

If you stop treatment abruptly with paroxetine, 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 stopping treatment, such as abdominal pain, nervousness, and mood changes.

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

Like all medications, Paroxetina Davur may cause 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 people). If you experience any of the following symptoms while taking paroxetine, inform your doctor immediately or go to the nearest hospital:

• Swelling of the face, eyelids, lips, mouth, or tongue
• Skin rashes or urticaria (itching on the skin) anywhere on the body
• 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 people) when taking Paroxetina Davur are:

• Nausea. This side effect may decrease by taking your medication in the morning after breakfast
• Sexual dysfunction (lack of orgasm, and in men, abnormal erection and ejaculation)
• Difficulty concentrating

The following side effects may be frequent (may affect between 1 and 10 in every 100 people):

• Decreased appetite
• Insomnia (lack of sleep) or drowsiness

• Dizziness, tremor

• Agitation
• Blurred vision
• Yawning
• Dry mouth, vomiting, diarrhea, constipation
• Sweating, weakness
• Weight gain

The side effects that may appear infrequently (may affect between 1 and 10 in every 1,000 people) during treatment with Paroxetina Davur include:

• Petechiae (purple discoloration that occurs due to blood accumulation under the skin), mucosal bleeding

• Confusion
• Hallucinations
• Extrapyramidal symptoms (disorders of movement and coordination)
• Sinus tachycardia (alteration of heart rhythm)
• Transient increases or decreases in blood pressure, which may cause dizziness or fainting when standing up quickly, usually in patients with high blood pressure or anxiety
• Skin rashes (spots on the skin), itching on the skin
• Urinary retention, urinary incontinence
• Altered blood sugar control in diabetic patients
• Pupil dilation
• Decreased white blood cell count

The side effects that may appear rarely (may affect between 1 and 10 in every 10,000 people) during treatment with Paroxetina Davur include:

• Hyponatremia (decreased sodium levels in the blood), especially in older people, or those with the syndrome of inappropriate antidiuretic hormone secretion (SIADH), which may cause symptoms such as weakness and drowsiness (sleepiness)

• Seizures
• Manic reactions (euphoria)
• Anxiety
• Panic attacks
• Loss of personality
• Bradycardia (decreased heart rate)
• Increased liver enzymes
• Milk production (galactorrhea)
• 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)
• Alterations in menstrual cycle (including heavy or irregular periods, bleeding between periods, and absence or delay of period)

The side effects that may appear very rarely (may affect fewer than 1 in 10,000 people) are:

• Serotonin syndrome; symptoms may include agitation, confusion, sweating, hallucinations, hyperreflexia (increased response to reflexes), 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)
• Stomach mucosa bleeding
• Thrombocytopenia (decreased platelet count in the blood)
• If you develop a skin rash with redness and blisters, swelling of the face, eyelids, lips, mouth, or tongue, itching, or difficulty breathing or swallowing, and a feeling of weakness or dizziness that may cause a collapse or loss of consciousness, contact your doctor or go to the hospital immediately.
• Skin rash, in which small blisters with a central dark spot surrounded by a pale area, with a dark ring around it, called erythema multiforme may appear
• Widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• Widespread rash covering a large body surface with blisters and skin peeling (toxic epidermal necrolysis)
• Priapism (prolonged and abnormal erection of the penis)

Unknown (frequency cannot be estimated from available data):

• 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.

Some patients have experienced persistent ringing, buzzing, beeping, or other sounds in the ears (tinnitus) when taking Paroxetina Davur.

It has been observed that people taking medications like Paroxetina Davur have a higher risk of bone fractures.

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 it 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 effect, it does not mean you will not be able to stop your treatment.

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

• Dizziness, emotional instability
• Sensory alterations, including pins and needles, burning, and, less frequently, sensations of electroshock (even in the head), ringing, or other persistent sounds in the ears (tinnitus)
• Sleep disturbances (including vivid dreams, nightmares, insomnia)
• Anxiety
• Headache

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

• Nausea
• Sweating (including nocturnal sweating)
• Agitation
• Tremor
• Confusion
• Emotional instability
• Visual disturbances
• Palpitations
• Diarrhea
• Irritability

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

?Decreased appetite

?Tremor (uncontrollable shaking)

?Abnormal sweating

?Hypervigilance

?Hostile or unfriendly behavior (mainly in children under 12 years old with obsessive-compulsive disorders)

?Agitation

?Emotional instability, including crying, mood swings, self-harm attempts, thoughts, and attempts of suicide (mainly in studies of adolescents with major depression)

The additional side effects that are frequently observed in children and adolescents under 18 years old who stop paroxetine treatment are: emotional instability (including crying, mood swings, self-harm attempts, thoughts, and attempts of suicide), dizziness, nausea, abdominal pain, and nervousness.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear 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.

This medication does not require special storage conditions.

Store in the original packaging.

Expiration Date

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

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to properly dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Paroxetina Davur

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

- The other components (excipients) are:

Tablet core: microcrystalline cellulose, mannitol E-421, magnesium stearate, and sodium starch glycolate (from potato).

Tablet coating: Eudragit E-100, Opadry AMB white compound consisting of: partially hydrolyzed polyvinyl alcohol, titanium dioxide E-171, talc, soy lecithin E-322, and xanthan gum E-415.

Appearance of the product and contents of the packaging

The tablets are white, round, biconvex, 10 mm in diameter, scored on one side and printed on the other with P20.

The score is only for breaking and facilitating swallowing, but not for dividing into equal doses. Paroxetina Davur is presented in blister packs of 14, 28, and 56 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Teva Parma, S.L.U

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Responsible for manufacturing:

Teva Pharma, S.L.U.

Polígono Malpica C/ C, 4.

50016 Zaragoza

Spain

This leaflet was approved in December 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/