Package Insert: Information for the User

Paroxetina Kern Pharma 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 for you and should not be given to others, even if they have the same symptoms of the disease, 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.

Paroxetina Kern Pharma belongs to a group of medicines called antidepressants and acts on the central nervous system.

Paroxetina 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 Kern Pharma

• if you are allergic to the active ingredient or any of the other components of Paroxetina Kern Pharma
• if you are being treated with a medication called thioridazine or pimozide or a type of medication for the treatment of depression called MAO inhibitors (IMAO) or if you have been treated with this in the last two weeks

Warnings and precautions

• 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 any disease that causes high eye pressure (glaucoma),

• if you have bruising or bleeding easily or are being treated with a medication that may increase bleeding, or if you are pregnant (see "Pregnancy")
• if you are taking neuroleptics (for the treatment of mental illnesses),
• if you are taking any product containing St. John's Wort,
• if you are pregnant, think you are pregnant, or plan to become pregnant, as well as if you are breastfeeding,

• 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 noticed in a few weeks. In some cases, symptoms of depression or other psychiatric conditions may include thoughts of self-harm or suicide. It is possible that these symptoms will continue or worsen until the full antidepressant effect of the medication is achieved. Inform your doctor immediately or go to 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 illness.

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

Children and adolescents

Paroxetina should not be used normally in the treatment of children and adolescents under 18 years old. At the same time, you should know that in patients under 18 years old, there is a higher risk of adverse effects such as attempts at suicide, suicidal thoughts, and hostility (primarily aggression, confrontational behavior, and irritability) when taking this type of medication. However, the doctor who prescribes it may prescribe Paroxetina to patients under 18 years old when they decide it is best for the patient. If the doctor who prescribes it has prescribed Paroxetina 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 paroxetina. At the same time, the long-term effects of paroxetina on safety and related to growth, maturity, and cognitive and behavioral development in this age group have not yet been demonstrated.

Use of Paroxetina Kern Pharma with other medications

Inform your doctor or pharmacist that you are using or have recently used or may need to use other medications.

Especially Paroxetina 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 clotting (e.g. oral anticoagulants, aspirin, and others)
• some medications used to treat 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

Paroxetina Kern Pharma with food, drink, 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

Consult your doctor or pharmacist before using 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 Kern Pharma or continue with it.

If you take Paroxetina in the final stages 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 this medication to be able to advise you.

Some studies have suggested a possible increase in the risk of heart defects in newborns whose mothers received paroxetina 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.

DRIVING AND USING MACHINES

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

Follow exactly the administration instructions for Paroxetina Kern Pharma indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Your doctor will inform you 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 Kern Pharma 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 adults:

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

Pediatric population:

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

Patients with renal or hepatic insufficiency

If you have renal or hepatic insufficiency, 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 Kern Pharma is too strong or too weak, inform your doctor or pharmacist.

If you take more Paroxetina Kern Pharma than you should

If you have taken more Paroxetina Kern Pharma than you should, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone: (91)5620420, 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. In case of an overdose, go to your doctor as soon as possible, or contact the emergency service of the nearest hospital.

The treatment includes the usual general measures used in case of an overdose of 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 vital sign monitoring and observation of the patient is recommended.

If you forgot to take Paroxetina Kern Pharma

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

If you forgot to take Paroxetina Kern Pharma, 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 Kern Pharma all day, do not take a double dose the next day.

If you interrupt treatment with Paroxetina Kern Pharma

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 doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, Paroxetina Kern Pharma may cause side effects, although not everyone will experience them.

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

The frequencies of side effects have been listed below according to the following definitions:

Very common: May affect more than 1 in 10 people

Common: May affect up to 1 in 10 people

Uncommon: May affect up to 1 in 100 people

Rare: May affect up to 1 in 1,000 people

Very rare: May affect up to 1 in 10,000 people

Possible side effects during treatment:

Some people may be allergic to certain medications, although this occurs in very rare occasions (less than 1 person in 10,000). 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 rash 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.

Very common:

• Nausea (this side 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)

Common:

• Loss of appetite
• Insomnia (lack of sleep) or drowsiness
• Dizziness, tremor
• Restlessness
• Blurred vision
• Yawning
• Dry mouth, diarrhea, constipation
• Sweating, weakness
• Weight gain

Uncommon:

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

Rare:

• 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 (sleepiness)
• 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)

Very rare:

• 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 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 extremities)
• Mucosal bleeding in the stomach
• Thrombocytopenia (decreased platelet count in the blood)
• Allergic reactions (including urticaria and angioedema)

• Priapism (abnormal and prolonged erection of the penis)

Unknown frequency:

• 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 occur 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 occur 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)
• Sleep disturbances (including vivid dreams, nightmares, insomnia)
• Anxiety
• Headache

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

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

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

• Loss of appetite

• Tremor (involuntary shaking)
• Abnormal sweating
• Hypervigilance
• Hostile or unfriendly behavior (mainly in children under 12 years old with obsessions and compulsive disorders)
• Restlessness
• 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.

If you notice side effects not described in this prospectus or if you experience any of the side effects described as severe, inform your doctor or pharmacist.

Keep out of the sight and reach of children.

No special storage conditions are required.

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

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

Composition ofParoxetina Kern Pharma:

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

• The other components are:calcium phosphate anhydrous, sodium croscarmellose, magnesium stearate, hypromellose, titanium dioxide (E171), and macrogol 400.

Appearance of the product and content of the packaging

Paroxetina Kern Pharma is presented in the form of coated tablets with a white film coating, circular, and scored. The score serves to break and facilitate swallowing but not to divide into equal doses.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

This leaflet was approved in November 2023

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