PAROXETINE KERN PHARMA 20 mg FILM-COATED TABLETS

2. What you need to know before taking Paroxetine Kern Pharma

Do not take Paroxetine Kern Pharma

• if you are allergic to the active substance or any of the other components of Paroxetine Kern Pharma
• if you are being treated with a medication called thioridazine or pimozide, or with a type of medication 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

• if you have kidney, liver, or heart problems,
• if you have had manic episodes,
• if you have epilepsy or have seizures,
• if you have diabetes,
• if you have a 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 that contains 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 over 65 years old, as 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.

Like other medications of this type, relief from your symptoms will not occur immediately. Generally, improvement begins to be noticed in a few weeks. Occasionally, symptoms of depression or other psychiatric conditions may include thoughts of self-harm or suicide. It is possible that these symptoms will continue or increase 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 same group as Paroxetine Kern Pharma (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment is discontinued.

Children and adolescents

Paroxetine should not normally be used in the treatment of children and adolescents under 18 years of age. However, you should be aware that in patients under 18 years of age, there is a higher risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this class of medications. 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 mentioned above progress or if complications occur when patients under 18 years of age are taking paroxetine. Additionally, the long-term effects on safety, growth, maturity, and cognitive and behavioral development of paroxetine in this age group have not yet been demonstrated.

Use of Paroxetine 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, Paroxetine may modify the effect of the following medications:

• 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 medications 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 medications
• tramadol (used for pain)
• antibiotics (linezolid)
• metabolism inhibitors

Paroxetine Kern Pharma with food, drink, and alcohol

As with all medications of this type, it is advisable 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

Consult your doctor or pharmacist before using any medication. Do not take paroxetine while pregnant or breastfeeding, unless advised by your doctor. Inform your doctor immediately if you discover you are pregnant or plan to become pregnant. Your doctor may recommend gradually stopping treatment with Paroxetine Kern Pharma or continuing with it.

If you take Paroxetine 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 be aware that you are taking this medication to advise you accordingly.

Some studies have suggested a possible increase in the risk of heart defects in newborns whose mothers received paroxetine in the first months of pregnancy. These studies showed that less than 2% of children whose mothers received paroxetine at the beginning of pregnancy had some heart problems, compared to 1% observed in the general population.

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 the treatment with Paroxetine affects you.

3. How to take Paroxetine Kern Pharma

Follow the administration instructions for Paroxetine Kern Pharma indicated by your doctor. Consult your doctor or pharmacist if you have any questions.

Remember to take your medication.

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

It is recommended to administer Paroxetine 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 working.

Adults:

Depression

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

Generalized anxiety disorder

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

Elderly patients:

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

Pediatric population:

The use of paroxetine is not recommended in children under 18 years of age (see section 2: Before taking Paroxetine 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 problems before starting treatment.

If you think the effect of Paroxetine Kern Pharma is too strong or too weak, inform your doctor or pharmacist.

If you take more Paroxetine Kern Pharma than you should

If you have taken more Paroxetine Kern Pharma than you should, consult your doctor or pharmacist immediately or contact the Toxicology Information Service, phone: (91) 5620420, indicating the medication 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 package are consumed. If this occurs, go to your doctor without delay or contact the emergency department of the nearest hospital.

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

If you forget to take Paroxetine Kern Pharma

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

If you forget to take Paroxetine Kern Pharma, take it as soon as you remember, and the next day, take your usual dose at the corresponding time.

If you forget to take Paroxetine Kern Pharma throughout the day, do not take a double dose the next day.

If you stop treatment with Paroxetine Kern Pharma

If treatment with paroxetine is stopped abruptly, some disorders due to withdrawal may appear, 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 other questions about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Paroxetina Kern Pharma can cause adverse effects, although not all people suffer from them.

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

The frequencies of adverse 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 adverse effects during treatment:

Some people may be allergic to some medicines, although this occurs very rarely (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 rashes or hives (itching on the skin) anywhere on the body
• Difficulty breathing or swallowing

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

Very common:

• 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)

Common:

• Decreased appetite
• Insomnia (lack of sleep) or drowsiness
• Dizziness, tremors
• Agitation
• Blurred vision
• Dry mouth, diarrhea, constipation
• Sweating, weakness
• Weight gain

Uncommon:

• Ecchymosis (purple discoloration caused by blood accumulation under the skin), bleeding from mucous membranes
• Decreased white blood cell count
• Confusion
• Hallucinations
• Extrapyramidal effects (disorders of movement and coordination)
• Sinus tachycardia (alteration of heart rhythm)
• Transient increases or decreases in blood pressure, usually in patients with high blood pressure or anxiety
• Skin rashes (spots on the skin), itching on the skin
• Urinary retention

Rare:

• Hyponatremia (decrease in sodium levels in the blood), especially in elderly people or those with the syndrome of inappropriate antidiuretic hormone secretion (SIADH), which can lead to symptoms such as weakness and drowsiness (feeling of sleep)
• Seizures
• Manic reactions (of euphoria)
• Anxiety
• Panic attacks
• Loss of personality

• Bradycardia (decrease in heart rate)

• Increased liver enzymes
• Galactorrhea (abundant or excessive secretion of breast milk)
• Muscle and joint pain
• Feeling of restlessness and need to move called akathisia (inability to remain seated, need to walk back and forth, to 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 tremors
• 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 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 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)

Frequency not known:

• 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 placebo. It is more likely that these symptoms will appear if you have taken paroxetine for a long time, are in a phase of increasing dosage, 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 disturbances, including feelings of pinching, burning, and, less frequently, sensations of the electroshock type (even in the head)
• Sleep disturbances (including vivid dreams, nightmares, insomnia)
• Anxiety
• Headache

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

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

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

• Decreased appetite

• Tremors (uncontrollable shaking)
• Abnormal sweating
• Hyperactivity
• Hostile/unfriendly behavior (mainly in children under 12 years old 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.

If you notice any adverse effects not described in this leaflet or if you suffer from any of the adverse effects described in a severe form, inform your doctor or pharmacist.

5. Conservation of Paroxetina Kern Pharma

Keep out of sight and reach of children.

No special storage conditions are required.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines 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 medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Paroxetina Kern Pharma:

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

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

Appearance of the Product and Package Contents

Paroxetina Kern Pharma is presented in the form of white, circular, and scored film-coated tablets. The score line is to facilitate breaking and swallowing but not to divide into equal doses.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This leaflet was approved in November 2023

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