SERTRALINE KERN PHARMA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sertraline Kern Pharma 50 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

Contents of the pack:

1. What Sertraline Kern Pharma is and what it is used for
2. Before you take Sertraline Kern Pharma
3. How to take Sertraline Kern Pharma
4. Possible side effects
5. Storing Sertraline Kern Pharma
6. Further information

1. What Sertraline Kern Pharma is and what it is used for

Sertraline Kern Pharma contains sertraline as the active ingredient. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders.

Sertraline Kern Pharma can be used to treat:

• Depression and prevention of depression relapse (in adults).
• Social anxiety disorder (in adults).
• Post-traumatic stress disorder (PTSD) (in adults).
• Panic disorder (in adults).
• Obsessive-compulsive disorder (OCD) (in adults and in children and adolescents aged 6-17 years).

Depression is a clinical condition with symptoms such as feelings of sadness, inability to sleep well or enjoy life as you used to.

OCD and anxiety disorders are conditions related to anxiety, with symptoms such as being constantly worried about recurring ideas (obsessions) that lead to repetitive rituals (compulsions).

PTSD is a disorder that can occur after a highly traumatic emotional experience, and has some symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related condition. It is characterized by intense anxiety or distress in social situations (e.g., talking to strangers, public speaking, eating or drinking in front of others, or worrying about behaving shamefully).

Your doctor has considered that this medicine is suitable for treating your condition.

If you are not sure why you have been prescribed Sertraline Kern Pharma, you should consult your doctor.

2. Before you take Sertraline Kern Pharma

Do not take Sertraline Kern Pharma

• If you are allergic (hypersensitive) to sertraline or any of the other ingredients of Sertraline Kern Pharma.
• If you are taking or have taken medicines called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other medicines similar to MAOIs (such as linezolid). If you stop treatment with sertraline, you must wait at least one week before starting treatment with an MAOI. After stopping treatment with an MAOI, you must wait at least two weeks before starting treatment with sertraline.
• If you are taking another medicine called pimozide (an antipsychotic medicine).

Be cautious with Sertraline Kern Pharma

Medicines are not always suitable for everyone. Before starting treatment with Sertraline Kern Pharma, tell your doctor if you have or have had any of the following:

• Serotonin syndrome. This syndrome can occur rarely when taking certain medicines at the same time as sertraline. (To see the symptoms, read section 4. Possible side effects). Your doctor will indicate if you have presented this syndrome previously.
• If you have low sodium levels in your blood, as this situation may occur as a result of treatment with sertraline. You should also inform your doctor if you are taking any medicine for hypertension, as these medicines can also alter sodium levels in your blood.
• Be cautious if you are elderly, as you may be at greater risk of having low sodium levels in your blood (see above).
• Liver disease; your doctor may consider that you should take a lower dose of sertraline.
• Diabetes; sertraline may alter your blood sugar levels, so it may be necessary to adjust the dose of your diabetes medicines.
• Epilepsy or history of epilepsy. If you have a seizure (convulsions), call your doctor immediately.
• If you have manic-depressive illness (bipolar disorder) or schizophrenia. If you have a manic episode, call your doctor immediately.
• If you have had suicidal thoughts (see below thoughts of suicide and worsening of your depression or anxiety disorder).

If you have had bleeding disorders or have been taking medicines that reduce blood clotting (such as acetylsalicylic acid (aspirin) or warfarin) or that may increase the risk of bleeding, or if you are pregnant (see "Pregnancy").

• If you are a child or adolescent under 18 years of age. Sertraline should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder. If you are going to be treated for this disorder, your doctor will want to monitor you closely (see below Use in children and adolescents).
• If you are receiving electroconvulsive therapy (ECT).

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

Restlessness/Akathisia

The use of sertraline has been associated with akathisia (unpleasant restlessness and need to move, often accompanied by an inability to remain seated or standing). This occurs more often during the first few weeks of treatment. An increase in dose, in patients who develop these symptoms, may be harmful.

Withdrawal symptoms

When treatment is stopped, it is common for withdrawal symptoms to appear, particularly if treatment is stopped abruptly (see section 4. Possible side effects). The risk of experiencing withdrawal symptoms depends on the duration of treatment, the dose, and the rate at which the dose is reduced. Generally, these symptoms are mild or moderate. However, in some patients, they can be severe. These symptoms usually appear during the first few days after stopping treatment. In general, these symptoms usually resolve on their own and normally disappear within two weeks. In some patients, they can last longer (2-3 months or more). It is recommended that, when stopping treatment with sertraline, the dose should be gradually reduced over a period of several weeks or even months, according to the needs of each patient.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. This can increase at the beginning of treatment with antidepressants, due to the fact that all these medicines take time to work, which is usually a few weeks, but can sometimes be longer.

This is more likely to happen

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. There is information from clinical trials that shows an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who are being treated with an antidepressant.

If you have thoughts of self-harm or suicide at any time, contact your doctor or go to the hospital immediately.

It may be helpful for you to explain to a family member or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Use in children and adolescents

Normally, sertraline should not be used in the treatment of children and adolescents under 18 years of age, except in the case of patients with obsessive-compulsive disorder. Patients under 18 years of age have a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and anger) when they are being treated with this class of medicines. Nevertheless, it is possible that your doctor may decide to prescribe Sertraline Kern Pharma to a patient under 18 years of age if they consider it to be in the best interest of the patient. If your doctor has prescribed Sertraline Kern Pharma to a patient under 18 years of age and you wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen when a patient under 18 years of age is taking sertraline.

At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of sertraline in this age group have not yet been demonstrated.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Some medicines can affect how Sertraline Kern Pharma works, or Sertraline Kern Pharma may reduce the effectiveness of other medicines that you are taking at the same time.

The use of Sertraline Kern Pharma with the following medicines may cause serious side effects

• Medicines called monoamine oxidase inhibitors (MAOIs, such as moclobemide (for depression), selegiline (for Parkinson's disease), and the antibiotic linezolid). Do not use sertraline with MAOIs.
• Medicines for treating mental disorders (pimozide). Do not use sertraline with pimozide.

Tell your doctor if you are taking the following medicines

• Herbal medicines containing St. John's Wort (Hypericum perforatum). The effects of St. John's Wort may last 1-2 weeks. Inform your doctor.
• Products containing the amino acid tryptophan.
• Medicines for treating severe pain (e.g., tramadol).
• Medicines for treating migraines (e.g., sumatriptan).
• Medicines that reduce blood clotting (warfarin).
• Medicines for treating pain/arthritis (non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics.
• Medicines for treating epilepsy (phenytoin).
• Medicines for treating diabetes (tolbutamide).
• Medicines for treating stomach acid and ulcers (cimetidine).
• Medicines for treating mania and depression (lithium).
• Other medicines for treating depression (such as amitriptyline, nortriptyline).
• Medicines for treating schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).

Taking Sertraline Kern Pharma with food and drinks

Sertraline Kern Pharma tablets can be taken with or without food.

Alcohol consumption should be avoided while being treated with sertraline.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

The safety of sertraline in pregnant women has not been fully established. Sertraline should only be administered to pregnant women if, in the doctor's judgment, the benefit to the mother outweighs any possible risk to the fetus. Women of childbearing age who are being treated with sertraline should use an adequate contraceptive method.

If you take Sertraline in the final 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 know that you are taking this medicine so that they can advise you.

There are indications that sertraline is excreted in breast milk. Therefore, sertraline can only be used in breastfeeding women if, in the doctor's judgment, the benefit to the mother outweighs any possible risk to the child.

Driving and using machines

Antidepressant medicines like sertraline can affect your ability to drive or use machines. Therefore, do not drive or operate heavy machinery until you know how this medicine affects your ability to perform these activities.

Sertraline Kern Pharma contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Sertraline Kern Pharma

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Sertraline Kern Pharma tablets can be taken with or without food.

Take your medicine once a day, either in the morning or at night.

The recommended dose is:

Adults

Depression and Obsessive-Compulsive Disorder:

For depression and OCD, the usual effective dose is 50 mg per day. The daily dose can be increased in increments of 50 mg, at intervals of at least one week, and so on for several weeks. The maximum recommended dose is 200 mg per day.

Panic Disorder, Social Anxiety Disorder, and Post-Traumatic Stress Disorder

For panic disorder, social anxiety disorder, and PTSD, treatment should be started with a dose of 25 mg per day, and increased to 50 mg per day after one week.

The daily dose can be increased in increments of 50 mg over a period of several weeks. The maximum recommended dose is 200 mg per day.

Children and Adolescents

Sertraline Kern Pharma should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder.

Obsessive-Compulsive Disorder:

Children aged 6 to 12 years:The recommended starting dose is 25 mg per day. After one week, your doctor may increase the dose to 50 mg per day. The maximum dose is 200 mg per day.

Adolescents aged 13 to 17 years:The recommended starting dose is 50 mg per day. The maximum dose is 200 mg per day.

If you have liver or kidney problems, inform your doctor and follow their instructions.

Your doctor will indicate the duration of treatment with this medicine. The duration will depend on the nature of your condition and your response to treatment. It will take several weeks before your symptoms start to improve.

If you take more Sertraline Kern Pharma than you should

If you accidentally take an overdose of sertraline, contact your doctor or go to the emergency department of the nearest hospital. Always take the medicine package with you, whether it still contains medicine or not.

You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, tremors, agitation, dizziness, and in rare cases, loss of consciousness.

If you forget to take Sertraline Kern Pharma

If you forget to take a dose, do not take it when you remember. Take the next dose when it is due.

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

If you stop taking Sertraline Kern Pharma

Do not stop taking Sertraline Kern Pharma unless your doctor tells you to. Your doctor will want to gradually reduce the dose of Sertraline Kern Pharma over a period of several weeks before you stop taking this medicine altogether. If you stop treatment abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling unwell or being dizzy, and tremors. If you experience any of these side effects, or any other side effects during the interruption of your treatment with Sertraline Kern Pharma, please inform your doctor.

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

4. Possible Adverse Effects

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

If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

The most common adverse effect is nausea. Adverse effects depend on the dose and often disappear when continuing treatment.

Inform your doctor immediately

If you experience any of the following symptoms after taking this medication, as these symptoms can be severe.

• If you develop a severe skin rash that causes blisters (erythema multiforme), (can affect the mouth and tongue). These can be signs of a disease known as Stevens-Johnson Syndrome or toxic epidermal necrolysis (TEN). In these cases, your doctor will interrupt treatment.
• Allergic reaction or allergy, which can present symptoms such as skin rash with itching, breathing problems, wheezing, swelling of the eyelids, face, or lips.
• If you present agitation, confusion, diarrhea, increased temperature and blood pressure, excessive sweating, and accelerated pulse. These are symptoms of serotonin syndrome.

In rare cases, this syndrome can occur when taking certain medications at the same time as sertraline. Your doctor may decide to interrupt treatment.

• If you present a yellowish color of the skin and eyes, which can indicate liver damage.
• If you present depressive symptoms with suicidal ideas.
• If, after starting treatment with Sertralina Kern Pharma, you begin to feel restless and are unable to sit or stand. You should inform your doctor if you start to feel restless.

The following adverse effects were observed in clinical trials in adults.

Very frequent adverse effects (occurring in more than 1 patient in 10):

Insomnia, dizziness, somnolence, headache, diarrhea, feeling of discomfort, dry mouth, ejaculation problems, and fatigue.

Frequent adverse effects (occurring in between 1 and 10 out of 100 patients):

Sore throat, anorexia, increased appetite, depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased sexual interest, teeth grinding, numbness and tingling, tremor, muscle tension, abnormal taste, lack of concentration, visual disturbances, ringing in the ears, palpitations, hot flashes, yawning, abdominal pain, vomiting, constipation, stomach discomfort, gas, rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, and chest pain.

Infrequent adverse effects (occurring in between 1 and 10 out of 1,000 patients):

Chest cold, runny nose, hallucinations, excess happiness, lack of care, abnormal thoughts, convulsions, involuntary muscle contractions, abnormal coordination, continuous movements, amnesia, decreased sensitivity, speech disorders, dizziness when standing up, migraines, ear pain, rapid pulse, high blood pressure, hot flashes, breathing difficulties possibly noisy, shortness of breath, nasal bleeding, esophagus problems, difficulty swallowing, hemorrhoids, increased salivation, tongue alteration, belching, eye swelling, purple spots on the skin, hair loss, cold sweat, dry skin, hives, arthritis, muscle weakness, back pain, muscle spasms, need to urinate at night, urinary retention, increased urine amount, increased frequency of urination, urinary disorders, vaginal bleeding, female sexual dysfunction, discomfort, chills, fever, weakness, thirst, weight loss, and weight gain.

Rare adverse effects (occurring in between 1 and 10 out of 10,000 patients):

Intestinal problems, ear infection, cancer, lymph node swelling, high cholesterol, elevated blood sugar, physical symptoms due to stress or emotions, drug dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation, coma, abnormal movements, difficulty moving, increased sensitivity, sensory alterations, glaucoma, tear problems, appearance of spots in the visual field, double vision, eye damage from light, eye bleeding, irregular pupils, visual disturbances, and tear problems.

Adverse effects since the marketing of sertraline

Decrease in the number of white blood cells, decrease in platelets, low levels of thyroid hormones, endocrine problems, low sodium levels in the blood, abnormal terror dreams, suicidal behavior, muscle movement problems (such as constant movements, muscle tension, and difficulty walking), syncope, abnormal vision, bleeding problems (such as nosebleeds, stomach bleeding, or blood in urine), pancreatitis, severe liver function problems, yellowish skin, skin swelling, sun-related skin reaction, itching, joint pain, muscle cramps, breast enlargement, irregularities in the menstrual cycle, swollen legs, coagulation problems, and severe allergic reactions.

Rare:vision of spots in front of the eyes, glaucoma, double vision, photophobia (eye sensitivity to light), eye bleeding, irregular pupils, visual disturbances, and tear problems.

Frequency not known: partial loss of vision, colon inflammation (causing diarrhea), abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information. Muscle weakness and intense muscle pain, which can be a sign of multiple acyl-CoA dehydrogenase deficiency (MADD).

Adverse effects in children and adolescents

In clinical trials in children and adolescents, the adverse effects were generally similar to those reported in adults (see above). The most frequent adverse effects in children and adolescents were headache, insomnia, diarrhea, and nausea.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Sertralina Kern Pharma

Keep out of sight and reach of children.

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

Store below 30°C.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Sertralina Kern Pharma

• The active ingredient is sertraline (hydrochloride). Each tablet contains 50 mg of sertraline.
• The other components are:

Tablet core: anhydrous colloidal silica, microcrystalline cellulose (E-460i), sodium croscarmellose, copovidone, lactose monohydrate, and magnesium stearate (E-470b). Coating: hypromellose (E-464), hydroxypropylcellulose (E-463), titanium dioxide (E-171), and macrogol.

Appearance of the product and package contents

Sertralina Kern Pharma 50 mg are film-coated tablets, white or almost white, with a capsule shape and scored. The tablets are presented in PVC/Aluminum blisters in packages containing 30 tablets.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This prospectus was revised inJune 2025

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