Sertraline Kern Pharma 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sertraline Kern Pharma 50 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

Package leaflet contents:

1. What Sertraline Kern Pharma is and what it is used for
2. Before taking Sertraline Kern Pharma
3. How to take Sertraline Kern Pharma
4. Possible side effects
5. Storage of Sertraline Kern Pharma
6. Contents of the pack and other information

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

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

Sertralina Kern Pharma can be used to treat:

• Depression and prevention of recurrence of depression (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 illness with symptoms such as feelings of sadness, inability to sleep well, or to enjoy life as one used to.

OCD and panic disorders are anxiety-related illnesses, with symptoms such as persistent worry about recurring thoughts (obsessions) that lead to repetitive rituals (compulsions).

PTSD is a disorder that may occur following an emotionally traumatic experience and has some symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterized by intense anxiety or distress in social situations (for example: speaking with strangers, speaking in public, eating or drinking in front of others, or worrying about behaving in an embarrassing way).

Your doctor has determined that this medicine is appropriate for treating your condition.

If you are unsure why Sertralina Kern Pharma has been prescribed for you, you should consult your doctor.

2. Before taking Sertralina Kern Pharma

Do not take Sertralina Kern Pharma

• If you are allergic (hypersensitive) to sertraline or to any of the other components of Sertralina Kern Pharma.
• If you are taking or have recently 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).

Take special care with Sertralina Kern Pharma

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

• Serotonin syndrome. This syndrome may rarely occur when you are taking certain medicines at the same time as sertraline. (For symptoms, see section 4. Possible side effects). Your doctor will advise you if you have previously experienced this syndrome.
• Low sodium levels in the blood, as this condition may occur as a result of treatment with sertraline. You should also inform your doctor if you are taking any medicine for high blood pressure, as these medicines may also alter sodium levels in the blood.
• Take special care if you are elderly, as you may be at increased risk of low sodium levels in the 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 a history of epilepsy. If you have a seizure (convulsion), contact your doctor immediately.
• If you have bipolar disorder (manic-depressive illness) or schizophrenia. If you experience a manic episode, contact your doctor immediately.
• If you have or have previously had suicidal thoughts (see below, Suicidal thoughts and worsening of depression or anxiety disorder).

If you have had bleeding disorders or have been taking medicines that reduce blood clotting (e.g., acetylsalicylic acid (aspirin), or warfarin), or medicines 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 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 Sertralina 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 an urge to move, often accompanied by an inability to sit or stand still). This occurs most frequently during the first few weeks of treatment. Increasing the dose in patients who develop these symptoms may be harmful.

Withdrawal symptoms

When stopping treatment, withdrawal symptoms are common, 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 may be severe. These symptoms usually appear within the first few days after stopping treatment. In general, these symptoms resolve on their own and usually disappear within two weeks. In some patients, they may 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 individual needs of the patient.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide. This may increase at the beginning of treatment with antidepressants, because all these medicines take some time to work—usually about two weeks, but sometimes longer.

You are more likely to experience this if:

• You have previously had thoughts of suicide or self-harm.
• You are a young adult. Clinical trial data show an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with an antidepressant.

If you have thoughts of harming yourself or of suicide at any time, contact your doctor or go to hospital immediately.

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

Use in children and adolescents

Sertraline is generally not recommended for use in children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder. Patients under 18 years of age have a higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behaviour, and anger reaction) when taking this type of medicine. Nevertheless, your doctor may decide to prescribe Sertralina Kern Pharma to a patient under 18 years of age if they consider it to be in the patient’s best interest. If your doctor has prescribed Sertralina Kern Pharma to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. Inform your doctor if any of the symptoms listed above appear or worsen while a patient under 18 years of age is taking sertraline.

In addition, the long-term effects on safety and on growth, maturation, and cognitive and behavioural development of sertraline in this age group have not yet been fully established.

Taking other medicines

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

Some medicines may affect how Sertralina Kern Pharma works, or Sertralina Kern Pharma may reduce the effectiveness of other medicines taken at the same time.

Using Sertralina Kern Pharma together with the following medicines may cause serious adverse effects

• Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (for treating depression), selegiline (for treating Parkinson’s disease), and the antibiotic linezolid. Do not use sertraline together with MAOIs.
• Medicines for treating mental disorders (pimozide). Do not use sertraline together 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 drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics.
• Medicines for treating epilepsy (phenytoin).
• Medicines for treating diabetes (tolbutamide).
• Medicines for treating stomach acidity 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 Sertralina Kern Pharma with food and drink

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

Alcohol intake 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 given to pregnant women if, in the doctor’s opinion, 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 method of contraception.

If you take Sertraline in the late 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 this medicine so they can advise you.

There is evidence that sertraline is excreted in breast milk. Therefore, sertraline may only be used in women who are breastfeeding if, in the doctor’s opinion, the benefit to the mother outweighs any possible risk to the infant.

Driving and using machines

Antidepressant medicines such as sertraline may affect your ability to drive or operate machinery. Therefore, do not drive or operate heavy machinery until you know how this medicine affects your ability to perform these activities.

Sertralina Kern Pharma contains lactose

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

3. How to take Sertralina Kern Pharma

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

The recommended dose is:

Adults

Depression and Obsessive-Compulsive Disorder (OCD):

For depression and OCD, the usual effective dose is 50 mg per day. The daily dose may be increased in 50 mg increments at intervals of at least one week, over 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 post-traumatic stress disorder, treatment should be initiated at a dose of 25 mg per day, increasing to 50 mg per day after one week.

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

Children and adolescents

Sertralina Kern Pharma should only be used to treat children and adolescents aged 6 to 17 years who have OCD.

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 your 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 the instructions he or she gives you.

Your doctor will determine how long you should take this medicine. The duration will depend on the nature of your illness and your response to treatment. It may take several weeks before your symptoms begin to improve.

If you take more Sertralina Kern Pharma than you should

If you accidentally take too much sertraline, contact your doctor or go to the nearest hospital emergency department. Always take the medicine packaging with you, whether or not there is any medicine left.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

Symptoms of overdose may include drowsiness, nausea and vomiting, increased heart rate, tremors, agitation, dizziness, and in rare cases, loss of consciousness.

If you forget to take Sertralina Kern Pharma

If you forget to take a dose, do not take it when you remember. Take the next dose at the usual time.

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

If you stop taking Sertralina Kern Pharma

Do not stop treatment with Sertralina Kern Pharma unless your doctor tells you to. Your doctor will want to gradually reduce your dose of Sertralina Kern Pharma over several weeks before you stop taking this medicine completely. If you stop treatment suddenly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling unwell, or dizziness and tremor. If you experience any of these adverse effects, or any others, while stopping treatment with Sertralina Kern Pharma, please inform your doctor.

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

4. Possible adverse effects

Like all medicines, Sertraline Kern Pharma may cause adverse effects, although not everyone will experience them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, please inform your doctor or pharmacist.

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

Tell your doctor immediately

If you experience any of the following symptoms after taking this medicine, as they may be serious:

• If you develop a severe skin rash causing blisters (erythema multiforme), which may affect the mouth and tongue. These may be signs of a condition known as Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). In such cases, your doctor will stop treatment.
• Allergic reaction or allergy, which may present symptoms such as itchy skin rash, difficulty breathing, wheezing, swelling of the eyelids, face or lips.
• If you experience agitation, confusion, diarrhea, increased body temperature and blood pressure, excessive sweating, and rapid pulse. These are symptoms of serotonin syndrome.

This syndrome may rarely occur when taking certain medications at the same time as sertraline. Your doctor may decide to discontinue treatment.

• If you notice yellowing of the skin or eyes, which may indicate liver damage.
• If you experience depressive symptoms with suicidal thoughts.
• If, after starting treatment with Sertraline Kern Pharma, you begin to feel restless and unable to sit or stand still. You should inform your doctor if you start feeling restless.

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

Very common adverse effects (occur in more than 1 in 10 patients):

Insomnia, dizziness, drowsiness, headache, diarrhea, malaise, dry mouth, ejaculation disorders, and fatigue.

Common adverse effects (occur in 1 to 10 of every 100 patients):

Sore throat, anorexia, increased appetite, depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased libido, teeth grinding, numbness and tingling, tremor, muscle tension, abnormal taste, difficulty concentrating, visual disturbances, tinnitus (ringing in the ears), palpitations, hot flushes, yawning, abdominal pain, vomiting, constipation, stomach discomfort, flatulence, rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, and chest pain.

Uncommon adverse effects (occur in 1 to 10 of every 1,000 patients):

Cold (chest), runny nose, hallucinations, excessive happiness, lack of care, abnormal thoughts, seizures, involuntary muscle contractions, abnormal coordination, continuous movements, amnesia, decreased sensitivity, speech disorders, dizziness upon standing, migraines, ear pain, rapid pulse, elevated blood pressure, hot flushes, difficulty breathing possibly noisy, shortness of breath, nosebleeds, esophageal problems, difficulty swallowing, hemorrhoids, increased salivation, tongue disorders, burping, eye swelling, purple spots on the skin, hair loss, cold sweat, dry skin, urticaria, osteoarthritis, muscle weakness, back pain, muscle twitching, need to urinate at night, urinary retention, increased urine volume, increased frequency of urination, urinary disorders, vaginal bleeding, female sexual dysfunction, malaise, chills, fever, weakness, thirst, weight loss, and weight gain.

Rare adverse effects (occur in 1 to 10 of every 10,000 patients):

Intestinal problems, ear infection, cancer, swollen lymph nodes, 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, movement difficulty, increased sensitivity, sensory disturbances, glaucoma, tear problems, appearance of spots in the visual field, double vision, light damage to the eyes, blood in the eye, dilated pupils, heart attack, decreased heart rate, heart problems, circulation problems in arms and legs, throat spasm, rapid breathing, slow breathing, difficulty speaking, hiccups, blood in stool, mouth sores, tongue ulceration, dental and tongue problems, mouth ulceration, liver function problems, skin problems with blisters, capillary rash, abnormal hair texture, abnormal skin odor, bone abnormalities, decreased urine volume, urinary incontinence, interrupted urination, excessive vaginal bleeding, vaginal dryness, pain and redness of the penis and foreskin, genital discharge, prolonged erection, nipple discharge, hernia, injection site scar, reduced tolerance to medications, difficulty walking, abnormal laboratory tests, abnormal semen, injury, vasodilation procedure.

The following adverse effects have been reported since sertraline has been marketed:

Decreased number of white blood cells, decreased platelets, low levels of thyroid hormones, endocrine problems, low blood sodium levels, abnormal nightmares, suicidal behavior, muscle movement disorders (such as constant movements, muscle tension, and difficulty walking), syncope (fainting), abnormal vision, bleeding problems (such as nosebleeds, stomach bleeding, or blood in urine), pancreatitis, severe liver function problems, yellowing of the skin, skin swelling, skin reaction to sunlight, itching, joint pain, muscle cramps, breast enlargement, menstrual irregularities, swollen legs, coagulation problems, and severe allergic reactions.

Rare: seeing spots in front of the eyes, glaucoma, double vision, photophobia (light sensitivity), eye hemorrhages, irregular pupils, visual disturbances, lacrimal problems.

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

Adverse effects in children and adolescents

In clinical trials in children and adolescents, adverse effects were generally similar to those reported in adults (see above). The most common 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 they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sertraline Kern Pharma

Keep out of sight and reach of children.

Do not use Sertraline Kern Pharma after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Sertraline Kern Pharma

• The active substance 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 contents of the pack

Sertraline Kern Pharma 50 mg are film-coated tablets, white or almost white, capsule-shaped and scored. The tablets are presented in PVC/aluminum blisters in packs containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain

This leaflet was last revised in June 2025

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