Package Leaflet: Information for the User

Sertraline Kern Pharma 100 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine.

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 additional information

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

Sertralina 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).

- Anxiety disorder (in adults).

- Obsessive-compulsive disorder (OCD) (in adults, and in children and adolescents aged 6-17 years).

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

OCD and anxiety disorders are diseases linked to anxiety, with symptoms such as being constantly preoccupied with repeated ideas (obsessions) that lead to repetitive rituals (compulsions).

PTSD is a disorder that may occur after a very emotionally traumatic experience, and has some symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety disorder. It is characterized by feeling intense anxiety or anguish in social situations (for example: speaking to strangers, speaking in public, eating or drinking in front of others, or worrying about behaving in a shameful manner).

Your doctor has considered this medication suitable for treating your condition.

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

Do not take Sertralina Kern Pharma

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

Be careful with Sertralina Kern Pharma

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

• Serotonin syndrome. In rare cases, this syndrome can occur when taking certain medications at the same time as sertraline. (See section 4. Possible side effects). Your doctor will let you know if you have had this syndrome before.
• If you have low sodium levels in your blood, as this situation can occur as a result of treatment with sertraline. Also, inform your doctor if you are taking any medications for high blood pressure, as these medications can also alter sodium levels in the blood.
• Be careful 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 you may need to adjust the dose of your diabetes medications.
• Epilepsy or a history of epilepsy. If you have a seizure (convulsion), 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 or have had suicidal thoughts (see later suicidal thoughts and worsening of your depression or anxiety).

If you have had bleeding disorders or have been taking medications that decrease blood clotting (such as 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 old. Sertraline should only be used to treat children and adolescents aged 6 to 17 years who have obsessive-compulsive disorder. If you are to be treated for this disorder, your doctor will want to monitor you closely (see later Use in children and adolescents).
• If you are receiving electroconvulsive therapy (ECT).

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

Restlessness/Acatisia

The use of sertraline has been associated with acatisia (unpleasant restlessness and a need to move, often accompanied by an inability to sit or stand still). This occurs more often during the first few weeks of treatment. Increasing the dose in patients who develop these symptoms may be harmful.

Withdrawal symptoms

When treatment is stopped, withdrawal symptoms are common, particularly if treatment is stopped abruptly (see section 4 Possible side effects). The risk of withdrawal symptoms depends on the duration of treatment, the dose, and the rate at which the dose is reduced. These symptoms are usually mild or moderate. However, in some patients, they can be severe. These symptoms usually occur during the first few days after stopping treatment. In general, these symptoms usually resolve on their own and usually resolve 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 be gradually reduced over a period of several weeks or even months, as needed for each patient.

Suicidal thoughts and worsening of your depression or anxiety

If you are depressed and/or have anxiety disorders, you may have thoughts of harming yourself or committing suicide. This can increase at the beginning of treatment with antidepressants, as all these medications take time to take effect, which is usually two weeks, but sometimes longer.

This is more likely to happen

• If you have had thoughts of suicide or self-harm before.
• 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 with psychiatric illnesses, who were being treated with an antidepressant.

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

It may be helpful for you to explain to a close family member or friend that you are depressed or have anxiety, 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 to treat children and adolescents under 18 years old, except in the case of patients with obsessive-compulsive disorder. Children and adolescents under 18 years old have a higher risk of adverse effects such as suicidal thoughts, suicidal behavior, and hostility (predominantly aggression, confrontational behavior, and irritable reaction) when treated with this class of medications. However, your doctor may decide to prescribe Sertralina Kern Pharma to a patient under 18 years old if they consider it to be the best option for the patient. If your doctor has prescribed Sertralina Kern Pharma 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 appear or worsen when a patient under 18 years old 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 medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Some medications may affect how Sertralina Kern Pharma works, or Sertralina Kern Pharma itself may reduce the effectiveness of other medications you are taking at the same time.

The use of Sertralina Kern Pharma with the following medications may cause severe side effects

• Medications called monoamine oxidase inhibitors (MAOIs), such as moclobemide (to treat depression), selegiline (to treat Parkinson's disease), and the antibiotic linezolid. Do not take sertraline with MAOIs.
• Medications to treat mental disorders (pimozide). Do not take sertraline with pimozide.

Inform your doctor if you are taking the following medications

• Medications based on plants that contain 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.
• Medications to treat severe pain (such as tramadol).
• Medications to treat migraines (such as sumatriptan).
• Medications that decrease blood clotting (warfarin).
• Medications to treat pain/arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin).
• Sedatives (diazepam).
• Diuretics.
• Medications to treat epilepsy (phenytoin).
• Medications to treat diabetes (tolbutamide).
• Medications to treat stomach acid and ulcers (cimetidine).
• Medications to treat mania and depression (lithium).
• Other medications to treat depression (such as amitriptyline, nortriptyline).
• Medications to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).

Taking Sertralina Kern Pharma with food and drinks

Sertraline tablets can be taken with or without food.

Alcohol should be avoided while being treated with sertraline.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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 opinion, the benefits for the mother outweigh any possible risk to the fetus. Women of childbearing age who are being treated with sertraline should use an appropriate contraceptive method.

If you take Sertralina 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 this medication to be able to advise you.

There is evidence that sertraline is excreted in breast milk. Therefore, sertraline can only be used in women during breastfeeding if, in the doctor's opinion, the benefits for the mother outweigh any possible risk to the baby.

Driving and operating machinery

Antidepressants like sertraline can affect your ability to drive or operate machinery. Therefore, do not drive or operate heavy machinery until you know how this medication affects your ability to perform these activities.

Sertralina Kern Pharma contains lactose

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

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

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

Take your medication 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 commonly effective dose is 50 mg per day. The daily dose can be increased by 50 mg at intervals of at least one week, and thus over several weeks. The maximum recommended dose is 200 mg per day.

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

For anxiety disorder, social anxiety disorder, and post-traumatic stress disorder, treatment should begin with a dose of 25 mg per day, and increased to 50 mg per day after one week.

The daily dose can be increased at intervals of 50 mg 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 with 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 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 medication. The duration will depend on the nature of your illness and your response to treatment. It will take several weeks for your symptoms to begin to improve.

If you take more Sertralina Kern Pharma than you should

If you accidentally take an excessive amount of sertralina, contact your doctor or go to the nearest hospital emergency department. Always carry the medication packaging with you, whether it contains medication or not.

You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of overdose may include drowsiness, nausea, vomiting, rapid 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 when it is due.

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

If you interrupt treatment with Sertralina Kern Pharma

Do not interrupt treatment with Sertralina Kern Pharma unless your doctor tells you to. Your doctor will want to gradually reduce the dose of Sertralina Kern Pharma over several weeks before stopping treatment completely. If you stop treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling unwell, or feeling dizzy and trembling. If you experience any of these adverse effects, or any other during the interruption of your treatment with Sertralina Kern Pharma, please inform your doctor.

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

Like all medicines, Sertralina Kern Pharma can cause side effects, although not everyone will experience them.

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

The most common side effect is nausea. Side effects depend on the dose and often disappear as treatment continues.

Inform your doctor immediately

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

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

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

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

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

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

Insomnia, dizziness, drowsiness, headache, diarrhea, feeling unwell, dry mouth, ejaculation problems, and fatigue.

Common side effects (occur in between 1 and 10 in 100 patients):

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

Uncommon side effects (occur in between 1 and 10 in 1,000 patients):

Cold (of the chest), runny nose, hallucinations, excessive 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 flushes, noisy breathing difficulties, shortness of breath, nasal bleeding, esophageal problems, difficulty swallowing, hemorrhoids, increased salivation, altered tongue, belching, eye swelling, purple spots on the skin, hair loss, cold sweat, dry skin, urticaria, arthritis, muscle weakness, back pain, muscle spasms, nocturia, urinary retention, increased urine output, urinary disorders, vaginal bleeding, female sexual dysfunction, discomfort, chills, fever, weakness, thirst, weight loss, and weight gain.

Rare side effects (occur in between 1 and 10 in 10,000 patients):

Gastrointestinal problems, ear infection, cancer, lymph node swelling, high cholesterol, elevated blood sugar, physical symptoms due to stress or emotions, medication dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation, coma, abnormal movements, difficulty moving, increased sensitivity, sensory disturbances, glaucoma, eye problems, visual field defects, double vision, light damage to the eyes, bleeding in the eyes, irregular pupils, visual disturbances, heart attack, decreased heart rate, heart problems, circulation problems in the arms and legs, throat spasms, rapid breathing, slow breathing, speech difficulties, hiccups, bloody stools, 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 alterations, decreased urine output, urinary incontinence, interrupted urination, excessive vaginal bleeding, vaginal dryness, penile and prepuce pain and redness, genital secretion, prolonged erection, breast secretion, hernia, injection site scar, decreased tolerance to medications, difficulty walking, abnormal laboratory tests, abnormal semen, injury, vascular relaxation procedure.

Since the marketing of sertraline, the following side effects have been reported

Decreased white blood cell count, decreased platelet count, low thyroid hormone levels, endocrine problems, low sodium levels in the blood, abnormal nightmares, suicidal behavior, movement disorders (such as continuous movements, muscle tension, and difficulty walking), syncope, abnormal vision, bleeding problems (such as nasal bleeding, stomach bleeding, or blood in urine), pancreatitis, severe liver function problems, yellow skin, skin swelling, sun sensitivity, itching, joint pain, muscle cramps, breast enlargement, irregular menstrual cycles, swollen legs, coagulation problems, and severe allergic reactions.

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

Frequency unknown:partial loss of vision, colon inflammation (which causes diarrhea), excessive vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Side effects in children and adolescents

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

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

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Sertralina Kern Pharma

• The active ingredient is sertraline (hydrochloride). Each tablet contains 100 mg of sertraline.
• The other components are:

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

Appearance of the product and content of the packaging

Sertralina Kern Pharma 100 mg are film-coated tablets, white or almost white, in capsule shape and scored. The tablets are presented in PVC/Aluminum blisters in packaging containing 30 tablets.

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 reviewed in January 2021.

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/.