SERTRALINE SUN 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sertraline Sun 50 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Sertraline Sun is and what it is used for.
2. What you need to know before you take Sertraline Sun 50 mg tablets.
3. How to take Sertraline Sun.
4. Possible side effects.
5. Storing Sertraline Sun.

1. Contents of the pack and other information

1. What Sertraline Sun is and what it is used for

Sertraline Sun 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 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 to 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 performing 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 feeling intense anxiety or distress in social situations (e.g., talking to strangers, speaking in public, eating or drinking in front of others, or worrying about behaving in a shameful way).

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

If you are not sure why you have been prescribed sertraline, you should ask your doctor.

2. What you need to know before you take Sertraline Sun

Do not take Sertraline Sun:

• If you are allergic to sertraline or any of the other ingredients of this medicine (listed in section 6).
• If you are taking or have taken in the last 14 days 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 (a medicine used to treat mental disorders such as psychosis).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Sertraline Sun.

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

• If you have epilepsy (seizures) or a history of seizures: 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 or have had thoughts of harming yourself or suicidal thoughts (see below - Suicidal thoughts and worsening of your depression or anxiety).
• If you have Serotonin Syndrome. This syndrome can occur when taking certain medicines at the same time as sertraline. (For symptoms, see section 4. Possible side effects). Your doctor will tell you if you have had this syndrome before.

if you are taking certain medications that may increase the risk of serotonin syndrome.

Restlessness/Akathisia:

The use of sertraline has been associated with unpleasant restlessness and a need to move, often accompanied by an inability to sit or stand still (akathisia). This occurs more often during the first few weeks of treatment. An increase in dose may be harmful, so if you develop these symptoms, you should contact your doctor.

Withdrawal symptoms

Side effects related to stopping treatment (withdrawal symptoms) are common, especially if treatment is stopped abruptly (see section 3. If you stop taking Sertraline Sun and section 4. Possible side effects). The risk of withdrawal symptoms depends on the duration of treatment, dose, and 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 occur 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, and you should always agree with your doctor on the best way to stop treatment.

Suicidal thoughts and worsening of your depression or anxiety:

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or suicidal thoughts. This may increase at the beginning of treatment with antidepressants, due to the fact that 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 had suicidal thoughts 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 of age with psychiatric disorders who are being treated with an antidepressant.

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

It may be helpful for you to tell a relative 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 worried about changes in your behavior.

Sexual problems:

Some medicines like sertraline (called SSRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents:

Sertraline should not normally be used in the treatment of children and adolescents under 18 years, except in patients with obsessive-compulsive disorder (OCD). Patients under 18 years have an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and anger) when they are treated with this class of medicines. However, it may be that your doctor decides to prescribe sertraline to a patient under 18 years if they consider it is in the patient's best interest. If your doctor has prescribed sertraline to you and you are under 18 years, and you want to discuss this decision, please go back to your doctor. You should tell your doctor if any of the symptoms mentioned above appear or worsen when you are taking sertraline. The long-term safety of sertraline in terms of growth, maturation, and cognitive and behavioral development was evaluated in a long-term study in over 900 children aged 6-16 years who were monitored for a period of 3 years. In general, the study results showed that children treated with sertraline developed normally, except for a slight increase in weight in those treated with a higher dose.

Other medicines and Sertraline Sun

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may affect the way sertraline works, or sertraline itself may reduce the effectiveness of other medicines being taken at the same time.

The use of sertraline 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), the antibiotic linezolid, and methylthioninium chloride (methylene blue) (for high levels of methemoglobin in the blood). Do not use sertraline with these medicines.
• Medicines for treating mental disorders such as psychosis (pimozide). Do not use sertraline with pimozide.

Tell your doctor if you are taking the following medicines:

• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity.

• Herbal medicines containing St. John's Wort (Hypericum perforatum).

The effects of St. John's Wort may last for 1-2 weeks.

• Products containing the amino acid tryptophan.
• Medicines for treating severe or chronic pain (opioids, such as tramadol, fentanyl).
  • Medicines used in anesthesia (such as fentanyl, mivacurium, and suxamethonium).

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• Medicines for treating migraines (such as sumatriptan).
• Medicines that reduce blood clotting (warfarin).
• Medicines for treating pain/arthritis [such as metamizole, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)].

Taking Sertraline Sun with food, drinks, and alcohol

Sertraline tablets can be taken with or without food.

You should avoid drinking alcohol while being treated with sertraline.

Sertraline tablets should not be taken in combination with grapefruit juice, as it can increase the levels of sertraline in your body.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The safety of sertraline in pregnant women has not been fully established. If you are pregnant, sertraline will only be given to you if your doctor considers that the benefit to you outweighs any possible risk to the developing baby.

If you take Sertraline Sun during the last 3 months of pregnancy, you may experience an increased risk of heavy vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Sertraline Sun so they can advise you.

When taken during pregnancy, especially during the last 3 months, medicines like sertraline may increase the risk of a serious condition in babies called persistent pulmonary hypertension (PPHN), which makes the baby breathe faster and have a bluish appearance. These symptoms usually start during the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

Your newborn baby may have other conditions, which usually appear during the first 24 hours after birth. The symptoms include:

• difficulty breathing,
• bluish or too hot or cold skin,
• bluish lips,
• vomiting or feeding problems,
• excessive tiredness, inability to sleep or excessive crying,
• stiffness or decreased muscle tone,
• tremors, restlessness, or convulsions,
• increased reflexes,
• irritability,
• low blood sugar levels.

If your baby has any of these symptoms at birth, or you are concerned about your baby's health, consult your doctor or midwife for advice.

Breastfeeding

Consult your doctor or pharmacist before taking any medicine.

There are indications that sertraline passes into breast milk. Therefore, sertraline can only be used in breastfeeding women if your doctor considers that the benefit outweighs any possible risk to the baby.

In animal studies, it has been shown that some medicines like sertraline may reduce sperm quality. Theoretically, this could affect fertility; however, the impact on human fertility has not yet been determined.

Driving and using machines:

Psychotropic medicines like sertraline may 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 Sun contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Sertralina Sun

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

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.

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

For anxiety disorder, social anxiety disorder, and post-traumatic stress disorder, 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 intervals of 50 mg over a period of several weeks. The maximum recommended dose is 200 mg per day.

Use in children and adolescents:

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

Obsessive-Compulsive Disorder:

Children from 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 from 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 they give you.

Method of administration:

Sertralina tablets can be taken with or without food.

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

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 start improving. Treatment of depression should normally continue for 6 months after improvement.

If you take more Sertralina Sun than you should:

If you accidentally take an excess of sertralina, contact your doctor or go to the emergency department of the nearest hospital. Always carry the medication package with you, whether or not there is medication left in it.

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

The symptoms of overdose may include drowsiness, nausea, and vomiting, increased heart rate, tremors, agitation, dizziness, and rarely loss of consciousness.

If you forget to take Sertralina Sun:

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, do not take it when you realize it. Take the next dose when it is due.

If you interrupt treatment with Sertralina:

Do not interrupt treatment with sertralina unless your doctor indicates it. Your doctor will want to gradually reduce the dose of sertralina over several weeks before you stop taking this medication definitively. If you interrupt treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors. If you experience any of these adverse effects, or any other during the interruption of your treatment with sertralina, please inform your doctor.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

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

Tell your doctor immediately:

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

• If you develop a severe skin rash with 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 experience agitation, confusion, diarrhea, increased temperature and blood pressure, excessive sweating, and increased pulse. These are symptoms of serotonin syndrome.

Rarely, this syndrome can occur when taking certain medications at the same time as sertralina. Your doctor may decide to interrupt treatment.

• If you present yellowing of the skin and eyes, which can indicate liver damage.
• If you present depressive symptoms with ideas of self-harm or suicide (suicidal thoughts).

The following adverse effects were observed in clinical trials in adults and after marketing, "Adverse effects".

Very common (may affect more than 1 in 10 patients):

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

Common (may affect up to 1 in 10 patients):

• chest cold, sore throat, runny nose,
• loss of appetite, increased appetite,
• anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, teeth grinding,
• tremors, muscle movement problems (such as constant movement, muscle tension, difficulty walking, and stiffness, spasms, and involuntary muscle movements), numbness and tingling, increased muscle tone, lack of concentration, abnormal taste,
• visual disturbances,
• ringing in the ears,
• palpitations,
• hot flashes,
• yawning,
• stomach discomfort, constipation, abdominal pain, vomiting, gas,
• increased sweating, rash,
• back pain, joint pain, muscle pain,
• irregular menstrual cycle, erectile dysfunction
• discomfort, chest pain, weakness, fever,
• weight gain,
• injury.

Uncommon (may affect up to 1 in 100 patients):

• diverticulitis, swollen lymph nodes, decreased platelets*, decreased white blood cell count*,
• endocrine problems,
• high cholesterol, problems controlling blood sugar levels (diabetes), low blood sugar, high blood sugar*, low sodium levels in the blood*,
• physical symptoms due to stress or emotions, abnormal nightmares, drug dependence, sleepwalking, premature ejaculation,
• severe allergic reaction,
• coma, abnormal movements, difficulty moving, increased sensitivity, severe headache (which can be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS))*, sensory disturbances,
• vision problems, glaucoma, double vision, photophobia (eye sensitivity to light), eye bleeding, irregular pupils*, visual disturbances*, tear problems,
• heart attack, dizziness, fainting or chest discomfort that may be signs of changes in heart activity (seen on an electrocardiogram) or abnormal heart rhythm*,
• decreased heart rate,
• circulation problems in the arms and legs,
• throat spasms, rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, slow breathing, difficulty speaking, hiccups,
• pancreatitis, blood in stool, mouth sores, tongue ulcers, mouth ulcers,
• liver function problems, severe liver function problems*, yellowing of the skin and eyes (jaundice)*,
• sunburn*, skin swelling* capillary rash, abnormal hair texture, abnormal skin odor,
• muscle rupture*, bone disorder
• decreased urine volume, interrupted urination,

• increased chest size*, vaginal dryness, penile pain and redness, genital discharge, prolonged erection, breast secretion,

• hernia, decreased drug tolerance,
• abnormal semen, increased cholesterol levels, abnormal laboratory tests*, coagulation problems*,
• relaxation of blood vessel procedure.

Rare (may affect up to 1 in 1000 patients):

• diverticulitis, swollen lymph nodes, decreased platelets*, decreased white blood cell count*,
• endocrine problems,
• high cholesterol, problems controlling blood sugar levels (diabetes), low blood sugar, high blood sugar*, low sodium levels in the blood*,
• physical symptoms due to stress or emotions, abnormal nightmares, drug dependence, sleepwalking, premature ejaculation,
• severe allergic reaction,
• coma, abnormal movements, difficulty moving, increased sensitivity, severe headache (which can be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS))*, sensory disturbances,
• vision problems, glaucoma, double vision, photophobia (eye sensitivity to light), eye bleeding, irregular pupils*, visual disturbances*, tear problems,
• heart attack, dizziness, fainting or chest discomfort that may be signs of changes in heart activity (seen on an electrocardiogram) or abnormal heart rhythm*,
• decreased heart rate,
• circulation problems in the arms and legs,
• throat spasms, rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, slow breathing, difficulty speaking, hiccups,
• pancreatitis, blood in stool, mouth sores, tongue ulcers, mouth ulcers,
• liver function problems, severe liver function problems*, yellowing of the skin and eyes (jaundice)*,
• sunburn*, skin swelling* capillary rash, abnormal hair texture, abnormal skin odor,
• muscle rupture*, bone disorder
• decreased urine volume, interrupted urination,

• increased chest size*, vaginal dryness, penile pain and redness, genital discharge, prolonged erection, breast secretion,

• hernia, decreased drug tolerance,
• abnormal semen, increased cholesterol levels, abnormal laboratory tests*, coagulation problems*,
• relaxation of blood vessel procedure.

Frequency not known: cannot be estimated from the available data:

• jaw locking*,
• nocturnal enuresis*,
• colon inflammation (which causes diarrhea),
• partial loss of vision,
• excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information,
• muscle weakness and severe muscle pain, which can be a sign of multiple acyl-CoA dehydrogenase deficiency (MADD)*.

*Adverse effects reported after marketing

Other 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.

Symptoms that may appear when treatment is interrupted:

If you interrupt treatment with this medication abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors (see section 3. "If you interrupt treatment with Sertralina").

An increased risk of bone fractures has been observed in patients taking this type of medication.

Reporting of adverse effects

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

5. Conservation of Sertralina Sun

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away through wastewater or household waste. Deposit the packages and medications you no longer need in the SIGRE point of your usual pharmacy. Ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Sertralina Sun 50mg tablets

The active ingredient is sertralina. Each tablet contains 50 mg of sertralina (equivalent to 55.96 mg of sertralina hydrochloride).

The other components are: microcrystalline cellulose, calcium phosphate dihydrate, sodium starch glycolate (Type A), hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, and talc.

Appearance of the product and package contents

Sertralina Sun 50 mg are film-coated, oblong tablets, scored on one side and white in color. They are available in packages of 30 tablets.

Date of the last revision of this leaflet:June 2025

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