Sertraline Sun 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Sertraline Sun 50 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Sertraline Sun 50 mg tablets.

3. How to take Sertraline Sun.

4. Possible side effects.

5. How to store Sertraline Sun.

6. Contents of the pack and other information.

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

Sertralina Sun contains sertraline as the active substance. Sertraline belongs to a group of medicines known as Selective Serotonin Re-uptake Inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders.

Sertraline 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 you used to.

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

PTSD is a disorder that may occur after an emotionally traumatic experience, and which 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: talking to 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 suitable for treating your condition.

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

2. What you need to know before taking Sertraline Sun

Do not take Sertraline Sun:

• If you are allergic to sertraline or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking or have recently taken medicines known as monoamine oxidase inhibitors (MAOIs), such as selegiline or 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

Talk to your doctor or pharmacist before starting Sertraline Sun.

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

• If you have epilepsy (seizures) or a history of seizures: If you have a seizure, 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 had or currently have thoughts of harming yourself or of suicide (see below – Suicidal thoughts and worsening of depression or anxiety disorder).
• If you have Serotonin Syndrome. This syndrome may rarely occur when taking certain medicines together with sertraline. (For symptoms, see section 4. Possible side effects.) Your doctor will advise whether you have previously experienced this syndrome.
• If you have 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 medicines for high blood pressure, as these may also affect blood sodium levels.
• If you are elderly, as you may be at increased risk of low blood sodium levels (see previous point).
• If you have liver disease; your doctor may decide that you should take a lower dose of sertraline.
• If you have diabetes: Sertraline may affect your blood sugar levels, so it may be necessary to adjust the dose of your diabetes medicines.
• If you have a history of bleeding disorders (tendency to bruise easily), or if you are pregnant (see section Pregnancy, breastfeeding and fertility) or have been taking medicines that reduce blood clotting [e.g., acetylsalicylic acid (aspirin), or warfarin] or that may increase the risk of bleeding. 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 (OCD). If you are being treated for this condition, your doctor will want to monitor you closely (see below – “Use in children and adolescents”).
• If you are receiving electroconvulsive therapy (ECT).
• If you have any eye disorders, such as certain types of glaucoma (increased intraocular pressure).
• If you have been told you have an abnormality on the heart tracing obtained from an electrocardiogram (ECG), known as QT interval prolongation.
• If you have heart disease, low levels of potassium or magnesium, a family history of QTc prolongation, slow heart rate, or are taking concomitantly medicines that prolong the QTc interval.

Restlessness/Akathisia:

The use of sertraline has been associated with unpleasant restlessness and an urge to move, often accompanied by an inability to sit or stand still (akathisia). This occurs most frequently during the first weeks of treatment. Increasing the 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 experiencing withdrawal symptoms depends on how long you have been taking the medicine, the dose, and how quickly the dose is reduced. Generally, these symptoms are mild or moderate. However, in some patients they may be severe. These symptoms usually begin in 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, and you should always discuss the best way to discontinue treatment with your doctor.

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 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.
• If 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 getting worse, or if they are concerned about changes in your behaviour.

Sexual problems:

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

Children and adolescents:

Sertraline should normally not be used in the treatment of children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder (OCD). Patients under 18 years of age have a higher risk of adverse effects such as suicide attempts, thoughts of self-harm or suicide (suicidal ideation), and hostility (mainly aggression, confrontational behaviour, and anger reactions) when taking this class of medicines. Nevertheless, your doctor may decide to prescribe sertraline 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 sertraline to you and you are under 18 years of age and wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen while you are taking sertraline. The long-term safety effects of sertraline on growth, maturation, cognitive development, and behavioural development were evaluated in a long-term study involving more than 900 children aged 6 to 16 years, monitored over a period of 3 years. Overall, study results showed that children treated with sertraline developed normally, except for a slight increase in weight in those receiving higher doses.

Other medicines and Sertraline Sun

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

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

Using sertraline together with the following medicines may cause serious adverse effects:

• Medicines known as monoamine oxidase inhibitors (MAOIs), such as moclobemide (for treating depression), selegiline (for treating Parkinson’s disease), the antibiotic linezolid, and methylene blue (for treating high levels of methaemoglobin in the blood). Do not use sertraline with these medicines.
• Medicines used to treat mental disorders such as psychosis (pimozide). Do not use sertraline together 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 1–2 weeks.
• Products containing the amino acid tryptophan.
• Medicines for severe or chronic pain (opioids, e.g., tramadol, fentanyl).
  • Medicines used in anaesthesia (e.g., fentanyl, mivacurium, and suxamethonium).
• Medicines for migraine (e.g., sumatriptan).
• Medicines that reduce blood clotting (warfarin).
• Medicines for pain/arthritis [e.g., metamizole, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)].
• Sedatives (diazepam).
• Diuretics.
• Medicines for epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines for diabetes (tolbutamide).
• Medicines for acidity, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medicines for mania and depression (lithium).
• Other medicines for depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medicines for schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medicines for high blood pressure, chest pain, or to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide, propafenone).
• Medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Medicines used to treat HIV/AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
• Medicines known to increase the risk of changes in the heart’s electrical activity (e.g., some antipsychotics and antibiotics).

Taking Sertraline with food, drinks, and alcohol

Sertraline tablets can be taken with or without food.

Alcohol should be avoided while you are being treated with sertraline.

Sertraline tablets should not be taken with grapefruit juice, as it may increase 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 become pregnant, consult your doctor or pharmacist before using 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 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 Sertraline Sun so they can advise you appropriately.

When taken during pregnancy, especially during the last three months, medicines like sertraline may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.

Your newborn baby may experience other conditions, which usually appear within the first 24 hours after birth. Symptoms include:

• difficulty breathing,
• blue or unusually hot or cold skin,
• blue lips,
• vomiting or feeding problems,
• excessive tiredness, inability to sleep, or excessive crying,
• muscle stiffness or decreased muscle tone,
• tremors, restlessness, or seizures,
• increased reflex responses,
• irritability,
• low blood sugar.

If your baby shows any of these symptoms at birth, or if 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 is evidence that sertraline passes into breast milk. Therefore, sertraline can only be used in women who are breastfeeding if your doctor considers that the benefit outweighs any possible risk to the infant.

Animal studies have shown that some medicines like sertraline may reduce sperm quality. This could theoretically affect fertility; however, the impact on human fertility has not yet been determined.

Driving and use of machines:

Psychotropic 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.

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 Sertraline Sun

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

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 increments of 50 mg 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.

Use in children and adolescents:

Sertraline 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 the instructions he or she gives you.

Method of administration:

Sertraline tablets may be taken with or without food.

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

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. Treatment for depression should usually continue for 6 months after improvement occurs.

If you take more Sertraline Sun than you should:

If you accidentally take too much sertraline, contact your doctor or go to the nearest hospital emergency department. Always bring the medicine packaging with you, even if no medication remains.

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

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 Sertraline Sun:

Do not take a double dose to make up for missed doses. If you forget to take a dose, do not take it when you remember. Take the next dose at the scheduled time.

If you stop taking Sertraline Sun:

Do not stop treatment with sertraline unless your doctor tells you to. Your doctor will want to gradually reduce the dose of sertraline over several weeks before you stop taking this medicine completely. If you stop treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremor. If you experience any of these adverse effects, or any other symptoms, while discontinuing treatment with sertraline, please inform your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The most common adverse effect is nausea. Adverse effects are dose-dependent and often diminish or disappear with continued treatment.

Tell your doctor immediately:

If you experience any of the following symptoms after taking this medicine, as these symptoms 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 discontinue treatment.
• Allergic reaction or allergy, which may present symptoms such as skin rash with itching,

breathing difficulties, 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 concomitantly with 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 thoughts of self-harm or suicide (suicidal thoughts).

• If, after starting treatment with sertraline, you begin to feel restless and are unable to sit or stand still. You should inform your doctor if you start feeling restless.

• If you have a seizure (convulsion).

• If you experience a manic episode (see section 2. Warnings and precautions).

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, somnolence, headache, diarrhea, malaise, dry mouth, ejaculation disorders, 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,
• Tremor, movement disorders (such as constant movements, muscle tension, difficulty walking, rigidity, spasms, and involuntary muscle movements), numbness and tingling, increased muscle tone, difficulty concentrating, abnormal taste,
• Visual disturbances,
• Ringing in the ears,
• Palpitations,
• Hot flushes,
• Yawning,
• Stomach discomfort, constipation, abdominal pain, vomiting, flatulence,
• Increased sweating, rash,
• Back pain, joint pain, muscle pain,
• Menstrual irregularities, erectile dysfunction,
• Malaise, chest pain, weakness, fever,
• Weight gain,
• Injury.

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

• Gastroenteritis, ear infection,
• Tumour,
• Hypersensitivity, seasonal allergy,
• Low levels of thyroid hormones,
• Suicidal thoughts, suicidal behaviour*, psychotic disorders, abnormal thoughts, lack of self-care, hallucinations, aggression, excessive happiness, paranoia,
• Amnesia, decreased sensitivity, involuntary muscle contractions, fainting, continuous movements, migraine, seizures, dizziness upon standing, abnormal coordination, speech disorders, dilated pupils,
• Ear pain,
• Rapid pulse, heart problems,
• Bleeding disorders (such as stomach bleeding)*, elevated blood pressure, hot flushes, blood in urine,
• Shortness of breath, nosebleeds, difficulty breathing possibly noisy,
• Black stools, dental disorders, inflammation of the oesophagus, tongue disorders, haemorrhoids, increased salivation, difficulty swallowing, burping, tongue disorders,
• Swelling of eyes, urticaria, hair loss, itching, purple spots on the skin, blistering skin disorders, dry skin, facial swelling, cold sweats,
• Osteoarthritis, muscle twitching, muscle cramps*, muscle weakness,
• Increased frequency of urination, urinary disorders, urinary retention, urinary incontinence, increased urine volume, need to urinate at night,
  • Sexual dysfunction, excessive vaginal bleeding, vaginal bleeding, female sexual dysfunction,
  • Swollen legs, chills, difficulty walking, thirst,
• Increased liver enzyme levels, weight loss,
• Cases of suicidal thoughts and behaviour have been reported during treatment with sertraline or shortly after discontinuation (see section 2).

Rare (may affect up to 1 in 1,000 patients):

• Diverticulitis, swollen lymph nodes, decreased platelet count*, decreased white blood cell count*,
• Endocrine disorders,
• High cholesterol, difficulty controlling blood sugar levels (diabetes), low blood sugar, increased blood sugar levels*, low blood sodium levels*,
• Physical symptoms due to stress or emotions, abnormal nightmares, drug dependence, sleepwalking, premature ejaculation,
• Severe allergic reaction,
• Coma, abnormal movements, difficulty moving, increased sensitivity, sudden severe headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS))*, sensory disturbances,
• Seeing spots in front of the eyes, glaucoma, double vision, photophobia (eye sensitivity to light), eye bleeding, irregular pupils*, visual disturbances*, tear problems,
• Heart attack, dizziness, fainting or chest discomfort which could be signs of changes in electrical activity (seen on electrocardiogram) or abnormal heart rhythm*,
• Decreased heart rate,
• Circulation problems in arms and legs,
• Throat spasm, rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, slower breathing, difficulty speaking, hiccups,
• Pancreatitis, blood in stools, mouth sores, tongue ulceration, mouth ulceration,
• Liver function problems, serious liver dysfunction*, yellow skin and eyes (jaundice)*,
• Skin reaction to sunlight*, skin swelling*, capillary rash, abnormal hair texture, abnormal skin odour,
• Rhabdomyolysis*, bone disorder,
• Reduced urine volume, interrupted urination,
• Breast enlargement*, vaginal dryness, pain and redness of the penis and foreskin, genital discharge, prolonged erection, milk secretion,
• Hernia, decreased tolerance to the medicine,
• Abnormal semen, increased cholesterol levels, abnormal laboratory tests*, coagulation problems*,
• Relaxation of blood vessel processes.

Frequency not known: cannot be estimated from available data:

• Jaw locking*,
• Nocturnal urinary incontinence*,
• Inflammation of the colon (causing diarrhea),
• Partial loss of vision,
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see “Pregnancy, breastfeeding and fertility” in section 2 for more information,
• Muscle weakness and severe muscle pain, which may be a sign of multiple acyl-coenzyme A 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 occur when treatment is discontinued:

If you stop treatment with this medicine abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremor (see section 3. “If you stop taking Sertraline”).

An increased risk of bone fracture has been observed in patients taking this type of medicine.

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sertraline Sun

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

6. Pack contents and additional information

Composition of Sertraline Sun 50 mg tablets

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

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

Appearance of the product and pack contents

Sertraline Sun 50 mg are white, film-coated, oval, scored tablets on one side. They are available in packs of 30 tablets.

Date of the last review of this leaflet: June 2025

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/