SERTRALINE VIR PHARMA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sertraline VIR-PHARMA 50 mg film-coated tablets EFG

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

• 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

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

1. What is SERTRALINE VIR-PHARMA and what is it used for

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

Sertraline Vir-Pharma can be used to treat:

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

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

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

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

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

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

2. BEFORE TAKING SERTRALINA VIR-PHARMA

Do not take Sertralina Vir-Pharma:

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

Be careful with Sertralina Vir-Pharma:

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

• Serotonin syndrome. This syndrome can occur rarely when taking certain medicines at the same time as sertraline. (See section 4, Possible side effects). Your doctor will tell you 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. You should also inform your doctor if you are taking any medicine for high blood pressure, as these medicines 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 it may be necessary to adjust the dose of your diabetes medicines.
• Epilepsy or history of epilepsy. If you have a seizure (convulsions), call your doctor immediately.
• If you have manic-depressive illness (bipolar disorder) or schizophrenia. If you have a manic episode, call your doctor immediately.
• If you have or have had suicidal thoughts (see below, Suicidal thoughts and worsening of your depression or anxiety).
• If you have had bleeding disorders, have been taking medicines that reduce blood clotting (e.g., aspirin, warfarin) or that may increase the risk of bleeding, or if you are pregnant (see "Pregnancy").
• If you are a child or adolescent under 18 years of age. Sertraline should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder. If you are going to be treated for this disorder, your doctor will want to monitor you closely (see below, Use in children and adolescents).
• If you are receiving electroconvulsive therapy (ECT).

Restlessness/ Akathisia

The use of sertraline has been associated with akathisia (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 interrupted, it is common for withdrawal symptoms to appear, particularly if treatment is stopped abruptly (see section 4, Possible side effects).

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

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 committing suicide. 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 sometimes can be longer.

This is more likely to happen

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

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

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

There has been an observed increase in the risk of bone fractures in patients treated with this type of medicine.

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

Use in children and adolescents

Normally, sertraline should not be used in the treatment of children and adolescents under 18 years of age, except in the case of patients with obsessive-compulsive disorder. Patients under 18 years of age have a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and anger) when they are treated with this class of medicines. Nevertheless, it is possible that your doctor may decide to prescribe Sertraline Vir-Pharma to a patient under 18 years of age if they consider it is the most suitable option for the patient. If your doctor has prescribed Sertraline Vir-Pharma to a patient under 18 years of age and you wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen when a patient under 18 years of age is taking sertraline. Also, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of sertraline in this age group have not yet been demonstrated.

Use of other medicines

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

Some medicines may affect how Sertralina Vir-Pharma works, or Sertralina Vir-Pharma may reduce the effectiveness of other medicines that you are taking at the same time.

The use of Sertralina Vir-Pharma with the following medicines may cause serious side effects

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

Tell your doctor if you are taking the following medicines

• Herbal medicines containing St. John's Wort (Hypericum perforatum). The effects of St. John's Wort may last 1-2 weeks. Inform your doctor.
• Products containing the amino acid tryptophan.
• Medicines for treating severe pain (e.g., tramadol).
• Medicines for treating migraines (e.g., sumatriptan).
• Medicines that reduce blood clotting (warfarin).
• Medicines for treating pain/arthritis (non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen, 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 Vir-Pharma with food and drinks

Sertralina Vir-Pharma tablets can be taken with or without food.

You should avoid drinking alcohol while being treated with sertraline.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

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

Make sure your midwife and/or doctor knows that you are taking Sertralina Vir-Pharma. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Sertralina Vir-Pharma may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take Sertralina in the final stage of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Sertralina so they can advise you.

Breastfeeding

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

Some medicines like sertraline may reduce sperm quality in animal studies. Theoretically, this could affect fertility, but the impact on human fertility has not been observed yet.

Driving and using machines

Antidepressant 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.

Important information about some of the ingredients of Sertralina Vir-Pharma

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

3. HOW TO TAKE SERTRALINA VIR-PHARMA

Follow the instructions for taking Sertralina Vir-Pharma exactly as indicated by your doctor.

Sertralina Vir-Pharma tablets can be taken with or without food.

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

Consult your doctor or pharmacist if you have any doubts.

The recommended dose is:

Adults:

Depression and Obsessive-Compulsive Disorder:

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

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

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

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

Children and Adolescents:

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

Obsessive-Compulsive Disorder:

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

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

If you have liver or kidney problems, inform your doctor and follow the instructions they give you.

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

If you take more Sertralina Vir-Pharma than you should

If you accidentally take too much sertraline, contact your doctor or go to the emergency department of the nearest hospital. Always take the medicine packaging with you, whether it contains medicine or not.

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

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

If you forget to take Sertralina Vir-Pharma

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

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

If you stop taking Sertralina Vir-Pharma

Do not stop taking Sertralina Vir-Pharma unless your doctor tells you to. Your doctor will want to gradually reduce the dose of Sertralina Vir-Pharma over a period of several weeks before you stop taking this medicine altogether. If you stop treatment abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling unwell, or feeling dizzy and trembling. If you experience any of these side effects, or any other side effects during the interruption of your treatment with Sertralina Vir-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, Sertralina Vir-Pharma can cause adverse effects, although not all people suffer from them.

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

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

Inform your doctor immediately

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

• If you develop a severe skin rash that causes blisters (erythema multiforme), (can affect the mouth and tongue). These can be signs of a disease known as Stevens-Johnson Syndrome or toxic epidermal necrolysis (TEN). In these cases, your doctor will interrupt treatment.
• Allergic reaction or allergy, which can present symptoms such as skin rash with itching, breathing problems, wheezing, swelling of the eyelids, face, or lips.
• If you present agitation, confusion, diarrhea, increased temperature and blood pressure, excessive sweating, and accelerated pulse. These are symptoms of serotonin syndrome. In rare cases, this syndrome can occur when taking certain medications at the same time as sertraline. Your doctor may decide to interrupt treatment.
• If you present a yellowish color of the skin and eyes, which can indicate liver damage.
• If you experience depressive symptoms with suicidal ideas.
• If after starting treatment with Sertralina Vir-Pharma, you begin to feel a sensation of restlessness and are unable to sit or stand. You should inform your doctor if you start to feel restless.

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

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

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

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

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

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

Chest cold, 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 flashes, difficulty breathing possibly noisy, shortness of breath, nasal bleeding, esophageal problems, difficulty swallowing, hemorrhoids, increased salivation, alteration of the tongue, belching, eye swelling, purple spots on the skin, hair loss, cold sweat, dry skin, hives, arthritis, muscle weakness, back pain, muscle spasms, need to urinate at night, urinary retention, increased urine volume, increased frequency of urination, urinary disorders, vaginal hemorrhage, female sexual dysfunction, discomfort, chills, fever, weakness, thirst, weight loss, and weight gain.

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

Intestinal problems, ear infection, cancer, lymph node swelling, high cholesterol, elevated blood sugar, physical symptoms due to stress or emotions, drug dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation, coma, abnormal movements, difficulty moving, increased sensitivity, sensory disturbances, glaucoma, lacrimation problems, appearance of spots in the visual field, double vision, eye damage from light, blood in the eye, dilated pupils, heart attack, decreased heart rate, heart problems, circulation problems in the arms and legs, throat spasm, rapid breathing, slower breathing, difficulty speaking, hiccups, blood in stool, mouth sores, tongue ulcers, dental and tongue problems, mouth ulcers, liver function problems, skin problems with blisters, capillary rash, abnormal hair texture, abnormal skin odor, bone alteration, decreased urination, urinary incontinence, interrupted urination, excessive vaginal bleeding, vaginal dryness, pain and redness of the penis and foreskin, genital secretion, prolonged erection, breast secretion, hernia, injection site scar, decreased drug tolerance, difficulty walking, abnormal laboratory tests, abnormal semen, injury, vascular relaxation procedure, vision of spots in front of the eyes, glaucoma, double vision, photophobia (eye sensitivity to light), eye bleeding, irregular pupils, visual disturbances, tear problems.

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

Partial loss of vision, colon inflammation (causing diarrhea), abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information, muscle weakness and intense muscle pain, which can be a sign of multiple acyl-CoA dehydrogenase deficiency (MADD).

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

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

Adverse effects in children and adolescents

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 VIR-PHARMA

Keep out of the reach and sight of children.

Do not use Sertralina Vir-Pharma after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

6. ADDITIONAL INFORMATION

Composition of Sertralina Vir-Pharma

• The active ingredient of Sertralina Vir-Pharma is sertraline (hydrochloride). Each tablet contains 50 mg of sertraline.

The other components are: microcrystalline cellulose, lactose monohydrate, copovidone, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica.

Coating: hypromellose, hydroxypropylcellulose, titanium dioxide (E-171), and macrogol.

Appearance of the product and packaging content

Sertralina Vir-Pharma 50 mg is presented in film-coated tablets of white or almost white color, capsule-shaped, and scored.

Sertralina Vir-Pharma is available in two packaging sizes: 30 and 500 tablets. The tablets are presented in PVC-Aluminum blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Industria Química y Farmacéutica VIR, S.A.

C/. Laguna 66-68-70, 28923 ALCORCÓN (Madrid)

Spain

Manufacturer:

KERN PHARMA, S.L.

Pol. Ind. Colon II

Venus, 72, E-08228. TERRASSA. (Barcelona)

Spain

or

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

This prospectus was revised in August 2025