Sertraline Vir Pharma 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sertraline VIR-PHARMA 100 mg film-coated tablets EFG

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

• 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you experience is serious or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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

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

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

Sertralina Vir-Pharma can be used to treat:

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

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

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

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

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

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

2. BEFORE TAKING SERTRALINE VIR-PHARMA

Do not take Sertraline Vir-Pharma:

• If you are allergic (hypersensitive) to sertraline or to any of the other components of Sertralina Vir-Pharma.
• If you are taking or have recently taken medicines called 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 (an antipsychotic medicine).

Take special care with Sertraline Vir-Pharma:

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

• Serotonin syndrome. In rare cases, this syndrome may occur when you are taking certain medicines at the same time as sertraline. (For symptoms, see section 4. Possible side effects.) Your doctor will advise you if you have previously experienced this syndrome.
• Low sodium levels in the blood, as this condition may occur as a result of treatment with sertraline. You should also inform your doctor if you are taking any medicines for high blood pressure, as these medicines may also affect sodium levels in the blood.
• Take special care if you are elderly, as you may be at increased risk of low sodium levels in the blood (see above).
• Liver disease; your doctor may decide that you should take a lower dose of sertraline.
• Diabetes; sertraline may alter your blood sugar levels, so it may be necessary to adjust the dose of your diabetes medicines.
• Epilepsy or a history of epilepsy. If you have a seizure (convulsion), contact your doctor immediately.
• If you have bipolar disorder (manic-depressive illness) or schizophrenia. If you experience a manic episode, contact your doctor immediately.
• If you have or have previously had suicidal thoughts (see below: Suicidal thoughts and worsening of depression or anxiety disorder).
• If you have had bleeding disorders, have been taking medicines that reduce blood clotting (e.g., acetylsalicylic acid (aspirin) or warfarin), or medicines that may increase the risk of bleeding, or if you are pregnant (see "Pregnancy").
• If you are a child or adolescent under 18 years of age. Sertraline should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder. If you are being 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 most frequently during the first weeks of treatment. Increasing the dose in patients who develop these symptoms may be harmful.

Withdrawal symptoms

When stopping treatment, withdrawal symptoms are common, particularly if treatment is stopped abruptly (see section 4. Possible side effects).

The risk of experiencing withdrawal symptoms depends on the duration of treatment, the dose, and the rate at which the dose is reduced. Generally, these symptoms are mild or moderate. However, in some patients they may be severe. These symptoms usually begin during 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 discontinuing treatment with sertraline, the dose should be gradually reduced over a period of several weeks or even months, according to each patient's individual needs.

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 risk 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 suicidal thoughts or thoughts of self-harm.
• You are a young adult. Clinical trial data show an increased risk of suicidal behavior in psychiatric patients under 25 years of age who are being treated with an antidepressant.

If you have thoughts of harming yourself or of 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 an anxiety disorder, and ask them to read this leaflet. You may also ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behavior.

An increased risk of bone fractures has been observed in patients treated with this type of medicine.

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

Use in children and adolescents

Normally, sertraline should not be used to treat children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder. Patients under 18 years of age have a higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and anger reactions) when taking this class of medicines. Nevertheless, your doctor may decide to prescribe Sertraline Vir-Pharma to a patient under 18 years of age if they consider it to be in the patient’s best interest. If your doctor has prescribed Sertraline Vir-Pharma to a patient under 18 years of age and you 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 a patient under 18 years of age is taking sertraline. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioral development of sertraline in this age group have not yet been established.

Taking other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may affect how Sertraline Vir-Pharma works, or Sertraline Vir-Pharma itself may reduce the effectiveness of other medicines taken at the same time.

Using Sertraline Vir-Pharma together with the following medicines may cause serious adverse effects:

• Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression), selegiline (used to treat Parkinson’s disease), and the antibiotic linezolid. Do not use sertraline together with MAOIs.
• Medicines used to treat mental disorders (pimozide). Do not use sertraline together with pimozide.

Tell your doctor if you are taking the following medicines:

• Herbal remedies 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 used to treat severe pain (e.g., tramadol).
• Medicines used to treat migraines (e.g., sumatriptan).
• Medicines that reduce blood clotting (warfarin).
• Medicines used to treat pain/arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics.
• Medicines used to treat epilepsy (phenytoin).
• Medicines used to treat diabetes (tolbutamide).
• Medicines used to treat stomach acidity and ulcers (cimetidine).
• Medicines used to treat mania and depression (lithium).
• Other medicines used to treat depression (such as amitriptyline, nortriptyline).
• Medicines used to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).

Taking Sertraline Vir-Pharma with food and drinks

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

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Pregnancy

The safety of sertraline in pregnant women has not been fully established. Sertraline should only be given to pregnant women if, in the doctor’s opinion, the benefit to the mother outweighs any possible risk to the fetus. Women of childbearing age who are being treated with sertraline should use an adequate method of contraception.

Make sure your midwife and/or doctor knows that you are taking Sertraline Vir-Pharma. Medicines such as Sertraline Vir-Pharma, when taken during pregnancy—particularly during the last 3 months of pregnancy—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 bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take sertraline in late 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 sertraline so they can advise you.

Breastfeeding

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

Some medicines such as sertraline may reduce sperm quality in animal studies. Theoretically, this could affect fertility, but no impact on human fertility has been observed so far.

Driving and using machines

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

Important information about some of the components of Sertraline 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 SERTRALINE VIR-PHARMA

Follow exactly the dosing instructions for Sertraline Vir-Pharma provided by your doctor.

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

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

Consult your doctor or pharmacist if you have any doubts.

Recommended dosage:

Adults:

Depression and Obsessive-Compulsive Disorder (OCD):

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

Panic Disorder, Social Anxiety Disorder, and Post-Traumatic Stress Disorder (PTSD):

For panic disorder, social anxiety disorder, and post-traumatic stress disorder, treatment should be initiated at a dose of 25 mg per day, increasing to 50 mg per day after one week.

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

Children and adolescents:

Sertraline Vir-Pharma should only be used to treat children and adolescents aged 6 to 17 years with OCD.

Obsessive-Compulsive Disorder (OCD):

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 given.

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

If you take more Sertraline Vir-Pharma than you should

If you accidentally take too much sertraline, contact your doctor or go to the nearest hospital emergency department immediately. 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 name of the medication and the amount ingested.

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

If you forget to take Sertraline Vir-Pharma

If you miss a dose, do not take it when you remember. Take the next dose at the scheduled time.

Do not take a double dose to make up for a missed dose.

If you stop taking Sertraline Vir-Pharma

Do not stop treatment with Sertraline Vir-Pharma unless your doctor advises you to do so. Your doctor will want to gradually reduce your dose of Sertraline Vir-Pharma over several weeks before you stop taking the medication completely. If you stop treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feelings of discomfort, dizziness, and tremors. If you experience any of these adverse effects—or any others—while discontinuing treatment with Sertraline 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, Sertraline Vir-Pharma may cause adverse effects, although not everyone experiences them.

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

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

Tell your doctor immediately

If you experience any of the following symptoms after taking this medicine, as 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 stop treatment.
• Allergic reaction or allergy, which may present symptoms such as itchy skin rash, difficulty breathing, wheezing, swelling of the eyelids, face or lips.
• If you experience agitation, confusion, diarrhoea, increased body temperature and blood pressure, excessive sweating, and rapid pulse. These are symptoms of serotonin syndrome. Rarely, this syndrome may occur when taking certain medicines at the same time as sertraline. Your doctor may decide to stop treatment.
• If you notice yellowing of the skin or eyes, which may indicate liver damage.
• If you experience depressive symptoms with suicidal thoughts.
• If, after starting treatment with Sertraline Vir-Pharma, you begin to feel restless and are unable to sit or stand still. You should inform your doctor if you start feeling restless.

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

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

Insomnia, dizziness, somnolence, headache, diarrhoea, malaise, dry mouth, ejaculation disorders, and fatigue.

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

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

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

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

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

Intestinal problems, ear infection, cancer, swollen lymph nodes, high cholesterol, elevated blood sugar, physical symptoms due to stress or emotions, drug dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation, coma, abnormal movements, difficulty moving, increased sensitivity, sensory disturbances, glaucoma, tear problems, appearance of spots in the visual field, double vision, light damage to the eyes, blood in the eye, dilated pupils, heart attack, decreased heart rate, heart problems, circulation problems in arms and legs, throat spasm, rapid breathing, slowed breathing, difficulty speaking, hiccups, blood in stools, mouth ulcers, tongue ulceration, problems with teeth and tongue, mouth ulceration, liver function problems, skin problems with blisters, capillary rash, abnormal hair texture, abnormal skin odour, bone abnormalities, decreased urine volume, urinary incontinence, interrupted urination, excessive vaginal bleeding, vaginal dryness, penile and foreskin redness and pain, genital discharge, prolonged erection, nipple discharge, hernia, injection site scar, reduced tolerance to medicines, difficulty walking, abnormal laboratory tests, abnormal semen, injury, vasodilation procedure, seeing spots before the eyes, glaucoma, double vision, photophobia (eye sensitivity to light), eye haemorrhages, irregular pupils, visual disturbances, tear problems.

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

Partial loss of vision, inflammation of the colon (causing diarrhoea), heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see "Pregnancy" 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).

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

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

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, diarrhoea, and nausea.

Reporting of adverse effects:

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

5. Storage of SERTRALINE VIR-PHARMA

Keep out of the reach and sight of children.

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Sertraline Vir-Pharma

• The active substance of Sertraline Vir-Pharma is sertraline (hydrochloride). Each tablet contains 100 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 contents of the pack

Sertraline Vir-Pharma 100 mg is presented as white or almost white film-coated tablets, capsule-shaped and scored.

Sertraline Vir-Pharma is available in two pack 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 patient information leaflet has been reviewed in August 2025