Package Insert: Information for the User

Sertraline VIR-PHARMA 50 mg Film-Coated Tablets

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm 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 package insert, inform your doctor or pharmacist.

1. What Sertraline Vir-Pharma is and for what it is used

2. Before taking Sertraline Vir-Pharma

3. How to take Sertraline Vir-Pharma

4. Possible adverse effects

5. Storage of Sertraline Vir-Pharma

6. Additional information

Sertralina 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.

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

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

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

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

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

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

Do not take Sertralina 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 been taking medications called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other similar medications to MAO (such as linezolid). If you discontinue sertraline treatment, wait at least one week before starting MAOI treatment. After discontinuing MAOI treatment, wait at least two weeks before starting sertraline treatment.
• If you are taking another medication called pimozide (an antipsychotic medication).

Be especially 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. In rare cases, this syndrome can occur when taking certain medications at the same time as sertraline. (See section 4. Possible side effects). Your doctor will let you know if you have had this syndrome before.
• If you have low sodium levels in your blood, as this can occur as a result of sertraline treatment. Also, inform your doctor if you are taking any medications for high blood pressure, as these medications can also alter sodium levels in the blood.
• Be especially careful if you are elderly, as you may be at greater risk of having low sodium levels in the blood (see above).
• Liver disease; your doctor may consider that you should take a lower dose of sertraline.
• Diabetes; sertraline may alter your blood sugar levels, so you may need to adjust the dose of your diabetes medications.
• Epilepsy or a history of epilepsy. If you have a seizure (convulsion), call your doctor immediately.
• If you have manic-depressive illness (bipolar disorder), or schizophrenia. If you have a manic episode, call your doctor immediately.
• If you have or have had suicidal thoughts (see below, suicidal thoughts and worsening of depression or anxiety).
• If you have had bleeding disorders, have been taking medications that decrease blood clotting (such as aspirin or warfarin), or if you are pregnant (see“Pregnancy”).
• If you are a child or adolescent under 18 years old. Sertraline should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder. If you are 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/Acatisia

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

Withdrawal symptoms

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

The risk of withdrawal symptoms depends on the duration of treatment, the dose, and the rate at which the dose is reduced. These symptoms are usually mild or moderate. However, in some patients, they can be severe. These symptoms usually occur during the first few days after treatment is stopped. In general, these symptoms resolve on their own and usually resolve within two weeks. In some patients, they may last longer (2-3 months or more). It is recommended that when discontinuing sertraline treatment, the dose be gradually reduced over several weeks or even months, as needed for each patient.

Suicidal thoughts and worsening of depression or anxiety

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. This can increase at the beginning of treatment with antidepressants, as these medications take time to become effective, which is usually two weeks, but sometimes 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 with psychiatric disorders who are being treated with an antidepressant.

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

It may be helpful for you to explain to a close family member or friend that you are depressed or have anxiety, and ask them to read this leaflet. You may 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 increased risk of bone fractures in patients treated with this type of medication.

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

Use in children and adolescents

Normally, sertraline should not be used to treat children and adolescents under 18 years old, except in the case of patients with obsessive-compulsive disorder. Young patients are at greater risk of side effects such as suicidal thoughts, suicidal behavior, and hostility (primarily aggression, confrontational behavior, and irritable reactions) when treated with this class of medications. However, your doctor may decide to prescribe Sertralina Vir-Pharma to a patient under 18 years old if they consider it to be the best option for the patient. If your doctor has prescribed Sertralina Vir-Pharma to a patient under 18 years old and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen in a patient under 18 years old taking sertraline. Additionally, the long-term safety effects and those related to growth, maturity, and cognitive and behavioral development of sertraline in this age group have not yet been demonstrated.

Use of other medications

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

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

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

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

Inform your doctor if you are taking the following medications

• Herbal products containing St. John's Wort (Hypericum perforatum). The effects of St. John's Wort may persist for 1-2 weeks. Inform your doctor.
• Products containing the amino acid tryptophan.
• Medications for severe pain (e.g., tramadol).
• Medications for migraines (e.g., sumatriptan).
• Medications that decrease blood clotting (warfarin).
• Medications for pain/arthritis (nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin).
• Sedatives (diazepam).
• Diuretics.
• Medications for epilepsy (phenytoin).
• Medications for diabetes (tolbutamide).
• Medications for stomach acid and ulcers (cimetidine).
• Medications for mania and depression (lithium).
• Other medications for depression (such as amitriptyline, nortriptyline).
• Medications for 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.

It is recommended to avoid drinking alcohol while being treated with sertraline.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Make sure your midwife and/or doctor know that you are taking Sertralina Vir-Pharma. When taken during pregnancy, particularly in the last three months of pregnancy, medications like Sertralina Vir-Pharma 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 turn blue. These symptoms usually start within 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 stages of pregnancy, there may be 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 Sertralina so they can advise you.

Breastfeeding

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

Some medications, such as sertraline, may reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but there is no observed impact on human fertility so far.

Driving and operating machinery

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

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

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

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

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

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

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

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

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

Children and Adolescents:

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

Obsessive-Compulsive Disorder:

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

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

If you have liver or kidney problems, inform your doctor and follow their instructions..

Your doctor will indicate the duration of treatment with this medication. The duration will depend on the nature of your illness and your response to treatment. It may take several weeks for your symptoms to improve.

If you take more Sertralina Vir-Pharma than you should:

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

You can also call the 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, rapid heart rate, 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 compensate for the missed doses.

If you interrupt treatment with Sertralina Vir-Pharma:

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

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

Like all medications, Sertralina Vir-Pharma may cause side effects, although not everyone will experience them.

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

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

Inform your doctor immediately

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

• If you develop a severe skin rash that causes 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 these cases, your doctor will discontinue treatment.
• Allergic reaction or allergy, which may present symptoms such as skin rash with itching, breathing problems, ringing in the ears, swelling of the eyelids, face, or lips.
• If you experience agitation, confusion, diarrhea, increased temperature and blood pressure, excessive sweating, and rapid pulse. These are symptoms of serotonin syndrome. In rare cases, this syndrome may occur when taking certain medications at the same time as sertralina. Your doctor may decide to discontinue treatment.
• If you experience yellowing of the skin and eyes, which may indicate liver damage.
• If you experience depressive symptoms with suicidal thoughts.
• If you start feeling restless and are unable to sit or stand after initiating treatment with Sertralina Vir-Pharma. Inform your doctor if you start feeling restless.

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

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

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

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

Sore throat, loss of appetite, increased appetite, depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased libido, teeth grinding, numbness and tingling, tremor, 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.

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

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

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

Intestinal problems, ear infection, cancer, lymph node swelling, high cholesterol, elevated blood sugar, physical symptoms due to stress or emotions, medication dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation, coma, abnormal movements, difficulty moving, increased sensitivity, sensory disturbances, glaucoma, eye tear problems, visual field spots, double vision, eye light damage, blood in the eye, dilated pupils, heart attack, decreased heart rate, heart problems, circulation problems in the arms and legs, throat spasms, rapid breathing, slow breathing, speech difficulties, hiccups, blood in stool, mouth sores, tongue ulceration, dental and tongue problems, mouth ulceration, liver function problems, skin blisters, capillary eruption, abnormal hair texture, abnormal skin odor, bone alterations, decreased urine production, urinary incontinence, interrupted urination, excessive vaginal bleeding, vaginal dryness, penile and prepuce pain and redness, genital secretion, prolonged erection, breast secretion, hernia, injection site scar, decreased tolerance to medications, walking difficulties, abnormal laboratory tests, abnormal semen, injury, vasodilation procedure, visual spots in front of the eyes, glaucoma, double vision, photophobia (sensitivity to light), eye hemorrhages, irregular pupils, visual disturbances, eye tear problems

Unknown frequency(cannot be estimated from available data):

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

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

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

Side effects in children and adolescents

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

Reporting of side effects:

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

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 disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

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 contents of the package

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

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Industria Química y Farmacéutica VIR, S.A.

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

Spain

Responsible for manufacturing:

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 leaflet has been reviewed in January 2021