Leaflet: information for theuser

Besitran 50mg film-coated tablets

Sertralina

Read this leaflet carefully before you start taking thismedicine, because 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 youonly, and you should not give it to others even if they have the same symptomsas you, as it may harm them.
• Ifyou experienceside effects, consultyour doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1. What isBesitranand what it is used for

2. What you need to know before taking Besitran

3. How to take Besitran

4. Possible side effects

5. Storage of Besitran

6. Contents of the pack and additional information

Besitrancontains sertraline as the active ingredient. Sertralinebelongs to a group of medications known asInhibitors ofSelective Serotonin Reuptake(ISRS); these medications are used to treat depression and/or anxiety disorders.

Besitrancan 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 this medication suitable for treating your condition.

If you are unsure why you have been prescribed Besitran, you should consult your doctor.

Do not take Besitran:

• If you are allergic to sertraline or any of the other components of this medication (including those listed in section 6).
• If you are taking or have taken medications called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other similar medications (such as linezolid). If you stop taking sertraline, wait at least one week before starting treatment with an MAOI. After stopping treatment with an MAOI, wait at least two weeks before starting treatment with sertraline.
• If you are taking another medication called pimozide (a medication used to treat mental disorders such as psychosis).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Besitran.

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

• If you have epilepsy (seizures) or a history of convulsions. 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 thoughts of harming yourself or committing suicide (see below Thoughts of suicide and worsening of your depression or anxiety).
• If you have Serotonin Syndrome. In rare cases, this syndrome can occur when taking certain medications at the same time as sertraline. (To see symptoms, read 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 may occur as a result of treatment with Besitran. Also, inform your doctor if you are taking any medication for high blood pressure, as these medications can also alter sodium levels in the blood.
• If you are elderly, as you may be at greater risk of having low sodium levels in the blood (see previous point).
• If you have liver disease; your doctor may consider that you should take a lower dose of Besitran.
• If you have diabetes; Besitran may alter your blood sugar levels, so you may need to adjust the dose of your diabetes medication.
• If you have a history of bleeding disorders (tendency to develop hemorrhages), or if you are pregnant (see section Pregnancy, breastfeeding and fertility) or have taken medications that reduce blood clotting [such as aspirin, or warfarin] or that may increase the risk of bleeding.
• If you are a child or adolescent under 18 years old. Besitran should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder (OCD). If you are to be treated for this disorder, your doctor will want to monitor you closely (see below "Children and adolescents").
• If you are receiving electroconvulsive therapy (ECT).
• If you have any eye disorder, such as certain types of glaucoma (increased intraocular pressure).
• If you have been told that you have an abnormality in the heart rhythm that is obtained after an electrocardiogram (ECG), known as prolongation of the QT interval.
• If you have heart disease, low potassium or magnesium levels, or a family history of QTc prolongation, low heart rate, or are taking medications that prolong the QTc interval.

Restlessness/Acatisia:

The use of sertraline has been associated with unpleasant restlessness and a need to move, often accompanied by an inability to sit or stand still (acatisia). This occurs more often during the first few 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, particularly if treatment is stopped abruptly (see section 3. If you stop taking Besitran and 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. Generally, these symptoms are mild or moderate. However, in some patients, they can be severe. These symptoms usually occur during the first few days after stopping treatment. In general, these symptoms usually resolve on their own and usually resolve 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 be gradually reduced over a period of several weeks or even months, and you should always agree with your doctor on the best way to stop treatment.

Thoughts of suicide and worsening of your depression or anxiety:

If you are depressed and/or have anxiety disorders, you may have thoughts of harming yourself or committing suicide. This may increase at the beginning of treatment with antidepressants, as all these medications take time to take effect, which is usually two weeks but sometimes longer.

You are more likely to experience this:

• If you have previously had thoughts of suicide or harming yourself.
• 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 were 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 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.

Sexual problems:

Some medications in the group to which Besitran belongs (called ISRS) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

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 (OCD). Young patients are at greater risk of side effects such as attempts to commit suicide, thoughts of harming themselves or committing suicide (suicidal thoughts), and hostility (predominantly aggression, confrontational behavior, and irritable reaction) when treated with this class of medications. However, your doctor may decide to prescribe Besitran to a patient under 18 years old if they consider it to be the most suitable option for the patient. If your doctor has prescribed Besitran and you are under 18 years old and want to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen when you are taking Besitran. The long-term effects on safety and related to growth, maturity, and learning (cognitive development) and behavioral development of Besitran were evaluated in a long-term study in over 900 children aged 6 to 16 years who were monitored for a period of 3 years. In general, the results of the study showed that children treated with sertraline developed normally, except for a slight increase in weight in those treated with a higher dose.

Other medications and Besitran:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

The use of Besitran with the following medications may cause severe side effects:

• Medications called 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 methemoglobin in the blood). Do not use Besitran with these medications.
• Medications for treating mental disorders such as psychosis (pimozide). Do not use Besitran with pimozide.

Inform your doctor if you are taking the following medications:

• Medications containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).
• Medications based on plants that contain St. John's Wort (Hypericum perforatum). The effects of St. John's Wort may last 1-2 weeks.
• Products containing the amino acid tryptophan.
• Medications for treating severe or chronic pain (opioids, for example tramadol, fentanyl).
• Medications used in anesthesia (for example fentanyl, mivacurium, and suxamethonium).
• Medications for treating migraines (for example sumatriptan).
• Medications that reduce blood clotting (warfarin).
• Medications for treating pain/arthritis [for example, metamizole, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin].
• Sedatives (diazepam).
• Diuretics.
• Medications for treating epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medications for treating diabetes (tolbutamide).
• Medications for treating acid reflux, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medications for treating mania and depression (lithium).
• Other medications for treating depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medications for treating schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medications for treating high blood pressure, chest pain, or to regulate heart rate (such as verapamil, diltiazem, flecainide, propafenone).
• Medications used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
• Medications used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Medications used to treat HIV/AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir).
• Medications used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
• Medications known to increase the risk of changes in heart rhythm (such as some antipsychotics and antibiotics).

Taking Besitran with food, drinks, and alcohol:

Besitran tablets can be taken with or without food.

Alcohol should be avoided while being treated with Besitran.

Do not take sertraline with grapefruit juice, as it may increase the levels of sertraline in your body.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The safety of sertraline has not been fully established in pregnant women. If you are pregnant, sertraline will only be administered if your doctor considers that the benefits for you outweigh any possible risk to the developing fetus.

If you take Besitran in the final stages of pregnancy, there may be an increased risk of excessive vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Besitran so that they can advise you.Besitran may increase the risk of a serious condition in newborns called persistent pulmonary hypertension (PPHN), which causes the baby to breathe faster and appear blue. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

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

• difficulty breathing,

• blue skin or too hot or cold,

• blue lips,

• vomiting or feeding problems,

• excessive tiredness, unable to sleep, or crying a lot,

• muscle stiffness or decreased muscle tone,

• tremors, restlessness, or convulsions,

• increased reflexes,

• irritability,

• low blood sugar.

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

There is evidence that sertraline passes into breast milk. Therefore, sertraline can only be used in women while breastfeeding if your doctor considers that the benefits outweigh any possible risk to the baby.

In animal studies, some medications like sertraline have been shown to reduce sperm quality. Theoretically, this could affect fertility, but it has not been determined in humans.

Driving and operating machinery:

Psychotropic medications 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.

Besitran contains sodium:

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

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

The recommended dose is:

Adults:

Depression and Obsessive-Compulsive Disorder:

The usually effective dose for depression and OCD is 50mg per day. The daily dose can be increased by 50mg at intervals of at least one week, and thus forseveral weeks. The maximum recommended dose is 200mg 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 25mg per day, and increased to 50mg per day after one week.

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

Use in children and adolescents:

Besitran 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 25mg per day. After one week, your doctor may increase the dose to 50mg per day. The maximum dose is 200mg per day.

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

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

Administration form:

Besitran tablets can be taken with or without food.

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

Your doctor will indicate the duration of treatment with this medication. The duration will depend on the nature of your illness and your response to treatment. It will take several weeks for your symptoms to improve. Depression treatment should continue for 6 months after improvement.

If you take more Besitran than you should

If you accidentally take an excess ofBesitran, contact your doctor or go to the nearest hospital emergency service. Always carry the medication packaging with you, whether it is empty 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 Besitran

Do not take a double dose to compensate for the missed doses. If you forget to take a dose, do not take it when you remember.Take the next dose when it is due.

If you interrupt treatment with Besitran

Do not stop treatment withBesitranunless your doctor tells you to. Your doctor will want to gradually reduce the dose ofBesitranover several weeks before stopping it completely. If you stop treatment abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors. If you experience any of these side effects or any other during the interruption of your treatment withBesitran, please inform your doctor.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

The most common side effect is nausea. Side effects depend on the dose and often disappear or decrease 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 stop treatment.
• Allergic reaction or allergy, which may present symptoms such as skin rash with itching, breathing problems, ringing, 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 sertraline. Your doctor may decide to stop treatment.
• If you experience yellowing of the skin and eyes, which may indicate liver damage.
• If you experience depressive symptoms with thoughts of self-harm or suicide (suicidal thoughts).
• If you start feeling restless and are unable to sit or stand after starting treatment with Besitran. Inform your doctor if you start feeling restless.
• If you experience a seizure (convulsions).
• If you experience a manic episode (see section 2. Warnings and precautions).

The following side effects were observed in clinical trials in adults and after marketing.

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

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

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

• Common cold (chest), sore throat, runny nose,
• Loss of appetite, increased appetite,
• Anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, bruxism,
• Tremor, muscle movement disorders(such as constant movements, muscle tension, difficulty walking, and stiffness, spasms, and involuntary muscle movements)*,Numbness and tingling, increased muscle tone, difficulty concentrating, abnormal taste,
• Visual disturbances,
• Tinnitus in the ears,
• Palpitations,
• Angina,
• Yawning,
• Abdominal discomfort, constipation, abdominal pain, vomiting, gas,
• Increased sweating, rash,
• Back pain, joint pain, muscle pain,
• Irregular menstrual cycle, erectile dysfunction,
• Feeling unwell, chest pain, weakness, fever,
• Weight gain,
• Lesion.

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

• Gastroenteritis, ear infection,
• Tumor,
• Hypersensitivity, seasonal allergy,
• Low thyroid hormone levels,
• Suicidal thoughts, suicidal behavior*, psychotic disorders, abnormal thoughts, neglect, hallucinations, aggression, excessive happiness, paranoia,
• Amnesia, decreased sensitivity, involuntary muscle contractions, fainting, continuous movements, migraine, convulsions, dizziness when standing, abnormal coordination, speech disorders,
• Dilated pupils,
• Ear pain,
• Rapid pulse, heart problems,
• Bleeding problems (such as stomach bleeding)*, high blood pressure, angina, blood in urine,
• Shortness of breath, nasal bleeding, possibly noisy breathing difficulties,
• Black stools, dental disorders, esophageal inflammation, tongue problems, hemorrhoids, excessive salivation, difficulty swallowing, belching, tongue disorders,
• Swollen eyes, urticaria, hair loss, itching, purple spots on the skin, skin disorders with blisters, dry skin, facial swelling, cold sweat,
• Arthritis, muscle spasms, muscle cramps*, muscle weakness,
• Increased frequency of urination, urinary disorders, urinary retention, incontinence, increased urine volume, nocturia,
• Female sexual dysfunction, excessive vaginal bleeding, vaginal hemorrhage, female sexual dysfunction,
• Swollen legs, chills, difficulty walking, thirst,
• Increased liver enzymes, weight loss,
• Cases of suicidal thoughts and behavior have been reported during treatment with sertraline or shortly after its discontinuation (see section 2).

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

• Diverticulitis, lymph node swelling, low platelet count*, low white blood cell count*,
• Severe allergic reaction,
• Endocrine problems*,
• High cholesterol, difficulty controlling blood sugar levels (diabetes), low blood sugar,high blood sugar*, low sodium levels in the blood*,
• Physical symptoms due to stress or emotions,abnormal nightmares*, medication dependence, somnambulism, premature ejaculation,
• Coma, abnormal movements, difficulty moving, increased sensitivity,severe headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS))*,sensorial disturbances,
• Seeing spots in front of the eyes, glaucoma, double vision, photophobia (light sensitivity), eye hemorrhages, irregular pupils*, visual disturbances*, eye disorders,
• Heart attack,dizziness, fainting, or chest discomfort that may be signs of changes in electrical activity (seen on the electrocardiogram) or abnormal heart rhythm*, decreased heart rate,
• Problems with circulation in the arms and legs,
• Accelerated breathing,progressive formation of lung tissue scars (interstitial lung disease)*, throat spasm, difficulty speaking, slower breathing, hiccups,
• A type of lung disease in which eosinophils (a type of white blood cell) appear in the lungs in large numbers (eosinophilic pneumonia),
• Mouth ulcers, pancreatitis*, blood in stool, tongue ulcers, mouth sores,
• Liver function problems,severe liver function problems*, yellow skin and eyes (jaundice)*,
• Sun sensitivity reaction*, skin swelling*, abnormal hair texture, abnormal skin odor,capillary eruption,
• Muscle tissue rupture*, bone disorders,
• Intermittent urination, decreased urine volume,
• Mammary secretion, vaginal dryness,genital secretion, pain and redness of the penis and prepuce, breast enlargement*, prolonged erection,
• Hernia, decreased tolerance to the medication,
• Increased cholesterol levels,abnormal laboratory results*, abnormal semen, coagulation disorders*,
• Relaxation of blood vessel procedure.

Frequency not known: cannot be estimated from available data:

• Trigeminal nerve block*,
• Nocturnal urinary incontinence*,
• Partial loss of vision,
• Colitis (which causes diarrhea)*,
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy, lactation, and fertility” in section 2 for more information.

*Side effects reported after marketing.

Other 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.

Symptoms that may appear when treatment is stopped

If you stop treatment abruptly, you may experience side effects such asdizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremor(see section 3. If you stop treatment with Besitran).

A higher risk of bone fractures has been observed in patients taking this type of medication.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for the Vigilance 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.

Keepthis medicationout ofsight and out of reach of children.

Do not usethis medicationafter the expiration date that appears on the packagingafter CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection pointofthepharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. In this way, you will help protect the environment.

Composition of Besitran

• Each film-coated tablet contains sertraline hydrochloride equivalent to 50mg of sertraline.

The other components are:

calcium dihydroxide phosphate (E341), microcrystalline cellulose (E460), hydroxypropyl cellulose (E463), sodium glycolate starch (type A, from potato),(see section 2 “Besitran contains sodium”), magnesium stearate (E572), hypromellose 2910/3mPas(E464), hypromellose 2910/6 mPas(E464), titanium dioxide (E171), macrogol 400 (E1521), macrogol 8000 (E1521) and polysorbate 80 (E433).

Appearance of the product and contents of the package

Besitran 50 mg is presented in white, film-coated tabletswith a capsule shape (10.3 x 4.2 mm), engraved with “VLE” on one side and “ZLT50”on the other. The tablets can be divided into equal parts.

Besitran is available in blisters containing 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 98, 100, 200, 294, 300 or 500 tablets, and in blister strips containing 30x1.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

TOWA Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97,

Martorelles,

08107 Barcelona,

Spain

or

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1?

79108 Freiburg Im Breisgau

Germany

or

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

Calle General Aranaz, 86

28027 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Last revision date of this leaflet: March 2025

Further detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/