Leaflet: information for theuser

Besitran10mg film-coated tablets

Sertraline

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

• Keep thisleaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your 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 starting totakeBesitran

3. How to takeBesitran

4. Possible side effects

5. Storage ofBesitran

6. Contents of the pack and additional information

Besitrancontains sertraline as its active ingredient. Sertralinebelongs to a group of medications known asIndoleSelectiveSerotoninReuptakeInhibitors(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 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 (a medication used to treat mental disorders such as psychosis).

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Besitran.

Medications are not always suitable for everyone. Before starting treatment with Besitran, inform 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, 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 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. (See section 4. Possible side effects). Your doctor will inform you if you have previously had this syndrome.
• If you have low sodium levels in your blood, as this condition 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 a higher 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).
• 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 closely monitor you (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 abnormal heart rhythm that is obtained after an electrocardiogram (ECG), known as QT prolongation.
• If you have heart disease, low potassium or magnesium levels, a family history of QT prolongation, low heart rate, or are taking medications that prolong the QT 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 discontinuation of treatment (withdrawal symptoms) are common, particularly if treatment is discontinued 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, dose, and rate of dose reduction. Generally, these symptoms are mild or moderate. However, in some patients, they can be severe. These symptoms usually occur within the first few days after discontinuing treatment. In general, these symptoms usually resolve on their own and typically 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 a period of several weeks or even months, and you should always agree with your doctor on the best way to discontinue treatment.

Thoughts of suicide and worsening of 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 can be longer.

You are more likely to experience this:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. 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 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.

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 treatment is discontinued.

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). Children and adolescents under 18 years old are at a higher risk of side effects such as suicidal thoughts, thoughts of self-harm, or suicide (suicidal ideation) and hostility (predominantly aggression, confrontational behavior, and irritable reaction) when treated with this class of medications. However, it is possible that 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 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 while 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 containing St. John's Wort (Hypericum perforatum). The effects of St. John's Wort may last 1-2 weeks.
• Products containing the amino acid tryptophan.
• Medications for treating severe or chronic pain (opioids, such as tramadol, fentanyl).
• Medications used in anesthesia (such as fentanyl, mivacurium, and suxamethonium).
• Medications for treating migraines (such as sumatriptan).
• Medications that reduce blood clotting (warfarin).
• Medications for treating pain/arthritis [such as metamizole, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)].
• Sedatives (diazepam).
• Diuretics.
• Medications for treating epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medications for treating diabetes (tolbutamide).
• Medications for treating acid reflux, ulcers, and stomach burning (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 regulating 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.

Avoid consuming alcohol while being treated with Besitran.

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

Pregnancy, breastfeeding, and fertility:

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

The safety of sertraline in pregnant women has not been fully established. 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 be aware that you are taking Besitran so that they can advise you.

When taken during pregnancy, especially in the last three months, medications like 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 begin 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, inability to sleep, or excessive crying,

• muscle stiffness or decreased muscle tone,

• tremors, restlessness, or seizures,

• increased reflexes,

• irritability,

• low blood sugar.

If your baby has any of these symptoms at birth, or if 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 who are 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; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.

The recommended dose is:

Adults:

Depression and Obsessive-Compulsive Disorder:

The usually effective dose for depression and OCD is 50 mg per day. The daily dose can be increased by 50 mg at intervals of at least one week, and thus for 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.

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 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..

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, even if it is empty.

You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of overdose may include drowsiness, nausea, 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.Do not take the missed dose 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 medicines, this medicine can 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 medicine, as these symptoms can be serious.

• If you develop a severe skin rash that causes blisters (erythema multiforme), (which can 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 can 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 can occur when taking certain medicines 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):

• Cold (chest), sore throat, coughing,
• Loss of appetite, increased appetite,
• Anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, teeth grinding,
• Tremor, muscle movement problems(such as constant movements, muscle tension, difficulty walking, and stiffness, spasms, and involuntary muscle movements)*,Numbness and tingling, increased muscle tone, lack of concentration, 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, lack of care, hallucinations, aggression, excessive happiness, paranoia,
• Amnesia, decreased sensitivity, involuntary muscle contractions, fainting, continuous movements, migraine, convulsions, dizziness when standing up, 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 difficulty,
• 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, need to urinate at night,
• 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*, dependence on medicines, sleepwalking, 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 problems,
• 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 ulceration, pancreatitis*, blood in stool, tongue ulceration, 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 medicine,
• Increased cholesterol levels,abnormal laboratory tests*, abnormal semen, coagulation problems*,
• Relaxation of blood vessel procedure.

Frequency not known: cannot be estimated from available data:

• Trigeminal nerve block*,
• Nocturnal urinary incontinence*,
• Partial loss of vision,
• Colonic inflammation (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 Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 packaging and unused medications at the SIGRE collection pointofthepharmacy.In case of doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Besitran

• Each film-coated tablet contains sertraline hydrochloride equivalent to 100mg of sertraline.

The other components are:

calcium hydrogen phosphate dihydrate (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 100 mg is presented in white, film-coated tabletswith a capsule shape (13.1 x 5.2 mm), engraved with “VLE” on one side and “ZLT 100” on the other.

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 responsible manufacturer

Marketing authorization holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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 review date of this leaflet: March2025

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/