BESITRAN 20 mg/ml ORAL SOLUTION CONCENTRATE

Introduction

Package Leaflet: Information for the User

Besitran 20mg/ml oral solution concentrate

Sertraline

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Besitran and what is it 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. Package contents and additional information

1. What is Besitran and what is it used for

Besitran contains sertraline as the active ingredient. Sertraline belongs to the group of medications called Selective Serotonin Reuptake Inhibitors (SSRIs); 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).
• Panic disorder (in adults).
• Obsessive-compulsive disorder (OCD) (in adults and in children and adolescents aged 6-17 years).

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

Obsessive-compulsive disorder and anxiety disorders are anxiety-related illnesses with symptoms such as being constantly worried about recurring ideas (obsessions) that lead to repetitive rituals (compulsions).

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

Your doctor has considered that this medication is suitable for treating your illness.

If you are not sure why you have been prescribed Besitran, you should consult your doctor.

2. What you need to know before taking Besitran

Do not take Besitran:

• If you are allergic to sertraline or any of the other components of this medicine (listed in section 6).
• If you are taking or have taken medicines called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other medicines similar to MAOIs (such as linezolid). If you stop treatment with sertraline, you 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 (a medicine used to treat mental disorders such as psychosis).
• If you are taking or have taken disulfiram in the last 2 weeks. Besitran concentrated oral solution should not be used in combination with disulfiram or during the first 2 weeks after stopping treatment with disulfiram.

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 (convulsions), call your doctor immediately.
• If you have manic-depressive illness (bipolar disorder) or schizophrenia. If you have a manic episode, call your doctor immediately.
• If you have or have had thoughts of harming yourself or committing suicide (see below Thoughts of suicide and worsening of your depression or anxiety disorder).
• If you have Serotonin Syndrome. This syndrome can rarely occur when taking certain medicines at the same time as sertraline. (To see the 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 can occur as a result of treatment with Besitran. You should also inform your doctor if you are taking any medicine for hypertension, as these medicines can also alter sodium levels in your blood.
• If you are elderly, as you may be at greater risk of having low sodium levels in your blood (see above).
• 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 it may be necessary to adjust the dose of your diabetes medicines.
• If you have a history of bleeding disorders (tendency to develop bruises), or if you are pregnant (see section Pregnancy, breastfeeding, and fertility) or have been taking medicines that reduce blood clotting [such as acetylsalicylic acid (aspirin) or warfarin] or that may increase the risk of bleeding.
• If you are a child or adolescent under 18 years of age. Besitran should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder (OCD). If you are going 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 graph of your heart that is obtained after an electrocardiogram (ECG), known as prolongation of the QT interval.
• If you have heart disease, have low potassium or magnesium levels, a family history of QTc prolongation, a low heart rate, or are taking concomitantly medicines that prolong the QTc interval.

Restlessness/Akathisia:

The use of sertraline has been associated with unpleasant restlessness and a need to move, often accompanied by an inability to remain seated or standing (akathisia). This occurs more often during the first few weeks of treatment. An increase in 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 experiencing withdrawal symptoms depends on the duration of treatment, dose, and 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 normally disappear within two weeks. In some patients, they can last longer (2-3 months or more). It is recommended that when stopping treatment with sertraline, the dose should be gradually reduced over a period of several weeks or even months, 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 disorder:

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, because all these medicines take time to work, which is usually a few weeks but can sometimes be longer.

This is more likely to happen to you:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. There is information from clinical trials that shows an increased risk of suicidal behavior in adults under 25 years of age with psychiatric illnesses 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 family member or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Sexual problems

Some medicines in the group to which Besitran belongs (called SSRIs) 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 in the treatment of children and adolescents under 18 years of age, except in the case of patients with obsessive-compulsive disorder (OCD). Patients under 18 years of age have a higher risk of adverse effects such as suicidal attempts, thoughts of self-harm or suicide (suicidal ideas), and hostility (predominantly aggression, confrontational behavior, and anger) when they are being treated with this class of medicines. Nevertheless, it is possible that your doctor may decide to prescribe Besitran 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 Besitran and you are under 18 years of age and wish to discuss this decision, please go back to your doctor. You must inform your doctor if any of the symptoms mentioned 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.

Besitran concentrated oral solution contains alcohol (ethanol) and may affect young children (see "Besitran contains alcohol (ethanol)").

Other medicines and Besitran

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

Taking Besitran with the following medicines may cause serious side effects:

• Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (for depression), selegiline (for Parkinson's disease), the antibiotic linezolid, and methylthioninium chloride (methylene blue) (for high levels of methemoglobin in the blood). Do not take Besitran with these medicines.
• Medicines for treating mental disorders such as psychosis (pimozide). Do not take Besitran with pimozide.
• Do not take Besitran concentrated oral solution with disulfiram.

Tell your doctor if you are taking the following medicines:

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

Taking Besitran with food, drinks, and alcohol

Besitran concentrated oral solution can be taken with or without food.

You should avoid drinking alcohol while being treated with Besitran.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The safety of sertraline in pregnant women has not been fully established. If you are pregnant, sertraline will only be given to you if your doctor considers that the benefit to you outweighs any possible risk to the developing baby.

If you use Besitran in the final stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are using Besitran so that they can advise you. When used during pregnancy, especially during the last 3 months, medicines like Besitran may increase the risk of a serious disease in babies called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and have a bluish appearance. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

Besitran concentrated oral solution contains alcohol (ethanol). If you are pregnant, consult your doctor or pharmacist before taking this medicine.

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

• difficulty breathing,
• bluish or too hot or cold skin,
• bluish lips,
• vomiting or feeding problems,
• excessive tiredness, inability to sleep or excessive crying,
• stiffness or decreased muscle tone,
• tremors, restlessness, or convulsions,
• increased reflexes,
• irritability,
• low blood sugar levels.

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 are indications that sertraline passes into breast milk. Therefore, sertraline can only be used in breastfeeding women if their doctor considers that the benefit outweighs any possible risk to the baby.

Besitran concentrated oral solution contains alcohol (ethanol). If you are breastfeeding, consult your doctor or pharmacist before taking this medicine.

In animal studies, it has been seen that some medicines like sertraline may reduce sperm quality. This could theoretically affect fertility; however, the impact on human fertility has not yet been determined.

Driving and using machines

Psychotropic medicines like sertraline may affect your ability to drive or use machines. Therefore, do not drive or operate heavy machinery until you know how this medicine affects your ability to perform these activities.

Besitran contains alcohol (ethanol)

• Each 25 mg (1.25 ml) of Besitran concentrated oral solution contains 181 mg of anhydrous ethanol, which is equivalent to less than 5 ml of beer or 2 ml of wine.
• Each 50 mg (2.5 ml) of Besitran concentrated oral solution contains 362 mg of anhydrous ethanol, which is equivalent to less than 10 ml of beer or 4 ml of wine.
• Each 200 mg (10 ml) of Besitran concentrated oral solution contains 1447 mg of anhydrous ethanol, which is equivalent to less than 37 ml of beer or 15 ml of wine.

It is unlikely that the amount of alcohol in this medicine will have an effect on adults and adolescents, and it is likely that its effect on children will not be significant. It may have some effects on young children, such as drowsiness.

If you have a history of alcoholism, consult your doctor or pharmacist before taking this medicine.

The amount of alcohol in this medicine may alter the effects of other medicines. Consult your doctor or pharmacist if you are taking other medicines.

Besitran contains glycerol

At high doses, it may cause headache, stomach upset, and diarrhea.

The packaging of this medicine contains latex. It may cause severe allergic reactions.

3. How to Take Besitran

Follow your doctor's or pharmacist's administration instructions for this medication exactly. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults:

Depression and Obsessive-Compulsive Disorder:

For depression and OCD, the usual effective dose is 50 mg (2.5 ml) per day. The daily dose may be increased in increments of 50 mg (2.5 ml) at intervals of at least one week, and so on for several weeks. The maximum recommended dose is 200 mg (10 ml) 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 be started with a dose of 25 mg (1.25 ml) per day, and increased to 50 mg (2.5 ml) per day after one week.

The daily dose may be increased in increments of 50 mg (2.5 ml) over a period of several weeks. The maximum recommended dose is 200 mg (10 ml) per day.

Use in Children and Adolescents:

Besitran should only be used to treat children and adolescents aged 6 to 17 years who have OCD.

Obsessive-Compulsive Disorder:

Children aged 6 to 12 years:The recommended starting dose is 25 mg (1.25 ml) per day. After one week, your doctor may increase the dose to 50 mg (2.5 ml) per day. The maximum dose is 200 mg (10 ml) per day.

Adolescents aged 13 to 17 years:The recommended starting dose is 50 mg (2.5 ml) per day. The maximum dose is 200 mg (10 ml) per day.

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

Method of administration:

Besitran oral solution concentrate can be taken with or without food.

Take your medication once a day, either 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 start improving. Treatment of depression usually needs to continue for 6 months after improvement.

Instructions for Taking Besitran Correctly:

The oral solution concentrate should always be diluted before taking. Never drink the concentrate undiluted.

The first time you open the oral concentrate bottle, you must put the dropper in the bottle as follows:

1. Unscrew the cap by pressing it down hard while turning it to the left (counterclockwise). Remove the cap.
2. Put the dropper in the bottle and squeeze it well. You can find the dropper inside the package.
3. To open the bottle later, press the dropper down hard while turning it to the left (counterclockwise).
4. After using the dropper, put it back in the bottle.

Dose Measurement:

Use the dropper to measure the dose prescribed by your doctor.

Mix the measured dose with 120 ml (a glass) of liquid, which can be water, ginger ale, lemon/lime soda, lemonade, or orange juice.

Do not mix the concentrated liquid with any other liquid except those mentioned above. The mixture should be taken immediately after preparation. The mixture may be slightly cloudy, but this is normal.

If You Take More Besitran Than You Should

If you accidentally take an excess of Besitran, contact your doctor or go to the emergency department of the nearest hospital. Always carry the medication package with you, whether there is medication left in it or not.

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

Overdose symptoms may include drowsiness, nausea, and vomiting, rapid heart rate, tremors, agitation, dizziness, and rarely, loss of consciousness.

If You Forget to Take Besitran

Do not take a double dose to make up for forgotten 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 interrupt treatment with Besitran unless your doctor tells you to. Your doctor will want to gradually reduce the dose of Besitran over several weeks before you stop taking this medication altogether. 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 with Besitran, please inform your doctor.

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

4. Possible Side Effects

Like all medications, this medication 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.

Tell Your Doctor Immediately:

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

• If you develop a severe skin rash that causes blisters (erythema multiforme), (can affect the mouth and tongue). These can be signs of a disease known as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN). In these cases, your doctor will interrupt treatment.
• Allergic reaction or allergy, which can present symptoms such as skin rash with itching, breathing problems, wheezing, swelling of the eyelids, face, or lips.
• If you 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 medications at the same time as sertraline. Your doctor may decide to interrupt treatment.
• If you present yellowing of the skin and eyes, which can indicate liver damage.
• If you experience depressive symptoms with ideas of self-harm or suicide (suicidal thoughts).
• If, after starting treatment with Besitran, you begin to feel restless and are unable to sit or stand. You should inform your doctor if you start to feel restless.
• If you have a seizure (convulsions).
• If you have 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, runny nose,
• loss of appetite, increased appetite,
• anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, teeth grinding,
• tremors, muscle movement problems (such as constant movement, muscle tension, difficulty walking, and stiffness, spasms, and involuntary muscle movements)*, numbness and tingling, increased muscle tone, lack of concentration, abnormal taste,
• visual disturbances,
• ringing in the ears,
• palpitations,
• hot flashes,
• yawning,
• stomach upset, constipation, abdominal pain, vomiting, gas,
• increased sweating, rash,
• back pain, joint pain, muscle pain,
• irregular menstrual cycle, erectile dysfunction,
• malaise, chest pain, weakness, fever,
• weight gain,
• injury.

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 movement, 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, hot flashes, blood in urine,
• shortness of breath, nosebleeds, difficulty breathing possibly noisy,
• black stools, dental problems, esophagus inflammation, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders,
• eye swelling, hives, hair loss, itching, purple spots on the skin, skin problems with blisters, dry skin, facial swelling, cold sweat,
• arthrosis, muscle spasms, muscle cramps*, muscle weakness,
• increased urination frequency, urinary disorders, urinary retention, incontinence, increased urine output, need to urinate at night,
• sexual dysfunction, excessive vaginal bleeding, vaginal hemorrhage, female sexual dysfunction,
• swollen legs, chills, difficulty walking, thirst,
• increased liver enzyme levels, weight loss,
• There have been reports of suicidal thoughts and behavior during treatment with sertraline or shortly after its interruption (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, problems 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*, drug dependence, sleepwalking, premature ejaculation,
• coma, abnormal movements, difficulty moving, increased sensitivity, severe headache (which can be a sign of a serious disease known as reversible cerebral vasoconstriction syndrome (RCVS))*, sensory disturbances,
• vision of spots in front of the eyes, glaucoma, double vision, photophobia (eye sensitivity to light), eye bleeding, irregular pupils*, visual disturbances*, tear problems,
• heart attack, dizziness, fainting or chest discomfort that could be signs of changes in electrical activity (seen on an electrocardiogram) or abnormal heart rhythm*, slow heart rate,
• circulation problems in the arms and legs,
• rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, throat spasm, difficulty speaking, slow breathing, hiccups,
• a type of lung disease in which eosinophils (a type of white blood cell) appear in the lungs in high numbers (eosinophilic pneumonia),
• mouth ulcers, pancreatitis*, blood in stool, tongue ulcers, mouth sores,
• liver function problems, serious liver function problems*, yellowing of the skin and eyes (jaundice)*,
• sunburn*, skin swelling*, abnormal hair texture, abnormal skin odor, hair rash,
• muscle rupture*, bone disorder,
• urinary hesitation, decreased urine output,
• breast secretion, vaginal dryness, genital secretion, penile and foreskin pain and redness, breast enlargement*, prolonged erection,
• hernia, decreased drug tolerance,
• increased cholesterol levels, abnormal laboratory tests*, abnormal semen, coagulation problems*,
• relaxation of blood vessel procedure.

Frequency not known: cannot be estimated from available data:

• jaw locking*,
• nocturnal urinary incontinence*,
• partial loss of vision,
• colon inflammation (causing diarrhea)*,
• excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, Breastfeeding, and Fertility" in section 2 for more information.
• Muscle weakness and severe muscle pain, which can be a sign of multiple acyl-CoA dehydrogenase deficiency (MADD).

*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 Stopping Treatment

If you stop treatment with this medication abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors (see section 3. If You Interrupt Treatment with Besitran).

An increased risk of bone fractures has been observed in patients taking this type of medication.

Reporting 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 Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Besitran

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Once the package is opened for the first time, it can be used for 28 days (4 weeks).

Do not store above 30°C.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Besitran Composition

• Each ml of oral solution concentrate contains 20 mg of sertraline (as hydrochloride).
• The other components are: glycerol (E422), ethanol (see section 2 "Besitran contains alcohol (ethanol)" and "Besitran contains glycerol"), butylhydroxytoluene (E321), and levomenthol.

Product Appearance and Package Contents

Besitran oral solution concentrate is a clear, colorless solution that comes in a 60 ml amber glass bottle with a calibrated dropper.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Farmasierra Manufacturing S.L.

Carretera de Irún, Km. 26.200

28709 San Sebastián de los Reyes

Madrid, Spain

or

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

You can request more information about this medication from the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 Madrid

Spain

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

Date of the Last Revision of this Leaflet:July 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/