Besitran 20 mg/ml concentrate for oral solution: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Besitran 20mg/ml oral solution concentrate

Sertraline

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

Keep this leaflet, 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 should not give it to other people, even if they have the same symptoms as you, since it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

What Besitran is and what it is used for
What you need to know before taking Besitran
How to take Besitran
Possible side effects
How to store Besitran
Contents of the pack and other information

1. What Besitran is and what it is used for

Besitran contains sertraline as the active substance. Sertraline belongs to a group of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders.

Besitran can be used to treat:

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

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

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

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

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

If you are unsure why Besitran has been prescribed for you, 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 recently taken medicines called monoamine oxidase inhibitors (MAOIs), such as selegiline or moclobemide, or other medicines similar to MAOIs (such as linezolid). If you stop treatment with sertraline, you must wait at least one week before starting treatment with an MAOI. After stopping treatment with an MAOI, you must wait at least two weeks before starting treatment with sertraline.
If you are taking another medicine called pimozide (a medicine used to treat mental disorders such as psychosis).
If you are taking or have taken disulfiram within the last 2 weeks. Besitran oral solution concentrate must not be used in combination with disulfiram, nor during the first 2 weeks after stopping disulfiram treatment.

Warnings and precautions

Talk to your doctor or pharmacist before starting Besitran.

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

If you have epilepsy (seizures) or a history of seizures. If you have a seizure, contact your doctor immediately.
If you have manic-depressive illness (bipolar disorder) or schizophrenia. If you experience a manic episode, contact your doctor immediately.
If you have or have previously had thoughts of harming yourself or committing suicide (see section below on Suicidal thoughts and worsening of depression or anxiety disorder).
If you have Serotonin Syndrome. This syndrome may rarely occur when taking certain medicines together with sertraline. (For symptoms, see section 4. Possible side effects.) Your doctor will advise you if you have previously experienced this syndrome.
If you have low sodium levels in the blood, as this may occur as a result of treatment with Besitran. You should also inform your doctor if you are taking any medicines for high blood pressure, as these may also affect sodium levels in the blood.
If you are elderly, as you may be at increased risk of low blood sodium levels (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 affect 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 bruise easily), or if you are pregnant (see section Pregnancy, breastfeeding and fertility) or have been taking medicines that reduce blood clotting [e.g. 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 being treated for this disorder, your doctor will want to monitor you closely (see section below on Children and adolescents).
If you are receiving electroconvulsive therapy (ECT).
If you have an eye disorder, such as certain types of glaucoma (increased intraocular pressure).
If you have been told you have an abnormal heart trace on an electrocardiogram (ECG), known as QT interval prolongation.
If you have heart disease, low levels of potassium or magnesium, a family history of QTc prolongation, slow heart rate, or are taking other 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 sit or stand still (akathisia). This occurs more frequently during the first few weeks of treatment. Increasing the dose may worsen this condition, 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 how long you have been taking the medicine, the dose, and how quickly the dose is reduced. These symptoms are usually mild or moderate. However, in some patients they may be severe. These symptoms usually appear in the first few days after stopping treatment. In general, these symptoms resolve on their own and usually disappear within two weeks. In some patients, they may last longer (2–3 months or more). It is recommended that when 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 discontinue treatment.

Suicidal thoughts and worsening of depression or anxiety disorder:

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

You are more likely to experience this if:

You have previously had thoughts of suicide or self-harm.
You are a young adult. Clinical trial data show an increased risk of suicidal behaviour in psychiatric patients under 25 years of age being treated with an antidepressant.

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

It may be helpful for you to tell a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may also ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.

Sexual problems:

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

Children and adolescents

Sertraline should normally not be used to treat children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder (OCD). Patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, thoughts of self-harm or suicide (suicidal ideation), and hostility (mainly aggression, confrontational behaviour, and anger reactions) when taking this class of medicine. Nevertheless, 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 to you and you are under 18 years of age and wish to discuss this decision, please speak to your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen while you are taking Besitran. The long-term safety effects on growth, maturation, learning (cognitive development), and behavioural development of Besitran were evaluated in a long-term study involving over 900 children aged 6 to 16 years, monitored over a period of 3 years. Overall, the study results showed that children treated with sertraline developed normally, except for a slight increase in weight in those treated with a higher dose.

Besitran oral solution concentrate 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 need to take any other medicines.

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

Using Besitran together with the following medicines may cause serious adverse effects:

Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression), selegiline (used to treat Parkinson’s disease), the antibiotic linezolid, and methylene blue (used to treat high levels of methaemoglobin in the blood). Do not use Besitran with these medicines.
Medicines used to treat mental disorders such as psychosis (pimozide). Do not use Besitran with pimozide.
Do not use Besitran oral solution concentrate with disulfiram.

Tell your doctor if you are taking any of 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 1–2 weeks.
Products containing the amino acid tryptophan.
Medicines used to treat severe or chronic pain (opioids, e.g. tramadol, fentanyl).
Medicines used in anaesthesia, e.g. fentanyl, mivacurium, and suxamethonium.
Medicines used to treat migraines (e.g. sumatriptan).
Medicines that reduce blood clotting (warfarin).
Medicines used to treat pain/arthritis [e.g. metamizole, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)].
Sedatives (diazepam).
Diuretics.
Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
Medicines used to treat diabetes (tolbutamide).
Medicines used to treat acidity, ulcers, and heartburn (cimetidine, omeprazole, lansoprazol, pantoprazole, rabeprazole).
Medicines used to treat mania and depression (lithium).
Other medicines used to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
Medicines used to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
Medicines used to treat high blood pressure, chest pain, or to regulate 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 the heart’s electrical activity (e.g. certain antipsychotics and antibiotics).

Taking Besitran with food, drinks and alcohol

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

Alcohol intake should be avoided while being treated with Besitran.

Sertraline should not be taken with grapefruit juice, as it may increase sertraline levels in your body.

Pregnancy, breastfeeding and fertility

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

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 benefit to you outweighs any possible risk to the developing baby.

If you use Besitran in the late 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 be informed that you are taking Besitran so they can advise you. When used during pregnancy, especially during the last 3 months, medicines like Besitran may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.

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

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

Difficulty breathing,
Bluish or unusually hot or cold skin,
Bluish lips,
Vomiting or feeding problems,
Excessive tiredness, inability to sleep, or excessive crying,
Muscle stiffness or decreased muscle tone,
Tremors, restlessness, or seizures,
Increased reflex responses,
Irritability,
Low blood sugar.

If your baby shows any of these symptoms at birth, or if you are concerned about your baby’s health,

consult your doctor or midwife for advice.

Evidence suggests that sertraline passes into breast milk. Therefore, sertraline may only be used in breastfeeding women if your doctor considers that the benefit outweighs any possible risk to the infant.

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

Animal studies have shown that some medicines like sertraline may reduce sperm quality. This could theoretically affect fertility, but the impact on human fertility has not yet been determined.

Driving and using machines

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

Besitran contains alcohol (ethanol)

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

The amount of alcohol in this medicine is unlikely to have an effect in adults and adolescents, and its effect in children is likely to be negligible. It may have some effects in young children, for example, drowsiness.

If you suffer from 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 discomfort, and diarrhoea.

This medicine’s container contains latex rubber. It may cause severe allergic reactions.

3. How to take Besitran

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults:

Depression and Obsessive-Compulsive Disorder (OCD):

For depression and OCD, the usually 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, over several weeks. The maximum recommended dose is 200 mg (10 ml) per day.

Panic disorder, social anxiety disorder, and post-traumatic stress disorder:

For panic disorder, social anxiety disorder, and post-traumatic stress disorder, treatment should be initiated with a dose of 25 mg (1.25 ml) per day, increasing 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 with 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 he or she gives you.

Method of administration:

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

Take your medicine once daily, either in the morning or in the evening.

Your doctor will determine how long you should take this medicine. The duration will depend on the nature of your illness and your response to treatment. It may take several weeks before your symptoms begin to improve. Treatment for depression should usually continue for 6 months after improvement occurs.

Instructions for taking Besitran correctly:

The oral concentrate solution must always be diluted before use. Never drink the concentrate undiluted.

The first time you open the bottle of oral concentrate, you must insert the dropper into the bottle as follows:

Unscrew the cap by pressing firmly down on the cap while turning it to the left (counterclockwise). Remove the cap.
Insert the dropper into the bottle and press it firmly in place. The dropper can be found inside the package.
To open the bottle subsequently, press firmly down on the dropper while turning it to the left (counterclockwise).
After using the dropper, place it back into the bottle.

Measuring the dose:

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

Mix the measured dose with 120 ml (one glass) of liquid, such as water, ginger ale, lemon/lime soda, lemonade, or orange juice.

Do not mix the concentrate with any other liquid than those listed above. The mixture should be taken immediately after preparation. The mixture may appear slightly cloudy, but this is normal.

If you take more Besitran than you should

If you accidentally take too much Besitran, contact your doctor or go to the nearest hospital emergency department. Always bring the medicine container with you, whether or not there is any medicine left.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to take Besitran

Do not take a double dose to make up for a missed dose. If you forget to take a dose, do not take it when you remember. Take the next dose at the usual time.

If you stop taking Besitran

Do not stop taking Besitran unless your doctor tells you to. Your doctor will want to gradually reduce your dose of Besitran over several weeks before you stop taking this medicine completely. If you stop treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremor. If you experience any of these adverse effects, or any other symptoms, while stopping treatment with Besitran, please inform your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Tell your doctor immediately:

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

If you develop a severe skin rash causing blisters (erythema multiforme), (which may affect the mouth and tongue). These may be signs of a condition known as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN). In such cases, your doctor will discontinue treatment.
Allergic reaction or allergy, which may present symptoms such as itchy skin rash, breathing difficulties, wheezing, swelling of the eyelids, face, or lips.
If you experience agitation, confusion, diarrhea, increased body temperature and blood pressure, excessive sweating, and rapid pulse. These are symptoms of serotonin syndrome. This syndrome may rarely occur when taking certain medications concomitantly with sertraline. Your doctor may decide to discontinue treatment.
If you notice yellowing of the skin or eyes, which may indicate liver damage.
If you experience depressive symptoms with thoughts 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 still. Inform your doctor if you start feeling restless.
If you have a seizure (convulsions).
If you experience a manic episode (see section 2. Warnings and precautions).

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

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

Insomnia, dizziness, somnolence, headache, diarrhea, malaise, dry mouth, ejaculation disorders, 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,
Tremor, movement disorders (such as constant movements, muscle tension, difficulty walking, stiffness, spasms, and involuntary muscle movements)*, numbness and tingling, increased muscle tone, difficulty concentrating, abnormal taste,
Visual disturbances,
Tinnitus (ringing in the ears),
Palpitations,
Hot flushes,
Yawning,
Stomach discomfort, constipation, abdominal pain, vomiting, flatulence,
Increased sweating, rash,
Back pain, joint pain, muscle pain,
Menstrual irregularities, erectile dysfunction,
Malaise, chest pain, weakness, fever,
Weight gain,
Injury.

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

Gastroenteritis, ear infection,
Tumour,
Hypersensitivity, seasonal allergy,
Low levels of thyroid hormones,
Suicidal thoughts, suicidal behaviour*, psychotic disorders, abnormal thinking, lack of self-care, hallucinations, aggression, excessive happiness, paranoia,
Amnesia, decreased sensitivity, involuntary muscle contractions, fainting, continuous movements, migraine, seizures, dizziness upon standing, abnormal coordination, speech disorders,
Dilated pupils,
Ear pain,
Rapid pulse, heart problems,
Bleeding disorders (such as stomach bleeding)*, elevated blood pressure, hot flushes, blood in urine,
Shortness of breath, nosebleeds, difficulty breathing possibly with noise,
Black stools, dental disorders, oesophageal inflammation, tongue disorders, haemorrhoids, increased salivation, difficulty swallowing, burping, tongue disorders,
Swelling of eyes, urticaria, hair loss, itching, purple spots on the skin, blistering skin disorders, dry skin, facial swelling, cold sweat,
Osteoarthritis, muscle jerks, muscle cramps*, muscle weakness,
Increased frequency of urination, urinary disorders, urinary retention, urinary incontinence, increased urine volume, need to urinate at night,
Sexual dysfunction, excessive vaginal bleeding, vaginal bleeding, female sexual dysfunction,
Swollen legs, chills, difficulty walking, thirst,
Increased liver enzyme levels, weight loss,
Cases of suicidal thoughts and behaviour have been reported during treatment with sertraline or shortly after discontinuation (see section 2).

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

Diverticulitis, swollen lymph nodes, decreased platelet count*, decreased white blood cell count*,
Severe allergic reaction,
Endocrine disorders*,
High cholesterol, difficulty controlling blood sugar levels (diabetes), low blood sugar, increased blood sugar*, low blood sodium levels*,
Physical symptoms due to stress or emotions, abnormal nightmares*, drug dependence, sleepwalking, premature ejaculation,
Coma, abnormal movements, difficulty moving, increased sensitivity, sudden severe headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS))*, sensory disturbances,
Seeing spots before 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 which could be signs of changes in electrical activity (seen on electrocardiogram) or abnormal heart rhythm*, decreased heart rate,
Circulation problems in arms and legs,
Rapid breathing, progressive scarring in lung tissue (interstitial lung disease)*, throat spasm, difficulty speaking, slower breathing, hiccups,
A form of lung disease in which eosinophils (a type of white blood cell) appear in the lungs in high numbers (eosinophilic pneumonia),
Mouth ulceration, pancreatitis*, blood in stools, tongue ulceration, mouth sores,
Problems with liver function, severe liver function disorders*, yellowing of skin and eyes (jaundice)*,
Skin reaction to sunlight*, skin swelling*, abnormal hair texture, abnormal skin odour, capillary rash,
Rupture of muscle tissue*, bone disorder,
Interrupted urination, decreased urine volume,
Breast secretion, vaginal dryness, genital discharge, penile and foreskin redness and pain, breast enlargement*, prolonged erection,
Hernia, decreased tolerance to the medicine,
Increased cholesterol levels, abnormal laboratory tests*, abnormal semen, coagulation disorders*,
Relaxation of blood vessel dilation process.

Frequency not known: cannot be estimated from available data:

Jaw locking*,
Nocturnal urinary incontinence*,
Partial loss of vision,
Inflammation of the colon (causing diarrhea)*,
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for further information.
Muscle weakness and severe muscle pain, which may be a sign of multiple acyl-coenzyme A dehydrogenase deficiency (MADD).

*Adverse effects reported after marketing.

Other adverse effects in children and adolescents

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

Symptoms that may occur when stopping treatment

If you stop treatment with this medicine abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremor (see section 3. If you stop taking Besitran).

An increased risk of bone fracture has been observed in patients taking this type of medicine.

Reporting of adverse effects

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

5. Storage of Besitran

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

After first opening the container, the medicine may be used for 28 days (4 weeks).

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Besitran

Each ml of oral concentrate solution 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.

Appearance of the product and contents of the pack

Besitran oral concentrate solution is a clear, colourless solution supplied in a 60 ml amber glass bottle together with a calibrated dropper.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Farmasierra Manufacturing S.L.

Carretera de Irún, Km. 26,200

28706 San Sebastián de los Reyes

Madrid, Spain

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

Further information on this medicinal product is available from the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.

Calle General Aranaz, 86

28027 Madrid

Spain

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

Austria	Tresleen
Belgium, Luxembourg	Serlain
Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden	Zoloft
Ireland, United Kingdom (Northern Ireland)	Lustral
Spain	Besitran

Date of the most recent review of this leaflet: July 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/