SERTRALINE MABO 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sertraline Mabo 50 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Sertraline Mabo is and what it is used for
2. What you need to know before you take Sertraline Mabo
3. How to take Sertraline Mabo
4. Possible side effects
5. Storage of Sertraline Mabo
6. Contents of the pack and other information

1. What Sertraline Mabo is and what it is used for

This medicine contains sertraline as the active ingredient. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders.

Sertraline Mabo can be used to treat

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

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

OCD and anxiety disorders are anxiety-related conditions with symptoms such as being constantly worried about recurring ideas (obsessions) that lead to performing repetitive rituals (compulsions).

PTSD 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 condition. It is characterized by feeling intense anxiety or distress in social situations (e.g., talking to strangers, speaking in public, eating or drinking in front of others, or worrying about behaving in a shameful way).

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

If you are not sure why you have been prescribed this medicine, you should ask your doctor.

2. What you need to know before you take Sertraline Mabo

Do not take Sertraline Mabo

• If you are allergic to sertraline or any of the other ingredients of this medicine (listed in section 6).
• If you are taking or have taken in the last 14 days 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 (an antipsychotic medicine).

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you start taking this medicine

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

• Serotonin syndrome. This syndrome can occur when taking certain medicines at the same time as sertraline. (See 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 condition may occur as a result of treatment with sertraline. You should also tell your doctor if you are taking any medicine for high blood pressure, as these medicines can also affect sodium levels in your blood.
• Be extra careful if you are elderly, as you may have a higher risk of having low sodium levels in your blood (see above).
• Liver disease; your doctor may consider that you should take a lower dose of sertraline.
• Diabetes; sertraline may affect your blood sugar levels, so you may need to adjust the dose of your diabetes medicines.
• Epilepsy or history of epilepsy. 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 suicide (see below thoughts of suicide and worsening of your depression or anxiety disorder).
• If you have had bleeding disorders, 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. Sertraline should only be used to treat children and adolescents aged 6 to 17 years who have obsessive-compulsive disorder. 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).

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

Restlessness/ Akathisia

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

Withdrawal symptoms

When treatment is stopped, it is common for withdrawal symptoms to appear, particularly if treatment is stopped abruptly (see 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 appear 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, according to the needs of each patient.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or suicide. This may increase at the start of treatment with antidepressants, due to the fact that these medicines take time to work, which is usually a few weeks, but sometimes longer.

This is more likely to happen

• 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 conditions, who were being treated with an antidepressant.

If you have thoughts of self-harm or suicide at any time, contact your doctor or go to the hospital immediately.

It may be helpful for you to tell a relative 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 worried about changes in your behavior.

An increased risk of bone fractures has been observed in patients treated with this type of medicine.

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. Patients under 18 years of age have a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and anger) when they are treated with this class of medicines. Nevertheless, it is possible that your doctor may decide to prescribe this medicine to a patient under 18 years of age if they consider it is the best option for the patient. If your doctor has prescribed this medicine to a patient under 18 years of age and you want to discuss this decision, please go back to your doctor. You should tell your doctor if any of the above symptoms appear or worsen when a patient under 18 years of age is taking sertraline. Also, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of sertraline in this age group have not been established yet.

Other medicines and Sertraline Mabo

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

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

The use of Sertraline Mabo 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), and the antibiotic linezolid). Do not use sertraline with MAOIs.
• Medicines for treating mental disorders (pimozide). Do not use sertraline with pimozide.

Tell your doctor if you are taking the following medicines

• Herbal medicines containing St. John's Wort (Hypericum perforatum). The effects of St. John's Wort may last 1-2 weeks. Tell your doctor.
• Products containing the amino acid tryptophan.
• Medicines for treating severe pain (e.g., tramadol).
• Medicines for treating migraines (e.g., sumatriptan).
• Medicines that reduce blood clotting (warfarin).
• Medicines for treating pain/arthritis (non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin).
• Sedatives (diazepam).
• Diuretics.
• Medicines for treating epilepsy (phenytoin).
• Medicines for treating diabetes (tolbutamide).
• Medicines for treating stomach acid and ulcers (cimetidine).
• Medicines for treating mania and depression (lithium).
• Other medicines for treating depression (such as amitriptyline, nortriptyline).
• Medicines for treating schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).

Taking Sertraline Mabo with food and drinks

Sertraline tablets can be taken with or without food.

You should avoid drinking alcohol while being treated with sertraline.

Pregnancy, breastfeeding, and fertility

Ask your doctor or pharmacist for advice before taking any medicine.

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. Sertraline should only be used during pregnancy if your doctor considers it essential.

Women of childbearing age who are taking sertraline should use a suitable contraceptive method.

If you take sertraline in the late stage 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 taking sertraline so they can advise you.

Make sure your midwife and/or doctor knows that you are taking Sertraline. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Sertraline may increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

There are indications that sertraline is excreted in breast milk. Therefore, sertraline can only be used in breastfeeding women if your doctor considers that the benefit to the mother outweighs any possible risk to the baby.

Some medicines like Sertraline may reduce sperm quality in animal studies. This could theoretically affect fertility, but the impact on human fertility has not been observed yet.

Driving and using machines

Antidepressant 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.

Sertraline Mabo contains lactose.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Sertraline Mabo contains sodium.

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

3. How to take Sertraline Mabo

Follow exactly the administration instructions of Sertraline Mabo given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Sertraline tablets can be taken with or without food.

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

The recommended dose is:

Adults

Depression and Obsessive-Compulsive Disorder

For depression and OCD, the effective dose is usually 50 mg per day. The daily dose can be increased in increments of 50 mg, at intervals of at least one week, over several weeks. The maximum recommended dose is 200 mg per day.

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

For panic disorder, social anxiety disorder, and PTSD, treatment should start with a dose of 25 mg per day, which can be increased to 50 mg per day after one week.

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

Use in children and adolescents

This medicine should only be used to treat children and adolescents aged 6 to 17 years who have obsessive-compulsive disorder.

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, tell your doctor and follow their instructions.

Your doctor will tell you how long you should take this medicine. The duration will depend on the nature of your condition and your response to treatment. It will take a few weeks before your symptoms start to improve.

If you take more Sertraline Mabo than you should

If you accidentally take too much sertraline, contact your doctor or go to the emergency department of the nearest hospital. Always take the medicine pack with you, even if it is empty.

You can also call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

Symptoms of overdose may include drowsiness, nausea, and vomiting, increased heart rate, tremors, agitation, dizziness, and in rare cases, unconsciousness.

If you forget to take Sertraline Mabo

If you forget to take a dose, do not take it when you remember. Take the next dose when it is due.

Do not take a double dose to make up for forgotten doses.

If you stop taking Sertraline Mabo

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

If you have any further questions on 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 all people suffer from them.

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

The most common adverse effect is nausea. Adverse effects depend on the dose and often disappear when continuing treatment.

Tell 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), (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 present agitation, confusion, diarrhea, increased temperature and blood pressure, excessive sweating, and accelerated 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 yellowish color of the skin and eyes, which can indicate liver damage.
• If you present depressive symptoms with suicidal ideas.
• If after starting treatment with sertraline, you begin to feel restlessness and are unable to sit or stand. You should inform your doctor if you start to feel restless.

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

Very common adverse effects (can affect more than 1 patient in 10)

Insomnia, dizziness, somnolence, headache, diarrhea, feeling of discomfort, dry mouth, ejaculation problems, and fatigue.

Common adverse effects (can affect up to 1 in 10 patients)

Sore throat, anorexia, increased appetite, depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased sexual interest, teeth grinding, numbness and tingling, tremor, muscle tension, abnormal taste, lack of concentration, visual disturbances, ringing in the ears, palpitations, hot flashes, yawning, abdominal pain, vomiting, constipation, stomach discomfort, gas, rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, and chest pain.

Uncommon adverse effects (can affect up to 1 in 100 patients)

Cold (chest), runny nose, hallucinations, excessive happiness, lack of care, abnormal thoughts, convulsions, involuntary muscle contractions, abnormal coordination, continuous movements, amnesia, decreased sensitivity, speech disorders, dizziness when standing up, migraines, ear pain, rapid pulse, high blood pressure, hot flashes, difficulty breathing possibly noisy, shortness of breath, nasal bleeding, esophagus problems, difficulty swallowing, hemorrhoids, increased salivation, alteration of the tongue, belching, eye swelling, purple spots on the skin, hair loss, cold sweat, dry skin, hives, arthritis, muscle weakness, back pain, muscle spasms, need to urinate at night, urinary retention, increased urine volume, increased frequency of urination, urinary disorders, vaginal hemorrhage, female sexual dysfunction, discomfort, chills, fever, weakness, thirst, weight loss, and weight gain.

Rare adverse effects (can affect up to 1 in 1,000 patients)

Intestinal problems, ear infection, cancer, lymph node swelling, high cholesterol, elevated blood sugar, physical symptoms due to stress or emotions, drug dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation, coma, abnormal movements, difficulty moving, increased sensitivity, sensory disturbances, glaucoma, lacrimation problems, appearance of spots in the visual field, double vision, eye damage from light, blood in the eye, dilated pupils, vision of spots in front of the eyes, glaucoma, double vision, photophobia (eye sensitivity to light), eye hemorrhages, irregular pupils, visual disturbances, lacrimal problems, heart attack, decreased heart rate, heart problems, circulation problems in the arms and legs, throat spasm, rapid breathing, slower breathing, difficulty speaking, hiccups, blood in stool, mouth sores, tongue ulcers, tooth and tongue problems, mouth ulcers, liver function problems, skin problems with blisters, capillary rash, abnormal hair texture, abnormal skin odor, bone alteration, decreased urine volume, urinary incontinence, interrupted urination, excessive vaginal hemorrhage, vaginal dryness, pain and redness of the penis and foreskin, genital secretion, prolonged erection, breast secretion, hernia, injection site scar, decreased drug tolerance, difficulty walking, abnormal laboratory tests, abnormal semen, injury, vascular relaxation procedure.

Adverse effects of unknown frequency (cannot be estimated from known data)

Partial loss of vision, colon inflammation (causing diarrhea), abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information, muscle weakness and intense muscle pain, which can be a sign of multiple acyl-coenzyme A dehydrogenase deficiency (MADD).

Since the marketing of sertraline, the following adverse effects have been reported

Decrease in white blood cell count, decrease in platelets, low thyroid hormone levels, endocrine problems, low sodium levels in the blood, abnormal terror dreams, suicidal behavior, muscle movement problems (such as constant movements, muscle tension, and difficulty walking), syncope, abnormal vision, hemorrhage problems (such as nasal, stomach, or blood in urine), pancreatitis, serious liver function problems, yellowish skin, skin swelling, sun-related skin reaction, itching, joint pain, muscle cramps, breast enlargement, irregularities in the menstrual cycle, swollen legs, coagulation problems, and severe allergic reactions.

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.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Sertralina Mabo

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Store in the original packaging.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Sertralina Mabo

• The active principle of this medicine is sertraline (hydrochloride). Each tablet contains 50 mg of sertraline.
• The other components are: anhydrous colloidal silica (E-551), microcrystalline cellulose (E-460), sodium croscarmellose (E-468), copovidone, lactose monohydrate, magnesium stearate. Coating: hypromellose (E-464), hydroxypropyl cellulose (E-463), titanium dioxide (E-171), and macrogol 400.

Appearance of the product and package contents

Sertralina Mabo 50 mg is presented in film-coated tablets, scored, white, with the mark "50" on one of its faces.

Sertralina Mabo 50 mg is available in two package sizes: 30 and 60 tablets. The tablets are presented in PVC blisters with an aluminum foil on the back.

Marketing authorization holder and manufacturer

Marketing authorization holder:

MABO-FARMA S.A.

Vía de los Poblados Street, 3,

Building 6, 28033 Madrid,

Spain.

Manufacturer:

TEVA PHARMA S.L.U

C/C, n 4 Malpica Industrial Park

50016, Zaragoza Spain

or

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

Laguna 66-70. Urtinsa II Industrial Park

28923 Alcorcón (Madrid) Spain

Date of the last revision of this prospectus: September 2025

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