Sertraline Mabo 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sertralina Mabo 50 mg film-coated tablets EFG

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could 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

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

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

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

Sertralina Mabo 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 with symptoms such as feelings of sadness, inability to sleep well, or to enjoy life as you used to.

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

PTSD is a disorder that may occur after an emotionally traumatic experience 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: talking to strangers, speaking in public, eating or drinking in front of others, or worrying about behaving in an embarrassing way).

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

If you are unsure why this medicine has been prescribed for you, you should consult your doctor.

2. What you need to know before taking Sertraline Mabo

Do not take Sertraline Mabo

• If you are allergic to sertraline or to any of the other ingredients 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 taking 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

Talk to your doctor, pharmacist, or nurse before starting this medicine.

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

• Serotonin syndrome. This syndrome may rarely occur when you are taking certain medicines together with sertraline. (For symptoms, see section 4. Possible side effects.) Your doctor will determine whether you have previously experienced this syndrome.
• Low sodium levels in the blood, as this may occur as a result of treatment with sertraline. You should also inform your doctor if you are taking any medicines for high blood pressure, as these may also affect blood sodium levels.
• Take special care if you are elderly, as you may be at increased risk of low sodium levels in the blood (see above).
• Liver disease; your doctor may consider that you should take a lower dose of sertraline.
• Diabetes; sertraline may alter your blood sugar levels, so it may be necessary to adjust the dose of your diabetes medicines.
• Epilepsy or a history of epilepsy. If you have a seizure (convulsion), contact your doctor immediately.
• If you have bipolar disorder (manic-depressive illness) or schizophrenia. If you experience a manic episode, contact your doctor immediately.
• If you have or have previously had suicidal thoughts (see further below: Suicidal thoughts and worsening of depression or anxiety disorder).
• If you have bleeding disorders, are pregnant (see section Pregnancy, breastfeeding and fertility), or have been taking medicines that reduce blood clotting (e.g. acetylsalicylic acid (aspirin), 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 with obsessive-compulsive disorder. If you are being treated for this condition, your doctor will want to monitor you closely (see section below: Children and adolescents).
• If you are receiving electroconvulsive therapy (ECT).

Some medicines in the same class as this medicine (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may 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 most commonly occurs during the first weeks of treatment. Increasing the dose in patients who develop these symptoms may be harmful.

Withdrawal symptoms

When stopping treatment, withdrawal symptoms are common, particularly if treatment is stopped abruptly (see section 4. Possible side effects). The risk of experiencing withdrawal symptoms depends on the duration of treatment, the dose, and the rate at which the dose is reduced. Generally, these symptoms are mild or moderate. However, in some patients they may be severe. These symptoms usually appear during 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, according to individual patient needs.

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 of suicide. This may increase at the beginning of treatment with antidepressants, because 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 suicidal thoughts or thoughts of 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 who are being treated with an antidepressant.

If you have thoughts of harming yourself or of 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.

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

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. Patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontation behaviour, and anger reactions) when taking this class of medicines. Nevertheless, your doctor may decide to prescribe this medicine to a patient under 18 years of age if they consider it to be the most appropriate treatment. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please speak to your doctor again. Inform your doctor immediately if any of the symptoms listed above appear or worsen while a patient under 18 years of age is taking sertraline. In addition, the long-term effects on safety as well as on growth, maturation, and cognitive and behavioural development of sertraline in this age group have not yet been established.

Other medicines and Sertraline Mabo

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 sertraline works, or sertraline may reduce the effectiveness of other medicines taken at the same time.

Using Sertraline Mabo 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), and the antibiotic linezolid. Do not use sertraline together with MAOIs.
• Medicines used to treat mental disorders (pimozide). Do not use sertraline together with pimozide.

Tell your doctor if you are taking the following medicines:

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

Taking Sertraline Mabo with food and drink

Sertraline tablets can be taken with or without food.

Alcohol should be avoided while you are being treated with sertraline.

Pregnancy, breastfeeding and fertility

Consult your doctor or pharmacist before using any medicine.

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. Sertraline should only be given to pregnant women if, in the doctor’s judgment, the benefit to the mother outweighs any possible risk to the fetus. Women of childbearing age who are being treated with sertraline should use an appropriate contraceptive method.

If you take sertraline 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 aware that you are taking sertraline so they can advise you.

Ensure that your midwife and/or doctor knows you are taking Sertraline. Medicines such as Sertraline, when taken during pregnancy—particularly during the last three months—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.

There is evidence that sertraline is excreted in breast milk. Therefore, sertraline may only be used in breastfeeding women if, in the doctor’s judgment, the benefit to the mother outweighs any possible risk to the infant.

Some medicines such as sertraline have been shown in animal studies to reduce sperm quality. This could theoretically affect fertility, but an effect on human fertility has not been observed so far.

Driving and using machines

Antidepressant 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 such activities.

Sertraline Mabo contains lactose.

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

Sertraline Mabo contains sodium.

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

3. How to take Sertraline Mabo

Follow exactly the administration instructions for Sertraline Mabo provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Sertraline tablets can be taken with or without food.

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

Recommended dose:

Adults

Depression and Obsessive-Compulsive Disorder (OCD)

For depression and OCD, the usually effective dose is 50 mg per day. The daily dose may be increased in 50 mg increments 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 post-traumatic stress disorder, treatment should be initiated at a dose of 25 mg per day, increasing to 50 mg per day after one week.

The daily dose may be increased in 50 mg increments over a period of 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 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 your 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 he or she gives you.

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.

If you take more Sertraline Mabo than you should

If you accidentally take too much sertraline, contact your doctor or go to the nearest hospital emergency department. Always bring the medicine packaging with you, whether or not any medication remains.

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

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

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 at the scheduled time.

Do not take a double dose to make up for a missed dose.

If you stop taking Sertraline Mabo

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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

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 these cases, your doctor will stop treatment.
• Allergic reaction or allergy, which may present symptoms such as itchy skin rash, difficulty breathing, 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 medicines at the same time as sertraline. Your doctor may decide to stop treatment.
• If you develop yellowing of the skin or eyes, which may indicate liver damage.
• If you experience depressive symptoms with suicidal thoughts.
• If, after starting treatment with sertraline, you begin to feel restless and are unable to sit or stand still. You should inform your doctor if you start feeling restless.

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

Very common adverse effects (may affect more than 1 in 10 people)

Insomnia, dizziness, somnolence, headache, diarrhea, malaise, dry mouth, ejaculation disorders, and fatigue.

Common adverse effects (may affect up to 1 in 10 people)

Sore throat, anorexia, increased appetite, depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased libido, teeth grinding, numbness and tingling, tremor, muscle tension, abnormal taste, difficulty concentrating, visual disturbances, tinnitus, palpitations, hot flushes, yawning, abdominal pain, vomiting, constipation, stomach discomfort, flatulence, rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, and chest pain.

Uncommon adverse effects (may affect up to 1 in 100 people)

Cold (chest), runny nose, hallucinations, excessive happiness, lack of care, abnormal thoughts, seizures, involuntary muscle contractions, abnormal coordination, continuous movements, amnesia, decreased sensitivity, speech disorders, dizziness upon standing, migraines, ear pain, rapid pulse, elevated blood pressure, hot flushes, difficulty breathing possibly noisy, shortness of breath, nosebleeds, esophageal disorders, difficulty swallowing, hemorrhoids, increased salivation, tongue disorders, belching, eye swelling, purple spots on the skin, hair loss, cold sweat, dry skin, urticaria, osteoarthritis, muscle weakness, back pain, muscle twitches, need to urinate at night, urinary retention, increased urine volume, increased frequency of urination, urinary disorders, vaginal bleeding, female sexual dysfunction, malaise, chills, fever, weakness, thirst, weight loss, and weight gain.

Rare adverse effects (may affect up to 1 in 1,000 people)

Intestinal problems, ear infection, cancer, swollen lymph nodes, 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, movement difficulty, increased sensitivity, sensory disturbances, glaucoma, tear problems, appearance of spots in the visual field, double vision, light damage to the eyes, blood in the eye, dilated pupils, seeing spots before the eyes, glaucoma, double vision, photophobia (eye sensitivity to light), eye hemorrhages, irregular pupils, visual disturbances, tear problems, heart attack, decreased heart rate, heart problems, circulation problems in arms and legs, throat spasm, rapid breathing, slow breathing, difficulty speaking, hiccups, blood in stools, mouth sores, tongue ulceration, dental and tongue problems, mouth ulceration, liver function problems, skin problems with blisters, capillary rash, abnormal hair texture, abnormal skin odor, bone abnormalities, decreased urine output, urinary incontinence, interrupted urination, excessive vaginal bleeding, vaginal dryness, penile and foreskin redness and pain, genital discharge, prolonged erection, breast discharge, hernia, injection site scar, reduced tolerance to medicines, difficulty walking, abnormal laboratory tests, abnormal semen, injury, blood vessel relaxation procedure.

Adverse effects with unknown frequency (cannot be estimated from available data)

Partial loss of vision, inflammation of the colon (causing diarrhea), heavy 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 may be a sign of multiple acyl-coenzyme A dehydrogenase deficiency (MADD).

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

Decreased white blood cell count, decreased platelet count, low thyroid hormone levels, endocrine problems, low blood sodium levels, abnormal frightening dreams, suicidal behavior, muscle movement problems (such as constant movements, muscle tension, and difficulty walking), syncope, abnormal vision, bleeding problems (such as nosebleeds, stomach bleeding, or blood in urine), pancreatitis, serious liver function problems, yellow skin, skin swelling, skin reaction to sunlight, itching, joint pain, muscle cramps, breast enlargement, menstrual cycle irregularities, 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 not listed in this leaflet. You may also report them directly through 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 Sertraline Mabo

Keep this medicine out of the sight and reach of children.

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

No special storage conditions are required.

Store in the original packaging.

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

6. Contents of the pack and other information

Composition of Sertraline Mabo

• The active substance in 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 contents of the pack

Sertraline Mabo 50 mg is presented as white, film-coated, scored tablets marked with "50" on one side.

Sertraline Mabo 50 mg is available in two pack sizes: 30 and 60 tablets. The tablets are supplied in PVC blisters with an aluminium backing.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

MABO-FARMA S.A.

Calle Vía de los Poblados, 3,

Edificio 6, 28033 Madrid,

Spain.

Manufacturer:

TEVA PHARMA S.L.U

C/C, n 4 Polígono Industrial Malpica

50016, Zaragoza Spain

or

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-70. Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid) Spain

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

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