SERTRALINE ALTER 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sertraline Alter 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, as 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 symptoms are the same as yours.
• If you experience 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 is Sertraline Alter and what is it used for
2. What you need to know before you take Sertraline Alter
3. How to take Sertraline Alter
4. Possible side effects
5. Storage of Sertraline Alter
6. Contents of the pack and further information

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

Sertraline Alter 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.

Sertraline Alter 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 illness with symptoms such as feelings of sadness, inability to sleep well or to enjoy life as you used to.

OCD and anxiety disorders are illnesses related to anxiety, with symptoms such as being constantly worried about recurring ideas (obsessions) that lead to 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 illness related to anxiety. It is characterized by feeling intense anxiety or panic in social situations (e.g., talking to strangers, speaking in public, eating or drinking in front of others, or worrying about behaving shamefully).

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

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

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

Do not take Sertraline Alter:

• 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 medicines called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other medicines similar to MAOIs (such as linezolid) in the last two weeks. 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 (a medicine used to treat mental disorders such as psychosis).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Sertraline Alter.

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

• 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 have a manic episode, contact 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).
• If you have serotonin syndrome. This syndrome can occur rarely when taking certain medicines at the same time as sertraline. (For symptoms, 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 can occur as a result of treatment with sertraline. You should also tell your doctor if you are taking any medicines for high blood pressure, as these medicines can also affect 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 sertraline.
• If you have diabetes; sertraline may affect your blood sugar levels, so you may need 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 (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 old. Sertraline Alter 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 Use in children and adolescents).
• If you are receiving electroconvulsive therapy (ECT).
• If you have any eye disorder, such as certain types of glaucoma (increased eye pressure).
• If you have been told 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, have a family history of QT prolongation, have a low heart rate, or are taking medicines that prolong the QT 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 often during the first few weeks of treatment. Increasing the dose may be harmful, so if you develop these symptoms, you should contact your doctor.

Withdrawal symptoms

Side effects related to stopping treatment (withdrawal symptoms) are common, particularly if treatment is stopped abruptly (see section 3. If you stop taking Sertraline and 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 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

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, due to the fact that these medicines take time to work, which is usually a few weeks, but sometimes can be 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 old 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 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.

Sexual problems

Some medicines in the same group as Sertraline Alter (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 not normally be used in the treatment of children and adolescents under 18 years old, except in patients with obsessive-compulsive disorder (OCD). Patients under 18 years old have a higher risk of side effects such as suicidal attempts, thoughts of self-harm or suicide (suicidal ideas), and hostility (mainly aggression, confrontational behavior, and anger) when they are treated with this class of medicines. Nevertheless, your doctor may decide to prescribe Sertraline Alter to a patient under 18 years old if they consider it is in the patient's best interest. If your doctor has prescribed Sertraline Alter for you and you are under 18 years old and wish to discuss this decision, please go back to your doctor. You should tell your doctor if any of the symptoms mentioned above occur or worsen when you are taking Sertraline Alter. The long-term safety of sertraline in terms of growth, maturation, and cognitive and behavioral development has been 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 study results showed that children treated with sertraline developed normally, except for a slight increase in weight in those treated with a higher dose.

Other medicines and Sertraline

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 Alter works, or Sertraline Alter may reduce the effectiveness of other medicines that you are taking at the same time.

Taking Sertraline Alter 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, and methylthioninium chloride (methylene blue) (for high levels of methemoglobin in the blood). Do not take sertraline with these medicines.
• Medicines for treating mental disorders such as psychosis (pimozide). Do not take sertraline with pimozide.

Tell your doctor if you are taking the following medicines

• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).
• Medicines based on plants that contain St. John's Wort (Hypericum perforatum).
• Products containing the amino acid tryptophan.
• Medicines for treating severe or chronic pain (opioids, e.g., tramadol, fentanyl).
• Medicines used in anesthesia (e.g., fentanyl, mivacurium, and suxamethonium).
• Medicines for treating migraines (e.g., sumatriptan).
• Medicines that reduce blood clotting (warfarin).
• Medicines for treating pain/arthritis (e.g., 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 (e.g., some antipsychotics and antibiotics).

Taking Sertraline Alter with food, drinks, and alcohol

Sertraline Alter tablets can be taken with or without food.

Alcohol should be avoided while being treated with sertraline.

Sertraline should not be taken in combination with grapefruit juice, as it can 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 take Sertraline 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 taking Sertraline so they can advise you.

When taken during pregnancy, especially during the last three months, medicines like Sertraline Alter may increase the risk of a serious disease in babies called persistent pulmonary hypertension (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.

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 seizures,
• increased reflexes,
• irritability,
• low blood sugar levels.

If your baby has any of these symptoms at birth, or you are worried 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 the doctor considers that the benefit to the mother outweighs any possible risk to the baby.

In animal studies, it has been shown that some medicines like sertraline may reduce sperm quality. Theoretically, this could 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.

Sertraline Alter contains sodium

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

3. How to Take Sertralina Alter

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

In case of 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 per day. The daily dose can be increased in increments of 50 mg, at intervals of at least one week, and so on for several weeks. The maximum recommended dose is 200 mg per day.

Anxiety Disorder, Social Anxiety Disorder, and Post-Traumatic Stress Disorder:

For anxiety disorder, social anxiety disorder, and post-traumatic stress disorder, treatment should be started with a dose of 25 mg per day, and increased to 50 mg per day after one week.

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

Use in Children and Adolescents

Sertralina 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 per day. After one week, your doctor may increase the dose to 50 mg per day. The maximum dose is 200 mg per day.

Adolescents aged 13 to 17 years:The recommended starting dose is 50 mg per day. The maximum dose is 200 mg per day.

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

Method of Administration:

Sertralina tablets 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.

If You Take More Sertralina Alter Than You Should

If you accidentally take an excess of sertralina, 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.

The symptoms of overdose may include drowsiness, nausea and vomiting, increased heart rate, tremors, agitation, dizziness, and rarely loss of consciousness.

If You Miss a Dose of Sertralina Alter

Do not take a double dose to make up for missed doses. If you miss a dose, do not take it when you realize it. Take the next dose when it is due.

If You Interrupt Treatment with Sertralina Alter

Do not interrupt treatment with sertralina unless your doctor tells you to. Your doctor will want to gradually reduce the dose of sertralina over several weeks before you stop taking this medication altogether. If you interrupt 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 treatment interruption,

please inform your doctor.

If you have any other questions 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 all people experience them.

The most common side effect is nausea. Side 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 medication, as these symptoms can be serious.

• If you develop a severe skin rash with blisters (erythema multiforme), (which 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 increased heart rate. These are symptoms of serotonin syndrome. In rare cases, this syndrome can occur when taking certain medications at the same time as sertralina. Your doctor may decide to interrupt treatment.
• If you have a yellowish color of the skin and eyes, which can indicate liver damage.
• If you experience depressive symptoms with thoughts of self-harm or suicide (suicidal thoughts).
• If after starting treatment with this medication, 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):

• diverticulitis, swollen lymph nodes, decreased platelets*, decreased 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 condition known as reversible cerebral vasoconstriction syndrome (RCVS))*, sensory disturbances,
• seeing 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 heart activity (seen on an electrocardiogram) or abnormal heart rhythm*, decreased heart rate,
• circulation problems in the arms and legs,
• rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, throat spasms, 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, capillary rash,
• muscle rupture*, bone disorder,
• urination problems, decreased urine volume,
• breast secretion, vaginal dryness, genital discharge, penile 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.

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

• diverticulitis, swollen lymph nodes, decreased platelets*, decreased 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 condition known as reversible cerebral vasoconstriction syndrome (RCVS))*, sensory disturbances,
• seeing 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 heart activity (seen on an electrocardiogram) or abnormal heart rhythm*, decreased heart rate,
• circulation problems in the arms and legs,
• rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, throat spasms, 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, capillary rash,
• muscle rupture*, bone disorder,
• urination problems, decreased urine volume,
• breast secretion, vaginal dryness, genital discharge, penile 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 enuresis*,
• partial loss of vision,
• inflammation of the colon (which causes 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 Treatment is Interrupted

If you interrupt 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 this medication).

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: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Sertralina Alter

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the package after "EXP". The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the pharmacy's SIGRE collection point. 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

Sertralina Alter Composition

The active ingredient of Sertralina Alter 50 mg is sertralina (hydrochloride). Each tablet contains 50 mg of sertralina.

The other ingredients are:

Core of the tablet: calcium phosphate dibasic dihydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hydroxypropylcellulose,

Tablet coating: hypromellose, titanium dioxide (E171), and glycerol triacetate (E422).

Appearance of the Product and Package Contents

Sertralina Alter 50 mg is presented in film-coated tablets, round and lenticular, white in color, scored. It is presented in blisters, in packages of 30 or 60 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

or

Laboratorios Alter, S.A.

C/Zeus, 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

Date of Last Revision of This Leaflet:July 2025

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