SERTRALINE PENSA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Sertraline Pensa 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 Pensa 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 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 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 illness. 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 Sertralina Pensa, you should ask your doctor.

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

Do not take Sertraline Pensa:

• 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). 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).

Warnings and precautions:

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

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

• If you have Serotonin Syndrome. This syndrome can occur rarely when taking certain medicines at the same time as sertraline. (To see the symptoms, read section 4. Possible side effects). Your doctor will indicate if you have presented this syndrome previously.
• If you have low sodium levels in the blood, as this situation can occur as a result of treatment with sertraline. You should also inform your doctor if you are taking any medication for hypertension, as these medications can also alter sodium levels in the blood.
• If you are elderly, as you may be at greater risk of having low sodium levels in the blood (see previous point).
• If you have liver disease; your doctor may consider that you should take a lower dose of sertraline.
• If you have diabetes; sertraline may alter your blood sugar levels, so it may be necessary to adjust the dose of your diabetes medications.
• If you have epilepsy (seizures) or a history of seizures. If you have a seizure, call your doctor immediately.
• If you have manic-depressive illness (bipolar disorder) or schizophrenia. If you have a manic episode, call your doctor immediately.
• If you have or have had thoughts of harming yourself or suicidal thoughts (see below suicidal thoughts and worsening of your depression or anxiety disorder).
• If you have a history of bleeding disorders or have been taking medications that reduce blood clotting (such as acetylsalicylic acid (aspirin) or warfarin) or that may increase the risk of bleeding, or if you are pregnant (see "Pregnancy and breastfeeding").
• 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 (OCD). If you are going to be treated for this disorder, your doctor will want to monitor you closely (see below "Children and adolescents").
• If you are receiving electroconvulsive therapy (ECT).
• If you have any eye disorder, such as certain types of glaucoma (increased intraocular pressure).
• If you have been told that you have an anomaly in the graph of the 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, family history of QTc prolongation, low heart rate, or use concomitantly medications that prolong the QTc interval.

Sexual dysfunction

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

Restlessness/ Akathisia

The use of sertraline has been associated with unpleasant restlessness and a need to move, often accompanied by an inability to remain seated or standing (akathisia). This occurs more often during the first few weeks of treatment. An increase in dose may be harmful, so if you develop these symptoms, you should contact your doctor.

Withdrawal symptoms

Side effects related to stopping treatment (withdrawal symptoms) are common, particularly if treatment is stopped abruptly (see section 3. "If you stop taking Sertraline Pensa" and section 4 "Possible side effects"). The risk of presenting withdrawal symptoms depends on the duration of treatment, dose, and rate at which the dose is reduced. Generally, these symptoms are mild or moderate. However, in some patients, they can be severe. These symptoms usually occur during the first few days after stopping treatment. In general, these symptoms usually resolve on their own and normally disappear within two weeks. In some patients, they can last longer (2-3 months or more). It is recommended that when stopping treatment with sertraline, the dose should be gradually reduced over a period of several weeks or even months, and you should always agree with your doctor on the best way to stop treatment.

Suicidal thoughts 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 suicidal thoughts. This can 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 can sometimes be longer.

This is more likely to happen:

• If you have previously had thoughts of harming yourself or suicidal thoughts.
• If you are a young adult. There is information from clinical trials that shows that there is an increased risk of suicidal behavior in adults under 25 years of age with psychiatric illnesses, who are being treated with an antidepressant.

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

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

Children and adolescents

Normally, sertraline should not be used in the treatment of children and adolescents under 18 years of age, except in the case of patients with obsessive-compulsive disorder (OCD). Patients under 18 years of age have a higher risk of adverse effects such as suicidal attempts, thoughts of harming themselves or suicidal thoughts (suicidal ideas), and hostility (mainly aggression, confrontational behavior, and anger) when they are being treated with this class of medicines. However, it is possible that your doctor may decide to prescribe Sertraline Pensa to a patient under 18 years of age if they consider it to be in the best interest of the patient. If your doctor has prescribed Sertraline Pensa and you are under 18 years of age and wish to discuss this decision, please go back to your doctor. You must inform your doctor if any of the symptoms mentioned above appear or worsen when you are taking sertraline. At the same time, the long-term effects on safety and related to growth, maturity, and learning (cognitive development) and behavioral development of sertraline in this age group have not yet been demonstrated.

Other medicines and Sertraline Pensa

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

Taking Sertraline Pensa with the following medicines may cause serious side effects

• Medicines called monoamine oxidase inhibitors (MAOIs, such as moclobemide (for depression), selegiline (for Parkinson's disease), the antibiotic linezolid, and methylthioninium chloride (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).
• 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 for treating severe pain (e.g., tramadol).
• Medicines used in anesthesia or for the treatment of chronic pain (e.g., fentanyl, mivacurium, and suxamethonium).
• Medicines for treating migraines (e.g., sumatriptan).
• Medicines that reduce blood clotting (warfarin).
• Medicines for treating pain/arthritis (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 electrical activity (e.g., some antipsychotics and antibiotics).

Taking Sertraline Pensa with food, drinks, and alcohol

Sertraline Pensa tablets can be taken with or without food.

You should avoid drinking alcohol while being treated with sertraline.

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

Pregnancy and breastfeeding

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.

Make sure your midwife and/or doctor know that you are taking Sertraline Pensa. If you take it during pregnancy, especially during the last 3 months, medicines like Sertraline Pensa may increase the risk of a serious disease in babies called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and have a bluish appearance. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take Sertraline Pensa in the final stages of pregnancy, there may be a greater 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 that they can advise you.

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

• difficulty breathing,
• blue-tinged skin or being too hot or cold,
• blue 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 concerned about your baby's health, consult your doctor or midwife for advice.

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

In animal studies, it has been seen 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

During treatment with sertraline, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with sertraline affects you.

Sertraline Pensa contains lactose and sodium

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

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

3. How to take Sertralina pensa

Follow the administration instructions of 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 intervals of 50 mg over a period of several weeks. The maximum recommended dose is 200 mg per day.

Use in children and adolescents:

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

Obsessive-Compulsive Disorder:

Children from6 to12 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 from13 to17 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 pensa 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 pensa 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 packaging 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 forget to take Sertralina pensa

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

If you interrupt treatment with Sertralina pensa

Do not interrupt treatment with Sertralina pensa unless your doctor tells you to. Your doctor will want to gradually reduce the dose of Sertralina pensa over several weeks before you stop taking this medication altogether. If you interrupt treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors. If you experience any of these adverse effects, or any other during the interruption of your treatment with Sertralina pensa, please inform your doctor.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people 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 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 present yellowing 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 Sertralina pensa, 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 adverse 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,
• depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased libido, 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, 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, joint pain, back pain,
• irregular menstrual cycle, erectile dysfunction,
• discomfort, 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 sudden headache (which can be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS)*, sensory disturbances,
• glaucoma, tear problems, vision problems, double vision, photophobia (eye sensitivity to light), eye bleeding, irregular pupils*, visual disturbances*,
• 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,
• throat spasms, rapid breathing, slower breathing, difficulty speaking, hiccups, progressive scarring of lung tissue (interstitial lung disease)*,
• blood in stool, mouth ulcers, esophagus inflammation, tongue problems,
• hemorrhoids, increased salivation, difficulty swallowing, tongue disorders, belching,
• eye swelling, purple spots on the skin, hair loss, cold sweat, dry skin, hives, skin problems with blisters, facial swelling, itching,
• osteoarthritis, muscle weakness, muscle twitches, muscle cramps*,
• nocturia, urinary retention, increased urine volume, increased frequency of urination, urinary disorders, urinary incontinence,
• sexual dysfunction, excessive vaginal bleeding, vaginal hemorrhage, female sexual dysfunction,
• swollen legs, chills, difficulty walking, thirst,
• increased liver enzyme levels, weight loss,
• cases of suicidal thoughts and behavior have been reported during treatment with sertralina or shortly after its interruption (see section 2).

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 sudden headache (which can be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS)*, sensory disturbances,
• glaucoma, tear problems, vision problems, double vision, photophobia (eye sensitivity to light), eye bleeding, irregular pupils*, visual disturbances*,
• 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,
• throat spasms, rapid breathing, slower breathing, difficulty speaking, hiccups, progressive scarring of lung tissue (interstitial lung disease)*,
• blood in stool, mouth ulcers, esophagus inflammation, tongue problems,
• hemorrhoids, increased salivation, difficulty swallowing, tongue disorders, belching,
• eye swelling, purple spots on the skin, hair loss, cold sweat, dry skin, hives, skin problems with blisters, facial swelling, itching,
• osteoarthritis, muscle weakness, muscle twitches, muscle cramps*,
• nocturia, urinary retention, increased urine volume, increased frequency of urination, urinary disorders, urinary incontinence,
• sexual dysfunction, excessive vaginal bleeding, vaginal hemorrhage, female sexual dysfunction,
• swollen legs, chills, difficulty walking, thirst,
• increased liver enzyme levels, weight loss,
• affecting the blood and lymphatic system, bone marrow failure*, severe decrease in blood platelets*, severe decrease in white blood cells*,
• severe skin reactions, Stevens-Johnson syndrome*, toxic epidermal necrolysis*,
• hearing loss, deafness*,
• seizures*,
• eye problems, blindness*,
• increased risk of bleeding*,
• increased risk of fractures*,
• inflammation of the pancreas*,
• severe liver problems*,
• allergic reactions, anaphylaxis*,
• angioedema*,
• increased blood pressure*,
• cardiovascular problems, heart attack*, stroke*,
• abnormal heart rhythms*,
• low blood pressure*,
• respiratory problems, asthma*, chronic obstructive pulmonary disease (COPD)*,
• gastrointestinal problems, stomach ulcers*, intestinal obstruction*,
• liver problems, liver failure*,
• kidney problems, kidney failure*,
• blood disorders, anemia*,
• hormonal problems, thyroid problems*, adrenal insufficiency*,
• muscle problems, muscle weakness*, muscle atrophy*,
• bone problems, osteoporosis*,
• nervous system problems, multiple sclerosis*, Parkinson's disease*,
• psychiatric problems, psychosis*, schizophrenia*,
• eye problems, cataracts*, glaucoma*,
• hearing problems, tinnitus*,
• skin problems, psoriasis*,
• hair problems, alopecia*,
• nail problems, onycholysis*,
• immune system problems, lupus*, rheumatoid arthritis*,
• endocrine problems, diabetes*, thyroid problems*,
• metabolic problems, gout*,
• nutritional problems, vitamin deficiencies*,
• infections, sepsis*,
• injuries, fractures*,
• surgical and medical procedures, transplantation*,
• social circumstances, social isolation*,
• other, unknown*.

Frequency not known (cannot be estimated from the available data):

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

• Adverse effects reported after marketing.

Other adverse effects in children and adolescents

In clinical trials in children and adolescents, the 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 appear when treatment is interrupted

If you interrupt treatment with this medication abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors (see section 3. If you interrupt treatment with Sertralina pensa).

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

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 leaflet. 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 medication.

5. Conservation of Sertralina pensa

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

Do not use this medication 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.

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

6. Content of the packaging and additional information

Composition of Sertralina pensa

• The active ingredient is sertralina (hydrochloride). Each tablet contains 50 mg of sertralina.
• The other components (excipients) are anhydrous colloidal silica, microcrystalline cellulose (E 460), sodium croscarmellose, copovidone, lactose, and magnesium stearate (E 572). Coating (Opadry white): hypromellose (E 464), hydroxypropylcellulose (E 463), macrogol 400 (E 1521), and titanium dioxide (E 171).

Appearance of the product and packaging content

Sertralina pensa is presented in film-coated tablets, white or grayish-white in color.

Sertralina pensa is available in three packaging sizes: 30, 60, and 500 tablets. The tablets are presented in aluminum/PVC-PVDC blisters.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Laboratorios Cinfa, S.A. C/Olaz-Chipi, 10

31620 Huarte – Pamplona

Spain

or

Farmalider, S.A. C/Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

or

Toll Manufacturing Services, S.L.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of the last revision of this leaflet:June 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/