Sertraline Pensa 50 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sertralina pensa 50 mg film-coated tablets EFG

Read the entire 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 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

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

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

Sertralina pensa 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 pensa 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 one used to.

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

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

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

If you are unsure why Sertralina Pensa has been prescribed for you, you should consult your doctor.

2. What you need to know before taking Sertralina pensa

Do not take Sertralina pensa:

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 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:

Talk to your doctor or pharmacist before starting to take Sertralina pensa.

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

If you have serotonin syndrome. This syndrome rarely may occur when 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.
If you have 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 medicine for high blood pressure, as these medicines can also affect blood sodium levels.
If you are elderly, as you may be at higher risk of low blood sodium levels (see previous point).
If you have liver disease; your doctor may decide 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 medicines.
If you have epilepsy (seizures) or a history of seizures. If you have a seizure, 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 had or currently have thoughts of harming yourself or of suicide (see below: suicidal thoughts and worsening of depression or anxiety disorder).
If you have a history of bleeding disorders or have been taking medicines that reduce blood clotting (e.g., 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 being treated for this condition, 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 disorders, such as certain types of glaucoma (increased intraocular pressure).
If you have been told you have an abnormality on the heart tracing obtained from an electrocardiogram (ECG), known as QT interval prolongation.
If you have heart disease, low potassium or magnesium levels, a family history of QTc prolongation, slow heart rate, or are taking concomitantly medicines that prolong the QTc interval.

Sexual dysfunction

Some medicines in the same class as Sertralina 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 sit or stand still (akathisia). This occurs more frequently during the first weeks of treatment. Increasing the dose may be harmful; therefore, 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 Sertralina pensa” 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 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, and you should always agree with your doctor on the best way to discontinue treatment.

Suicidal thoughts and worsening of depression or anxiety disorder

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

This is more likely to happen if:

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

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

It may be helpful for you to tell a family member or close 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.

Children and adolescents

Sertraline should normally not be used in the treatment of children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder (OCD). Patients under 18 years of age have a higher risk of adverse effects such as suicide attempts, thoughts of self-harm or suicide (suicidal ideation), and hostility (predominantly aggression, confrontational behaviour, and anger reactions) when taking this type of medicine. Nevertheless, your doctor may decide to prescribe Sertralina pensa to a patient under 18 years of age if they consider it to be the most appropriate treatment. If your doctor has prescribed Sertralina pensa to you and you are under 18 years of age and wish to discuss this decision, please return to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while you are taking sertraline. In addition, the long-term safety effects on growth, maturation, cognitive development, and behavioural development of sertraline in this age group have not yet been established.

Other medicines and Sertralina pensa

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 Sertralina pensa works, or Sertralina pensa itself may reduce the effectiveness of other medicines taken at the same time.

The use of Sertralina pensa together with the following medicines may cause serious adverse effects:

Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression), selegiline (used to treat Parkinson’s disease), the antibiotic linezolid, and methylene blue (used to treat high levels of methemoglobin in the blood). Do not use sertraline with these medicines.
Medicines used to treat mental disorders such as psychosis (pimozide). Do not use 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 used to treat severe pain (e.g., tramadol).
Medicines used in anesthesia or for the treatment of chronic pain (e.g., fentanyl, mivacurium, and suxamethonium).
Medicines used to treat migraines (e.g., sumatriptan).
Medicines that reduce blood clotting (warfarin).
Medicines used to treat pain/arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
Sedatives (diazepam).
Diuretics.
Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
Medicines used to treat diabetes (tolbutamide).
Medicines used to treat acidity, ulcers, and heartburn (cimetidine, omeprazole, lansoprazol, pantoprazole, rabeprazole).
Medicines used to treat mania and depression (lithium).
Other medicines used to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
Medicines used to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
Medicines used to treat high blood pressure, chest pain, or to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide, propafenone).
Medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
Medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
Medicines used to treat HIV/AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir).
Medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
Medicines known to increase the risk of changes in the heart's electrical activity (e.g., some antipsychotics and antibiotics).

Taking Sertralina pensa with food, drinks, and alcohol

Sertralina pensa tablets can be taken with or without food.

Alcohol intake should be avoided while being treated with sertraline.

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

Pregnancy and breastfeeding

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

The safety of sertraline in pregnant women has not been fully established. If you are pregnant, sertraline will only be administered if your doctor considers that the benefit to you outweighs any possible risk to the developing baby.

Ensure that your midwife and/or doctor know that you are taking Sertralina pensa. If you take it during pregnancy, especially during the last 3 months, medicines like Sertralina pensa 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 blue. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.

If you take Sertralina pensa late in 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.

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

difficulty breathing,
blue or too hot or cold skin,
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.

If your baby shows any of these symptoms at birth, or if you are concerned about your baby’s health, consult your doctor or midwife for advice.

There is evidence indicating that sertraline passes into breast milk. Therefore, sertraline may only be used in women who are breastfeeding if the doctor considers that the benefit outweighs any possible risk to the child.

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

Driving and use of machines

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

Sertralina pensa contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain 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 exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults:

Depression and Obsessive-Compulsive Disorder (OCD):

For depression and OCD, the usually effective dose is 50 mg 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 (PTSD):

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:

Sertralina pensa 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.

Method of administration:

Sertralina pensa tablets can be taken with or without food.

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

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

If you take more Sertralina pensa than you should

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

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

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

If you forget to take Sertralina pensa

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

If you stop taking Sertralina pensa

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

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

4. Possible adverse effects

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

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

Tell your doctor immediately

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

If you develop a severe skin rash causing blisters (erythema multiforme), (which may affect the mouth and tongue). These may be signs of a condition known as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN). In such cases, your doctor will discontinue treatment.
Allergic reaction or allergy, which may present symptoms such as itchy skin rash, breathing difficulties, wheezing, swelling of the eyelids, face or lips.
If you experience agitation, confusion, diarrhea, increased body temperature and blood pressure, excessive sweating, and rapid pulse. These are symptoms of serotonin syndrome. Rarely, this syndrome may occur when taking certain medications together with sertraline. Your doctor may decide to discontinue treatment.
If you notice yellowing of the skin or eyes, which may indicate liver damage.
If you experience depressive symptoms with thoughts of harming yourself or suicide (suicidal thoughts).
If after starting treatment with Sertralina pensa you feel restless and are unable to sit or stand still. You should inform your doctor if you begin to feel restless.
If you have a seizure (convulsion).
If you experience a manic episode (see section 2 “Warnings and precautions”).

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

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

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

Common (may affect up to 1 in 10 people):

Cold (chest), sore throat, runny nose,
Loss of appetite, increased appetite,
Depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased libido, teeth grinding,
Tremor, movement disorders (such as constant movements, muscle tension, difficulty walking and stiffness, spasms and involuntary muscle movements)*, numbness and tingling, increased muscle tone, abnormal taste, difficulty concentrating,
Visual disturbances,
Ringing in the ears,
Palpitations,
Hot flushes,
Yawning,
Abdominal pain, vomiting, constipation, stomach discomfort, gas,
Rash, increased sweating,
Muscle pain, joint pain, back pain,
Irregular menstrual cycle, erectile dysfunction,
Malaise, chest pain, weakness, fever,
Weight gain,
Injury.

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

Gastroenteritis, ear infection,
Tumor,
Hypersensitivity, seasonal allergy,
Low levels of thyroid hormone,
Suicidal thoughts, suicidal behaviour*, psychotic disorders, abnormal thoughts, lack of self-care, hallucinations, aggression, excessive happiness, paranoia,
Amnesia, decreased sensitivity, involuntary muscle contractions, fainting, continuous movements, seizures, abnormal coordination, speech disorders, dizziness upon standing, migraine,
Dilated pupils,
Ear pain,
Rapid pulse, heart problems,
Bleeding disorders (such as stomach bleeding)*, high blood pressure, hot flushes, blood in urine,
Shortness of breath, nosebleeds, difficulty breathing possibly with noise,
Black stools, dental disorders, inflammation of the esophagus, tongue disorders,
Hemorrhoids, increased salivation, difficulty swallowing, tongue disorders, burping,
Swelling of eyes, purple spots on the skin, hair loss, cold sweat, dry skin, urticaria, skin disorders with blisters, facial swelling, itching,
Osteoarthritis, muscle weakness, muscle jerks, muscle cramps*,
Need to urinate at night, 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 behaviour have been reported during treatment with sertraline or shortly after discontinuation (see section 2).

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

Diverticulitis, swollen lymph nodes, decreased platelets*, decreased white blood cell count*,
Severe allergic reaction,
Endocrine disorders*,
High cholesterol, problems controlling blood sugar levels (diabetes), low blood sugar, increased blood sugar levels*, low blood sodium levels*,
Physical symptoms due to stress or emotions, abnormal nightmares*, drug dependence, sleepwalking, premature ejaculation,
Coma, abnormal movements, difficulty moving, increased sensitivity, sudden severe headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS)*, sensory disturbances,
Glaucoma, tear problems, seeing spots in front of the eyes, double vision, photophobia (eye sensitivity to light), eye hemorrhages, irregular pupils*, visual disturbances*,
Heart attack, dizziness, fainting or chest discomfort which could be signs of changes in electrical activity (seen on electrocardiogram) or abnormal heart rhythm*, decreased heart rate,
Circulation problems in arms and legs,
Throat spasm, rapid breathing, slower breathing, difficulty speaking, hiccups, progressive scarring in lung tissue (interstitial lung disease)*,
Blood in stools, mouth sores, tongue ulceration, mouth ulceration, pancreatitis*,
Liver function disorders, serious liver function problems*, yellowing of skin or eyes (jaundice)*,
Skin reaction to sunlight*, skin swelling*, capillary rash, abnormal hair texture, abnormal skin odor,
Bone disorder, muscle tissue breakdown*,
Decreased urine volume, interrupted urination,
Vaginal dryness, pain and redness of penis and foreskin, genital discharge, prolonged erection, nipple discharge, breast enlargement*,
Hernia, decreased tolerance to the medicine,
Increased cholesterol levels, abnormal laboratory tests*, abnormal semen, coagulation disorders*,
Relaxation of blood vessel constriction process.

Frequency not known (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 and breastfeeding” in section 2 for more information,
Jaw locking*,
Urinary incontinence during sleep*,
Muscle weakness and severe muscle pain, which may be a sign of multiple acyl-coenzyme A dehydrogenase deficiency (MADD)*.
Adverse effects reported after marketing.

Other adverse effects in children and adolescents

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

Symptoms that may occur when stopping treatment

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

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

Reporting of adverse effects:

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

5. Storage of Sertraline pensa

Keep this medicine out of sight and reach of children.

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sertralina pensa

The active substance is sertraline (hydrochloride). Each tablet contains 50 mg of sertraline.
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), polyethylene glycol 400 (E 1521), and titanium dioxide (E 171).

Appearance of the product and contents of the pack

Sertralina pensa is presented as film-coated tablets, white or greyish-white in colour.

Sertralina pensa is available in three pack sizes: 30, 60 and 500 tablets. The tablets are supplied 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

Farmalider, S.A.
C/Aragoneses, 2
28108 Alcobendas (Madrid)
Spain

Toll Manufacturing Services, S.L.
C/Aragoneses, 2
28108 Alcobendas (Madrid)
Spain

Date of the most recent revision of this leaflet: June 2025

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