Leaflet: information for the user

Sertraline pensa 100 mg film-coated tablets

Read this 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 you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Sertraline pensa

3. How to take Sertraline pensa

4. Possible side effects

5. Storage of Sertraline pensa

6. Contents of the pack and additional information

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

Sertralina 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).

- Anxiety disorder (in adults).

- Obsessive-compulsive disorder (OCD) (in adults, and in children and adolescents aged 6-17 years).

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

OCD and anxiety disorders are anxiety-related diseases with symptoms such as being constantly preoccupied with repeated ideas (obsessions) that lead to repetitive rituals (compulsions).

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

Your doctor has considered this medication suitable for treating your condition.

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

Do not take Sertralina pensa: think of the following:

• If you are allergic to sertralina or any of the other components of this medication (listed in section 6).
• If you are taking or have taken medications called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other similar medications to MAOIs (such as linezolid). If you interrupt the treatment with sertralina, you should wait at least one week before starting treatment with a MAOI. After interrupting treatment with a MAOI, you should wait at least two weeks before starting treatment with sertralina.
• If you are taking another medication called pimozide (a medication used to treat mental disorders such as psychosis).

Warnings and precautions:

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

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

• If you have serotonin syndrome. In rare cases, this syndrome may occur when taking certain medications at the same time as sertralina. (See the symptoms in section 4. Possible side effects). Your doctor will indicate if you have previously presented this syndrome.
• If you have low sodium levels in your blood, as this situation may occur as a result of treatment with sertralina. You should also inform your doctor if you are taking any medication for hypertension, as these medications may 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 sertralina.
• If you have diabetes; sertralina may alter your blood sugar levels, so you may need to adjust the dose of your diabetes medications.
• If you have epilepsy (seizures) or a history of convulsions.If you have a seizure (convulsions), call your doctor immediately.
• If you have manic-depressive illness (bipolar disorder), or schizophrenia. If you have a manic episode, call your doctor immediately.
• If you have or have had thoughts of harming yourself or committing suicide (see more below thoughts of suicide and worsening of your depression or anxiety).
• If you have a history of bleeding disorders or have taken medications that decrease blood clotting (such as aspirin, 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 old. Sertralina should only be used to treat children and adolescents aged 6 to 17 years old who have obsessive-compulsive disorder (OCD). If you are to be treated for this disorder, your doctor will want to monitor you closely (see more 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 that you have an abnormality in your heart rhythm that is obtained after an electrocardiogram (ECG), known as prolongation of the QT interval.
• If you have heart disease, low potassium or magnesium levels, a family history of QTc prolongation, low heart rate, or are taking medications that prolong the QTc interval.

Sexual dysfunction

Some medications in the group to which Sertralina pensa belongs (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Restlessness/Acatisia

The use of sertralina has been associated with unpleasant restlessness and a need to move, often accompanied by an inability to sit or stand still (acatisia). This occurs more often during the first 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 the suppression of treatment (withdrawal symptoms) are common, particularly if treatment is interrupted abruptly (see section 3. "If you interrupt treatment with Sertralina pensa" and section 4 "Possible side effects"). The risk of 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 days after treatment interruption. In general, these symptoms usually resolve on their own and usually resolve within two weeks. In some patients, they may last longer (2-3 months or more). It is recommended that when interrupting treatment with sertralina, the dose 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, you may sometimes have thoughts of harming yourself or committing suicide. This may increase at the beginning of treatment with antidepressants, as these medications take time to take effect, which is usually two weeks but can be longer.

This is more likely to happen::

• If you have previously had thoughts of harming yourself or committing suicide.
• 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 disorders, 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 explain to a family member or close friend that you are depressed or have anxiety, and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behavior.

Children and adolescents

Normally, sertralina should not be used to treat children and adolescents under 18 years old, except in the case of patients with obsessive-compulsive disorder (OCD). Young patients are at greater risk of side effects such as attempts at suicide, thoughts of harming themselves or committing suicide (suicidal thoughts) and hostility (predominantly aggression, confrontational behavior, and irritable reaction) when treated with this class of medications. However, it is possible that your doctor may decide to prescribe Sertralina pensa to a patient under 18 years old if they consider it to be the most suitable option for the patient. If your doctor has prescribed Sertralina pensa and you are under 18 years old and want to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen when you are taking sertralina. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of sertralina in this age group have not yet been demonstrated.

Other medications and Sertralina pensa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Some medications may affect how Sertralina pensa works, or Sertralina pensa may reduce the effectiveness of other medications you are taking at the same time.

The use of Sertralina pensa with the following medications may cause severe side effects:

• Medications called monoamine oxidase inhibitors (MAOIs), such as moclobemide (to treat depression), selegiline (to treat Parkinson's disease), the antibiotic linezolid, and methylene blue (to treat high levels of methemoglobin in the blood). Do not take sertralina with these medications.
• Medications to treat mental disorders such as psychosis (pimozide). Do not take sertralina with pimozide.

Inform your doctor if you are taking the following medications:

• Medications containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).
• Medications based on plants that contain St. John's Wort (Hypericum perforatum). The effects of St. John's Wort may persist for 1-2 weeks.
• Amino acid tryptophan.
• Medications to treat severe pain (such as tramadol).
• Medications used in anesthesia or to treat chronic pain (such as fentanyl, mivacurium, and suxamethonium).
• Medications to treat migraines (such as sumatriptan).
• Medications that decrease blood clotting (warfarin).
• Medications to treat pain/arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin).
• Sedatives (diazepam).
• Diuretics.
• Medications to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medications to treat diabetes (tolbutamide).
• Medications to treat acid reflux, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medications to treat mania and depression (lithium).
• Other medications to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medications to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medications to treat high blood pressure, chest pain, or to regulate heart rate (such as verapamil, diltiazem, flecainide, propafenone).
• Medications used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
• Medications used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Medications used to treat HIV/AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir).
• Medications known to increase the risk of changes in heart rhythm (such as some antipsychotics and antibiotics).

Taking Sertralina pensa with food, drinks, and alcohol

Sertralina pensa tablets can be taken with or without food.

Alcohol should be avoided while being treated with sertralina.

Do not take sertralina with grapefruit juice, as it may increase the levels of sertralina in your body.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The safety of sertralina in pregnant women has not been fully established. If you are pregnant, sertralina will only be administered to you if your doctor considers that the benefits for you outweigh any possible risks to the developing fetus.

Make sure your midwife and/or doctor know that you are taking Sertralina pensa. If you take sertralina during the last three months of pregnancy, medications like Sertralina pensa may increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear blue. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

Taking sertralina in the final stages of pregnancy may increase the risk of heavy vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking sertralina so they can advise you.

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

• difficulty breathing,
• blue skin or being too hot or cold,
• blue lips,
• vomiting or feeding problems,
• excessive tiredness, inability to sleep, or crying a lot,
• stiffness or decreased muscle tone,
• shaking, restlessness, or convulsions,
• 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 is evidence that sertralina passes into breast milk. Therefore, sertralina can only be used in women who are breastfeeding if your doctor considers that the benefits outweigh any possible risks to the baby.

In animal studies, some medications like sertralina have been shown to reduce the quality of sperm. Theoretically, this could affect fertility, but it has not yet been determined in humans.

Driving and operating machinery

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

Sertralina pensa contains lactose and sodium

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

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

Follow exactly the administration instructions of this medication 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:

The commonly effective dose for depression and OCD is 50 mg per day. The daily dose can be increased by 50 mg at intervals of at least one week, and thus over 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 begin with a dose of 25 mg per day, and increased to 50 mg per day after one week.

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

Use in children and adolescents:

Sertraline pensa 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..

Administration form:

Sertraline 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 may take several weeks for your symptoms to improve. Depression treatment should continue for 6 months after improvement.

If you take more Sertraline pensa than you should:

If you accidentally take an excessive amount of sertraline, contact your doctor or go to the nearest hospital emergency department. Always carry the medication packaging with you, even if it is empty.

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, rapid heart rate, tremors, agitation, dizziness, and in rare cases, loss of consciousness.

If you forget to take Sertraline pensa:

Do not take a double dose to compensate for the missed doses. If you forget to take a dose, do not take it when you remember. Take the next dose when it is due.

If you interrupt treatment with Sertraline pensa:

Do not stop treatment with Sertraline pensa unless your doctor tells you to. Your doctor will want to gradually reduce the dose of Sertraline pensa over several weeks before stopping treatment completely. If you stop 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 the interruption of your treatment with Sertraline pensa, please inform your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most common side effect is nausea. Side effects depend on the dose and often disappear or decrease as treatment continues.

Inform your doctor immediately

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

• If you develop a severe skin rash that causes blisters (erythema multiforme), (which can 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 skin rash with itching, breathing problems, ringing in the ears, swelling of the eyelids, face, or lips.
• If you experience agitation, confusion, diarrhea, increased temperature and blood pressure, excessive sweating, and rapid pulse. These are symptoms of serotonin syndrome. In rare cases, this syndrome can occur when taking certain medications at the same time as sertraline. Your doctor may decide to stop treatment.
• If you experience yellowing of the skin and eyes, which may indicate liver damage.
• If you experience depressive symptoms with thoughts of self-harm or suicide (suicidal thoughts).
• If you start to feel restless and are unable to sit or stand after starting treatment with Sertraline. Inform your doctor if you start to feel restless.
• If you experience a seizure (convulsions).
• If you experience 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):

• Common cold (of the chest), sore throat, runny nose,
• Loss of appetite, increased appetite,
• Depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased libido, teeth grinding,
• Tremor, muscle movement problems (such as constant movements, 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,
• Angina,
• Yawns,
• Abdominal pain, vomiting, constipation, stomach discomfort, gas,
• Rash, increased sweating,
• Muscle pain, joint pain, back pain,
• Irregular menstrual cycle, erectile dysfunction,
• Feeling unwell, chest pain, weakness, fever,
• Weight gain,
• Lesion.

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

• Gastroenteritis, ear infection,
• Tumor,
• Hypersensitivity, seasonal allergy,
• Low thyroid hormone levels,
• Suicidal thoughts, suicidal behavior*, psychotic disorders, abnormal thoughts, lack of care, hallucinations, aggression, excessive happiness, paranoia,
• Amnesia, decreased sensitivity, involuntary muscle contractions, fainting, continuous movements, convulsions, abnormal coordination, speech disorders, dizziness when standing up, migraine,
• Dilated pupils,
• Ear pain,
• Rapid pulse, heart problems,
• Bleeding problems (such as stomach bleeding)*,
• High blood pressure, angina, shortness of breath, hematuria,
• Shortness of breath, nasal bleeding, possible noisy breathing,
• Black stools, dental disorders, esophageal inflammation, tongue problems,
• Hemorrhoids, increased salivation, difficulty swallowing, tongue disorders, belching,
• Swollen eyes, purple spots on the skin, hair loss, cold sweat, dry skin, urticaria, skin problems with blisters, facial swelling, itching,
• Arthritis, muscle weakness, muscle spasms, muscle cramps*,
• Nocturia, urinary retention, increased urine production, increased frequency of urination, urinary disorders, urinary incontinence,
• Sexual dysfunction, excessive vaginal bleeding, vaginal bleeding, female sexual dysfunction,
• Swollen legs, chills, difficulty walking, thirst,
• Increased liver enzymes, weight loss,
• Cases of suicidal thoughts and behavior have been reported during treatment with sertraline or shortly after stopping treatment (see section 2).

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

• Diverticulitis, lymph node swelling, low platelet count*, low white blood cell count*,
• Severe allergic reaction,
• Endocrine problems*,
• High cholesterol, difficulty 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*, medication dependence, somnambulism, premature ejaculation,
• Coma, abnormal movements, difficulty moving, increased sensitivity, sudden and severe headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS)*, sensory disturbances,
• Glaucoma, eye problems, spots in front of the eyes, double vision, photophobia (sensitivity to light), eye bleeding, irregular pupils*,
• Heart attack, dizziness, fainting, or chest pain that may be signs of changes in electrical activity (seen on the electrocardiogram) or abnormal heart rhythm*, decreased heart rate,
• Problems with circulation in the arms and legs,
• Throat spasm, rapid breathing, slower breathing, difficulty speaking, hiccups, progressive formation of lung tissue scars (interstitial lung disease)*,
• Blood in stool, mouth sores, tongue ulcers, mouth ulcers, pancreatitis*,
• Liver function problems, severe liver function problems*, yellow skin or eyes (jaundice)*,
• Sun sensitivity*, skin swelling*, capillary rash, abnormal skin texture, abnormal skin odor,
• Bone disorders, muscle tissue rupture*,
• Decreased urine volume, interrupted urination,
• Vaginal dryness, penile and preputial pain and swelling, genital secretion, prolonged erection, breast secretion, breast enlargement*,
• Hernia, decreased tolerance to the medication,
• Increased cholesterol levels, abnormal laboratory results*, abnormal semen, coagulation problems*,
• Relaxation of blood vessel procedure.

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

• Partial loss of vision,
• Colitis (which causes diarrhea)*,
• Excessive vaginal bleeding after childbirth (postpartum hemorrhage), see “Pregnancy and lactation” in section 2 for more information,
• Trigeminal neuralgia*,
• Nocturnal urinary incontinence*.

* 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 stopped

If you stop treatment with this medicine 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 stop treatment with Sertraline).

A higher risk of bone fractures has been observed in patients taking this type of medication.

Reporting of side effects:

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

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

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

No special storage conditions are required.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Sertralina pensa

• The active ingredient is sertraline (hydrochloride). Each tablet contains 100 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), macrogol 400 (E 1521), and titanium dioxide (E 171).

Appearance of the product and content of the packaging

Sertralina pensa is presented in coated tablets with a white or light gray film.

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

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

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

Last review date of this leaflet:January 2021

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/