Package Leaflet: Information for the User

Sertraline Cuve 50 mg Film-Coated Tablets

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should 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, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

This medication 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.

This medication may 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 diseases linked to anxiety, 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 disorder. It is characterized by feeling 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 that this medication is suitable for treating your disease.

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

Do not take Sertralina Cuve:

• If you are allergic to sertraline 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 stop taking sertraline, wait at least one week before starting treatment with an MAOI. After stopping treatment with an MAOI, wait at least two weeks before starting treatment with sertraline.
• 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 this medication.

Medications are not always suitable for everyone. Before starting treatment with sertraline, 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 sertraline. (See 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 sertraline. Also, inform your doctor if you are taking any medication for high blood pressure, 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 sertraline.
• If you have diabetes; sertraline 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 (convulsion), 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 below thoughts of suicide and worsening of your depression or anxiety).
• - If you have a history of bleeding disorders (tendency to develop thrombocytopenia), or if you are pregnant (see Pregnancy, breastfeeding, and fertility) or have taken medications that reduce blood clotting [such as aspirin, or warfarin] or that may increase the risk of bleeding.
• If you are a child or adolescent under 18 years old. Sertraline should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder (OCD). If you are 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 abnormality in your heart rhythm that is obtained after an electrocardiogram (ECG), known as prolongation of the QT interval.
• If you have heart disease, have low levels of potassium or magnesium, have a family history of QTc prolongation, have a low heart rate, or are taking medications that prolong the QTc interval.

Restlessness/Acatisia

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

Withdrawal symptoms

Side effects related to the suspension of treatment (withdrawal symptoms) are common, particularly if the suspension of treatment is abrupt (see section 3. If you stop taking this medication and section 4 Possible side effects). The risk of developing 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 stopping treatment. 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 stopping treatment with sertraline, 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 disorders, you may sometimes have thoughts of harming yourself or committing suicide. This may increase at the beginning of treatment with antidepressants, as all these medications take time to take effect, which is usually two weeks but sometimes longer.

You would be more prone to having these thoughts:

• 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 with psychiatric disorders, who were 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 close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

There has been an observed increase in the risk of bone fractures in patients treated with this type of medication.

Sexual problems:

Some medications in the group to which this medication belongs (called ISRS) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Normally, sertraline should not be used to treat children and adolescents under 18 years old, except in the case of patients with obsessive-compulsive disorder (OCD). Children and adolescents under 18 years old have a higher risk of adverse effects such as suicidal thoughts, thoughts of self-harm or suicide (suicidal ideation), and hostility (predominantly aggression, confrontational behavior, and irritable reaction) when treated with this class of medications. However, your doctor may decide to prescribe Sertralina Cuve 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 Cuve to a patient under 18 years old and wants 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 a patient under 18 years old is taking sertraline. At the same time, the long-term effects on safety and related to growth, maturation, and cognitive and behavioral development of sertraline were 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 results of the study showed that children treated with sertraline developed normally, except for a slight increase in weight in those treated with a higher dose

Other medications and Sertralina Cuve

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 sertraline works, or sertraline itself may reduce the effectiveness of other medications you are taking at the same time.

The use of Sertralina Cuve 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 use sertraline with these medications
• Medications to treat mental disorders such as psychosis (pimozide). Do not use sertraline 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.
• Products containing the amino acid tryptophan.
• Medications to treat severe pain (such as tramadol).
• Medications used in anesthesia (such as fentanyl, mivacurium, and suxamethonium).
• Medications to treat migraines (such as sumatriptan).
• Medications that reduce 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 stomach acid, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, 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 used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant)
• Medications known to increase the risk of changes in heart rhythm (such as some antipsychotics and antibiotics).

Taking Sertralina Cuve with food, drinks, and alcohol

Sertralina Cuve tablets can be taken with or without food.

Alcohol should be avoided while taking sertraline.

Do not take sertraline with grapefruit juice, as it may increase the levels of sertraline 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 sertraline in pregnant women has not been fully established. Sertraline should only be administered to pregnant women if, in the opinion of the doctor, the benefits for the mother outweigh any possible risk to the fetus. Women of childbearing age who are being treated with sertraline should use an appropriate contraceptive method.

If you are taking Sertralina Cuve 50 mg tablets in the final stages of pregnancy, there may be an increased risk of excessive vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking this medication to be able to advise you.

When taken during pregnancy, particularly in the last three months of pregnancy, medications like sertraline may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

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 too hot or cold,

• blue lips,

• vomiting or feeding problems,

• excessive tiredness, unable to sleep, or crying a lot,

• muscle stiffness or decreased muscle tone,

• tremors, 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.

Some medications, such as sertraline, may reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but the impact on human fertility has not been observed so far.

There are indications that sertraline is excreted in breast milk. Therefore, sertraline can only be used in women during breastfeeding if, in the opinion of the doctor, the benefits for the mother outweigh any possible risk to the baby.

Driving and operating machinery

Antidepressants like sertraline may affect your ability to drive or operate machinery. Therefore, do not drive or operate heavy machinery until you know how this medication affects your ability to perform these activities.

Sertralina Cuve contains lactose:

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

Sertralina Cuve contains sodium:

This medication contains less than 1mmol of sodium (23 mg) 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 start 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 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 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 Cuve 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. Treatment of depression usually should continue for 6 months after improvement.

If you take more Sertraline Cuve 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, vomiting, rapid heart rate, tremors, agitation, dizziness, and in rare cases, loss of consciousness.

If you forget to take Sertraline Cuve

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 Cuve

Do not stop treatment with sertraline unless your doctor tells you to. Your doctor will want to gradually reduce the dose of sertraline over several weeks before stopping it completely. If you stop treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling unwell, or feeling dizzy and trembling. If you experience any of these adverse effects, or any other during the interruption of your treatment with Sertraline Cuve, 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 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.They may be signs of a condition known as Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). In these cases, your doctor will stop treatment.

• If you develop a severe skin rash that causes blisters (erythema multiforme), (which may affect the mouth and tongue). These may be signs of a condition known as Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). In these cases, your doctor will stop treatment.
• Allergic reaction or allergy, which may present symptoms such as 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 heart rate. These are symptoms of serotonin syndrome. In rare cases, this syndrome may 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 ofharming yourself or committing suicide (suicidal thoughts
• If you start to feel restless and are unable to sit or stand after starting treatment with Sertralina Cuve. 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 side effects (occur in more than 1 in 10 patients):

Insomnia, dizziness, drowsiness, headache, diarrhea, feeling unwell, dry mouth, ejaculation problems, and fatigue.

Common side effects (occur between 1 and 10 in 100 patients):

• Sore throat, cold (of the chest), runny nose
• Loss of appetite, increased appetite,
• Depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased libido, teeth grinding,
• Numbness and tingling, tremor, muscle movement problems (such as constant movements, muscle tension, difficulty walking, and involuntary muscle movements)*, increased muscle tone, abnormal taste, lack of concentration,
• Visual disturbances,
• Ringing in the ears,
• Palpitations,
• Hot flushes,
• Yawning,
• Abdominal pain, vomiting, constipation, stomach discomfort, gas,
• Rash, increased sweating,
• Muscle pain, back pain, joint pain,
• Irregular menstrual cycle, erectile dysfunction,
• Chest pain, weakness, fever, feeling unwell,
• Weight gain,
• Lesion.

Uncommon side effects (occur between 1 and 10 in 1,000 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, migraine, convulsions, dizziness when standing up, abnormal coordination, speech disorders,
• Dilated pupils,
• Ear pain,
• Rapid pulse, heart problems,
• Bleeding problems (such as stomach bleeding)*, high blood pressure, hot flushes, blood in urine,
• Shortness of breath, nasal bleeding, possible noisy breathing,
• Black stools, dental disorders, esophageal inflammation, tongue problems, hemorrhoids, excessive salivation, difficulty swallowing, belching, tongue disorders,
• Swollen eyes, urticaria, hair loss, itching, purple spots on the skin, skin disorders with blisters, dry skin, swollen face, cold sweat,
• Arthritis, muscle spasms, muscle cramps*, muscle weakness,
• Increased frequency of urination, urinary disorders, urinary retention, incontinence, increased urine volume, need to urinate at night,
• Sexual dysfunction, excessive vaginal bleeding, vaginal bleeding, female sexual dysfunction,
• Swollen legs, chills, difficulty walking, thirst,
• Increased liver enzyme levels, weight loss,
• There have been reports of suicidal thoughts and behavior during treatment with sertraline or shortly after stopping treatment (see section 2).

Rare side effects (occur between 1 and 10 in 10,000 patients):

• Diverticulitis, swollen lymph nodes, low platelet count*, low 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*,
• Physical symptoms due to stress or emotions, abnormal nightmares*, medication dependence, somnambulism, 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,
• Seeing spots in front of the eyes, glaucoma, double vision, photophobia (light sensitivity), eye bleeding, irregular pupils*, visual disturbances*, eye disorders,
• Heart attack, dizziness, fainting, or chest discomfort that may be signs of changes in electrical activity (seen on the electrocardiogram) or abnormal heart rhythm*, decreased heart rate,
• Arm and leg circulation problems,
• Accelerated breathing, progressive scarring of lung tissue (interstitial lung disease)*, throat spasm, difficulty speaking, slower breathing, hiccups,
• Mouth ulcers, pancreatitis*, blood in stool, tongue ulcers, mouth sores,
• Liver function problems, severe liver function disorders*, yellow skin and eyes (jaundice)*,
• Sun sensitivity*, skin swelling*, abnormal hair texture, abnormal skin odor, capillary eruption,
• Muscle rupture*, bone disorders,
• Intermittent urination, decreased urine volume,
• Milk secretion, vaginal dryness, genital secretion, penile and preputial pain and redness, breast enlargement*, prolonged erection,
• Hernia, decreased tolerance to the medication,
• Increased cholesterol levels, abnormal laboratory results*, abnormal semen, coagulation disorders*,
• Relaxation of blood vessel procedure.

Unknown frequency:cannot be estimated from available data:

-Colitis (which causes diarrhea),

-Excessive vaginal bleeding after childbirth (postpartum hemorrhage), see «Pregnancy and lactation» in section 2 for more information,

-Trigeminal nerve block*,

-Nocturnal urinary incontinence*,

-Partial loss of vision.

*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 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 Sertralina Cuve).

There has been an increased risk of bone fractures in patients taking this type of medication.

Reporting of 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 System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not use Sertralina Cuve 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.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the 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 Cuve

• The active ingredient is sertraline (hydrochloride). Each tablet contains 50 mg of sertraline.
• The other components are: microcrystalline cellulose (E 460), lactose monohydrate, copovidone, croscarmellose sodium, magnesium stearate, anhydrous colloidal silica, hypromellose, hydroxypropylmethylcellulose (E 463), titanium dioxide (E 171) and macrogol.

Appearance of the product and contents of the packaging

Sertralina Cuve 50 mg film-coated tablets are white or almost white, capsule-shaped, scored tablets.

Sertralina Cuve 50 mg tablets are packaged in cardboard boxes containing 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba) – Spain

Date of the last review of this leaflet:October 2022

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