SERTRALINE CUVE 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sertraline Cuve 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 and other information:

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

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

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

This medicine 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 condition with symptoms such as feelings of sadness, inability to sleep well or to enjoy life as you used to.

OCD and anxiety disorders are conditions 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 condition. It is characterized by feeling intense anxiety or distress in social situations (e.g., talking to strangers, public speaking, eating or drinking in front of others, or worrying about behaving in a shameful way).

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

If you are not sure why you have been prescribed Sertraline Cuve, you should ask your doctor.

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

Do not take Sertraline Cuve:

• 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 in the last 14 days 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 to take this medicine.

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

• If you have serotonin syndrome. This syndrome can rarely occur 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 your blood, as this situation can occur as a result of treatment with sertraline. You should also inform your doctor if you are taking any medicine for hypertension, as these medicines can also alter sodium levels in your blood.
• If you are elderly, as you may be at greater risk of having low sodium levels in your blood (see 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 medicines.
• 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 suicide (see below thoughts of suicide and worsening of your depression or anxiety disorder).
• If you have a history of bleeding disorders (tendency to develop bruises), or if you are pregnant (see section Pregnancy, breast-feeding and fertility) or have been taking medicines that reduce blood clotting [such as acetylsalicylic acid (aspirin) or warfarin] or that may increase the risk of bleeding.
• 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 abnormality in the graph of your heart that is obtained after an electrocardiogram (ECG), known as prolongation of the QT interval.
• If you have heart disease, have low potassium or magnesium levels, a family history of QT prolongation, a low heart rate, or are taking concomitantly medications that prolong the QT interval.

Restlessness/ Akathisia

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

Withdrawal symptoms

Side effects related to discontinuation of treatment (withdrawal symptoms) are common, particularly if treatment is discontinued abruptly (see section 3. If you stop taking this medicine and section 4. Possible side effects). The risk of presenting withdrawal symptoms depends on the duration of treatment, the dose, and the rate at which the dose is reduced. Generally, these symptoms are mild or moderate. However, in some patients, they can be severe. These symptoms usually occur during the first few days after discontinuation of 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 discontinuing 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.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or suicide. This can increase at the beginning of treatment with antidepressants, due to the fact that all these medicines take time to work, which is usually a few weeks but can sometimes be longer.

You would be more likely to have 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 that there is an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who are being treated with an antidepressant.

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

An increased risk of bone fractures has been observed in patients treated with this type of medicine.

Sexual problems:

Some medicines in the group to which this medicine belongs (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

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 greater risk of adverse effects such as suicidal attempts, thoughts of self-harm or suicide (suicidal ideas), and hostility (predominantly aggression, confrontational behavior, and anger) when they are being treated with this class of medicines. Nevertheless, it is possible that your doctor may decide to prescribe Sertraline Cuve 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 Cuve to a patient under 18 years of age and you wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen when a patient under 18 years of age is 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 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 medicines and Sertraline Cuve

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 works, or sertraline may reduce the effectiveness of other medicines that are being taken at the same time.

The use of Sertraline Cuve 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 methylene blue (for high levels of methemoglobin in the blood). Do not use sertraline with these medicines.
• Medicines for treating 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 for treating severe pain (e.g., tramadol).
• Medicines used in anesthesia (e.g., fentanyl, mivacurium, and suxamethonium).
• Medicines for treating migraines (e.g., sumatriptan).
• Medicines that reduce blood clotting (warfarin).
• Medicines for treating pain/arthritis (non-steroidal anti-inflammatory medicines (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 stomach acidity, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, 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 Cuve with food, drinks, and alcohol

Sertraline Cuve tablets can be taken with or without food.

Alcohol consumption should be avoided while being treated with sertraline.

Sertraline should not be taken in combination with grapefruit juice, as it can increase the levels of sertraline in your body.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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. Sertraline should only be administered to pregnant women if, in the opinion of the doctor, the benefit to the mother outweighs any possible risk to the fetus. Women of childbearing age who are being treated with sertraline should use a suitable contraceptive method.

If you take Sertraline Cuve 50 mg tablets in the final stage of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking this medicine so that they can advise you.

When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like sertraline 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 turn blue. These symptoms usually start during 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 appear during 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 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 medicines like sertraline may reduce sperm quality in animal studies. Theoretically, this could affect fertility, but the impact on human fertility has not been observed yet.

There are indications that sertraline is excreted in breast milk. Therefore, sertraline can only be used in women during breast-feeding if, in the opinion of the doctor, the benefit to the mother outweighs any possible risk to the baby.

Driving and using machines

Antidepressant medicines like sertraline may affect your ability to drive or use machines. Therefore, do not drive or operate heavy machinery until you know how this medicine affects your ability to perform these activities.

Sertraline Cuve contains lactose:

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

Sertraline Cuve contains sodium:

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

3. How to take Sertralina Cuve

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:

For depression and OCD, the usual effective dose is 50 mg per day. The daily dose can be increased in increments of 50 mg, at intervals of at least one week, and so on for several weeks. The maximum recommended dose is 200 mg per day.

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

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

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

Use in children and adolescents

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

Obsessive-Compulsive Disorder:

Children from 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 from 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 indicate .

Method of administration

Sertralina 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 will take several weeks for your symptoms to start improving. The treatment of depression should normally continue for 6 months after improvement.

If you take more Sertralina Cuve than you should

If you accidentally take an excess of sertralina, contact your doctor or go to the emergency department of the nearest hospital. Always carry the medication package with you, whether there is medication left in it or not.

You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

If you forget to take Sertralina Cuve

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 Cuve

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

The most common side effect is nausea. Side effects depend on the dose and often disappear 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), (can affect the mouth and tongue). These can be signs of a disease known as Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). In these cases, your doctor will interrupt treatment.
• Allergic reaction or allergy, which can present symptoms such as skin rash with itching, breathing problems, wheezing, swelling of the eyelids, face, or lips.
• If you experience agitation, confusion, diarrhea, increased temperature and blood pressure, excessive sweating, and increased heart rate. These are symptoms of serotonin syndrome. In rare cases, this syndrome can occur when taking certain medications at the same time as sertralina. Your doctor may decide to interrupt treatment.
• If you have a yellowish color of the skin and eyes, which can indicate liver damage.
• If you experience depressive symptoms with thoughts of self-harm or suicide (suicidal thoughts
• If after starting treatment with Sertralina Cuve, you begin to feel restless and are unable to sit or stand. You should inform your doctor if you start to feel restless.
• If you have a seizure (convulsions).
• If you have a manic episode (see section 2. Warnings and precautions).

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

Very common side effects (occur in more than 1 patient in 10):

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

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

• Sore throat, chest cold, runny nose
• Lack of appetite, increased appetite,
• Depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased libido, teeth grinding,
• Numbness and tingling, tremors, muscle movement problems (such as constant movement, muscle tension, difficulty walking, and involuntary muscle movements)*, increased muscle tone, abnormal taste, lack of concentration,
• Visual disturbances,
• Ringing in the ears,
• Palpitations,
• Hot flashes,
• 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,
• Injury.

Uncommon side effects (occur in between 1 and 10 out of 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 movement, migraine, convulsions, dizziness when standing, abnormal coordination, speech disorders,
• Dilated pupils,
• Ear pain,
• Increased heart rate, heart problems,
• Bleeding problems (such as stomach bleeding)*, high blood pressure, hot flashes, blood in urine,
• Shortness of breath, nosebleeds, difficulty breathing possibly noisy,
• Black stools, dental problems, esophagitis, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders,
• Eye swelling, urticaria, hair loss, itching, purple spots on the skin, skin problems with blisters, dry skin, facial swelling, cold sweat,
• Arthritis, muscle spasms, muscle cramps*, muscle weakness,
• Increased urination frequency, urinary disorders, urinary retention, urinary incontinence, increased urine volume, need to urinate at night,
• Sexual dysfunction, excessive vaginal bleeding, vaginal hemorrhage, 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 sertralina or shortly after its interruption (see section 2).

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

• Diverticulitis, lymph node swelling, decreased platelet count*, 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 blood*,
• Physical symptoms due to stress or emotions, abnormal nightmares*, drug dependence, sleepwalking, premature ejaculation,
• Coma, abnormal movements, movement difficulties, increased sensitivity, severe headache (which can be a sign of a serious disease known as reversible cerebral vasoconstriction syndrome (RCVS))*, sensory disturbances,
• Seeing spots in front of the eyes, glaucoma, double vision, photophobia (eye sensitivity to light), eye bleeding, irregular pupils*, visual disturbances*, tear problems,
• Heart attack, dizziness, fainting or chest discomfort that could be signs of changes in electrical activity (seen on an electrocardiogram) or abnormal heart rhythm*, decreased heart rate,
• Circulation problems in the arms and legs,
• Rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, throat spasm, difficulty speaking, slow breathing, hiccups,
• Mouth ulcers, pancreatitis*, blood in stools, tongue ulcers, mouth sores,
• Liver function problems, serious liver function problems*, yellowing of the skin and eyes (jaundice)*,
• Sunburn*, skin swelling*, abnormal hair texture, abnormal skin odor, capillary rash,
• Muscle rupture*, bone disorder,
• Urination problems, decreased urine volume,
• Breast secretion, vaginal dryness, genital secretion, penile and foreskin pain and redness, breast enlargement*, prolonged erection,
• Hernia, decreased drug tolerance,
• Increased cholesterol levels, abnormal laboratory tests*, abnormal semen, coagulation problems*,
• Relaxation of blood vessel procedure.

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

• Colon inflammation (causing diarrhea),
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and lactation" in section 2 for more information,
• Jaw locking*,
• 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 interrupted

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

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

Reporting side effects

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

5. Conservation of Sertralina Cuve

Keep out of sight and reach of children.

Do not use Sertralina Cuve 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.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at 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. Package contents and additional information

Sertralina Cuve composition

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

Product appearance and packaging contents

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

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

Marketing authorization holder and manufacturer

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba) – Spain

Date of the last revision of this leaflet:October 2022

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