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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sertraline Cuve 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. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

This medicine 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.

This medicine 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 condition characterized by 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 conditions, with symptoms such as persistent worry about recurring thoughts (obsessions) that lead to repetitive rituals (compulsions).

PTSD is a disorder that may occur following an emotionally traumatic experience and has some symptoms similar to those of 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: talking to 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 appropriate for treating your condition.

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

2. What you need to know before taking Sertraline Cuve

Do not take Sertraline Cuve:

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 taking this medicine.

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

If you have serotonin syndrome. This syndrome may rarely occur when taking certain medicines together with sertraline (see section 4 for symptoms). Your doctor will determine whether you have previously experienced this syndrome.
If you have low sodium levels in the blood, as this condition may result from treatment with sertraline. You should also inform your doctor if you are taking any medicines for high blood pressure, as these may also affect blood sodium levels.
If you are elderly, as you may be at increased 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 experience 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 further information below on suicidal thoughts and worsening depression or anxiety disorders).
If you have a history of bleeding disorders (tendency to bruise easily), or if you are pregnant (see section on Pregnancy, breastfeeding and fertility) or have been taking medicines that reduce blood clotting (e.g., 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 being treated for this condition, your doctor will want to monitor you closely (see section below on 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 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 if you are taking concomitant medicines that prolong the QTc 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 sit or stand still). This occurs most frequently during the first few weeks of treatment. Increasing the dose in patients who develop these symptoms may be harmful; therefore, if you experience such 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 this medicine, 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. These symptoms usually occur during the first few days after stopping treatment. In general, these symptoms resolve on their own and usually disappear within two weeks. However, 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 discuss the best way to discontinue treatment with your doctor.

Suicidal thoughts and worsening of depression or anxiety disorder

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

You are more likely to have these types of thoughts:

If you have previously had thoughts of suicide or self-harm.
If you are a young adult. Clinical trial data show an increased risk of suicidal behavior in psychiatric patients under 25 years of age treated with an antidepressant.

If you have thoughts of harming yourself or of suicide at any time, contact your doctor or go to the hospital immediately. It may be helpful for you to inform 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 inform you if they think your depression or anxiety is worsening, 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 same group as this one (called SSRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Sertraline is generally not recommended for use in children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder (OCD). Patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, thoughts of self-harm or suicide (suicidal ideation), and hostility (mainly aggression, confrontational behavior, and anger reactions) when treated with this class of medicines. Nevertheless, your doctor may decide to prescribe Sertraline Cuve to a patient under 18 years of age if they consider it appropriate. If your doctor has prescribed Sertraline Cuve to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You should inform your doctor if any of the symptoms listed above appear or worsen while a patient under 18 years of age is taking sertraline. In addition, the long-term safety effects of sertraline on growth, maturation, and cognitive and behavioral development were evaluated in a long-term study involving more than 900 children aged 6 to 16 years monitored over a 3-year period. Overall, the study results showed that children treated with sertraline developed normally, except for a slight increase in weight in those treated with higher doses.

Other medicines and Sertraline Cuve

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

Using Sertraline Cuve together with the following medicines may cause serious adverse effects:

Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (for treating depression), selegiline (for treating Parkinson's disease), the antibiotic linezolid, and methylene blue (for treating 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 for severe pain (e.g., tramadol).
Medicines used in anesthesia (e.g., fentanyl, mivacurium, and suxamethonium).
Medicines for migraine (e.g., sumatriptan).
Medicines that reduce blood clotting (warfarin).
Medicines for pain/arthritis (non-steroidal anti-inflammatory drugs [NSAIDs] such as ibuprofen, acetylsalicylic acid [aspirin]).
Sedatives (diazepam).
Diuretics.
Medicines for epilepsy (phenytoin, phenobarbital, carbamazepine).
Medicines for diabetes (tolbutamide).
Medicines for stomach acid, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, rabeprazole).
Medicines for mania and depression (lithium).
Other medicines for depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
Medicines for schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
Medicines for 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., certain antipsychotics and antibiotics).

Taking Sertraline Cuve with food, drinks, and alcohol

Sertraline Cuve tablets can be taken with or without food.

Alcohol should be avoided while being treated with sertraline.

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

Pregnancy and breastfeeding

If you are pregnant or 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. Sertraline should only be given to pregnant women if, in the doctor’s judgment, the benefit to the mother outweighs any possible risk to the fetus. Women of childbearing potential who are being treated with sertraline should use an adequate method of contraception.

If you take Sertraline Cuve 50 mg tablets in the late stages 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 be informed that you are taking this medicine so they can advise you.

When taken during pregnancy, particularly during the last three months, medicines like sertraline 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 happens to your baby, contact your midwife and/or doctor immediately.

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

Difficulty breathing,
Bluish or unusually hot or cold skin,
Blue lips,
Vomiting or feeding problems,
Extreme tiredness, inability to sleep, or excessive crying,
Muscle stiffness or decreased muscle tone,
Tremors, restlessness, or seizures,
Increased reflex responses,
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.

Some medicines like sertraline may reduce sperm quality in animal studies. Theoretically, this could affect fertility, but no impact on human fertility has been observed so far.

There is evidence that sertraline is excreted in breast milk. Therefore, sertraline may only be used in women who are breastfeeding if, in the doctor’s judgment, the benefit to the mother outweighs any possible risk to the infant.

Driving and using machines

Antidepressant medicines like sertraline may affect your ability to drive or operate machinery. 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 certain sugars, consult with them before taking this medicine.

Sertraline Cuve contains sodium:

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

3. How to take Sertraline Cuve

Follow exactly the instructions for using 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 daily. 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 daily.

Panic disorder, social anxiety disorder, and post-traumatic stress disorder:

For panic disorder, social anxiety disorder, and post-traumatic stress disorder, treatment should begin with a dose of 25 mg daily, increasing to 50 mg daily 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 daily.

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 daily. After one week, your doctor may increase your dose to 50 mg daily. The maximum dose is 200 mg daily.

Adolescents aged 13 to 17 years: The recommended starting dose is 50 mg daily. The maximum dose is 200 mg daily.

If you have liver or kidney problems, inform your doctor and follow the instructions he or she gives you.

Method of administration

Sertraline Cuve tablets can be taken with or without food.

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

Your doctor will tell you 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.

If you take more Sertraline Cuve 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 packaging with you, whether or not there is any medicine left.

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

Symptoms of overdose may include drowsiness, nausea and vomiting, increased 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 make up for forgotten doses.

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 Sertraline Cuve

Do not stop treatment with sertraline unless your doctor tells you to. Your doctor will want to gradually reduce your dose of sertraline over several weeks before you stop taking this medicine completely. If you stop treatment suddenly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feelings of discomfort, or feeling dizzy and shaky. If you experience any of these adverse effects, or any other symptoms, while stopping treatment with Sertraline Cuve, 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 will experience them.

The most common adverse effect is nausea. Adverse effects depend on the dose and often disappear during 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 could 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 self-harm or suicide (suicidal thoughts).
If, after starting treatment with Sertralina Cuve, you begin to feel restless and unable to sit or stand still. You should inform your doctor if you start feeling 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 adverse effects (occur in more than 1 in 10 patients):

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

Common adverse effects (occur in 1 to 10 out of 100 patients):

Sore throat, chest cold, runny nose
Loss of appetite, increased appetite
Depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased libido, teeth grinding
Numbness and tingling, tremor, movement disorders (such as constant movements, muscle tension, difficulty walking, and involuntary muscle movements)*, increased muscle tone, abnormal taste, difficulty concentrating
Visual disturbances
Ringing in the ears
Palpitations
Hot flushes
Yawning
Abdominal pain, vomiting, constipation, stomach discomfort, flatulence
Rash, increased sweating
Muscle pain, back pain, joint pain
Menstrual irregularities, erectile dysfunction
Chest pain, weakness, fever, malaise
Weight gain
Injury

Uncommon adverse effects (occur in 1 to 10 out of 1,000 patients):

Gastroenteritis, ear infection
Tumor
Hypersensitivity, seasonal allergy
Low levels of thyroid hormones
Suicidal thoughts, suicidal behaviour*, psychotic disorders, abnormal thinking, lack of self-care, hallucinations, aggression, excessive happiness, paranoia
Amnesia, decreased sensitivity, involuntary muscle contractions, fainting, continuous movements, migraine, seizures, dizziness upon standing, 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, nosebleeds, difficulty breathing possibly with noise
Black stools, dental disorders, inflammation of the esophagus, tongue disorders, hemorrhoids, increased salivation, difficulty swallowing, burping, tongue disorders
Swelling of eyes, hives, hair loss, itching, purple spots on the skin, blistering skin disorders, dry skin, facial swelling, cold sweat
Osteoarthritis, muscle jerks, muscle cramps*, muscle weakness
Increased frequency of urination, urinary disorders, urinary retention, urinary 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
Cases of suicidal thoughts and behaviour have been reported during treatment with sertraline or shortly after discontinuation (see section 2).

Rare adverse effects (occur in 1 to 10 out of 10,000 patients):

Diverticulitis, swollen lymph nodes, decreased platelet count*, decreased white blood cell count*
Severe allergic reaction
Endocrine disorders*
High cholesterol, difficulty controlling blood sugar levels (diabetes), low blood sugar, increased blood sugar*, low blood sodium levels*
Physical symptoms due to stress or emotions, abnormal nightmares*, drug dependence, sleepwalking, premature ejaculation
Coma, abnormal movements, movement difficulty, 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 hemorrhages, irregular pupils*, visual disturbances*, tear problems
Heart attack, dizziness, fainting or chest discomfort that could indicate changes in electrical activity (seen on electrocardiogram) or abnormal heart rhythm*, decreased heart rate
Circulation problems in arms and legs
Rapid breathing, progressive scarring in lung tissue (interstitial lung disease)*, throat spasm, difficulty speaking, slower breathing, hiccups
Mouth ulceration, pancreatitis*, blood in stools, tongue ulceration, mouth sores
Liver function problems, serious liver dysfunction*, yellowing of skin and eyes (jaundice)*
Skin reaction to sunlight*, skin swelling*, abnormal hair texture, abnormal skin odor, capillary rash
Muscle tissue breakdown*, bone disorder
Interrupted urination, decreased urine volume
Breast secretion, vaginal dryness, genital discharge, pain and redness of penis and foreskin, breast enlargement*, prolonged erection
Hernia, decreased drug tolerance
Increased cholesterol levels, abnormal laboratory tests*, abnormal semen, coagulation problems*
Relaxation of blood vessel constriction process

Frequency not known: cannot be estimated from available data:

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*
Partial loss of vision
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 treatment is discontinued

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 Cuve).

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, talk to your doctor, pharmacist, or nurse, 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 Cuve

Keep out of sight and reach of children.

Do not use Sertraline Cuve 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 drains or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly 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 Cuve

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

Appearance of the product and contents of the pack

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

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

Marketing Authorisation Holder and Manufacturer

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba) – Spain

Date of the most recent review of this leaflet: October 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es