Package Leaflet: Information for the User

Sertraline Aristo 100 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. Do not pass it on to others even if their symptoms are the same. It may harm them.

-If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2.What you need to know before you start taking Sertraline Aristo

3.How to take Sertraline Aristo

4.Possible side effects

5Storage of Sertraline Aristo

6.Contents of the pack and other information

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

Sertralina Aristo 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).

-Panic 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 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 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 humiliating manner).

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

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

Do not take Sertralina Aristo:

-If you are allergic to sertraline or any of the other components of this medication (including those listed in section 6).

-If you are taking or have been taking 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 sertraline, you should wait at least one week before starting treatment with an MAOI. After interrupting treatment with an MAOI, you should wait at least two weeks before starting treatment with sertraline.

-If you are taking another medication called pimozide (an antipsychotic medication).

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:

-Serotonin syndrome. In rare cases, this syndrome may occur when taking certain medications such as buprenorphine at the same time as sertraline. (To see the symptoms, read section 4. Possible side effects). Your doctor will indicate if you have previously presented this syndrome. This syndrome is a potentially life-threatening disease (see <>).

-If you have low sodium levels in your blood, as this situation may occur as a consequence of treatment with sertraline. You should 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.

-Be especially careful if you are elderly, as you may have a higher risk of having low sodium levels in the blood (see above).

-Liver disease; your doctor may consider that you should take a lower dose of sertraline.

-Diabetes; sertraline may alter your blood sugar levels, so you may need to adjust the dose of your diabetes medications.

-Epilepsy or a history of epilepsy. 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 suicide (see below thoughts of suicide and worsening of your depression or anxiety disorder).

-If you have had bleeding disorders or have been taking medications that decrease blood clotting (such as aspirin, or warfarin) or that may increase the risk of bleeding, or if you are pregnant (see <>).

-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. If you are to be treated for this disorder, your doctor will want to monitor you closely (see below Use in children and adolescents).

-If you are receiving electroconvulsive therapy (ECT).

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

Pregnancy1

If you take this medication in the final stages of pregnancy, it may increase the risk of excessive vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking sertraline to be able to advise you.

Restlessness/Acatisia

The use of sertraline has been associated with acatisia (unpleasant restlessness and a need to move, often accompanied by an inability to sit or stand still). This occurs more often during the first weeks of treatment. Increasing the dose in patients who develop these symptoms may be harmful.

Withdrawal symptoms

When treatment is stopped, withdrawal symptoms are common, particularly if the treatment is stopped abruptly (see 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 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, as needed for each patient.

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

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may have thoughts of self-harm or suicide. These may increase when you first start taking antidepressants, as all these medications take time to start working, usually around 2-4 weeks, although in some cases it may take longer.

This is more likely to happen to you

You would be more prone to having these thoughts:

- If you have previously had thoughts of self-harm or suicide.

- If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders who were treated with an antidepressant.

- If you have thoughts of self-harm or suicide, contact your doctor or go to the hospital immediately.

It may be helpful to tell a family member or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. They may be able to tell if your depression or anxiety disorder has worsened or if they are concerned about changes in your behavior.

Use in 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. Young patients have a higher risk of adverse effects such as suicidal thoughts, suicidal behavior, and hostility (predominantly aggression, confrontational behavior, and irritable reactions) when treated with this class of medications. However, your doctor may decide to prescribe sertraline 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 sertraline to a patient under 18 years old and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen in a patient under 18 years old taking sertraline. At the same time, the long-term effects on safety and related to growth, maturation, and cognitive and behavioral development of sertraline in this age group have not yet been demonstrated.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Some medications may affect how sertraline works, or this medication itself may reduce the effectiveness of other medications you are taking at the same time.

The use of sertraline 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), and the antibiotic linezolid. Do not use sertraline with MAOIs.

-Medications to treat mental disorders (pimozide). Do not use sertraline with pimozide.

-Sertraline may interact with buprenorphine and may experience symptoms such as involuntary rhythmic muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience these symptoms.

Inform your doctor if you are taking the following medications

-Medications based on plants containing St. John's Wort (Hypericum perforatum).

The effects of St. John's Wort may persist for 1-2 weeks. Inform your doctor.

-Products containing the amino acid tryptophan.

-Medications to treat severe pain (such as tramadol).

-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).

-Medications to treat diabetes (tolbutamide).

-Medications to treat stomach acid and ulcers (cimetidine).

-Medications to treat mania and depression (lithium).

-Other medications to treat depression (such as amitriptyline, nortriptyline).

-Medications to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).

Taking Sertralina Aristo with food and drinks

This medication can be taken with or without food.

Alcohol should be avoided while being treated with sertraline.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become 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 doctor's opinion, 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.

Some medications, such as sertraline, may reduce the quality of sperm 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 can only be used in breastfeeding women if, in the doctor's opinion, the benefits for the mother outweigh any possible risk to the baby.

Make sure your midwife and/or doctor know that you are taking this medication. When taken during pregnancy, particularly in the last three months of pregnancy, medications like sertraline may increase the risk of a serious disease 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.

Consult your doctor or pharmacist before using any medication.

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 Aristo contains lactose

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.

Sertralina Aristo contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

This medication can be taken with or without food. Take your medication once a day in the morning or evening.

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:The 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.

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 their instructions..

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.

If you take more Sertraline Aristo 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 Aristo

If you forget to take a dose, do not take it when you remember. Take the next dose when it is due.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Sertraline Aristo

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 you stop taking this medication completely. If you stop treatment abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling unwell, or feeling dizzy and trembling. If you experience any of these side effects, or any other during the interruption of your treatment with sertraline, 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.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 severe.

-If you develop a severe skin rash that causes blisters (erythema multiforme),

(it 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 can present symptoms such as skin rash with itching, breathing problems, ringing, 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 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.

The following side effects were observed in clinical trials in adults.

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

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

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

Sore throat, loss of appetite, increased appetite, depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased sex drive, teeth grinding, numbness and tingling, tremors, muscle tension, abnormal taste, lack of concentration, visual disturbances, ringing in the ears, palpitations, hot flashes, yawning, abdominal pain, vomiting, constipation, stomach discomfort, gas, rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, and chest pain.

Rare side effects (may affect up to 1 in 100 people):

Cold (chest), runny nose, hallucinations, excessive happiness, lack of care, abnormal thoughts, convulsions, involuntary muscle contractions, abnormal coordination, continuous movements, amnesia, decreased sensitivity, speech disorders, dizziness when standing up, migraines, ear pain, rapid pulse, high blood pressure, hot flashes, possible noisy breathing difficulties, shortness of breath, nasal bleeding, esophageal problems, difficulty swallowing, hemorrhoids, increased salivation, altered tongue, belching, eye swelling, purple spots on the skin, hair loss, cold sweat, dry skin, urticaria, arthritis, muscle weakness, back pain, muscle spasms, nocturia, urinary retention, increased urine production, urinary disorders, vaginal bleeding, female sexual dysfunction, discomfort, chills, fever, weakness, thirst, weight loss, and weight gain.

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

Intestinal problems, ear infection, cancer, swollen lymph nodes, high cholesterol, elevated blood sugar, physical symptoms due to stress or emotions, medication dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation, coma, abnormal movements, difficulty moving, increased sensitivity, sensory disturbances, spots in front of the eyes, glaucoma, double vision, photophobia (sensitivity to light), eye bleeding, irregular pupils, visual disturbances, eye problems, dilated pupils, heart attack, decreased heart rate, heart problems, circulation problems in the arms and legs, throat spasms, rapid breathing, slow breathing, speech difficulties, hiccups, blood in stool, mouth sores, tongue ulceration, dental and tongue problems, mouth ulceration, liver function problems, skin problems with blisters, capillary rash, abnormal hair texture, abnormal skin odor, bone alterations, decreased urine production, urinary incontinence, interrupted urination, excessive vaginal bleeding, vaginal dryness, penile and prepuce pain and redness, genital secretion, prolonged erection, breast secretion, hernia, injection site scar, decreased tolerance to medications, difficulty walking, abnormal laboratory tests, abnormal semen, injury, vasodilation procedure.

Unknown frequency

Partial vision loss, excessive vaginal bleeding shortly after delivery (postpartum hemorrhage), see 1 in section 2 for more information.

Since the marketing of sertraline, the following side effects have been reportedDecreased white blood cell count, decreased platelet count, low thyroid hormone levels, endocrine problems, low sodium levels in the blood, abnormal nightmares, suicidal behavior, movement disorders (such as continuous movements, muscle tension, and difficulty walking), syncope, abnormal vision, bleeding problems (such as nasal bleeding, stomach bleeding, or blood in urine), pancreatitis, severe liver function problems, yellow skin, skin swelling, sun sensitivity, itching, joint pain, muscle cramps, breast enlargement, irregular menstrual cycles, swollen legs, coagulation problems, severe allergic reactions, and inflammatory bowel disease (which causes diarrhea).

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.

Reporting of suspected adverse reactions

It is essential to report suspected adverse reactions to the medicine after its authorization. This allows for continuous monitoring of the benefit-risk ratio of the medicine. Healthcare professionals are invited to report suspected adverse reactions through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

Keep out of sight and reach of children.

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

Do not store at a temperature above25ºC.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Sertralina Aristo

The active ingredient of Sertralina Aristo is sertraline (hydrochloride). Each tablet contains 100 mg of sertraline.

The other components are:

Tablet core:lactose monohydrate, microcrystalline cellulose (E460i), povidone, sodium croscarmellose and magnesium stearate (E572).

Coating film:hypromellose (E464), titanium dioxide (E171), talc, propylene glycol (E1520) and hypromellose 15.

Appearance of the product and content of the container

Sertralina Aristo 100 mg film-coated tablets are white, round, biconvex and scored on one face.

Sertralina Aristo is available in containers of 30 and 60 tablets. The tablets are presented in PVC/PVDC/Aluminum blisters.

Only some container sizes may be marketed

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

ARISTO PHARMA IBERIA, S.L

c/ Solana, 26

28850- Torrejón de Ardoz

Madrid, Spain

Responsible manufacturer:

ACTAVIS LIMITED

BLB016 Bulebel Industrial Estate

ZTN 08, Zejtun

Malta

or

Laboratorios Medicamentos Internacionales S.A.

C/Solana, 26

28850 – Torrejón de Ardoz

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/