SERTRALINE AUROVITAS 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sertraline Aurovitas 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

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

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

Sertraline Aurovitas 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.

Sertraline 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 anxiety-related conditions with symptoms such as being constantly worried about recurring ideas (obsessions) that lead to 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 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, you should ask your doctor.

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

Do not take Sertraline Aurovitas

• 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 medicines called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other medicines similar to MAOIs (such as linezolid). If you stop taking 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 a medicine called pimozide (a medicine used to treat mental disorders such as psychosis).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Sertraline Aurovitas.

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 conditions:

• If you have epilepsy (seizures) or a history of seizures. If you have a seizure, contact your doctor immediately.
• If you have manic-depressive illness (bipolar disorder) or schizophrenia. If you have a manic episode, contact your doctor immediately.
• If you have, or have had, thoughts of harming yourself or suicidal thoughts (see below suicidal thoughts and worsening of your depression or anxiety disorder).
• If you have serotonin syndrome. This syndrome can occur rarely when taking certain medicines at the same time as sertraline (for symptoms, see section 4. Possible side effects). Your doctor will indicate if you have had this syndrome before.
• If you are taking medicines containing buprenorphine. The use of these medicines with sertraline can cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Sertraline Aurovitas").
• If you have low sodium levels in your blood, as this condition may occur as a result of treatment with sertraline. You should also inform your doctor if you are taking any medicine for high blood pressure, 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 above).
• 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 a history of bleeding disorders (with a tendency to develop bruises) or if you are pregnant (see "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 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 eye problems, such as certain types of glaucoma (increased pressure in the eye).
• 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 a prolonged QT interval.
• If you have heart disease, have low potassium or magnesium levels, a family history of QT prolongation, a slow heart rate, or are taking concomitantly medicines that prolong the QT interval.

Sexual problems

Some medicines in the same group as sertraline (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Restlessness/Akathisia

The use of sertraline has been associated with an unpleasant feeling of restlessness and a need to move, often accompanied by an inability to sit or stand still (akathisia). This occurs more often during the first few weeks of treatment. An increase in dose may be harmful, so if you develop these 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 Sertraline Aurovitas and section 4 Possible side effects). The risk of experiencing withdrawal symptoms depends on the duration of treatment, dose, and 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 stopping treatment. In general, these symptoms usually resolve on their own and normally resolve within two weeks. In some patients, they can 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 agree with your doctor on the best way to stop treatment.

Suicidal thoughts 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 suicidal thoughts. These can increase at the start of treatment with antidepressants, as all these medicines take time to work, which is usually a few weeks, but sometimes can be longer.

This is more likely to happen

• 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 conditions who are being treated with any antidepressant.

If you have thoughts of harming yourself or suicidal thoughts at any time, contact your doctor or go to the hospital immediately.

It may be helpful for you to tell a relative 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 worried about changes in your behavior.

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 (mainly aggression, confrontational behavior, and anger) when they are treated with this class of medicines. Nevertheless, your doctor may decide to prescribe sertraline to a patient under 18 years of age if they consider it is in the best interest of the patient. If your doctor has prescribed sertraline for you and you are under 18 years of age and wish to discuss this decision, consult your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen when you are taking sertraline. The long-term effects of sertraline on growth, maturity, and learning (cognitive and behavioral development) 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 Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines can affect how sertraline works or sertraline can reduce the effectiveness of other medicines that you are taking at the same time.

The use of sertraline with the following medicines can cause serious side effects:

• Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (for depression), selegiline (for Parkinson's disease), the antibiotic linezolid, and methylthioninium chloride (methylene blue) (for high levels of methemoglobin in the blood). Do not take sertraline with these medicines.
• Medicines for treating mental disorders such as psychosis (pimozide). Do not take 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 can last 1-2 weeks.
• Products containing the amino acid tryptophan.
• Medicines for treating severe or chronic pain (opioids, e.g., tramadol, fentanyl) and opioid dependence (medicines containing buprenorphine).
• 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 (e.g., metamizole, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, acetylsalicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics (water pills).
• Medicines for treating epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines for treating diabetes (tolbutamide).
• Medicines for treating stomach acidity, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, 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, and 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 for treating HIV/AIDS and hepatitis C (protease inhibitors, such as ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
• Medicines that increase the risk of changes in heart electrical activity (e.g., some antipsychotics and antibiotics).
• Metamizole, a medicine used to treat pain and fever.

Some medicines can increase the effects of sertraline and, in some cases, can cause very serious reactions. Do not take any other medicine while taking sertraline without consulting your doctor first, especially:

• Medicines containing buprenorphine. These medicines can interact with sertraline, and you may experience symptoms such as involuntary muscle contractions, including muscles 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.

Taking Sertraline Aurovitas with food, drinks, and alcohol

Sertraline tablets can be taken with or without food.

You should avoid drinking alcohol while taking sertraline.

You should not take sertraline in combination with grapefruit juice, as it can increase the levels of sertraline in your body.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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. If you are pregnant, sertraline will only be given to you if your doctor considers that the benefit to you outweighs any possible risk to the developing baby.

If you take sertraline during the late 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 sertraline so they can advise you. When taken during pregnancy, especially during the last 3 months, medicines like sertraline can increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN), which makes the baby breathe faster and have a bluish appearance. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

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

• difficulty breathing.
• bluish or too hot or cold skin.
• bluish lips.
• vomiting or difficulty feeding.
• excessive tiredness, inability to sleep, or excessive crying.
• stiffness or decreased muscle tone.
• tremors, restlessness, or seizures.
• increased reflexes.
• irritability.
• low blood sugar levels.

If your baby has any of these symptoms at birth, or if you are concerned about your baby's health, contact your doctor or midwife, who will advise you.

There are indications that sertraline passes into breast milk. Therefore, sertraline can only be used in breastfeeding women if the doctor considers that the benefit to the mother outweighs any possible risk to the baby.

In animal studies, it has been seen that some medicines like sertraline may reduce sperm quality. This could theoretically affect fertility, but this impact on fertility has not been observed in humans yet.

Driving and using machines

Psychotropic medicines like sertraline can affect your ability to drive or use machines. Therefore, you should not drive or operate machinery until you know how this medicine affects your ability to perform these activities.

Sertraline Aurovitas contains sodium

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

3. How to take Sertralina Aurovitas

Follow the administration instructions of this medication exactly as indicated by your doctor. 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, 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:

Sertraline 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 give you.

Method of administration:

Sertraline tablets can be taken with or without food.

Take your medication once a day, 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 a few weeks for your symptoms to start improving. Treatment of depression should normally continue for 6 months after improvement.

If you take more Sertralina Aurovitas than you should

If you accidentally take too much sertraline, contact your doctor or go to the emergency department of the nearest hospital. Always carry the medication packaging with you, whether or not there is medication left in it.

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

Overdose symptoms may include drowsiness, nausea, and vomiting, increased heart rate, tremors, agitation, dizziness, and, in rare cases, loss of consciousness.

If you forget to take Sertralina Aurovitas

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 stop treatment with Sertralina Aurovitas

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 altogether. If you stop treatment abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling unwell or dizzy, and tremors. If you experience any of these side effects, or any other during the interruption of your treatment with sertraline, 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 everyone will experience them.

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

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 that causes 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 stop treatment.
• Allergic reaction or allergy, which can include 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 sertraline. Your doctor may decide to stop treatment.
• If you have yellowing of the skin and eyes, which can indicate liver damage.
• If you have depressive symptoms with thoughts of self-harm or suicide (suicidal thoughts).
• If, after starting treatment with sertraline, 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(may affect more than 1 in 10 people):

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

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

• Cold (chest), sore throat, runny nose.
• Lack of appetite, increased appetite.
• Anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, teeth grinding.
• Tremors, muscle movement problems (such as constant movement, muscle tension, difficulty walking, and stiffness, spasms, and involuntary muscle movements)*, numbness and tingling, muscle tension, lack of concentration, abnormal taste.
• Visual disturbances.
• Ringing in the ears.
• Palpitations.
• Hot flashes.
• Stomach upset, constipation, abdominal pain, vomiting, gas.
• Increased sweating, rash.
• Back pain, joint pain, muscle pain.
• Irregular menstrual cycle, erectile dysfunction.
• Feeling unwell, chest pain, weakness, fever.
• Weight gain.
• Injury.

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

• 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 up, abnormal coordination, speech disorders.
• Ear pain.
• Bleeding problems (such as stomach bleeding)*, high blood pressure, hot flashes, blood in urine.
• Shortness of breath, nosebleeds, breathing difficulties possibly noisy.
• Black stools, tooth disorders, esophagitis, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders.
• Eye swelling, hives, 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 sertraline or shortly after its interruption (see section 2).

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

• Diverticulitis, lymph node swelling, 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 in the 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 condition 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 may be signs of changes in heart activity (seen on an electrocardiogram) or abnormal heart rhythm*, slow 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.
• A type of lung disease in which eosinophils (a type of white blood cell) appear in the lungs in high numbers (eosinophilic pneumonia).
• Mouth ulcers, pancreatitis*, blood in stools, tongue ulcers, mouth sores.
• Liver function problems, serious liver function problems*, yellowing of the skin and eyes (jaundice)*.
• Sun-related skin reaction*, skin swelling*, abnormal hair texture, abnormal skin odor, capillary rash.
• Muscle rupture*, bone disorder.
• Interrupted urination, decreased urine volume.
• Breast secretion, vaginal dryness, genital secretion, pain and redness of the penis and foreskin, breast enlargement*.
• 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 available data:

• Jaw locking.
• Nocturnal urinary incontinence*.
• Partial loss of vision.
• Colon inflammation (which causes diarrhea).
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.
• Muscle weakness and severe muscle pain, which can be a sign of multiple acyl-CoA dehydrogenase deficiency (MADD)*.

*Side effects reported after marketing.

Other side effects in children and adolescents

In clinical trials in children and adolescents, side effects were generally similar to those reported in adults (see above). The most common side effects in children and adolescents were headache, insomnia, diarrhea, and nausea.

Symptoms that may appear when treatment is stopped

If you stop treatment with this 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 stop treatment with Sertralina Aurovitas").

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

Reporting side effects

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

5. Conservation of Sertralina Aurovitas

Keep this medication out of sight and reach of children.

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

This medication does not require special storage conditions.

Medications should not be thrown away in drains or 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 Aurovitas composition

• The active ingredient is sertraline. Each film-coated tablet contains sertraline hydrochloride equivalent to 50 mg of sertraline.
• The other ingredients are:

Core of the tablet:microcrystalline cellulose (Grade 101), sodium carboxymethyl starch (Type A) of potato, hydroxypropylcellulose, calcium hydrogen phosphate dihydrate, magnesium stearate.

Tablet coating:Opadry White OY-S-7355, which contains: titanium dioxide (E171), hypromellose 5cp (low viscosity), macrogol 400, polysorbate 80.

Appearance of the product and package contents

White, biconvex, capsule-shaped film-coated tablets, with the mark "A" on one side and a score line between "8" and "1" on the other. The size is approximately 10.5 mm × 4.3 mm. The tablet can be divided into equal doses.

Sertralina Aurovitas film-coated tablets are available in blister packs.

Package sizes:20, 30, 60, and 100 film-coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medication is authorized in the member states of the European Economic Area under the following names:

Date of the last revision of this leaflet: September 2025

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