Sertraline Aurovitas 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Sertraline Aurovitas 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 only, and you must not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Sertralina Aurovitas contains sertraline as the active substance. 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 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 with symptoms such as feelings of sadness, inability to sleep well, or to enjoy life as you 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 after 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: speaking with 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 suitable for treating your condition.

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

2. What you need to know before taking 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 recently taken medicines known as 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 a medicine called pimozide (a medicine used to treat mental disorders such as psychosis).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Sertraline Aurovitas.

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 epilepsy (seizures) or a history of seizures. If you have 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 or have previously had thoughts of harming yourself or committing suicide (see further information below on suicidal thoughts and worsening of depression or anxiety disorder).
• If you have serotonin syndrome. Rarely, this syndrome may occur when taking certain medicines at the same time as sertraline (see symptoms in section 4. Possible side effects). Your doctor will advise you if you have previously experienced this syndrome.
• If you are taking medicines containing buprenorphine. Using these medicines together with sertraline may 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 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 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 affect 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 (tendency to bruise easily) 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 being treated for this condition, your doctor will monitor you closely (see section below on 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 you have an abnormality on the heart tracing obtained from an electrocardiogram (ECG), known as QT interval prolongation.
• If you have heart disease, low levels of potassium or magnesium, a family history of QTc prolongation, slow heart rate, or are taking concomitantly medicines that prolong the QTc interval.

Sexual problems

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

Restlessness/Akathisia

Use of sertraline has been associated with unpleasant restlessness and a need to move, often accompanied by an inability to sit or stand still (akathisia). This occurs most often during the first weeks of treatment. Increasing the dose may be harmful, so if you develop these symptoms, 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, the dose, and the speed at which the dose is reduced. Generally, these symptoms are mild or moderate. However, in some patients they may be severe. These symptoms usually appear during the first few days after stopping treatment. In general, these symptoms resolve on their own and typically disappear 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 should be gradually reduced over a period of several weeks or even months, and you should always discuss the best way to stop 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 committing suicide. These may increase at the beginning of treatment with antidepressants, as all these medicines take time to work—usually about two weeks, but sometimes longer.

You are more likely to experience this if:

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

If you have thoughts of harming yourself or committing suicide at any time, consult your doctor or go to hospital immediately.

It may be helpful for you to tell a family member or close friend that you are depressed or have anxiety disorders, and ask them to read this leaflet. You may also ask them to let you know if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour.

Children and adolescents

Sertraline should normally not be used in the treatment of 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 (predominantly aggression, confrontational behaviour, and anger reactions) when taking this type of medicine. Nevertheless, your doctor may decide to prescribe sertraline to a patient under 18 years of age if they consider it the most appropriate treatment. If your doctor has prescribed sertraline to you and you are under 18 years of age and wish to discuss this decision, speak to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while you are taking sertraline. The long-term safety effects of sertraline on growth, maturation, and cognitive and behavioural development were evaluated in a long-term study involving more than 900 children aged 6 to 16 years, followed for a period of 3 years. Overall, study results showed that children treated with sertraline developed normally, except for a slight increase in weight gain in those receiving higher doses.

Other medicines and Sertraline Aurovitas

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 itself may reduce the effectiveness of other medicines taken at the same time.

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

• Medicines known as monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression), selegiline (used to treat Parkinson’s disease), the antibiotic linezolid, and methylene blue (used to treat high levels of methaemoglobin 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 used to treat severe or chronic pain (opioids, e.g., tramadol, fentanyl) and opioid dependence (medicines containing buprenorphine).
• Medicines used in anaesthesia (e.g., fentanyl, mivacurium, and suxamethonium).
• Medicines used to treat migraines (e.g., sumatriptan).
• Medicines that reduce blood clotting (warfarin).
• Medicines used to treat pain/arthritis (e.g., metamizole, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, acetylsalicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics (water tablets).
• Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines used to treat diabetes (tolbutamide).
• Medicines used to treat stomach acidity, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medicines used to treat mania and depression (lithium).
• Other medicines used to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medicines used to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medicines used to treat high blood pressure, chest pain, or to regulate 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 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 that increase the risk of changes in the heart’s electrical activity (e.g., some antipsychotics and antibiotics).
• Metamizole, a medicine used to treat pain and fever.

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

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

Alcohol intake should be avoided while taking sertraline.

Sertraline should not be taken with grapefruit juice, as it may increase sertraline levels in your body.

Pregnancy, breastfeeding and fertility

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

If you take sertraline 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 aware that you are taking sertraline so they can advise you. When taken during pregnancy, especially during the last three months, medicines such as sertraline may increase the risk of a serious condition 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 occurs in your baby, contact your midwife and/or doctor immediately.

Your newborn may also experience other conditions, which usually begin within the first 24 hours after birth. Symptoms include:

• Difficulty breathing.
• Bluish or unusually hot or cold skin.
• Bluish lips.
• Vomiting or difficulty feeding.
• 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, contact your doctor or midwife, who will advise you.

There is evidence that sertraline passes into breast milk. Therefore, sertraline may only be used in breastfeeding women if your doctor considers that the benefit outweighs any possible risk to the child.

Animal studies have shown that some medicines like sertraline may reduce sperm quality. This could theoretically affect fertility, but this effect on fertility has not yet been observed in humans.

Driving and use of machines

Psychotropic medicines such as sertraline may affect your ability to drive or operate machinery. Therefore, do 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 Sertraline Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

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 increments of 50 mg 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 be initiated at a dose of 25 mg daily, increasing to 50 mg daily after one week. The daily dose may be increased in increments of 50 mg 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 tablets may be taken with or without food.

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

Your doctor will determine 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 occurs.

If you take more Sertraline Aurovitas 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 ingested.

Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, tremors, agitation, dizziness, and, rarely, loss of consciousness.

If you forget to take Sertraline Aurovitas

Do not take a double dose to make up for missed doses. If you forget to take a dose, do not take it when you remember. Take the next dose at the scheduled time.

If you stop taking Sertraline 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 medicine completely. If you stop treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feelings of discomfort, or dizziness and tremor. If you experience any of these adverse effects, or any other symptoms, while discontinuing treatment with sertraline, inform your doctor.

If you have any other 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 or decrease 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) (may affect the mouth and tongue). These may be signs of a condition known as Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). In these cases, your doctor will stop treatment.
• Allergic reaction or allergy, which may include symptoms such as itchy skin rash, difficulty breathing, 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 medicines together with sertraline. Your doctor may decide to discontinue treatment.
• If you develop yellowing of the skin and 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 sertraline, you begin to feel restless and are unable to sit or stand still. You should inform your doctor if you start to feel 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 (may affect more than 1 in 10 people):

• Insomnia, dizziness, drowsiness, headache, diarrhea, discomfort, dry mouth, ejaculation disorders, fatigue.

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

• Cold (chest), sore throat, runny nose.
• Loss of appetite, increased appetite.
• Anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, teeth grinding.
• Tremor, movement disorders (such as constant movements, muscle tension, difficulty walking and stiffness, spasms and involuntary muscle movements)*, numbness and tingling, muscle tension, difficulty concentrating, abnormal taste.
• Visual disturbances.
• Ringing in the ears.
• Palpitations.
• Hot flushes.
• Yawning.
• Stomach discomfort, constipation, abdominal pain, vomiting, flatulence.
• Increased sweating, rash.
• Back pain, joint pain, muscle pain.
• Menstrual irregularities, erectile dysfunction.
• Malaise, chest pain, weakness, fever.
• Weight gain.
• Injury.

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

• Gastroenteritis, ear infection.
• Tumour.
• 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 noisy.
• Black stools, dental disorders, oesophagitis, tongue disorders, haemorrhoids, increased salivation, difficulty swallowing, burping, tongue disorders.
• Swelling of eyes, hives, hair loss, itching, purple spots on the skin, blistering skin problems, 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 (may affect up to 1 in 1,000 people):

• Diverticulitis, swollen lymph nodes, decreased platelets*, decreased white blood cell count*.
• Severe allergic reaction.
• Endocrine disorders*.
• High cholesterol, problems 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, difficulty moving, increased sensitivity, sudden severe headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS))*, sensory disturbances.
• Seeing spots in front of the eyes, glaucoma, double vision, photophobia (eye sensitivity to light), eye bleeding, irregular pupils*, visual disturbances*, tear problems.
• Heart attack, dizziness, fainting or chest discomfort which could be signs of 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.
• A form of lung disease in which eosinophils (a type of white blood cell) appear in the lungs in high numbers (eosinophilic pneumonia).
• Mouth ulceration, pancreatitis*, blood in stools, tongue ulceration, mouth sores.
• Liver function problems, severe liver function problems*, yellowing of the skin and eyes (jaundice)*.
• Skin reaction to sunlight*, skin swelling*, abnormal hair texture, abnormal skin odour, capillary rash.
• Muscle tissue breakdown*, bone disorder.
• Interrupted urination, decreased urine volume.
• Breast secretion, vaginal dryness, genital secretion, pain and redness of the penis and foreskin, breast enlargement*, prolonged erection.
• Hernia, reduced drug tolerance.
• Increased cholesterol levels, abnormal laboratory tests*, abnormal semen, coagulation problems*.
• Relaxation of blood vessel dilation process.

Frequency not known: cannot be estimated from available data:

• Jaw locking.
• Nocturnal urinary incontinence*.
• Partial loss of vision.
• Inflammation of the colon (causing diarrhea).
• Heavy 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 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, headache, nausea, vomiting, and tremor (see section 3 “If you stop taking Sertraline Aurovitas”).

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sertraline Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sertralina Aurovitas

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

Tablet core: microcrystalline cellulose (Grade 101), sodium carboxymethylstarch (potato, Type A), hydroxypropylcellulose, calcium hydrogen phosphate dihydrate, magnesium stearate.

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

Nature of the product and pack contents

White, biconvex, capsule-shaped film-coated tablets with the mark “A” on one side and a score between “8” and “1” on the other side. 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.

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

Only some pack 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain:	Sertraline Aurovitas 50 mg film-coated tablets
Malta:	Sertraline Aurobindo 50 mg film-coated tablets
Poland:	ApoSerta
Portugal:	Sertraline Aurovitas

Date of the most recent review of this leaflet: September 2025

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