Sertraline Sandoz Farmacéutica 50 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Sertraline Sandoz Farmacéutica 50 mg film-coated tablets EFG

Sertraline Sandoz Farmacéutica 100 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 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 only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

1. What Sertraline Sandoz Farmacéutica is and what it is used for

2. What you need to know before taking Sertraline Sandoz Farmacéutica

3. How to take Sertraline Sandoz Farmacéutica

4. Possible side effects

5. How to store Sertraline Sandoz Farmacéutica

6. Contents of the pack and other information

1. What Sertralina Sandoz Farmacéutica is and what it is used for

Sertralina Sandoz Farmacéutica 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.

Sertralina Sandoz Farmacéutica 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 to 17 years).

Depression is a clinical illness with symptoms such as feelings of sadness, inability to sleep properly, or inability to enjoy life as you used to.

OCD and panic disorders are anxiety-related illnesses, with symptoms such as constant worry about recurring thoughts (obsessions) that lead you to perform repetitive rituals (compulsions).

PTSD is a disorder that may occur after an emotionally traumatic experience and has some symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterized by intense anxiety or fear 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 appropriate for the treatment of your condition.

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

2. What you need to know before taking Sertraline Sandoz Farmacéutica

Do not take Sertraline Sandoz Farmacéutica:

• 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 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 starting sertraline.

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 of suicide (see below “Suicidal thoughts and worsening of depression or anxiety disorder”).
• If you have serotonin syndrome. This syndrome may rarely occur when taking certain medicines together with sertraline. (See symptoms in section 4. Possible side effects.) Your doctor will advise whether you have previously experienced this syndrome.
• If you have low sodium levels in the blood, as this condition may occur as a result of 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 consider 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 section 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 below “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 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.

Restlessness/Akathisia

The 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 usually occurs during the first weeks of treatment. Increasing the dose may worsen this condition, so if you develop these symptoms, you should contact your doctor.

Withdrawal symptoms

Side effects related to stopping treatment (withdrawal symptoms) are common, especially if treatment is stopped abruptly (see section 3. If you stop taking Sertraline Sandoz Farmacéutica 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 are usually mild or moderate. However, in some patients they may be severe. These symptoms typically occur in the first few days after stopping treatment. In general, these symptoms resolve on their own and usually disappear within two weeks. In some patients, they may last longer (2 to 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 experience this if:

• You have previously had suicidal thoughts or thoughts of 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 an antidepressant.

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

It may be helpful for you to tell 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 behaviour.

Sexual problems:

Some medicines in the same group as sertraline (called SSRIs) may 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 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 to be the most appropriate treatment. If your doctor has prescribed sertraline to you, you are under 18 years of age, and you wish to discuss this decision, please speak to your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen while taking sertraline. In addition, the long-term safety effects on growth, maturation, and cognitive and behavioural development of sertraline were evaluated in a long-term study involving over 900 children aged 6 to 16 years monitored over a period of 3 years. Overall, the study results 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 Sandoz Farmacéutica

Inform 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 Sandoz Farmacéutica together with the following medicines may cause serious adverse effects:

• Medicines called 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 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 to 2 weeks.
• Products containing the amino acid tryptophan.
• Medicines used to treat severe or chronic pain (opioids, e.g., tramadol, fentanyl, 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 for pain/arthritis [e.g., metamizole, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)].
• Sedatives (diazepam).
• Diuretics.
• Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines used to treat diabetes (tolbutamide).
• Medicines used to treat 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, 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 Sandoz Farmacéutica with food, drinks, and alcohol

Sertraline can be taken with or without food.

You should avoid alcohol while taking sertraline.

You should not take sertraline 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 are planning 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 prescribed 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 informed that you are taking sertraline so they can advise you. When taken during pregnancy, especially 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 bluish. 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 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,
• Bluish lips,
• Vomiting or feeding problems,
• Excessive tiredness, inability to sleep, or excessive crying,
• Muscle stiffness or decreased muscle tone,
• Tremors, restlessness, or seizures,
• Increased reflex responses,
• 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, consult your doctor or midwife for advice.

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

Animal studies have shown that some medicines like sertraline may reduce sperm quality. Theoretically, this could affect fertility; however, the impact on human fertility has not yet been determined.

Driving and using machines

Psychotropic medicines such as 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 Sandoz Farmacéutica contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., it is essentially “sodium-free”.

3. How to take Sertraline Sandoz Farmacéutica

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

The recommended dose is:

Adults:

Depression and Obsessive-Compulsive Disorder (OCD):

For depression and OCD (obsessive-compulsive disorder), the usually effective dose is 50 mg per day. 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 per day.

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 per day, increasing to 50 mg per day 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 per day.

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 per day. After one week, your doctor may increase your 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 the instructions he or she gives you.

Method of administration:

Sertraline may be taken with or without food.

The tablet may be divided into equal doses.

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

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 Sandoz Farmacéutica than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose may include drowsiness, nausea and vomiting, increased heart rate, tremors, agitation, dizziness, and, rarely, unconsciousness.

If you forget to take Sertraline Sandoz Farmacéutica

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 usual time.

If you stop taking Sertraline Sandoz Farmacéutica

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 completely stop taking this medicine. If you stop treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremor. If you experience any of these adverse effects, or any other symptoms, during discontinuation of sertraline treatment, 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 gets them.

The most common adverse effect is nausea. Adverse effects depend on the dose and often disappear or decrease with 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 may be signs of a condition known as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN). In such cases your doctor will stop 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, diarrhoea, 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 or eyes, which may indicate liver damage.
• If you experience depressive symptoms with thoughts of harming yourself 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 feeling restless.
• If you have a seizure (convulsions).
• If you experience a manic episode (see section 2. Warnings and precautions).

The following adverse effects were observed in clinical trials in adults and during post-marketing surveillance.

Very common adverse effects (may affect more than 1 in 10 patients):

insomnia, dizziness, somnolence, headache, diarrhoea, malaise, dry mouth, ejaculation disorders and fatigue.

Common adverse effects (may affect up to 1 in 10 patients):

• 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 rigidity, 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,
• irregular menstrual cycle, erectile dysfunction,
• malaise, chest pain, weakness, fever,
• weight gain,
• injury.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• gastroenteritis, ear infection,
• tumor,
• hypersensitivity, seasonal allergy,
• low levels of thyroid hormones,
• suicidal thoughts, suicidal behavior*, psychotic disorders, abnormal thinking, lack of self-care, hallucinations, aggression, excessive happiness, paranoia,
• amnesia, decreased sensation, 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 noisy respiration,
• black stools, dental disorders, inflammation of the esophagus, tongue disorders, hemorrhoids, increased salivation, difficulty swallowing, burping, tongue disorders,
• swelling of eyes, urticaria, hair loss, itching, purple spots on the skin, skin disorders with blisters, dry skin, facial swelling, cold sweat,
• osteoarthritis, muscle jerks, muscle cramps*, muscle weakness,
• increased frequency of urination, urinary disorders, urinary retention, urinary incontinence, increased volume of urine, 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 behavior have been reported during treatment with sertraline or shortly after discontinuation (see section 2).

Rare adverse effects (may affect up to 1 in 1,000 patients):

• diverticulitis, swollen lymph nodes, decreased platelet count*, decreased white blood cell count*,
• severe allergic reaction,
• endocrine disorders*,
• elevated cholesterol, difficulty controlling blood sugar levels (diabetes), low blood sugar, increased blood sugar levels*, 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 before the eyes, glaucoma, double vision, photophobia (sensitivity of the eyes to light), eye hemorrhages, irregular pupils*, visual disturbances*, lacrimation problems,
• heart attack, dizziness, fainting or chest discomfort which could be signs of changes in electrical activity (seen on electrocardiogram) or abnormal heart rhythm*, slowed heart rate,
• circulation problems in arms and legs,
• rapid breathing, progressive scarring in lung tissue (interstitial lung disease)*, throat spasm, difficulty speaking, slowed 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 stool, tongue ulceration, mouth sores,
• liver function problems, serious liver function disorders*, yellowing of the skin and eyes (jaundice)*,
• skin reaction to sunlight*, skin swelling*, abnormal hair texture, abnormal skin odor, capillary rash,
• muscle tissue rupture*, bone disorder,
• interrupted urination, decreased urine volume,
• breast secretion, vaginal dryness, genital discharge, pain and redness of the penis and foreskin, breast enlargement*, prolonged erection,
• hernia, reduced drug tolerance,
• increased cholesterol levels, abnormal laboratory test results*, abnormal semen, coagulation problems*,
• relaxation of the blood vessel procedure.

Adverse effects of unknown frequency (cannot be estimated from available data):

• jaw locking,

• urinary incontinence during sleep*,

• partial loss of vision,

• inflammation of the colon (causing diarrhea),

• heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see "Pregnancy" 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 stopping treatment

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 Sertraline Sandoz Farmacéutica").

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

Reporting of adverse effects

If you experience any kind of 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 through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sertraline Sandoz Farmacéutica

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

Do not use this medicine 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 or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sertraline Sandoz Farmacéutica

• Sertraline Sandoz Farmacéutica 50 mg tablets: The active substance is sertraline (hydrochloride). Each tablet contains sertraline hydrochloride equivalent to 50 mg of sertraline.

• Sertraline Sandoz Farmacéutica 100 mg tablets: The active substance is sertraline (hydrochloride). Each tablet contains sertraline hydrochloride equivalent to 100 mg of sertraline.

• The other components are:

Tablet core: microcrystalline cellulose, sodium carboxymethyl starch potato (type A), calcium hydrogen phosphate dihydrate, hydroxypropyl cellulose and magnesium stearate.
Tablet coating: titanium dioxide (E171), talc and hypromellose.

Appearance of the product and contents of the pack

Sertraline Sandoz Farmacéutica 50 mg tablets:
White, film-coated, capsule-shaped tablets, scored and marked with "SE 50" on one side.

Sertraline Sandoz Farmacéutica 50 mg film-coated tablets are available in packs of 30 or 60 tablets. The tablets are presented in PVC/aluminum blisters.

Sertraline Sandoz Farmacéutica 100 mg tablets:
White, film-coated, capsule-shaped tablets, scored and marked with "SE 100" on one side.

Sertraline Sandoz Farmacéutica 100 mg film-coated tablets are available in packs of 30 or 60 tablets. The tablets are presented in PVC/aluminum blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Sandoz Farmacéutica, S.A.
Parque Norte Business Park
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer:
Salutas Pharma GmbH
Otto Von Guericke Allee, 1
(Barleben) - D-39179
Germany

or

Lek Pharmaceuticals d.d.
Trimlini 2d
9220 Lendava
Slovenia

or

Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia

or

Lek S.A.
Ul. Podlipie 16
95-010 Strykow
Poland

Date of the latest revision of this leaflet: October 2025

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