Package Insert: Information for the User

Sertralina Sandoz Pharmaceutical50 mg Film-Coated Tablets EFG

Sertralina Sandoz Pharmaceutical100 mg Film-Coated Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Conserve this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

Sertralina Sandoz Pharmaceuticalcontains 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.

Sertralina Sandoz Pharmaceuticalcan be used to treat:

• depression and prevention of depression relapse (in adults),
• social anxiety disorder (in adults),
• post-traumatic stress disorder (PTSD) (in adults),

-anxiety disorder (in adults),

• obsessive-compulsive disorder (OCD) (in adults, and in children and adolescents aged 6 to 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 anxiety-related diseases, with symptoms such as being constantly preoccupied with repeated ideas (obsessions) that lead to repetitive rituals (compulsions).

PTSD is a disorder that can occur after a very emotionally traumatic experience, and has some symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related disease. It is characterized by intense anxiety or anxiety in social situations (for example: speaking to strangers, speaking in public, eating or drinking in front of others, or worrying about behaving in a shameful manner).

Your doctor has considered that this medicine is suitable for the treatment of your disease.

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

Do not takeSertraline Sandoz Pharmaceutical:

• 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 similar medicines (such as linezolid).If you stop taking sertraline, wait at least one week before starting treatment with an MAOI.After stopping treatment with an MAOI, 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

Consult your doctor or pharmacist before starting to take sertraline.

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 circumstances:

• If you have epilepsy (seizures) or a history of convulsions. If you have a seizure, 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 harming yourself or committing suicide (see "Thoughts of suicide and worsening of your depression or anxiety disorder").
• If you have serotonin syndrome. In rare cases, this syndrome can occur when you take certain medicines at the same time as sertraline. (To see symptoms, read section 4. Possible side effects). Your doctor will tell you if you have had this syndrome before.
• If you have low sodium levels in your blood, as this can occur as a result of treatment with sertraline. Also, tell your doctor if you are taking any medicines 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 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 alter your blood sugar levels, so you may need to adjust the dose of your diabetes medicines..
• If you have had bleeding disorders or have been taking medicines that decrease blood clotting (such as aspirin or warfarin) or that may increase the risk of bleeding, or if you are pregnant (see "Pregnancy, breastfeeding and fertility").
• 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 (OCD). If you are to be treated for this disorder, your doctor will want to monitor you closely (see "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 that you have an abnormal heart rhythm that is shown on an electrocardiogram (ECG), known as QT prolongation.
• If you have heart disease, low potassium or magnesium levels, a family history of QT prolongation, a slow heart rate, or are taking medicines that prolong the QT interval.

Restlessness/Acatisia

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 (acatisia). This occurs more often during the first few weeks of treatment. Increasing the 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 Sandoz Pharmaceutical and 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 within the first few days after stopping treatment. In general, these symptoms occur on their own and usually resolve 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 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.

Some medicines in the group to which sertraline belongs (called SSRIs/SNRIs) may cause sexual dysfunction side effects (see section 4). In some cases, these side effects persist after stopping treatment.

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 harming yourself or committing suicide. This may increase at the beginning of treatment with antidepressants, as all these medicines take time to work, which is usually two weeks but can be longer.

This is more likely to happen

• If you have had thoughts of suicide or harming yourself before.
• 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 disorders who are being treated with an antidepressant.

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

It may be helpful for you to explain to a close family member or 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 concerned about changes in your behavior.

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 (OCD). Young patients are at greater risk of side effects such as suicidal thoughts, thoughts of harming themselves or committing suicide (suicidal ideas) and hostility (predominantly aggression, confrontational behavior, and irritable reaction) when treated with this class of medicines.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 for you and you are under 18 years old and want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen while taking sertraline. At the same time, the long-term safety effects and those related to growth, maturity, and cognitive and behavioral development of sertraline in this age group have not yet been demonstrated.

Other medicines and Sertraline Sandoz Pharmaceutical

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

Some medicines may affect how sertraline works, orsertralinemay reduce the effectiveness of other medicines you are taking at the same time.

The use ofSertraline Sandoz Pharmaceuticalwith the following medicines may cause serious side effects

• Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (for depression), selegiline (for Parkinson's disease), the antibiotic linezolid, and 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.

Inform your doctor if you are taking the following medicines

• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).
• Medicines based on plants containing St. John's Wort (Hypericum perforatum). The effects of St. John's Wort may last for 1 to 2 weeks.
• Products containing the amino acid tryptophan.
• Medicines for treating severe pain (opioids, such as tramadol, fentanyl, buprenorphine).
• Medicines used in anesthesia or for chronic pain treatment (such as fentanyl, mivacurium, and suxamethonium).
• Medicines for treating migraines (such as sumatriptan).
• Medicines that decrease blood clotting (warfarin).
• Medicines for treating pain/arthritis?non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin?.
• Sedatives (diazepam).
• Diuretics.
• Medicines for treating epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines for treating diabetes (tolbutamide).
• Medicines for treating acid reflux, ulcers, and stomach burning (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 to regulate heart rate (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 heart rhythm (such as some antipsychotics and antibiotics).

TakingSertraline Sandoz Pharmaceutical with food, drinks, and alcohol

Sertralinecan be taken with or without food.

Alcohol should be avoided while taking sertraline.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or 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 given to you if your doctor considers that the benefits for you outweigh any possible risk to the developing baby.

Make sure your midwife and/or doctor know that you are taking sertraline. If you take sertraline during pregnancy, especially in the last three months, medicines like sertraline may increase the risk of a serious condition in newborn babies called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear blue. 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 baby may have other conditions, which usually occur within the first 24 hours after birth. The symptoms include:

• difficulty breathing,
• blue skin or being too hot or cold,
• blue lips,
• vomiting or feeding problems,
• excessive tiredness, unable to sleep, or crying a lot,
• stiffness or decreased muscle tone,
• shaking, restlessness, or convulsions,
• increased reflexes,
• irritability,
• low blood sugar levels.

If your baby has any of these symptoms at birth, or you are concerned about your baby's health, consult your doctor or midwife for advice.

If you take sertraline in the final stages of pregnancy, there may be a greater risk of heavy vaginal bleeding 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.

There is evidence that sertraline passes into breast milk. Therefore, sertraline can only be used by women who are breastfeeding if your doctor considers that the benefits outweigh any possible risk to the baby.

Studies in animals have shown that some medicines, such as sertraline, may reduce the quality of sperm. This could theoretically affect fertility, but the impact on human fertility has not yet been determined.

Driving and operating machinery

During treatment with sertraline, you may feel drowsy or dizzy. Do not drive or operate machinery until you know how sertraline affects you.

Sertraline Sandoz Pharmaceutical contains sodium

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

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

The recommended dose is:

Adults:

Depression and Obsessive-Compulsive Disorder:

For depression and OCD (obsessive-compulsive disorder), the commonly effective dose is 50 mg per day. The daily dose can be increased by 50 mg increments, at intervals of at least one week, and thus 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 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 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:

Sertralineshould 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.

Administration form:

Sertralinecan be taken with or without food.

The tablet can be divided into equal doses.

Take your medication once a day, either 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 may take several weeks for your symptoms to improve. Treatment of depression usually should continue for 6 months after improvement.

If you take moreSertralineSandoz Farmacéutica than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

If you forgot to takeSertralineSandoz Farmacéutica

Do not take a double dose to compensate for the missed doses. If you forget to take a dose, do not take it when you remember. Take the next dose when it is due.

If you interrupt treatment withSertralineSandoz Farmacéutica

Do not interrupt treatment withsertralineunless your doctor tells you to. Your doctor will want to gradually reduce the dose ofsertralineover several weeks before stopping it completely. If you stop treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors. If you experience any of these adverse effects, or any other during the interruption of your treatment withsertraline, please inform your doctor.

If you have any other doubts 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.

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

Inform your doctor immediately:

If you experience any of the following symptoms after taking this medicine, as these symptoms can be serious.

• If you develop a severe skin rash that causes blisters (erythema multiforme), (which 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 may present symptoms such as skin rash with itching, breathing problems, ringing in the ears, 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 medicines 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 thoughts of self-harm or suicide (suicidal thoughts).
• If you start feeling restless and are unable to sit or stand after starting treatment with sertraline. Inform your doctor if you start feeling 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 side effects (may affect more than 1 in 10 patients):

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

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

• common cold (of the chest), sore throat, coughing,
• loss of appetite, increased appetite,
• anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, teeth grinding,
• shaking, muscle movement problems (such as constant movements, 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,
• angina,
• yawns,
• uncomfortable stomach, constipation, abdominal pain, vomiting, gas,
• increased sweating, rash,
• back pain, joint pain, muscle pain,
• irregular menstrual cycle, erectile dysfunction,
• uncomfortable feeling, chest pain, weakness, fever,
• weight gain,
• injury.

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

• gastroenteritis, ear infection,
• tumor,
• hypersensitivity, seasonal allergy,
• low thyroid hormone levels,
• suicidal thoughts, suicidal behavior*, psychotic disorders, abnormal thoughts, neglect, hallucinations, aggression, excessive happiness, paranoia,
• amnesia, decreased sensitivity, involuntary muscle contractions, fainting, continuous movements, migraine, convulsions, dizziness when standing, abnormal coordination, speech disorders,
• dilated pupils,
• ear pain,
• rapid pulse, heart problems,
• bleeding problems (such as stomach bleeding)*, high blood pressure, angina, hematuria,
• shortness of breath, nasal bleeding, possibly noisy breathing difficulties,
• black stools, dental disorders, esophageal inflammation, tongue problems, hemorrhoids, excessive salivation, difficulty swallowing, belching, tongue disorders,
• swelling of the eyes, urticaria, hair loss, itching, purple spots on the skin, skin disorders with blisters, dry skin, facial swelling, cold sweat,
• arthritis, muscle spasms, muscle cramps*, muscle weakness,
• increased frequency of urination, urinary disorders, urinary retention, urinary incontinence, increased urine volume, nocturia,
• female 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 stopping treatment (see section 2).

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

• diverticulitis, lymph node swelling, low platelet count*, low white blood cell count*,
• severe allergic reaction,
• endocrine problems*,
• high cholesterol, difficulty 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*, medication dependence, sleepwalking, premature ejaculation,
• coma, abnormal movements, difficulty moving, increased sensitivity, sudden and severe headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS))*, sensory disturbances,
• spots in front of the eyes, glaucoma, double vision, photophobia (light sensitivity), eye bleeding, irregular pupils, visual disturbances, eye disorders,
• heart attack, dizziness, fainting, or chest discomfort that may be signs of changes in electrical activity (seen on the electrocardiogram) or abnormal heart rhythm*, decreased heart rate,
• circulation problems in the arms and legs,
• rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, throat spasm, difficulty speaking, slower breathing, hiccups,
• mouth ulcers, pancreatitis*, blood in stool, tongue ulcers, mouth sores,
• liver function problems, severe liver function disorders*, yellow skin and eyes (jaundice)*,
• sun sensitivity reaction*, skin swelling*, abnormal hair texture, abnormal skin odor, capillary eruption,
• muscle tissue rupture*, bone disorders,
• interrupted urination, decreased urine volume,
• milk secretion, vaginal dryness, genital secretion, penile and preputial pain and redness, breast enlargement*, prolonged erection,
• hernia, decreased tolerance to the medication,
• increased cholesterol levels, abnormal laboratory results*, abnormal semen, coagulation disorders*,
• relaxation of blood vessel procedure.

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

• jaw lock,

• nocturnal urinary incontinence*,
• partial loss of vision,
• inflammatory colon disease (causing diarrhea),

• excessive vaginal bleeding after childbirth (postpartum hemorrhage), see «Pregnancy» in section 2 for more information.

*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 medicine 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 Sandoz Farmacéutica).

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, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not usethis medicationafter the expiration date that appears on the packaging, after CAD/EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

Composition ofSertraline Sandoz Pharmaceutical

• Sertraline Sandoz Pharmaceutical50 mg tablets: The active ingredient is sertraline (hydrochloride). Each tablet contains sertraline hydrochloride equivalent to 50 mg of sertraline.
• Sertraline Sandoz Pharmaceutical100 mg tablets: The active ingredient 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 (type A), dihydrate calcium hydrogen phosphate, hydroxypropyl cellulose, magnesium stearate.Tablet coating: titanium dioxide (E171), talc and hypromellose.

Appearance of the product and contents of the package

Sertraline Sandoz Pharmaceutical50 mg tablets:

They are film-coated tablets of white color, capsule-shaped, scored and marked with SE 50 on one side.

Sertraline Sandoz Pharmaceutical50 mg film-coated tablets are available in packages of 30 or 60 tablets. The tablets are presented in PVC/Aluminum blisters.

Sertraline Sandoz Pharmaceutical100 mg tablets:arefilm-coated tablets of white color, capsule-shaped, scored and marked with SE 100 on one side.

Sertraline Sandoz Pharmaceutical100 mg film-coated tablets are available in packages of 30, 60 tablets. The tablets are presented in PVC/Aluminum blisters.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Sandoz Pharmaceutical, S.A.

Corporate Business Park

Roble Building

c/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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

Last review date of this leaflet: March 2024

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/