Package Insert: Information for the User

Sertraline Viatris 100 mg Film-Coated Tablets

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for 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.

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

Sertraline may be used to treat:

• Depression and prevention of depression relapse (in adults).
• Social anxiety disorder (in adults).
• Post-traumatic stress disorder (PTSD) (in adults).
• Anxiety disorder (in adults).
• Obsessive-compulsive disorder (OCD) (in adults, and in children and adolescents aged 6-17 years).

Depression is a clinical disease with symptoms such as feelings of sadness, inability to sleep well or to enjoy life as one used to.

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

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

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

Do not take Sertralina Viatris

• If you are allergic to sertraline or any of the other ingredients in this medication (listed in section 6).
• If you are taking or have taken medications called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other similar medications (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 medication called pimozide (a medication used to treat mental disorders such as psychosis).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sertralina Viatris.

Medications 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:

• 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 suicide (see below, thoughts of suicide and worsening of depression or anxiety).
• Serotonin syndrome. In rare cases, this syndrome can occur when taking certain medications at the same time as sertraline. (See 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 condition may occur as a result of treatment with sertraline. Also, inform your doctor if you are taking any medication for high blood pressure, as these medications may also alter sodium levels in the blood.
• Be especially careful if you are elderly, as you may be at greater risk of having low sodium levels in the blood (see above).
• Liver disease; your doctor may consider that you should take a lower dose of sertraline.
• Diabetes; sertraline may alter your blood sugar levels, so you may need to adjust the dose of your diabetes medication.
• You have a history of bleeding disorders (tendency to develop thrombocytopenia), or if you are pregnant (see Pregnancy, breastfeeding and fertility) or have taken medications that decrease blood clotting (such as aspirin or warfarin) or that may increase the risk of bleeding.
• 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 below, Use in children and adolescents).
• If you are receiving electroconvulsive therapy (ECT).
• If you have any eye disorder, such as certain types of glaucoma (increased intraocular pressure).
• If you have been told that you have an abnormal heart rhythm that is obtained after an electrocardiogram (ECG), known as QT prolongation.
• If you have heart disease, low potassium or magnesium levels, a family history of QT prolongation, low heart rate, or are taking medications that prolong the QT interval.

Restlessness/Acatisia

The use of sertraline has been associated with acatisia 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 weeks of treatment. Increasing the dose in patients who develop these symptoms may be harmful, so 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 Sertralina Viatris 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 during the first few days after stopping treatment. In general, these symptoms usually resolve on their own and usually resolve within two weeks. In some patients, they may last longer (2-3 months or more). It is recommended that, when stopping treatment with sertraline, the dose be gradually reduced over a period of several weeks or even months, and you should always agree with your doctor on the best way to stop treatment.

Thoughts of suicide and worsening of depression or anxiety

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 medications take time to take effect, which is usually two weeks, but sometimes it may be longer.

This is more likely to happen

• If you have had thoughts of suicide or self-harm 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 old 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 to explain to a close family member or friend that you are depressed or have anxiety disorders, 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.

Sexual dysfunction

Medications such as sertraline (also known as ISRS/IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

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). Children and adolescents under 18 years old have a higher risk of side effects such as suicidal thoughts, thoughts of self-harm or suicide, and hostility (predominantly aggression, confrontational behavior, and irritable reaction) when treated with this class of medications. However, it is possible that your doctor may decide to prescribe sertraline to a child or adolescent under 18 years old if they consider it to be the most suitable option for the patient. If your doctor has prescribed sertraline to a child or adolescent under 18 years old and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen when a child or adolescent under 18 years old is taking sertraline. At the same time, the long-term effects on safety and related to growth, maturation, and learning (cognitive development) and behavioral development of sertraline in this age group have not yet been demonstrated. Sertraline was 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 medications and Sertralina Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

The use of sertraline with the following medications may cause severe side effects

• Medications called monoamine oxidase inhibitors (MAOIs), such as moclobemide (to treat depression), selegiline (to treat Parkinson's disease), and the antibiotic linezolid and methylene blue (to treat high levels of methemoglobin in the blood). Do not use sertraline with these medications.
• Medications to treat mental disorders such as psychosis (pimozide). Do not use sertraline with pimozide.

Inform your doctor if you are taking the following medications

• Medications containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).
• Medications based on plants that contain St. John's Wort (Hypericum perforatum). The effects of St. John's Wort may last 1-2 weeks.
• Products containing the amino acid tryptophan.
• Medications to treat severe or chronic pain (opioids, such as tramadol, fentanyl).
• Medications used in anesthesia or to treat chronic pain (such as fentanyl, mivacurium, and suxamethonium).
• Medications to treat migraines (such as sumatriptan).
• Medications that decrease blood clotting (warfarin).
• Medications to treat pain and arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin).
• Medications to treat pain and fever (metamizol).
• Sedatives (diazepam).
• Diuretics.
• Medications to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medications to treat diabetes (tolbutamide).
• Medications to treat acid reflux, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medications to treat mania and depression (lithium).
• Other medications to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medications to treat high blood pressure, chest pain, or to regulate heart rate (such as verapamil, diltiazem, flecainide, propafenone).
• Medications to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medications used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
• Medications used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Medications used to treat HIV/AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir).
• Medications used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
• Medications known to increase the risk of changes in heart rhythm (such as some antipsychotics and antibiotics).

Taking Sertralina Viatris with food, drinks, and alcohol

Sertralina Viatris tablets can be taken with or without food.

Avoid drinking alcohol while being treated with 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, consult your doctor or pharmacist before using this medication.

The safety of sertraline in pregnant women has not been fully established. If you are pregnant, sertraline will only be administered to you if your doctor considers that the benefits for you outweigh any possible risk to the developing fetus.

If you take sertraline in the final 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 know that you are taking sertraline so that they can advise you. When taking sertraline during pregnancy, especially in the last three months of pregnancy, medications like sertraline may increase the risk of a serious condition in newborns 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 manifest within the first 24 hours after birth. The symptoms include:

• Difficulty breathing.
• Blue skin or too hot or cold.
• Blue lips.
• Vomiting or feeding problems.
• Extreme tiredness, inability to sleep, or excessive crying.
• Rigidity or decreased muscle tone.
• Tremors, 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.

There is evidence that sertraline passes into breast milk. Therefore, sertraline can only be used in 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 medications, such as sertraline, may reduce the quality of sperm. Theoretically, this could affect fertility, but it has not yet been determined in humans.

Driving and operating machinery

Medications like sertraline can affect your ability to drive or operate machinery. Therefore, do not drive or operate heavy machinery until you know how this medication affects your ability to do so.

Sertralina Viatris contains sodium

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

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

You may notice that this medication has an unusual smell and/or taste. This is normal and can be minimized by taking it with a glass of water, immediately after bringing it to your mouth.

The recommended dose is:

Adults:

Depression and Obsessive-Compulsive Disorder:

The commonly effective dose for depression and OCD is 50 mg per day. The daily dose can be increased by 50 mg, at intervals of at least one week, and thus 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 intervals 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 from 6 to 17 years old who present with 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..

Administration form:

Sertraline Viatris tablets can be taken with or without food.

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 will take several weeks for your symptoms to start improving. Treatment of depression should continue for 6 months after improvement.

If you take more Sertraline Viatris than you should

If you have taken more sertraline than you should, contact your doctor or pharmacist or go to the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (Tel: 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, unconsciousness.

If you forgot to take Sertraline Viatris

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 with Sertraline Viatris

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 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 with sertraline, please inform your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, sertraline may 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 medication, as these symptoms may be serious.

• If you develop a severe skin rash that causes 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 these cases, your doctor will discontinue 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 may occur when taking certain medications at the same time as sertraline. Your doctor may decide to discontinue treatment.
• If you experience yellowing of the skin and eyes, which may indicate liver damage.
• If you experience depressive symptoms with suicidal thoughts.
• If you start 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, runny nose.
• Loss of appetite, increased appetite.

• Anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, bruxism.
• Tremor, 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.
• Tinnitus in the ears.
• Palpitations.
• Hot flashes.
• Yawning.
• Abdominal discomfort, constipation, abdominal pain, vomiting, gas.
• Increased sweating, rash.
• Back pain, joint pain, muscle pain.
• Irregular menstrual cycle, erectile dysfunction.
• Discomfort, chest pain, weakness, fever.
• Weight gain.
• Lesion.

Uncommon side 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 thoughts, lack of care, hallucinations, aggression, excessive happiness, paranoia.

-Amnesia, decreased sensitivity, involuntary muscle contractions, fainting, continuous movements, migraine, convulsions, dizziness when standing up, abnormal coordination, speech disorders.

-Dilated pupils.

-Ear pain.

-Accelerated pulse, heart problems.

-Bleeding problems (such as stomach bleeding)*, high blood pressure, hot flashes, blood in urine.

-Shortness of breath, nasal bleeding, possible noisy breathing.

-Black stools, dental disorders, esophageal inflammation, tongue problems, hemorrhoids, excessive salivation, difficulty swallowing, belching, tongue disorders.

-Swollen 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, need to urinate at night.

-Sexual dysfunction, excessive vaginal bleeding, vaginal bleeding, female sexual dysfunction.

-Swollen legs, chills, difficulty walking, thirst.

-Altered liver enzymes, weight loss.

-There have been reports of thoughtsandbehavioral changes during treatment with sertraline or shortly after discontinuation (see section 2).

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

-Diverticulitis, swollen lymph nodes, decreased platelets*, decreased 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 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 (light sensitivity), eye bleeding, irregular pupils*, visual disturbances*, eye problems.

-Appearance of spots in the visual field, glaucoma, double vision, eye damage from light, blood in the eye, unequal pupil size*, abnormal vision*, eye problems.

-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.

-Problems with circulation in the arms and legs.

-Accelerated breathing, progressive scarring of lung tissue (interstitial lung disease)*, throat spasms, difficulty speaking, slower breathing, hiccups.

-Mouth ulcers, pancreatitis*, blood in stools, tongue ulcers, mouth sores.

-Liver function problems, severe liver function disorders*, yellow skin and eyes (jaundice)*.

-Sun sensitivity*, 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.

-High cholesterol levels, abnormal analytical tests*, abnormal semen, coagulation problems*.

-Relaxation of blood vessel procedure.

Unknown frequency(cannot be estimated from available data):

-Trigeminal nerve block,

-Nocturnal urinary incontinence*.

-Partial loss of vision.

-Colitis inflammation (causing diarrhea).

-Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy, lactation, and fertility” 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 discontinued

If you discontinue 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 discontinue treatment with Sertralina Viatris).

There has been an increased risk of bone fractures in patients taking this type of medication.

Reporting of 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 Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children

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

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at your local SIGRE collection pointat your usual pharmacy. If in doubt, please ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sertralina Viatris

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

• The other components are: microcrystalline cellulose (E-460), anhydrous calcium phosphate, sodium carboxymethyl starch, magnesium stearate (E-572) and purified water.

Coating: hypromellose (E-464), titanium dioxide (E-171), polydextrose (E-1200), triacetin (E-1518) and macrogol.

Appearance of the product and content of the packaging

Sertralina Viatris 100 mg is presented in coated tablets with a white color, scored on one side, with the inscription “ST” and “100” on each side of the score and with the letter “G” on the back.

Sertralina Viatris is presented in packaging with blisters of 30 and 500 (clinical packaging) tablets and pre-cut single-dose blisters of 30x1 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible manufacturer:

McDermott Laboratories Limited trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

or

Mylan Hungary Kft

Mylan utca, 1

H-2900 Komárom

Hungary

Last review date of thisleaflet:December 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/