Prospect: Information for the User

Sertralina TecniGen 50 mg Film-Coated Tablets

Read this prospect carefully before starting to take this medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you must not give it 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 prospect. See section 4.

5Storage of Sertralina TecniGen

6.Contents of the package and additional information

Sertralina TecniGen 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.

Sertralina TecniGen can be used to treat:

• Depression and prevention of depression relapse (in adults).
• Social anxiety disorder (in adults).
• Post-traumatic stress disorder (PTSD) (in adults).
• 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 diseases linked to anxiety, 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 disorder. 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 shameful manner).

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

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

Do not take Sertralina TecniGen:

• If you are allergic to sertraline or any of the other components of 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 to MAOIs (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 TecniGen.

Medicines are not always suitable for everyone. Before starting treatment with Sertralina TecniGen, tell your doctor if you have or have had any of the following circumstances:

• If you have Serotonin Syndrome. In rare cases, this syndrome may occur when taking certain medications at the same time as sertraline. (See section 4. Possible side effects). Your doctor will indicate if you have previously presented this syndrome.
• If you have low sodium levels in your blood, as this situation 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).
• 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 medications.
• If you have epilepsy (seizures) or a history of epilepsy. If you have a seizure (convulsions), 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 below thoughts of suicide and worsening of your depression or anxiety).
• If you have or have had bleeding disorders or have been taking medications that decrease blood clotting (such as aspirin, 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 being treated for this disorder, your doctor will closely monitor you (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 that you have an abnormal heart rhythm that is obtained after an electrocardiogram (ECG), known as QT interval prolongation.

Some medications in the group to which Sertralina TecniGen belongs (called ISRS/IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Restlessness/Acatisia

The use of sertraline has been associated with acatisia (unpleasant restlessness and a need to move, often accompanied by an inability to sit or stand still). This occurs more often during the first weeks of treatment. Increasing the dose may be harmful, so if you develop these symptoms, you should contact your doctor.

Withdrawal symptoms

When treatment is stopped, it is common for withdrawal symptoms to occur, particularly if treatment is stopped abruptly (see 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 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 always agree with your doctor on the best way to stop treatment.

Thoughts of suicide and worsening of your 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 can be longer.

It is more likely to happen:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. There is information from clinical trials that shows an increased risk of suicidal behavior in adults under 25 years with psychiatric 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. Young patients have a higher risk of adverse effects such as suicidal thoughts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritable reaction) when treated with this class of medications. However, it is possible that your doctor may decide to prescribe Sertralina TecniGen 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 Sertralina TecniGen to a patient under 18 years old and wants 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 patient under 18 years old is taking sertraline. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of sertraline in this age group have not yet been demonstrated.

Taking Sertralina TecniGen with other medications

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 Sertralina TecniGen works, or Sertralina TecniGen itself may reduce the effectiveness of other medications you are taking at the same time.

The use of Sertralina TecniGen 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 (pimozide). Do not use sertraline with pimozide.

Inform your doctor if you are taking the following medications:

• Herbal medicines containing St. John's Wort.
• Products containing the amino acid tryptophan.
• Medications to treat severe pain (such as tramadol).
• Medications used in anesthesia or to treat chronic pain (fentanyl, mivacurium, and suxamethonium).
• Medications to treat migraines (such as sumatriptan).
• Medications that decrease blood clotting (warfarin).
• Medications to treat pain/arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin).
• Sedatives (diazepam).
• Diuretics (also called "water savers").
• 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 schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medications to treat high blood pressure, chest pain, or to regulate heart rate (such as verapamil, diltiazem, flecainide, propafenone).
• 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 TecniGen with food, drinks, and alcohol

Sertralina TecniGen tablets can be taken with or without food.

Alcohol should be avoided while being treated with sertraline.

Do 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, or think you may be pregnant, consult your doctor or pharmacist before taking this medication.

Consult your doctor or pharmacist before using any medication.

If you take sertraline in the final stages of pregnancy, there may be an increased risk of excessive 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.

The safety of sertraline in pregnant women has not been fully established. Sertraline should only be administered to pregnant women if, in the doctor's opinion, the benefits for the mother outweigh any possible risk to the fetus. Women of childbearing age who are being treated with sertraline should use an appropriate contraceptive method.

Ensure that your midwife and/or doctor know that you are taking Sertralina TecniGen. When taken during pregnancy, particularly in the last three months of pregnancy, medications like Sertralina TecniGen 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 turn blue. These symptoms usually start within the first 24 hours after the baby is born. 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,
• 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.

There is evidence that sertraline is excreted in breast milk. Therefore, sertraline can only be used in breastfeeding women if, in the doctor's opinion, the benefits for the mother outweigh any possible risk to the baby.

In animal studies, some medications like sertraline have been shown to reduce sperm quality. Theoretically, this could affect fertility, but the impact on human fertility has not yet been determined.

Driving and operating machinery

Psychotropic 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 perform these activities.

Sertralina TecniGen contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it 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.

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 over several weeks. The maximum recommended dose is 200 mg per day.

Anxiety Disorder, Social Anxiety Disorder, and Post-Traumatic Stress Disorder:The 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 at intervals of 50 mg over a period of several weeks. The maximum recommended dose is 200 mg per day.

Children and Adolescents:

Sertralina TecniGen 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 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 the instructions they give you.

Administration form:

Sertralina TecniGen 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 may take several weeks for your symptoms to improve.The treatment of depression usually should continue for 6 months after improvement.

If you take more Sertralina TecniGen than you should

If you accidentally take an excessive amount of sertralina, contact your doctor or go to the nearest hospital emergency service. Always carry the medication packaging with you, even if it is empty.

You can also 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, vomiting, rapid heart rate, tremors, agitation, dizziness, and in rare cases, loss of consciousness.

If you forget to take Sertralina TecniGen

If you forget to take a dose, do not take it when you remember. Take the next dose when it is due.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Sertralina TecniGen

Do not stop treatment with Sertralina TecniGen unless your doctor tells you to. Your doctor will want to gradually reduce the dose of Sertralina TecniGen 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, feeling unwell, or feeling dizzy and trembling. If you experience any of these adverse effects, or any other during the interruption of your treatment with Sertralina TecniGen, please inform your doctor.

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

Like all medications,this medicationcan 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 as treatment continues.

Inform your doctor immediately

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

• If you develop a severe skin rash that causes blisters (erythema multiforme), (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 medications 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 ofharming yourself orsuiciding(suicidal thoughts).
• If you start feeling restless and are unable to sit or stand after starting treatment with Sertralina TecniGen, inform your doctor if you start feeling restless.
• If you experience a seizure (convulsions).
• If you experience a manic episode (see section 2.“Warnings and precautions”).

The following side effects were observed in clinical trials in adults.

Very common side effects (can affect more than 1 in 10 people):

Insomnia, dizziness, drowsiness, headache, diarrhea, feeling of discomfort, dry mouth, ejaculation problems, and fatigue.

Common side effects (can affect up to 1 in 10 people):

• Sore throat, anorexia, increased appetite,
• depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased libido, teeth grinding, numbness and tingling, tremors, muscle tension, abnormal taste, lack of concentration,
• visual disturbances, ringing in the ears,
• palpitations, hot flashes,
• abdominal pain, vomiting, constipation, stomach discomfort, gas,
• skin rash, increased sweating, muscle pain, erectile dysfunction, and chest pain
• joint pain
• discomfort

Uncommon side effects (can affect up to 1 in 100 people):

• Common cold (of the chest), runny nose,
• hypersensitivity
• low thyroid hormone levels,
• hallucinations, excessive happiness, lack of care, abnormal thoughts, aggression
• seizures, involuntary muscle contractions, abnormal coordination, continuous movements, amnesia, decreased sensitivity, speech disorders, dizziness when standing up,loss of consciousness,migraines,dilated pupils
• ear pain, rapid pulse, high blood pressure, hot flashes,
• possible noisy breathing, shortness of breath, nasal bleeding,
• inflammation of the esophagus, difficulty swallowing, hemorrhoids, increased salivation, altered tongue, belching,
• swelling of the eyes, purple spots on the skin,swelling of the face,hair loss, cold sweat, dry skin, urticaria,itching,
• arthritis, muscle weakness, back pain, muscle spasms,
• need to urinate at night, urinary retention, increased urine production, increased frequency of urination, urinary disorders,incontinence of urine,
• vaginal bleeding,sexual dysfunction,female sexual dysfunction,irregularities in the menstrual cycle,swollen legs,discomfort, chills, fever, weakness, thirst,increased liver enzyme levels,weight loss and weight gain.

Rare side effects (can affect up to 1 in 1,000 people):

• Gastrointestinal problems, ear infection, cancer, swollen lymph nodes, high cholesterol, elevated blood sugar,
• physical symptoms due to stress or emotions, dependence on medication, psychotic disorders, paranoia, suicidal thoughts, sleepwalking, premature ejaculation,
• severe allergic reaction,
• coma, abnormal movements, difficulty moving, increased sensitivity, sensory disturbances, glaucoma, eye problems, eye spots, double vision, eye damage, blood in the eye,
• problems controlling blood sugar levels (diabetes),
• heart attack, decreased heart rate, heart problems, circulation problems in the arms and legs, throat spasms, rapid breathing, slow breathing, difficulty speaking, hiccups,
• blood in stool, mouth sores, tongue ulcers, dental and tongue problems, mouth ulcers, liver function problems,
• skin problems with blisters, capillary rash, abnormal hair texture, abnormal skin odor,
• bone alterations,
• decreased urine production, incontinence of urine, interrupted urination,
• excessive vaginal bleeding, vaginal dryness, penile and prepuce pain and redness, genital secretion, prolonged erection, breast secretion,
• hernia, decreased tolerance to medication, difficulty walking, abnormal semen,increased cholesterol levels, injury, relaxation of blood vessel procedure.
• spots in front of the eyes, glaucoma, double vision, photophobia (sensitivity to light), eye hemorrhages, irregular pupils, visual disturbances, eye problems
• Cases of suicidal thoughts and behavior have been reported during treatment with sertraline or shortly after its discontinuation (see section 2).

Side effects of unknown frequency

• Partial loss of vision
• Inflammation of the colon (which causes diarrhea)
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy, lactation, and fertility” in section 2 for more information.

Since the marketing of sertraline, the following side effects have been reported

• Decreased white blood cell count, decreased platelet count, endocrine problems, low sodium levels in the blood,elevated blood sugar levels,
• abnormal nightmares, suicidal thoughts,
• muscle movement problems (such as continuous movements, muscle tension, and difficulty walking),sudden severe headache [which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS)],
• abnormal vision,unequal pupil size,bleeding problems (such as stomach bleeding), pancreatitis, severe liver function problems, yellow skin and eyes (jaundice),
• swelling of the skin, sun sensitivity, itching, muscle cramps, breast enlargement, bleeding problems,abnormal laboratory results,nocturnal incontinence of urine. Dizziness, fainting, or chest discomfort that may be signs of changes in electrical activity (seen on the electrocardiogram) or abnormal heart rhythm.

Other side effects in children and adolescents

In clinical trialsin 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 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 withSertralinaTecniGen).

A higher risk of bone fracture has been observed in patients treated with this type of medication.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to 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. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not dispose of medications through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Sertralina TecniGen

• The active ingredient is sertraline (hydrochloride).

• Each coated tablet contains 50 mg of sertraline.

The other components are:

calcium phosphate dibasic, microcrystalline cellulose, sodium carboxymethylcellulose from potato, anhydrous colloidal silica, and magnesium stearate. The coating includes: polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol 300, and talc.

Appearance of the product and content of the container

Sertralina TecniGen 50 mg is presented as coated tablets with a white film coating, round, convex, and scored, packaged in blisters.

It is presented in containers with 10, 14, 28, 30, 56, 60, or 500 tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Tecnimede España, Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) ESPAÑA

Responsible for manufacturing:

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº 2, Abrunheira, 24710-189 Sintra

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Portugal: Sertralina Aserta 50 mg tablets

Spain: Sertralina TecniGen 50 mg coated tablets EFG

Last review date of this text: July 2022

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