SERTRALINE TECNIGEN 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sertraline TecniGen 50 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Sertraline TecniGen and what is it used for
2. What you need to know before you take Sertraline TecniGen
3. How to take Sertraline TecniGen
4. Possible side effects

5 Storage of Sertraline TecniGen

1. Contents of the pack and further information

1. What is Sertraline TecniGen and what is it used for

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

Sertraline 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).
• Panic disorder (in adults).
• Obsessive-compulsive disorder (OCD) (in adults, and in children and adolescents aged 6-17 years).

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

OCD and anxiety disorders are conditions related to anxiety, with symptoms such as being constantly worried about recurring ideas (obsessions) that lead to repetitive rituals (compulsions).

PTSD is a disorder that can occur after a highly traumatic emotional experience, and has some symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related condition. It is characterized by intense anxiety or distress in social situations (e.g., talking to strangers, speaking in public, eating or drinking in front of others, or worrying about behaving in a shameful way).

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

If you are not sure why you have been prescribed Sertraline TecniGen, you should ask your doctor.

2. What you need to know before you take Sertraline TecniGen

Do not take Sertraline TecniGen:

• 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 in the last 14 days medicines called monoamine oxidase inhibitors (MAOIs), such as selegiline, moclobemide, or other medicines similar to MAOIs (such as linezolid). If you stop treatment with sertraline, you must wait at least one week before starting treatment with an MAOI. After stopping treatment with an MAOI, you must wait at least two weeks before starting treatment with sertraline.
• If you are taking another medicine called pimozide (a medicine used to treat mental disorders such as psychosis).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Sertraline TecniGen.

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

• If you have serotonin syndrome. This syndrome can occur rarely when taking certain medicines at the same time as sertraline. (See section 4, Possible side effects, for symptoms). 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. You should also tell your doctor if you are taking any medicines for high blood pressure, as these medicines can also affect sodium levels in your blood.
• Be particularly careful if you are elderly, as you may be at greater risk of having low sodium levels in your 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 affect your blood sugar levels, so it may be necessary to adjust the dose of your diabetes medicines.
• If you have epilepsy (seizures) or a history of epilepsy. 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 had thoughts of harming yourself or suicidal thoughts (see below, Thoughts of suicide and worsening of your depression or anxiety disorder).
• If you have had bleeding disorders or have been taking medicines that reduce 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 going to be treated for this disorder, 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 disorder, such as certain types of glaucoma (increased intraocular pressure).
• If you have been told you have an abnormality in the graph of your heart that is obtained after an electrocardiogram (ECG), known as prolongation of the QT interval.

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

Restlessness/ Akathisia

The use of sertraline has been associated with akathisia (unpleasant and distressing restlessness and a need to move, often accompanied by an inability to sit or stand still). 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

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 few days after stopping treatment. In general, these symptoms usually resolve on their own and normally disappear within two weeks. In some patients, they can last longer (2-3 months or more). It is recommended that when stopping treatment with sertraline, the dose should be gradually reduced over a period of several weeks or even months; you should always agree with your doctor on the best way to stop treatment.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or suicidal thoughts. This may increase at the start of treatment with antidepressants, due to the fact that these medicines take time to work, which is usually a few weeks, but sometimes can be longer.

This 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 suicidal thoughts at any time, contact your doctor or go to the hospital immediately.

It may be helpful for you to tell a relative or close 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 worried about changes in your behavior.

Children and adolescents

Normally, sertraline should not be used in the treatment of children and adolescents under 18 years, except in the case of patients with obsessive-compulsive disorder. Patients under 18 years have a greater risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when they are treated with this class of medicines. Nevertheless, your doctor may decide to prescribe Sertraline TecniGen to a patient under 18 years if they consider it is the best option for the patient. If your doctor has prescribed Sertraline TecniGen to a patient under 18 years and you want to discuss this decision, please go back to your doctor. You should tell your doctor if any of the symptoms mentioned above appear or worsen when a patient under 18 years is taking sertraline. Also, 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 established.

Taking Sertraline TecniGen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may affect how Sertraline TecniGen works, or Sertraline TecniGen itself may reduce the effectiveness of other medicines that are being taken at the same time.

Taking Sertraline TecniGen with the following medicines may cause serious side effects

• Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (for depression), selegiline (for Parkinson's disease), and 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 (pimozide). Do not take sertraline with pimozide.

Tell your doctor if you are taking the following medicines:

• Herbal medicines containing St. John's Wort (Hypericum perforatum). The effects of St. John's Wort may last 1-2 weeks. Tell your doctor.
• Products containing the amino acid tryptophan.
• Medicines for treating severe pain (e.g., tramadol).
• Medicines used in anesthesia or for treating chronic pain (fentanyl, mivacurium, and suxamethonium).
• Medicines for treating migraines (e.g., sumatriptan).
• Medicines that reduce blood clotting (warfarin).
• Medicines for treating pain/arthritis (non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen, aspirin).
• Sedatives (diazepam).
• Diuretics (also called "water" savers).
• Medicines for treating epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines for treating diabetes (tolbutamide).
• Medicines for treating acidity, ulcers, and heartburn (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 for regulating 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 ketoconazol, 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 electrical activity (e.g., some antipsychotics and antibiotics).

Taking Sertraline TecniGen with food, drinks, and alcohol

Sertraline TecniGen tablets can be taken with or without food.

Alcohol consumption should be avoided while being treated with sertraline.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Consult your doctor or pharmacist before taking any medicine.

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 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 potential benefit to the mother outweighs any potential risk to the fetus. Women of childbearing age who are treated with sertraline should use a suitable contraceptive method.

Make sure your midwife and/or doctor knows that you are taking Sertraline TecniGen. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Sertraline TecniGen may increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during 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 appear during the first 24 hours after birth. The symptoms include:

• difficulty breathing,
• blue-tinged skin or being too hot or cold,
• blue lips,
• vomiting or feeding problems,
• excessive tiredness, inability to sleep, or excessive crying,
• stiffness or decreased muscle tone,
• tremors, restlessness, or seizures,
• 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 are indications that sertraline is excreted in breast milk. Therefore, sertraline can only be used in breastfeeding women if, in the doctor's opinion, the potential benefit to the mother outweighs any potential risk to the baby.

In animal studies, it has been seen 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 like sertraline can affect your ability to drive or use machines. Therefore, do not drive or operate heavy machinery until you know how this medicine affects your ability to perform these activities.

Sertraline TecniGen contains sodium

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

3. How to take Sertralina TecniGen

Follow the administration instructions for this medication exactly 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:

For depression and OCD, the usual effective dose is 50 mg per day. The daily dose can be increased in increments of 50 mg, at intervals of at least one week, and so on 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 be started 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.

Children and Adolescents:

Sertralina TecniGen should only be used to treat children and adolescents aged 6 to 17 years who have 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.

Method of administration:

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

If you take more Sertralina TecniGen than you should

If you accidentally take an overdose of sertralina, contact your doctor or go to the emergency department of the nearest hospital. Always carry the medication package with you, whether it still contains medication or not.

You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Overdose symptoms may include drowsiness, nausea, and vomiting, rapid heartbeat, tremors, agitation, dizziness, and rarely 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 make up for missed doses.

If you stop 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 you stop taking this medication altogether. If you stop treatment abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling unwell or dizziness, and tremors. If you experience any of these side 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.

4. Possible side effects

Like all medications, this medication 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 with continued treatment.

Tell 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 with blisters (erythema multiforme), (which can affect the mouth and tongue). These can 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 can present with symptoms such as skin rash with itching, breathing problems, wheezing, 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 sertralina. Your doctor may decide to stop treatment.
• If you have yellowing of the skin and eyes, which can indicate liver damage.
• If you experience depressive symptoms with thoughts of self-harm or suicide (suicidal thoughts).
• If, after starting treatment with Sertralina TecniGen, you begin to feel restless and are unable to sit or stand. You should inform your doctor if you start to feel 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.

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

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

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

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

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

• Cold (chest), runny nose,
• hypersensitivity
• low levels of thyroid hormones,
• 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,
• difficulty breathing possibly noisy, shortness of breath, nasal bleeding,
• esophageal inflammation, difficulty swallowing, hemorrhoids, increased salivation, tongue alteration, belching,
• eye swelling, skin spots, facial swelling, hair loss, cold sweat, dry skin, hives, itching,
• bone alteration,
• decreased urination, urinary incontinence, interrupted urination,
• excessive vaginal bleeding, vaginal dryness, penile and foreskin pain and redness, genital discharge, prolonged erection, breast secretion,
• hernia, decreased tolerance to medications, difficulty walking, abnormal semen, increased cholesterol levels, injury, relaxation of blood vessel procedures.
• vision of spots in front of the eyes, glaucoma, double vision, photophobia (eye sensitivity to light), eye bleeding, irregular pupils, visual disturbances, tear problems
• There have been reports of suicidal thoughts and behavior during treatment with sertralina or shortly after its interruption (see section 2).

Side effects with unknown frequency

• Partial loss of vision
• Colon inflammation (which causes diarrhea)
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.
• Muscle weakness and intense muscle pain, which can be a sign of multiple acyl-CoA dehydrogenase deficiency (MADD).

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

• Decrease in white blood cell count, decrease in platelets, endocrine disorders, low sodium levels in the blood, increased blood sugar levels,
• abnormal terror dreams, suicidal behavior,
• muscle movement problems (such as constant movements, muscle tension, and difficulty walking), sudden severe headache [which can be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS)],
• abnormal vision, uneven pupil size, bleeding problems (such as stomach bleeding), pancreatitis, serious liver function problems, yellowing of the skin and eyes (jaundice),
• skin swelling, sun-related skin reaction, itching, muscle cramps, breast enlargement, coagulation problems, abnormal laboratory tests, nocturnal urinary incontinence. Dizziness, fainting, or chest discomfort that could be signs of changes in electrical activity (seen on an electrocardiogram) or abnormal heart rhythm.

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 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 stop treatment with Sertralina TecniGen).

An increased risk of bone fracture has been observed in patients treated with this type of medication.

Reporting side effects

If you experience any side effects, 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 through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Sertralina TecniGen

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the package, after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Sertralina TecniGen composition

• The active ingredient is sertralina (hydrochloride).

• Each coated tablet contains 50 mg of sertralina.

The other components are:

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

Appearance of the product and package contents

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

It is available in packages of 10, 14, 28, 30, 56, 60, or 500 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Tecnimede España, Industria Farmacéutica, S.A.

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

28108 Alcobendas (Madrid) SPAIN

Manufacturer:

Atlantic Pharma - Produções Farmacêuticas, S.A.

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

Portugal

This medication is authorized in the member states of the European Economic Area under the following names:

Portugal: Sertralina Aserta 50 mg tablets

Spain: Sertralina TecniGen 50 mg film-coated tablets EFG

Date of last revision of this text: July 2022

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