Sertraline Tecnigen 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Sertraline TecniGen 50 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Sertraline TecniGen is and what it is used for
2. What you need to know before taking Sertraline TecniGen
3. How to take Sertraline TecniGen
4. Possible adverse effects
5. How to store Sertraline TecniGen
6. Contents of the pack and other information

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

Sertralina TecniGen contains sertraline as the active substance. Sertraline belongs to a group of medicines known as Selective Serotonin Reuptake Inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders.

Sertralina TecniGen can be used to treat:

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

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

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

PTSD is a disorder that may occur following an emotionally traumatic experience and has some symptoms similar to those of depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterized by intense anxiety or distress in social situations (for example: speaking with strangers, speaking in public, eating or drinking in front of others, or worrying about behaving in an embarrassing way).

Your doctor has determined that this medicine is appropriate for treating your condition.

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

2. What you need to know before taking Sertraline TecniGen

Do not take Sertraline TecniGen:

• If you are allergic to sertraline or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking or have recently taken medicines called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide), or other medicines similar to MAOIs (such as linezolid). If you stop treatment with sertraline, you must wait at least one week before starting treatment with an MAOI. After stopping treatment with an MAOI, you must wait at least two weeks before starting treatment with sertraline.
• If you are taking another medicine called pimozide (a medicine used to treat mental disorders such as psychosis).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Sertraline TecniGen.

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

• If you have serotonin syndrome. This syndrome may rarely occur when taking certain medicines at the same time as sertraline. (For symptoms, see section 4. Possible side effects.) Your doctor will determine whether you have previously experienced this syndrome.
• If you have low sodium levels in the blood, as this condition may occur as a result of treatment with sertraline. You should also inform your doctor if you are taking any medication for high blood pressure, as these medicines may also affect blood sodium levels.
• Exercise special caution if you are elderly, as you may be at increased risk of low blood sodium levels (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 it may be necessary to adjust the dose of your diabetes medications.
• If you have epilepsy (seizures) or a history of epilepsy. If you have a seizure (convulsion), contact your doctor immediately.
• If you have bipolar disorder (manic-depressive illness) or schizophrenia. If you experience a manic episode, contact your doctor immediately.
• If you have had or currently have thoughts of harming yourself or of suicide (see further information below on suicidal thoughts and worsening of depression or anxiety disorder).
• If you have had bleeding disorders or have been taking medicines that reduce blood clotting (e.g. acetylsalicylic acid (aspirin), or warfarin), or medicines 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 of age. Sertraline should only be used to treat children and adolescents aged 6 to 17 years who have obsessive-compulsive disorder (OCD). If you are being treated for this condition, your doctor will want to monitor you closely (see below "Children and adolescents").
• If you are receiving electroconvulsive therapy (ECT).
• If you have any eye disorders, such as certain types of glaucoma (increased intraocular pressure).
• If you have been told you have an abnormality on the heart tracing obtained from an electrocardiogram (ECG), known as QT interval prolongation.

Some medicines in the group to which Sertraline TecniGen belongs (called SSRIs/SNRIs) 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 restlessness and an urge to move, often accompanied by an inability to sit or stand still). This occurs more frequently 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 stopping treatment, withdrawal symptoms are common, particularly if treatment is stopped abruptly (see section 4. Possible side effects). The risk of experiencing withdrawal symptoms depends on the duration of treatment, the dose, and the rate at which the dose is reduced. These symptoms are usually mild or moderate. However, in some patients they may be severe. These symptoms usually appear during the first days after stopping treatment. In general, these symptoms resolve on their own and usually disappear within two weeks. In some patients, they may last longer (2–3 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. Always discuss the best way to discontinue treatment with your doctor.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide. This risk may increase at the beginning of treatment with antidepressants, because all these medicines take time to become effective, usually about two weeks, but sometimes longer.

You are more likely to experience this:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. Clinical trial data show an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with an antidepressant.

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

It may be helpful for you to 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 may also ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.

Children and adolescents

Sertraline should not normally be used to treat children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder. Patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behaviour, and anger reactions) when taking this type of medicine. Nevertheless, your doctor may decide to prescribe Sertraline TecniGen to a patient under 18 years of age if they consider it the most appropriate treatment. If your doctor has prescribed Sertraline TecniGen to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen while a patient under 18 years of age is taking sertraline. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioural development of sertraline in this age group have not yet been established.

Taking Sertraline TecniGen with other medicines

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

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

The use of Sertraline TecniGen together with the following medicines may cause serious adverse effects

• Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (for treating depression), selegiline (for treating Parkinson's disease), and the antibiotic linezolid and methylene blue (for treating high levels of methaemoglobin in the blood). Do not use sertraline with these medicines.
• Medicines for treating mental disorders (pimozide). Do not use sertraline with pimozide.

Inform 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. Inform your doctor.
• Products containing the amino acid tryptophan.
• Medicines for treating severe pain (e.g. tramadol).
• Medicines used in anaesthesia 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 drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics (also known as "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 amitriptiline, 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 and rhythm (such as verapamil, diltiazem, flecainide, propafenone).
• Medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Medicines used to treat HIV/AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
• Medicines known to increase the risk of changes in the heart's electrical activity (e.g. some antipsychotics and antibiotics).

Taking Sertraline TecniGen with food, drinks and alcohol

Sertraline TecniGen tablets can be taken with or without food.

Alcohol intake should be avoided while being treated with sertraline.

Grapefruit juice should not be consumed with sertraline, as it may increase sertraline levels in your body.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Consult your doctor or pharmacist before using any medicine.

If you take sertraline in the late stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware 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 given to pregnant women if, in the doctor's judgment, the benefit to the mother outweighs any possible risk to the fetus. Women of childbearing age taking sertraline should use an adequate method of contraception.

Ensure that your midwife and/or doctor knows that you are taking Sertraline TecniGen. Medicines such as Sertraline TecniGen, when taken during pregnancy, particularly during the last three months of pregnancy, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

Your newborn baby may have other conditions, which usually appear within the first 24 hours after birth. Symptoms include:

• difficulty breathing,
• bluish or unusually hot or cold skin,
• blue lips,
• vomiting or feeding problems,
• excessive tiredness, inability to sleep or excessive crying,
• muscle stiffness or decreased muscle tone,
• tremors, restlessness or seizures,
• increased reflex responses,
• irritability,
• low blood sugar.

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

There is evidence that sertraline is excreted in breast milk. Therefore, sertraline may only be used in women who are breastfeeding if, in the doctor's judgment, the benefit to the mother outweighs any possible risk to the infant.

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

Driving and use of machines

Psychotropic medicines such as sertraline may affect your ability to drive or operate machinery. Therefore, do not drive or operate heavy machinery until you know how this medicine affects your ability to perform these activities.

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

The recommended dose is:

Adults:

Depression and Obsessive-Compulsive Disorder (OCD):

For depression and OCD, the usually effective dose is 50 mg daily. The daily dose may be increased in increments of 50 mg at intervals of at least one week, over several weeks. The maximum recommended dose is 200 mg per day.

Panic Disorder, Social Anxiety Disorder, and Post-Traumatic Stress Disorder (PTSD): For panic disorder, social anxiety disorder, and post-traumatic stress disorder, treatment should be initiated at a dose of 25 mg daily, increasing to 50 mg daily after one week.

The daily dose may 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 with OCD.

Obsessive-Compulsive Disorder (OCD):

Children aged 6 to 12 years: The recommended starting dose is 25 mg daily. After one week, your doctor may increase the dose to 50 mg daily. The maximum dose is 200 mg per day.

Adolescents aged 13 to 17 years: The recommended starting dose is 50 mg daily. The maximum dose is 200 mg per day.

If you have liver or kidney problems, inform your doctor and follow the instructions he or she gives you.

Method of administration:

Sertralina TecniGen tablets can be taken with or without food.

Take your medicine once a day, either in the morning or in the evening.

Your doctor will determine how long you should take this medicine. The duration will depend on the nature of your illness and your response to treatment. It may take several weeks before your symptoms begin to improve. Treatment for depression should usually continue for 6 months after improvement occurs.

If you take more Sertralina TecniGen than you should

If you accidentally take too much sertraline, contact your doctor or go to the nearest hospital emergency department. Always bring the medicine package with you, whether or not there is any medication left.

You can also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose may include drowsiness, nausea and vomiting, increased heart rate, tremors, agitation, dizziness, and 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 at the scheduled time.

Do not take a double dose to make up for missed doses.

If you stop taking 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 completely stop taking this medicine. If you stop treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feelings of discomfort, or feeling dizzy and tremulous. If you experience any of these adverse effects, or any other symptoms, while discontinuing treatment with Sertralina TecniGen, please inform your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The most common adverse effect is nausea. Adverse effects depend on the dose and often disappear during continued treatment.

Tell your doctor immediately

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

• If you develop a severe skin rash causing blisters (erythema multiforme), (which may affect the mouth and tongue). These may be signs of a condition known as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN). In such cases, your doctor will stop the treatment.
• Allergic reaction or allergy, which may present symptoms such as itchy skin rash, breathing difficulties, wheezing, swelling of the eyelids, face or lips.
• If you experience agitation, confusion, diarrhea, increased body temperature and blood pressure, excessive sweating, and rapid pulse. These are symptoms of serotonin syndrome. This syndrome may rarely occur when taking certain medicines at the same time as sertraline. Your doctor may decide to discontinue treatment.
• If you notice yellowing of the skin or eyes, which may 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 unable to sit or stand still. You should inform your doctor if you start feeling restless.
• If you have a seizure (convulsions).
• If you experience a manic episode (see section 2. "Warnings and precautions").

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

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

Insomnia, dizziness, somnolence, headache, diarrhea, malaise, dry mouth, ejaculation disorders, and fatigue.

Common adverse 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,
• visual disturbances, tinnitus (ringing in the ears),
• palpitations, hot flushes, yawning,
• abdominal pain, vomiting, constipation, stomach discomfort, flatulence,
• skin rash, increased sweating, muscle pain, erectile dysfunction, chest pain,
• joint pain,
• malaise.

Uncommon adverse 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 upon standing, loss of consciousness, migraines, dilated pupils,
• ear pain, rapid pulse, elevated blood pressure, hot flushes,
• difficulty breathing possibly noisy, shortness of breath, nosebleeds,
• inflammation of the esophagus, difficulty swallowing, hemorrhoids, increased salivation, tongue disorders, burping,
• swelling of eyes, purple spots on the skin, facial swelling, hair loss, cold sweat, dry skin, hives, itching,
• osteoarthritis, muscle weakness, back pain, muscle jerks,
• need to urinate at night, urinary retention, increased urine volume, increased frequency of urination, urinary disorders, urinary incontinence,
• vaginal bleeding, sexual dysfunction, female sexual dysfunction, menstrual irregularities,
• swollen legs, chills, fever, weakness, thirst, increased liver enzyme levels, weight loss and weight gain.

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

• Intestinal problems, ear infection, cancer, swollen lymph nodes, high cholesterol, elevated blood sugar,
• physical symptoms due to stress or emotions, drug dependence, psychotic disorders, paranoia, suicidal thoughts, sleepwalking, premature ejaculation,
• severe allergic reaction,
• coma, abnormal movements, difficulty moving, increased sensitivity, sensory disturbances, glaucoma, tear problems, appearance of spots in the visual field, double vision, light damage to the eyes, blood in the eye,
• problems controlling blood sugar levels (diabetes),
• heart attack, decreased heart rate, heart problems, circulation problems in arms and legs, throat spasm, rapid breathing, slower breathing, difficulty speaking, hiccups,
• blood in stools, mouth sores, tongue ulceration, dental and tongue problems, mouth ulceration, liver function problems,
• skin problems with blisters, capillary rash, abnormal hair texture, abnormal skin odor,
• bone disorders,
• decreased urine output, urinary incontin游戏副本

5. Storage of Sertraline TecniGen

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

Do not use this medicine after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Sertraline TecniGen

• The active substance is sertraline (hydrochloride).

• Each coated tablet contains 50 mg of sertraline.

The other components are:

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

Appearance of the product and pack contents

Sertraline TecniGen 50 mg is presented as white, round, biconvex, film-coated tablets with a score line, packed in blisters.

Available pack sizes contain 10, 14, 28, 30, 56, 60 or 500 tablets.

Only certain pack sizes may be commercially available.

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 medicinal product is authorized in the European Economic Area member states under the following names:

Portugal: Sertralina Aserta 50 mg tablets

Spain: Sertralina TecniGen 50 mg film-coated tablets EFG

Date of the most recent text revision: July 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es