Sertraline Tecnigen 100 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Sertraline TecniGen 100 mg film-coated tablets EFG

Read all of this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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 side effects

5 Storage of Sertraline TecniGen

1. 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 with symptoms such as feelings of sadness, inability to sleep well or to enjoy life as one previously did.

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

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, tell 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 you are 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 medicine for high blood pressure, as these medicines may also affect sodium levels in the blood.
• Take special care 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 medicines.
• 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 or have previously had thoughts of harming yourself or committing 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 with 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 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, it is common for withdrawal symptoms to occur, 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. Generally, these symptoms are mild or moderate. However, in some patients, they may be severe. These symptoms usually appear during the first few 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. You should always discuss with your doctor the best way to discontinue treatment.

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 may increase at the beginning of treatment with antidepressants, because all these medicines take some time to work, 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 (predominantly aggression, confrontational behaviour, and anger reactions) when taking this class of medicines. Nevertheless, your doctor may decide to prescribe Sertraline TecniGen to a patient under 18 years of age if they consider it to be 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 and on 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 itself 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 methemoglobin in the blood). Do not use sertraline with these medicines.
• Medicines for treating mental disorders (pimozide). Do not use sertraline with pimozide.

Tell your doctor if you are taking the following medicines:

• Herbal remedies 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, lansoprazol, 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 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. certain 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 taken 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 are planning 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 administered 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 being treated with 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 blue. 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,
• blue or excessively 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 reflexes,
• irritability,
• low blood sugar levels.

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 child.

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

Driving and using 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 use of this medicine given by your doctor or pharmacist. If in doubt, please 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 daily.

Panic disorder, social anxiety disorder, and post-traumatic stress disorder:
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 daily.

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 daily. After one week, your doctor may increase the dose to 50 mg daily. The maximum dose is 200 mg daily.

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

If you have liver or kidney problems, inform your doctor and follow the instructions provided by him/her.

Method of administration:

Sertralina TecniGen tablets can be taken with or without food.

Take your medicine once daily, either in the morning or at night.

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 name of the medicine and the amount ingested.

Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, 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 usual time.

Do not take a double dose to make up for forgotten 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 your dose of Sertralina TecniGen over several weeks before you stop taking the medicine completely. If you stop treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, feeling unwell, 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 may 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 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 together with sertraline. Your doctor may decide to stop 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, tremor, muscle tension, abnormal taste, lack of concentration,
• 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 ulcers, tongue ulceration, dental and tongue problems, mouth ulceration, liver function problems,
• skin problems with blisters, hair eruption, abnormal hair texture, abnormal skin odor,
• bone abnormalities,
• decreased urine volume, urinary incontinence, interrupted urination,
• excessive vaginal bleeding, vaginal dryness, pain and redness of the penis and foreskin, genital discharge, prolonged erection, breast discharge,
• hernia, reduced tolerance to medicines, difficulty walking, abnormal semen, increased cholesterol levels, injury, relaxation of blood vessel procedures.
• Seeing spots in front of the eyes, glaucoma, double vision, photophobia (eye sensitivity to light), eye hemorrhages, irregular pupils, visual disturbances, tear problems.
• Cases of suicidal thoughts and behavior have been reported during treatment with sertraline or shortly after discontinuation (see section 2).

Adverse effects with frequency not known

• Partial loss of vision
• Inflammation of the colon (causing diarrhea)
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see "Pregnancy, breastfeeding and fertility" in section 2 for more information.
• Muscle weakness and severe muscle pain, which may be a sign of multiple acyl-coenzyme A dehydrogenase deficiency (MADD).

The following adverse effects have been reported since sertraline has been marketed:

• Decrease in white blood cell count, decrease in platelets, endocrine problems, low blood sodium levels, increased blood sugar levels,
• abnormal nightmares, suicidal behavior,
• muscle movement problems (such as constant 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, yellowing of the skin and eyes (jaundice),
• skin swelling, skin reaction to sunlight, itching, muscle cramps, breast enlargement, coagulation problems, abnormal laboratory tests, urinary incontinence during sleep. Dizziness, fainting, or chest discomfort which could be signs of changes in electrical activity (seen on electrocardiogram) or abnormal heart rhythm.

Other adverse effects in children and adolescents

In clinical trials in children and adolescents, adverse effects were generally similar to those reported in adults (see above). The most common adverse effects in children and adolescents were headache, insomnia, diarrhea, and nausea.

Symptoms that may occur when stopping treatment

If you stop treatment with this medicine abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremor (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 medicine.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

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. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help 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 100 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 includes: polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol 300 and talc.

Appearance of the product and contents of the pack

Sertraline TecniGen 100 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 some 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 100 mg tablets

Spain: Sertraline TecniGen 100 mg film-coated tablets EFG

Date of the most recent revision of this text: July 2022

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