Sertraline Tecnigen: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sertralina TecniGen 50 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Contents of this leaflet:

What Sertralina TecniGen is and what it is used for
What you need to know before taking Sertralina TecniGen
How to take Sertralina TecniGen
Possible side effects
How to store Sertralina TecniGen
Contents of the pack and other information

1. WHAT SERTRALINA TECNIGEN IS AND WHAT IT IS USED FOR

Sertralina TecniGen contains the active substance sertraline. Sertraline belongs to a group of
medicines called 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 to 17 years).

Depression is a clinical illness with symptoms such as feeling sad, inability to sleep properly or to enjoy life as you used to.
OCD and panic disorder are anxiety-related illnesses with symptoms such as being constantly troubled by persistent thoughts (obsessions) leading to performing repetitive ritualistic actions (compulsions).
PTSD is a condition that may occur after a strongly traumatic emotional experience and has some symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterised by intense anxiety or stress in social situations (e.g. speaking to strangers, speaking in public, eating or drinking in front of others, or fear of behaving in an embarrassing way).
Your doctor has determined that this medicine is suitable for treating your condition.
You should contact your doctor if you are unsure why Sertralina TecniGen has been prescribed for you.

2. WHAT YOU SHOULD KNOW BEFORE TAKING SERTRALINE TECNIGEN

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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 drugs with MAOI-like activity (such as linezolid). If you stop treatment with sertraline, you must wait at least one week before restarting treatment with an MAOI. After stopping treatment with an MAOI, you must wait at least 2 weeks before starting treatment with sertraline.
If you are taking another medicine called pimozide (a medicine for mental disorders such as psychosis).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Sertraline TecniGen.
Medicines are not always suitable for everyone. Inform your doctor before taking Sertraline TecniGen if you
have or have previously had any of the following conditions:

Epilepsy or history of seizures. In case of epileptic seizure (convulsions), contact your doctor immediately.
If you have suffered from bipolar disorder (manic-depressive illness) or schizophrenia. In case of a manic episode, contact your doctor immediately.
If you have thoughts of harming or killing yourself (see below – Suicidal thoughts and worsening of depression or anxiety disorder).
Serotonin syndrome. In rare cases, this syndrome may occur when certain medicines are taken together with sertraline (for symptoms, see section 4 “Possible Side Effects”). Your doctor will inform you if you have previously experienced this condition.
If you have low levels of sodium in the blood, as this condition may occur as a result of treatment with Sertraline TecniGen. You should also inform your doctor if you are taking certain medicines for hypertension, as these medicines may also alter sodium levels in the blood.
Pay particular attention if you are elderly, as you may be at increased risk of low sodium levels in the blood (see above).
Liver disease: your doctor may decide to prescribe a lower dose of Sertraline TecniGen.
Diabetes: blood glucose levels may be altered by treatment with Sertraline TecniGen, and it may be necessary to adjust the dose of your diabetes medicines.
If you have had bleeding problems or are taking medicines that thin the blood (e.g., acetylsalicylic acid (aspirin) or warfarin) or that may increase the risk of bleeding, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
If you are a child or adolescent under 18 years of age. Sertraline TecniGen should only be used to treat children and adolescents aged 6 to 17 years suffering from obsessive-compulsive disorder. If you are being treated for this disorder, your doctor will monitor you closely (see below “Children and adolescents”).
If you are undergoing electroconvulsive therapy (ECT).
If you have eye problems, such as certain types of glaucoma (increased pressure inside the eye).

Medicines such as Sertraline TecniGen (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
Restlessness/Akathisia
The use of sertraline has been associated with distressing restlessness and an urge to move, often accompanied by an inability to sit or stand still (akathisia). This condition is more likely to occur during the first weeks of treatment. Increasing the dose may be harmful; therefore, if you experience such symptoms, you should contact your doctor.
Withdrawal reaction
Undesirable effects related to stopping treatment (withdrawal reactions) are common, especially if treatment is stopped abruptly (see section 3 “If you stop taking Sertraline TecniGen” and section 4 “Possible side effects”). The risk of withdrawal reactions depends on the duration of treatment, the dose, and the extent of dose reduction. Generally, these symptoms are mild to moderate in intensity. However, in some patients, they may be severe. They usually occur within the first few days after stopping treatment. In general, these symptoms resolve on their own within 2 weeks. In some patients, they may last longer (2–3 months or more). When stopping treatment with sertraline, it is recommended to gradually reduce the dose over several weeks or 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 or killing yourself. These thoughts may worsen when starting antidepressants, as all these medicines take time to become effective, usually about 2 weeks but sometimes longer.
You are more likely to have such thoughts if:

you have previously had thoughts of harming or killing yourself
you are a young adult. Available data from clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric conditions treated with an antidepressant.

If at any time you have thoughts of harming or killing yourself, contact your doctor or go immediately to the nearest hospital.
It may be helpful to inform a family member or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them to observe whether your depression or anxiety disorder is worsening or whether they are concerned about changes in your behaviour.
Children and adolescents
Sertraline should not routinely be used in children and adolescents under 18 years of age, except for patients with Obsessive-Compulsive Disorder. Patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, self-harm or suicidal thoughts, and hostile behaviour (mainly aggression, oppositional behaviour and anger) when treated with this class of medicines. However, your doctor may decide to prescribe Sertraline TecniGen to a patient under 18 years of age if this is in the patient’s best interest. If your doctor has prescribed Sertraline TecniGen to a patient under 18 years of age and you wish to discuss this decision, please contact your doctor.
Furthermore, if any of the symptoms listed above develop or worsen while you are taking Sertraline TecniGen, you must inform your doctor. Finally, the long-term safety of Sertraline TecniGen on growth, maturation, learning ability (cognitive development), and behavioural development in this age group has not yet been established.
Other medicines and Sertraline TecniGen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect the activity of Sertraline TecniGen, or Sertraline TecniGen may reduce the effectiveness of other medicines taken simultaneously.
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Taking Sertraline TecniGen with the following medicines may cause serious side effects:

Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (for treating depression), selegiline (for treating Parkinson’s disease), and the antibiotic linezolid. Do not use Sertraline TecniGen together with these medicines.
Medicines for treating mental disorders such as psychosis (pimozide). Do not use Sertraline TecniGen together with pimozide.

Inform your doctor if you are taking any of the following medicines:

Herbal remedy containing St. John’s wort (Hypericum perforatum). The effects of St. John’s wort may last for 1–2 weeks.
Products containing the amino acid tryptophan.
Medicines for treating severe pain (e.g., tramadol).
Medicines used in anaesthesia or for treating chronic pain (fentanyl).
Medicines for treating migraine (e.g., sumatriptan).
Medicines to thin the blood (warfarin).
Medicines for treating pain/arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
Sedatives (diazepam).
Diuretics
Medicines for treating epilepsy (phenytoin).
Medicines for treating diabetes (tolbutamide).
Medicines for treating excess stomach acid and ulcers (cimetidine).
Medicines for treating mania and depression (lithium).
Other medicines for treating depression (such as amitriptyline, nortriptyline).
Medicines for treating schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
Medicines used to regulate heart rate and rhythm (such as flecainide, propafenone).

Sertraline TecniGen with food, drinks and alcohol
Sertraline TecniGen tablets may be taken with or without food.
Alcohol consumption should be avoided during treatment with Sertraline TecniGen.
Sertraline should not be taken together with grapefruit juice, as it may increase sertraline levels in the body.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of sertraline in pregnant women has not been fully established. Sertraline should be given to pregnant women only if your doctor considers that the benefit to the mother outweighs any possible risk to the fetus. If you are a woman of childbearing age, you should use an adequate method of contraception (such as oral contraceptives) during treatment with sertraline.
If you take Sertraline TecniGen near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed easily). Inform your treating doctor or midwife that you are taking Sertraline TecniGen, so they can advise you on what to do.
Ensure that your midwife and/or doctor know that you are being treated with Sertraline TecniGen. If taken during pregnancy, particularly during the last 3 months of pregnancy, medicines such as Sertraline TecniGen 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 the baby’s birth. If this happens to your baby, you must contact your midwife and/or doctor immediately.
The newborn may also experience other conditions that generally occur within the first 24 hours after birth. Symptoms include:

breathing difficulties,
bluish, too hot, or too cold skin,
blue lips,
vomiting or inability to feed properly,
feeling very tired, inability to sleep or excessive crying,
stiff or floppy muscles,
tremors, nervousness or seizures,
increased reflex responses,
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, contact your doctor or midwife for advice.
There is evidence that sertraline is excreted in breast milk. Sertraline should be used during breastfeeding only if your doctor considers that the benefit outweighs any possible risk to the infant.
In animal studies, some medicines such as sertraline may reduce sperm quality.
Theoretically, this may affect fertility, but the impact on human fertility has not yet been observed.
Driving and using machines
Psychotropic medicines such as sertraline may affect your ability to drive or operate machinery. Therefore, you should not drive or operate machinery until you know how this medicine affects your ability to perform these activities.

3. HOW TO TAKE SERTRALINE TECNIGEN

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Sertraline TecniGen tablets can be taken with or without food.
Take the medicine once daily, in the morning or in the evening.
If you have any doubts, consult your doctor or pharmacist.

Recommended dose:
Adults:
Depression and Obsessive-Compulsive Disorder (OCD)
For depression and OCD, the usual effective dose is 50 mg/day. 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/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 start at a dose of 25 mg/day, which should then be increased to 50 mg/day after one week. The daily dose may then be increased in increments of 50 mg over several weeks. The maximum recommended dose is 200 mg/day.

Use in children and adolescents:
Sertraline TecniGen should only be used for the treatment of children and adolescents aged 6 to 17 years with Obsessive-Compulsive Disorder (OCD).

Obsessive-Compulsive Disorder
Children aged 6–12 years: the recommended starting dose is 25 mg once daily. After one week, the doctor may increase the dose to 50 mg once daily. The maximum dose is 200 mg once daily.
Adolescents aged 13–17 years: the recommended starting dose is 50 mg/day. The maximum dose is 200 mg/day.

If you have liver or kidney problems, inform your doctor and follow the instructions provided.
Your doctor will tell you how long you should take this medicine. This depends on the nature of your illness and your response to treatment. It may take several weeks before symptoms begin to improve. Treatment for depression should generally continue for 6 months after improvement is observed.

The tablet may be divided into equal parts.

If you take more Sertraline TecniGen than you should
If you accidentally take too much Sertraline TecniGen, contact your doctor immediately or go to the nearest emergency department. Always carry the medicine pack with its label, whether or not it still contains medicine.
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 Sertraline TecniGen
If you forget to take a dose, do not take the missed dose. Take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Sertraline TecniGen
Do not stop taking Sertraline TecniGen unless your doctor tells you to. Your doctor may want to gradually reduce the dose of Sertraline TecniGen over several weeks before stopping the medicine completely. If you stop taking this medicine suddenly, you may experience unwanted effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, feeling unwell, vomiting, and tremor. If you experience any of these unwanted effects, or any other side effects during treatment with Sertraline TecniGen, speak to your doctor.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Nausea is the most common adverse reaction. Adverse reactions are dose-dependent and often transient with continued treatment.

Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they may be serious:

If you develop a severe skin reaction causing blistering (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. In such cases, your doctor will discontinue treatment.
Allergic reactions or allergies, which may include symptoms such as itchy rash, breathing difficulties, wheezing, swelling of the eyelids, face, or lips.
If you experience agitation, confusion, diarrhea, high fever, high blood pressure, excessive sweating, and rapid heartbeat. These are symptoms of Serotonin Syndrome. In rare cases, this syndrome may occur when certain medicines are taken together with sertraline. Your doctor may decide to discontinue treatment.
If you develop 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 you begin to feel inner restlessness and are unable to sit or stand still after starting treatment with Sertralina TecniGen. You must inform your doctor if you start feeling restless.
If you have a seizure (convulsion).
If you experience a manic episode (see section 2 “Warnings and precautions”).

The following adverse reactions have been observed in clinical trials conducted in adult patients.

Very common adverse reactions (occur in more than 1 in 10 patients):
insomnia, dizziness, drowsiness, headache, diarrhea, nausea, dry mouth, ejaculation failure, fatigue.

Common adverse reactions (occur in 1 to 10 in 100 patients):

sore throat, loss of appetite, increased appetite;
depression, feeling strange, nightmares, anxiety, agitation, nervousness, reduced sexual interest, teeth grinding;
numbness and tingling, tremors, muscle tension, altered taste, lack of attention;
visual disturbances, ringing in the ears;
palpitations, hot flushes, yawning;
abdominal pain, vomiting, constipation, stomach discomfort, gas in the stomach;
skin rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, chest pain.

Uncommon adverse reactions (occur in 1 to 10 in 1,000 patients):

cold feeling in the chest, runny nose;
hallucinations, feeling excessively happy, lack of personal care, altered thinking;
seizures, involuntary muscle contractions, coordination disturbances, excessive movements, amnesia, reduced sensation, speech disorders, dizziness upon standing, migraine;
ear pain, rapid heartbeat, high blood pressure, facial flushing;
breathing difficulties, possible wheezing, shortness of breath, nosebleeds;
esophagitis, difficulty swallowing, hemorrhoids, increased salivation, tongue disorders, belching;
eye swelling, development of red spots on the skin, hair loss, cold sweats, dry skin, urticaria;
osteoarthritis, muscle weakness, back pain, muscle cramps;
nocturia, inability to urinate, increased urine volume, increased frequency of urination, urinary problems;
vaginal bleeding, female sexual dysfunction, malaise, chills, fever, weakness, thirst, weight loss, weight gain.

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Rare adverse reactions (occur in 1 to 10 in 10,000 patients):

intestinal problems, ear infections, cancer, swollen glands, elevated cholesterol levels, low blood sugar levels;
physical symptoms due to stress or emotions, drug dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation;
coma, abnormal movements, difficulty moving, increased sensation, sensorial disturbances;
glaucoma, tear problems, development of spots on the eye, double vision, light sensitivity, presence of blood in the eye, pupil dilation;
heart attack, slow heartbeat, heart problems, poor blood circulation to arms and legs, tightness in the throat, rapid breathing, slow breathing, difficulty speaking, hiccups;
blood in stools, sore throat, tongue ulceration, dental disorders, tongue problems, mouth ulceration, liver function problems;
skin problems with blister formation, inflammation of hair follicles, changes in hair structure, altered skin odor, bone disorders;
reduced urination, urinary incontinence, hesitation in urination;
excessive vaginal bleeding, dryness of the vaginal area, red and painful penis and foreskin, genital discharge, prolonged erection, breast secretion;
hernia, scar tissue formation at injection site, reduced drug tolerance, difficulty walking, abnormal laboratory tests, altered seminal fluid, wounds, blood vessel dilation;
cases of suicidal ideation or suicidal behaviour have been reported during treatment with sertraline or immediately after discontinuation of treatment (see section 2);
development of spots on the eye, glaucoma, double vision (diplopia), sensitivity to light (photophobia), collection of blood in the anterior chamber of the eye (hyphaema), pupils of unequal size, abnormal vision, altered tear production.

Adverse reactions with unknown frequency:

partial loss of vision;
inflammation of the colon (causing diarrhea);
heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see section 2, Pregnancy, breastfeeding and fertility, for further information.

The following adverse reactions have been reported during post-marketing experience with sertraline:

decreased number of white blood cells, decreased number of blood clotting cells, low levels of thyroid hormones, endocrine problems, low levels of sodium in the blood, problems controlling blood sugar levels (diabetes), increased blood sugar levels;
altered, frightening dreams, suicidal behaviour;
movement disorders (such as frequent movements, tense muscles, difficulty walking and stiffness, spasms and involuntary muscle movements), fainting, severe sudden headache (which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS));
altered vision, bleeding problems (such as nosebleeds, stomach bleeding, or blood in urine), pancreatitis, severe liver function problems, yellowing of the skin and eyes (jaundice);
skin edema, skin reaction to sunlight, itching, joint pain, muscle cramps, breast enlargement, menstrual irregularities, leg swelling, coagulation problems, and severe allergic reactions.

Adverse reactions in children and adolescents
In clinical studies in children and adolescents, adverse reactions were generally similar to those observed in adults (see above). The most common adverse reactions in children and adolescents were headache, insomnia, diarrhea, and feeling unwell.
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Symptoms that may occur when treatment is discontinued
If you stop treatment with this medicine abruptly, you may experience adverse reactions such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, feeling unwell, vomiting, and tremor (see section 3 “If you stop taking Sertralina TecniGen”).

An increased risk of bone fractures has been observed in patients taking this type of medicine.

If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE 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 pack after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Sertralina TecniGen contains

The active substance is sertraline (as hydrochloride). Each coated tablet of Sertralina TecniGen contains 50 mg of sertraline.
The other excipients are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate (Type A), anhydrous colloidal silicon dioxide, magnesium stearate (tablet core) and polyvinyl alcohol, titanium dioxide (E171), macrogol/PEG 300 and talc (tablet coating).

Description of the appearance of Sertralina TecniGen and pack contents
Sertralina TecniGen 50 mg are film-coated tablets packed in blisters.
Sertralina TecniGen 50 mg is available in packs of 15 and 30 tablets.
Marketing Authorization Holder
TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande 2, Abrunheira
2710-089 Sintra (Portugal)
Sales Concessionaire:
TECNIGEN S.r.l.
Via Galileo Galilei 40
20092 Cinisello Balsamo (MI)
Manufacturers responsible for batch release
9/23
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira
2710-089 Sintra
Portugal
This patient information leaflet was last approved on
10/23

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sertraline TecniGen 100 mg film-coated tablets

Generic medicinal product
Please read this entire leaflet carefully before taking this medicine as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist or nurse.

Contents of this leaflet:

What Sertraline TecniGen is and what it is used for
What you need to know before taking Sertraline TecniGen
How to take Sertraline TecniGen
Possible side effects
How to store Sertraline TecniGen
Contents of the pack and other information

1. WHAT SERTRALINA TECNIGEN IS AND WHAT IT IS USED FOR

Sertralina TecniGen contains the active substance sertraline. 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 to 17 years).

Depression is a clinical illness with symptoms such as feeling sad, inability to sleep properly, or inability to enjoy life as one used to.
11/23
OCD and panic disorder are anxiety-related conditions with symptoms such as persistent, intrusive worries (obsessions) that lead to repetitive ritualistic behaviors (compulsions).
PTSD is a condition that may occur after a strongly traumatic emotional 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 stress in social situations (e.g., speaking to strangers, speaking in public, eating or drinking in front of others, or fear of behaving in an embarrassing way).
Your doctor has determined that this medicine is suitable for treating your condition.
You should consult your doctor if you are unsure why Sertralina TecniGen has been prescribed for you.

2. WHAT YOU SHOULD 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 drugs with similar action 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 2 weeks before starting treatment with sertraline.
if you are taking another medicine called pimozide (a medicine used for mental disorders such as psychosis).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Sertraline TecniGen.
Medicines are not always suitable for everyone. Inform your doctor before taking Sertraline TecniGen
if you suffer or have previously suffered from any of the following conditions:

Epilepsy or history of seizures. If you experience a seizure (convulsions), contact your doctor immediately.
If you have suffered from manic-depressive disorders (bipolar disorders) or schizophrenia. In case of a manic episode, contact your doctor immediately.
If you have thoughts of harming or killing yourself (see below – Suicidal thoughts and worsening of depression or anxiety disorder).

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Serotonin syndrome. In rare cases, this syndrome may occur when taking certain medicines together with sertraline (for symptoms, see section 4 “Possible Side Effects”). Your doctor will inform you if you have previously experienced this condition.
If you have low levels of sodium in the blood, as this condition may occur as a result of treatment with Sertraline TecniGen. You should also inform your doctor if you are taking certain medicines for high blood pressure, as these medicines may also alter sodium levels in the blood.
Pay special attention if you are elderly, as you may be at increased risk of low sodium levels in the blood (see above).
Liver disease: your doctor may decide to prescribe you a lower dose of Sertraline TecniGen.
Diabetes: blood glucose levels may be affected by treatment with Sertraline TecniGen, and it may be necessary to adjust the dose of your diabetes medicines.
If you have experienced bleeding problems or have taken medicines that thin the blood (e.g. acetylsalicylic acid (aspirin) or warfarin) or that may increase the risk of bleeding, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
If you are a child or adolescent under 18 years of age. Sertraline TecniGen should only be used to treat children and adolescents aged 6 to 17 years suffering from obsessive-compulsive disorder. If you are being treated for this disorder, your doctor will want to monitor you closely (see below “Children and adolescents”).
If you are undergoing electroconvulsive therapy (ECT).
If you have eye problems, such as certain types of glaucoma (increased pressure inside the eye).

Medicines such as Sertraline TecniGen (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
Restlessness/Akathisia
Use of sertraline has been associated with anxious restlessness and a need to move, often accompanied by an inability to sit still or remain motionless (akathisia). This condition is more likely to occur during the first weeks of treatment. Increasing the dose may be harmful; therefore, if you experience such symptoms, you should contact your doctor.
Withdrawal reaction
Undesirable effects related to stopping treatment (withdrawal reactions) are common, especially if treatment is stopped abruptly (see section 3 “If you stop taking Sertraline TecniGen” and section 4 “Possible side effects”). The risk of withdrawal reactions depends on the duration of treatment, the dose, and the extent of dose reduction. Generally, these symptoms are mild to moderate in intensity. However, in some patients, they may be severe. They usually occur within the first few days after stopping treatment. In general, these symptoms resolve spontaneously within 2 weeks. In some patients, they may last longer (2–3 months or more). When discontinuing treatment with sertraline, it is recommended to gradually reduce the dose over a period of several weeks or months. You should always discuss with your doctor the best way to stop treatment.
Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or have anxiety disorders, you may sometimes think about harming or killing yourself.
These thoughts may worsen when you first start taking antidepressants, as all these medicines require some time before they become effective, usually about 2 weeks but sometimes longer.
You are more likely to have such thoughts:

if you have previously thought about harming or killing yourself
if you are a young adult. Available data from clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric conditions treated with an antidepressant.

If at any time you think about harming or killing yourself, contact your doctor or go immediately to the nearest hospital.
It may be helpful to inform a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them to observe whether your depression or anxiety disorder is worsening, or whether they are concerned about changes in your behaviour.
Children and adolescents
Sertraline should not normally be used in children and adolescents under 18 years of age, except for patients with Obsessive-Compulsive Disorder. Patients under 18 years of age have an increased risk of adverse effects, such as suicide attempts, self-harm or suicidal thoughts, and hostile behaviour (mainly aggression, oppositional behaviour and anger) when treated with this class of medicines. However, your doctor may decide to prescribe Sertraline TecniGen to a patient under 18 years of age if this is in the patient’s best interest. If your doctor has prescribed Sertraline TecniGen to a patient under 18 years of age and you wish to discuss this decision, please contact your doctor.
Moreover, if any of the symptoms listed above develop or worsen while you are taking Sertraline TecniGen, you must inform your doctor. Finally, the long-term safety of Sertraline TecniGen on growth, maturation, learning ability (cognitive development), and behavioural development in this age group has not yet been established.
Other medicines and Sertraline TecniGen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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Some medicines may affect the activity of Sertraline TecniGen, or Sertraline TecniGen may reduce the effectiveness of other medicines taken simultaneously.
Taking Sertraline TecniGen together with the following medicines may cause serious side effects:

Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression), selegiline (used to treat Parkinson’s disease), and the antibiotic linezolid. Do not use Sertraline TecniGen together with these medicines.
Medicines used to treat mental disorders such as psychosis (pimozide). Do not use Sertraline TecniGen together with pimozide.

Inform your doctor if you are taking any of the following medicines:

Herbal medicine containing St. John’s wort (Hypericum perforatum). The effects of St. John’s wort may last for 1–2 weeks.
Products containing the amino acid tryptophan.
Medicines used to treat severe pain (e.g. tramadol).
Medicines used in anaesthesia or for treatment of chronic pain (fentanyl).
Medicines used to treat migraine (e.g. sumatriptan).
Medicines used to thin the blood (warfarin).
Medicines used to treat pain/arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
Sedatives (diazepam).
Diuretics
Medicines used to treat epilepsy (phenytoin).
Medicines used to treat diabetes (tolbutamide).
Medicines used to treat excess stomach acid and ulcers (cimetidine).
Medicines used to treat mania and depression (lithium).
Other medicines used to treat depression (such as amitriptyline, nortriptyline).
Medicines used to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine and olanzapine).
Medicines used to regulate heart rate and rhythm (such as flecainide, propafenone).

Sertraline TecniGen with food, drinks and alcohol
Sertraline TecniGen tablets can be taken with or without food.
Alcohol consumption should be avoided during treatment with Sertraline TecniGen.
Sertraline should not be taken together with grapefruit juice, as it may increase sertraline levels in the body.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
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The safety of sertraline in pregnant women has not been fully established. Sertraline should be given to pregnant women only if your doctor considers that the benefit to the mother outweighs any possible risk to the fetus. If you are a woman of childbearing age, you should use an adequate method of contraception (such as the contraceptive pill) during treatment with sertraline.
If you take Sertraline TecniGen near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (a tendency to bleed easily). Inform your doctor or midwife that you are taking Sertraline TecniGen so they can advise you on what to do.
Ensure that your midwife and/or doctor know that you are being treated with Sertraline TecniGen. If taken during pregnancy, particularly during the last 3 months of pregnancy, medicines such as Sertraline TecniGen 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.
The newborn may also experience other conditions that generally occur within the first 24 hours after birth. Symptoms include:

breathing difficulties
bluish, too hot, or too cold skin
blue lips
vomiting or inability to feed properly
extreme tiredness, inability to sleep, or excessive crying
stiff or floppy muscles
tremors, restlessness, or seizures
increased reflex responses
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, contact your doctor or midwife for advice.
There is evidence that sertraline is excreted in breast milk. Sertraline should be used during breastfeeding only if your doctor considers that the benefit outweighs any possible risk to the baby.
In animal studies, some medicines such as sertraline may reduce sperm quality.
In theory, this could affect fertility, but the impact on human fertility has not yet been observed.
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Driving and using machines
Psychotropic medicines such as sertraline may affect your ability to drive or operate machinery. Therefore, you should not drive or operate machinery until you know how this medicine affects your ability to perform these activities.

3. HOW TO TAKE SERTRALINE TECNIGEN

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Sertraline TecniGen tablets can be taken with or without food.
Take the medicine once daily, in the morning or in the evening.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults:
Depression and Obsessive-Compulsive Disorder (OCD)
For depression and OCD, the usual effective dose is 50 mg/day. 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/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 begin
at a dose of 25 mg/day, which should then be increased to 50 mg/day after one week.
The daily dose may then be increased in increments of 50 mg over several weeks. The maximum
recommended dose is 200 mg/day.
Use in children and adolescents:
Sertraline TecniGen should only be used for the treatment of children and adolescents aged 6 to 17
years with Obsessive-Compulsive Disorder (OCD).
Obsessive-Compulsive Disorder (OCD)
Children aged 6–12 years: the recommended starting dose is 25 mg daily.
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After one week, your doctor may increase the dose to 50 mg daily. The maximum dose is 200 mg daily.
Adolescents aged 13–17 years: the recommended starting dose is 50 mg/day. The maximum dose is
200 mg/day.
If you have liver or kidney problems, inform your doctor and follow the instructions provided.
Your doctor will tell you how long you should take this medicine. This depends on the nature of your
condition and your response to treatment. It may take several weeks before symptoms begin to improve.
Treatment for depression should generally continue for 6 months after improvement is observed.
The tablet may be divided into equal parts.
If you take more Sertraline TecniGen than you should
If you accidentally take an excessive dose of Sertraline TecniGen, contact your doctor immediately or
go to the nearest emergency department. Always carry the medicine pack with its label, whether or not
it still contains medicine.
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 Sertraline TecniGen
If you forget to take a dose, do not take the missed dose. Take the next dose at the scheduled time.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Sertraline TecniGen
Do not stop treatment with Sertraline TecniGen unless your doctor tells you to.
Your doctor may wish to gradually reduce the dose of Sertraline TecniGen over several weeks before
completely stopping treatment. If you stop taking this medicine suddenly, you may experience
undesirable effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache,
feeling unwell, vomiting, and tremor. If you experience any of these undesirable effects, or any other
side effects during treatment with Sertraline TecniGen, talk to your doctor.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
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4. POSSIBLE ADVERSE REACTIONS

Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they may be serious:

If you develop a severe skin reaction causing blistering (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. In such cases, your doctor will discontinue treatment.
Allergic reactions or allergies, which may include symptoms such as itchy rash, breathing difficulties, wheezing, swelling of the eyelids, face, or lips.
If you experience agitation, confusion, diarrhea, high fever and high blood pressure, excessive sweating, and rapid heartbeat. These are symptoms of Serotonin Syndrome. In rare cases, this syndrome may occur when certain medicines are taken together with sertraline. Your doctor may decide to discontinue treatment.
If you develop 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 you begin to feel inner restlessness and are unable to sit or stand still after starting treatment with Sertralina TecniGen. You must inform your doctor if you start feeling restless.
If you have a seizure (convulsion).
If you experience a manic episode (see section 2 “Warnings and precautions”).

The following adverse reactions have been observed in clinical studies conducted in adult patients.

Very common adverse reactions (occur in more than 1 in 10 patients):
insomnia, dizziness, drowsiness, headache, diarrhea, nausea, dry mouth, ejaculation failure, fatigue.

Common adverse reactions (occur in 1 to 10 in 100 patients):

sore throat, anorexia, increased appetite;
depression, feeling strange, nightmares, anxiety, agitation, nervousness, reduced sexual interest, teeth grinding;
numbness and tingling, tremor, muscle tension, altered taste, lack of attention;
visual disturbances, tinnitus;
palpitations, hot flushes, yawning;
abdominal pain, vomiting, constipation, stomach discomfort, gas in the stomach;
rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, chest pain.

Uncommon adverse reactions (occur in 1 to 10 in 1,000 patients):

cold chest, runny nose;
hallucinations, feeling excessively happy, lack of personal care, altered thoughts;
seizures, involuntary muscle contractions, coordination disturbances, excessive movements, amnesia, reduced sensations, speech disorders, dizziness upon standing, migraine;
ear pain, rapid heartbeat, high blood pressure, facial flushing;
breathing difficulties, possible wheezing, shortness of breath, nosebleeds;
esophagitis, difficulty swallowing, hemorrhoids, increased salivation, tongue disorders, belching;
eye swelling, red spots on the skin, hair loss, cold sweats, dry skin, urticaria;
osteoarthritis, muscle weakness, back pain, muscle cramps;
nocturia, inability to urinate, increased urine volume, increased urinary frequency, urinary difficulties;
vaginal bleeding, female sexual dysfunction, malaise, chills, fever, weakness, thirst, weight loss, weight gain.

Rare adverse reactions (occur in 1 to 10 in 10,000 patients):

intestinal problems, ear infections, cancer, gland swelling, elevated cholesterol levels, low blood sugar levels;
physical symptoms due to stress or emotions, drug dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation;
coma, abnormal movements, movement difficulties, increased sensations, sensory disturbances;
glaucoma, tearing problems, red spots on the eye, double vision, light sensitivity (photophobia), blood in the anterior chamber of the eye (hyphaema), unequal pupil size, abnormal vision, altered tearing;
heart attack, slow heartbeat, heart problems, poor blood circulation to arms and legs, tight throat, rapid breathing, slow breathing, speech difficulties, hiccups;
blood in stools, sore throat, tongue ulceration, dental problems, tongue problems, mouth ulceration, liver function disorders;
skin problems with blistering, inflammation of hair follicles, changes in hair structure, altered skin odor, bone disorders;
reduced urination, urinary incontinence, urinary hesitation;
excessive vaginal bleeding, dryness of the vaginal area, red and painful penis and foreskin, genital discharge, prolonged erection, breast secretion;
hernia, scar tissue formation at injection site, reduced drug tolerance, walking difficulties, laboratory test abnormalities, altered seminal fluid, wounds, blood vessel dilation.
Cases of suicidal ideation or behaviour have been reported during treatment with sertraline or immediately after discontinuation of treatment (see section 2);
spots on the eye, glaucoma, double vision (diplopia), light sensitivity (photophobia), blood collection in the anterior chamber of the eye (hyphaema), unequal pupil size, abnormal vision, altered tearing.

Adverse reactions with unknown frequency:

partial loss of vision;
inflammation of the colon (causing diarrhea);
heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, Pregnancy, breastfeeding and fertility, for further information.

The following adverse reactions have been reported during post-marketing experience with sertraline:

reduced number of white blood cells, reduced number of blood clotting cells (platelets), low levels of thyroid hormones, endocrine problems, low levels of salt in the blood, problems controlling blood sugar levels (diabetes), increased blood sugar levels;
disturbing nightmares, suicidal behaviour;
movement disorders (such as frequent movements, muscle tension, walking difficulties and stiffness, spasms and involuntary muscle movements), fainting, severe sudden headache (which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS));
altered vision, bleeding problems (such as nosebleeds, stomach bleeding or blood in urine), pancreatitis, severe liver function problems, yellowing of the skin and eyes (jaundice);
skin swelling (angioedema), skin reaction to sunlight, itching, joint pain, muscle cramps, breast enlargement, menstrual irregularities, leg swelling, coagulation problems, and severe allergic reactions.

Symptoms that may occur when treatment is discontinued
If you stop treatment with this medicine abruptly, you may experience adverse reactions such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, malaise, vomiting, and tremor (see section 3 “If you stop taking Sertralina TecniGen”).

An increased risk of bone fractures has been observed in patients taking this type of medicine.

If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.

5. HOW TO STORE 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 packaging after "Exp." The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Sertralina TecniGen contains

The active substance is sertraline (as hydrochloride). Each coated tablet of Sertralina TecniGen contains 100 mg of sertraline.
The other excipients are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate (Type A), anhydrous colloidal silica, magnesium stearate (tablet core), and polyvinyl alcohol, titanium dioxide (E171), macrogol/PEG 300, and talc (tablet coating).

Description of the appearance of Sertralina TecniGen and pack contents
Sertralina TecniGen 100 mg are film-coated tablets supplied in blisters.
Sertralina TecniGen 100 mg is available in packs containing 15 and 30 tablets.
Marketing Authorisation Holder
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TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande 2, Abrunheira
2710-089 Sintra (Portugal)
Sales Licence Holder:
TECNIGEN S.r.l.
Via Galileo Galilei 40
20092 Cinisello Balsamo (MI)
Responsible manufacturers for batch release
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira
2710-089 Sintra
Portugal
This summary of product characteristics was last approved on
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