Sertraline: full package insert, how to take, contraindications, side effects.

The information presented here was taken directly from the original package insert for the medicine., ensuring data accuracy and reliability.

This guide has been designed to provide you with a clear and simplified understanding of the use, indications, contraindications and precautions required when using this medicine.

Read carefully and if you have any questions, do not hesitate to consult your doctor or pharmacist.

What is Sertraline used for?

Sertraline hydrochloride coated tablets are indicated for adult use in the following treatments:

• Symptoms of depression, including when accompanied by anxiety, in patients with or without a history of mania;
• Panic disorder: helps reduce the frequency and intensity of panic attacks;
• Post-traumatic stress disorder (PTSD): reduces PTSD symptoms such as flashbacks and intense anxiety;
• Social phobia or social anxiety disorder: reduces anxiety in social situations and excessive fear of being judged or observed.;
• (STPM) Symptoms of premenstrual syndrome or/and premenstrual dysphoric disorder.

Additionally, sertraline hydrochloride coated tablets are indicated for use in adults and children over 6 years of age in the treatment of obsessive-compulsive disorder (OCD).

How does it work?

Sertraline hydrochloride coated tablets act on a substance in the brain called serotonin, increasing its availability. This helps to alleviate the symptoms of depression and anxiety, which are common in the disorders for which it is indicated.

The effects of sertraline hydrochloride begin to be noticed in about 7 days.

Mechanism of action:

• Increased Serotonin: Sertraline “blocks” serotonin from being reabsorbed by neurons, which means more serotonin becomes available at the synapses (connections between neurons). This helps improve communication between nerve cells and stabilizes mood.
• Symptom Relief: By increasing serotonin levels, sertraline alleviates symptoms of depression and anxiety, as well as helping to control the symptoms of other disorders for which it is indicated.

Action time:

Complete Answer: In some cases, it may take a few weeks for the full therapeutic effects to be seen.

Onset of Effect: Sertraline begins to act in approximately 7 days, but the time needed to observe clinical improvement may vary according to the individual characteristics of the patient and the type of disorder being treated.

However, the time required to observe clinical improvement may vary, depending on the patient's characteristics and the type of disorder being treated.

When should I not use it?

Allergy: Do not use sertraline hydrochloride if you have a history of allergy to sertraline or any other component of the formula.

Monoamine Oxidase Inhibitors (MAOIs): Do not use this medicine if you are taking antidepressants known as monoamine oxidase inhibitors.

Pimozide: Avoid using this medicine if you are using pimozide.

Pregnancy: This medicine should not be used by pregnant women without the guidance of a doctor or dentist.

What should I know before using?

Always tell your doctor about all the medications you are taking when you receive a new prescription. This is crucial so that he or she can assess possible interactions between medications that may alter their action.

Serotonin syndrome and neuroleptic malignant syndrome

The use of medications that increase the availability of serotonin, such as sertraline hydrochloride coated tablets, can cause serotonin syndrome and neuroleptic malignant syndrome.

Serotonin syndrome may include changes in mental status and movement. Neuroleptic malignant syndrome may involve severe muscle twitching, fever, increased heart rate, electrocardiogram changes, and tremors.

The risk of these syndromes is greater when sertraline is combined with other medications that increase serotonin.

Other drugs that increase serotonin

Medications that can increase serotonin include:

• Monoamine oxidase inhibitors (MAOIs), such as selegiline, moclobemide, linezolid, and methylene blue.
• Some antipsychotics and dopamine antagonists.
• Amphetamines, tryptophans, fenfluramine, fentanyl and its analogues, tramadol, dextromethorphan, tapentadol, pethidine, methadone, pentazocine and St. John's wort.

Tell your doctor if you are taking any of these or any other medications.

Sertraline and Dipyrone

The combination of sertraline with dipyrone may reduce sertraline blood concentrations, decreasing its effectiveness. Therefore, caution and monitoring of clinical response and/or drug levels as necessary are recommended.

Replacement of antidepressants

If you are being treated with another antidepressant, do not switch to sertraline hydrochloride without first consulting a doctor.

Monitoring glucose levels

Diabetic patients should be carefully monitored for blood glucose levels, as sertraline may cause changes in these levels. Tell your doctor if you have diabetes.

False positive results in urine tests

There have been reports of false-positive results in urine tests for benzodiazepines in patients taking sertraline, due to the lack of specificity of the tests.

These false-positive results may occur for several days after stopping sertraline treatment. Other confirmatory tests can detect sertraline in urine.

Sexual dysfunction

Medications that are selective serotonin reuptake inhibitors, such as sertraline hydrochloride, can lead to symptoms of sexual dysfunction.

There are reports of long-lasting sexual dysfunction, even after discontinuation of these medications.

Risk of bone fractures

Studies show an increased risk of bone fractures in patients using sertraline, although the mechanism of this risk is not fully understood.

Glaucoma and mydriasis

Sertraline may cause mydriasis (pupil dilation) and should be used with caution in patients with closed-angle glaucoma or a history of glaucoma, as this dilation may increase intraocular pressure and cause closed-angle glaucoma, especially in predisposed patients.

Worsening symptoms of depression and suicidal thoughts

Patients and their families should be informed about the possibility of worsening symptoms of depression and suicidal thoughts, especially at the beginning of treatment or when changing the dose.

Tell your doctor if you have any other health problems.

Use in pregnant and lactating women

This medicine should not be used by pregnant women or during breastfeeding without medical advice.

Monitoring pediatric patients

Pediatric patients on long-term treatment should be monitored by physicians.

Ability to drive vehicles and operate machinery

Do not drive vehicles or operate machinery during treatment, as your ability and reaction capacity may be impaired.

Risk of falls and accidents

Use of this medicine may cause dizziness, fainting or loss of consciousness, increasing the risk of falls or accidents.

Communication with the doctor

Tell your doctor or dentist if you are taking any other medications.

Always tell your doctor about all the medications you are taking when you receive a new prescription. This is crucial so that he or she can assess possible interactions between medications that may alter their action.

How should I use this medicine?

Route of Administration: Take sertraline hydrochloride coated tablets orally once a day, in the morning or evening, with or without food. Preferably, take it at the same time each day.

Pediatric Patients (6 to 12 years): Treatment should start with 25 mg per day.

Pediatric Patients (over 12 years old): The starting dose should be 50 mg per day.

Maximum Dose: The maximum recommended dose is 200 mg per day.

Dose Adjustments: They must be done according to the clinical response, as per medical assessment and guidance.

Medical Guidance: Always follow your doctor's instructions, respecting the times, doses and duration of treatment.

Where, how and for how long can I store this medicine?

Storage: Store sertraline hydrochloride coated tablets at room temperature (between 15ºC and 30ºC) and protect it from moisture. Keep it in the original packaging.

Batch and Expiration Information: Check the batch number and manufacturing and expiration dates on the packaging. Do not use the medicine after the expiration date.

Note Before Use: Before using, check the appearance of the medicine. If it is within the expiration date but has changed in appearance, consult a pharmacist to find out if it can still be used.

All medicines must be kept out of the reach of children.

What to do if I forget to use it?

Missing a dose may compromise the effectiveness of the treatment.

If you forget to take sertraline hydrochloride at the scheduled time, take it as soon as you remember. However, if it is close to the time of your next dose, skip the missed dose and continue with your normal dosing schedule.

Do Not Take Double Dose: Do not take a double dose of the medicine to make up for a forgotten dose. If you have any questions, seek advice from your pharmacist, doctor or dentist.

Side effects

Very common reactions (occur in 101% of patients)

• Insomnia
• Dizziness
• Headache
• Diarrhea
• Nausea (feeling sick)

Common reactions (occur between 1% and 10% of patients)

• Decreased or increased appetite
• Symptoms of depression
• Anxiety
• Agitation
• Bruxism (teeth grinding)
• Nightmare
• Decreased sexual desire
• Hypertonia (increased muscle tension)
• Tremor (involuntary muscle contractions)
• Sleepiness
• Paresthesia
• Visual impairment
• Buzzing
• Palpitations
• Blush
• Yawn
• Vomiting
• Constipation
• Abdominal pain
• Dry mouth
• Dyspepsia (indigestion)
• Rash
• Hyperhidrosis (excessive sweating)
• Arthralgia (joint pain)
• Ejaculation disorders
• Sexual dysfunction
• Irregular menstruation
• Chest pain
• Discomfort
• Pyrexia (fever)
• Asthenia (weakness)
• Fatigue
• Weight gain

Uncommon reactions (occur between 0.1% and 1% of patients)

• Hypersensitivity (allergic reaction)
• Hallucination
• Aggressiveness
• Mental confusion
• Euphoria
• Syncope (fainting)
• Extrapyramidal disorders (coarse tremors, slow movements)
• Involuntary muscle contractions
• Hypoesthesia (decreased sensitivity)
• Hyperkinesia (excessive muscle activity)
• Migraine
• Mydriasis (dilation of the pupils)
• Periorbital edema (swelling around the eyes)
• Tachycardia (increased heart rate)
• Bleeding
• Hypertension (high blood pressure)
• Bronchospasm (contraction of the bronchi and bronchioles)
• Epistaxis (nosebleed)
• Gastrointestinal bleeding
• Increased alanine aminotransferase
• Increased aspartate aminotransferase (change in liver function)
• Urticaria
• Purpura (small purple spots on the skin or mucous membranes)
• Pruritus (itching)
• Alopecia (hair loss)
• Muscle spasms
• Trapped urine
• Hematuria (blood in the urine)
• loose urine
• Gait disorders
• Peripheral edema (swelling in the extremities of the body)
• Weight loss

Rare reactions (occur between 0.01% and 0.1% of patients)

• Fracture
• Thrombocytopenia (decrease in platelets)
• Leukopenia (reduction in the number of white blood cells)
• Abnormal platelet test
• Anaphylactoid reaction (severe allergic reaction)
• Inappropriate secretion of antidiuretic hormone
• Hyperprolactinemia (increased prolactin)
• Hypothyroidism (change in thyroid function)
• Diabetes mellitus
• Hyponatremia (decreased blood sodium levels)
• Hypoglycemia
• Hyperglycemia (decreased or increased blood sugar levels)
• Psychotic disorder (hallucination and delusion)
• Increased serotonin syndrome
• Eat
• Convulsion
• Dystonia (involuntary movements)
• Akathisia (feeling of restlessness)
• Torsades de pointes (severe arrhythmia)
• Cerebral vasoconstriction
• Eosinophilic pneumonia
• Pancreatitis (inflammation of the pancreas)
• Liver injury
• Toxic epidermal necrolysis
• Stevens-Johnson syndrome
• Angioedema (swelling of vascular origin)
• Exfoliative rash (red patches of flaking skin)
• Photosensitivity reaction (exaggerated sensitivity of the skin to light)
• Trismus (difficulty opening the mouth)
• Rhabdomyolysis
• Enuresis
• Priapism (prolonged and painful erection)
• Galactorrhea (milk secretion)
• Gynecomastia (enlarged breasts in men)
• Facial edema
• Drug withdrawal syndrome
• Abnormal laboratory test
• QT interval prolongation on electrocardiogram (electrocardiogram change)
• Increased blood cholesterol

Download the complete package insert

For more detailed information on the use of Sertraline hydrochloride, click the button below and download the complete package insert from each manufacturer:

Sources and bibliography:

This article was extracted from the original package insert from the manufacturer CIMED, in July 2024, under the technical supervision of the responsible pharmacist.

To check the leaflet of other brands, you can visit ANVISA electronic bulletin board and search for the manufacturer of your choice.

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