Package leaflet: Information for the user

SERTRALINA ALTER 50 mg film-coated tablets, 100 mg film-coated tablets

Sertraline
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 or pharmacist.
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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What SERTRALINA ALTER is and what it is used for

SERTRALINA ALTER 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 ALTER can be used to treat the following conditions:

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 one used to.
OCD and panic disorder are anxiety-related illnesses with symptoms such as persistent worrying
about intrusive thoughts (obsessions) leading to ritualistic behaviors (compulsions).
PTSD is a condition that may occur after a strongly traumatic experience, and some
symptoms of this condition are similar to those of depression and anxiety. Social anxiety disorder (social phobia)
is an anxiety-related illness. It is characterized by intense feelings of anxiety or distress in social
situations (e.g., speaking to strangers, speaking in public, eating or drinking in the presence of others, or fear of behaving in an embarrassing way).
Your doctor has determined that this medicine is suitable for treating your condition.
Ask your doctor if you are unsure why SERTRALINA ALTER has been prescribed for you.

2. What you should know before taking SERTRALINA ALTER

Do not take SERTRALINA ALTER:

If you are allergic to sertraline or to any of the other ingredients of this medicine (listed in section 6).
If you are currently taking or have recently taken medicines called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or medicines with MAOI-like activity (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. Do not take SERTRALINA ALTER if you are currently taking another medicine called pimozide (a medicine used for mental disorders such as psychosis).

Warnings and precautions.
Talk to your doctor or pharmacist before taking SERTRALINA ALTER.
Medicines such as SERTRALINA ALTER (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 have been observed to persist after discontinuation of treatment.
Medicines are not always suitable for everyone. Inform your doctor before taking SERTRALINA ALTER if you suffer or have previously suffered from any of the following conditions:

If you suffer from epilepsy (seizures) or have a history of convulsions. In case of a seizure (convulsion), 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 are having or have ever had thoughts of harming yourself or of suicide (see below - Suicidal thoughts and worsening of depression or anxiety disorder).
If you suffer from 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 advise you if you have previously experienced this condition.
If you have low sodium levels in the blood, as this condition may occur during treatment with SERTRALINA ALTER. You should also inform your doctor if you are taking certain medicines for high blood pressure, as these medicines may also alter blood sodium levels.
If you are elderly, as you are at higher risk of low sodium levels in the blood (see above).
If you have liver disease: your doctor may decide to prescribe you a lower dose of SERTRALINA ALTER.
If you have diabetes: blood glucose levels may be altered due to treatment with SERTRALINA ALTER, and it may be necessary to adjust the dose of your diabetes medicines.
If you have had bleeding problems or if you 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”). Children or adolescents under 18 years of age. SERTRALINA ALTER should only be used to treat children and adolescents aged 6 to 17 years suffering from obsessive-compulsive disorder (OCD). If a child or adolescent is being treated for this disorder, the doctor will want to monitor them closely (see below - Use in children and adolescents).
If you are undergoing electroconvulsive therapy (ECT).
If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
If you have been diagnosed with an abnormality in your electrocardiogram (ECG) known as QT interval prolongation.

Restlessness/Akathisia
The use of sertraline has been associated with distressing restlessness and an urge to move, often accompanied by an inability to sit still or remain motionless (akathisia). This condition is more likely to occur during the first few weeks of treatment. Increasing the dose may be harmful for patients who develop these symptoms; therefore, discuss this with 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 SERTRALINA ALTER” 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 stopping treatment with sertraline, it is recommended to gradually reduce the dose over several weeks or months. Always talk to your doctor to determine 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 about harming yourself or of suicide. These thoughts may worsen when starting antidepressants for the first time, as all these medicines require time before they become effective, usually about 2 weeks but sometimes longer.
You are more likely to have such thoughts if:

You have previously had thoughts of suicide or self-harm.
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 yourself or of suicide, 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 whether they think 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 (OCD). Patients under 18 years of age have a higher risk of adverse effects such as suicide attempts, thoughts of self-harm or suicide (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 SERTRALINA ALTER to a patient under 18 years of age if this is in the patient’s best interest. If your doctor has prescribed SERTRALINA ALTER to you and you are under 18 years of age and wish to discuss this decision with your doctor, please contact them. Furthermore, if any of the symptoms listed above appear or worsen while a patient under 18 years of age is being treated with SERTRALINA ALTER, you must inform the doctor.
Finally, the long-term safety of SERTRALINA ALTER on growth, maturation, learning ability (cognitive development), and behavioural development in this age group has not been established.
Other medicines and SERTRALINA ALTER
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 SERTRALINA ALTER, or SERTRALINA ALTER may reduce the effectiveness of other medicines taken simultaneously.
Taking SERTRALINA ALTER with the following medicines may cause serious adverse events:

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

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

Herbal medicines 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 the treatment of severe pain (e.g. tramadol).
Medicines used in anaesthesia or for the treatment of chronic pain (e.g. fentanyl).
Medicines for the treatment of migraine (e.g. sumatriptan).
Medicines to thin the blood (warfarin).
Medicines for the treatment of pain/arthritis (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
Sedatives (diazepam).
Diuretics.
Medicines for the treatment of epilepsy (phenytoin, phenobarbital, carbamazepine).
Medicines for the treatment of diabetes (tolbutamide).
Medicines for the treatment of excess stomach acid, ulcers and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
Medicines for the treatment of mania and depression (lithium).
Other medicines for the treatment of depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
Medicines for the treatment of schizophrenia and other mental disorders (such as perphenazine, levomepromazine and olanzapine).
Medicines used for the treatment of high blood pressure, chest pain, or to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide and propafenone).
Medicines used for the treatment of bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
Medicines used for the treatment of fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
Medicines used for the treatment of 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).

SERTRALINA ALTER with food, drinks and alcohol
SERTRALINA ALTER tablets may be taken with or without food.
Alcohol consumption should be avoided during treatment with SERTRALINA ALTER.
Sertraline must not be taken together with grapefruit juice, as this 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 administered to pregnant women only if the doctor considers that the benefit to the mother outweighs any possible risk to the developing baby. If you are a woman of childbearing age, you should use a reliable method of contraception (such as the contraceptive pill) while being treated with sertraline.
Ensure that your midwife and/or doctor are aware that you are being treated with SERTRALINA ALTER.
If you take Sertralina Alter 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 doctor or midwife that you are taking Sertralina Alter so they can advise you on what to do.
When taken during pregnancy, particularly during the last three months, medicines such as SERTRALINA ALTER may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN). This condition causes rapid breathing and a bluish skin colour in the newborn. These symptoms usually begin within the first 24 hours after birth. If your baby develops this condition, contact your midwife and/or doctor immediately.
Your baby may also experience other conditions, which usually begin within the first 24 hours after birth.
Symptoms include:

breathing difficulties,
bluish skin colour or being too hot or too cold,
blue lips,
vomiting or feeding difficulties,
being very tired, unable to sleep or crying excessively,
stiff or floppy muscles,
tremors, nervousness, jerks,
increased reflex responses,
irritability,
low blood sugar levels.

If your baby shows any of the symptoms listed above at birth, or if you have any concerns about your baby’s health, contact your doctor or midwife, who will be able to advise you.
There is evidence that sertraline is excreted in human breast milk. Sertraline should be used during breastfeeding only if the doctor considers that the benefit to the mother outweighs any possible risk to the baby.
In animal studies, some medicines like sertraline may reduce sperm quality. In theory, this could affect fertility, but no impact on human fertility has been observed so far.
Driving and using machines
Psychotropic medicines such as sertraline may affect your ability to drive vehicles or operate machinery. Therefore, do not drive or operate machinery until you are certain that this medicine does not impair your ability to perform these activities.

3. How to take SERTRALINE ALTER

Take this medicine exactly as directed by your doctor or pharmacist. 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 once daily. The daily dose may be increased by 50 mg at intervals of at least one week over several weeks. The maximum recommended dose is 200 mg once daily.

Panic Disorder, Social Anxiety Disorder, and Post-Traumatic Stress Disorder (PTSD):
For panic disorder, social anxiety disorder, and PTSD, treatment should begin at a dose of 25 mg once daily, which should then be increased to 50 mg once daily 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 once daily.

Use in children and adolescents

SERTRALINE ALTER 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 once daily.
After one week, your doctor may increase the dose by 50 mg once daily. The maximum dose is 200 mg once daily.

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

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

Method of administration

SERTRALINE ALTER tablets can be taken with or without food.

Take the medicine once daily, either in the morning or in the evening.

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

If you take more SERTRALINE ALTER than you should

If you accidentally take too much SERTRALINE ALTER, contact your doctor immediately or go to the nearest emergency room. Always bring the medicine pack with you, whether or not it still contains any 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 ALTER

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, do not take the missed dose. Take the next dose at the usual time.

If you stop taking SERTRALINE ALTER

Do not stop taking SERTRALINE ALTER unless your doctor tells you to. Your doctor may wish to gradually reduce the dose of SERTRALINE ALTER over several weeks before stopping completely. If you stop taking this medicine suddenly, you may experience unwanted effects such as dizziness, numbness or tingling sensations, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and tremors. If you experience any of these side effects, or any other side effects during treatment with SERTRALINE ALTER, talk to your doctor.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Nausea is the most common side effect. Side effects depend on the dose and often disappear or decrease with continued treatment.
Inform your doctor immediately if:
You experience any of the following symptoms after taking this medicine, as these symptoms may be serious.

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 an itchy rash, breathing difficulties, wheezing, swelling of the eyelids, face or lips.
You experience agitation, confusion, diarrhoea, 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 taking certain medicines together with sertraline. Your doctor may decide to discontinue treatment.
You develop yellowing of the skin and eyes, which may indicate liver damage.
You develop depressive symptoms with thoughts of harming yourself or of suicide (suicidal thoughts).
You begin to feel inner restlessness and are no longer able to sit still or remain still after starting treatment with SERTRALINA ALTER. You must inform your doctor if you start feeling restless.
You have seizures.
You experience a manic episode (see section 2 “Warnings and precautions”).

The following side effects were observed in clinical trials conducted in adult patients:
Very common (may affect more than 1 in 10 people):
insomnia, dizziness, drowsiness, headache, diarrhoea, nausea, dry mouth, ejaculation disorder, fatigue.
Common (may affect up to 1 in 10 people):

sore throat, anorexia, increased appetite,
depression, feeling strange, nightmares, anxiety, agitation, nervousness, reduced sexual interest, teeth grinding,
numbness and tingling, tremors, muscle tension, taste disturbance, lack of attention,
visual disturbances, tinnitus,
palpitations, hot flushes, yawning,
abdominal pain, vomiting, constipation, stomach discomfort, bloating,
skin rash, increased sweating, muscle pain, erectile dysfunction, chest pain,
joint pain,
malaise.

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

cold extremities, runny nose,
hypersensitivity,
low levels of thyroid hormones,
hallucinations, feeling excessively happy, lack of personal care, altered thinking, aggression,
seizures, involuntary muscle contractions, coordination disturbances, excessive movements, amnesia, reduced sensation, speech disorders, dizziness upon standing, fainting, migraine,
pupil dilation,
ear pain, rapid heartbeat, high blood pressure, facial flushing,
breathing difficulties, possible wheezing, shortness of breath, nosebleeds,
oesophagitis, difficulty swallowing, haemorrhoids, increased salivation, tongue disorders, burping,
eye swelling, development of red spots on the skin, facial oedema, hair loss, cold sweats, dry skin, urticaria, itching,
osteoarthritis, muscle weakness, back pain, muscle cramps,
nocturia, inability to urinate, increased urine volume, increased urinary frequency, urinary difficulties, urinary incontinence,
vaginal bleeding, sexual dysfunction, female sexual dysfunction, menstrual irregularities, leg swelling, chills, fever, weakness, thirst, increased liver enzyme levels, weight loss, weight gain.

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

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, paranoia, suicidal thoughts, sleepwalking, premature ejaculation,
severe allergic reaction,
coma, abnormal movements, movement difficulties, increased sensations, sensorial disturbances,
development of spots on the eye, glaucoma, double vision (diplopia), discomfort caused by light (photophobia), blood accumulation in the anterior chamber of the eye (hyphaema), unequal pupil size, abnormal vision, altered tear production,
problems controlling blood sugar levels (diabetes),
heart attack, slow heartbeat, heart problems, poor blood circulation to arms and legs, throat closure, rapid breathing, slow breathing, difficulty speaking, hiccups,
blood in stools, mouth pain, 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 odour, bone disorders,
reduced urination, initial difficulty urinating, blood in urine,
excessive vaginal bleeding, vaginal dryness, red and painful penis and foreskin, genital discharge, prolonged erection, breast secretion,
hernia, reduced tolerance to the medicine, difficulty walking, altered semen, increased blood cholesterol levels, wounds, procedure for blood vessel relaxation,
Cases of suicidal thoughts and suicidal behaviour have been reported in patients receiving sertraline or shortly after discontinuation of treatment (see section 2).

Not known (frequency cannot be estimated from the available data):

Partial loss of vision,
Inflammation of the colon (causing diarrhoea). Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage). See section 2, “Pregnancy, breastfeeding and fertility”, for further information.
Muscle weakness and severe muscle pain, which may be signs of a disorder similar to multiple acyl-coenzyme A dehydrogenase deficiency (MADD).

The following side effects have been reported during the post-marketing phase of sertraline:

Decreased number of white blood cells, decreased number of blood clotting cells, endocrine problems, low levels of sodium in the blood, increased blood sugar levels,
Altered, frightening dreams, suicidal behaviour,
Movement disorders (such as frequent movements, tense muscles, difficulty walking, stiffness, spasms and involuntary muscle movements), sudden severe headaches (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS)).
Altered vision, unequal pupils, bleeding problems (such as gastrointestinal bleeding), progressive scarring of lung tissue (Interstitial Lung Disease), pancreatitis, severe liver function problems, yellowing of the skin and eyes (jaundice),
Skin oedema, skin reaction to sun exposure, muscle cramps, breast enlargement, coagulation problems, altered laboratory tests, enuresis.
Feeling of emptiness in the head, fainting or chest pain, which could be signs of changes in the heart's electrical activity (as seen on electrocardiogram) or abnormal heart rhythm.

Side effects in children and adolescents:
In clinical trials in children and adolescents, side effects were generally similar to those observed in adults (see above). The most common side effects in children and adolescents were headache, insomnia, diarrhoea and nausea.
Symptoms that may occur when treatment is discontinued:
If you stop taking this medicine abruptly, you may experience side effects such as dizziness, tingling, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and tremor (see section 3 “If you stop taking SERTRALINA ALTER”).
An increased risk of bone fractures has been observed in patients taking this type of medicine.
Reporting of side effects.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SERTRALINA ALTER

Store below 30°C in the original packaging to protect the medicine from moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the product when unopened and properly stored.
DO NOT USE IF THERE ARE VISIBLE SIGNS OF DETERIORATION
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What SERTRALINA ALTER contains
SERTRALINA ALTER 50 mg film-coated tablets
Each tablet contains:

The active substance is sertraline hydrochloride 56 mg (equivalent to sertraline 50 mg)
The excipients are calcium hydrogen phosphate, microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide (E 171), glycerol triacetate.

SERTRALINA ALTER 100 mg film-coated tablets
Each tablet contains:

The active substance is sertraline hydrochloride 112 mg (equivalent to sertraline 100 mg)
The excipients are calcium hydrogen phosphate, microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide (E 171), glycerol triacetate.

Description of the appearance of SERTRALINA ALTER and contents of the pack
50 mg film-coated tablets in blisters containing 15 or 30 divisible tablets.
100 mg film-coated tablets in blisters containing 15 or 30 tablets.

Marketing Authorization Holder
Laboratori Alter S.r.l.
Via Egadi, 7 – 20144 Milan, Italy

Manufacturer
Laboratorios Alter S.A., C/ Mateo Inurria, 30 – 28036 Madrid, Spain
Laboratorios Alter S.A, C/ Zeus 6 Polígono Industrial R2 - 28880 Meco (Madrid), Spain

February 2026

Sertraline Alter