Sertraline Alter 100 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sertraline Alter 100 mg film-coated tablets EFG

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

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

Sertralina Alter can be used to treat:

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

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

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

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

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

If you are not sure why you have been prescribed sertraline, you should consult your doctor.

2. What you need to know before starting to take Sertraline Alter

Do not take Sertraline Alter:

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 or moclobemide, or other medicines similar to MAOIs (such as linezolid). If you stop treatment with sertraline, you must wait at least one week before starting treatment with an MAOI. After stopping treatment with an MAOI, you must wait at least two weeks before starting treatment with sertraline.
If you are taking another medicine called pimozide (a medicine used to treat mental disorders such as psychosis).

Warnings and precautions

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

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

If you have epilepsy (seizures) or a history of seizures. If you have a seizure, contact your doctor immediately.
If you have bipolar disorder (manic-depressive illness) or schizophrenia. If you experience a manic episode, contact your doctor immediately.
If you have or have previously had thoughts of harming yourself or committing suicide (see further below: Suicidal thoughts and worsening of depression or anxiety disorder).
If you have Serotonin Syndrome. This syndrome rarely occurs when taking certain medicines at the same time as sertraline. (For symptoms, see section 4. Possible side effects.) Your doctor will advise you if you have previously experienced this syndrome.
If you have low blood sodium levels, as this may occur as a result of treatment with sertraline. You should also inform your doctor if you are taking any medicines for high blood pressure, as these may also affect blood sodium levels.
If you are elderly, as you may be at higher risk of low blood sodium levels (see previous point).
If you have liver disease; your doctor may decide that you should take a lower dose of sertraline.
If you have diabetes; sertraline may alter your blood sugar levels, so it may be necessary to adjust the dose of your diabetes medication.
If you have a history of bleeding disorders (tendency to bruise easily), or if you are pregnant (see section "Pregnancy, breastfeeding and fertility"), or have been taking medicines that reduce blood clotting [for example, acetylsalicylic acid (aspirin), or warfarin] or that may increase the risk of bleeding.
If you are a child or adolescent under 18 years of age. Sertraline Alter should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder (OCD). If you are being treated for this condition, your doctor will want to monitor you closely (see below: Children and adolescents).
If you are receiving electroconvulsive therapy (ECT).
If you have eye disorders, such as certain types of glaucoma (increased intraocular pressure).
If you have been told you have an abnormality on the heart tracing obtained from an electrocardiogram (ECG), known as QT interval prolongation.
If you have heart disease, low levels of potassium or magnesium, a family history of QTc prolongation, slow heart rate, or are taking concomitantly medicines that prolong the QTc interval.

Restlessness / Akathisia

The use of sertraline has been associated with unpleasant restlessness and a need to move, often accompanied by an inability to sit or stand still (akathisia).

This occurs most frequently during the first weeks of treatment. Increasing the dose may be harmful, so if you develop these symptoms, you should contact your doctor.

Withdrawal symptoms

Side effects related to stopping treatment (withdrawal symptoms) are common, particularly if treatment is stopped abruptly (see section 3 if you stop taking Sertraline Alter and section 4. Possible side effects).

The risk of experiencing withdrawal symptoms depends on the duration of treatment, the dose, and the rate at which the dose is reduced. Generally, these symptoms are mild or moderate. However, in some patients they may be severe. These symptoms usually appear in the first few days after stopping treatment. In general, these symptoms resolve on their own and usually disappear within two weeks. In some patients, they may last longer (2–3 months or more). It is recommended that when stopping treatment with sertraline, the dose should be gradually reduced over a period of several weeks or even months, and you should always agree with your doctor on the best way to discontinue treatment.

Suicidal thoughts and worsening of depression or anxiety disorder

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

You are more likely to experience this if:

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

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

It may be helpful for you to explain to a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may also ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.

Sexual problems

Some medicines in the class to which Sertraline Alter belongs (called SSRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Normally, sertraline should not be used to treat children and adolescents under 18 years of age, except in 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 ideation), and hostility (predominantly aggression, confrontational behaviour, and anger reactions) when taking this class of medicines. Nevertheless, your doctor may decide to prescribe Sertraline Alter to a patient under 18 years of age if they consider it to be the most appropriate treatment. If your doctor has prescribed Sertraline Alter and you are under 18 years of age and wish to discuss this decision, please speak to your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen while you are taking Sertraline Alter.

The long-term safety effects of sertraline on growth, maturation, learning (cognitive development), and behavioural development were evaluated in a long-term study involving more than 900 children aged 6 to 16 years, monitored over a period of 3 years. Overall, study results showed that children treated with sertraline developed normally, except for a slight increase in weight gain in those receiving a higher dose.

Other medicines and Sertraline Alter

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

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

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

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

Inform your doctor if you are taking the following medicines:

Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).
- Herbal medicines containing St. John's wort (Hypericum perforatum). The effects of St. John's wort may last 1–2 weeks.
- Products containing the amino acid tryptophan.
Medicines for severe or chronic pain (opioids, for example tramadol, fentanyl).
Medicines used in anaesthesia (for example fentanyl, mivacurium, and suxamethonium).
Medicines for treating migraines (for example sumatriptan).
Medicines that reduce blood clotting (warfarin).
Medicines for treating pain/arthritis [for example, metamizole, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)].
Sedatives (diazepam).
Diuretics.
Medicines for treating epilepsy (phenytoin, phenobarbital, carbamazepine).
Medicines for treating diabetes (tolbutamide).
Medicines for treating acidity, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
Medicines for treating mania and depression (lithium).
Other medicines for treating depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
Medicines for treating schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
Medicines for treating high blood pressure, chest pain, or for regulating heart rate and rhythm (such as verapamil, diltiazem, flecainide, propafenone).
Medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
Medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
Medicines used to treat HIV/AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir).
Medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
Medicines known to increase the risk of changes in the heart's electrical activity (e.g., certain antipsychotics and antibiotics).

Taking Sertraline Alter with food, drinks, and alcohol:

Sertraline Alter tablets can be taken with or without food.

Alcohol intake should be avoided while being treated with sertraline.

Sertraline should not be taken together with grapefruit juice, as it may increase sertraline levels in your body.

Pregnancy, breastfeeding and fertility

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

The safety of sertraline in pregnant women has not been fully established. You will only be given sertraline during pregnancy if your doctor considers that the benefit to you outweighs any possible risk to the developing baby.

If you take Sertraline Alter in the late stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Sertraline Alter so they can advise you. When taken during pregnancy, especially during the last three months, medicines such as Sertraline Alter may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.

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

Difficulty breathing,
Bluish or unusually hot or cold skin,
Blue lips,
Vomiting or feeding problems,
Excessive tiredness, inability to sleep, or excessive crying,
Muscle stiffness or decreased muscle tone,
Tremors, restlessness, or seizures,
Increased reflex responses,
Irritability,
Low blood sugar levels.

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

There is evidence that sertraline passes into breast milk. Therefore, sertraline may only be used in women who are breastfeeding if your doctor considers that the benefit outweighs any possible risk to the infant.

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

Driving and using machines

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

Sertraline Alter contains sodium:

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Sertraline Alter

Follow exactly the dosing instructions for this medicine provided by your doctor or pharmacist.

If you are unsure, consult your doctor or pharmacist again.

Recommended dose:

Adults:

Depression and Obsessive-Compulsive Disorder (OCD):

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

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

For panic disorder, social anxiety disorder, and post-traumatic stress disorder, treatment should be initiated at a dose of 25 mg daily, increasing to 50 mg daily after one week.

The daily dose may be increased in 50 mg increments over a period of several weeks. The maximum recommended dose is 200 mg per day.

Use in children and adolescents:

Sertraline should only be used to treat children and adolescents aged 6 to 17 years with OCD.

Obsessive-compulsive disorder:

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

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

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

Method of administration:

Sertraline tablets may be taken with or without food.

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

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

If you take more Sertraline Alter than you should

If you accidentally take too much sertraline, contact your doctor or go to the nearest hospital emergency department. Always bring the medicine packaging with you, whether or not any medicine remains.

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

Symptoms of overdose may include drowsiness, nausea and vomiting, increased heart rate, tremors, agitation, dizziness, and rarely, loss of consciousness.

If you forget to take Sertraline Alter

Do not take a double dose to make up for missed doses. If you forget to take a dose, do not take it when you remember. Take the next dose at the scheduled time.

If you stop taking Sertraline Alter

Do not stop treatment with sertraline unless your doctor tells you to. Your doctor will want to gradually reduce your dose of sertraline over several weeks before you completely stop taking this medicine. If you stop treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremor. If you experience any of these adverse effects, or any others, during discontinuation of your Sertraline Alter treatment, please inform your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

Tell your doctor immediately:

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

If you develop a severe skin rash causing blisters (erythema multiforme), (which may affect the mouth and tongue). These may be signs of a condition known as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN). In such cases, your doctor will discontinue treatment.
Allergic reaction or allergy, which may present symptoms such as itchy skin rash, breathing difficulties, wheezing, swelling of the eyelids, face or lips.
If you experience agitation, confusion, diarrhea, increased body temperature and blood pressure, excessive sweating, and rapid pulse. These are symptoms of serotonin syndrome. Rarely, this syndrome may occur when taking certain medications together with sertraline. Your doctor may decide to discontinue treatment.
If you notice yellowing of the skin or eyes, which may indicate liver damage.
If you experience depressive symptoms with thoughts of self-harm or suicide (suicidal thoughts).
If, after starting treatment with this medicine, you begin to feel restless and unable to sit or stand still. You should inform your doctor if you start feeling restless.
If you have a seizure (convulsion).
If you experience a manic episode (see section 2. Warnings and precautions).

The following adverse effects were observed in clinical trials in adults and after marketing.

Very common (may affect more than 1 in 10 patients):

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

Common (may affect up to 1 in 10 patients):

Cold (chest), sore throat, runny nose,
Loss of appetite, increased appetite,
Anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, teeth grinding,
Tremor, movement disorders (such as constant movements, muscle tension, difficulty walking and stiffness, spasms and involuntary muscle movements)*, numbness and tingling, increased muscle tone, difficulty concentrating, abnormal taste,
Visual disturbances,
Ringing in the ears,
Palpitations,
Hot flushes,
Yawning,
Stomach discomfort, constipation, abdominal pain, vomiting, flatulence,
Increased sweating, rash,
Back pain, joint pain, muscle pain,
Menstrual irregularities, erectile dysfunction,
Malaise, chest pain, weakness, fever,
Weight gain,
Injury.

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

Gastroenteritis, ear infection,
Tumour,
Hypersensitivity, seasonal allergy,
Low levels of thyroid hormones,
Suicidal thoughts, suicidal behaviour*, psychotic disorders, abnormal thinking, lack of self-care, hallucinations, aggression, excessive happiness, paranoia,
Amnesia, decreased sensitivity, involuntary muscle contractions, fainting, continuous movements, migraine, seizures, dizziness upon standing, abnormal coordination, speech disorders,
Dilated pupils,
Ear pain,
Rapid pulse, heart problems,
Bleeding problems (such as stomach bleeding)*, high blood pressure, hot flushes, blood in urine,
Shortness of breath, nosebleeds, difficulty breathing possibly with noise,
Black stools, dental disorders, oesophagitis, tongue problems, haemorrhoids, increased salivation, difficulty swallowing, burping, tongue disorders,
Swelling of eyes, urticaria, hair loss, itching, purple spots on the skin, blistering skin problems, dry skin, facial swelling, cold sweats,
Osteoarthritis, muscle twitches, muscle cramps*, muscle weakness,
Increased frequency of urination, urinary disorders, urinary retention, urinary incontinence, increased urine volume, need to urinate at night,
Sexual dysfunction, excessive vaginal bleeding, vaginal bleeding, female sexual dysfunction,
Swollen legs, chills, difficulty walking, thirst,
Increased liver enzyme levels, weight loss,
Cases of suicidal thoughts and behaviour have been reported during treatment with sertraline or shortly after discontinuation (see section 2).

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

Diverticulitis, swollen lymph nodes, decrease in platelets*, decrease in white blood cell count*,
Severe allergic reaction,
Endocrine disorders*,
High cholesterol, problems controlling blood sugar levels (diabetes), low blood sugar, increased blood sugar*, low blood sodium levels*,
Physical symptoms due to stress or emotions, abnormal nightmares*, drug dependence, sleepwalking, premature ejaculation,
Coma, abnormal movements, difficulty moving, increased sensitivity, sudden severe headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS))*, sensory disturbances,
Seeing spots before the eyes, glaucoma, double vision, photophobia (eye sensitivity to light), eye bleeding, irregular pupils*, visual disturbances*, tear problems,
Heart attack, dizziness, fainting or chest discomfort that could indicate changes in electrical activity (seen on electrocardiogram) or abnormal heart rhythm*, decreased heart rate,
Circulation problems in arms and legs,
Rapid breathing, progressive scarring in lung tissue (interstitial lung disease)*, throat spasm, difficulty speaking, slower breathing, hiccups,
A form of lung disease in which eosinophils (a type of white blood cell) appear in the lungs in high numbers (eosinophilic pneumonia),
Mouth ulceration, pancreatitis*, blood in stools, tongue ulceration, mouth sores,
Problems with liver function, serious liver function problems*, yellowing of skin and eyes (jaundice)*,
Skin reaction to sunlight*, skin swelling*, abnormal hair texture, abnormal skin odour, capillary rash,
Rupture of muscle tissue*, bone disorder,
Interrupted urination, decreased urine volume,
Breast secretion, vaginal dryness, genital discharge, pain and redness of penis and foreskin, breast enlargement*, prolonged erection,
Hernia, reduced drug tolerance,
Increased cholesterol levels, abnormal laboratory tests*, abnormal semen, coagulation problems*,
Relaxation of blood vessel processes.

Frequency not known (cannot be estimated from available data):

Jaw locking*,
Nocturnal urinary incontinence*,
Partial loss of vision,
Inflammation of the colon (causing diarrhoea)*,
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.
Muscle weakness and severe muscle pain, which may be a sign of multiple acyl-coenzyme A dehydrogenase deficiency (MADD).

*Adverse effects reported after marketing.

Other adverse effects in children and adolescents

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

Symptoms that may occur when stopping treatment

If you stop treatment with this medicine abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and tremor (see section 3. If you stop taking this medicine).

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

Reporting of adverse effects

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

5. Storage of Sertraline Alter

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

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sertraline Alter

The active substance in Sertraline Alter 50 mg is sertraline (hydrochloride). Each tablet contains 50 mg of sertraline.

The other components are:

Tablet core: dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium carboxymethylstarch (from potato), magnesium stearate, hydroxypropylcellulose.

Tablet coating: hypromellose, titanium dioxide (E171), glyceryl triacetate (E422).

Appearance of the product and contents of the pack

Sertraline Alter 50 mg is presented as film-coated, round, biconvex tablets, white in colour and scored. It is available in blisters, in pack sizes of 30 or 60 tablets.

Marketing Authorisation Holder and 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

Date of the most recent revision of this leaflet: July 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/