Package Leaflet: Information for the User

Sertraline Alter 50 mg Film-Coated Tablets

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2. What you need to know before you start taking Sertraline Alter

3. How to take Sertraline Alter

4. Possible side effects

5. Storage of Sertraline Alter

6. Contents of the pack and additional information

Sertralina Alter contains sertraline as the active ingredient. Sertraline belongs to a group of medications called selective serotonin reuptake inhibitors (SSRIs); these medications are used to treat depression and/or anxiety disorders.

Sertralina Alter may be used to treat:

- Depression and prevention of depression relapse (in adults).

- Social anxiety disorder (in adults).

- Post-traumatic stress disorder (PTSD) (in adults).

- Anxiety disorder (in adults).

- Obsessive-compulsive disorder (OCD) (in adults, and in children and adolescents aged 6-17 years).

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

OCD and anxiety disorders are diseases linked to anxiety, with symptoms such as being constantly preoccupied with repeated ideas (obsessions) that lead to repetitive rituals (compulsions).

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

Your doctor has considered this medication suitable for treating your condition.

If you are unsure why you have been prescribed sertraline, you should consult your doctor.

Do not take Sertralina Alter:

• If you are allergic to sertralina or any of the other components of this medication (listed in section 6).
• If you are taking or have taken medications called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other similar medications to MAOIs (such as linezolid). If you stop taking sertralina, wait at least one week before starting treatment with an MAOI. After stopping treatment with an MAOI, wait at least two weeks before starting treatment with sertralina.
• If you are taking another medication called pimozide (a medication used to treat mental disorders such as psychosis).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sertralina Alter.

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

• If you have epilepsy (seizures) or a history of convulsions. If you have a seizure (convulsions), call your doctor immediately.
• If you have manic-depressive illness (bipolar disorder), or schizophrenia. If you have a manic episode, call your doctor immediately.
• If you have or have had thoughts of harming yourself or committing suicide (see below Thoughts of suicide and worsening of your depression or anxiety).
• If you have Serotonin Syndrome.In rare cases, this syndrome may occur when taking certain medications at the same time as sertralina. (See symptoms below in section 4. Possible side effects). Your doctor will tell you if you have had this syndrome before.
• If you have low sodium levels in your blood, as this condition may occur as a result of treatment with sertralina. Also, inform your doctor if you are taking any medication for high blood pressure, as these medications may also alter sodium levels in the blood.
• If you are elderly, as you may be at greater risk of having low sodium levels in the blood (see above).
• If you have liver disease; your doctor may consider that you should take a lower dose of sertralina.
• If you have diabetes; sertralina may alter your blood sugar levels, so you may need to adjust the dose of your diabetes medication.
• If you have a history of bleeding disorders (tendency to develop hemorrhages), or if you are pregnant (see section "Pregnancy, breastfeeding and fertility") or have taken medications that decrease blood clotting [such as aspirin, or Warfarin] or that may increase the risk of bleeding.
• If you are a child or adolescent under 18 years old. Sertralina Alter should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder (OCD). If you are to be treated for this disorder, your doctor will want to monitor you closely (see below Use in children and adolescents).
• If you are receiving electroconvulsive therapy (ECT).
• If you have any eye disorder, such as certain types of glaucoma (increased intraocular pressure).
• If you have been told that you have an abnormal heart rhythm that is obtained after an electrocardiogram (ECG), known as QT prolongation.
• If you have heart disease, low potassium or magnesium levels, a family history of QT prolongation, low heart rate, or are taking medications that prolong the QT interval.

Restlessness/Acatisia

The use of sertralina has been associated with unpleasant restlessness and a need to move, often accompanied by an inability to remain seated or standing (acatisia). This occurs more often during the first few 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 Sertralina and section 4. Possible side effects).

The risk of 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 can be severe. These symptoms usually occur during the first few days after stopping treatment. In general, these symptoms usually resolve on their own and usually resolve within two weeks. In some patients, they may last longer (2-3 months or more). It is recommended that when stopping treatment with sertralina, the dose 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 stop treatment.

Thoughts of suicide and worsening of your depression or anxiety

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. This may increase at the beginning of treatment with antidepressants, as all these medications take time to take effect, which is usually two weeks but sometimes longer.

This is more likely to happen

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. There is information from clinical trials that shows an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders, who were being treated with an antidepressant.

If you have thoughts of harming yourself or committing suicide at any time, contact your doctor or go to the 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 can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Sexual problems:

Some medications in the group to which Sertralina Alter belongs (called ISRS) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Normally, sertralina should not be used to treat children and adolescents under 18 years old, except in the case of patients with obsessive-compulsive disorder (OCD). Children and adolescents under 18 years old have a higher risk of side effects such as suicidal thoughts, thoughts of self-harm or suicide (suicidal ideation), and hostility (predominantly aggression, confrontational behavior, and irritable reaction) when treated with this class of medications. However, your doctor may decide to prescribe Sertralina Alter to a patient under 18 years old if they consider it to be the most suitable option for the patient. If your doctor has prescribed Sertralina Alter and you are under 18 years old and want to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen while you are taking Sertralina Alter.The long-term effects on safety and related to growth, maturity, and learning (cognitive development) and behavioral development of Sertralina were evaluated in a long-term study in over 900 children aged 6 to 16 years who were monitored for a period of 3 years. In general, the results of the study showed that children treated with sertralina developed normally, except for a slight increase in weight in those treated with a higher dose.

Other medications and Sertralina:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Some medications may affect how Sertralina Alter works, or Sertralina Alter itself may reduce the effectiveness of other medications you are taking at the same time.

The use of Sertralina Alter with the following medications may cause serious side effects

• Medications called monoamine oxidase inhibitors (MAOIs), such as moclobemide (to treat depression), selegiline (to treat Parkinson's disease), and the antibiotic linezolid and methylene blue (to treat high levels of methemoglobin in the blood). Do not use sertralina with these medications.
• Medications to treat mental disorders such as psychosis (pimozide). Do not use sertralina with pimozide.

Inform your doctor if you are taking the following medications

- Medications containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).

• Medications based on plants that contain St. John's Wort (Hypericum perforatum).

The effects of St. John's Wort may last 1-2 weeks.

• Products containing the amino acid tryptophan.
• Medications to treat severe or chronic pain (opioids, such as tramadol, fentanyl).
• Medications used in anesthesia (such as fentanyl, mivacurium, and suxamethonium).
• Medications to treat migraines (such as sumatriptan).
• Medications that decrease blood clotting (warfarin).
• Medications to treat pain/arthritis [such as metamizole, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin].
• Sedatives (diazepam).
• Diuretics.
• Medications to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medications to treat diabetes (tolbutamide).
• Medications to treat acid reflux, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medications to treat mania and depression (lithium).
• Other medications to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medications to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medications to treat high blood pressure, chest pain, or to regulate heart rate (such as verapamil, diltiazem, flecainide, propafenone).
• Medications used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
• Medications used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Medications used to treat HIV/AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir).
• Medications used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
• Medications known to increase the risk of changes in heart rhythm (such as some antipsychotics and antibiotics).

Taking Sertralina Alter with food, drinks, and alcohol:

Sertralina Alter tablets can be taken with or without food.

Alcohol should be avoided while being treated with sertralina.

Do not take sertralina with grapefruit juice, as it may increase sertralina levels in your body.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The safety of sertralina in pregnant women has not been fully established. If you are pregnant, sertralina will only be administered if your doctor considers that the benefits for you outweigh any possible risk to the developing fetus.

If you take Sertralina in the final stages of pregnancy, there may be an increased risk of excessive vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Sertralina so they can advise you.

When taken during pregnancy, especially during the last 3 months of pregnancy, medications like Sertralina Alter may increase the risk of a serious condition in newborns called persistent pulmonary hypertension (PPHN), which makes the baby breathe faster and appear blue. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

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

• difficulty breathing,

• blue skin or too hot or cold,

• blue lips,

• vomiting or feeding problems,

• excessive tiredness, unable to sleep, or crying a lot,

• muscle stiffness or decreased muscle tone,

• tremors, restlessness, or convulsions,

• increased reflexes,

• irritability,

• low blood sugar.

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

There is evidence that sertralina passes into breast milk. Therefore, sertralina can only be used in breastfeeding women if your doctor considers that the benefits outweigh any possible risk to the baby.

In animal studies, some medications like sertralina have been shown to reduce sperm quality. Theoretically, this could affect fertility, but it has not been determined in humans.

Driving and operating machinery

Medications like sertralina can affect your ability to drive or operate machinery. Therefore, do not drive or operate heavy machinery until you know how this medication affects your ability to perform these activities.

Sertralina Alter contains sodium:

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults:

Depression and Obsessive-Compulsive Disorder:

The commonly effective dose for depression and OCD is 50 mg per day. The daily dose can be increased by 50 mg at intervals of at least one week, and thus for several weeks. The maximum recommended dose is 200 mg per day.

Anxiety Disorder, Social Anxiety Disorder, and Post-Traumatic Stress Disorder:

For anxiety disorder, social anxiety disorder, and post-traumatic stress disorder, treatment should begin with a dose of 25 mg per day, and increased to 50 mg per day after one week.

The daily dose can be increased at intervals of 50 mg 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 per day. After one week, your doctor may increase the dose to 50 mg per day. The maximum dose is 200 mg per day.

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

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

Administration form:

Sertraline tablets can be taken with or without food.

Take your medication once a day, either in the morning or at night.

Your doctor will indicate the duration of treatment with this medication. The duration will depend on the nature of your illness and your response to treatment. It may take several weeks for your symptoms to improve.The treatment of depression usually should continue for 6 months after improvement.

If you take more Sertraline Alter than you should

If you accidentally take an excessive amount of sertraline, contact your doctor or go to the nearest hospital emergency service. Always carry the medication packaging with you, even if it is empty.

You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of overdose may include drowsiness, nausea, and vomiting, rapid heart rate, tremors, agitation, dizziness, and in rare cases, loss of consciousness.

If you forgot to take Sertraline Alter

Do not take a double dose to compensate for the missed doses. If you forget to take a dose, do not take it when you remember. Take the next dose when it is due.

If you interrupt the treatment with Sertraline Alter

Do not interrupt treatment with sertraline unless your doctor tells you to. Your doctor will want to gradually reduce the dose of sertraline over several weeks before stopping treatment completely. If you stop treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors. If you experience any of these adverse effects, or any other during the interruption of your treatment,

please inform your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most common side effect is nausea. Side effects depend on the dose and often disappear or decrease as treatment continues.

Inform your doctor immediately:

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

• If you develop a severe skin rash that causes blisters (erythema multiforme), (which can affect the mouth and tongue). These may be signs of a condition known as Stevens-Johnson syndrome or Toxic Epidermal Necrolysis (TEN). In these cases, your doctor will stop treatment.
• Allergic reaction or allergy, which may present symptoms such as skin rash with itching, breathing problems, ringing in the ears, swelling of the eyelids, face, or lips.
• If you experience agitation, confusion, diarrhea, increased temperature and blood pressure, excessive sweating, and rapid pulse. These are symptoms of serotonin syndrome. In rare cases, this syndrome can occur when taking certain medications at the same time as sertraline. Your doctor may decide to stop treatment.
• If you experience yellowing of the skin and eyes, which may indicate liver damage.
• If you experience depressive symptoms with thoughts of self-harm or suicide (suicidal thoughts).
• If you start feeling restless and are unable to sit or stand after starting treatment with this medicine. Inform your doctor if you start feeling restless.
• If you experience a seizure (convulsions).
• If you experience a manic episode (see section 2. Warnings and precautions).

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

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

Insomnia, dizziness, drowsiness, headache, diarrhea, feeling unwell, dry mouth, ejaculation problems, and fatigue.

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

- cold (chest), sore throat, coughing,

- loss of appetite, increased appetite,

- anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, teeth grinding,

- tremors, muscle movement problems (such as constant movements, muscle tension, difficulty walking, and stiffness, spasms, and involuntary muscle movements)*, numbness and tingling, increased muscle tone, lack of concentration, abnormal taste,

- visual disturbances,

- ringing in the ears,

- palpitations,

- hot flashes,

- yawning,

- stomach discomfort, constipation, abdominal pain, vomiting, gas,

- increased sweating, rash,

- back pain, joint pain, muscle pain,

- irregular menstrual cycle, erectile dysfunction,

- feeling unwell, chest pain, weakness, fever,

- weight gain,

- injury.

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

- gastroenteritis, ear infection,

- tumor,

- hypersensitivity, seasonal allergy,

- low thyroid hormone levels,

- suicidal thoughts, suicidal behavior*, psychotic disorders, abnormal thoughts, neglect, hallucinations, aggression, excessive happiness, paranoia,

- amnesia, decreased sensitivity, involuntary muscle contractions, fainting, continuous movements, migraine, convulsions, dizziness when standing, abnormal coordination, speech disorders,

- dilated pupils,

- ear pain,

- rapid pulse, heart problems,

- bleeding problems (such as stomach bleeding)*, high blood pressure, hot flashes, blood in urine,

- shortness of breath, nosebleed, possible noisy breathing,

- black stools, dental problems, esophageal inflammation, tongue problems, hemorrhoids, excessive salivation, difficulty swallowing, belching, tongue problems,

- eye swelling, urticaria, hair loss, itching, purple spots on the skin, skin problems with blisters, dry skin, facial swelling, cold sweat,

- arthritis, muscle spasms, muscle cramps*, muscle weakness,

- increased urination frequency, urinary problems, urinary retention, incontinence, increased urine volume, nocturia,

- 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 behavior have been reported during treatment with sertraline or shortly after stopping treatment (see section 2).

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

- diverticulitis, lymph node swelling, low platelet count*, low white blood cell count*,

- severe allergic reaction,

- endocrine problems*,

- high cholesterol, difficulty controlling blood sugar levels (diabetes), low blood sugar, high blood sugar*, low sodium levels*,

- physical symptoms due to stress or emotions, abnormal nightmares*, medication 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 in front of the eyes, glaucoma, double vision, photophobia (light sensitivity), eye bleeding, irregular pupils*, visual disturbances*, eye problems,

- heart attack, dizziness, fainting, or chest pain that may be signs of changes in electrical activity (seen on the electrocardiogram) or abnormal heart rhythm*, decreased heart rate,

- circulation problems in the arms and legs,

- rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, throat spasm, difficulty speaking, slower breathing, hiccups,

- a type of lung disease in which eosinophils (a type of white blood cell) appear in the lungs in large numbers (eosinophilic pneumonia),

- mouth ulcers, pancreatitis*, blood in stool, tongue ulcers, mouth sores,

- liver function problems, severe liver function problems*, yellow skin and eyes (jaundice)*,

- sunburn-like reaction*, skin swelling*, abnormal hair texture, abnormal skin odor, capillary eruption,

- muscle tissue rupture*, bone disorders,

- interrupted urination, decreased urine volume,

- nipple secretion, vaginal dryness, genital secretion, penile and preputial pain and redness, breast enlargement*, prolonged erection,

- hernia, decreased tolerance to the medication,

- increased cholesterol levels, abnormal laboratory results*, abnormal semen, coagulation problems*,

- vasodilation relaxation.

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

- mandibular blockage*,

- nocturia*,

- partial vision loss,

- colitis inflammation (which causes diarrhea)*,

- excessive postpartum vaginal bleeding (postpartum hemorrhage), see “Pregnancy, lactation, and fertility” in section 2 for more information.

*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, diarrhea, and nausea.

Symptoms that may appear when treatment is stopped

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

A higher risk of bone fractures has been observed in patients taking this type of medication.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly throughSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sertralina Alter

The active ingredient of Sertralina Alter 50 mg is sertraline (hydrochloride). Each tablet contains 50 mg of sertraline.

The other components are:

Tablet core: calcium phosphate dibasic dihydrate, microcrystalline cellulose, sodium carboxymethyl starch, magnesium stearate, hydroxypropyl cellulose,

Tablet coating: hypromellose, titanium dioxide (E171) and triacetin (E422).

Appearance of the product and content of the packaging

Sertralina Alter 50 mg is presented in film-coated tablets, round, lenticular, white, scored. It is presented in blisters, in packs of 30 or 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Last review date of this leaflet:May2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/