SERTRALINE NORMON 100 mg FILM-COATED TABLETS

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

Do not take Sertraline Normon

• If you are allergic to sertraline 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 medications similar to MAOIs (such as linezolid). If you interrupt treatment with sertraline, you should wait at least one week before starting treatment with an MAOI. After interrupting treatment with an MAOI, you should wait at least two weeks before starting treatment with sertraline.
• 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 Sertraline Normon.

Medications are not always suitable for everyone. Before starting treatment with Sertraline Normon, tell your doctor if you have or have had any of the following circumstances:

• 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 suicidal thoughts (see below Suicidal thoughts and worsening of your depression or anxiety disorder).
• If you have serotonin syndrome. This syndrome can occur rarely when taking certain medications at the same time as sertraline. (To see the symptoms, read section 4. Possible adverse effects). Your doctor will indicate if you have presented this syndrome previously.
• If you have low sodium levels in the blood, as this situation can occur as a consequence of treatment with Sertraline Normon. You should also inform your doctor if you are taking any medication for hypertension, as these medications can 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 previous point).
• If you have liver disease; your doctor may consider that you should take a lower dose of Sertraline Normon.
• If you have diabetes; Sertraline Normon can alter your blood sugar levels, so it may be necessary to adjust the dose of your diabetes medications.
• If you have a history of bleeding disorders (tendency to develop bruises), or if you are pregnant (see section Pregnancy, breastfeeding, and fertility) or have been taking medications that decrease blood coagulation (such as 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 Normon should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder (OCD). If you are going to be treated for this disorder, your doctor will want to monitor you closely (see below 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 anomaly in the heart graph obtained after an electrocardiogram (ECG), known as prolongation of the QT interval.
• If you have heart disease, have low potassium or magnesium levels, family history of QTc prolongation, low heart rate, or use concomitantly medications 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 remain seated or standing (akathisia). This occurs more often during the first few weeks of treatment.

An increase in dose can be harmful, so if you develop these symptoms, you should contact your doctor.

Withdrawal symptoms

Adverse effects related to treatment discontinuation (withdrawal symptoms) are common, particularly if treatment is discontinued abruptly (see section 3. If you interrupt treatment with Sertraline Normon and section 4. Possible adverse effects). The risk of presenting withdrawal symptoms depends on the duration of treatment, dose, and 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 treatment discontinuation. In general, these symptoms usually resolve on their own and normally disappear within two weeks. In some patients, they can last longer (2-3 months or more). It is recommended that when discontinuing 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 your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or suicidal thoughts. This can increase at the beginning of treatment with antidepressants, due to the fact that all these medications take time to take effect, which is usually a few weeks but can sometimes be longer.

This is more likely to happen to you

• 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 that there is an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who are being treated with an antidepressant.

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

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

Sexual problems

Some medications in the same group as Sertraline Normon (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment discontinuation.

Children and adolescents

Normally, sertraline should not be used in the treatment of children and adolescents under 18 years of age, except in the case of patients with obsessive-compulsive disorder (OCD). Patients under 18 years of age have a higher risk of adverse effects such as suicidal attempts, thoughts of self-harm or suicidal thoughts (suicidal ideas), and hostility (predominantly aggression, confrontational behavior, and anger) when they are being treated with this class of medications. Nevertheless, it is possible that your doctor may decide to prescribe Sertraline Normon to a patient under 18 years of age if they consider it to be in the best interest of the patient. If your doctor has prescribed Sertraline Normon and you are under 18 years of age and wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen when you are taking Sertraline Normon. The long-term effects on safety and related to growth, maturity, and learning (cognitive development) and behavioral development of sertraline 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 sertraline developed normally, except for a slight increase in weight in those treated with a higher dose.

Other medications and Sertraline Normon

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

Some medications can affect how Sertraline Normon works, or Sertraline Normon itself may reduce the effectiveness of other medications that are being taken at the same time.

The use of Sertraline Normon with the following medications can cause serious adverse effects

• Medications called monoamine oxidase inhibitors (MAOIs), such as moclobemide (for treating depression), selegiline (for treating Parkinson's disease), the antibiotic linezolid, and methylthioninium chloride (for treating high methemoglobin levels in the blood). Do not use Sertraline Normon with these medications.
• Medications for treating mental disorders such as psychosis (pimozide). Do not use Sertraline Normon with pimozide.

Tell your doctor if you are taking the following medications

• Medications containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).
• Herbal products containing St. John's Wort (Hypericum perforatum). The effects of St. John's Wort can last 1-2 weeks.
• Products containing the amino acid tryptophan.
• Medications for treating severe or chronic pain (opioids, e.g., tramadol, fentanyl).
• Medications used in anesthesia (e.g., fentanyl, mivacurium, and suxamethonium).
• Medications for treating migraines (e.g., sumatriptan).
• Medications that decrease blood coagulation (warfarin).
• Medications for treating pain/arthritis (e.g., metamizole, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics.
• Medications for treating epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medications for treating diabetes (tolbutamide).
• Medications for treating acidity, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medications for treating mania and depression (lithium).
• Other medications for treating depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medications for treating schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medications for treating high blood pressure, chest pain, or for regulating heart rate and rhythm (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 electrical activity (e.g., some antipsychotics and antibiotics).

Taking Sertraline Normon with food, drinks, and alcohol

Sertraline Normon tablets can be taken with or without food.

Alcohol consumption should be avoided while being treated with Sertraline Normon.

Do not take sertraline in combination with grapefruit juice, as it can increase sertraline levels in your body.

Pregnancy, breastfeeding, and fertility

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

The safety of sertraline in pregnant women has not been fully established. If you are pregnant, sertraline will only be administered to you if your doctor considers that the benefit to you outweighs any potential risk to the developing baby.

If you take Sertraline Normon tablets in the final stage 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 Sertraline Normon tablets to advise you accordingly. When taken during pregnancy, especially during the last 3 months, medications like Sertraline Normon may increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and have a bluish appearance. 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 appear within the first 24 hours after birth. The symptoms include:

• Difficulty breathing.
• Bluish or too hot or cold skin.
• Bluish lips.
• Vomiting or feeding problems.
• Excessive tiredness, inability to sleep, or excessive crying.
• Stiffness or decreased muscle tone.
• Tremors, restlessness, or convulsions.
• Increased reflexes.
• Irritability.
• Low blood sugar levels.

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 are indications that sertraline passes into breast milk. Therefore, sertraline can only be used in breastfeeding women if the doctor considers that the benefit outweighs any potential risk to the child.

In animal studies, it has been seen that some medications like sertraline may reduce sperm quality. Theoretically, this could affect fertility, but it has not yet been determined in humans.

Driving and using machines

Psychotropic medications like sertraline 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.

Sertraline Normon contains sodium

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

3. How to Take Sertralina Normon

Follow the administration instructions for this medication exactly as 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:

For depression and OCD, the usually effective dose is 50 mg per day. The daily dose can be increased in increments of 50 mg, at intervals of at least one week, and so on 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 be started with a dose of 25 mg per day, and increased to 50 mg per day after one week.

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

Use in Children and Adolescents:

This medication should only be used to treat children and adolescents aged 6 to 17 years who have OCD.

Obsessive-Compulsive Disorder:

Children from6 to12 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 from13 to17 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 give you.

Method of Administration

Sertralina Normon 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 will take several weeks for your symptoms to start improving. Treatment of depression usually needs to continue for 6 months after improvement.

If You Take More Sertralina Normon Than You Should

If you accidentally take an excess of sertralina, contact your doctor or go to the emergency department of the nearest hospital. Always carry the medication packaging with you, whether there is medication left in it or not.

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

The 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 Sertralina Normon

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, do not take it when you realize it. Take the next dose when it is due.

If You Interrupt Treatment with Sertralina Normon

Do not interrupt treatment with this medication unless your doctor indicates it. Your doctor will want to gradually reduce the dose of sertralina over several weeks before you stop taking this medication definitively. If you interrupt 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 with this medication, please inform your doctor.

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

4. Possible Adverse Effects

Like all medications, Sertralina Normon can cause adverse effects, although not all people experience them.

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

Tell Your Doctor Immediately

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

• If you develop a severe skin rash that causes blisters (erythema multiforme), (can affect the mouth and tongue). These can be signs of a disease known as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN). In these cases, your doctor will interrupt treatment.
• Allergic reaction or allergy, which can present symptoms such as skin rash with itching, breathing problems, wheezing, swelling of the eyelids, face, or lips.
• If you present agitation, confusion, diarrhea, increased temperature and blood pressure, excessive sweating, and increased heart rate. These are symptoms of serotonin syndrome. In rare cases, this syndrome can occur when taking certain medications at the same time as sertralina. Your doctor may decide to interrupt treatment.
• If you present yellowish color of the skin and eyes, which can indicate liver damage.
• If you present depressive symptoms with thoughts of self-harm or suicide (suicidal thoughts).
• If, after starting treatment with Sertralina Normon, you begin to feel restless and are unable to sit or stand. You should inform your doctor if you start to feel restless.
• If you have a seizure (convulsions).
• If you have 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, drowsiness, headache, diarrhea, feeling unwell, dry mouth, ejaculation problems, and fatigue.

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

• Cold (chest), sore throat, runny nose.
• Lack 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.
• Stomach upset, constipation, abdominal pain, vomiting, gas.
• Increased sweating, rash.
• Back pain, joint pain, muscle pain.
• Irregular menstrual cycle, erectile dysfunction.
• Malaise, chest pain, weakness, fever.
• Weight gain.
• Injury.

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

• Diverticulitis, lymph node swelling, low platelet count*, low white blood cell count*.
• Severe allergic reaction.
• Endocrine problems*.
• High cholesterol, problems controlling blood sugar levels (diabetes), low blood sugar, high blood sugar*, low sodium levels in the blood*.
• Physical symptoms due to stress or emotions, abnormal nightmares*, drug dependence, sleepwalking, premature ejaculation.
• Coma, abnormal movements, difficulty moving, increased sensitivity, severe headache (which can 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 (eye sensitivity to light), eye bleeding, irregular pupils*, visual disturbances*, tear problems.
• Heart attack, dizziness, fainting or chest discomfort that could be signs of changes in electrical activity (seen on an 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, slow breathing, hiccups.
• A type of lung disease in which eosinophils (a type of white blood cell) appear in the lungs in high numbers (eosinophilic pneumonia).
• Mouth ulcers, pancreatitis*, blood in stool, tongue ulcers, mouth sores.
• Liver function problems, serious liver function problems*, yellowing of the skin and eyes (jaundice)*.
• Sunburn*, skin swelling*, abnormal hair texture, abnormal skin odor, capillary rash.
• Muscle rupture*, bone disorder.
• Interrupted urination, decreased urine volume, urinary retention, urinary incontinence, increased urine volume, need to urinate at night.
• Sexual dysfunction, excessive vaginal bleeding, vaginal hemorrhage, female sexual dysfunction.
• Swollen legs, chills, difficulty walking, thirst.
• Increased liver enzyme levels, weight loss.
• There have been reports of suicidal thoughts and behavior during treatment with sertralina or shortly after its interruption (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, problems controlling blood sugar levels (diabetes), low blood sugar, high blood sugar*, low sodium levels in the blood*.
• Physical symptoms due to stress or emotions, abnormal nightmares*, drug dependence, sleepwalking, premature ejaculation.
• Coma, abnormal movements, difficulty moving, increased sensitivity, severe headache (which can 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 (eye sensitivity to light), eye bleeding, irregular pupils*, visual disturbances*, tear problems.
• Heart attack, dizziness, fainting or chest discomfort that could be signs of changes in electrical activity (seen on an 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, slow breathing, hiccups.
• A type of lung disease in which eosinophils (a type of white blood cell) appear in the lungs in high numbers (eosinophilic pneumonia).
• Mouth ulcers, pancreatitis*, blood in stool, tongue ulcers, mouth sores.
• Liver function problems, serious liver function problems*, yellowing of the skin and eyes (jaundice)*.
• Sunburn*, skin swelling*, abnormal hair texture, abnormal skin odor, capillary rash.
• Muscle rupture*, bone disorder.
• Interrupted urination, decreased urine volume, urinary retention, urinary incontinence, increased urine volume, need to urinate at night.
• Sexual dysfunction, excessive vaginal bleeding, vaginal hemorrhage, female sexual dysfunction.
• Swollen legs, chills, difficulty walking, thirst.
• Increased liver enzyme levels, weight loss.
• Average blood pressure.

Frequency Not Known: cannot be estimated from the available data

• Jaw locking*.
• Nocturnal urinary incontinence*.
• Partial loss of vision.
• Colon inflammation (which causes diarrhea).
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, Breastfeeding, and Fertility" in section 2 for more information.
• Muscle weakness and severe muscle pain, which can be a sign of multiple acyl-CoA 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, diarrhea, and nausea.

Symptoms That May Appear When Treatment is Interrupted

If you interrupt treatment with this medication abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors (see section 3. If You Interrupt Treatment with Sertralina Normon).

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

Reporting 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 through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Sertralina Normon

Keep this medication out of sight and reach of children.

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.

Store below 30 ºC.

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Sertralina Normon Composition

• The active ingredient of Sertralina Normon is sertralina (hydrochloride). Each tablet contains 100 mg of sertralina.

The other components are: calcium phosphate dibasic dihydrate, microcrystalline cellulose, sodium starch glycolate (type A), colloidal silicon dioxide, and magnesium stearate. Coating: hypromellose, titanium dioxide (E-171), talc, and macrogol 6000.

Product Appearance and Package Contents

Sertralina Normon 100 mg is presented as film-coated tablets, white or almost white, round, biconvex, scored, and engraved.

Sertralina Normon is available in three package sizes: 30, 60, and 500 tablets. The tablets are presented in PVC/Aluminum blisters.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the Last Revision of this Leaflet:August 2025

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

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/65922/P_65922.html