Package Leaflet: Information for the User

Sertraline Normon 50 mg Film-Coated Tablets EFG

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. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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

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

3.How to take Sertraline Normon

4.Possible side effects

5.Storage of Sertraline Normon

6.Contents of the pack and additional information

Sertralina Normoncontains 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 Normoncan be used to treat:

• Depression and prevention of depression relapse (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 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 humiliating way).

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 Normon

• If you are allergic to sertraline or any of the other ingredients of this medicine (listed in section 6).
• If you are taking or have taken medicines called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other similar medicines (such as linezolid).If you stop taking sertraline, you should wait at least one week before starting treatment with an MAOI.After stopping treatment with an MAOI, you should 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

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

Medicines are not always suitable for everyone. Before starting treatment with Sertralina 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, 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 Thoughts of suicide and worsening of your depression or anxiety).
• If you have serotonin syndrome. In rare cases, this syndrome can occur when you are taking certain medicines at the same time as sertraline. (To see the symptoms, read the 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 situation can occur as a result of treatment with Sertralina Normon. You should also inform your doctor if you are taking any medicines for high blood pressure, as these medicines can also alter sodium levels in your blood.
• If you are elderly, as you may be at greater risk of having low sodium levels in your blood (see above).
• If you have liver disease; your doctor may consider that you should take a lower dose of Sertralina Normon.
• If you have diabetes; Sertralina Normon can alter your blood sugar levels, so you may need to adjust the dose of your diabetes medicines.
• If you have a history of bleeding disorders (tendency to develop bruising), or if you are pregnant (see Pregnancy, breastfeeding and fertility) or have been taking medicines that reduce 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 Normon 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 keep a close eye on you (see below Children and adolescents).
• If you are receiving electroconvulsive therapy (ECT).
• If you have any eye disorders, 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 QTc prolongation, low heart rate, or are taking medicines that prolong the QTc interval.

Restlessness/Acatisia

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 (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 Normon 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 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 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 suicidal thoughts. This may increase at the beginning of treatment with antidepressants, as all these medicines take time to take effect, which is usually two weeks but can be longer.

This is more likely to happen

• If you have had thoughts of suicide or self-harm before.
• 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 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 close family member or friend that you are depressed or have anxiety, 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 medicines in the group to which Sertralina Normon belongs (called SSRIs) can cause sexual dysfunction symptoms (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 old, except in the case of patients with obsessive-compulsive disorder (OCD). Young patients are at greater risk of side effects such as suicidal thoughts, thoughts of self-harm, or hostility (mainly aggression, confrontational behavior, and irritable reactions) when treated with this class of medicines. However, your doctor may decide to prescribe Sertralina Normon 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 Normon and you are under 18 years old and want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen when you are taking Sertralina 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 medicines and Sertralina Normon

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

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

Using Sertralina Normon with the following medicines may cause serious side effects

• Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (for depression), selegiline (for Parkinson's disease), the antibiotic linezolid, and methylene blue (for high levels of methemoglobin in the blood). Do not take Sertralina Normon with these medicines.
• Medicines for treating mental disorders such as psychosis (pimozide). Do not take Sertralina Normon 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).
• Medicines based on plants 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 treating severe or chronic pain (opioids, such as tramadol, fentanyl).
• Medicines used in anesthesia (such as fentanyl, mivacurium, and suxamethonium).
• Medicines for treating migraines (such as sumatriptan).
• Medicines that reduce blood clotting (warfarin).
• Medicines for treating pain/arthritis (such as metamizole, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin).
• Sedatives (diazepam).
• Diuretics.
• Medicines for treating epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines for treating diabetes (tolbutamide).
• Medicines for treating acid reflux, 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 to regulate heart rate (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 heart rhythm (such as some antipsychotics and antibiotics).

Taking Sertralina Normon with food, drinks, and alcohol

Sertralina Normon tablets can be taken with or without food.

Alcohol should be avoided while being treated with Sertralina Normon.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or 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. If you are pregnant, sertraline will only be given to you if your doctor considers that the benefits for you outweigh any possible risk to the developing baby.

If you take Sertralina Normon tablets in the final stages of pregnancy, there may be a higher risk of excessive bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Sertralina Normon tablets so that they can advise you. When taken during pregnancy, especially in the last three months, medicines like Sertralina Normon may increase the risk of a serious condition in newborn babies called persistent pulmonary hypertension of the newborn (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 occur 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.
• Extreme tiredness, unable to sleep, or crying a lot.
• Rigidity 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 sertraline passes into breast milk. Therefore, sertraline can only be used in women who are breastfeeding if your doctor considers that the benefits outweigh any possible risk to the baby.

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

Driving and operating machinery

Psychotropic medicines like 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 develop these activities.

Sertralina Normon contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) 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 start with a dose of 25mg 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:

This medication should only be used to treat children and adolescents of6 to17 years of age who present OCD.

Obsessive-Compulsive Disorder:

Children aged6 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 aged13 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..

Administration form

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.The treatment of depression usually should continue for 6 months after improvement.

If you take more Sertralina Normon than you should

If you accidentally take an excessive amount of sertralina, contact your doctor or go to the nearest hospital emergency service. Always carry the medication packaging with you, whether it contains medication or not.

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 Sertralina Normon

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 treatment with Sertralina Normon

Do not stop treatment with this medication unless your doctor tells you to. Your doctor will want to gradually reduce the dose ofsertralinaover several weeks before stopping it 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 withsertralina, please inform your doctor.

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

Like all medications, Sertralina Normon may 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 medication, 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 heart rate. 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 ofharming oneself or committing suicide (suicidal thoughts).
• If you start to feel restless and are unable to sit or stand after starting treatment withSertralina Normon. 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 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):

• Common cold (chest), sore throat, runny nose.
• Loss of appetite, increased appetite.
• Anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, bruxism.
• Tremor, muscle movement problems (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.
• Tinnitus in the ears.
• Palpitations.
• Hot flashes.
• Yawning.
• Abdominal 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.
• Lesion.

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

• Gastroenteritis, ear infection.
• Tumor.
• Hypersensitivity, seasonal allergy.
• Low levels of thyroid hormones.
• Suicidal thoughts, suicidal behavior*, psychotic disorders, abnormal thoughts, neglect, hallucinations, aggression, excessive happiness, paranoia.
• Amnesia, decreased sensitivity, involuntary muscle contractions, fainting, continuous movements, migraine, seizures, dizziness when standing up, 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, nasal bleeding, possible noisy breathing.
• Black stools, dental disorders, esophageal inflammation, tongue problems, hemorrhoids, excessive salivation, difficulty swallowing, belching, tongue disorders.
• Swelling of the eyes, urticaria, hair loss, itching, purple spots on the skin, skin disorders with blisters, dry skin, swelling of the face, cold sweat.
• Arthritis, muscle spasms, muscle cramps*, muscle weakness.
• Increased frequency of urination, urinary disorders, urinary retention, incontinence, increased urine volume, need to urinate at night.
• Female sexual dysfunction, excessive vaginal bleeding, vaginal bleeding, female sexual dysfunction.
• Swollen legs, chills, difficulty walking, thirst.
• Increased liver enzymes, weight loss.
• Cases of suicidal thoughts and behavior 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 in the blood*.
• Symptoms due to stress or emotions, abnormal nightmares*, medication dependence, sleepwalking, premature ejaculation.
• Coma, abnormal movements, difficulty moving, increased sensitivity, sudden and 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 (sensitivity to light), eye hemorrhages, irregular pupils*, visual disturbances*, eye disorders.
• 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.
• Problems with circulation in the arms and legs.
• Accelerated breathing, progressive formation of scars in lung tissue (interstitial lung disease)*, throat spasm, difficulty speaking, rapid 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 disorders*, yellowing of the skin and eyes (jaundice)*.
• Sun sensitivity reaction*, skin swelling*, abnormal hair texture, abnormal skin odor, capillary eruption.
• Muscle tissue rupture*, bone disorders.
• Intermittent urination, decreased urine volume.
• Milk secretion, vaginal dryness, genital secretion, penile and preputial pain and redness, breast enlargement*, prolonged erection.
• Hernia, decreased tolerance to the medication.
• High cholesterol levels, abnormal analytical tests*, abnormal semen, coagulation disorders*.
• Relaxation of blood vessel procedure.

Frequency not known: cannot be estimated from available data

• Trigeminal nerve block*.
• Nocturnal urinary incontinence*.
• Partial loss of vision.
• Colitis (which causes diarrhea).
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see«Pregnancy, lactation, and fertility»in section 2 for more information.

*Adverse effects reported aftermarketing

Other adverse effects in children and adolescents

In clinical trials in children and adolescents, the 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 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 Sertralina Normon).

There has been an increased risk of bone fractures 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 through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the 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 below30 °C.

Medicines should not be thrown into the drains or intothe trash. Disposeof the packaging and the medicines that you no longer need at the pharmacy take-backpoint.If in doubtask your pharmacist how to dispose of the packaging and the medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Sertralina Normon

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

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

Appearance of the product and contents of the packaging

Sertralina Normon 50 mg is presented as coated tablets with a film coatingof white or almost white color, round biconvex shape, scored and printed.

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

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

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

Date of the last review of this leaflet:June 2024

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/

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

https://cima.aemps.es/cima/dochtml/p/65923/P_65923.html