SERTRALINE QUALIGEN FARMA 50 mg FILM-COATED TABLETS

2. What you need to know before you take Sertraline Qualigen Farma

Do not take Sertraline Qualigen Farma:

• 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 in the last 14 days medicines called monoamine oxidase inhibitors (MAOIs), such as selegiline, 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.

Warnings and precautions:

Consult your doctor or pharmacist before starting treatment with Sertraline Qualigen Farma.

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

• Epilepsy or history of epilepsy. 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.
• Serotonin syndrome. This syndrome can occur rarely when taking certain medicines at the same time as sertraline. (To see the symptoms, read section 4. Possible side effects). Your doctor will tell you if you have had this syndrome before.
• If you have low sodium levels in the blood, as this condition may occur as a result of treatment with sertraline. 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 above).
• Liver disease; your doctor may consider 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 medications.
• If you have had bleeding disorders, bleeding tendencies (tendency to develop bruises), or if you are pregnant (see section Pregnancy, breastfeeding, and fertility) or have been taking medications that decrease blood clotting [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 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 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 abnormality in the graph of the heart 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 QT prolongation, low heart rate, or use concomitantly medications that prolong the QT 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 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 and section 4. Possible side effects). The risk of experiencing 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 stopping treatment. 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 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.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or committing suicide. This may increase at the beginning of treatment with antidepressants, due to the fact that all these medications take time to work, which is usually a few weeks but can sometimes be 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 of age with psychiatric disorders who are 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 family member or close 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 medicines in the same group as sertraline (called SSRIs) may 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 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 side effects such as suicidal attempts, thoughts of self-harm or suicide (suicidal ideas), and hostility (mainly aggression, confrontational behavior, and anger). However, it is possible that your doctor may decide to prescribe Sertraline Qualigen Farma to a patient under 18 years of age if they consider it is the best option for the patient. If your doctor has prescribed this medicine and you are under 18 years of age and wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen when you are taking sertraline.

At the same time, the long-term effects on safety and related to growth, maturity, and learning (cognitive development) and behavioral development of sertraline in this age group have not yet been demonstrated.

Other medicines and Sertraline Qualigen Farma

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

Some medicines may affect the way this medicine works or this medicine may reduce the effectiveness of other medicines that are being taken at the same time.

Taking Sertraline Qualigen Farma 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 methylthioninium chloride (methylene blue) (for high levels of methemoglobin in the blood). Do not take sertraline with these medicines.

• Medicines for treating mental disorders such as psychosis (pimozide). Do not take sertraline with pimozide.

Tell 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 treating severe or chronic pain (opioids, e.g., tramadol, fentanyl).
• Medicines used in anesthesia (e.g., fentanyl, mivacurium, and suxamethonium).
• Medicines for treating migraines (e.g., sumatriptan).
• Medicines that decrease blood clotting (warfarin).
• Medicines for treating pain/arthritis [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 heart activity (e.g., some antipsychotics and antibiotics).
• Metamizole, a medicine used to treat pain and fever.

Taking Sertraline Qualigen Farma with food, drinks, and alcohol

This medicine can be taken with or without food.

Alcohol consumption should be avoided while being treated with sertraline.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 benefit to you outweighs any possible risk to the developing baby.

If you take sertraline during 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 be aware that you are taking Sertraline Qualigen Farma so they can advise you.

When taken during pregnancy, especially during the last 3 months, medicines like sertraline may increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby 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 possible risk to the baby.

In animal studies, it has been seen that some medicines like sertraline may reduce sperm quality. Theoretically, this could affect fertility; however, the impact on human fertility has not yet been determined.

Driving and using machines

During treatment with Sertraline Qualigen Farma, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with Sertraline Qualigen Farma affects you.

Sertraline Qualigen Farma contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to Take Sertralina Qualigen Farma

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

Sertralina Qualigen Farma can be taken with or without food.

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

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 usual 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:

Sertralina Qualigen Farma should only be used to treat children and adolescents aged 6 to 17 years who have 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 give you.

Method of administration:

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.

If you take more Sertralina Qualigen Farma than you should

If you accidentally take an excess of sertraline, contact your doctor or go to the emergency department of the nearest hospital. Always carry the medication package with you, whether it still contains medication 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 in rare cases, loss of consciousness.

If you forget to take Sertralina Qualigen Farma

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 remember. Take the next dose when it is due.

Do not take a double dose to make up for forgotten doses.

If you stop treatment with Sertralina Qualigen Farma

Do not stop treatment with Sertralina Qualigen Farma unless your doctor tells you to. Your doctor will want to gradually reduce the dose of this medication over several weeks before you stop taking it altogether. If you stop treatment abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors. If you experience any of these side effects, or any other during the interruption of your treatment with sertraline, please inform your doctor.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not all people experience them.

The most common side effect is nausea. Side 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 with blisters (erythema multiforme), (which 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 stop 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 experience agitation, confusion, diarrhea, increased temperature and blood pressure, excessive sweating, and increased pulse 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 can indicate liver damage.
• If you experience depressive symptoms with thoughts of self-harm or suicide (suicidal thoughts).
• If, after starting treatment with sertraline, you begin to feel restless and are unable to sit or stand still. 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 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
• 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,
• tremors, muscle movement problems (such as constant movement, 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 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):

• gastroenteritis, ear infection,
• tumor,
• hypersensitivity, seasonal allergy,
• low thyroid hormone levels,
• suicidal thoughts, suicidal behavior*, psychotic disorders, abnormal thoughts, lack of care, hallucinations, aggression, excessive happiness, paranoia,
• amnesia, decreased sensitivity, involuntary muscle contractions, fainting, continuous movement, migraine, convulsions, dizziness when standing up, abnormal coordination, speech disorders,
• dilated pupils,
• ear pain,
• rapid heartbeat, heart problems,
• bleeding problems (such as stomach bleeding)*, high blood pressure, hot flashes, blood in urine,
• shortness of breath, nosebleeds, difficulty breathing possibly noisy,
• black stools, dental problems, esophageal inflammation, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders,
• eye swelling, hives, 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 disorders, 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 sertraline or shortly after its discontinuation (see section 2).

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

• diverticulitis, lymph node swelling, decreased platelet count*, decreased 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 heart 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,
• mouth ulcers, pancreatitis*, blood in stool, tongue ulcers, mouth sores,
• liver function problems, severe 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,
• urinary hesitation, decreased urine volume,
• breast secretion, vaginal dryness, genital secretion, penile and foreskin pain and redness, breast enlargement*, prolonged erection,
• hernia, decreased drug tolerance,
• increased cholesterol levels, abnormal laboratory tests*, abnormal semen, coagulation problems*,
• relaxation of blood vessel procedure.

Frequency not known (cannot be estimated from 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).

*Side effects reported after marketing.

Other side effects in children and adolescents

In clinical trials in children and adolescents, side effects were generally similar to those reported in adults (see above). The most common side 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 medication 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 Qualigen Farma).

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

Reporting side effects:

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Sertralina Qualigen Farma

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging, after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

6. Package Contents and Additional Information

Sertralina Qualigen Farma Composition

• The active ingredient of Sertralina Qualigen Farma is sertraline (hydrochloride). Each tablet contains 50 mg of sertraline.
• The other ingredients are anhydrous colloidal silica, microcrystalline cellulose (E-460i), sodium croscarmellose (E-466), copovidone (E-1208), hydrated lactose, and magnesium stearate (E-572). Coating (Opadry white): hypromellose (E-464), hydroxypropylcellulose (E-463), macrogol 400 (E-1521), and titanium dioxide (E-171).

Product Appearance and Package Contents

Sertralina Qualigen Farma is presented in white or grayish-white film-coated tablets.

Sertralina Qualigen Farma is available in three package sizes: 30, 60, and 500 tablets. The tablets are presented in aluminum/PVC-PVDC blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Av. Barcelona, 69

08970 – Sant Joan Despí

Barcelona – Spain

Manufacturer:

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10, Polígono Industrial Areta

(Huarte-Pamplona) – 31620

Spain

O

Toll Manufacturing Services, S.L.

Aragoneses 2, 28108 Alcobendas

Madrid – Spain

Date of the last revision of this leaflet: June 2025

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