Package Insert: Information for the User

Sertraline Qualigen Farma 50 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Sertralina Qualigen Farma contains sertraline as the active ingredient. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs); these

medicines are used to treat depression and/or anxiety disorders.

Sertralina Qualigen Farma can 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 anxiety-related diseases 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-related disease. It is characterized by 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 that this medicine is suitable for treating your condition.

If you are unsure why you have been prescribed Sertralina Qualigen Farma, you should consult your doctor.

Do not take Sertralina Qualigen Farma:

• If you are allergic to sertraline or any of the other ingredients 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 sertraline, 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 sertraline.

Do not take Sertralina Qualigen Farma 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 Qualigen Farma.

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

• Epilepsy or a 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. In rare cases, this syndrome can occur when taking certain medications at the same time as sertraline. (See 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 sertraline. Also, inform your doctor if you are taking any medication for high blood pressure, 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).
• 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 you may need to adjust the dose of your diabetes medication.
• If you have had bleeding disorders, clotting disorders (tendency to develop petechiae), or if you are pregnant (see Pregnancy, breastfeeding and fertility) or have taken medications 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. Sertraline 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 Use in 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 QT prolongation, low heart rate, or are taking medications that prolong the QT 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 sertraline 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 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 depression or anxiety disorder:

If you are depressed and/or have anxiety disorders, you may 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 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 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 sertraline belongs (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 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 suicide (suicidal ideas), and hostility (predominantly aggression, confrontational behavior, and irritable reaction) when treated with this class of medications. However, your doctor may decide to prescribe Sertralina Qualigen Farma 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 this medication 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 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 medications and Sertralina Qualigen Farma:

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 this medication works, or this medication itself may reduce the effectiveness of other medications you are taking at the same time.

The use of Sertralina Qualigen Farma with the following medications may cause serious side effects:

• Medications 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 sertraline with these medications.

• Medications to treat mental disorders such as psychosis (pimozide). Do not take sertraline 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 containing St. John's Wort (Hypericum perforatum).
• 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 reduce blood clotting (warfarin).
• Medications to treat pain/arthritis [non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin (acetylsalicylic acid)].
• 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).
• Metamizole, a medication used to treat pain and fever.

Taking Sertralina Qualigen Farma with food, drinks, and alcohol:

You can take this medication with or without food.

Avoid drinking alcohol while taking sertraline.

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, 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 benefits for you outweigh any possible risk to the developing fetus.

If you take sertraline in the final stages of pregnancy, there may be a higher 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 Qualigen Farma so that they can advise you.

When taken during pregnancy, especially in the last three months, medications like sertraline may increase the risk of a serious condition in newborns 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 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 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.

Sertraline may pass 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.

Studies in animals have shown that some medications, such as sertraline, may reduce the quality of sperm. Theoretically, this could affect fertility, but it has not yet been determined in humans.

Driving and operating machinery:

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

Sertralina Qualigen Farma contains lactose and sodium:

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

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

Follow exactly the administration instructions of this medication 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.

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

The recommended dose is:

Adults:

Depression and Obsessive-Compulsive Disorder:

For depression and OCD, the commonly effective dose is 50 mg per day. The daily dose can be increased by 50 mg at intervals of at least one week, and thus over 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:

Sertralina Qualigen Farma 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 their instructions.

Administration form:

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.

If you take more Sertralina Qualigen Farma 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 forget to take Sertralina Qualigen Farma

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.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Sertralina Qualigen Farma

Do not interrupt 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 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 with sertralina, 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 interrupt treatment.
• Allergic reaction or allergy, which may present symptoms such as skin rash with itching, breathing problems, ringing, swelling of the eyelids, face, or lips.

• If you experience agitation, confusion, diarrhea, increased temperature, and 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 interrupt 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 to feel restless and are unable to sit or stand after starting treatment with sertraline. Inform your doctor if you start to feel 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,
• Discomfort,
• Dry mouth,
• Sexual dysfunction
• Fatigue.

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

• Common cold (of the chest), sore throat, runny nose,
• Loss of appetite, increased appetite,
• Anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, teeth grinding,
• Tremor, muscle movement disorders (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,
• Tinnitus in the ears,
• Palpitations,
• Angina,
• Yawns,
• Abdominal discomfort, constipation, abdominal pain, vomiting, gas,
• Increased sweating, rash,
• Back pain, joint pain, muscle pain,
• Irregular menstrual cycle, erectile dysfunction,
• Discomfort, 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, 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, angina, hematuria,
• Shortness of breath, nasal bleeding, possible noisy breathing,
• Black stools, dental disorders, esophageal inflammation, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders,
• Swollen eyes, urticaria, hair loss, itching, purple spots on the skin, skin disorders with blisters, dry skin, facial swelling, cold sweat,
• Arthritis, muscle spasms, muscle cramps*, muscle weakness,
• Increased frequency of urination, urinary disorders, urinary retention, urinary incontinence, increased urine volume, nocturia,
• 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 have been reported 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, 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 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 (light sensitivity), eye bleeding, irregular pupils*, visual disturbances*, eye disorders,
• Heart attack, dizziness, fainting, or chest discomfort that may be signs of changes in electrical activity (seen on the electrocardiogram) or abnormal heart rhythm*, decreased heart rate,
• Leg and arm circulation problems,
• Accelerated breathing, progressive scarring of lung tissue (interstitial lung disease)*, throat spasm, difficulty speaking, slower breathing, hiccups,
• Mouth ulceration, pancreatitis*, bloody stools, tongue ulceration, mouth sores,
• Liver function problems, severe liver function disorders*, yellow skin and eyes (jaundice)*,
• Sun sensitivity*, 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,
• Increased cholesterol levels, abnormal laboratory results*, abnormal semen, bleeding disorders*,
• Relaxation of blood vessel function.

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 after childbirth (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 interrupted

If you interrupt treatment with this medicine 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 Qualigen Farma).

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 through the Spanish System for the Vigilance of Medicines for Human Use: 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.

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.

No special storage conditions are required.

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. This will help protect the environment.

at your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Sertralina Qualigen Farma

Appearance of the product and content of the packaging

Sertralina Qualigen Farma is presented in coated tablets with a white or light gray film.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Neuraxpharm Spain, S.L.U.

Av. Barcelona, 69

08970 – Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing:

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10, Industrial Estate Areta

(Huarte-Pamplona) – 31620

Spain

O

Toll Manufacturing Services, S.L.

Aragoneses 2, 28108 Alcobendas

Madrid – Spain

Last review date of this leaflet: July 2022

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