Sertraline Qualigen Farma 100 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sertraline Qualigen Farma 100 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

What Sertraline Qualigen Farma is and what it is used for
What you need to know before taking Sertraline Qualigen Farma
How to take Sertraline Qualigen Farma
Possible adverse effects
How to store Sertraline Qualigen Farma
Contents of the pack and other information

1. What Sertralina Qualigen Farma is and what it is used for

Sertralina Qualigen Farma contains sertraline as the active substance. 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 recurrence of depression (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 illness with symptoms such as feelings of sadness, inability to sleep well, or inability to enjoy life as one used to.

OCD and panic disorders are anxiety-related conditions, with symptoms such as persistent worry about recurring thoughts (compulsions) that lead to repetitive rituals (obsessions).

PTSD is a disorder that may occur following an emotionally traumatic experience and has some symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterized by intense anxiety or distress in social situations (for example: speaking with strangers, speaking in public, eating or drinking in front of others, or worrying about behaving in an embarrassing way).

Your doctor has determined that this medicine is appropriate for treating your condition.

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

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

Do not take Sertraline Qualigen Farma:

If you are allergic to sertraline or to any of the other ingredients of this medicine (listed in section 6).
If you are taking or have recently taken medicines known as 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.
If you are taking another medicine called pimozide (a medicine used to treat mental disorders such as psychosis).

Warnings and precautions:

Talk to your doctor or pharmacist before taking 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 previously had any of the following conditions:

Epilepsy or a history of epilepsy. If you have a seizure (convulsion), contact your doctor immediately.
Bipolar disorder (manic-depressive illness) or schizophrenia. If you experience a manic episode, contact your doctor immediately.
Serotonin syndrome. This syndrome may rarely occur when taking certain medicines together with sertraline. (For symptoms, see section 4. Possible side effects.) Your doctor will advise you if you have previously experienced this syndrome.
Low blood sodium levels, as this condition may occur as a result of treatment with sertraline. You should also inform your doctor if you are taking any medicines for high blood pressure, as these medicines may also affect blood sodium levels.
Advanced age, as you may have an increased risk of low blood sodium levels (see previous point).
Liver disease; your doctor may decide that you should take a lower dose of sertraline.
Diabetes; sertraline may alter your blood sugar levels, so it may be necessary to adjust the dose of your diabetes medication.
A history of bleeding disorders, hemorrhagic tendencies (tendency to develop bruises), or if you are pregnant (see section Pregnancy, breastfeeding and fertility) or have been taking medicines that reduce blood clotting [for example, 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 being treated for this disorder, your doctor will want to monitor you closely (see section Use in children and adolescents below).
If you are receiving electroconvulsive therapy (ECT).
Eye disorders, such as certain types of glaucoma (increased intraocular pressure).
If you have been told you have an abnormality in the heart tracing obtained from an electrocardiogram (ECG), known as QT interval prolongation.
If you have heart disease, low levels of potassium or magnesium, a family history of QTc prolongation, slow heart rate, or if you are taking concomitantly medicines 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 sit or stand still (akathisia). This occurs most frequently during the first few weeks of treatment. Increasing the dose may be harmful; therefore, 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, the dose, and the rate at which the dose is reduced. Generally, these symptoms are mild or moderate. However, in some patients they may be severe. These symptoms usually appear in the first few days after stopping treatment. In general, these symptoms resolve on their own and usually disappear 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 discontinue treatment.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts about harming yourself or committing suicide. This may increase at the beginning of treatment with antidepressants, because all these medicines take time to work, usually about two weeks, but sometimes longer.

You are more likely to experience this:

If you have previously had thoughts of suicide or self-harm.
If you are a young adult. Clinical trial data show an increased risk of suicidal behavior in psychiatric patients under 25 years of age treated with an antidepressant.

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

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

Sexual problems:

Some medicines 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

Sertraline should normally not be used to treat children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder (OCD). Patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, thoughts of self-harm or suicide (suicidal ideation), and hostility (predominantly aggression, confrontational behaviour, and anger reactions) when treated with this class of medicines. Nevertheless, your doctor may decide to prescribe Sertralina Qualigen Farma to a patient under 18 years of age if he or she considers it to be in the patient's best interest. If your doctor has prescribed this medicine and you are under 18 years of age and wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen while you are taking sertraline.

In addition, the long-term effects on safety regarding growth, puberty, learning (cognitive development), and behavioural development of sertraline in this age group have not yet been established.

Other medicines and Sertralina Qualigen Farma

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

Some medicines may affect how this medicine works, or this medicine may reduce the effectiveness of other medicines taken at the same time.

Using Sertralina Qualigen Farma together with the following medicines may cause serious adverse effects:

Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression), selegiline (used to treat Parkinson's disease), the antibiotic linezolid, and methylene blue (used to treat high levels of methaemoglobin in the blood). Do not use sertraline with these medicines.
Medicines used to treat mental disorders such as psychosis (pimozide). Do not use sertraline 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).
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 to treat severe or chronic pain (opioids, e.g. tramadol, fentanyl).
Medicines used in anaesthesia (e.g. fentanyl, mivacurium, and suxamethonium).
Medicines to treat migraines (e.g. sumatriptan).
Medicines that reduce blood clotting (warfarin).
Medicines to treat pain/arthritis [non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)].
Sedatives (diazepam).
Diuretics.
Medicines to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
Medicines to treat diabetes (tolbutamide).
Medicines to treat acidity, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
Medicines to treat mania and depression (lithium).
Other medicines to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
Medicines to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
Medicines to treat high blood pressure, chest pain, or to regulate 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 the electrical activity of the heart (e.g. some antipsychotics and antibiotics).
Metamizole, a medicine used to treat pain and fever.

Taking Sertralina Qualigen Farma with food, drinks, and alcohol

This medicine can be taken with or without food.

Alcohol intake should be avoided while being treated with sertraline.

Sertraline should not be taken together 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 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, you will only be given sertraline if your doctor considers that the benefit to you outweighs any possible risk to the developing baby.

If you take sertraline in the late stages of pregnancy, there may be an increased risk of heavy 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 Sertralina Qualigen Farma so they can advise you accordingly. When taken during pregnancy, especially during the last 3 months, medicines like sertraline may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.

Your newborn baby may experience other conditions, which usually appear within the first 24 hours after birth. Symptoms include:

difficulty breathing,
bluish or unusually hot or cold skin,
blue lips,
vomiting or feeding problems,
excessive tiredness, inability to sleep, or excessive crying,
muscle stiffness or decreased muscle tone,
tremors, restlessness, or seizures,
increased reflex responses,
irritability,
low blood sugar levels.

If your baby shows any of these symptoms at birth, or if 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 benefit outweighs any possible risk to the child.

Animal studies have shown that some medicines like sertraline may reduce sperm quality. This could theoretically affect fertility; however, the impact on human fertility has not yet been determined.

Driving and using machines

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 informed you that you have an intolerance to certain sugars, consult with him or her 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 Sertraline Qualigen Farma

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist.

Sertraline Qualigen Farma can be taken with or without food.

Take your medicine once daily, either in the morning or at night.

If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults:

Depression and Obsessive-Compulsive Disorder (OCD):

For depression and OCD, the usual effective dose is 50 mg per day. The daily dose may be increased in 50 mg increments at intervals of at least one week, over several weeks. The maximum recommended dose is 200 mg per day.

Panic disorder, social anxiety disorder, and post-traumatic stress disorder:

For panic disorder, social anxiety disorder, and post-traumatic stress disorder, treatment should be initiated at a dose of 25 mg per day, increasing to 50 mg per day after one week.

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

Use in children and adolescents:

Sertraline 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 the instructions provided by him/her.

Method of administration:

Your doctor will determine how long you should take this medicine. The duration will depend on the nature of your illness and your response to treatment. It may take several weeks before your symptoms begin to improve.

If you take more Sertraline Qualigen Farma than you should

If you accidentally take too much sertraline, contact your doctor or go to the nearest hospital emergency department. Always bring the medicine packaging with you, regardless of whether any medicine remains.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, tremors, agitation, dizziness, and, rarely, loss of consciousness.

If you forget to take Sertraline Qualigen Farma

Do not take a double dose to make up for forgotten doses. If you miss a dose, do not take it when you remember. Take the next dose at the scheduled time.

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

If you stop taking Sertraline Qualigen Farma

Do not stop treatment with Sertraline Qualigen Farma unless instructed by your doctor. Your doctor will want to gradually reduce the dose of this medicine over several weeks before you stop taking 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 tremor. If you experience any of these adverse effects, or any other symptoms, during discontinuation of sertraline treatment, please inform your doctor.

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

4. Possible adverse effects

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

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

Tell your doctor immediately

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

If you develop a severe skin rash causing blisters (erythema multiforme), (which may affect the mouth and tongue). These may be signs of a condition known as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN). In such cases, your doctor will discontinue treatment.
Allergic reaction or allergy, which may present symptoms such as itchy skin rash, breathing difficulties, wheezing, swelling of the eyelids, face, or lips.
If you experience agitation, confusion, diarrhea, increased body temperature and blood pressure, excessive sweating, and rapid pulse. These are symptoms of serotonin syndrome. Rarely, this syndrome may occur when taking certain medicines together with sertraline. Your doctor may decide to discontinue treatment.
If you notice yellowing of the skin or eyes, which may indicate liver damage.
If you experience depressive symptoms with thoughts of harming yourself or suicide (suicidal thoughts).
If, after starting treatment with sertraline, you begin to feel restless and are unable to sit or stand still. Inform your doctor if you start feeling restless.
If you have a seizure (convulsion).
If you experience 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 people):

Insomnia
dizziness,
somnolence,
headache,
diarrhea,
malaise,
dry mouth,
ejaculation problems,
fatigue.

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

cold (chest), sore throat, runny nose,
loss of appetite, increased appetite,
anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, teeth grinding,
tremor, movement disorders (such as constant movements, muscle tension, difficulty walking and rigidity, spasms, and involuntary muscle movements)*, numbness and tingling, increased muscle tone, difficulty concentrating, abnormal taste,
visual disturbances,
ringing in the ears,
palpitations,
hot flushes,
yawning,
stomach discomfort, constipation, abdominal pain, vomiting, flatulence,
increased sweating, rash,
back pain, joint pain, muscle pain,
menstrual irregularities, erectile dysfunction,
malaise, chest pain, weakness, fever,
weight gain,
injury.

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

gastroenteritis, ear infection,
tumor,
hypersensitivity, seasonal allergy,
low levels of thyroid hormones,
suicidal thoughts, suicidal behaviour*, psychotic disorders, abnormal thinking, lack of self-care, hallucinations, aggression, excessive happiness, paranoia,
amnesia, decreased sensitivity, involuntary muscle contractions, fainting, continuous movements, migraine, seizures, dizziness upon standing, abnormal coordination, speech disorders,
dilated pupils,
ear pain,
rapid pulse, heart problems,
bleeding problems (such as stomach bleeding)*, elevated blood pressure, hot flushes, blood in urine,
shortness of breath, nosebleeds, difficulty breathing possibly with noise,
black stools, dental disorders, inflammation of the esophagus, tongue disorders, hemorrhoids, increased salivation, difficulty swallowing, burping, tongue disorders,
swelling of eyes, hives, hair loss, itching, purple spots on the skin, blistering skin disorders, dry skin, facial swelling, cold sweat,
osteoarthritis, muscle jerks, muscle cramps*, muscle weakness,
increased frequency of urination, urinary disorders, urinary retention, urinary incontinence, increased urine volume, need to urinate at night,
sexual dysfunction, excessive vaginal bleeding, vaginal bleeding, female sexual dysfunction,
swollen legs, chills, difficulty walking, thirst,
increased liver enzyme levels, weight loss,
Cases of suicidal thoughts and behaviour have been reported during treatment with sertraline or shortly after discontinuation (see section 2).

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

diverticulitis, swollen lymph nodes, decreased platelet count*, decreased white blood cell count*,
severe allergic reaction,
endocrine disorders*,
high cholesterol, problems controlling blood sugar levels (diabetes), low blood sugar, increased blood sugar*, low blood sodium levels*,
physical symptoms due to stress or emotions, abnormal nightmares*, medication dependence, sleepwalking, premature ejaculation,
coma, abnormal movements, difficulty moving, increased sensitivity, sudden severe headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS))*, sensory disturbances,
seeing spots in front of the eyes, glaucoma, double vision, photophobia (eye sensitivity to light), eye hemorrhages, irregular pupils*, visual disturbances*, tear problems,
heart attack, dizziness, fainting or chest discomfort which could be signs of changes in electrical activity (seen on electrocardiogram) or abnormal heart rhythm*, decreased heart rate,
circulation problems in arms and legs,
rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, throat spasm, difficulty speaking, slower breathing, hiccups,
mouth ulceration, pancreatitis*, blood in stools, tongue ulceration, mouth sores,
problems with liver function, serious liver function problems*, yellowing of the skin and eyes (jaundice)*,
skin reaction to sunlight*, skin swelling*, abnormal hair texture, abnormal skin odor, capillary rash,
muscle tissue breakdown*, bone disorder,
interrupted urination, decreased urine volume,
breast milk secretion, vaginal dryness, genital discharge, pain and redness of the penis and foreskin, breast enlargement*, prolonged erection,
hernia, decreased tolerance to the medicine,
increased cholesterol levels, abnormal laboratory test results*, abnormal semen, coagulation problems*,
relaxation of blood vessel constriction process.

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

jaw locking*,
nocturnal urinary incontinence*,
partial loss of vision,
inflammation of the colon (causing diarrhea)*,
heavy 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 may be a sign of multiple acyl-coenzyme A 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 occur when stopping treatment

If you stop taking this medicine abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremor (see section 3. If you stop taking Sertralina Qualigen Farma).

An increased risk of bone fracture has been observed in patients taking this type of medicine.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sertraline Qualigen Farma

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

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist.

Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sertralina Qualigen Farma

The active substance in Sertralina Qualigen Farma is sertraline (hydrochloride). Each tablet contains 100 mg of sertraline.
The other components are anhydrous colloidal silica, microcrystalline cellulose (E-460i), sodium croscarmellose (E-466), copovidone (E-1208), lactose monohydrate, and magnesium stearate (E-572). Coating (Opadry White): hypromellose (E-464), hydroxypropylcellulose (E-463), polyethylene glycol 400 (E-1521), and titanium dioxide (E-171).

Appearance of the medicinal product and contents of the pack

Sertralina Qualigen Farma is presented as film-coated tablets, white or greyish-white in colour.

Sertralina Qualigen Farma is available in three pack 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

Toll Manufacturing Services, S.L.
Aragoneses 2, 28108 Alcobendas
Madrid – Spain

Date of the most recent revision of this leaflet: June 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/