Sertraline Pharma Combix 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sertralina Pharma Combix 50 mg film-coated tablets EFG

Sertraline hydrochloride

Read the entire leaflet carefully before you start taking this medicine.

• 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 and should not be given to other people, even if they have the same symptoms as you, because it may harm them.

• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Sertralina Pharma Combix is and what it is used for.
2. Before you take Sertralina Pharma Combix.
3. How to take Sertralina Pharma Combix.
4. Possible side effects.
5. How to store Sertralina Pharma Combix.
6. Further information.

1. What Sertralina Pharma Combix is and what it is used for

Sertralina Pharma Combix contains sertraline hydrochloride as the active substance. Sertraline belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders.

Sertralina Pharma Combix 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 to enjoy life as one used to.

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

PTSD is a disorder that may occur after an emotionally traumatic event and has some symptoms similar to those of 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 possibly 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 sertraline, you should consult your doctor.

2. Before taking Sertraline Pharma Combix

Do not take Sertraline Pharma Combix

• If you are allergic (hypersensitive) to the active substance, sertraline hydrochloride, or to any of the other excipients of this medicine.
• If you are taking or have recently taken 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.
• If you are taking a medicine called pimozide (an antipsychotic medicine).

Take special care with Sertraline Pharma Combix

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

• Epilepsy or a history of seizures. If you have a seizure, contact your doctor immediately.
• If you have bipolar disorder (manic-depressive illness) or schizophrenia. If you experience a manic episode, contact your doctor immediately.
• If you have or have previously had suicidal thoughts (see further below: Suicidal thoughts and worsening of depression or anxiety disorder).
• Serotonin syndrome. Rarely, this syndrome may occur when taking certain medicines at the same time as sertraline. (For symptoms, see section 4. Possible side effects.) Your doctor will advise you if you have previously experienced this syndrome.
• If you have low sodium levels in the blood, as this condition may occur as a result of treatment with Sertraline Pharma Combix. You should also inform your doctor if you are taking any medicine for high blood pressure, as these medicines may also affect sodium levels in the blood.
• Take special care if you are elderly, as you may be at increased risk of low sodium levels in the blood (see above).
• Liver disease; your doctor may consider 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 medicines.
• If you have had bleeding disorders or have been taking medicines that reduce blood clotting (e.g. acetylsalicylic acid (aspirin), or warfarin) or that may increase the risk of bleeding, or if you are pregnant (see "Fertility, pregnancy and breastfeeding").
• If you are a child or adolescent under 18 years of age. Sertraline Pharma Combix 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 below: Use in children and adolescents).
• If you are receiving electroconvulsive therapy (ECT).

Restlessness / Akathisia

The use of sertraline has been associated with akathisia (unpleasant restlessness and a need to move, often accompanied by an inability to sit or stand still). This occurs most frequently during the first weeks of treatment. Increasing the dose in patients who develop these symptoms may be harmful. If you develop these symptoms, contact your doctor.

Withdrawal symptoms

When stopping treatment, withdrawal symptoms are common, particularly if treatment is stopped abruptly (see 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 within 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, according to the individual needs of each patient.

Suicidal thoughts and worsening of depression or anxiety disorder

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

You are more likely to experience this if:

• You have previously had suicidal thoughts or thoughts of self-harm.
• You are a young adult. Clinical trial data show an increased risk of suicidal behaviour in psychiatric patients under 25 years of age who are being treated with an antidepressant.

If you have thoughts of harming yourself or of suicide at any time, contact your doctor or go to 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 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 behaviour.

An increased risk of bone fractures has been observed in patients treated with this type of medicine.

Some medicines in the group to which Sertraline Pharma Combix belongs (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Use in children and adolescents

Normally, sertraline should 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 a higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behaviour, and anger reactions) when taking this class of medicines. Nevertheless, your doctor may decide to prescribe sertraline to a patient under 18 years of age if they consider it to be in the patient's best interest. If your doctor has prescribed sertraline to a patient under 18 years of age and you wish to discuss this decision, please contact your doctor again. You should inform your doctor if any of the symptoms listed above appear or worsen while a patient under 18 years of age is taking Sertraline Pharma Combix.

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

Use of other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may affect how Sertraline Pharma Combix works, or Sertraline Pharma Combix may reduce the effectiveness of other medicines taken at the same time.

Taking Sertraline Pharma Combix 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), and the antibiotic linezolid. Do not use Sertraline Pharma Combix with MAOIs.
• Medicines used to treat mental disorders (pimozide). Do not use Sertraline Pharma Combix with pimozide.

Tell your doctor if you are taking the following medicines

• 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 used to treat severe pain (e.g. tramadol).
• Medicines used to treat migraines (e.g. sumatriptan).
• Medicines that reduce blood clotting (warfarin).
• Medicines used to treat pain/arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics.
• Medicines used to treat epilepsy (phenytoin).
• Medicines used to treat diabetes (tolbutamide).
• Medicines used to treat stomach acidity and ulcers (cimetidine).
• Medicines used to treat mania and depression (lithium).
• Other medicines used to treat depression (such as amitriptyline, nortriptyline).
• Medicines used to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medicines used to regulate heart rate and rhythm (such as flecainide, propafenone).

Taking Sertraline Pharma Combix with food and drink

Sertraline Pharma Combix tablets can be taken with or without food.

Alcohol intake should be avoided while being treated with Sertraline Pharma Combix.

Fertility, pregnancy and breastfeeding

Consult your doctor or pharmacist before using any 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 are a woman of childbearing age, you should use a reliable method of contraception (such as the oral contraceptive pill) while taking sertraline.

Ensure that your midwife and/or doctor know that you are taking sertraline. If you take it during pregnancy, especially during the last 3 months, medicines like Sertraline Pharma Combix 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.

If you take Sertraline Pharma Combix 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 know that you are taking Sertraline Pharma Combix so they can advise you.

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.

Fertility

Some medicines such as sertraline may reduce sperm quality in animal studies. Theoretically, this could affect fertility, but no impact on human fertility has been observed so far.

Driving and using machines

During treatment with sertraline, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how Sertraline Pharma Combix affects you.

Important information on some of the ingredients of Sertraline Pharma Combix

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

3. How to take Sertralina Pharma Combix

Follow exactly the instructions for taking Sertralina Pharma Combix as given by your doctor. Sertralina Pharma Combix tablets can be taken with or without food.

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

If you have any doubts, consult your doctor or pharmacist.

Recommended dose:

Adults:

Depression and Obsessive-Compulsive Disorder (OCD):

For depression and OCD, the usually 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.

Children and adolescents:

Sertralina Pharma Combix 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 your 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 provide.

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. Treatment for depression should usually continue for 6 months after improvement occurs.

If you take more Sertralina Pharma Combix than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and the amount ingested.

Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, tremors, agitation, dizziness, and in rare cases, unconsciousness.

If you forget to take Sertralina Pharma Combix

If you forget to take 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 Sertralina Pharma Combix

Do not stop treatment with Sertralina Pharma Combix unless your doctor tells you to. Your doctor will want to gradually reduce the dose of Sertralina Pharma Combix over several weeks before you completely stop taking this medicine. If you stop treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling unwell, dizziness (nausea, vomiting), and tremor. If you experience any of these adverse effects, or any other symptoms, while stopping treatment with Sertralina Pharma Combix, 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, Sertralina Pharma Combix may cause adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

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

Inform 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, difficulty breathing, 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 medications concomitantly with sertraline. Your doctor may decide to discontinue treatment.
• If you develop yellowing of the skin or eyes, which may indicate liver damage.
• If you experience depressive symptoms with suicidal thoughts.
• If, after starting treatment with Sertralina Pharma Combix, you begin to feel restless and unable to sit or stand still. You should inform your doctor if you start feeling restless.
• If you have a seizure (convulsion).
• If you experience a manic episode.

The following adverse effects were observed in clinical trials in adults.

Very common adverse effects (may affect more than 1 in 10 patients):

• Insomnia, dizziness, somnolence, headache, diarrhea, malaise, dry mouth, ejaculation disorders, and fatigue.

Common adverse effects (may affect between 1 and 10 in 100 patients):

• Sore throat, anorexia, increased appetite,
• depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased libido, teeth grinding,
• numbness and tingling, tremor, muscle tension, abnormal taste, difficulty concentrating,
• visual disturbances, tinnitus (ringing in the ears),
• palpitations, hot flushes, yawning,
• abdominal pain, vomiting, constipation, stomach discomfort, flatulence,
• rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, and chest pain.

Uncommon adverse effects (may affect between 1 and 10 in 1,000 patients):

• Cold (chest), runny nose,
• hallucinations, excessive happiness, lack of care, abnormal thoughts,
• seizures, involuntary muscle contractions, abnormal coordination, continuous movements, amnesia, decreased sensitivity, speech disorders, dizziness upon standing, migraines,
• ear pain, rapid pulse, elevated blood pressure, hot flushes,
• difficulty breathing possibly noisy, shortness of breath, nosebleeds,
• esophagitis, difficulty swallowing, hemorrhoids, increased salivation, tongue disorders, belching,
• eye swelling, purple spots on the skin, hair loss, cold sweat, dry skin, urticaria,
• osteoarthritis, muscle weakness, back pain, muscle jerks,
• need to urinate at night, urinary retention, increased urine volume, increased frequency of urination, urinary disorders,
• vaginal bleeding, female sexual dysfunction, malaise, chills, fever, weakness, thirst, weight loss, and weight gain.

Rare adverse effects (may affect between 1 and 10 in 10,000 patients):

• Intestinal problems, ear infection, cancer, swollen lymph nodes, high cholesterol, low blood sugar,

• physical symptoms due to stress or emotions, drug dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation,

• coma, abnormal movements, difficulty moving, increased sensitivity, 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, decreased heart rate, heart problems, circulation problems in arms and legs, throat spasm, rapid breathing, slow breathing, difficulty speaking, hiccups,

• blood in stool, mouth sores, tongue ulceration, dental and tongue problems, mouth ulceration, liver function problems,

• skin problems with blisters, capillary rash, abnormal hair texture, abnormal skin odor, bone disorders,

• decreased urine volume, urinary incontinence, interrupted urination,

• excessive vaginal bleeding, vaginal dryness, penile and foreskin redness and pain, genital discharge, prolonged erection, breast discharge,

• hernia, injection site scar, reduced tolerance to medications, difficulty walking, abnormal laboratory tests, abnormal semen, injury, blood vessel relaxation procedure.

• Cases of suicidal thoughts and behavior have been reported during treatment with sertraline or shortly after discontinuation (see section 2).

Adverse effects with unknown frequency:

• Partial loss of vision.
• Inflammation of the colon (causing diarrhea).
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see "Fertility, pregnancy and breastfeeding" 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).

Since the marketing of sertraline, the following adverse effects have been reported:

• Decreased white blood cell count, decreased platelet count, low thyroid hormone levels, endocrine disorders, low blood sodium levels,
• abnormal terrifying dreams, suicidal behavior,
• muscle movement disorders (such as constant movements, muscle tension, and difficulty walking), syncope (fainting),
• abnormal vision, bleeding problems (such as nosebleeds, stomach bleeding, or blood in urine), pancreatitis, severe liver function problems, yellowing of the skin and eyes (jaundice),
• skin swelling, sun-induced skin reaction, itching, joint pain, muscle cramps, breast enlargement, menstrual irregularities, swollen legs, coagulation problems, nocturnal urinary incontinence, and severe allergic reactions.

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 treatment is discontinued

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

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 or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Sertralina Pharma Combix

Keep out of the reach and sight of children.

Do not use Sertralina Pharma Combix after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month indicated.

Sertralina Pharma Combix does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional information

Composition of Sertralina Pharma Combix

The active substance is sertraline hydrochloride. Each tablet contains 50 mg of sertraline (equivalent to 55,953 mg of sertraline hydrochloride).

The other components are: monohydrate lactose, microcrystalline cellulose (E460i), povidone K-30, anhydrous colloidal silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171), polyethylene glycol, polysorbate 80.

Appearance of the product and contents of the pack

Sertralina Pharma Combix 50 mg tablets are white or almost white, capsule-shaped, biconvex, film-coated tablets, scored on both sides. The tablet can be divided into equal halves.

Sertralina Pharma Combix 50 mg is available in blister packs containing 30 or 60 film-coated tablets.

Sertralina Pharma Combix is also available as 100 mg film-coated tablets in blister packs containing 30 or 60 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Combix S.L.U.

C/ Badajoz 2, Edificio 2, 28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

25, parc d’activités des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

This patient information leaflet was last reviewed in September 2025

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