SERTRALINE PHARMA COMBIX 50 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sertraline Pharma Combix 50 mg film-coated tablets EFG

Sertraline hydrochloride

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

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

Sertraline Pharma Combix contains sertraline hydrochloride 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.

Sertraline Pharma Combix 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).
• Panic disorder (in adults).
• Obsessive-compulsive disorder (OCD) (in adults, and in children and adolescents aged 6-17 years).

Depression is a clinical condition with symptoms such as feelings of sadness, inability to sleep well or to enjoy life as you used to.

OCD and anxiety disorders are conditions related to anxiety, with symptoms such as being constantly worried about recurring ideas (obsessions) that lead to performing repetitive rituals (compulsions).

PTSD is a disorder that can occur after a highly traumatic emotional experience, and has some symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related condition. It is characterized by feeling intense anxiety or distress in social situations (e.g., talking to strangers, public speaking, eating or drinking in front of others, or worrying about behaving in a shameful way).

Your doctor has considered that this medicine is suitable for treating your condition.

If you are not sure why you have been prescribed sertraline, you should ask your doctor.

2. Before you take Sertraline Pharma Combix

Do not take Sertraline Pharma Combix

• If you are allergic (hypersensitive) to the active ingredient, sertraline hydrochloride, or to any of the other ingredients of this medicine.
• If you are taking or have 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 should wait at least one week before starting treatment with an MAOI. After stopping treatment with an MAOI, you should wait at least two weeks before starting treatment with sertraline.
• If you are taking a medicine called pimozide (an antipsychotic medicine).

Be careful 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 had any of the following:

• Epilepsy or history of seizures. 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.
• If you have had suicidal thoughts (see below for suicidal thoughts and worsening of your depression or anxiety disorder).
• Serotonin syndrome. This syndrome can occur rarely when taking certain medicines at the same time as sertraline. (To see the symptoms, read the section 4. Possible side effects). Your doctor will tell you if you have had this syndrome before.
• If you have low sodium levels in your blood, as this situation can occur as a result of treatment with Sertraline Pharma Combix. You should also inform your doctor if you are taking any medicine for high blood pressure, as these medicines can also alter sodium levels in your blood.
• Be careful if you are elderly, as you may be at greater risk of having low sodium levels in your 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 (such as 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. If you are going to be treated for this disorder, your doctor will want to monitor you closely (see below for 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 need to move, often accompanied by an inability to remain seated or standing). This occurs more often during the first few weeks of treatment. Increasing the dose in patients who develop these symptoms may be harmful. If you develop these symptoms, you should contact your doctor.

Withdrawal symptoms

When treatment is stopped, it is common for withdrawal symptoms to appear, 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 can be severe. These symptoms usually appear during the first few days after stopping treatment. In general, these symptoms usually disappear on their own and normally resolve 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, according to the needs of each patient.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, 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 medicines take time to work, which is usually a few weeks but can sometimes be longer.

This is more likely to happen

• If you have had suicidal thoughts before.
• If you are a young adult. There is information from clinical trials that shows that there is an increased risk of suicidal behavior in adults under 25 years of age with psychiatric illnesses 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 worried about changes in your behavior.

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

Some medicines in the same group as Sertraline Pharma Combix (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 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 adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and anger) when they are treated with this class of medicines. Nevertheless, it is possible that your doctor may decide to prescribe sertraline to a patient under 18 years of age if they consider it is the most suitable for the patient. If your doctor has prescribed sertraline to a patient under 18 years of age and you want 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 a patient under 18 years of age is taking Sertraline Pharma Combix.

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

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used 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 that you are taking at the same time.

The use of Sertraline Pharma Combix 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), and the antibiotic linezolid). Do not use Sertraline Pharma Combix with MAOIs.
• Medicines for treating 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 for treating severe pain (e.g., tramadol).
• Medicines for treating migraines (e.g., sumatriptan).
• Medicines that reduce blood clotting (warfarin).
• Medicines for treating pain/arthritis (non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics.
• Medicines for treating epilepsy (phenytoin).
• Medicines for treating diabetes (tolbutamide).
• Medicines for treating stomach acid and ulcers (cimetidine).
• Medicines for treating mania and depression (lithium).
• Other medicines for treating depression (such as amitriptyline, nortriptyline).
• Medicines for treating schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medicines for regulating heart rate and rhythm (such as flecainide, propafenone).

Taking Sertraline Pharma Combix with food and drinks

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

You should avoid drinking alcohol while being treated with Sertraline Pharma Combix.

Pregnancy, breastfeeding, and fertility

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, 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 are a woman of childbearing age, you should use a reliable contraceptive method (such as the contraceptive pill) while taking sertraline.

Make sure 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 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.

If you take Sertraline Pharma Combix in the final stages of pregnancy, there may be a higher 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 that they can advise you.

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.

Fertility

Some medicines like sertraline may reduce sperm quality in animal studies. This could theoretically affect fertility, but the impact on human fertility has not been observed yet.

Driving and using machines

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

Important information about 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 Sertraline Pharma Combix

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

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

Consult your doctor or pharmacist if you have any doubts.

The recommended dose is:

Adults:

Depression and Obsessive-Compulsive Disorder:

For depression and OCD, the effective dose is usually 50 mg per day. The daily dose can be increased in increments of 50 mg, 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 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 several weeks. The maximum recommended dose is 200 mg per day.

Children and Adolescents:

Sertraline Pharma Combix should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder.

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.

Your doctor will tell you how long you should take this medicine. The duration will depend on the nature of your illness and your response to treatment. It will take a few weeks before your symptoms start to improve. Treatment of depression usually needs to continue for 6 months after improvement.

If you take more Sertraline Pharma Combix than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

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

If you forget to take Sertraline Pharma Combix

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 taking Sertraline Pharma Combix

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

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

4. Possible Adverse Effects

Like all medicines, Sertralina Pharma Combix can cause adverse effects, although not all people suffer from them.

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

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 that causes blisters (erythema multiforme), (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 interrupt 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 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 present a yellowish color of the skin and eyes, which can indicate liver damage.
• If you experience depressive symptoms with suicidal ideas.
• If after starting treatment with Sertralina Pharma Combix, you begin to feel restless and are unable to sit or stand. You should inform your doctor if you start to feel restless.
• If you have a seizure (convulsions).
• If you have a manic episode.

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

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

• Insomnia, dizziness, somnolence, headache, diarrhea, feeling of discomfort, dry mouth, ejaculation problems, and fatigue.

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

• Sore throat, anorexia, increased appetite,
• depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased sexual interest, teeth grinding,
• numbness and tingling, tremors, muscle tension, abnormal taste, lack of concentration,
• visual disturbances, ringing in the ears,
• palpitations, hot flashes, yawning,
• abdominal pain, vomiting, constipation, stomach discomfort, gas,
• rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, and chest pain.

Uncommon adverse effects (may affect between 1 and 10 out of 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 when standing up, migraines,
• ear pain, rapid pulse, high blood pressure, hot flashes,
• difficulty breathing possibly noisy, shortness of breath, nasal bleeding,
• esophageal inflammation, difficulty swallowing, hemorrhoids, increased salivation, tongue alteration, belching,
• eye swelling, purple spots on the skin, hair loss, cold sweat, dry skin, hives,
• arthritis, muscle weakness, back pain, muscle spasms,
• need to urinate at night, urinary retention, increased urine volume, increased frequency of urination, urinary disorders,
• vaginal bleeding, female sexual dysfunction, discomfort, chills, fever, weakness, thirst, weight loss, and weight gain.

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

• Intestinal problems, ear infection, cancer, lymph node swelling, 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 alterations,
• vision of spots in front of the eyes, glaucoma, double vision, photophobia (eye sensitivity to light), eye bleeding, irregular pupils, visual disturbances, tear problems,
• heart attack, decreased heart rate, heart problems, circulation problems in the arms and legs, throat spasms, rapid breathing, slower breathing, difficulty speaking, hiccups,
• blood in stool, mouth sores, tongue ulcers, tooth and tongue problems, mouth ulcers, liver function problems,
• skin problems with blisters, capillary rash, abnormal hair texture, abnormal skin odor, bone alteration,
• decreased urine volume, urinary incontinence, interrupted urination,
• excessive vaginal bleeding, vaginal dryness, pain and redness of the penis and foreskin, genital secretion, prolonged erection, breast secretion,
• hernia, injection site scar, decreased drug tolerance, difficulty walking, abnormal laboratory tests, abnormal semen, injury, vascular relaxation procedure.

• There have been reports of suicidal thoughts and behavior during treatment with sertraline or shortly after its interruption (see section 2).

Adverse effects of unknown frequency:

• Partial loss of vision.
• Colon inflammation (causing diarrhea).
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Fertility, pregnancy, and breastfeeding" in section 2 for more information.
• Muscle weakness and intense muscle pain, which can be a sign of multiple acyl-CoA dehydrogenase deficiency (MADD).

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

• Decrease in white blood cell count, decrease in platelets, low thyroid hormone levels, endocrine problems, low sodium levels in blood,
• abnormal terror dreams, suicidal behavior,
• muscle movement problems (such as constant movements, muscle tension, and difficulty walking), fainting,
• abnormal vision, bleeding problems (such as nasal bleeding, stomach bleeding, or blood in urine), pancreatitis, serious liver function problems, yellowing of the skin and eyes (jaundice),
• skin swelling, sun-related skin reaction, itching, joint pain, muscle cramps, breast enlargement, irregularities in the menstrual cycle, 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 appear when treatment is interrupted:

If you abruptly stop treatment with this medication, 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 sertraline).

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

Reporting adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Sertralina Pharma Combix:

Keep out of the reach and sight of children.

Do not use Sertralina Pharma Combix after the expiration date that appears on the blister pack and carton. The expiration date is the last day of the month indicated.

Sertralina Pharma Combix does not require special storage conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Additional Information:

Composition of Sertralina Pharma Combix:

The active ingredient is sertraline hydrochloride. Each tablet contains 50 mg of sertraline (equivalent to 55.953 mg of sertraline hydrochloride).

The other components are: lactose monohydrate, 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 packaging content:

Sertralina Pharma Combix 50 mg tablets are film-coated, capsule-shaped, biconvex, scored on both sides. The tablet can be divided into two 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 in 100 mg film-coated tablets in blister packs containing 30 or 60 film-coated tablets.

Only some 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 prospectus was revised in September 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/