PATIENT INFORMATION LEAFLET

Sertraline Pharma Combix 50 mg Film-Coated Tablets

Sertraline Hydrochloride

Read this 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. Do not pass it on to others even if their symptoms are the same. It may harm them.

• If you think you have suffered a side effect you can report it directly via:

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

Sertralina Pharma Combix can be used to treat:

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 linked to anxiety, with symptoms such as being constantly preoccupied with repeated ideas (obsessions) that lead to repetitive rituals.

PTSD is a disorder that can occur after a very emotionally traumatic experience, and has some symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety disorder. 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 humiliating manner).

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

If you are unsure why you have been prescribed sertraline, you should consult your doctor.

Do not take Sertralina Pharma Combix

• If you are allergic (hypersensitive) to the active ingredient, hydrochloride of sertraline, or to any of the other excipients of this medicine.
• If you are taking or have taken medications called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other similar medications to MAO (such as linezolid). If you interrupt the treatment with sertraline, you must wait at least one week before starting treatment with an MAOI. After interrupting treatment with an MAOI, you must wait at least two weeks before starting treatment with sertraline.
• If you are taking a medication called pimozide (an antipsychotic medication).

Be careful with Sertralina Pharma Combix

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

• Epilepsy or a 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 or have had thoughts of suicide (see below for thoughts of suicide and worsening of your depression or anxiety).
• 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 situation can occur as a result of treatment with Sertralina Pharma Combix. 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.
• Be careful if you are elderly, as you may have a higher risk of having low sodium levels in the blood (see above).
• Liver disease; your doctor may consider that you should take a lower dose of sertraline.
• Diabetes; sertraline may alter your blood sugar levels, so you may need to adjust the dose of your diabetes medications.
• If you have had bleeding disorders or have been taking medications that decrease blood clotting (such as 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 old. Sertralina Pharma Combix should only be used to treat children and adolescents aged 6 to 17 years old who have obsessive-compulsive disorder. If you are to be treated for this disorder, your doctor will want to monitor you closely (see below Use in children and adolescents).
• If you are receiving electroconvulsive therapy (ECT).

Restlessness/Acatisia

The use of sertraline has been associated with acatisia (unpleasant restlessness and a need to move, often accompanied by an inability to sit or stand still). 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, contact your doctor.

Withdrawal symptoms

When treatment is stopped, withdrawal symptoms are common, particularly if the treatment is stopped abruptly (see 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. These symptoms are usually 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, as needed for each patient.

Thoughts of suicide and worsening of your depression or anxiety

If you are depressed and/or have anxiety disorders, you may have thoughts of harming yourself or committing suicide. This can 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 old 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 concerned about changes in your behavior.

There has been an increase in the risk of bone fractures in patients treated with this type of medication.

Some medications in the group to which Sertralina Pharma Combix belongs (called ISRS/IRSN) can cause sexual dysfunction symptoms (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 old, except in the case of patients with obsessive-compulsive disorder (OCD). Patients under 18 years old have a higher risk of adverse effects such as suicidal thoughts, suicidal behavior, and hostility (predominantly aggression, confrontational behavior, and irritable reaction) when treated with this class of medications. However, your doctor may decide to prescribe sertraline to a patient under 18 years old if they consider it to be the best option for the patient. If your doctor has prescribed sertraline to a patient under 18 years old and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen in a patient under 18 years old taking Sertralina 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 Sertralina Pharma Combix in this age group have not yet been demonstrated.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Some medications may affect how Sertralina Pharma Combix works, or Sertralina Pharma Combix itself may reduce the effectiveness of other medications you are taking at the same time.

The use of Sertralina Pharma Combix with the following medications may cause severe side effects

• Medications called monoamine oxidase inhibitors (MAOIs), such as moclobemide (to treat depression), selegiline (to treat Parkinson's disease), and the antibiotic linezolid. Do not use Sertralina Pharma Combix with MAOIs.
• Medications to treat mental disorders (pimozide). Do not use Sertralina Pharma Combix with pimozide.

Inform your doctor if you are taking the following medications

• Medications based on plants that contain St. John's Wort (Hypericum perforatum). The effects of St. John's Wort may persist for 1-2 weeks.
• Products containing the amino acid tryptophan.
• Medications to treat severe pain (such as tramadol).
• Medications to treat migraines (such as sumatriptan).
• Medications that decrease blood clotting (warfarin).
• Medications to treat pain/arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin).
• Sedatives (diazepam).
• Diuretics.
• Medications to treat epilepsy (phenytoin).
• Medications to treat diabetes (tolbutamide).
• Medications to treat stomach acid and ulcers (cimetidine).
• Medications to treat mania and depression (lithium).
• Other medications to treat depression (such as amitriptyline, nortriptyline).
• Medications to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medications to regulate heart rate and rhythm (such as flecainide, propafenone).

Taking Sertralina Pharma Combix with food and drinks

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

Alcohol should be avoided while being treated with Sertralina Pharma Combix.

Fertility, pregnancy, and breastfeeding

Consult your doctor or pharmacist before using any medication.

The safety of sertraline has not been fully established in pregnant women. 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 are a woman of childbearing age, you should use a reliable contraceptive method (such as the 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 three months of pregnancy, medications like Sertralina Pharma Combix may increase the risk of a serious disease in babies 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.

If you take Sertralina Pharma Combix in the final stages of pregnancy, there may be an increased risk of heavy vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Sertralina Pharma Combix so they can advise you.

There are indications that sertraline passes 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.

Fertility

Some medications, such as sertraline, may reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but there is no observed impact on human fertility so far.

Driving and operating machinery

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

Important information about some of the components of Sertralina Pharma Combix

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

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

Take your medication 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:

The commonly effective dose for depression and OCD 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 daily dose is 200 mg.

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 daily dose is 200 mg.

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 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.

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. Depression treatment should continue for 6 months after symptoms improve.

If you take more Sertralina Pharma Combix than you should:

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

Symptoms of overdose may include drowsiness, nausea, vomiting, rapid heart rate, tremors, agitation, dizziness, and in rare cases, loss of consciousness.

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 when it is due.

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

If you interrupt treatment with 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 stopping treatment completely. If you stop treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling unwell, nausea, vomiting, and tremors. If you experience any of these adverse effects or any other during the interruption of your treatment with Sertralina Pharma Combix, please inform your doctor.

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

Like all medicines, Sertralina Pharma Combix can cause side effects, although not everyone will experience them.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 severe.

• 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 can 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 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 experience yellowing of the skin and eyes, which may indicate liver damage.
• If you experience depressive symptoms with suicidal thoughts.
• If you start feeling restless and are unable to sit or stand after starting treatment with Sertralina Pharma Combix. Inform your doctor if you start feeling restless.
• If you experience a seizure (convulsions).
• If you experience a manic episode

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

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

• Dizziness, insomnia, somnolence, headache, diarrhea, feeling unwell, dry mouth, ejaculation problems, and fatigue.

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

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

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

• Intestinal problems, ear infection, cancer, lymph node swelling, high cholesterol, decreased blood sugar,
• physical symptoms due to stress or emotions, dependence on medication, psychotic disorders, aggression, paranoia, suicidal thoughts, somnambulism, premature ejaculation,
• coma, abnormal movements, difficulty moving, increased sensitivity, sensory disturbances,
• seeing spots in front of the eyes, glaucoma, double vision, photophobia (light sensitivity), eye hemorrhages, irregular pupils, visual disturbances, eye problems,
• heart attack, decreased heart rate, heart problems, circulation problems in the 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 abnormalities,
• decreased urine output, urinary incontinence, interrupted urination,
• excessive vaginal bleeding, vaginal dryness, penile and prepuce pain and redness, genital secretion, prolonged erection, breast secretion,
• hernia, injection site scar, decreased tolerance to medication, difficulty walking, abnormal laboratory tests, abnormal semen, injury, vasodilation procedure.

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

Side effects of unknown frequency:

• Partial loss of vision.
• Colitis inflammation (which causes diarrhea)
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Fertility, pregnancy, and lactation" in section 2 for more information.

Since the marketing of sertraline, the following side effects have been reported

• Decreased white blood cell count, decreased platelet count, low thyroid hormone levels, endocrine problems, low sodium levels in the blood,
• abnormal nightmares, suicidal behavior,
• muscle movement problems (such as constant movements, muscle tension, and difficulty walking), syncope,
• abnormal vision, bleeding problems (such as nosebleeds, stomach bleeding, or blood in urine), pancreatitis, severe liver function problems, yellow skin and eyes (jaundice),
• skin swelling, sun sensitivity, itching, joint pain, muscle cramps, breast enlargement, irregular menstrual cycles, swollen legs, blood clotting problems, nocturnal urinary incontinence, and severe allergic reactions.

Side effects in children and adolescents

In clinical trials in children and adolescents, side effects were generally similar to those reported in adults (see above). The most common side effects in children and adolescents were headache, insomnia, diarrhea, and nausea.

Symptoms that may appear when treatment is interrupted

If you interrupt treatment abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors (see section 3. If you interrupt treatment with sertraline).

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

Reporting side effects

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

Keep out of the reach and sight of children.

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

Sertralina Pharma Combix does not require special conditions for conservation.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines 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 medicines you no longer need. By doing so, you will help protect the environment.

Composition of Sertralina Pharma Combix

The active ingredient is hydrochloride of sertraline. 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 contents of the package

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

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

Sertralina Pharma Combixis also available in film-coated tablets of 100 mg in blister packs, containing 30 or 60 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization

Laboratorios Combix S.L.U.

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

Spain

Responsible for manufacturing

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 leaflet has been revised in January 2021

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/