PATIENT INFORMATION LEAFLET

Sertraline Pharma Combix 100 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 may 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 diseases linked to anxiety, with symptoms such as being constantly preoccupied with repeated ideas (obsessions) that lead to repetitive rituals.

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

Your doctor has considered this medication 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 medicines called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other medicines similar to MAOIs (such as linezolid). If you stop taking sertraline, you should wait at least one week before starting treatment with a MAOI. After stopping treatment with a MAOI, you should wait at least two weeks before starting treatment with sertraline.
• If you are taking a medicine called pimozide (an antipsychotic).

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 convulsions. If you have a seizure (convulsion), 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 thoughts of suicide and worsening of your depression or anxiety).
• Serotonin syndrome. In rare cases, this syndrome can occur when you are taking certain medicines 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, you should tell your doctor if you are taking any medicines for high blood pressure, as these medicines can also alter sodium levels in the blood.
• Be careful if you are elderly, as you may be at greater 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 medicines.
• If you have had bleeding disorders or have been taking medicines 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 with obsessive-compulsive disorder. If you are to be treated for this disorder, your doctor will want to keep a close eye on you (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, you should 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 is 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 sometimes have thoughts of harming yourself or of suicide. This may increase at the beginning of treatment with antidepressants, as all these medicines take time to have an 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 behaviour in adults under 25 years with psychiatric illnesses, 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 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 may 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 behaviour.

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

Some medicines in the same group as Sertralina Pharma Combix (called SSRIs/SNRIs) 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). Young patients are at greater risk of side effects such as suicidal thoughts, suicidal behaviour, and hostility (mainly aggression, confrontational behaviour, and irritable reactions) when treated with this class of medicines. 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 go back to your doctor. You should tell 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 safety effects and those related to growth, maturity, and learning (cognitive development) and behavioural development of Sertralina 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 other medicines, even those bought without a prescription.

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

The use of Sertralina Pharma Combix with the following medicines may cause serious side effects

• Medicines 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.
• Medicines to treat mental disorders (pimozide). Do not use Sertralina Pharma Combix with pimozide.

Tell your doctor if you are taking the following medicines

• Medicines based on plants that contain 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 pain (such as tramadol).
• Medicines to treat migraines (such as sumatriptan).
• Medicines that decrease blood clotting (warfarin).
• Medicines to treat pain/arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin).
• Sedatives (diazepam).
• Diuretics.
• Medicines to treat epilepsy (phenytoin).
• Medicines to treat diabetes (tolbutamide).
• Medicines to treat stomach acid and ulcers (cimetidine).
• Medicines to treat mania and depression (lithium).
• Other medicines to treat depression (such as amitriptyline, nortriptyline).
• Medicines to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medicines 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 medicine.

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 baby. 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, medicines like Sertralina Pharma Combix may increase the risk of a serious illness 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 a greater 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 is some indication 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 medicines, such as sertraline, may reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but there has been 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 medicine contains lactose. If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medicine.

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:

For depression and OCD, the commonly effective dose is 50 mg per day. The daily dose can be increased by 50 mg at intervals of at least one week, and so 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 are experiencing 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 serious.

• If you develop a severe skin rash that causes blisters (erythema multiforme), (which can affect the mouth and tongue). These may be signs of a condition known as Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). In these cases, your doctor will stop treatment.
• Allergic reaction or allergy, which can present symptoms such as skin rash with itching, breathing problems, ringing in the ears, 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 stop treatment.
• If you experience yellowing of the skin and eyes, which can 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):

• Insomnia, dizziness, drowsiness, headache, diarrhea, feeling unwell, dry mouth, ejaculation problems, and fatigue.

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

• Sore throat, loss of appetite, increased appetite,
• depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased libido, teeth grinding,
• numbness and tingling, tremors, 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, swollen lymph nodes, high cholesterol, decreased blood sugar,
• physical symptoms due to stress or emotions, dependence on medication, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation,
• coma, abnormal movements, difficulty moving, increased sensitivity, sensory disturbances,
• 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 spasms, 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 secretions, prolonged erection, breast secretions,
• 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 continuous 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 stopped

If you stop 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 stop treatment with sertraline).

A higher 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 Pharmacovigilance of Medicines 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 100 mg of sertraline (equivalent to 111,906 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 100 mg tablets are film-coated tablets of white or off-white color, capsule-shaped, biconvex, smooth on both faces.

Sertralina Pharma Combix 100 mg is presented in blister packs, containing 30 or 60 tablets.

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

Only some package sizes may be commercially available.

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/