Package Insert: Information for the User

Sertraline Mabo 50 mg Film-Coated Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Sertraline Mabo and for what it is used

2. What you need to know before starting to takeSertraline Mabo

3. How to take Sertraline Mabo

4. Possible adverse effects

5. Storage of Sertraline Mabo

6. Contents of the package andadditional information

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

Sertralina Mabo 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).

- Anxiety disorder (in adults).

- Obsessive-compulsive disorder (OCD) (in adults, and in children and adolescents aged 6-17 years).

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 (compulsions).

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 feeling 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 that this medication is suitable for treating your disease.

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

Do not take Sertralina Mabo

• If you are allergic to sertraline or any of the other ingredients in this medicine (listed in section 6)
• 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 an MAOI. After stopping treatment with an MAOI, you should wait at least two weeks before starting treatment with sertraline.
• If you are taking another medicine called pimozide (an antipsychotic)

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take this medicine

Medicines are not always suitable for everyone. Before starting treatment with this medicine, tell your doctor if you have or have had any of the following circumstances:

• 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 sertraline. You should also inform your doctor if you are taking any medicines for high blood pressure, as these medicines can also alter sodium levels in the blood.
• Be particularly 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 can alter your blood sugar levels, so you may need to adjust the dose of your diabetes medicines.
• Epilepsy or a history of epilepsy. If you have a fit (seizure), 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 suicidal thoughts (see below suicidal thoughts and worsening of your depression or anxiety).
• If you have had bleeding disorders, if you are pregnant (see Pregnancy, breastfeeding and fertility)or have been taking medicines that decrease blood clotting (for example aspirin, or warfarin) or that may increase the risk of bleeding.
• If you are a child or adolescent under 18 years old. Sertraline 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 Children and adolescents).
• If you are receiving electroconvulsive therapy (ECT).

Sometimes medicines in the same group as this one (called SSRIs/SNRIs) can cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

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 happens more often during the first few weeks of treatment. Increasing the dose in patients who develop these symptoms can be harmful.

Withdrawal symptoms

When treatment is stopped, withdrawal symptoms are common, particularly if 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 in 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 can 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.

Suicidal thoughts 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 can increase at the beginning of treatment with antidepressants, because 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 suicide at any time, contact your doctor or go to the hospital immediately.

It may be helpful 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.

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. Young patients are at greater risk of side effects such as suicidal thoughts, suicidal behaviour, and hostility (mainly aggression, confrontational behaviour, and irritable reaction) when treated with this type of medicine. However, your doctor may decide to prescribe this medicine to a patient under 18 years old if they consider it to be the best option for the patient. If your doctor has prescribed this medicine to a patient under 18 years old and wants to discuss this decision, please go back 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 sertraline. At the same time, the long-term safety effects and those related to growth, maturity, and cognitive and behavioural development of sertraline in this age group have not yet been demonstrated.

Other medicines and Sertralina Mabo

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

Some medicines can affect how sertraline works, or sertraline itself can reduce the effectiveness of other medicines you are taking at the same time.

The use of Sertralina Mabo 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 take sertraline with MAOIs.
• Medicines to treat mental disorders (pimozide). Do not take sertraline with pimozide.

Inform 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 can last 1-2 weeks. Tell your doctor.
• Products containing the amino acid tryptophan.
• Medicines to treat severe pain (for example tramadol).
• Medicines to treat migraines (for example 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).

Taking Sertralina Mabo with food and drink

Sertraline tablets can be taken with or without food.

Alcohol should be avoided while being treated with sertraline.

Pregnancy, breastfeeding and fertility

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The safety of sertraline in pregnant women has not been fully established. Sertraline should only be administered to pregnant women if, in the opinion of the doctor, the benefits for the mother outweigh any possible risk to the fetus. Women of childbearing age who are being treated with sertraline should use an appropriate contraceptive method.

If you take sertraline in the final stages of pregnancy, there may be a greater 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 so that they can advise you.

Make sure your midwife and/or doctor know that you are taking Sertralina. When taken during pregnancy, especially in the last three months of pregnancy, medicines like Sertralina may increase the risk of a serious illness in newborn babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby is born. If this happened to your baby, contact your midwife and/or doctor immediately.

There is some indication that sertraline is excreted in breast milk. Therefore, sertraline can only be used in women during breastfeeding if, in the opinion of the doctor, the benefits for the mother outweigh any possible risk to the baby.

Some medicines, such as Sertralina, may reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but the impact on human fertility has not been observed so far.

Driving and operating machinery

Antidepressants like sertraline can affect your ability to drive or operate machinery. Therefore, do not drive or operate heavy machinery until you know how this medicine affects your ability to perform activities.

Sertralina Mabo contains lactose.

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

Sertralina Mabo contains sodium.

This medicine contains sodium. This medicine contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially "sodium-free".

Follow exactly the administration instructions for Sertralina Mabo indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Sertralina tablets can be taken with or without food.

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

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 thus over several weeks. The maximum recommended dose is 200 mg per day.

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 dose is 200 mg per day.

Use in children and adolescents

This medication should only be used to treat children and adolescents aged 6 to 17 years with OCD.

Obsessive-Compulsive Disorder

Children aged 6 to 12 years:The recommended starting dose is 25 mg per day. After one week, your doctor may increase the dose to 50 mg per day. The maximum dose is 200 mg per day.

Adolescents aged 13 to 17 years:The recommended starting dose is 50 mg per day. The maximum dose is 200 mg per day.

If you have liver or kidney problems, inform your doctor and follow the instructions they give you.

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 start improving.

If you take more Sertralina Mabo than you should

If you accidentally take an excessive amount of sertralina, contact your doctor or go to the nearest hospital emergency department. Always carry the medication packaging with you, even if it is empty.

You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The 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 Mabo

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 the missed doses.

If you interrupt treatment with Sertralina Mabo

Do not stop treatment with sertralina unless your doctor tells you to. Your doctor will want to gradually reduce the dose of sertralina over several weeks before stopping treatment completely. If you stop treatment abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation, or anxiety, headaches, feeling unwell, or feeling dizzy and trembling. If you experience any of these side effects, or any other during the interruption of your treatment with sertralina, please inform your doctor.

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

Like all medicines, this medicine 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 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 stop treatment.
• Allergic reaction or allergy, which may 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 stop 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 to feel restless and are unable to sit or stand after starting treatment with sertraline. Inform your doctor if you start to feel restless.

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 up to 1 in 10 patients)

Sore throat, loss of appetite, increased appetite, depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased sex drive, 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 up to 1 in 100 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 flushes, possible noisy breathing difficulties, shortness of breath, nasal bleeding, esophageal problems, difficulty swallowing, hemorrhoids, increased salivation, altered tongue, belching, eye swelling, purple spots on the skin, hair loss, cold sweat, dry skin, urticaria, arthritis, muscle weakness, back pain, muscle spasms, nocturia, urinary retention, increased urine output, urinary disorders, vaginal bleeding, female sexual dysfunction, discomfort, chills, fever, weakness, thirst, weight loss, and weight gain.

Rare side effects (may affect up to 1 in 1,000 patients)

Intestinal problems, ear infection, cancer, swollen lymph nodes, high cholesterol, elevated blood sugar, physical symptoms due to stress or emotions, medication dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation, coma, abnormal movements, difficulty moving, increased sensitivity, sensory disturbances, glaucoma, eye tear problems, appearance of spots in the visual field, double vision, eye light damage, blood in the eye, dilated pupils, spots in front of the eyes, glaucoma, double vision, photophobia (sensitivity to light), eye hemorrhages, irregular pupils, visual disturbances, tear 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 alterations, 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 medications, difficulty walking, abnormal laboratory tests, abnormal semen, injury, vascular relaxation procedure.

Side effects of unknown frequency (cannot be estimated from available data)

Partial vision loss, colon inflammation (causing diarrhea), excessive vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, lactation, and fertility" 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, movement disorders (such as continuous movements, muscle tension, and difficulty walking), syncope, abnormal vision, bleeding problems (such as nasal bleeding, stomach bleeding, or blood in urine), pancreatitis, severe liver function problems, yellow skin, skin swelling, sun sensitivity, itching, joint pain, muscle cramps, breast enlargement, irregular menstrual cycles, swollen legs, coagulation problems, and severe allergic reactions.

Other 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.

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 mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance 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 medicine.

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

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Store in the original packaging.

Medications should not be disposed of through drains or trash. Deposit empty containers and unused medications at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Sertralina Mabo

• The active ingredient of this medication is sertraline (hydrochloride). Each tablet contains 50 mg of sertraline.
• The other components are: anhydrous colloidal silica (E-551), microcrystalline cellulose (E-460), sodium croscarmellose (E-468), copovidone, lactose monohydrate, magnesium stearate. Coating: hypromellose (E-464), hydroxypropyl cellulose (E-463), titanium dioxide (E-171) and macrogol 400.

Appearance of the product and content of the packaging

Sertralina Mabo 50 mg is presented in coated tablets with a scored film, white in color, with the mark "50" on one of its faces.

Sertralina Mabo 50 mg is available in two packaging sizes: 30 and 60 tablets. The tablets are presented in PVC blisters with an aluminum foil backing.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

MABO-FARMA S.A.

Calle Rejas 2, planta 1

28821 Coslada

Madrid España

Responsible for manufacturing:

TEVA PHARMA S.L.U

C/C, n 4 Polígono Industrial Malpica

50016, Zaragoza España

or

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-70. Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid) España

Last review date of this leaflet : February 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/