Package Leaflet: Information for the User

Sertraline Davur 100 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicinebecause it contains important information for you.

• 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 only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.

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

2. What you need to know before you start taking Sertraline Davur

3. How to take Sertraline Davur

4. Possible side effects

5. Storage of Sertraline Davur

6. Contents of the pack and additional information

Sertralina Davur 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 Davur may 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 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 Sertralina Davur, you should consult your doctor.

Do not take Sertralina Davur

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

Warnings and precautionsTell your doctor if you have or have had any of the following conditions:

• Serotonin syndrome and neuroleptic malignant syndrome. In rare cases, these syndromes can occur when you take certain medicines at the same time as sertraline.This risk increases when you take medicines that affect serotonin (such as buprenorphine and triptans).(See section 4 for symptoms. Your doctor will tell you if you have had either of these syndromes before.
• If you have low sodium levels in your blood, as this can occur as a result of treatment with sertraline. Also, tell your doctor if you are taking any medicines for high blood pressure, as these can also affect 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 can affect 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 seizure (convulsion), call your doctor immediately.
• If you have bipolar disorder (manic-depressive illness) 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 depression or anxiety).
• 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 “Pregnancy and breastfeeding”).
• 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 being 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).
• If you have any eye problems, such as certain types of glaucoma (increased intraocular pressure).
• If you have been told that you have a heart condition known as a prolonged QT interval.

Restlessness/Acatisia

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 can be harmful.

Withdrawal symptoms

When treatment is stopped, withdrawal symptoms are common, particularly if treatment is stopped abruptly (see section 4 for 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, but in some patients they can be severe. These symptoms usually occur in the first few days after stopping treatment. In general, these symptoms 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 be gradually reduced over a period of several weeks or even months, as needed for each patient.

Thoughts of suicide and worsening of 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, as all these medicines take time to work, 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 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 behaviour.

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

Some medicines in the same group as Sertralina Davur (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. Young patients have a higher risk of side effects such as suicidal thoughts, suicidal behaviour, and hostility (mainly aggression, confrontational behaviour, and anger reactions) when taking this type of medicine. However, your doctor may decide to prescribe Sertralina Davur to a patient under 18 years old if they consider it to be the best option for the patient. If your doctor has prescribed Sertralina Davur to a patient under 18 years old and you want 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 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 DavurTell your doctor or pharmacist if you are using or have recently used other medicines, even those bought without a prescription.

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

The use of Sertralina Davur with the following medicines can 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 take sertraline with MAOIs.
• Medicines for mental disorders (pimozide). Do not take sertraline 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 can last for 1-2 weeks. Tell your doctor.

• Products containing the amino acid tryptophan.
• Pain medicines (such as tramadol).
• Medicines used in anaesthesia or for chronic pain (fentanil).
• Migraine medicines (such as sumatriptan).
• Medicines that decrease blood clotting (warfarin).
• Medicines for pain and arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin).
• Sedatives (diazepam).
• Diuretics.
• Medicines for epilepsy (phenytoin).
• Medicines for diabetes (tolbutamide).
• Medicines for stomach acid and ulcers (cimetidine).
• Medicines for mania and depression (lithium).
• Other medicines for depression (such as amitriptyline, nortriptyline).

• Medicines for schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medicines that affect serotonin, such as buprenorphine, as they may increase the risk of serotonin syndrome.

Take Sertralina Davur with food and drink

Sertralina Davur tablets can be taken with or without food.

Avoid drinking alcohol while being treated with sertraline.

Sertralina Davur tablets should not be taken with grapefruit juice, as this can increase the levels of sertraline in your body.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be 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 given to pregnant women if, in the doctor's opinion, 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.

Make sure your midwife and/or doctor know that you are taking Sertralina Davur. If you take it during pregnancy, especially in the last three months, medicines like Sertralina Davur can increase the risk of a serious condition 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 sertraline 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 so they can advise you.

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

Some medicines, such as sertraline, can reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but there is no evidence of this in humans.

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 do so.

Sertralina Davur contains lactose

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

Sertralina Davur contains sodium

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

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Follow exactly the administration instructions of this medication indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

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

Anxiety Disorder, Social Anxiety Disorder, and PTSD:

For anxiety disorder, social anxiety disorder, and post-traumatic stress disorder, treatment should start 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.

Children and adolescents:

Sertralina Davur 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 will take several weeks for your symptoms to start improving.

If you take more Sertralina Davur 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, whether it contains medication or not.

You can also call the Toxicology 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 Davur:

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 Davur:

Do not stop treatment with Sertralina Davur unless your doctor tells you to. Your doctor will want to gradually reduce the dose of Sertralina Davur 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 Davur, 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 are experiencing are serious 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 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, 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 Sertralina Davur. Inform your doctor if you start to feel restless.

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

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

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

Common side effects (occur 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.

Uncommon side effects (occur between 1 and 10 in 1,000 patients):

Cold (chest), runny nose, hallucinations, excessive happiness, lack of care, abnormal thoughts, convulsions, 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, 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 production, urinary disorders, vaginal bleeding, female sexual dysfunction, discomfort, chills, fever, weakness, thirst, weight loss, and weight gain.

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

Intestinal problems, ear infection, cancer, lymph node swelling, 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, tear duct problems, appearance of spots in the visual field, double vision, eye damage from light, blood in the eye, dilated pupils, 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 eruption, abnormal hair texture, abnormal skin odor, bone alterations, decreased urine production, urinary incontinence, interrupted urination, excessive vaginal bleeding, vaginal dryness, penile and prepuce pain and redness, genital secretion, prolonged erection, breast secretion, hernia, decreased tolerance to medications, difficulty walking, abnormal laboratory tests, abnormal semen, injury, vascular relaxation procedure,spots in front of the eyes, glaucoma, double vision, photophobia (sensitivity to light), eye hemorrhages, irregular pupils, visual disturbances, tear duct problems.

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

Partial vision loss, inflammation of the colon (which causes diarrhea).

Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy and breastfeeding" 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, difficulty controlling blood sugar levels (diabetes), increased blood sugar levels, abnormal nightmares, suicidal behavior, muscle movement disorders (such as continuous movements, muscle tension, and difficulty walking), interstitial lung disease, 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, reversible cerebral vasoconstriction syndrome, 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.

Reporting of 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 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 medicine.

Keep out of the sight and reach of children.

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

Store in the original packaging.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Sertralina Davur 100 mg

• The active ingredient of Sertralina Davur is sertraline (hydrochloride). Each tablet contains 100 mg of sertraline.
• The other components are:
• • Tablet core: colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, copovidone, lactose monohydrate, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide (E-171), and macrogol 400.
  • Coating film: Opadry White Y-5-7068.

Appearance of the product and content of the packaging

Sertralina Davur 100 mg is presented as coated tablets with a white film color with the mark “100” on one of its faces.

Sertralina Davur is available in two packaging sizes: 30 and 60 tablets. The tablets are presented in aluminum-PVC blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st Floor

28108 Alcobendas-Madrid

Spain

Responsible for manufacturing:

Teva Pharma S.L.U.

Malpica Industrial Estate, c/C nº 4

50016 Zaragoza

Spain

Last review date of this leaflet: October 2021

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)