Leaflet: information for the user

Aremis 50mg film-coated tablets

Sertraline

Read this leaflet carefully before you start taking this medicine because 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 give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Aremis and what it is used for

2.What you need to know before starting to take Aremis

3.How to take Aremis

4.Possible side effects

5.Storage of Aremis

6.Contents of the pack and additional information

Aremiscontains sertraline as its 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.

Aremismay be used to treat:

-Depression and prevention of depression relapse (in adults).

-Social anxiety disorder (in adults).

-Post-traumatic stress disorder (PTSD) (in adults).

-Panic disorder (in adults).

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

Depression is a clinical 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 humiliating manner).

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

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

Do not take Aremis:

• If you are allergic to sertraline or any of the other components of this medication (listed in section 6).
• If you are taking or have taken medications called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other similar medications 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 medication called pimozide (a medication used to treat mental disorders such as psychosis).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Aremis.

Medications are not always suitable for everyone. Before starting treatment with Aremis, inform your doctor if you have or have had any of the following circumstances:

• If you have epilepsy (seizures) or a history of convulsions. If you have a 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 thoughts of harming yourself or committing suicide (see "Thoughts of suicide and worsening of depression or anxiety" below).
• If you have Serotonin Syndrome. In rare cases, this syndrome can occur when taking certain medications at the same time as sertraline. (See "Possible side effects" for symptoms. Your doctor will tell you if you have had this syndrome before.
• If you have low sodium levels in your blood, as this condition may occur as a result of treatment with Aremis. 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.
• If you are elderly, as you may be at increased risk of having low sodium levels in the blood (see previous point).
• If you have liver disease; your doctor may consider that you should take a lower dose of Aremis.
• If you have diabetes; Aremis may alter your blood sugar levels, so you may need to adjust the dose of your diabetes medication.
• If you have a history of bleeding disorders (tendency to develop ecchymoses), or if you are pregnant (see Pregnancy, breastfeeding, and fertility) or have taken medications that decrease blood clotting (such as aspirin, warfarin) or may increase the risk of bleeding.
• If you are a child or adolescent under 18 years old. Aremis should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder (OCD). If you are to be treated for this disorder, your doctor will want to monitor you closely (see "Children and adolescents" below).
• If you are receiving electroconvulsive therapy (ECT).
• If you have any eye disorder, such as certain types of glaucoma (increased intraocular pressure).
• If you have been told that you have an abnormal heart rhythm that is obtained after an electrocardiogram (ECG), known as QT prolongation.
• If you have heart disease, low potassium or magnesium levels, family history of QTc prolongation, low heart rate, or are taking medications that prolong QTc.

Anxiety/Acatisia:

The use of sertraline has been associated with unpleasant anxiety and a need to move, often accompanied by an inability to sit or stand still (acatisia). This occurs more often during the first few weeks of treatment. Increasing the dose may be harmful, so if you develop these symptoms, you should contact your doctor.

Withdrawal symptoms:

Side effects related to stopping treatment (withdrawal symptoms) are common, particularly if treatment is stopped abruptly (see section 3. If you stop taking Aremis and section 4. Possible side effects). The risk of withdrawal symptoms depends on the duration of treatment, dose, and rate at which the dose is reduced. Generally, these symptoms are mild or moderate. However, in some patients, they can be severe. These symptoms usually 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, and you should always agree with your doctor on the best way to stop treatment.

Thoughts of suicide and worsening of depression or anxiety:

If you are depressed and/or have anxiety disorders, you may have thoughts of harming yourself or committing suicide. This may 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.

It is more likely to happen:

• If you have previously had thoughts of suicide or self-harm.
• 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 with psychiatric disorders, 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 to explain to a close family member or friend that you are depressed or have anxiety, 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.

Some medications in the group to which Aremis belongs (called ISRS) may cause sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

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). Children and adolescents under 18 years old are at increased risk of side effects such as suicidal thoughts, thoughts of self-harm, or suicide (suicidal ideation) and hostility (predominantly aggression, confrontational behavior, and irritable reaction) when treated with this class of medications. However, your doctor may decide to prescribe Aremis to a patient under 18 years old if they consider it to be the most suitable option for the patient. If your doctor has prescribed Aremis and you are under 18 years old and want to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen while you are taking Aremis. The long-term effects on safety and related to growth, maturity, and learning (cognitive development) and behavioral development of Aremis were evaluated in a long-term study in over 900 children aged 6 to 16 years who were monitored for a period of 3 years. In general, the results of the study showed that children treated with sertraline developed normally, except for a slight increase in weight in those treated with a higher dose.

Combination of Aremis with other medications

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

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

The use of Aremis with the following medications may cause severe side effects:

• Medications called monoamine oxidase inhibitors (MAOIs), such as moclobemide (for depression), selegiline (for Parkinson's disease), the antibiotic linezolid, and methylene blue (for high levels of methemoglobin in the blood). Do not use Aremis with these medications.
• Medications for treating mental disorders such as psychosis (pimozide). Do not use Aremis with pimozide.

Inform your doctor if you are taking the following medications:

• Medications containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).
• Herbal products containing St. John's Wort (Hypericum perforatum). The effects of St. John's Wort may last 1-2 weeks.
• Products containing the amino acid tryptophan.
• Medications for treating severe or chronic pain (opioids, such as tramadol, fentanyl).
• Medications used in anesthesia (such as fentanyl, mivacurium, and suxamethonium).
• Medications for treating migraines (such as sumatriptan).
• Medications that decrease blood clotting (warfarin).
• Medications for treating pain/arthritis [nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin (acetylsalicylic acid)].
• Sedatives (diazepam).
• Diuretics.
• Medications for treating epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medications for treating diabetes (tolbutamide).
• Medications for treating acid reflux, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medications for treating mania and depression (lithium).
• Other medications for treating depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medications for treating schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medications for treating high blood pressure, chest pain, or regulating heart rate (such as verapamil, diltiazem, flecainide, propafenone).
• Medications used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
• Medications used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Medications used to treat HIV/AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir).
• Medications used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
• Medications known to increase the risk of changes in heart rhythm (such as some antipsychotics and antibiotics).

Combination of Aremis with food, drinks, and alcohol

Aremis tablets can be taken with or without food.

Alcohol should be avoided while taking Aremis.

Do not take sertraline with grapefruit juice, as it may increase sertraline levels 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 medication.

Aremis has not been fully established as safe in pregnant women. If you are pregnant, sertraline will only be administered to you if your doctor considers that the benefit to you outweighs any possible risk to the developing fetus.

If you take Aremis in the final stages of pregnancy, there may be an increased 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 Aremis so they can advise you.If you take it during pregnancy, especially in the last three months, medications like Aremis may increase the risk of a serious condition in newborns called persistent pulmonary hypertension (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.

Your newborn baby may have other conditions, which usually manifest within the first 24 hours after birth. Symptoms include:

• difficulty breathing,

• blue skin or too hot or cold,

• blue lips,

• vomiting or feeding problems,

• excessive tiredness, unable to sleep, or crying a lot,

• muscle stiffness or decreased muscle tone,

• tremors, restlessness, or convulsions,

• increased reflexes,

• irritability,

• low blood sugar.

If your baby has any of these symptoms at birth, or you are concerned about your baby's health, consult your doctor or midwife for advice.

There is evidence that sertraline passes into breast milk. Therefore, sertraline can only be used in women who are breastfeeding if your doctor considers that the benefit outweighs any possible risk to the baby.

Studies in animals have shown that some medications, such as sertraline, may reduce sperm quality. Theoretically, this could affect fertility, but it has not yet been established in humans.

Driving and operating machines

Psychotropic medications like sertraline may affect your ability to drive or operate machines. Therefore, do not drive or operate heavy machinery until you know how this medication affects your ability to perform these activities.

Sodium content
This medication contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor

or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults:

Depression and Obsessive-Compulsive Disorder:

The commonly effective dose for depression and OCD is 50mg per day. The daily dose can be increased by 50mg at intervals of at least one week, and thus over several weeks. The maximum recommended dose is 200mg 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 start with a dose of 25mg per day, and increased to 50mg per day after one week.

The daily dose can be increased at intervals of 50mg over a period of several weeks. The maximum recommended dose is 200mg per day.

Use in children and adolescents:

Aremis 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 25mg per day.

After one week, your doctor may increase the dose to 50mg per day. The maximum dose is 200mg per day.

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

If you have liver or kidney problems, inform your doctor and follow their instructions..

Administration form:

Aremis tablets can be taken with or without food.

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

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

If you take more Aremis than you should

If you accidentally take an excess of Aremis, contact your doctor or go to the nearest hospital emergency service. Always carry the medication packaging with you, whether it contains medication or not.

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, unconsciousness.

If you forgot to take Aremis:

Do not take a double dose to compensate for the missed doses. If you forget to take a dose, do not take it when you remember. Take the next dose when it is due.

If you interrupt treatment with Aremis:

Do not interrupt treatment with Aremis unless your doctor tells you to. Your doctor will want to gradually reduce the dose of Aremis 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, nausea, vomiting, and tremors. If you experience any of these adverse effects, or any other during the interruption of your treatment with Aremis, 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.

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, 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 thoughts of self-harm or suicide (suicidal thoughts).

-If you start to feel restless and are unable to sit or stand after starting treatment with Aremis, inform your doctor if you start to feel restless.

-If you have a seizure (convulsions).

-If you have a manic episode (see section 2. Warnings and precautions).

The following side effects were observed in clinical trials in adults and after marketing.

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

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

Common (may affect up to 1 in 10 patients):

-Common cold (of the chest),sore throat, runny nose,

-Loss of appetite, increased appetite,

-Anxiety,depression, agitation, decreased libido, nervousness, feeling strange, nightmares, bruxism,

-Tremor, muscle movement problems (such as constant movements, muscle tension, difficulty walking, and stiffness, spasms, and involuntary muscle movements)*, numbness and tingling, increased muscle tone, difficulty concentrating, abnormal taste,

-Visual disturbances,

-Tinnitus in the ears,

-Palpitations,

-Headaches,

- Yawns,

-Uncomfortable stomach, constipation,abdominal pain, vomiting, gas,

-Increased sweating, rash,

-Back pain, joint pain,muscle pain,

-Irregular menstrual cycle,erectile dysfunction,

-Feeling unwell, chest pain, weakness, fever,

-Weight gain,

-Lesion.

Common (may affect up to 1 in 100 patients):

-Gastroenteritis, ear infection,

-Tumor,

-Hypersensitivity, seasonal allergy,

-Low levels of thyroid hormones,

-Suicidal thoughts, suicidal behavior*, psychotic disorders, abnormal thoughts, lack of care, hallucinations, aggression, excessive happiness, paranoia,

-Amnesia, decreased sensitivity, involuntary muscle contractions, fainting, continuous movements, migraine, convulsions, dizziness when standing up, abnormal coordination, speech disorders,

-Dilated pupils,

-Ear pain,

-Fast pulse, heart problems,

-Bleeding problems (such as stomach bleeding)*, high blood pressure, hot flashes, blood in urine,

-Difficulty breathing, possibly noisy,

-Black stools, dental disorders,esophageal inflammation, tongue problems, hemorrhoids, excessive salivation, difficulty swallowing, belching, tongue disorders,

-Swollen eyes, urticaria, hair loss, itching, purple spots on the skin, skin disorders with blisters, dry skin, facial swelling, cold sweat,

-Arthritis, muscle spasms, muscle cramps*, muscle weakness,

-Increased frequency of urination, urinary disorders, urinary retention, urinary incontinence, increased urine volume, nocturia,

-Female sexual dysfunction, excessive vaginal bleeding, vaginal hemorrhage, female sexual dysfunction,

-Swollen legs, chills,difficulty walking, thirst,

-Increased liver enzymes, weight loss,

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

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

-Diverticulitis, swollen lymph nodes, low platelet count*, low white blood cell count*,

-Severe allergic reaction,

-Endocrine disorders*,

-High cholesterol, difficulty controlling blood sugar levels (diabetes), low blood sugar, high blood sugar*, low sodium levels in the blood*,

-Symptoms due to stress or emotions, abnormal nightmares*, drug dependence, somnambulism, premature ejaculation,

-Coma, abnormal movements, difficulty moving, increased sensitivity, severe headache (which can be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS))*, sensory disturbances,

-Seeing spots in front of the eyes, glaucoma, double vision, photophobia (sensitivity to light), eye bleeding, irregular pupils*, abnormal vision*, eye disorders,

-Heart attack, dizziness, fainting, or chest discomfort that could be signs of changes in electrical activity (seen on the electrocardiogram) or abnormal heart rhythm*, slow heart rate,

-Problems with circulation in the arms and legs,

-Accelerated breathing, progressive scarring of lung tissue (interstitial lung disease)*,throat spasms, difficulty speaking, slower breathing, hiccups,

-Mouth ulcers, pancreatitis*,blood in stools, tongue ulcers, mouth sores,

-Liver function problems, severe liver function disorders*, yellow skin and eyes (jaundice)*,

-Sun sensitivity*, skin swelling*, abnormal hair texture, abnormal skin odor, hair loss,

-Muscle tissue rupture*, bone disorders,

-Intermittent urination,decreased urine volume,

-Mastitis, vaginal dryness, genital secretion, pain and redness of thepene and prepucio, breast enlargement*, prolonged erection,

-Hernia, decreased tolerance to the medication,

-Increased cholesterol levels, abnormal analytical tests*, abnormal semen, coagulation disorders*,

-Relaxation of blood vessel procedure.

Frequency not known (cannot be estimated from available data):

• Partial loss of vision,
• Trigeminal nerve block*,
• Nocturnal urinary incontinence*,
• Colitis (which causes diarrhea)*,
• Excessive vaginal bleeding after childbirth (postpartum hemorrhage), see “Pregnancy, lactation, and fertility” in section 2 for more information.

*Side effects reported after marketing.

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.

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 Aremis”).

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear 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 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.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Aremis:

• Each film-coated tablet contains sertraline hydrochloride equivalent to 50 mg of sertraline.

The other components are: calcium dihydrogen phosphate dihydrate (E341), microcrystalline cellulose (E460), hydroxypropyl cellulose (E463), sodium starch glycolate type A, magnesium stearate (E572), titanium dioxide (E171), hypromellose (E464), macrogol 400 (E1521), macrogol 6000 (E1521), and polysorbate 80 (E433).

Appearance of the product and contents of the packaging

Aremis 50 mg is presented in film-coated tablets of white or almost white color, elongated, biconvex, with the logo “AREMIS” and scored on one face and “50” on the other.

Aremis is available in blisters containing 30, 60, or 500 (clinical packaging) tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona (Spain)

Responsible for manufacturing:

TOWA Pharmaceutical Europe S.L.

c/ de Sant Marti, 75-97

08107 Martorelles (Spain)

Date of the last review of this leaflet: June 2022

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/