Package Leaflet: Information for the User

Semonic 200 mg 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Semonic is and what it is used for

2. What you need to know before you start taking Semonic

3. How to take Semonic

4. Possible side effects

5. Storage of Semonic

6. Contents of the pack and additional information

This medicationcontains 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.

This medicationmay 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 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 condition.

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

Do not take Semonic:

• If you are allergic to sertraline or any of the other components of this medication (including those 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, 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 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 this medication.

Medications are not always suitable for everyone. Before starting treatment with sertraline, tell 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 (convulsions), call your doctor immediately.
• If you have manic-depressive illness (bipolar disorder) or schizophrenia. If you have a manic episode, call your doctor immediately.
• If you have or have had thoughts of harming yourself or committing suicide (see "Thoughts of suicide and worsening of your depression or anxiety disorder" 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 sertraline. 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 greater 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 sertraline.
• If you have diabetes; sertraline may alter your blood sugar levels, so you may need to adjust the dose of your diabetes medication.
• If you have had bleeding disorders or have been taking medications that reduce blood clotting (such as aspirin or warfarin) or that may increase the risk of bleeding, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility" below).
• If you are a child or adolescent under 18 years old. This medication 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 closely monitor you (see "Children and adolescents" below).
• If you are receiving electroconvulsive therapy (ECT).
• If you have any eye disorders, 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, a family history of QT prolongation, low heart rate, or are taking medications that prolong the QT interval.
• Some medications in the same group as this medication (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see "Possible side effects"). In some cases, these symptoms persist after stopping treatment.

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 "If you stop taking sertraline" and "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. 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 your depression or anxiety disorder:

If you are depressed and/or have anxiety disorders, you may sometimes 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.

You are more likely to experience this:

• 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 for you to explain to a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

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 greater 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 this medication 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 this medication to you 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 when you are taking this medication. At the same time, the long-term safety effects and those related to growth, maturity, and learning (cognitive development) and behavioral development of sertraline in this age group have not yet been demonstrated.

Other medications and Semonic:

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 sertraline works, or sertraline itself may reduce the effectiveness of other medications you are taking at the same time. The use of sertraline with the following medications may cause severe side effects:

• Medications called monoamine oxidase inhibitors (MAOIs), such as moclobemide (for treating depression), selegiline (for treating Parkinson's disease), the antibiotic linezolid, and methylene blue (for treating high levels of methemoglobin in the blood). Do not take sertraline with these medications.
• Medications for treating mental disorders such as psychosis (pimozide). Do not take sertraline 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).
• Medications 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.
• Medications for treating severe pain (such as tramadol).
• Medications used in anesthesia or for chronic pain (such as fentanyl, mivacurium, and suxamethonium).
• Medications for treating migraines (such as sumatriptan).
• Medications that reduce blood clotting (warfarin).
• Medications for treating pain/arthritis [non-steroidal 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).
• Metamizole, a medication used to treat pain and fever.

Taking Semonic with food, drinks, and alcohol:

This medication can be taken with or without food.

Alcohol should be avoided while being treated with sertraline.

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

The safety of sertraline in pregnant women has not been fully established. If you are pregnant, sertraline will only be administered to you if your doctor considers that the benefits for you outweigh any possible risk to the developing fetus.

If you take sertraline in the final stages of pregnancy, there may be an increased risk of excessive 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 sertraline. If you take it during pregnancy, especially in the last three months, medications like Semonic may increase the risk of a serious condition in newborns 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.

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

• difficulty breathing,

• blue skin or too hot or cold,

• blue lips,

• vomiting or feeding problems,

• excessive tiredness, inability to sleep, or excessive crying,

• 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 benefits outweigh any possible risk to the baby.

In animal studies, some medications like sertraline have been shown to reduce sperm quality. Theoretically, this could affect fertility, but the impact on human fertility has not yet been determined.

Driving and operating machinery:

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

Semonic contains lactose and sodium:

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

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

Follow exactly the administration instructions of this medication as 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 50 mg per day. The daily dose can be increased by 50 mg increments at intervals of at least one week, and thus for 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 in increments of 50 mg over a period of several weeks. The maximum recommended dose is 200 mg per day.

Use in children and adolescents:

Semonic 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.

The doses of 150 and 200 mg are indicated for maintenance treatment, after 3 weeks from the start of therapy. The initial treatment begins with low doses.

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

Administration form:

Semonic tablets can be taken with or without food.

Take your medication once a day, either 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 Semonic than you should:

If you accidentally take an excess ofSemonic, 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 forget to take Semonic:

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 Semonic:

Do not interrupt treatment withSemonicunless your doctor tells you to. Your doctor will want to gradually reduce the dose ofSemonicover several weeks before stopping treatment completely. If you interrupt 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 withSemonic,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 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 medicines 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 thoughts of self-harm or suicide (suicidal thoughts).
• If you start to feel restless and are unable to sit or stand after starting treatment withsertraline. You should 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, drowsiness, headache, diarrhea, feeling unwell, dry mouth, ejaculation problems, and fatigue.

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

• Common cold (chest), sore throat, coughing,
• Loss of appetite, increased appetite,
• Anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, teeth grinding,
• Tremor, muscle movement disorders(such as constant movements, muscle tension, difficulty walking, and stiffness, spasms, and involuntary muscle movements)*,Numbness and tingling, muscle tension, lack of concentration, abnormal taste,
• Visual disturbances,
• Tinnitus in the ears,
• Palpitations,
• Angina,
• Yawning,
• Abdominal discomfort, 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.

Uncommon (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,
• Rapid pulse, heart problems,
• Bleeding problems (such as stomach bleeding)*, high blood pressure, angina, blood in urine,
• Shortness of breath, nasal bleeding, possible noisy breathing,
• 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, swollen face, cold sweat,
• Arthritis, muscle spasms, muscle cramps*, muscle weakness,
• Increased frequency of urination, urinary disorders, urinary retention, incontinence, increased urine volume, need to urinate at night,
• Female sexual dysfunction, excessive vaginal bleeding, vaginal bleeding, female sexual dysfunction,
• Swollen legs, chills, difficulty walking, thirst,
• Increased liver enzymes, weight loss,
• Cases of suicidal thoughts and behavior have been reported during treatment with sertraline or shortly after its discontinuation (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 problems*,
• High cholesterol, difficulty controlling blood sugar levels (diabetes), low blood sugar*, high blood sugar*, low sodium levels in the blood*,
• Physical symptoms due to stress or emotions,abnormal nightmares*, dependence on medication, sleepwalking, premature ejaculation,
• Coma, abnormal movements, difficulty moving, increased sensitivity,severe headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS))*,sensorial disturbances,
• Appearance of spots in the visual field, glaucoma, double vision, eye damage, blood in the eye,unequal pupil size*, abnormal vision*, eye dryness,
• Heart attack,dizziness, fainting, or chest discomfort that may be signs of changes in electrical activity (seen on the electrocardiogram) or abnormal heart rhythm*, decreased heart rate,
• Problems with circulation in the arms and legs,
• Accelerated breathing,progressive formation of lung tissue scars (interstitial lung disease)*, throat spasm, difficulty speaking, slower breathing, hiccups,
• Mouth ulceration, pancreatitis*, blood in stool, tongue ulceration, mouth sores,
• Problems with liver function,severe liver function problems*, yellow skin and eyes (jaundice)*,
• Sun sensitivity*, skin swelling*, abnormal hair texture, abnormal skin odor,capillary eruption,
• Muscle tissue rupture*, bone disorders,
• Intermittent urination, decreased urine volume,
• Milk secretion from the breasts, vaginal dryness,genital secretion, pain and redness of the penis and foreskin, breast enlargement*, prolonged erection,
• Hernia, decreased tolerance to the medication,
• Increased cholesterol levels,abnormal laboratory results*, abnormal semen, coagulation problems*,
• Relaxation of blood vessel procedure.

Unknown frequency: cannot be estimated from available data:

• Trigeminal nerve block,
• Nocturnal urinary incontinence*.
• Partial loss of vision
• Colitis inflammation (which causes diarrhea)
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see «Pregnancy, lactation, and fertility» in section 2 for more information.

*Adverse effects reported after marketing.

Other adverse 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 asdizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremor(see section 3. If you stop treatment with Semonic).

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

Reporting of adverse effects

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or 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 Semonic

• Each film-coated tablet contains sertraline hydrochloride equivalent to 200 mg of sertraline.

The other components are: anhydrous colloidal silica, microcrystalline cellulose (E460), sodium croscarmellose, copovidone, lactose monohydrate, stearic acid, magnesium stearate (E572), hypromellose 2910, titanium dioxide (E171), macrogol (E1521), and yellow iron oxide (E172).

Appearance of the product and contents of the packaging

Semonic 200 mg is presented in yellow, oblong, biconvex film-coated tablets (17 x 7 mm).

Semonic 200 mg is available in aluminum/PVC/PVDC blisters, in packs containing 20, 30, 50, 60, and 100 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer responsible:

FERRER INTERNACIONAL, S.A.

Joan Buscallà 1-9

E-08190 Sant Cugat del Vallès

Barcelona – Spain

SVUS Pharma a.s.

Smetanovo nábrezí 1238/20a

500 02 Hradec Králové

Republic of Czech

Neuraxpharm Arzneimittel GmbH,

Elisabeth – Selbert-Str. 23

40764 Langenfeld

Germany

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

This medicinal product is authorized in:

Last review date of this leaflet: December 2021

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