Package Leaflet: Information for the User

Sertraline STADA 100 mg Film-Coated Tablets

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. See section 4.

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

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

3. How to take Sertraline Stada

4. Possible side effects

5. Storage of Sertraline Stada

6. Contents of the pack and additional information

Sertralina Stada 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.

Sertraline 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 anxiety-related diseases, 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-related disease. 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 sertraline, you should consult your doctor.

Do not take Sertralina Stada

-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 (a medicine used to treat mental disorders such as psychosis).

Warnings and precautions

Consult your doctor or pharmacist before starting to take sertraline.

Medicines 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, 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 suicidal thoughts (see "Thoughts of suicide and worsening of your depression or anxiety" below).

-If you have Serotonin Syndrome. In rare cases, this syndrome can occur when you are taking certain medicines 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 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 affect sodium levels in your blood.

-If you are elderly, as you may be at greater risk of having low sodium levels in your blood (see above).

-If you have liver disease; your doctor may consider that you should take a lower dose of sertraline.

-If you have diabetes; sertraline can affect your blood sugar levels, so you may need to adjust the dose of your diabetes medicines.

-If you have had bleeding disorders or have been taking medicines that decrease blood clotting (such as aspirin, warfarin) or that may increase the risk of bleeding, or if you are pregnant (see "Pregnancy, breastfeeding and fertility").

-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 (OCD). If you are to be treated for this condition, your doctor will want to keep a close eye on 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 can be seen on an electrocardiogram (ECG), known as QT prolongation.
• If you have heart disease, low potassium or magnesium levels, a family history of QT prolongation, a slow heart rate, or are taking other medicines that prolong the QT interval.

Restlessness/Acatisia

The use of sertraline has been associated with unpleasant restlessness and a need to move, often accompanied by an inability to sit or stand still (acatisia). This is more likely to happen 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 sertraline and 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. 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 normally 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 should 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

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide. This may be more likely to happen when you first start taking antidepressants, as these medicines take time to work, usually two weeks but sometimes longer.

This is more likely to happen if

-You have had thoughts of suicide or harming yourself before.

-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 friend or family member 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 behaviour.

Sexual problems

Some medicines in the group to which Sertralina Stada belongs (called ISRS) can cause sexual dysfunction symptoms (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). Patients under 18 years old are at greater risk of side effects such as suicidal thoughts, thoughts of harming themselves or suicide, and hostility (mainly aggression, confrontational behaviour, and irritable mood) when taking this class of medicines. However, your doctor may decide to prescribe sertraline to a patient under 18 years old if they consider it to be the best option for the patient. If your doctor has prescribed sertraline and you are under 18 years old and want 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 while you are taking sertraline.

At the same time, the long-term safety and effects on growth, maturity, and learning (cognitive development) and behaviour development of sertraline in this age group have not yet been demonstrated.

Taking Sertralina Stada with other medicines

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 may reduce the effectiveness of other medicines you are taking at the same time.

The use of sertraline 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), the antibiotic linezolid, and methylene blue (for high levels of methaemoglobin in the blood). Do not take sertraline with these medicines.
• Medicines for treating mental disorders such as psychosis (pimozide). Do not take sertraline with pimozide.
• Inform your doctor if you are taking the following medicines:
• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).
• Medicines based on plants containing St. John's Wort (Hypericum perforatum). The effects of St. John's Wort can last 1-2 weeks.
• Products containing the amino acid tryptophan.
• Medicines for treating severe pain (such as tramadol).
• Medicines used in anaesthesia or for chronic pain (such as fentanyl, mivacurium, and suxamethonium).
• Medicines for treating migraines (such as sumatriptan).
• Medicines that decrease blood clotting (warfarin).
• Medicines for treating arthritis pain [non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin (acetylsalicylic acid)].
• Sedatives (diazepam).
• Diuretics.
• Medicines for treating epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines for treating diabetes (tolbutamide).
• Medicines for treating acid reflux, ulcers, and stomach burning (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medicines for treating mania and depression (lithium).
• Other medicines for treating depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medicines for treating schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medicines used to treat high blood pressure, chest pain, or to regulate heart rate (such as verapamil, diltiazem, flecainide, propafenone).
• Medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Medicines used to treat HIV/AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
• Medicines known to increase the risk of changes in heart rhythm (such as some antipsychotics and antibiotics).
• Medicines used to treat pain and fever (metamizole).

Taking Sertralina Stada with food, drinks, and alcohol

Sertraline tablets can be taken with or without food. You should avoid drinking alcohol while taking sertraline.

Do not take sertraline 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, 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. If you are pregnant, sertraline will only be given to you if your doctor considers that the benefits for you outweigh any possible risks to the developing baby.

Make sure your midwife and/or doctor know that you are taking sertraline. If you take sertraline during pregnancy, especially in the last three months, certain medicines like sertraline may increase the risk of a serious condition in newborn 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.

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

• difficulty breathing,

• blue skin or being too hot or cold,

• blue lips,

• vomiting or feeding problems,

• excessive tiredness, inability 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.

If you take sertraline in the final stages of pregnancy, there may be a greater risk of heavy vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking sertraline so they can advise you.

There is some 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 risks to the baby.

Studies in animals have shown that some medicines, such as sertraline, can reduce the quality of sperm. This could theoretically affect fertility, but the impact on fertility in humans has not yet been determined.

Driving and operating machinery

Medicines 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 Stada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this 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 50 mg per day. The daily dose can be increased by 50 mg 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 at intervals of 50 mg over a period of several weeks.

The maximum recommended dose is 200 mg per day.

Children and Adolescents:

Sertraline should only be used to treat children and adolescents aged 6 to 17 years who present 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..

Administration Form:

Sertraline tablets can be taken with or without food.

Take your medication once a day in the morning or evening.

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. Depression treatment should be continued for 6 months after improvement.

If you take more Sertraline Stada than you should

If you accidentally take an excessive amount of sertraline, 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, and vomiting, rapid heart rate, tremors, agitation, dizziness, and in rare cases, unconsciousness.

If you forget to take Sertraline Stada

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 Sertraline Stada

Do not interrupt treatment with sertraline unless your doctor tells you to. Your doctor will want to gradually reduce the dose of sertraline over 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 with sertraline, 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 may 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 in the ears, swelling of the eyelids, face, or lips.

-If you experience agitation, confusion, diarrhea, increased temperature and blood pressure, excessive sweating, and rapid pulse. These are symptoms of serotonin syndrome. In rare cases, this syndrome may 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 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 Sertraline Stada, 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 (of the chest), sore throat, runny nose,
• 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, increased muscle tone, lack of concentration, abnormal taste,
• Visual disturbances,
• Ringing in the ears,
• Palpitations,
• Angina,
• Yawning,
• Uncomfortable stomach, constipation, abdominal pain, vomiting, gas,
• Increased sweating, rash,
• Back pain, joint pain, muscle pain,
• Irregular menstrual cycle, erectile dysfunction,
• Uncomfortable feeling, 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, neglect, 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, hematuria,
• Dyspnea, 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, urinary incontinence, increased urine volume, nocturia,
• 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 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*,
• Physical symptoms due to stress or emotions, abnormal nightmares*, medication dependence, somnambulism, premature ejaculation,
• Coma, abnormal movements, difficulty moving, increased sensitivity, sudden and severe headache (which may 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 (light sensitivity), eye bleeding, irregular pupils*, visual disturbances*, eye disorders,
• 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,
• Arm and leg circulation problems,
• Accelerated breathing, progressive scarring of lung tissue (interstitial lung disease)*, throat spasm, difficulty speaking, slow breathing, hiccups,
• Mouth ulcers, pancreatitis*, bloody 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, capillary eruption,
• Muscle rupture*, bone disorders,
• Intermittent urination, decreased urine volume,
• Milk secretion, vaginal dryness, genital secretion, penile and preputial pain and redness, breast enlargement*, prolonged erection,
• Hernia, decreased tolerance to the medication,
• Increased cholesterol levels, abnormal laboratory tests*, abnormal semen, bleeding disorders*,
• Relaxation of blood vessel function.

Frequency not known: cannot be estimated from available data:

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

*Adverse effects reported aftermarketing.

Otheradverse 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 with this medicine abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors (see section 3. If you stop treatment with sertraline).

A higher risk of bone fractures has been observed in patients taking this type of medication.

Reporting 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 Vigilance of Medicinal Products 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 medicationout of the sight andreach of children.

No special storage conditions are required.

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 dispose of medications through drains or in the trash. Dispose of packaging and unusedmedications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Sertralina Stada

-The active ingredient is sertraline (hydrochloride). Each tablet contains 100 mg of sertraline, equivalent to 111.92 mg of sertraline hydrochloride.

-The other components are:core of the tablets: microcrystalline cellulose, calcium dihydrogen phosphate dihydrate, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate.Coating with a film: hypromellose (E 464), titanium dioxide (E 171), macrogol 400, and talc.

Appearance of the product and content of the container

Sertralina Stada 100 mg is presented in containers that contain 30 or 60 film-coated tablets, white, oblong, with the inscription “100” on one face and a groove on the other.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

STADA Laboratorio, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Responsible for manufacturing:

LAMP S. PROSPERO S.P.A.

Via Della Pace, 25/A

41030 San Prospero (MO)

Italy

or

STADA Arzneimittel AG

Stadastrasse 2- 18

61118 Bad Vilbel

Germany

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This leaflet was approved in December 2021

The detailed information of this medicine is available on the website of the Spanish Agency of Medicaments and Sanitary Products (AEMPS) http://www.aemps.gob.es/