SERTRALINE ALMUS 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sertraline Almus 50mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Sertraline Almus and what is it used for
2. What you need to know before you take Sertraline Almus
3. How to take Sertraline Almus
4. Possible side effects

5 Storage of Sertraline Almus

1. Contents of the pack and further information

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

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

Sertraline Almuscan 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 condition with symptoms such as feelings of sadness, inability to sleep well or to enjoy life as you used to.

OCD and anxiety disorders are conditions related to anxiety, with symptoms such as being constantly worried about recurring ideas (obsessions) that lead to performing repetitive rituals (compulsions).

PTSD is a disorder that can occur after a highly traumatic emotional experience, and has some symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related condition. It is characterized by feeling intense anxiety or distress in social situations (e.g., talking to strangers, public speaking, eating or drinking in front of others, or worrying about behaving shamefully).

Your doctor has considered that this medicine is suitable for treating your condition.

If you are not sure why you have been prescribed Sertraline Almus, you should ask your doctor.

2. What you need to know before you take Sertraline Almus

Do not take Sertraline Almus:

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

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Sertraline Almus.

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

• Serotonin syndrome. This syndrome can occur rarely when taking certain medicines at the same time as sertraline. (To see the symptoms, read section 4. Possible side effects). Your doctor will tell you if you have had this syndrome before.
• If you have low sodium levels in your blood, as this situation may occur as a result of treatment with sertraline. You should also inform your doctor if you are taking any medicine for high blood pressure, as these medicines can also alter sodium levels in your blood.
• Be especially 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 may alter your blood sugar levels, so it may be necessary to adjust the dose of your diabetes medicines.
• Epilepsy or history of epilepsy. 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 had suicidal thoughts (see below suicidal thoughts and worsening of your depression or anxiety disorder).
• If you have had bleeding disorders or have been taking medicines that reduce blood clotting (such as acetylsalicylic acid (aspirin) or warfarin) or that may increase the risk of bleeding. Or if you are pregnant (see "Pregnancy"*).
• If you are a child or adolescent under 18 years of age. Sertraline should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder. If you are going to be treated for this disorder, your doctor will want to monitor you closely (see below Use in children and adolescents).
• If you are receiving electroconvulsive therapy (ECT).
• If you have any eye disorder, such as certain types of glaucoma (increased intraocular pressure).

Urinalyses of people taking sertraline may give "false positive" results for benzodiazepines. If your doctor has prescribed a urinalysis, tell your doctor that you are taking sertraline.

Some medicines in the same group as Sertraline Almus (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Pregnancy*

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

Restlessness/ Akathisia

The use of sertraline has been associated with akathisia (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. An increase in dose, in patients who develop these symptoms, may be harmful.

Withdrawal symptoms

When treatment is stopped, it is common for withdrawal symptoms to occur, particularly if treatment is stopped abruptly (see section 4. Possible side effects). The risk of experiencing 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 disappear on their own and normally 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 should be gradually reduced over a period of several weeks or even months, according to the needs of each patient.

Suicidal thoughts 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, due to the fact that all these medicines take time to work, which is usually a few weeks but can sometimes be longer.

This 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 of age with psychiatric disorders who are being treated with an antidepressant.

If you have thoughts of self-harm or suicide at any time, contact your doctor or go to the hospital immediately.

It may be helpful for you to tell a relative or close 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 worried about changes in your behavior.

Children and adolescents

Normally, sertraline should not be used in the treatment of children and adolescents under 18 years of age, except in the case of patients with obsessive-compulsive disorder. Patients under 18 years of age have a greater risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and anger) when they are treated with this class of medicines. Nevertheless, it is possible that your doctor may decide to prescribe Sertraline Almus to a patient under 18 years of age if they consider it to be in the best interest of the patient. If your doctor has prescribed Sertraline Almus to a patient under 18 years of age and you wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen when a patient under 18 years of age is taking sertraline. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of sertraline in this age group have not yet been demonstrated.

Taking Sertraline Almus with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Some medicines may affect the way Sertraline Almus works, or Sertraline Almus itself may reduce the effectiveness of other medicines that are being taken at the same time.

The use of Sertraline Almus with the following medicines may 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 use sertraline with MAOIs.
• Medicines for treating mental disorders (pimozide). Do not use 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 may last 1-2 weeks. Tell your doctor.
• Products containing the amino acid tryptophan.
• Medicines for treating severe pain (e.g., tramadol).
• Medicines used in anesthesia or for treating chronic pain (fentanyl).
• Medicines for treating migraines (e.g., sumatriptan).
• Medicines that reduce blood clotting (warfarin).
• Medicines for treating pain/arthritis (non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics.
• Medicines for treating epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines for treating diabetes (tolbutamide).
• Medicines for treating stomach acidity, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazol).
• 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 for treating high blood pressure, chest pain, or for regulating heart rate and rhythm (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).

Taking Sertraline Almus with food, drinks, and alcohol

Sertraline Almus tablets can be taken with or without food.

Alcohol consumption should be avoided while being treated with sertraline.

Sertraline should not be taken in combination with grapefruit juice, as it may increase sertraline levels in your body.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

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

Make sure your doctor or midwife knows that you are taking Sertraline Almus. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Sertraline Almus 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 have a bluish appearance. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, you should contact your doctor or midwife immediately.

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

• difficulty breathing,
• bluish or too hot or cold skin,
• bluish lips,
• vomiting or feeding problems,
• excessive tiredness, inability to sleep or excessive crying,
• stiffness or decreased muscle tone,
• tremors, restlessness, or convulsions,
• increased reflexes,
• irritability,
• low blood sugar levels.

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.

Breastfeeding

There are indications that sertraline passes into breast milk. Therefore, sertraline can only be used in breastfeeding women if, in the opinion of the doctor, the benefit to the mother outweighs any possible risk to the baby.

Fertility

Some medicines like sertraline may reduce sperm quality in animal studies. This could theoretically affect fertility, but the impact on human fertility has not been observed yet.

Driving and using machines

Antidepressant medicines like sertraline may affect your ability to drive or use machines. Therefore, do not drive or operate heavy machinery until you know how this medicine affects your ability to perform these activities.

Sertraline Almus contains sodium

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

3. How to Take Sertralina Almus

Follow the administration instructions of Sertralina Almus as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Sertralina Almus tablets can be taken with or without food.

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

The recommended dose is:

Adults:

Depression and Obsessive-Compulsive Disorder:

For depression and OCD, the usual effective dose is 50 mg per day. The daily dose can be increased in increments of 50 mg, at intervals of at least one week, and so on 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 be started 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:

SertralinaAlmusshould only be used to treat children and adolescents aged 6 to 17 years who have OCD.

Obsessive-Compulsive Disorder:

Children from 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 from 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 the instructions they give you.

Your doctor will indicate the duration of treatment with this medication. The duration will depend on the nature of your illness and your response to treatment. It will take several weeks for your symptoms to start improving.

If you take more Sertralina Almus than you should

If you accidentally take an excess of sertraline, contact your doctor or go to the emergency department of the nearest hospital. Always carry the medication package with you, whether or not there is medication left in it.

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 and vomiting, rapid heart rate, tremors, agitation, dizziness, and rarely loss of consciousness.

If you forget to take Sertralina Almus

If you forget to take a dose, do not take it when you realize it. Take the next dose when it is due.

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Sertralina Almus

Do not interrupt treatment with Sertralina Almus unless your doctor tells you to. Your doctor will want to gradually reduce the dose of Sertralina Almus over several weeks before you stop taking this medication altogether. If you stop treatment abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling unwell or dizziness, and tremors.

If you experience any of these side effects, or any other during the interruption of your treatment with Sertralina Almus, please inform your doctor.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

If you consider that any of the side effects you suffer from is 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 with continued treatment.

Tell your doctor immediately

If you experience any of the following symptoms after taking this medication, as these symptoms can be serious.

• If you develop a severe skin rash with blisters (erythema multiforme), (which can affect the mouth and tongue). These can be signs of a disease known as Stevens-Johnson Syndrome or toxic epidermal necrolysis (TEN). In these cases, your doctor will interrupt treatment.
• Allergic reaction or allergy, which can present symptoms such as skin rash with itching, breathing problems, wheezing, 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 interrupt treatment.
• If you have a yellowish color of the skin and eyes, which can indicate liver damage.
• If you experience depressive symptoms with suicidal thoughts.
• If, after starting treatment with Sertralina Almus, you begin to feel restless and are unable to sit or stand. You should inform your doctor if you start to feel restless.

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

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

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

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

• throat pain, anorexia, increased appetite,
• depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased sexual interest, teeth grinding,
• numbness and tingling, tremors, muscle tension, abnormal taste, lack of concentration,
• visual disturbances, ringing in the ears,
• palpitations, hot flashes, yawning,
• abdominal pain, vomiting, constipation, stomach discomfort, gas,
• rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, and chest pain.

Uncommon side effects (may affect up to 1 in 100 patients):

• cold (chest), runny nose,
• hallucinations, excessive happiness, lack of care, abnormal thoughts,
• seizures, involuntary muscle contractions, abnormal coordination, continuous movements, amnesia, decreased sensitivity, speech disorders, dizziness when standing up, migraines,
• ear pain, rapid pulse, high blood pressure, hot flashes,
• breathing difficulties, possibly noisy, shortness of breath, nasal bleeding,
• esophageal problems, difficulty swallowing, hemorrhoids, increased salivation, tongue disorders, belching,
• eye swelling, skin spots, hair loss, abnormal skin odor, bone disorders,
• decreased urination, urinary incontinence, interrupted urination, excessive vaginal bleeding, vaginal dryness, pain and redness of the penis and foreskin, genital discharge, prolonged erection, breast discharge,
• hernia, decreased drug tolerance, difficulty walking, abnormal laboratory tests, abnormal semen, injury, vascular relaxation procedure.
• There have been reports of suicidal thoughts and behavior during treatment with sertraline or shortly after its interruption (see section 2).

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

• partial loss of vision. Inflammation of the colon (which causes diarrhea),
• abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy"* in section 2 for more information.
• muscle weakness and intense muscle pain, which can be a sign of multiple acyl-coenzyme A dehydrogenase deficiency (MADD)**.

**Side effects reported after marketing.

The following side effects have been reported since the marketing of sertraline

• decrease in white blood cell count, decrease in platelets, low thyroid hormone levels, endocrine disorders, low sodium levels in the blood, problems controlling blood sugar levels (diabetes), increased blood sugar levels,

• abnormal terror dreams, suicidal behavior,

• muscle movement problems (such as constant movements, muscle tension, and difficulty walking) and stiffness, spasms, and involuntary muscle movements), fainting, sudden severe headache [which can be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS)].

• abnormal vision, uneven pupils, bleeding problems (such as nasal bleeding, stomach bleeding, or blood in urine), progressive scarring of lung tissue (interstitial lung disease), pancreatitis, serious liver function problems, yellowish skin,
• skin swelling, sun-related skin reaction, itching, joint pain, muscle cramps, breast enlargement, irregular menstrual cycle, swollen legs, coagulation problems, abnormal laboratory tests, nocturnal urinary incontinence, 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.

Symptoms that may appear when treatment is interrupted

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 interrupt treatment with Sertralina Almus).

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

Reporting side effects

If you experience any side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use. Website: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Sertralina Almus

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the package, after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Sertralina Almus Composition

• The active ingredient of Sertralina Almus is sertraline (hydrochloride). Each tablet contains 50 mg of sertraline.
• The other ingredients are: calcium phosphate dibasic, microcrystalline cellulose, potato starch carboxymethyl, anhydrous colloidal silica, and magnesium stearate.

Coating: polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol 300, and talc.

Product Appearance and Package Contents

Sertralina Almus 50 mg film-coated tablets are white, round, convex, and scored.

Sertralina Almus is available in a package of 30 tablets. The tablets are presented in PVC/Aluminum blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua De Tapada Grande 2

Abrunheira, Sintra 2710-228

Portugal

Date of the last revision of this leaflet:June 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.