Sertraline Almus 50 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sertraline Almus 50mg film-coated tablets EFG

Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.

Leaflet contents:

What Sertraline Almus is and what it is used for
What you need to know before taking Sertraline Almus
How to take Sertraline Almus
Possible side effects
How to store Sertraline Almus
Contents of the pack and other information

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

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

Sertralina Almus can be used to treat:

Depression and prevention of recurrence of depression (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 characterized by symptoms such as feelings of sadness, inability to sleep properly, and inability to enjoy life as one used to.

OCD and panic disorders are anxiety-related conditions, with symptoms such as persistent worry about recurring thoughts (obsessions) that lead to repetitive rituals (compulsions).

PTSD is a disorder that may occur following an emotionally traumatic experience and has some symptoms similar to those of depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterized by intense anxiety or fear in social situations (for example: speaking with strangers, speaking in public, eating or drinking in front of others, or worrying about behaving in an embarrassing way).

Your doctor has determined that this medicine is appropriate for treating your condition.

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

2. What you need to know before taking Sertraline Almus

Do not take Sertraline Almus:

If you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6).
If you are taking or have recently 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:

Talk to your doctor or pharmacist before taking Sertraline Almus.

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

Serotonin syndrome. This syndrome may rarely occur when you are taking certain medicines at the same time as sertraline. (For symptoms, see section 4. Possible side effects.) Your doctor will advise you if you have previously experienced this syndrome.
Low sodium levels in the blood, as this 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 may also affect sodium levels in the blood.
Be especially careful if you are elderly, as you may be at higher risk of developing low sodium levels in the 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 a history of epilepsy. If you have a seizure (convulsion), contact your doctor immediately.
If you have bipolar disorder (manic-depressive illness) or schizophrenia. If you experience a manic episode, contact your doctor immediately.
If you have or have previously had suicidal thoughts (see below, Suicidal thoughts and worsening of depression or anxiety disorder).
If you have had bleeding disorders or have been taking medicines that reduce blood clotting (e.g. 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 being 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 disorders, such as certain types of glaucoma (increased intraocular pressure).

Urine tests in people taking sertraline may give "false positive" results for benzodiazepines. If your doctor has prescribed a urine test, inform them that you are taking sertraline.

Some medicines in the same class 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 late 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 be aware that you are taking Sertraline Almus so 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 frequently during the first weeks of treatment. Increasing the dose in patients who develop these symptoms may be harmful.

Withdrawal symptoms

When stopping treatment, withdrawal symptoms are common, 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 may be severe. These symptoms usually begin during the first few days after stopping treatment. In general, these symptoms resolve on their own and usually disappear 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, according to the individual needs of the patient.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide. This may increase at the beginning of treatment with antidepressants, because all these medicines take time to work, usually about two weeks but sometimes longer.

You are more likely to experience this if:

You have previously had thoughts of suicide or self-harm.
You are a young adult. Clinical trial data show an increased risk of suicidal behaviour in psychiatric patients under 25 years of age being treated with an antidepressant.

If you have thoughts of harming yourself or of suicide at any time, contact your doctor or go to hospital immediately.

It may be helpful for you to inform a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may also ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.

Children and adolescents

Sertraline is generally not recommended for use in children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder. Patients under 18 years of age have a higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behaviour, and anger reactions) when taking this type of medicine. Nevertheless, your doctor may decide to prescribe Sertraline Almus to a patient under 18 years of age if they consider it to be the most appropriate treatment. If your doctor has prescribed Sertraline Almus to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You should inform your doctor if any of the symptoms listed above appear or worsen while a patient under 18 years of age is taking sertraline. In addition, the long-term effects on safety and on growth, maturation, and cognitive and behavioural development of sertraline in this age group have not yet been established.

Taking Sertraline Almus with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may affect how Sertraline Almus works, or Sertraline Almus may reduce the effectiveness of other medicines taken at the same time.

Using Sertraline Almus together with the following medicines may cause serious adverse effects:

Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (for treating depression), selegiline (for treating Parkinson's disease), and the antibiotic linezolid. Do not use sertraline together with MAOIs.
Medicines for treating mental disorders (pimozide). Do not use sertraline together 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. Inform your doctor.
Products containing the amino acid tryptophan.
Medicines for treating severe pain (e.g. tramadol).
Medicines used in anaesthesia 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 drugs (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, 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 for treating high blood pressure, chest pain, or to regulate 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 intake should be avoided while you are being treated with sertraline.

You should 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, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using any medicine.

Pregnancy

The safety of sertraline in pregnant women has not been fully established. Sertraline should only be given to pregnant women if, in the doctor's opinion, the benefit to the mother outweighs any possible risk to the fetus. Women of childbearing age taking sertraline should use an appropriate contraceptive method.

Make sure your doctor or midwife knows that you are taking Sertraline Almus. When taken during pregnancy, particularly during the last three 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 causes the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, inform your doctor or midwife immediately.

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

difficulty breathing,
bluish or too hot or too cold skin,
blue lips,
vomiting or feeding problems,
excessive tiredness, inability to sleep or excessive crying,
muscle stiffness or reduced muscle tone,
tremors, restlessness or seizures,
increased reflex responses,
irritability,
low blood sugar.

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

Breastfeeding

Evidence indicates that sertraline passes into breast milk. Therefore, sertraline may only be used in women who are breastfeeding if, in the doctor's opinion, the benefit to the mother outweighs any possible risk to the infant.

Fertility

Some medicines such as sertraline may reduce sperm quality in animal studies. Theoretically, this could affect fertility, but no impact on human fertility has been observed so far.

Driving and using machines

Antidepressant medicines such as sertraline may 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 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 Sertraline Almus

Follow exactly the instructions for using Sertraline Almus as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Sertraline Almus tablets can be taken with or without food.

Take your medicine once daily, either in the morning or at night.

The recommended dose is:

Adults:

Depression and Obsessive-Compulsive Disorder (OCD):

For depression and OCD, the usually effective dose is 50 mg per day. The daily dose may be increased in increments of 50 mg at intervals of at least one week, over several weeks. The maximum recommended dose is 200 mg per day.

Panic disorder, social anxiety disorder, and post-traumatic stress disorder (PTSD):

For panic disorder, social anxiety disorder, and PTSD, treatment should be initiated at a dose of 25 mg per day, increasing to 50 mg per day after one week.

The daily dose may 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:

Sertraline Almus 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 your 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 he or she gives you.

Your doctor will determine how long you should take this medicine. The duration will depend on the nature of your illness and your response to treatment. It may take several weeks before your symptoms begin to improve.

If you take more Sertraline Almus than you should

If you accidentally take too much sertraline, contact your doctor or go to the nearest hospital emergency department. Always bring the medicine pack with you, whether or not there is any medication left.

You may also call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, tremors, agitation, dizziness, and in rare cases, loss of consciousness.

If you forget to take Sertraline Almus

If you forget to take a dose, do not take it when you remember. Take the next dose at the usual time.

Do not take a double dose to make up for a missed dose.

If you stop taking Sertraline Almus

Do not stop treatment with Sertraline Almus unless your doctor tells you to. Your doctor will want to gradually reduce the dose of Sertraline Almus over several weeks before you stop taking this medicine completely. If you stop treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feelings of discomfort, or feeling dizzy and shaky.

If you experience any of these adverse effects, or any other symptoms, during discontinuation of your treatment with Sertraline Almus, please inform your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

The most common adverse effect is nausea. Adverse effects depend on the dose and often disappear during continued treatment.

Inform your doctor immediately

If you experience any of the following symptoms after taking this medicine, as these symptoms may be serious:

If you develop a severe skin rash causing blisters (erythema multiforme), (which may affect the mouth and tongue). These may be signs of a condition known as Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). In such cases, your doctor will discontinue treatment.
Allergic reaction or allergy, which may present symptoms such as itchy skin rash, difficulty breathing, wheezing, swelling of the eyelids, face, or lips.
If you experience agitation, confusion, diarrhea, increased body temperature and blood pressure, excessive sweating, and rapid pulse. These are symptoms of serotonin syndrome. Rarely, this syndrome may occur when taking certain medications together with sertraline. Your doctor may decide to stop treatment.
If you develop yellowing of the skin or eyes, which may indicate liver damage.
If you experience depressive symptoms with suicidal thoughts.
If, after starting treatment with Sertralina Almus, you begin to feel inner restlessness and are unable to sit or stand still. You should inform your doctor if you start feeling restless.

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

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

Insomnia, dizziness, drowsiness, headache, diarrhea, malaise, dry mouth, ejaculation disorders, and fatigue.

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

Sore throat, anorexia, increased appetite,
Depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased libido, teeth grinding,
Numbness and tingling, tremor, muscle tension, abnormal taste, difficulty concentrating,
Visual disturbances, ringing in the ears,
Palpitations, hot flushes, yawning,
Abdominal pain, vomiting, constipation, stomach discomfort, flatulence,
Rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, and chest pain.

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

Cold (chest), runny nose,
Hallucinations, excessive happiness, lack of self-care, abnormal thoughts,
Seizures, involuntary muscle contractions, abnormal coordination, continuous movements, amnesia, decreased sensitivity, speech disorders, dizziness upon standing, migraines,
Ear pain, rapid pulse, elevated blood pressure, hot flushes,
Difficulty breathing possibly noisy, shortness of breath, nosebleeds,
Esophageal problems, difficulty swallowing, hemorrhoids, increased salivation, tongue disorders, burping,
Swelling of eyes, purple spots on the skin, hair loss, cold sweat, dry skin, hives, osteoarthritis, muscle weakness, back pain, muscle twitches,
Need to urinate at night, urinary retention, increased urine volume, increased frequency of urination, urinary disorders,
Vaginal bleeding, female sexual dysfunction, malaise, chills, fever, weakness, thirst, weight loss, and weight gain.

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

Intestinal problems, ear infection, cancer, swollen lymph nodes, high cholesterol, elevated blood sugar,
Physical symptoms due to stress or emotions, drug dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation,
Coma, abnormal movements, difficulty moving, increased sensitivity, sensory disturbances,
Seeing spots in front of the eyes, glaucoma, double vision, photophobia (eye sensitivity to light), eye hemorrhages, irregular pupils, visual disturbances, tear problems,
Heart attack, decreased heart rate, heart problems, circulation problems in arms and legs, throat spasm, rapid breathing, slower breathing, difficulty speaking, hiccups,
Blood in stool, mouth sores, tongue ulceration, dental and tongue problems, mouth ulceration, liver function problems,
Skin problems with blisters, capillary rash, abnormal hair texture, abnormal skin odor, bone abnormalities,
Decreased urine output, urinary incontinence, interrupted urination, excessive vaginal bleeding, vaginal dryness, penile and foreskin redness and pain, genital discharge, prolonged erection, breast discharge,
Hernia, reduced tolerance to medications, difficulty walking, abnormal laboratory tests, abnormal semen, injury, blood vessel relaxation procedure.
Cases of suicidal thoughts and behavior have been reported during treatment with sertraline or shortly after discontinuation (see section 2).

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

Partial loss of vision. Inflammation of the colon (causing diarrhea),
Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see «Pregnancy»* in section 2 for more information.
Muscle weakness and severe muscle pain, which may be a sign of multiple acyl-coenzyme A dehydrogenase deficiency (MADD)**.

**Adverse effects reported after marketing.

Since the marketing of sertraline, the following adverse effects have been reported:

Decreased white blood cell count, decreased platelet count, low thyroid hormone levels, endocrine problems, low blood sodium levels, problems controlling blood sugar levels (diabetes), increased blood sugar levels,
Abnormal, frightening dreams, suicidal behavior,
Muscle movement problems (such as constant movements, muscle tension, and difficulty walking) and stiffness, spasms, and involuntary muscle movements, syncope, sudden severe headache [which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS)].
Abnormal vision, unequal pupil size, bleeding problems (such as nosebleeds, stomach bleeding, or blood in urine), progressive scarring in lung tissue (interstitial lung disease), pancreatitis, serious liver function problems, yellowish skin,
Skin swelling, skin reaction to sunlight, itching, joint pain, muscle cramps, breast enlargement, menstrual cycle irregularities, swollen legs, coagulation problems, abnormal blood tests, nocturnal urinary incontinence, and severe allergic reactions.

Adverse effects in children and adolescents

In clinical trials in children and adolescents, adverse effects were generally similar to those reported in adults (see above). The most common adverse effects in children and adolescents were headache, insomnia, diarrhea, and nausea.

Symptoms that may occur when treatment is discontinued

If you stop taking this medicine abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremor (see section 3: If you stop taking Sertralina Almus).

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sertraline Almus

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sertralina Almus

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

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

Appearance of the product and contents of the pack

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

Sertralina Almus is available in packs of 30 and 60 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

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua De Tapada Grande 2

Abrunheira, Sintra 2710-228

Portugal

Date of the most recent review of this leaflet: June 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.