Package Leaflet: Information for the User

Sertralina Almus 50mg 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 Sertralina Almus is and what it is used for

2.What you need to know before you start taking Sertralina Almus

3.How to take Sertralina Almus

4.Possible side effects

5Storage of Sertralina Almus

6.Contents of the pack and other information

Sertralina Almuscontains 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.

Sertralina 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).
• 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 Sertralina Almus, you should consult your doctor.

Do not take Sertralina Almus:

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

Warnings and precautions:

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

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

• Serotonin syndrome. In rare cases, this syndrome may occur when taking certain medicines at the same time as sertraline. (See section 4. Possible side effects). Your doctor will tell you if you have previously had this syndrome.
• If you have low sodium levels in your blood, as this situation may occur as a result of treatment with sertraline. Also, inform your doctor if you are taking any medicines for high blood pressure, as these medicines may also alter sodium levels in your blood.
• Be particularly 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 you may need to adjust the dose of your diabetes medicines.
• Epilepsy or a history of epilepsy. If you have a seizure (convulsion), 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 suicide (see below thoughts of suicide and worsening of your depression or anxiety disorder).
• If you have had bleeding disorders or have been taking medicines that decrease blood clotting (such as 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 old. Sertraline should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder. If you are to be treated for this disorder, your doctor will want to keep a close eye on you (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).

Urinary tests of people taking sertraline may give false-positive results for benzodiazepines. If your doctor has prescribed a urine test, tell your doctor that you are taking sertraline..

Some medicines in the group to which Sertralina Almus belongs (called ISRS/IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Pregnancy*

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

Restlessness/Acatisia

The use of sertraline has been associated with acatisia (unpleasant restlessness and a need to move, often accompanied by an inability to sit or stand still). This occurs more often during the first weeks of treatment. Increasing the dose in patients who develop these symptoms may be harmful.

Withdrawal symptoms

When treatment is stopped, withdrawal symptoms are common, particularly if treatment is stopped abruptly (see 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 may 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, as needed for each patient.

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 of suicide. This may increase at the beginning of treatment with antidepressants, as all these medicines take time to have an effect, which is usually two weeks but sometimes 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 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 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 may 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.

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. Young patients are at greater risk of side effects such as suicidal thoughts, suicidal behaviour, and hostility (mainly aggression, confrontational behaviour, and irritable mood) when treated with this class of medicines.However, your doctor may decide to prescribe Sertralina Almus to a patient under 18 years old if they consider it to be the best option for the patient. If your doctor has prescribed Sertralina Almus to a patient under 18 years old and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen in a patient under 18 years old taking sertraline. At the same time, the long-term safety effects of sertraline in this age group, in relation to growth, maturation, and cognitive and behavioural development, have not yet been demonstrated.

Use of Sertralina Almus with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

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

The use of Sertralina 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.

Inform 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 for 1-2 weeks. Inform your doctor.
• Products containing the amino acid tryptophan.
• Medicines for treating severe pain (such as tramadol).
• Medicines used in anaesthesia or for chronic pain (fentanil).
• Medicines for treating migraines (such as sumatriptan).
• Medicines that decrease blood clotting (warfarin).
• Medicines for treating arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin).
• Sedatives (diazepam).
• Diuretics.
• Medicines for treating epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines for treating diabetes (tolbutamide).
• Medicines for treating stomach acid, 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 (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).

Use of Sertralina Almus with food, drinks, and alcohol

Sertralina Almus tablets can be taken with or without food.

Alcohol should be avoided while being treated with sertraline.

Do not take sertraline with grapefruit juice, as this may increase the levels of sertraline in your body.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be 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 benefits for the mother outweigh any possible risk to the fetus. Women of childbearing age who are being treated with sertraline should use an appropriate contraceptive method.

Make sure your doctor or midwife knows that you are taking Sertralina Almus. When taken during pregnancy, particularly in the last three months of pregnancy, medicines like Sertralina Almus may increase the risk of a serious condition in the baby, 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, you should inform 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,

• blue skin or too hot or cold,

• blue lips,

• vomiting or feeding problems,

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

• muscle stiffness or decreased muscle tone,

• tremors, restlessness, or convulsions,

• increased reflexes,

• irritability,

• low blood sugar.

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

Breastfeeding

There is some evidence that sertraline passes into breast milk. Therefore, sertraline should only be used in breastfeeding women if, in the doctor's opinion, the benefits for the mother outweigh any possible risk to the baby.

Fertility

Some medicines, such as sertraline, may reduce the quality of sperm in animal studies. This could theoretically affect human fertility, but there is no evidence of this so far.

Driving and operating machinery

Antidepressants like 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.

Sertralina Almus contains sodium

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

Follow exactly the administration instructions for 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:

The usually 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 over several weeks. The maximum recommended daily dose is 200 mg.

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 intervals of 50 mg over a period of several weeks. The maximum recommended daily dose is 200 mg.

Use in children and adolescents:

Sertralina Almus should only be used to treat children and adolescents between 6 and 17 years of age who have 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 their instructions..

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 excessive amount ofsertralina, contact your doctor or go to the nearest hospital emergency department. Always carry the medication packaging with you, even if it is empty.

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, vomiting, rapid heart rate, tremors, agitation, dizziness, and in rare cases, loss of consciousness.

If you forget to take Sertralina Almus

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

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Sertralina Almus

Do not stop treatment withSertralina Almusunless your doctor tells you to. Your doctor will want to gradually reduce the dose ofSertralina Almusover several weeks before you stop taking this medication completely. If you stop treatment abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling unwell, or feeling dizzy and trembling.

If you experience any of these side effects, or any other side effects during the interruption of your treatment withSertralina Almus, 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.

If you consider that any of the side effects you experience are 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 when 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 suicidal thoughts.
• If you start to feel restless and are unable to sit or stand after starting treatment with Sertralina Almus. 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):

• sore throat, anorexia, increased appetite,
• depression, feeling strange, nightmares, anxiety, agitation, nervousness, decreased libido, grinding of teeth,
• numbness and tingling, tremor, muscle tension, abnormal taste, lack of concentration,
• visual disturbances, ringing in the ears,
• palpitations, hot flushes, 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):

• common cold, runny nose,
• hallucinations, excessive happiness, lack of care, abnormal thoughts,
• convulsions, involuntary muscle contractions, abnormal coordination, continuous movements, amnesia, decreased sensitivity, speech disorders, dizziness on standing, migraines,
• ear pain, rapid pulse, high blood pressure, hot flushes,
• breathing difficulties possibly noisy, shortness of breath, nasal bleeding,
• esophageal problems, difficulty swallowing, hemorrhoids, increased salivation, altered tongue, belching,
• swelling of the eyes, purple spots on the skin, hair loss, cold sweat, dry skin, urticaria, arthritis, muscle weakness, back pain, muscle spasms,
• nocturia, urinary retention, increased urine output, urinary frequency disorders,
• excessive vaginal bleeding, female sexual dysfunction, discomfort, chills, fever, weakness, thirst, weight loss, and weight gain.

Rare side 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, dependence on medication, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation,
• coma, abnormal movements, difficulty moving, increased sensitivity, sensory disturbances,
• spots in front of the eyes, glaucoma, double vision, photophobia (light sensitivity), eye hemorrhages, irregular pupils, visual disturbances, eye problems,
• heart attack, decreased heart rate, heart problems, circulation problems in the arms and legs, throat spasm, rapid breathing, slow 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 preputial pain and redness, genital secretions, prolonged erection, breast secretions,
• hernia, decreased tolerance to medication, 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 stopping treatment (see section 2).

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

• partial loss of vision. Inflammation of the colon (which causes diarrhea),
• excessive vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Since the marketing of sertraline, the following side effects have been reported

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

• abnormal nightmares, suicidal behavior,

• muscle movement problems (such as continuous 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 nasal bleeding, stomach bleeding, or blood in urine), progressive formation of lung tissue scars (interstitial lung disease), pancreatitis, severe liver function problems, yellow skin,
• skin swelling, sunburn reaction, itching, joint pain, muscle cramps, breast enlargement, irregular menstrual cycle, swollen legs, blood clotting problems, abnormal laboratory tests, nocturia, 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 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 Sertralina Almus).

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect not mentioned in this leaflet.You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use. Website:www.notificaram.es.By reporting side 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.

No special storage conditions are required.

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

Composition of SertralinaAlmus

- The active ingredient of Sertralina Almus is sertraline (hydrochloride). Each tablet contains 50 mg of sertraline.

- The other components are: calcium phosphate dibasic, microcrystalline cellulose, sodium carboxymethyl starch, anhydrous colloidal silica, and magnesium stearate.

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

Appearance of the product and contents of the packaging

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

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

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email:[email protected]

Responsible for manufacturing:

ATLANTIC PHARMA - PRODUÇOES FARMACEUTICAS, S.A.

Rua da Tapada Grande, No 2 Abrunheira, Sintra 270-089 PORTUGAL

Date of the last review of this leaflet:January 2021

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