Prospect: Information for the User

Sertraline Aurovitas 100 mg Film-Coated Tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Sertraline Aurovitas

3.How to take Sertraline Aurovitas

4.Possible adverse effects

5.Storage of Sertraline Aurovitas

6.Contents of the package and additional information

Sertralina Aurovitas 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).

•Generalized 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 linked to anxiety, with symptoms such as being constantly preoccupied with repeated ideas (obsessions) that lead to repetitive rituals (compulsions).

PTSD is a disorder that may occur after a very emotionally traumatic experience, and has some symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety disorder. It is characterized by intense anxiety or anxiety 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 this medication suitable for treating your condition.

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

Do not take Sertralina Aurovitas

•If you are allergic to sertraline or any of the other components of this medication (listed in section 6).

•If you are taking or have taken medications called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other similar medications to MAOIs (such as linezolid). If you stop taking sertraline, 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 a medication called pimozide (a medication used to treat mental disorders such as psychosis).

Warnings and precautions

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

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

•If you have epilepsy (seizure) or a history of convulsions. If you have a seizure (convulsions), call your doctor immediately.

•If you have manic-depressive illness (bipolar disorder) or schizophrenia. If you have a manic episode, call your doctor immediately.

•If you have, or have had previously, thoughts of harming yourself or committing suicide (see "Thoughts of suicide and worsening of depression or anxiety").

•If you have serotonin syndrome. In rare cases, this syndrome may occur when taking certain medications at the same time as sertraline (see "Possible side effects"). Your doctor will tell you if you have had this syndrome before.

•If you are taking medications that contain buprenorphine. The use of these medications with sertraline may cause serotonin syndrome, a potentially fatal condition (see "Other medications and Sertralina Aurovitas").

•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 medication for high blood pressure, as these medications may also alter sodium levels in the blood.

•If you are elderly, as you may be at higher risk of having low sodium levels in the blood (see previous point).

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

•If you have diabetes; sertraline may alter your blood sugar levels, so you may need to adjust the dose of your diabetes medications.

•If you have had a history of bleeding disorders (tendency to develop hematomas)or if you are pregnant (see "Pregnancy, breastfeeding, and fertility")or have been taking medications that reduce blood clotting (such as aspirin or warfarin) or that may increase the risk of bleeding.

•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 old who have obsessive-compulsive disorder (OCD). If you are to be treated for this disorder, your doctor will want to monitor you closely (see "Children and adolescents").

•If you are receiving electroconvulsive therapy (ECT).

•If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).

•If you have been told that you have an abnormal heart rhythm that is obtained after an electrocardiogram (ECG), known as prolongation of the QT interval.

•If you have heart disease, low potassium or magnesium levels, a family history of QTc prolongation, low heart rate, or are taking medications that prolong the QTc interval.

Sexual problems

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

Anxiety/Acatisia

The use of sertraline has been associated with an unpleasant restlessness and need to move, often accompanied by an inability to remain seated or standing (acatisia). This occurs more often during the first weeks of treatment. Increasing the dose may be harmful, so if you develop these symptoms, 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 Sertralina Aurovitas 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 days after stopping treatment. In general, these symptoms usually resolve on their own and usually resolve within two weeks. In some patients, they may last longer (2-3 months or more). It is recommended that, when stopping treatment with sertraline, the dose be gradually reduced over a period of several weeks or even months, and always agree with your doctor on the best way to stop treatment.

Thoughts of suicide and worsening of depression or anxiety

If you are depressed and/or have anxiety disorders, you may have thoughts of harming yourself or committing suicide. These may increase at the beginning of treatment with antidepressants, as all these medications take time to take effect, which is usually two weeks, but sometimes it may be longer.

This is more likely to happen

•If you have previously had thoughts of suicide or harming yourself.

•If you are anadult young. There is information from clinical trials that shows an increase in the risk of suicidal behavior in adults under 25 years old with psychiatric disorders who are being treated with some antidepressants.

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

It may be helpful for you to explain to a family member or close friendthat you are depressed or have anxiety disorders, and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Children and adolescents

Normally, sertraline should not be used to treat children and adolescents under 18 years old, except in the case of patients with obsessive-compulsive disorder (OCD). Patients under 18 years old have a higher risk of side effects such as attempts at suicide, thoughts of harming or committing suicide (suicidal thoughts) and hostility (mainly aggression, confrontational behavior, and irritable reaction) when treated with this class of medications. Despite this, your doctor may decide to prescribe sertraline to a patient under 18 years old if they consider it to be the most suitable option for the patient. If your doctor has prescribed sertraline and you are under 18 years old and want to discuss this decision, consult your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen when you are taking sertraline.The long-term safety effects of sertraline on growth, maturation, and learning (cognitive development) and behavior were evaluated in a long-term study in over 900 children aged 6 to 16 years who were monitored for a period of 3 years. In general, the results of the study showed that children treated with sertraline developed normally, except for a slight increase in weight in those treated with a higher dose.

Other medications and Sertralina Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

The use of sertraline with the following medications may cause serious side effects:

•Medications called monoamine oxidase inhibitors (MAOIs), such as moclobemide (to treat depression), selegiline (to treat Parkinson's disease), the antibiotic linezolid, and methylene blue (to treat high levels of methemoglobin in the blood). Do not use sertraline with these medications.

•Medications to treat mental disorders such as psychosis (pimozide). Do not use sertraline with pimozide.

Inform your doctor if you are taking the following medications:

•Medications that contain amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).

•Medications based on plants that contain St. John's Wort (Hypericum perforatum). The effects of St. John's Wort may persist for 1-2 weeks.

•Products that contain the amino acid tryptophan.

•Medications to treat intense or chronic pain (opioids, for example, tramadol, fentanil)and opioid dependence (medications that contain buprenorphine).

•Medications used in anesthesia (for example, fentanil, mivacurio, and suxametonio).

•Medications to treat migraines (for example, sumatriptan).

•Medications that reduce blood clotting (warfarin).

•Medications to treat pain/arthritis (for example, metamizol, anti-inflammatory non-steroidal medications (NSAIDs), such as ibuprofen, aspirin).

•Sedatives (diazepam).

•Diuretics (tablets to urinate).

•Medications to treat epilepsy (phenytoin, phenobarbital, carbamazepine).

•Medications to treat diabetes (tolbutamide).

•Medications to treat stomach acid, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).

•Medications to treat mania and depression (lithium).

•Other medications to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).

•Medications to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).

•Medications to treat high blood pressure, chest pain, or to regulate heart rate (such as verapamil, diltiazem, flecainide, and propafenone).

•Medications used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).

•Medications used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).

•Medications to treat HIV/AIDS and hepatitis C (protease inhibitors, such as ritonavir, telaprevir).

•Medications used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).

•Medications that increase the risk of changes in heart rhythm (for example, some antipsychotics and antibiotics).

•Metamizol, a medication used to treat pain and fever.

Some medications may increase the side effects of sertraline and, in some cases, may cause very serious reactions. Do not take any other medication while taking sertraline without first consulting your doctor, especially:

•Medications that contain buprenorphine. These medications may interact with sertraline and you may experience symptoms such as involuntary muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, high body temperature above 38°C. Contact your doctor if you experience these symptoms.

Taking Sertralina Aurovitas with food, drinks, and alcohol

Sertraline tablets can be taken with or without food.

Avoid consuming alcohol while taking sertraline.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

If you take sertraline during the final stages of pregnancy, there may be an increased risk of excessive vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking sertraline to be able to advise you. When taken during pregnancy, especially during the last 3 months of pregnancy, medications like sertraline may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

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

-Difficulty breathing.

-Blue skin or too hot or cold.

-Blue lips.

-Difficulty feeding or vomiting.

-Extreme tiredness, inability to sleep, or excessive crying.

-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, contact your doctor or midwife, who will advise you.

Sertraline may pass into breast milk. Therefore, sertraline can only be used in women who are breastfeeding if your doctor considers that the benefits outweigh any possible risk to the baby.

Studies in animals have shown that some medications, such as sertraline, may reduce the quality of sperm. Theoretically, this could affect fertility, but there is no evidence of this effect on fertility in humans.

Driving and operating machinery

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

Sertralina Aurovitas contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor. 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 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 start 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.

Use in children and adolescents:

Sertraline should only be used to treat children and adolescents aged 6 to 17 years with OCD.

Obsessive-Compulsive Disorder:

Children aged 6 to 12 years:The recommended starting dose is 25 mg per day. After one week, your doctor may increase the dose to 50 mg per day. The maximum dose is 200 mg per day.

Adolescents aged 13 to 17 years:The recommended starting dose is 50 mg per day. The maximum dose is 200 mg per day.

If you have liver or kidney problems, inform your doctor and follow their instructions.

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 may take several weeks for your symptoms to improve. Depression treatment should continue for 6 months after improvement.

If you take more Sertralina Aurovitas than you should

If you accidentally take too much sertraline, 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 Aurovitas

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 Sertralina Aurovitas

Do not stop 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 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 during the interruption of your treatment with sertraline, inform your doctor.

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

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

The most common side effect is nausea. Side effects depend on the dose and often disappear or decrease as treatment continues.

Inform your doctor immediately:

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

•If you develop a severe skin rash that causes blisters (erythema multiforme) (may 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 include 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. 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 people):

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

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

•Common cold (chest), sore throat, runny nose.

•Loss of appetite, increased appetite.

•Anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, bruxism.

•Tremor, muscle movement problems (such as constant movements, muscle tension, difficulty walking, and stiffness, spasms, and involuntary muscle movements)*, numbness and tingling, muscle tension, lack of concentration, abnormal taste.

•Visual disturbances.

•Tinnitus in the ears.

•Palpitations.

•Hot flushes.

•Yawning.

•Stomach discomfort, constipation, abdominal pain, vomiting, gas.

•Increased sweating, rash.

•Back pain, joint pain, muscle pain.

•Irregular menstrual cycle, erectile dysfunction.

•Feeling unwell, chest pain, weakness, fever.

•Weight gain.

•Lesion.

Uncommon(may affect up to 1 in 100 people):

•Gastroenteritis, ear infection.

•Tumor.

•Hypersensitivity, seasonal allergy.

•Low levels of thyroid hormones.

•Suicidal thoughts, suicidal behavior*, psychotic disorders, abnormal thoughts, lack of care, hallucinations, aggression, excessive happiness, paranoia.

•Amnesia, decreased sensitivity, involuntary muscle contractions, fainting, continuous movements, migraine, convulsions, dizziness when standing, abnormal coordination, speech disorders.

•Dilated pupils.

•Ear pain.

•Accelerated pulse, heart problems.

•Bleeding problems (such as stomach bleeding)*, high blood pressure, hot flushes, hematuria.

•Shortness of breath, nasal bleeding, possible noisy breathing.

•Black stools, dental disorders, esophageal inflammation, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders.

•Swollen eyes, urticaria, hair loss, itching, purple spots on the skin, skin disorders with blisters, dry skin, facial swelling, cold sweat.

•Arthritis, muscle spasms, muscle cramps*, muscle weakness.

•Increased frequency of urination, urinary disorders, urinary retention, incontinence, increased urine volume, nocturia.

•Female sexual dysfunction, excessive vaginal bleeding, vaginal hemorrhage, female sexual dysfunction.

•Swollen legs, chills, difficulty walking, thirst.

•Increased liver enzymes, weight loss.

•There have been reports of suicidal thoughts and behavior during treatment with sertraline or shortly after stopping treatment (see section 2).

Rare(may affect up to 1 in 1,000 people):

•Diverticulitis, swollen lymph nodes, decreased platelet count*, decreased white blood cell count*.

•Severe allergic reaction.

•Endocrine disorders*.

•High cholesterol, difficulty controlling blood sugar levels (diabetes), low blood sugar, increased 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, severe sudden 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 (sensitivity to light), eye hemorrhages, irregular pupils*, visual disturbances*, eye disorders.

•Heart attack, dizziness, fainting, or chest pain that may be signs of changes in electrical activity (seen on the electrocardiogram) or abnormal heart rhythm*, bradycardia.

•Problems with circulation in the arms and legs.

•Accelerated breathing, progressive formation of lung tissue scars (interstitial lung disease)*, throat spasm, difficulty speaking, slower breathing, hiccups.

•A type of lung disease in which eosinophils (a type of white blood cell) appear in the lungs in large numbers (eosinophilic pneumonia).

•Mouth ulcers, pancreatitis*, hematochezia, tongue ulcers, mouth ulcers.

•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.

•Mastitis, decreased tolerance to the medication.

•Increased cholesterol levels, abnormal laboratory tests*, abnormal semen, coagulation disorders*.

•Relaxation of blood vessel procedure.

Frequency not known:cannot be estimated from available data:

•Trigeminal neuralgia.

•Nocturnal enuresis*.

•Partial loss of vision.

•Colitis (which causes diarrhea).

•Postpartum hemorrhage (excessive vaginal bleeding after delivery), see “Pregnancy, lactation, and fertility” in section 2 for more information.

*Side effects reported after marketing.

Other 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 abruptly with this medicine, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremor (see section 3 “If you stop treatment with Sertralina Aurovitas”).

There has been an increased risk of bone fractures in patients taking this type of medication.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side 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: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 box. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition of Sertralina Aurovitas

-The active ingredient issertraline. Each film-coated tabletcontains hydrochloride ofsertraline equivalent to 100mg ofsertraline.

-The other components are:

Tablet core:microcrystalline cellulose (Grade 101), sodium carboxymethyl starch (Type A) from potato, hydroxypropyl cellulose, calcium dihydrogen phosphate, magnesium stearate.

Film coating:Opadry Blanco OY-S-7355, which contains: titanium dioxide (E171), low-viscosity hypromellose 5cp, macrogol 400, polisorbate 80.

Appearance of the product and contents of the package

White, biconvex, capsule-shaped film-coated tablets, with the mark “A” on one face and “82” on the other. The size is approximately 13.3 mm × 5.3 mm.

Sertralina Aurovitas film-coated tablets are available in blister packs.

Pack sizes:20, 30, 60, and 100 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer responsible:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: March 2024

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