PAROXETINE ALMUS PHARMA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Paroxetine Almus Pharma 20 mg 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:

1. What is Paroxetine Almus Pharma 20 mg tablets and what is it used for
2. What you need to know before you take Paroxetine Almus Pharma 20 mg tablets
3. How to take Paroxetine Almus Pharma 20 mg tablets
4. Possible side effects
5. Storage of Paroxetine Almus Pharma 20 mg tablets
6. Pack contents and further information

1. What is Paroxetine Almus Pharma and what is it used for

Paroxetine is used for the treatment of depression and/or anxiety disorders in adults.The anxiety disorders for which this medicine is indicated are: obsessive-compulsive disorder (obsessive thoughts, repetitive thoughts with uncontrolled behavior), panic disorder (panic attacks, including those caused by agoraphobia, which is the fear of open spaces), social phobia (fear or avoidance of social contact situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (feeling normally very anxious or nervous).

Paroxetine belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). The precise mechanism of action of this medicine and other SSRIs is not fully known, but they exert their action by increasing the level of serotonin in the brain. Properly treating depression or anxiety disorder is important to help you feel better.

2. What you need to know before you take Paroxetine Almus Pharma

Do not take Paroxetine Almus Pharma

• If you are being treated with medicines called monoamine oxidase inhibitors (MAOIs), including moclobemide and methylene blue (methylthioninium chloride), or if you have been under such treatment in the last two weeks.Your doctor will advise you how to start taking paroxetine once you have stopped taking the MAOI.
• If you are taking an antipsychotic medicine called thioridazine or the antipsychotic called pimozide.
• If you are allergic to paroxetine, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6).

If you are in any of these situations, tell your doctor and do not take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take paroxetine

• If you are taking other medicines (see the section "Other medicines and Paroxetine Almus Pharma").
• If you are taking tamoxifen for the treatment of breast cancer (or fertility problems).Paroxetine may make tamoxifen less effective, so your doctor should recommend taking another antidepressant.
• If you have any kidney, liver, or heart problems.
• If you have a heart condition after an electrocardiogram (ECG) known as QT interval prolongation.
• If you have a family history of QT interval prolongation, heart disease such as heart failure, low heart rate, or low potassium or low magnesium levels.
• If you have epilepsy or if you have seizures or epileptic fits.
• If you have had manic episodes (excessively active thoughts or behaviors).
• If you are being treated with electroconvulsive therapy (ECT).
• If you have a tendency to bleed or bruise, or are being treated with any medicine that may increase the risk of bleeding (including medicines such as warfarin (acenocoumarol), antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines for treating pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam).
• If you have diabetes.
• If you are on a low-sodium diet.
• If you have glaucoma (high eye pressure).
• If you are pregnant or think you may be pregnant (see the section "Pregnancy, breastfeeding, and fertility").
• If you are under 18 years of age (see the section "Children and adolescents under 18 years of age").

If your answer is YES to any of these situations and you have not yet consulted your doctor, ask your doctor how to take paroxetine.

Children and adolescents under 18 years of age

Paroxetine Almus Pharma should not be used in the treatment of children and adolescents under 18 years of age.

Also, you should know that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking paroxetine. If your doctor has prescribed paroxetine to you (or your child) and you wish to discuss this decision, consult your doctor. You should inform your doctor if any of the symptoms detailed above appear or worsen when you (or your child) are taking this medicine. The long-term effects of Paroxetine Almus on safety, related to growth, maturity, and cognitive and behavioral development in this age group, have not yet been demonstrated.

In studies conducted with paroxetine in patients under 18 years of age, the frequent adverse effects, which affected less than 1 in 10 children/adolescents, were: an increase in suicidal thoughts and attempts, self-harm behaviors, hostile, aggressive, or unfriendly behaviors, loss of appetite, tremors, abnormal sweating, hyperactivity (having too much energy), agitation, unstable emotions (including crying and mood changes), and the appearance of bruises or bleeding (such as nosebleeds). These effects were also observed in patients included in these studies who did not take paroxetine, although with less frequency.

When stopping treatment with paroxetine, in these studies, some of the patients under 18 years of age reported having withdrawal effects. These effects were very similar to those observed in adults who stopped treatment with paroxetine (see section 3 "How to take Paroxetine Almus"). Additionally, patients under 18 years of age frequently experienced (affecting 1 in 10) stomach pain, nervousness, and unstable emotions (including crying, mood changes, self-harm attempts, suicidal thoughts, and attempts).

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 suicide.These can increase at the beginning of treatment with antidepressants, as 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 were being treated with an antidepressant.

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

It may be useful 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.

Important side effects seen with paroxetine

Some patients who take paroxetine develop a disorder called akathisia, and feel restless and unable to sit or stay still. Other patients develop a condition called serotonin syndrome or neuroleptic malignant syndrome, and may have some or all of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, trembling, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden jerky movements, or increased heart rate. The severity can increase and lead to loss of consciousness. Consult your doctor if you have any of these symptoms.For more information on this or other side effects of Paroxetine Almus, see section 4.

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

Other medicines and Paroxetine Almus Pharma

Some medicines may alter the effect of paroxetine or make some side effects more likely. Paroxetine may also alter the effect of some medicines. For example:

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue (methylthioninium chloride)).See the section "Do not take Paroxetine Almus Pharma."
• Medicines known to increase the risk of changes in heart electrical activity (e.g., antipsychotics thioridazine or pimozide).See the section "Do not take Paroxetine Almus Pharma."
• Aspirin, ibuprofen, and other medicines called non-steroidal anti-inflammatory drugs, such as celecoxib, etodolac, diclofenac, and meloxicam, used to treat pain and inflammation.
• Tramadol, buprenorphine, and pethidine, painkillers.

• Buprenorphine combined with naloxone, substitution treatment for opiate addiction.
• Medicines called triptans, such as sumatriptan, used for migraine.
• Other antidepressants, including other selective serotonin reuptake inhibitors and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
• A dietary supplement called tryptophan.
• Mivacurium and suxamethonium (used in anesthesia).
• Medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat some psychiatric disorders.
• Fentanyl, used in anesthesia or to treat chronic pain.
• A combination of fosamprenavir and ritonavir, used to treat human immunodeficiency virus (HIV) infection.
• St. John's Wort, a herbal remedy for depression.
• Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizures or epilepsy.
• Atomoxetine, a medicine used to treat attention deficit hyperactivity disorder (ADHD).
• Procyclidine, used to relieve tremors, especially in Parkinson's disease.
• Warfarin and other medicines (called anticoagulants) used to make the blood more fluid.
• Propafenone, flecainide, and medicines used to treat heart rhythm disorders.
• Metoprolol, a beta-blocker used to treat high blood pressure and heart disorders.
• Pravastatin, used to treat high cholesterol.
• Rifampicin, used to treat tuberculosis (TB) and leprosy.
• Linezolid, an antibiotic.
• Tamoxifen, used to treat breast cancer (or fertility problems).

If you are taking or have recently taken any of these medicines, and you have not discussed this with your doctor, tell your doctor and ask what you should do.Your doctor may decide to change the dose or prescribe another medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those bought without a prescription.

Taking Paroxetine Almus Pharma with food, drinks, and alcohol

Do not drink alcohol while taking Paroxetine Almus.Alcohol can worsen your symptoms or side effects. Taking this medicine in the morning with food may reduce the likelihood of nausea.

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 this medicine.In some studies, an increased risk of malformations, particularly those affecting the heart, has been observed in newborns whose mothers took paroxetine during the first months of pregnancy. In the general population, approximately 1 in 100 newborns is born with a heart malformation. This proportion increased to 2 in 100 newborns in mothers who took paroxetine. Your doctor, in agreement with you, may change your treatment to another medicine or gradually stop treatment with this medicine while you are pregnant. However, depending on your circumstances, your doctor may recommend continuing to take this medicine.

Make sure your doctor or midwife knows you are taking paroxetine.If you take this medicine 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 this medicine to advise you. Medicines like paroxetine may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy, particularly at the end of it. The pressure in the blood vessels that go between the heart and lungs is very high in newborns with PPHN. If you are taking this medicine in the last trimester, your newborn may also have other symptoms that usually start during the first 24 hours after birth. These symptoms include:

• Difficulty breathing.
• Bluish skin or looking too hot or cold.
• Bluish lips.
• Vomiting or difficulty feeding.
• Feeling very tired, difficulty sleeping, or frequent crying.
• Stiffness or floppiness.
• Tremors, localized tremors, or seizures.
• Exaggerated reflexes.

If your baby has any of these symptoms at birth, or if you are concerned about your newborn's health, contact your doctor or midwife, who will advise you.

Paroxetine passes into breast milk in very small amounts.Consult your doctor if you are taking this medicine before starting to breastfeed. Your doctor, in agreement with you, may advise you to continue breastfeeding while taking this medicine.

Studies in animals have shown that paroxetine reduces sperm quality.Theoretically, this could affect fertility, but this impact has not yet been observed in humans.

Driving and using machines

Some of the side effects that this medicine can cause are dizziness, confusion, drowsiness, or blurred vision.If you experience any of these effects, do not drive or use machines.

Paroxetine Almus Pharma contains sodium

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

Paroxetine Almus Pharma contains soy lecithin

This medicine contains soy lecithin.If you are allergic to peanuts or soy, do not take this medicine.

3. How to take Paroxetina Almus Pharma

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Sometimes it may be necessary to take more than one tablet or half a tablet. The following table will show you how many tablets you should take:

The normal doses for the different indications are detailed in the following table:

Your doctor will indicate what dose you should take when starting treatment with paroxetine.Most people start to feel better after a couple of weeks. If after this time you do not start to feel better, consult your doctor who will indicate how to proceed. Your doctor may decide to gradually increase the dose, in increments of 10 mg, up to the maximum daily dose.

Take the tablets in the morning, with food.

The tablets should be swallowed with water.

The tablets should not be chewed.

The tablet can be divided into equal doses.

Your doctor will indicate the duration of the treatment. This period may be extended for several months or even longer.

Elderly patients

The maximum dose for people over 65 years old is 40 mg per day.

Patients with kidney or liver problems

If you have severe hepatic or renal insufficiency, your doctor may advise you to take smaller doses of this medication than usual.

If you take more Paroxetina Almus Pharma than you should

Never take more tablets than your doctor has recommended. If you take too many paroxetine tablets (or someone else does), consult your doctor or go to the hospital immediately. Show them the tablet packaging.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

A person who has taken an overdose of Paroxetina Almus Pharma may experience some of the symptoms that appear in section 4, Possible adverse effects,or some of the following symptoms: fever, involuntary muscle contraction.

If you forget to take Paroxetina Almus Pharma

Take your medication at the same time every day.

If you forget to take a dose and remember before going to bed, take it immediately. Take the next dose at the usual time.

If you remember during the night or the next day, skip the missed dose. You may experience some withdrawal symptoms, but they should disappear after taking the next dose at the usual time.

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

What to do if you do not feel better

Paroxetine will not improve your symptoms immediately. All antidepressants take time to work. Some people start to feel better after a couple of weeks, but others may require more time. Some people who take antidepressants feel worse before starting to notice improvement. If you do not start to feel better after a couple of weeks, tell your doctor, who will indicate what to do. It is possible that your doctor has scheduled a follow-up appointment after 2 weeks of starting your treatment. Inform your doctor if you have not started to feel better.

If you interrupt treatment with paroxetine

Do not interrupt treatment with Paroxetina Almus Pharma until your doctor indicates it.

When interrupting treatment with paroxetine, your doctor will indicate how to gradually reduce the doses over a period of several weeks or months. This will help reduce the risk of experiencing withdrawal symptoms. One way to do this is to gradually reduce the dose of this medication you are taking by 10 mg each week. Most people consider that the possible symptoms that occur when interrupting treatment with this medication are mild and disappear on their own within two weeks. For others, these symptoms can be more severe or last longer.

If you experience withdrawal effectswhile interrupting your treatment, your doctor may decide to interrupt it more slowly. If you experience severe withdrawal symptoms, please consult your doctor. Your doctor may advise you to start treatment again and then interrupt it more slowly.

Although you may experience some withdrawal effect, you will be able to interrupt your treatment with Paroxetina Almus Pharma.

Possible withdrawal effects when interrupting treatment

Studies have shown that 3 out of 10 patients experience one or more symptoms when interrupting their treatment with paroxetine. Some of these effects occur more frequently than others.

Common adverse effects

May affect up to 1 in 10 people

• • Feeling dizzy, unstable, or having balance disturbances.
• Numbness, burning sensations, and, less frequently, electric shock sensations, even in the head, buzzing, whistling, ringing, or other persistent noises in the ears (tinnitus).
• Sleep disturbances (very vivid dreams, nightmares, inability to sleep).
• Anxiety.
• Headaches.

Uncommon adverse effects

May affect up to 1 in 100 people

• Vomiting (nausea).
• Sweating (including night sweats).
• Restlessness or agitation.
• Tremors.
• Confusion or disorientation.
• Diarrhea (soft stools).
• Feeling very sensitive or irritable.
• Visual disturbances.
• Rapid or very strong heart palpitations.

Consult your doctor if you are concerned about the withdrawal effects of paroxetine.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people will experience them. It is more likely that adverse effects will appear during the first few weeks of treatment with this medication.

Tell your doctor if you experience any of the adverse effects described during treatment.

You may need to consult your doctor or go to the hospital immediately.

Uncommon adverse effects

May affect up to 1 in 100 people

• If you have bruising or unusual bleeding, such as blood in your vomit or stools, contact your doctor or go to the hospital immediately.
• If you experience difficulty urinating, contact your doctor or go to the hospital immediately.

Rare adverse effects

May affect up to 1 in 1,000 people

• If you experience seizures(epileptic fits), contact your doctor or go to the hospital immediately.
• If you have a feeling of restlessness, inability to sit still or stay still, called akathisia. Increasing the dose of this medication may worsen your symptoms. If you feel this way, consult your doctor.
• Weakness, confusion, and pain, stiffness, and lack of muscle coordination, may be due to low sodium levels in the blood. If you have these symptoms, consult your doctor.

Very rare adverse effects

May affect up to 1 in 10,000 people

• Allergic reactions to Paroxetina Almus Pharma that can be severe.

If you develop a skin rash with redness and bumps, swelling of the face, eyelids, lips, mouth, or tongue, itching, or difficulty breathing (shortness of breath) or swallowing, and a feeling of weakness or dizziness that can cause collapse or loss of consciousness, contact your doctor or go to the hospital immediately.

• If you notice any or all of the following symptoms, you may be experiencing serotonin syndrome or neuroleptic malignant syndrome. The symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, trembling, chills, hallucinations (strange sounds or visions), muscle stiffness, sudden jerky movements, or rapid heartbeats. The severity can increase and lead to loss of consciousness. If you feel this way, consult your doctor.
• Acute glaucoma.

If you experience eye pain and blurred vision, consult your doctor.

Frequency not known

The frequency cannot be estimatedfrom the available data:

• Some people have experienced thoughts of self-harm or suicide while taking Paroxetina Almus or shortly after stopping treatment (see section 2 What you need to know before taking Paroxetina Almus Pharma).
• Some people have experienced aggression while taking this medication.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see Pregnancy, breastfeeding, and fertilityin section 2 for more information.

If you experience these adverse effects, contact your doctor.

Other possible adverse effects during treatment

Very common adverse effects

May affect more than 1 in 10 people

• Feeling sick (nausea). This effect can be reduced by taking your medication in the morning after breakfast.
• Change in sexual desire or function, for example, lack of orgasm, and in men, abnormal erection or ejaculation.

Common adverse effects

May affect up to 1 in 10 people

• Increased cholesterol levels in the blood.
• Decreased appetite.
• Difficulty sleeping (insomnia) or drowsiness.
• Abnormal dreams (including nightmares).
• Dizziness, tremors.
• Headaches.
• Difficulty concentrating.
• Agitation.
• Unusual weakness.
• Blurred vision.
• Yawning, dry mouth.
• Diarrhea or constipation.
• Vomiting.
• Weight gain.
• Sweating.

Uncommon adverse effects

May affect up to 1 in 100 people

• Transient increases in blood pressure, or transient decreases in blood pressure that can cause dizziness or fainting when standing up quickly.
• Faster than normal heartbeats.
• Lack of movement, stiffness, tremors, or abnormal movements of the mouth and tongue.
• Dilated pupils.
• Skin rash.
• Itching.
• Confusion.
• Hallucinations (strange sounds or visions).
• Decreased white blood cell count.
• Inability to urinate (urinary retention) or uncontrolled urination (involuntary urination).
• If you are a diabetic patient, you may notice a loss of control over your blood sugar levels while taking Paroxetina Almus Pharma. Consult your doctor about how to adjust your insulin or diabetes medication dose.

Rare adverse effects

May affect up to 1 in 1,000 people

• Abnormal milk secretion in men and women.
• Decreased heart rate.
• Liver function test abnormalities.
• Panic attacks.
• Manic behavior or thoughts.
• Feeling detached from oneself (depersonalization).
• Anxiety.
• Irresistible urge to move the legs (Restless Legs Syndrome).
• Pain in joints or muscles.
• Increased levels of a hormone called prolactin in the blood.
• Menstrual disorders (including heavy or irregular periods, bleeding between periods, and absence or delay of period).

Very rare adverse effects

May affect up to 1 in 10,000 people

• Skin rash with blisters that have a target-like appearance (erythema multiforme).
• Widespread skin rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Widespread skin rash with blisters and peeling of the skin over a large body surface area (toxic epidermal necrolysis).

• Liver function abnormalities that cause yellowing of the skin or the whites of the eyes.
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH), which is a condition in which the body develops an excess of water and a decrease in sodium (salt) concentration due to inappropriate chemical signals. Patients with SIADH may feel severely ill or may have no symptoms.
• Water or fluid retention (causing swelling of arms or legs).
• Sensitivity to sunlight.
• Painful and prolonged erection of the penis.
• Decreased platelet count in the blood.

Frequency not known

The frequency cannot be estimatedfrom the available data:

• Inflammation of the colon (causing diarrhea).
• Teeth grinding.

Some patients have experienced buzzing, whistling, ringing, or other persistent noises in the ears (tinnitus) when taking paroxetine.

It has been observed that people taking this type of medication have a higher risk of bone fractures.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications. Website: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Paroxetina Almus Pharma

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack, tablet container, or outer packaging. The expiration date is the last day of the month indicated.

If you are using half-tablets, be careful to keep them safe in the container.

This medication does not require special storage conditions.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Paroxetina Almus Pharma

• The active ingredient is paroxetine.

Each 20 mg film-coated tablet contains 20 mg of paroxetine (as paroxetine hydrochloride).

• The other ingredients are: mannitol, microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium stearate.
• The film coating contains: basic butylated methacrylate copolymer, partially hydrolyzed poly(vinyl alcohol) (E1203), titanium dioxide (E171), talc (E553b), soybean lecithin (E322), and xanthan gum (E415).

Appearance of the Product and Packaging Content

The tablets are white, round, film-coated, biconvex, 10 mm in diameter, scored on one side and marked with P20 on the other.

The tablet can be divided into equal doses.

Package sizes:

Paroxetina Almus Pharma 20 mg is available in blisters of 14, 28, and 56 film-coated tablets and in perforated unit-dose blisters of 14, 28, and 56 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona),

Spain

Manufacturer

Teva Pharma S.L.U.

C/C, n° 4, Polígono Industrial Malpica

50016 Zaragoza,

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark: Zakkinter

Spain: Paroxetina Almus Pharma 20 mg, 30 mg film-coated tablets EFG

France: Paroxetine Almus Pharma 20 mg, scored film-coated tablet

Italy: Paroxetina Almus Pharma

Date of the last revision of this leaflet:February 2024

Other sources of information

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