Prospecto: information for the user

Oxicodona/Naloxona Viatris 5 mg/2,5 mg prolonged-release tablets EFG

oxycodone hydrochloride/naloxone hydrochloride

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 should not be given to other people, 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 Oxicodona/Naloxona Viatris and for what it is used

2.What you need to know before starting to take Oxicodona/Naloxona Viatris

3.How to take Oxicodona/Naloxona Viatris

4.Possible adverse effects

5.Storage of Oxicodona/Naloxona Viatris

6.Contents of the package and additional information

You have been prescribed Oxicodona/Naloxona Viatris for the treatment of intense pain, which can only be adequately treated with opioid analgesics.

How Oxicodona/Naloxona Viatris relieves pain

Oxicodona/Naloxona Viatris contains as active ingredients hydrochloride of oxicodona and hydrochloride of naloxona. Hydrochloride of oxicodona is responsible for the analgesic effect of Oxicodona/Naloxona Viatris, it is a potent analgesic that belongs to the group of medications called opioids.

The second active ingredient of Oxicodona/Naloxona Viatris, hydrochloride of naloxona, has the function of countering constipation. Intestinal dysfunction (for example, constipation) is a typical side effect of treatment with opioid analgesics.

Oxicodona/Naloxona Viatris is a prolonged-release tablet, which means that its active ingredients are released over a prolonged period. Its action lasts 12 hours.

Do not take Oxicodona/Naloxona Viatris

• if you are allergic to hydrochloride of oxicodona, hydrochloride of naloxona or any of the other components of this medication (listed in section 6),
• if you are unable to breathe in enough oxygen into your blood or remove the carbon dioxide produced in your body (respiratory depression),
• if you have a severe lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease or COPD),
• if you have a condition called cor pulmonale. This condition consists of the right side of the heart increasing in size due to increased pressure in the blood vessels of the lung, etc. (for example, as a result of COPD, see above),
• if you have severe bronchial asthma,
• if you have paralytic ileus (a type of intestinal obstruction) not caused by opioids,
• if you have moderate to severe liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Oxicodona/Naloxona Viatris:

• if you are an elderly or debilitated patient,
• if you have paralytic ileus (a type of intestinal obstruction) caused by opioids,
• if you have kidney problems,
• if you have mild liver problems,
• if you have severe lung problems (i.e., reduced ability to breathe),
• if you have a condition characterized by frequent interruptions in breathing that make you feel drowsy during the day (sleep apnea),
• if you have hypothyroidism (a thyroid disorder that is characterized by dryness, coldness, and swelling of the skin, which affects the face and extremities),
• if your thyroid gland does not produce enough hormones (hypothyroidism),
• if your adrenal gland does not function properly, for example, in Addison's disease,
• if you have a mental illness accompanied by a loss (partial) of the sense of reality (psychosis), due to alcoholism or intoxication by other substances (substance-induced psychosis),
• if you have gallstone problems,
• if you have an abnormal enlargement of the prostate (prostatic hypertrophy),
• if you have alcoholism or delirium tremens,
• if you have pancreatitis (inflammation of the pancreas),
• if you have low blood pressure (hypotension),
• if you have high blood pressure (hypertension),
• if you have a previous cardiovascular disease,
• if you have a head and brain trauma (due to the risk of increased pressure in the brain),
• if you have epilepsy or are prone to seizures,
• if you are also receiving treatment with MAO inhibitors (used to treat depression or Parkinson's disease), for example, medications containing tranilcipromina, phenelzine, isocarboxazide, moclobemide, and linezolid,
• if you feel drowsy or fall asleep sometimes.

Contact your doctor if you have severe upper abdominal pain that may extend to the back, nausea, vomiting, or fever, as these may be symptoms associated with pancreatitis or biliary tract system inflammation.

Tolerance, dependence, and addiction

This medication contains oxicodona, which is an opioid medication. Repeated use of opioid analgesics can make the medication less effective (you become accustomed to it, known as tolerance).The repeated use of Oxicodona/Naloxona Viatris can cause dependence, abuse, and addiction, which can lead to a life-threatening overdose.The risk of these side effects may increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel like you no longer have control over the amount of medication you need to take or how often you need to take it. You may feel like you need to continue taking the medication, even when it no longer helps to relieve your pain.

The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of becoming dependent or addicted to Oxicodona/Naloxona Viatris:

- if you or a family member has a history of abuse or dependence on alcohol, prescription medications, or illicit substances ("addiction"),

- if you smoke,

- if you have ever had problems with your mood (depression, anxiety, or personality disorder) or have received treatment from a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking Oxicodona/Naloxona Viatris, it could be a sign that you have become dependent or addicted.

- You need to take the medication for a longer period than recommended by your doctor.

- You need to take more doses than recommended.

- You are using the medication for reasons other than those prescribed, for example, "to stay calm" or "to help you sleep".

- You have made repeated and unsuccessful attempts to stop or control the use of the medication.

- You do not feel well when you stop taking the medication and feel better once you take it again (abstinence symptoms).

If you notice any of these signs, talk to your doctor to analyze the best treatment for you, including when it is appropriate to stop taking it and how to do it safely (see section 3, If you interrupt treatment with Oxicodona/Naloxona Viatris).

Consult your doctor if you have had any of these conditions in the past. Also, inform your doctor if you present any of them during treatment with this medication.

The most severe consequence of opioid overdose is respiratory depression (slow and shallow breathing). This can also cause a decrease in oxygen levels in the blood, which can lead to fainting, etc.

There is no clinical experience with this medication in patients with cancer associated with peritoneal metastases or in patients with advanced stages of digestive and pelvic cancer with initial intestinal obstruction.

Therefore, it is not recommended to use this medication in these patients.

Children and adolescents

This medication should not be administered to children and adolescents under 18 years old as its benefits and safety have not yet been demonstrated.

How to take Oxicodona/Naloxona Viatris correctly

Diarhea

If you experience intense diarrhea at the beginning of treatment, it may be due to the effect of naloxona. It may be a sign that intestinal function is normalizing. This diarrhea may occur in the first 3 to 5 days of treatment. If it persists after that period of 3 to 5 days, or if you are concerned, contact your doctor.

Switching to Oxicodona/Naloxona Viatris

If you have been receiving high doses of another opioid, you may experience withdrawal symptoms shortly after starting treatment with this medication, such as restlessness, sweating, and muscle pain. If you experience any of these symptoms, you may need special monitoring by your doctor. This medication is not suitable for the treatment of withdrawal.

Surgery

If you need to undergo surgery, tell the doctors that you are receiving treatment with oxicodona/naloxona.

Long-term treatment

You may experience tolerance if you use this medication for a long time. This means that you will need a higher dose to achieve the desired pain relief. Long-term use of this medication can also cause physical dependence. You may experience withdrawal symptoms if treatment is stopped abruptly (restlessness, sweating, muscle pain). If you no longer need treatment, you should gradually reduce your daily dose, consulting with your doctor.

Psychological dependence

The active principle hydrochloride of oxicodona without combination has the same abuse characteristics as other potent opioids (potent analgesics). It can create psychological dependence. Medications containing hydrochloride of oxicodona should be avoided in patients who have a history of abuse of alcohol, drugs, or medications.

Abuse

Do not dissolve the prolonged-release tablets of Oxicodona/Naloxona Viatris to inject them (for example, into a blood vessel). The reason is that they contain talc, which can cause local tissue destruction (necrosis) and alterations in lung tissue (pulmonary granuloma). This abuse can also have other serious consequences and even cause death.

Incorrect use of Oxicodona/Naloxona Viatris

The tablet should be swallowed whole and not divided, broken, chewed, or crushed.

Taking chewed or crushed tablets can affect the slow-release properties of the tablet and lead to the absorption of a potentially fatal dose of hydrochloride of oxicodona (see "If you take more Oxicodona/Naloxona Viatris than you should").

Abuse

You should never abuse Oxicodona/Naloxona Viatris, especially if you have a substance abuse problem. If you are addicted to substances such as heroin, morphine, or methadone, you are likely to experience severe withdrawal symptoms if you misuse this medication, because it contains the active substance naloxona. Withdrawal symptoms may worsen pre-existing withdrawal symptoms.

Doping

Athletes should be aware that this medication can cause a positive reaction in "doping tests". The use of oxicodona/naloxona as a doping agent can put your health at risk.

Other medications and Oxicodona/Naloxona Viatris

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

The risk of experiencing adverse effects increases if you take this medication at the same time as medications that affect brain function. In this case, the adverse effects of this medication may be potentiated and put your life at risk. For example, you may experience fatigue/drowsiness, or respiratory depression (slow and shallow breathing) or coma may worsen.Due to this, concomitant use should only be considered when other treatment options are not possible.

Examples of medications that affect brain function:

• other potent analgesics (opioids),
• medications for treating epilepsy, pain, and anxiety, such as gabapentina and pregabalina,
• somnifacients and tranquilizers (sedatives such as benzodiazepines, hypnotics, anxiolytics),
• antidepressants,
• medications used to treat allergies, dizziness, or nausea (antihistamines or antiemetics),
• other medications for treating mental or psychiatric disorders (antipsychotics that include phenothiazines or neuroleptics),
• muscle relaxants,
• medications for treating Parkinson's disease.

However, if your doctor prescribes oxicodona/naloxona along with sedatives, your doctor should limit the dose and duration of concomitant treatment.

The risk of experiencing adverse effects increases if you use antidepresants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medications may interact with oxicodona and you may experience symptoms such as involuntary muscle contractions, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38 °C. Contact your doctor if you experience these symptoms.

Inform your doctor about all sedatives you are taking and follow your doctor's recommendations closely. It may be helpful to inform friends or family members who are aware of the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

Inform your doctor if you are taking any of the following medications:

• medications that reduce blood clotting (coumarin derivatives), may increase or decrease blood clotting speed,
• macrolide antibiotics (such as clarithromycin),
• azole antifungals (for example, ketoconazole),
• ritonavir or other protease inhibitors (used to treat HIV),
• cimetidine (a medication for treating stomach ulcers, indigestion, or acid reflux),
• rifampicin (used to treat tuberculosis),
• carbamazepine (used to treat seizures or convulsions and certain painful diseases),
• phenytoin (used to treat seizures or convulsions).
• St. John's Wort (also known as Hypericum perforatum),
• quinidine (a medication for treating arrhythmias).

No interactions are expected between oxicodona/naloxona and paracetamol, acetylsalicylic acid, or naltrexone.

Taking Oxicodona/Naloxona Viatris with food, drinks, and alcohol

Drinking alcohol while taking this medication may make you feel more drowsy or increase the risk of severe adverse effects such as shallow breathing with the risk of stopping breathing, and loss of consciousness. It is recommended not to drink alcohol while taking this medication.

You should avoid drinking grapefruit juice while taking this medication.

Pregnancy and breastfeeding

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

Pregnancy

During pregnancy, this medication should be avoided as much as possible. If it is used during prolonged periods of pregnancy, hydrochloride of oxicodona may cause withdrawal symptoms in the newborn. If hydrochloride of oxicodona is administered during delivery, the newborn may experience respiratory depression (slow and shallow breathing).

Breastfeeding

Breastfeeding will be suspended during treatment with this medication. Hydrochloride of oxicodona passes into breast milk. It is not known if hydrochloride of naloxona also passes into breast milk. Therefore, the risk to the infant cannot be ruled out, especially if the mother receives several doses of this medication.

Driving and operating machinery

This medication may affect your ability to drive or operate machinery. In particular, this is more likely at the beginning of treatment with this medication, after increasing the dose, or after switching to a different medication. However, these adverse effects disappear once you have a stable dose of oxicodona/naloxona.

Medications containing oxicodona/naloxona, such as Oxicodona/Naloxona Viatris, have been associated with drowsiness and sudden episodes of falling asleep. If you experience this adverse effect, you should not drive or operate machinery. Inform your doctor if you experience these adverse effects.

Consult your doctor if you can drive or operate machinery.

Oxicodona/Naloxona Viatris contains sodium

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

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

Before starting treatment and periodically during treatment, your doctor will discuss with you what you can expect from the use of Oxicodona/Naloxona Viatris, when and for how long you should take it, when to contact your doctor, and when to stop taking it (see also “If you interrupt treatment with Oxicodona/Naloxona Viatris”).

Unless your doctor tells you otherwise, the usual dose is:

For pain treatment

Adults

The usual initial dose is 10 mg of hydrochloride of oxicodone / 5 mg of hydrochloride of naloxone in prolonged-release tablets every 12 hours.

Your doctor will decide on the dose of oxicodone/naloxone you should take per day and how to divide it into morning and evening doses. They will also decide if you need to adjust the dose during treatment. Your dose will be adjusted to your level of pain and individual sensitivity. You should receive the minimum dose necessary to relieve pain. If you have already received treatment with opioids, the initial dose of this medication may be higher.

The maximum daily dose is 160 mg of hydrochloride of oxicodone and 80 mg of hydrochloride of naloxone. If you need a higher dose, your doctor may give you additional hydrochloride of oxicodone without hydrochloride of naloxone. However, the maximum daily dose of hydrochloride of oxicodone should not exceed 400 mg.

The beneficial effect of hydrochloride of naloxone on intestinal activity may be affected if the dose of hydrochloride of oxicodone is increased without increasing the dose of hydrochloride of naloxone.

If you substitute this medication with another opioid analgesic, it is likely that your intestinal function will worsen.

If you experience pain between two doses of this medication, you may need to take an additional rapid-acting analgesic. This medication is not intended as treatment in this case. Discuss it with your doctor.

If you feel that the effect of this medication is too strong or too weak, consult your doctor or pharmacist.

Older patients

Generally, no dose adjustment is necessary in older patients with normal kidney and/or liver function.

Liver or kidney problems

If you have any degree of liver or kidney disorders or mild liver disorders, your doctor will prescribe this medication with special caution. If you have moderate or severe liver disorders, you should not take Oxicodona/Naloxona Viatris (see also section 2 “Do not take Oxicodona/Naloxona Viatris” and “Warnings and precautions”).

Children and adolescents under 18 years

Oxicodone/naloxone has not been studied in children and adolescents under 18 years. Its safety and efficacy have not been demonstrated in children and adolescents. Therefore, it is not recommended to use this medication in children and adolescents under 18 years.

Administration form

Oral.

Take this medication every 12 hours, following a fixed schedule (e.g., at 8 am and at 8 pm).

This medication should be taken with sufficient liquid (half a glass of water). The tablet should be swallowed whole and not divided, broken, chewed, or crushed. The tablet can be taken with or without food.

Duration of use

Do not take this medication for longer than necessary. If you receive this medication for a long time, your doctor should regularly check that you still need it.

If you take more Oxicodona/Naloxona Viatris than you should

If you have taken more oxicodone/naloxone than prescribed, inform your doctor immediately.

Consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

A overdose may cause:

• Constriction of the pupils
• Slow and shallow breathing (respiratory depression)
• A situation similar to narcosis (drowsiness that can lead to loss of consciousness)
• Low muscle tone (hypotonia)
• Reduced heart rate
• Decreased blood pressure
• A cerebral disorder (known as toxic leukoencephalopathy)

In severe cases, it may cause loss of consciousness (coma), accumulation of fluid in the lungs, and circulatory collapse, which can be fatal.

Avoid situations that require a high level of alertness, such as driving.

If you forgot to take Oxicodona/Naloxona Viatris

If you forgot to take this medication or if you take a dose lower than prescribed, you may not notice the analgesic effect.

If you forget to take a dose, follow these instructions:

• If 8 hours or more have passed since the next scheduled dose: take the missed prolonged-release tablet immediately, and continue with the regular schedule.
• If less than 8 hours have passed since the next scheduled dose: take the missed prolonged-release tablet. Wait 8 hours before taking the next prolonged-release tablet. Try to recover the original schedule (e.g., 8 am and 8 pm). Do not take more than one dose within an 8-hour period.

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

If you interrupt treatment with Oxicodona/Naloxona Viatris

Do not interrupt treatment with this medication without consulting your doctor.

If you no longer need to continue treatment, you should gradually reduce the daily dose, after discussing it with your doctor. This will help you avoid withdrawal symptoms, such as restlessness, sweating, and muscle pain.

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.

Important side effects to look out for and what to do if you experience them:

If you already experience any of the following important side effects, consult your nearest doctor immediately.

The slow and shallow breathing (respiratory depression) is the most serious side effect of opioid overdose. It mainly occurs in elderly and weakened patients. Opioids can also cause a severe decrease in blood pressure in susceptible patients.

Side effects are subdivided into two sections: pain treatment and treatment with hydrochloride of oxicodone as the active substance only.

The following side effects have been observed in patients receiving pain treatment

Frequent (can affect up to 1 in 10 people)

• Reduced or lost appetite
• Difficulty sleeping, fatigue or weakness
• Sensation of dizziness or feeling like "everything is spinning", headache, drowsiness
• Dizziness
• Flush
• Abdominal pain, constipation, diarrhea, dry mouth, indigestion, vomiting, nausea, flatulence
• Itching skin, skin reactions, sweating
• General discomfort

Rare (can affect up to 1 in 100 people)

• Allergic reactions
• Restlessness, abnormal thoughts, anxiety, confusion, depression, nervousness
• Decreased libido
• Seizures (especially in people with epilepsy or predisposition to seizures), difficulty concentrating, speech alteration, fainting, tremors
• Abnormal sense of taste
• Feeling drowsy or fatigued and lethargic
• Vision disturbances
• Sensation of chest oppression especially if you already have coronary heart disease, palpitations
• Decreased blood pressure, increased blood pressure
• Difficulty breathing, runny nose, cough
• Abdominal distension
• Increased liver enzymes, biliary colic
• Muscle cramps, muscle contractions, muscle pain
• Urgent need to urinate
• Symptoms of withdrawal such as agitation, chest pain, chills, general discomfort, pain, inflammation of hands, ankles or feet
• Thirst
• Weight loss
• Accidental injuries

Rare (can affect up to 1 in 1,000 people)

• Increased heart rate
• Yawns
• Dental alterations
• Weight gain
• Medication dependence

Unknown frequency (frequency cannot be estimated from available data)

• Euphoria, hallucinations, nightmares, aggression
• Tickling, intense drowsiness
• Shallow breathing
• Belching
• Difficulty urinating
• Erectile dysfunction

It is known that the active ingredient hydrochloride of oxicodone, if not combined with hydrochloride of naloxone, has the following side effects, different from those mentioned:

Oxicodone can cause respiratory problems (respiratory depression), pupil constriction, muscle cramps in the bronchial muscles and smooth muscles, as well as depression of the cough reflex.

Frequent (can affect up to 1 in 10 people)

• Mood changes and personality changes (e.g. depression, feeling extremely happy), decreased activity, increased activity
• Hypo
• Difficulty urinating

Rare (can affect up to 1 in 100 people)

• Dehydration
• Restlessness, perception disorders (e.g. hallucinations, derealization)
• Difficulty concentrating, migraines, increased muscle tension, involuntary muscle contractions, reduced sensitivity to pain or touch, coordination abnormalities
• Auditory difficulties
• Enlargement of blood vessels
• Voice alterations (dysphonia)
• Difficulty swallowing, ileus, mouth ulcers, inflamed gums
• Dry skin
• Fluid retention inflammation, medication tolerance
• Decreased levels of sex hormones that can affect sperm production in men or menstrual cycle in women

Rare (can affect up to 1 in 1,000 people)

• Herpes simplex
• Increased appetite
• Black stools (with tar-like appearance), gingival hemorrhage
• Itching rash (urticaria)

Unknown frequency (frequency cannot be estimated from available data)

• Generalized anaphylactic reactions
• Increased sensitivity to pain
• Dental caries
• Bile flow problems
• A problem affecting the intestinal valve that can cause severe abdominal pain (Oddi sphincter dysfunction)
• Absence of menstrual periods
• Prolonged use of oxicodone during pregnancy can cause withdrawal symptoms that put the newborn's life at risk. Symptoms to look for in the baby include irritability, hyperactivity, and abnormal sleep pattern, crying, tremors, illness, diarrhea, and weight loss

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it's a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es/www.notificaram.esBy 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. Store this medication in a safe and closed place where other people cannot access it. It can cause serious harm and be fatal to people when not prescribed.

Do not use this medication after the expiration date that appears on the box, in the bottle, or on the blister pack, after CAD or EXP. The expiration date is the last day of the month indicated.

Blister pack:

Do not store above 25°C.

Bottles:

Do not store above 30°C.

Shelf life after first opening: 3 months.

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

Composition of Oxicodona/Naloxona Viatris

The active ingredients are hydrochloride of oxicodona and hydrochloride of naloxona.

Each prolonged-release tablet contains 5 mg of hydrochloride of oxicodona (equivalent to 4.5 mg of oxicodona) and 2.5 mg of hydrochloride of naloxona (2.73 mg as hydrochloride of naloxona dihydrate, equivalent to 2.25 mg of naloxona).

The other components are:

Tablet core

Acetate of polyvinyl, povidone K30, lauril sulfate of sodium, anhydrous colloidal silica, microcrystalline cellulose, magnesium stearate

Tablet coating

Polivinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Appearance of the product and contents of the package

Prolonged-release white, round, biconvex tablet with a diameter of 4.7 mm and a height of 2.9 - 3.9 mm.

Oxicodona/Naloxona Viatris is available in:

Child-resistant blisters: 10, 14, 20, 28, 30, 50, 56, 60, 98, and 100 prolonged-release tablets.

Child-resistant bottles with safety closure: 50, 100, 250 prolonged-release tablets.

Only some package sizes may be marketed.

Marketing authorization holder andresponsible manufacturer:

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer

Develco Pharma GmbH

Grienmatt 27

D-79650 Schopfheim

Germany

Or

Mylan Hungary Kft.

Mylan utca 1

Komárom 2900

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of theEconomic European Spacewith the following names:

GermanyOxycodon-HCl/Naloxon-HCl Mylan 5 mg/2.5 mg Retardtabletten

SpainOxicodona/Naloxona Viatris 5 mg/2.5 mg prolonged-release tablets EFG

ItalyElatrex

United Kingdom (Northern Ireland) Oxyargin 5mg /2.5 mg prolonged release tablets

Revision date of this prospectus:October 2024

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/