FENTANIL MATRIX NORMON 100 micrograms/hour TRANSDERMAL PATCHES

Introduction

Package Leaflet: Information for the User

Fentanilo Matrix Normon 100 micrograms/h transdermal patch EFG

Fentanyl

Read all of this leaflet carefully before you start using 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Fentanilo Matrix Normon is and what it is used for
2. What you need to know before you use Fentanilo Matrix Normon
3. How to use Fentanilo Matrix Normon
4. Possible side effects
5. Storing Fentanilo Matrix Normon
6. Contents of the pack and other information

1. What Fentanilo Matrix Normon is and what it is used for

This medicine is called Fentanilo Matrix Normon

The patches help to relieve very strong and long-lasting pain:

• in adults who need continuous pain treatment
• in children over 2 years of age who are already using opioid medication and need continuous pain treatment.

Fentanilo Matrix Normon contains a medicine called fentanyl. It belongs to a group of strong pain-relieving medicines called opioids.

2. What you need to know before you use Fentanilo Matrix Normon

Do not use Fentanilo Matrix Normon

• If you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6)
• If you have short-term pain, such as sudden pain or pain after an operation
• If you have breathing difficulties, with slow or weak breathing

Do not use this medicine if you or your child are in any of the above situations. If you are not sure, talk to your doctor or pharmacist before using Fentanilo Matrix Normon.

Warnings and precautions

• Fentanilo Matrix Normon can have life-threatening side effects in people who are not regularly using prescribed opioids.
• Fentanilo Matrix Normon is a medicine that can be life-threatening to children, even if the patches have been used. Be aware that a sticky patch (used or unused) can be tempting to a child, and if it sticks to the child's skin or if the child puts it in their mouth, it can be fatal.
• Keep this medicine in a safe and protected place, where others cannot get to it (see section 5 for more information).

If the patch sticks to another person

The patch must only be used on the skin of the person it has been prescribed for. There have been cases where the patch has stuck accidentally to another family member through close physical contact or sharing the same bed with the person wearing the patch. If the patch sticks accidentally to another person (especially a child), the medicine in the patch can pass through the skin of the other person and can cause serious side effects, such as breathing difficulties, with slow or weak breathing that can be life-threatening. If the patch sticks to someone else's skin, it must be removed immediately and medical help must be sought.

Be careful with Fentanilo Matrix Normon

Talk to your doctor or pharmacist beforeusing this medicine if you are in any of the following situations. Your doctor will need to keep a closer check on you:

• If you have ever had lung or breathing problems
• If you have ever had heart, liver, or kidney problems, or low blood pressure
• If you have ever had a brain tumor
• If you have ever had persistent headaches or a head injury
• If you are elderly, as you may be more sensitive to the effects of this medicine.
• If you have a condition called "myasthenia gravis", where your muscles become weak and tired easily.

If you have any of the above conditions (or if you are not sure), talk to your doctor or pharmacist before using Fentanilo Matrix Normon.

Tell your doctor if you have breathing problems while you are sleeping.Opioids like Fentanilo Matrix Normon can cause sleep-related breathing problems, such as sleep apnea (pauses in breathing while sleeping) and sleep-related low blood oxygen levels. Talk to your doctor if you, your partner, or caregiver notice any of the following symptoms:

• pauses in breathing while sleeping
• waking up at night due to lack of breath
• difficulty staying asleep
• excessive sleepiness during the day.

Your doctor may decide to change the dose.

Tell your doctor if you notice a change in your pain.If you feel:

• that the patch is no longer relieving your pain
• an increase in pain
• a change in the way you feel pain (for example, you feel pain in a different part of your body)
• pain when you touch your body in a way that should not hurt.

Do not change the dose yourself. Your doctor may decide to change the dose or switch to a different treatment.

Side effects and Fentanilo Matrix Normon

• Fentanilo Matrix Normon can make you feel extremely sleepy and can slow down your breathing. In rare cases, these breathing problems can be life-threatening, especially in people who have not used strong opioid painkillers before (such as Fentanilo Matrix Normon or morphine). If you, your partner, or caregiver notice that the person wearing the patch is unusually sleepy, with slow or weak breathing:

• Remove the patch
• Call a doctor or go to the nearest hospital immediately
• Get the person to move and talk as much as possible

• If you have a fever while using Fentanilo Matrix Normon, talk to your doctor. This can increase the amount of medicine that passes through your skin.
• Fentanilo Matrix Normon can cause constipation; talk to your doctor or pharmacist for advice on how to prevent or relieve constipation.

You can find a complete list of possible side effects in section 4.

When wearing the patch, do not expose it to direct heat, such as heat pads, electric blankets, hot water bottles, water beds, heat lamps, or sunlamps. Do not take sunbaths, have long hot baths, or use saunas or hot tubs. If you do, you may increase the amount of medicine released from the patch.

Long-term use and tolerance

This medicine contains fentanyl, an opioid. Repeated use of opioid painkillers can make the medicine less effective (your body gets used to it, which is known as tolerance). You may also become more sensitive to pain when using Fentanilo Matrix Normon. This is known as hyperalgesia. Increasing the dose of the patches may continue to reduce pain for a while, but it can also be harmful. If you notice that the medicine is becoming less effective, talk to your doctor. Your doctor will decide whether it is best to increase the dose or gradually reduce the use of Fentanilo Matrix Normon.

Dependence and addiction

Repeated use of Fentanilo Matrix Normon can also lead to dependence, abuse, and addiction, which can result in a potentially life-threatening overdose. The risk of these side effects may be greater with higher doses and longer use. Dependence or addiction can lead to a feeling of loss of control over the amount of medicine you need to use or how often you need to use it. You may feel the need to keep using the medicine even if it is no longer relieving your pain.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to Fentanilo Matrix Normon may be greater if:

• You or a family member have abused alcohol, prescription medicines, or illegal drugs ("addiction").
• You smoke.
• You have ever had mood problems (depression, anxiety, or personality disorders) or have received treatment from a psychiatrist for other mental health problems.

If you notice any of the following symptoms while using Fentanilo Matrix Normon, it could be a sign of dependence or addiction.

• You need to use the medicine for longer than your doctor prescribed.
• You need to use a higher dose than recommended.
• You are using the medicine for reasons other than those prescribed, for example, to feel calm or to help you sleep.
• You have tried to stop using the medicine several times but have been unable to.
• You feel unwell when you stop using the medicine, and you feel better once you start using it again ("withdrawal symptoms").

If you notice any of these signs, talk to your doctor to determine the best course of treatment for you, when it is appropriate to stop the medicine, and how to do it safely.

Repeated use of Fentanilo Matrix Normon can also lead to dependence, abuse, and addiction, which can result in a potentially life-threatening overdose.

Withdrawal symptoms when stopping Fentanilo Matrix Normon

Do not stop using this medicine suddenly. You may experience withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling sick, diarrhea, loss of appetite, tremors, chills, or sweating. If you want to stop using this medicine, talk to your doctor first. Your doctor will tell you how to do it, usually by gradually reducing the dose so that the unpleasant withdrawal effects are minimized.

Other medicines and Fentanilo Matrix Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines you can buy without a prescription and herbal remedies. You should also tell your pharmacist if you are using Fentanilo Matrix Normon and you buy any medicines from the pharmacy.

Your doctor will know which medicines can be safely taken with Fentanilo Matrix Normon. You may need to be closely monitored if you are taking any of the following types of medicines or if you stop taking any of the following types of medicines, as this can affect the dose of Fentanilo Matrix Normon you need.

In particular, tell your doctor or pharmacist if you are taking:

• Other painkillers, such as other opioid painkillers (e.g., buprenorphine, nalbuphine, or pentazocine) and some painkillers for nerve pain (gabapentin and pregabalin).
• Medicines to help you sleep (such as temazepam, zaleplon, or zolpidem).
• Medicines to help you calm down (tranquilizers, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental health problems (antipsychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
• Medicines to relax your muscles (such as cyclobenzaprine or diazepam).
• Certain antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). - see below for more information
• Certain medicines for depression or Parkinson's disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). You must not use Fentanilo Matrix Normon in the 14 days after stopping these medicines. - see below for more information
• Certain antihistamines, especially those that cause drowsiness (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine).
• Certain antibiotics used to treat infections (such as erythromycin or clarithromycin).
• Medicines used to treat fungal infections (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
• Medicines used to treat HIV infection (such as ritonavir).
• Medicines used to treat irregular heartbeats (such as amiodarone, diltiazem, or verapamil).
• Medicines used to treat tuberculosis (such as rifampicin).
• Certain medicines used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin).
• Certain medicines used to treat nausea or vomiting (such as phenothiazines).
• Certain medicines used to treat heartburn or stomach ulcers (such as cimetidine).
• Certain medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
• Certain medicines used to treat blood cancer (such as idelalisib).

Using Fentanilo Matrix Normon with antidepressants

The risk of side effects increases if you are taking medicines such as certain antidepressants. Fentanilo Matrix Normon can interact with these medicines, and you may experience changes in your mental state, such as agitation, seeing, feeling, hearing, or smelling things that are not there (hallucinations), and other effects such as changes in blood pressure, rapid heartbeat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhea (these could be signs of a serotonin syndrome). If used together, your doctor may want to closely monitor you for these side effects, especially when starting treatment or when changing the dose of the medicine.

Using Fentanilo Matrix Normon with central nervous system depressants, including alcohol and some narcotics

Using Fentanilo Matrix Normon with sedative medicines, such as benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Fentanilo Matrix Normon with sedative medicines, your doctor will limit the dose and duration of concomitant treatment.

Tell your doctor about all sedative medicines you are taking, and follow your doctor's dosing instructions carefully. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.

Do not drink alcohol while using Fentanilo Matrix Normon, unless you have talked to your doctor first.

Use in athletes

Athletes are informed that this medicine contains a component that can result in a positive doping test.

Operations

If you are going to have an operation, tell your doctor or dentist that you are using Fentanilo Matrix Normon.

Pregnancy and breastfeeding

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 using this medicine.

Fentanilo Matrix Normon must not be used during pregnancy, unless you have discussed it with your doctor.

Fentanilo Matrix Normon must not be used during labor, as the medicine can affect the baby's breathing.

Long-term use of Fentanilo Matrix Normon during pregnancy can cause withdrawal symptoms in your newborn baby, such as crying, irritability, and diarrhea, which can be life-threatening if not recognized and treated. Talk to your doctor immediately if you think your baby may have withdrawal symptoms.

Do not use Fentanilo Matrix Normon if you are breastfeeding. You must not breastfeed for 3 days after removing the Fentanilo Matrix Normon patch. This is because the medicine can pass into breast milk.

Driving and using machines

Fentanilo Matrix Normon can affect your ability to drive or use machines or tools, as it can make you sleepy or dizzy. If this happens, do not drive or use machines or tools. Do not drive while using this medicine until you know how it affects you.

Talk to your doctor or pharmacist if you are unsure whether it is safe for you to drive while using this medicine.

3. How to use Fentanilo Matrix Normon

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

Your doctor will decide which concentration of Fentanilo Matrix Normon is most suitable for you, taking into account the intensity of your pain, your general condition, and the type of pain treatment you have received so far.

Before starting treatment and regularly during treatment, your doctor will also explain what you can expect from using Fentanilo Matrix Normon, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also section 2, «Withdrawal syndrome when stopping treatment with Fentanilo Matrix Normon»).

How to apply and change patches

• Each patch contains a sufficient amount of medication for 3 days (72hours).
• You should change the patch every three days, unless your doctor has indicated otherwise.
• Always remove the used patch beforeapplying a new one.
• Always change the patch at the same timeof day every 3 days (72 hours).
• If you are using more than one patch, change them all at the same time.
• Make a note of the day of the week, date, and time each time you apply a patch to remember when you need to change it.
• The following table shows when you should change the patch:

Where to apply the patch

Adults

• Apply the patch to a flat area of the torso or arm (never over a joint).

Children

• Always apply the patch to the upper back so that your child has difficulty reaching it or removing it.
• Check occasionally that the patch is still stuck to the skin.
• It is essential that the child does not remove the patch and put it in their mouth, as this could be life-threatening or fatal.
• Keep your child under close observation for 48 hours after:

• Applying the first patch
• Applying a patch with a higher dose

• The patch may take some time to reach its maximum effect. Therefore, your child may need other painkillers until the patch is effective. Your doctor will explain this to you.

Adults and children:

Do not apply the patch to

• The same site twice in a row.
• Areas that move a lot (joints), irritated skin, or skin with wounds.
• Areas of skin with a lot of hair. If there is hair, do not shave it (the skin becomes irritated with shaving). Instead, cut it as close to the skin as possible.

How to apply the patch

Prepare the skin

• Before applying the patch, check that the skin is completely dry, clean, and fresh
• If you need to wash the skin, use only cold water
• Do not use soap or other cleaners, creams, moisturizers, oils, or talc before applying the patch
• Do not apply the patch immediately after a hot bath or shower

Dispose of the patch

• As soon as you remove the patch, fold it well in half, so that the adhesive face sticks to itself
• Put it back in the original envelope and throw it away following the instructions of your pharmacist
• Keep used patches out of sight and reach of children; although they are used, the patches contain medication that can harm children and even be fatal

Wash

• Always wash your hands with only water after handling the patches

More information on the use of Fentanilo Matrix Normon

Daily activities during patch use

• The patches are water-resistant
• You can shower or bathe with the patch on, but do not rub it
• If your doctor agrees, you can exercise or play sports with the patch on
• You can also swim with the patch on, but:

• Do not use hot tubs or whirlpools
• Do not cover the patch with tight or elastic fabrics

• When wearing the patch, do not expose it to direct heat, such as thermal pillows, electric blankets, hot water bottles, waterbeds, or heat or tanning lamps. Do not sunbathe or take prolonged hot baths, and do not use saunas. If you do, you may increase the amount of medication released from the patch.

How long do the patches take to work?

• The first patch may take some time to reach its maximum effect.
• Your doctor may give you additional painkillers during the first few days.
• After that, the patch should help relieve pain continuously, so you can stop taking other painkillers. However, your doctor may prescribe additional painkillers occasionally.

How long will you need to use the patches?

• Fentanilo Matrix Normon patches are indicated for prolonged pain. Your doctor can tell you how long you can expect to use the patches.

If the pain worsens

• If your pain worsens suddenly after placing the last patch, check the patch. If it is no longer sticking well or has come off, you should replace the patch (see also the section If the patch comes off).
• If your pain worsens over time while using the patches, your doctor may try patches with a higher dose or prescribe additional painkillers (or both).
• If increasing the patch dose does not help, your doctor may decide to stop using the patches.

If you use too many patches or a patch with the wrong dose

If you have applied too many patches or a patch with the wrong dose, remove them and contact your doctor immediately or call the Toxicology Information Service, phone: (91) 562 04 20, indicating the medication and the amount applied, or go to the hospital.

The signs of overdose include breathing problems or weak breathing, fatigue, extreme drowsiness, inability to think clearly or walk or talk normally, and dizziness, dizziness, or confusion. An overdose can also cause a brain disorder known as toxic leukoencephalopathy.

If you forget to change the patch

• If you forget to change the patch, change it as soon as you remember and make a note of the day and time. Change the patch again after 3 days (72hours), as usual.
• If you are significantly delayed, you should talk to your doctor, as you may need additional painkillers, but do notapply additional patches.

If the patch comes off

• If the patch falls off before it is due to be changed, apply a new one immediately and make a note of the day and time. Choose a new skin area:
• On the torso or arm
• On the upper back of your child
• Inform your doctor about this and leave the patch on for another 3 days (72hours)or for the time indicated by your doctor, before changing the patch in the usual way
• If the patches tend to fall off, consult your doctor, pharmacist, or nurse

If you want to stop using the patches

• Do not stop using this medication abruptly. If you want to stop using this medication, talk to your doctor first. Your doctor will indicate how to do it, usually by gradually reducing the dose so that the unpleasant withdrawal effects are minimal. See also section 2, «Symptoms of withdrawal when stopping Fentanilo Matrix Normon».

• If you stop using the patches, do not use them again without consulting your doctor first. You may need a different dose when you resume treatment

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you, your partner, or caregiver notice any of the following signs in the person wearing the patch, remove the patch and call a doctor or go to the nearest hospital immediately. You may need urgent medical treatment.

• Unusual drowsiness, slower or weaker breathing than expected.

Follow the above recommendations and make the person wearing the patch move and talk as much as possible. In very rare cases, these breathing difficulties can be life-threatening or fatal, especially in people who have not previously used strong opioid painkillers (such as Fentanilo Matrix Normon or morphine). (Uncommon, may affect up to 1 in 100 people).

• Sudden swelling of the face or throat, severe irritation, redness, or blisters on the skin.

All of these can be signs of a severe allergic reaction. (Frequency cannot be estimated from available data).

• Seizures (convulsions). (Uncommon, may affect up to 1 in 100 people).

• Decreased level of consciousness or loss of consciousness. (Uncommon, may affect up to 1 in 100 people).

The following side effects have also been reported

Very common (may affect more than 1 in 10 people)

• Nausea, vomiting, constipation
• Feeling sleepy (drowsiness)
• Feeling dizzy
• Headache

Common (may affect up to 1 in 10 people)

• Allergic reaction
• Loss of appetite
• Difficulty sleeping
• Depression
• Feeling anxious or confused
• Seeing, feeling, hearing, or smelling things that are not present (hallucinations)
• Tremors or muscle spasms
• Abnormal sensation in the skin, such as tingling or numbness (paresthesia)
• Feeling that everything is spinning (vertigo)
• Fast or irregular heartbeats (palpitations, tachycardia)
• Increased blood pressure
• Shortness of breath (dyspnea)
• Diarrhea
• Dry mouth
• Stomach pain or indigestion
• Excessive sweating
• Itching, rash, or redness of the skin
• Difficulty urinating or emptying the bladder completely
• Extreme fatigue, weakness, or general malaise
• Feeling cold
• Swelling of the hands, ankles, or feet (peripheral edema)

Uncommon (may affect up to 1 in 100 people)

• Feeling agitated or disoriented
• Feeling extremely happy (euphoria)
• Decreased sensation or sensitivity, especially in the skin (hypoesthesia)
• Memory loss
• Blurred vision
• Slow heart rate (bradycardia) or low blood pressure
• Bluish color of the skin due to decreased oxygen in the blood (cyanosis)
• Loss of intestinal contractions (ileus)
• Skin rash with itching (eczema), allergic reaction, or other skin disorders where the patch is applied
• Flu-like illness
• Feeling of changed body temperature
• Fever
• Muscle contraction
• Difficulty getting or maintaining an erection (impotence) or problems with sexual intercourse

Rare side effects (may affect up to 1 in 1000 people)

• Pupil constriction (miosis)
• Occasional interruption of breathing (apnea)

• The following side effects have also been reported, but their exact frequency is unknown:Lack of male sex hormones (androgen deficiency)
• Delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that do not exist, sleep disturbances, nightmares)
• You may become dependent on Fentanilo Matrix Normon (see section 2).

You may notice rashes, redness, or mild itching of the skin at the patch application site. It is usually mild and disappears after removing the patch. If it does not, or if the patch irritates your skin a lot, inform your doctor.

Repeated use of the patches can cause the medication to lose its effectiveness (you get used to it or become more sensitive to pain) or can cause dependence.

If you switch from another painkiller to Fentanilo Matrix Normon or if you stop using Fentanilo Matrix Normon abruptly, you may experience withdrawal symptoms, such as dizziness, feeling sick, diarrhea, anxiety, or tremors. Inform your doctor if you notice any of these effects.

There have also been reports of newborns experiencing withdrawal symptoms after their mothers used Fentanilo Matrix Normon for a prolonged period during pregnancy.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fentanilo Matrix Normon

Where to store the patches

Keep all patches (used and unused) out of sight and reach of children.

Store this medication in a protected and secure place, where others cannot access it. It can be very harmful and cause death to people who may use this medication accidentally or intentionally when it has not been prescribed for them.

How long can you store Fentanilo Matrix Normon

Do not use this medication after the expiration date shown on the box and on the envelope. The expiration date is the last day of the month indicated. If the patches are expired, take them to the pharmacy.

Do not use this medication if you notice that the patches are damaged.

Store in the original packaging to protect it from moisture.

How to dispose of used or unused patches

Accidental exposure of another person to used and unused patches, especially in children, can result in a fatal outcome.

Used patches should be folded firmly in half, so that the adhesive side of the patch sticks to itself. Then, they should be thrown away safely by putting them back in the original envelope and keeping them out of sight and reach of others, especially children, until they are disposed of safely. Ask your pharmacist how to dispose of the packaging and medications you no longer need.

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

6. Package contents and additional information

Composition of Fentanilo Matrix Normon

• The active ingredient is fentanyl.

Each transdermal patch (60 cm2 area of the release surface) contains 19.2 mg of fentanyl, which releases a dose of 100 micrograms/hour.

• The other components of the patch are:

Adhesive layer:Acrylic polymer, lauric alcohol

Supporting film:Polyester film, silicone-treated.

Removable coating:Polyester/ethylene-vinyl acetate film

Printing ink

Appearance of the product and package contents

Fentanilo Matrix Normon 100 micrograms/h is a thin, transparent transdermal patch with rounded edges and the following printing: "fentanyl 100 µg/h".

Fentanilo Matrix Normon is available in packages of 5 transdermal patches.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

Fentanilo Matrix Normon 25 micrograms/h transdermal patch EFG

Fentanilo Matrix Normon 50 micrograms/h transdermal patch EFG

Fentanilo Matrix Normon 75 micrograms/h transdermal patch EFG

Date of the last revision of this leaflet: March 2025

Other sources of information

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