DOLOXITAL 12 micrograms/hour transdermal patches

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Doloxital 12micrograms/hour 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 signs of illness 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 is Doloxital and what is it used for
2. What you need to know before you use Doloxital
3. How to use Doloxital
4. Possible side effects
5. Storing Doloxital
6. Contents of the pack and other information

1. What is Doloxital and what is it used for

This medicine is called Doloxital.

The patches help to relieve severe 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.

Doloxital 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 Doloxital

Do not use Doloxital

• If you are allergic to fentanyl, peanuts, soya, 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, consult your doctor or pharmacist before using Doloxital.

Warnings and precautions

• Doloxital can have life-threatening side effects in people who are not regularly using prescribed opioids.
• Doloxital is a medicine that can be life-threatening to children, even if they have used the patches before. Be aware that a used or unused adhesive patch can be tempting to a child, and if the patch is stuck 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, out of the reach of other people (see section 5 for more information).

If the patch sticks to another person

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

Be especially careful withDoloxital

Consult your doctor or pharmacist beforeusing this medicine if you are in any of the following situations. Your doctor will need to monitor you more closely:

• 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), consult your doctor or pharmacist before using Doloxital

While using the patch, tell your doctor if you have breathing problems while you are asleep.Opioids like Doloxital can cause sleep-related breathing disorders such as sleep apnea (pauses in breathing while asleep) and sleep-related hypoxemia (low oxygen levels in the blood). Talk to your doctor if you, your partner, or caregiver notice any of the following symptoms:

• pauses in breathing while asleep
• 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.

While using the patch, tell your doctor if you notice a change in the pain you feel.If you:

• feel that the patch is no longer relieving your pain
• experience an increase in pain
• notice a change in the way you feel pain (for example, you feel pain in a different part of your body)
• feel 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 treatment.

Side effects andDoloxital

• Doloxital 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 Doloxital 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 Doloxital, talk to your doctor. This can increase the amount of medicine that passes through your skin.
• Doloxital can cause constipation; talk to your doctor or pharmacist for advice on how to prevent or relieve constipation.

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

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 pharmacological tolerance). You may also become more sensitive to pain when using Doloxital. 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, consult your doctor. Your doctor will decide whether to increase the dose or gradually reduce the use of Doloxital.

Dependence and addiction

This medicine contains fentanyl, which is an opioid. It can cause dependence and/or addiction.

Repeated use of Doloxital 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 cause 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 continue 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 Doloxital 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 disorder) or have received treatment from a psychiatrist for other mental health conditions.

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

• You need to use the medicine for longer than prescribed by your doctor.
• 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 made repeated unsuccessful attempts to stop using the medicine or control your use.
• You feel unwell when you stop using the medicine, and you feel better once you start taking it again ("withdrawal symptoms").

If you notice any of these signs, consult 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.

While 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 or have prolonged hot baths, and do not use saunas or hot tubs. If you do, you may increase the amount of medicine released from the patch.

Withdrawal symptoms when stopping Doloxital

Do not stop using this medicine suddenly. You may experience withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, awareness of your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhea, loss of appetite, tremors, shivers, 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 Doloxital

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This includes medicines obtained without a prescription and herbal remedies. You should also tell your pharmacist if you are using Doloxital when you buy any medicines from the pharmacy.

Your doctor will know which medicines can be taken safely with Doloxital. You may need to be monitored closely 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 may affect the dose of Doloxital you need.

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

• Other pain medicines, such as other strong opioid painkillers (e.g., buprenorphine, nalbuphine, or pentazocine) and some pain medicines for nerve pain (gabapentin and pregabalin).
• Medicines to help you sleep (such as temazepam, zaleplon, or zolpidem).
• Medicines to calm you (tranquilizers, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental health conditions (antipsychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
• Medicines to relax your muscles (such as cyclobenzaprine or diazepam).
• Certain medicines used to treat depression called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). More information can be found below.
• Certain medicines used to treat depression or Parkinson's disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). You should not use Doloxital in the 14 days after stopping these medicines. More information can be found below.
• Certain antihistamines, especially those that cause drowsiness (such as chlorphenamine, 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 Doloxital with antidepressants

The risk of side effects increases if you are taking medicines such as certain antidepressants. Doloxital 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 serotonin syndrome). If used together, your doctor may want to monitor you closely to detect these side effects, especially when starting treatment or when changing the dose of the medicine.

Using Doloxital with central nervous system depressants, including alcohol and some narcotics

Using Doloxital and sedative medicines such as benzodiazepines or related medicines at the same time increases the risk of feeling drowsy, having breathing difficulties (respiratory depression), coma, and can be life-threatening. Because of this, using them together should only be considered when no other treatment is possible.

However, if your doctor prescribes Doloxital with sedative medicines, the dose and duration of use should be limited by your doctor.

Tell your doctor about all sedative medicines you are taking, and follow your doctor's dosage recommendation. It may be helpful to inform friends or relatives to be aware of the signs and symptoms mentioned above. Consult your doctor if you experience any symptoms.

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

Surgery

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Doloxital should not be used during pregnancy, unless you have discussed it with your doctor.

Doloxital should not be used during labor, as the medicine can affect the baby's breathing.

Long-term use of Doloxital during pregnancy can cause withdrawal symptoms in your newborn baby, such as crying, irritability, convulsions, poor feeding, 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 Doloxital if you are breastfeeding. You should not breastfeed for 3 days after removing the Doloxital patch. This is because the medicine can pass into breast milk.

Driving and using machines

Doloxital can affect your ability to drive or use machines or tools, as it can make you feel 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.

Doloxital contains soya oil

This medicine contains soya oil. Do not use if you are allergic to peanuts or soya.

3. How to use Doloxital

Before starting treatment and on a regular basis during treatment, your doctor will also explain what you can expect from using Doloxital, 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, "Symptoms of withdrawal from stopping Doloxital").

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist again.

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

How to apply and change patches

• Each patch contains a sufficient amount of medication for 3 days (72 hours).
• You should change the patch every three days, unless your doctor has instructed you 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 or removing it.
• Check occasionally to ensure the patch is still attached 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 pain relievers 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

Step 1: 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 talcum powder before applying the patch.
• Do not apply the patch immediately after a hot bath or shower.

Step 2: Open the pouch

• Each patch is sealed in its own pouch.
• To open the pouch, first cut two notches, as indicated by the arrows.
• Then, carefully tear along both edges of the pouch completely (if using scissors, cut along the seal edge to avoid damaging the patch).

• Hold the two parts of the open pouch and pull to separate them.
• Remove the patch and use it immediately.
• Save the empty pouch to dispose of the used patch later.
• Use each patch only once.
• Do not remove the patch from its pouch until you are ready to use it.
• Check that the patch is not damaged.
• Do not use the patch if it is divided, cut, or damaged in any way.
• Never divide or cut the patch.

Step 3: Peel and press

• Make sure the patch will be covered by loose clothing and not stuck under tight or elastic fabric.
• Carefully peel off one half of the shiny plastic protective layer, starting from the center of the patch. Try not to touch the adhesive part of the patch.
• Press this adhesive part of the patch onto the skin.
• Remove the other part of the protective layer and press the entire patch onto the skin with the palm of your hand.
• Hold it pressed for at least 30 seconds. Make sure the patch is well adhered, especially around the edges.

Step 4: Dispose of the patch

• As soon as you remove the patch, fold it in half, so that the adhesive surface sticks to itself.
• Put it back in the original pouch and dispose of it according to your pharmacist's instructions.
• Keep used patches out of sight and reach of children; although used, patches contain medication that can harm children and even be fatal.

Step 5: Wash your hands

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

More information on using Doloxital

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 clothing.
• When wearing the patch, do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, waterbeds, or heat or tanning lamps. Do not sunbathe or take long 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 pain relievers during the first few days.
• Afterward, the patch should help relieve pain continuously, so you can stop taking other pain relievers. However, your doctor may prescribe additional pain relievers occasionally.

How long will you need to use the patches?

• Doloxital patches are indicated for prolonged pain. Your doctor will tell you how long you can expect to use the patches.

If the pain worsens

• If your pain worsens suddenly after applying the last patch, check the patch. If it is no longer adhering well or has come off, replace the patch (see also the section "If the patch comes off").
• If your pain worsens while using the patches, your doctor may try patches with a higher dose or prescribe additional pain relievers (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.

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

In case of overdose or incorrect dose, remove the patches and contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount administered.

If you forget to change the patch

• If you forget to change the patch, change it as soon as you remember and note the day and time. Then, change the patch again after three days(72 hours), as usual.
• If you are significantly late, you should contact your doctor because you may need additional pain relievers, 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 note the day and time. Choose a new skin area:

• On the torso or arm
• On the upper back of your child

• Inform your doctor and leave the patch on for another 3 days (72 hours)or for the time your doctor indicates 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 tell you how to do it, usually by gradually reducing the dose so that the unpleasant withdrawal effects are minimal. See also section 2, "Withdrawal symptoms when stopping Doloxital".
• If you stop using the patches, do not start using them again without asking your doctor first. You may need a different dose when you restart 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 rare cases, these breathing difficulties can be life-threatening or even fatal, especially in people who have not used strong opioid pain relievers (such as Doloxital or morphine) before. (Uncommon, may affect up to 1 in 100 patients).

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

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

The following side effects have also been reported

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

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

Common (may affect up to 1 in 10 people)

• Allergic reaction
• Lack of appetite
• Difficulty sleeping
• Depression
• Feeling anxious or confused
• Seeing, feeling, hearing, or smelling things that are not there (hallucinations)
• Tremors or muscle spasms
• Abnormal sensation in the skin, such as tingling or prickling (paresthesia)
• Feeling that everything is spinning (vertigo)
• Fast or irregular heartbeat (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 heartbeat (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
• Difficulty swallowing

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

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

Unknown frequency (cannot be estimated from available data)

• Lack of male sex hormones (androgen deficiency)
• Delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not really there, sleep disturbances, nightmares)
• You may become dependent on Doloxital (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 effectiveness (you get used to it or become more sensitive to pain) or can cause dependence.

If you switch from another pain reliever to Doloxital or if you stop using Doloxital 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 newborn babies experiencing withdrawal symptoms after their mothers used Doloxital for a prolonged period during pregnancy.

Reporting side effects

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

5. Storage of Doloxital

Where to store the patches

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

Store in the original pouch to protect it from light. This medication does not require any special storage temperature.

Keep this medication in a safe and protected place, where others cannot access it. This medication can cause serious harm and even be fatal if used accidentally or intentionally by someone who has not been prescribed it.

How long can you store Doloxital

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

How to dispose of used or unused patches

Accidental exposure of another person to used and unused patches, especially children, can be fatal.

Used patches should be folded firmly in half, so that the adhesive side sticks to itself. Then, they should be disposed of safely by placing them in the original pouch and keeping them out of sight and reach of others, especially children, until they are disposed of safely. Unused patches should be returned to the pharmacy.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection 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. Package Contents and Additional Information

Doloxital Composition

• The active ingredient is fentanyl.

Each transdermal patch contains 2.55 mg of fentanyl in a 4.25 cm2 surface area and releases 12.5 micrograms of fentanyl per hour

The other components are:

Matrix components:

Aloe vera oil extract (based on soy tocopherol acetate), colophony resin, poly (2-ethylhexyl, acrylate, vinyl acetate) (50:50).

Removable coating:

Polyethylene terephthalate, polyester, siliconized.

Supporting film:

Polyethylene terephthalate laminate, printing ink.

Product Appearance and Package Contents

Transdermal patch.

Opaque, colorless, rectangular patch with rounded corners and printed on the supporting film "Fentanyl 12 µg/h" in individually sealed pouches.

Doloxital is available in packages of 5, 10, and 20 transdermal patches.

Only some package sizes may be marketed.

Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 - Torrejón de Ardoz

Madrid, Spain

Manufacturer:

Luye Pharma AG

Am Windfeld 35

83714 Miesbach

Germany

Or

Laboratorios Medicamentos Internacionales, S.A. (Medinsa)

C/Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: Fenylat 12 Mikrogramm/Stunde transdermales Pflaster

Spain: Doloxital 12 micrograms/hour transdermal patch EFG

United Kingdom (Northern Ireland): Fenylat 12 micrograms/hour transdermal patch

Thisleafletwas approved in April 2025

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