Matrifen 50 micrograms/hour transdermal patch: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Matrifen 12 micrograms/hour transdermal patch

Matrifen 25 micrograms/hour transdermal patch

Matrifen 50 micrograms/hour transdermal patch

Matrifen 75 micrograms/hour transdermal patch

Matrifen 100 micrograms/hour transdermal patch

fentanyl

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

Keep this leaflet as you may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed only for you (or your child), and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

What Matrifen is and what it is used for
What you need to know before using Matrifen
How to use Matrifen
1. Possible side effects
2. How to store Matrifen
3. Contents of the pack and other information

1. What Matrifen is and what it is used for

This medicine is called Matrifen.

The patches help relieve severe and long-lasting pain:

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

Matrifen contains a medicine called fentanyl. It belongs to a group of strong pain-relieving medicines known as opioids.

2. What you need to know before using Matrifen

Do not use Matrifen:

If you are allergic to fentanyl or to 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 surgery.
If you have difficulty breathing, 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 unsure, consult your doctor or pharmacist before using Matrifen.

Warnings and precautions

Matrifen may cause life-threatening adverse effects in people who are not regularly using prescribed opioids.
Matrifen is a medicine that could be life-threatening to children, even if the patches have already been used. Be aware that a transdermal patch (used or unused) may be attractive to a child, and if it adheres to a child's skin or if the child puts it in their mouth, the result could be fatal.
Store this medicine in a safe and secure place, out of reach of others; see section 5 for more information.

If the patch adheres to another person

The patch must only be used on the skin of the person for whom the doctor has prescribed it. There have been cases where the patch has accidentally adhered to another family member through close physical contact or sharing the same bed with the person wearing the patch. If the patch accidentally adheres to another person (especially a child), the medicine from the patch may pass through the other person's skin and cause serious adverse effects, such as difficulty breathing, with slow or weak breathing, which could be fatal. If the patch adheres to another person’s skin, remove it immediately and seek medical attention.

Take special care with Matrifen

Consult your doctor or pharmacist before using 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 disorder called "myasthenia gravis," in which muscles become weak and tire easily.

If you have any of the above conditions (or are unsure), consult your doctor or pharmacist before using Matrifen.

While using the patch, inform your doctor if you have breathing problems during sleep.

Opioids such as Matrifen can cause sleep-related breathing disorders, such as sleep apnea (interruptions in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Inform your doctor if you, your partner, or caregiver notice any of the following symptoms:

Pauses in breathing during sleep.
Waking up at night due to difficulty breathing.
Difficulty staying asleep.
Excessive daytime sleepiness.

Your doctor may decide to adjust your dose.

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

Pain is no longer relieved by the patch.
An increase in pain.
A change in how you feel pain (e.g., pain in another part of your body).
Pain when something touches your body that would not normally cause pain.

Do not change the dose yourself. Your doctor may decide to adjust your dose or treatment.

Adverse effects and Matrifen

Matrifen may cause unusual drowsiness and may slow or weaken your breathing. In very rare cases, these breathing problems may be life-threatening or even fatal, especially in people who have not previously used strong opioid painkillers (such as Matrifen or morphine). If you, your partner, or caregiver notice that the person wearing the patch is unusually drowsy, with slow or weak breathing:
Remove the patch.
Call a doctor or go immediately to the nearest hospital.
Encourage the person to move and speak as much as possible.
If you develop a fever while using Matrifen, speak with your doctor. This may increase the amount of medicine passing through your skin.
Matrifen may cause constipation; speak with your doctor or pharmacist for advice on how to prevent or relieve constipation.

The complete list of possible adverse effects can be found in section 4.

While wearing the patch, do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, heated water beds, or heat or tanning lamps. Avoid prolonged sun exposure, hot baths, saunas, or hot tubs. Doing so 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 may make the drug less effective (the body becomes accustomed to it, known as pharmacological tolerance). You may also become more sensitive to pain while using Matrifen. This is known as hyperalgesia. Increasing the patch dose may continue to reduce pain for a time, but it may also be harmful. If you notice that the

medicine is losing effectiveness, consult your doctor. Your doctor will decide whether it is better to increase the dose or gradually reduce the use of Matrifen.

Dependence and addiction

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

Repeated use of Matrifen may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use. Dependence or addiction may cause a feeling of lack of control over the amount of medicine you need to take or how often you need to take it. You may feel the need to continue using the medicine even if it does not help relieve pain.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to Matrifen may be higher if:

• You or someone in your family has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").

• You are a smoker.

• You have ever had mood problems (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for another mental illness.

If you notice any of the following symptoms while using Matrifen, they could be signs 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 prescribed, e.g., "to stay calm" or "to help you sleep."

• You have made repeated unsuccessful attempts to stop using the medicine or control its use.

You feel unwell when you stop using the medicine, and feel better once you start again (“withdrawal effects”).

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

Withdrawal symptoms when stopping Matrifen

Do not stop using this medicine suddenly. Withdrawal symptoms may occur, such as restlessness, difficulty sleeping, irritability, agitation, anxiety, awareness of your heartbeat (palpitations), increased high blood pressure, nausea, vomiting, diarrhea, loss of appetite, tremors, chills, shaking, or sweating. If you wish to stop using this medicine, speak to your doctor first. Your doctor will advise you on how to do so, usually by gradually reducing the dose to minimize unpleasant withdrawal symptoms.

Using Matrifen with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This includes medicines obtained without a prescription and herbal remedies. You should also inform your pharmacist that you are using Matrifen if you purchase any medicine from the pharmacy.

Your doctor will know which medicines can be used safely with Matrifen. You may need to be monitored closely if you are using any of the types of medicines listed below or if you stop using any of them, as this may affect the dose of Matrifen you need.

In particular, inform your doctor or pharmacist if you are using:

Other pain medicines, such as other opioid analgesics (e.g., buprenorphine, nalbuphine, or pentazocine) and some analgesics for neuropathic 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 disorders (antipsychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
Medicines to relax muscles (such as cyclobenzaprine or diazepam).
Some antidepressants called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). – more information below
Some medicines used to treat depression or Parkinson’s disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). You must not use Matrifen within 14 days of stopping these medicines. – more information below
Some antihistamines, especially those that cause drowsiness (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine).
Some 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).
Some medicines used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin).
Some medicines used to treat nausea or dizziness (such as phenothiazines).
Some medicines used to treat stomach acid or ulcers (such as cimetidine).
Some medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
Some medicines used to treat blood cancer (such as idelalisib).

Using Matrifen with antidepressants

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

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

Concomitant use of Matrifen and sedative medicines, such as benzodiazepines or related drugs, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment alternatives are available.

However, if your doctor has prescribed Matrifen and sedative medicines simultaneously, the dose and duration of treatment should be limited by your doctor.

Inform your doctor of all sedative medicines you are using, and follow the dose recommended by your doctor.

It may be helpful to inform your family and friends about the signs and symptoms mentioned above. Speak with your doctor if you experience any of these symptoms.

Use in athletes

Athletes are advised that this medicine contains a component that may result in a positive doping test.

Surgery

If you are scheduled to receive anesthesia, inform your doctor or dentist that you are using Matrifen.

Using Matrifen with alcohol

Do not drink alcohol while using Matrifen, unless you have discussed it with your doctor.

Matrifen may cause drowsiness or slow breathing. Drinking alcohol may worsen these effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Matrifen should not be used during childbirth, as the medicine may affect the newborn's breathing.

Prolonged use of Matrifen during pregnancy may cause withdrawal symptoms (such as high-pitched crying, restlessness, seizures, poor feeding, and diarrhea) in your newborn baby, which may be life-threatening if not recognized and treated. Contact a doctor immediately if you think your baby may have withdrawal symptoms.

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

Driving and using machines

Matrifen may affect your ability to drive and operate machinery or tools, as it may cause drowsiness or dizziness. If so, do not drive or operate tools or machinery. Do not drive while using this medicine until you know how it affects you.

Speak with your doctor or pharmacist if you have any doubts about whether it is safe for you to drive while using this medicine.

3. How to use Matrifen

Follow exactly the instructions for using this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide which concentration of Matrifen 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 to you what you can expect from using Matrifen, 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 symptoms when you stop using Matrifen).

How to apply and change the patches

Each patch contains a sufficient amount of medicine 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 before applying a new one.
Change the patch always at the same time of day every 3 days (72 hours).
If you are using more than one patch, change all of them at the same time.
Record the day of the week, date, and time each time you apply a patch, so you remember when to change it.
The table below shows when you should change the patch:

Apply the patch on		Change the patch on
Monday		Thursday
Tuesday		Friday
Wednesday		Saturday
Thursday		Sunday
Friday		Monday
Saturday		Tuesday
Sunday		Wednesday

Where to apply the patch

Adults

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

Children

Always apply the patch to the upper back to make it difficult for your child to reach or remove it.
Check regularly to ensure the patch remains adhered to the skin.
It is important that your 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 full effect. Therefore, your child may need additional painkillers until the patch becomes effective. Your doctor will advise you on this.

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 excessive hair. If hair is present, do not shave it (shaving may irritate the skin). Instead, cut the hair as close to the skin as possible.

How to apply the patch

Step 1: Prepare the skin

Before applying the patch, ensure the skin is completely dry, clean, and cool.
If you need to wash the skin, use only cold water.
Do not use soap or other cleansers, 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.
Open the pouch by cutting along the dotted line with scissors.
Carefully cut all the way along the edge of the pouch to avoid damaging the patch inside.
Hold both parts of the opened pouch and pull them apart.
Remove the patch and use it immediately.
Keep 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 split, cut, or otherwise damaged.
Never divide or cut the patch.

Step 3: Peel and press

Ensure the patch will be covered by loose clothing and do not apply it under tight or elastic fabric.
Carefully peel off half of the shiny plastic protective layer, starting from the center of the patch. Avoid touching the adhesive surface of the patch.
Press this adhesive part of the patch onto the skin.
Remove the remaining part of the protective layer and press the entire patch onto the skin with the palm of your hand.
Press firmly for at least 30 seconds. Make sure the patch adheres well, especially around the edges.

Step 4: Disposing of the patch

Immediately after removing the patch, fold it in half so that the adhesive side sticks to itself.
Place it back into the original pouch and dispose of it according to your pharmacist’s instructions.
Keep used patches out of sight and reach of children; even when used, patches contain medicine that could harm children and may even be fatal.

Step 5: Washing hands

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

More information on using Matrifen

Daily activities while using the patches

The patches are water-resistant.
You may shower or bathe with the patch in place, but do not rub it.
If your doctor agrees, you may exercise or engage in sports while wearing the patch.
You may also swim while wearing the patch, but:
- Do not use hot whirlpool baths.
- Do not cover the patch with elastic or tight fabrics.
While wearing the patch, avoid direct heat sources such as heating pads, electric blankets, hot water bottles, heated water beds, heat or tanning lamps. Do not sunbathe, take prolonged hot baths, or use saunas. Exposure to heat may increase the amount of medicine released from the patch.

How long do the patches take to work?

The first patch may take some time to reach its full effect.
Your doctor may provide additional painkillers during the first few days.
Afterwards, the patch should help provide continuous pain relief, allowing you to stop taking other painkillers. However, your doctor may occasionally prescribe additional painkillers.

How long will you need to use the patches?

Matrifen patches are indicated for long-term pain. Your doctor will advise you on how long you can expect to use the patches.

If pain worsens

If your pain suddenly worsens after applying the latest patch, check the patch. If it is no longer adhering properly or has detached, replace the patch (see also 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 immediately and contact your doctor, go to a hospital, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and amount applied.

Symptoms of overdose include difficulty breathing or weak breathing, fatigue, extreme drowsiness, inability to think clearly or to walk or speak normally, dizziness, confusion, or disorientation. An overdose may also cause a brain disorder known as toxic leukoencephalopathy.

If you forget to change the patch

If you forget to change the patch, do so as soon as you remember, and note the date and time. Resume changing the patch every 3 days (72 hours) as usual.
If there is a significant delay, you should speak to your doctor, as you may need additional painkillers, but do not apply extra patches.

If the patch comes off

If the patch falls off before it is time to change it, apply a new one immediately and note the date and time. Choose a new skin site:
- On the trunk or arm
- On the upper back of your child
Inform your doctor about this and leave the new patch in place for another 3 days (72 hours) or for the time your doctor specifies, before changing the patch as usual.
If patches tend to come off frequently, consult your doctor, pharmacist, or nurse.

If you want to stop using the patches

Do not stop using this medicine suddenly. If you wish to discontinue the medicine, speak to your doctor first. Your doctor will advise you on how to do this, usually by gradually reducing the dose to minimize unpleasant withdrawal symptoms. See also section 2 “Withdrawal symptoms when stopping Matrifen”.
If you stop using the patches, do not restart them without first consulting your doctor. You may require a different dose when resuming treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you, or your partner or caregiver, notice any of the following signs in the person wearing the patch, remove the patch immediately and contact a doctor or go straight to the nearest hospital. Urgent medical treatment may be required.

Unusual drowsiness, slower or weaker breathing than expected.

Follow the above recommendations and encourage the person wearing the patch to move and speak as much as possible. In very rare cases, these breathing difficulties may be life-threatening or even fatal, especially in people who have not previously used strong opioid analgesics (such as Matrifen or morphine). (Uncommon, may affect up to 1 in 100 patients).

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

All of these may 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).
Reduced level of consciousness or loss of consciousness. (Uncommon, may affect up to 1 in 100 people).

The following adverse effects have also been reported

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

Nausea, vomiting, constipation
Feeling sleepy (somnolence)
Dizziness
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
Strange skin sensations such as tingling or prickling (paresthesia)
Sensation of spinning (vertigo)
Rapid or irregular heartbeat (palpitations, tachycardia)
High blood pressure
Shortness of breath (dyspnea)
Diarrhea
Dry mouth
Stomach pain or indigestion
Excessive sweating
Itching, rash, or redness of the skin
Inability to urinate or empty the bladder completely
Severe 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 restless 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 discoloration of the skin due to reduced oxygen in the blood (cyanosis)
Loss of intestinal contractions (ileus)
Itchy skin rash (eczema), allergic reaction, or other skin disorders at the application site
Flu-like illness
Sensation of body temperature changes
Fever
Muscle cramps
Difficulty achieving or maintaining an erection (impotence) or problems with sexual performance
Difficulty swallowing

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

Constriction of the pupils (miosis)
Occasional interruption of breathing (apnea)

Frequency not known (cannot be estimated from available data):

Deficiency 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 real, sleep disturbances, nightmares).
You may become dependent on Matrifen (see section 2).

You may experience skin rashes, redness, or mild itching at the site where the patch is applied. These are usually mild and disappear after removing the patch. If they do not, or if the patch causes significant skin irritation, inform your doctor.

Repeated use of the patches may cause the medicine to lose effectiveness (you may become accustomed to it or may become more sensitive to pain), or you may become dependent.

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

Cases have also been reported of newborn infants experiencing withdrawal symptoms after their mothers used Matrifen for a prolonged period during pregnancy.

Reporting of adverse effects

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

5. Storage of Matrifen

Where to store the patches

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

Store this medicine in a safe and secure place, where others cannot access it. It may cause serious harm or even death to individuals who accidentally or intentionally use this medicine when it has not been prescribed for them.

How long can you store Matrifen

Do not use this medicine after the expiry date stated on the carton and on the pouch. The expiry date refers to the last day of the month indicated (after EXP). If the patches have expired, return them to a pharmacy.

This medicine does not require any special storage conditions.

How to dispose of used patches or patches you no longer need

Accidental exposure of other individuals, especially children, to used or unused patches may result in a fatal outcome.

Used patches should be folded firmly in half so that the adhesive side sticks to itself. They should then be safely discarded by placing them back into the original pouch and keeping them out of sight and reach of others, particularly children, until they can be safely disposed of.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Additional information

Composition of Matrifen

The active substance is: Fentanyl.

The patches are available in 5 different doses (see table below).

Name of the patch	Each patch contains:	Each patch releases a dose of:	The active surface area of each patch is:
Matrifen 12 micrograms/hour transdermal patch	1.38 mg	12 micrograms/hour	4.2 cm²
Matrifen 25 micrograms/hour transdermal patch	2.75 mg	25 micrograms/hour	8.4 cm²
Matrifen 50 micrograms/hour transdermal patch	5.5 mg	50 micrograms/hour	16.8 cm²
Matrifen 75 micrograms/hour transdermal patch	8.25 mg	75 micrograms/hour	25.2 cm²
Matrifen 100 micrograms/hour transdermal patch	11 mg	100 micrograms/hour	33.6 cm²

The other components are:

Dipropylene glycol, hydroxypropylcellulose, dimethicone, silicone adhesive (amine-resistant), ethylene vinyl acetate (EVA, release membrane), polyethylene terephthalate (PET, outer plastic film), fluoropolymer-coated polyester (protective liner) and printing ink.

Appearance of the product and contents of the pack

Matrifen is a transparent, rectangular transdermal patch. Each patch is packed in a heat-sealed, child-resistant pouch made of paper, aluminium and polyethylene terephthalate (PET).

Each transdermal patch is printed in a specific colour with the brand name, active substance and dose:

Matrifen 12 micrograms/hour: brown print
Matrifen 25 micrograms/hour: red print
Matrifen 50 micrograms/hour: green print
Matrifen 75 micrograms/hour: light blue print
Matrifen 100 micrograms/hour: grey print

The patches are supplied in cardboard packs containing 1, 3, 5, 10 and 20 patches. Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

ISTITUTO GENTILI S.r.l.
Via San Giuseppe Cottolengo 15
20143 Milan, Italy

Manufacturer:

LTS Lohmann Therapie-Systeme AG
Lohmannstrasse 2D – 56626 Andernach
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Local representative:

Pharma International SA
Calle General Oraa 70
28006 Madrid (Spain)

Date of latest revision of the leaflet: 11-04-2025

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