Matrifen - Fentanyl patch uses, dose and side effects

Fentanyl contained in Matrifen may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

What you need to know before using Matrifen

Do not use Matrifen

if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6)
if you suffer from pain that lasts only a short period of time, such as sudden pain or pain after a surgical procedure
if you have difficulty breathing with slow or shallow breathing.

Do not use this medicine if any of the above apply to you or your child. If you have any further questions, ask your doctor or pharmacist before using Matrifen.

Warnings and cautions

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Matrifen can cause life-threatening side effects in people who are not already regularly taking prescription opioid medicines. Matrifen is a drug that can be life-threatening for children. This also applies to used patches. Keep in mind that a self-adhesive patch (unused or used) can be attractive to a child and if the patch sticks to the child’s skin or if the child puts it in his mouth, it can be fatal.

Depot patches that have adhered to another person

The patch should only be used on the skin of the person prescribed by the doctor. There are reported cases where a patch was accidentally stuck to a family member during close physical contact or when a bed was shared with the wearer of the patch. A patch that has adhered to another person (especially a child) can cause drugs to pass through the other person’s skin and cause serious side effects such as slow and shallow breathing difficulties, which can be fatal. If the patch has adhered to another person’s skin, remove the patch immediately and consult a physician.

Take special care with Matrifen

Talk to your doctor or pharmacist before using this medicine if any of the following apply to you – your doctor may need to examine you more carefully about:

Have you ever had problems with your lungs or breathing?
Have you ever had problems with your heart, liver, kidneys or had low blood pressure
You’ve ever had a brain tumor
Have you ever had a prolonged headache or a head injury
You are older – you may be more sensitive to the effects of this medicine
You have a disease called myasthenia gravis , when the muscles become weak and tired quickly
Have you ever abused or been addicted to alcohol, prescription drugs or illegal drugs.

If any of the above apply to you (or you feel unsure), talk to your doctor or pharmacist before using Matrifen.

Side effects and Matrifen

Matrifen can make you unusually sleepy and cause you to breathe more slowly and shallowly. In very rare cases, these breathing problems can be life-threatening or even fatal, especially in people who have never used strong painkillers with opioids (such as Matrifen or morphine). If you or your partner or caregiver notice that the person wearing the patch is unusually sleepy and is breathing slowly or shallowly:- Remove the patch- Call a doctor or go to the nearest hospital immediately- Make sure the person is moving and talking as much as possible
If you get a fever while using Matrifen, tell your doctor – it may cause an increased amount of medicine to pass through your skin.
Matrifen can cause constipation. Consult a physician or pharmacist for help in preventing or treating constipation.
Repeated, long-term treatment with the patches may make the medicine less effective (you will become “tolerant” of it) or make you addicted to it.

See section 4 for a complete list of possible side effects.

When 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 sun lamps. You should not sunbathe, take long hot baths, sauna, or take hot whirlpool baths. If you do this, you may get an increased amount of medication from the patch.

Other medicines and Matrifen

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines. You should also tell pharmacy staff that you are using Matrifen if you buy any medicines at the pharmacy.

Your doctor will know which medicines are safe to take with Matrifen. If you are taking any of the types of medicines listed below or if you stop taking any of these, you may need to be closely monitored as it may affect the dose of Matrifen you need.

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

Other analgesics such as smärtillande drugs with opioid ‘s (such as buprenorphine, nalbuphine or pentazocine)
Medicines to help you sleep (such as temazepam, zaleplon or zolpidem)
Medicines that make you feel calmer (sedatives such as alprazolam, clonazepam, diazepam , hydroxyzine or lorazepam) and medicines for mental problems (antipsychotics such as aripiprazole, haloperidol , olanzapine, risperidone or phentiazines)
Muscle relaxants (such as cyclobenzaprine or diazepam )
Some medicines used to treat depression, called SSRIs or SNRIs (such as citalopram , duloxetine, escitalopram, fluoxetine , fluvoxamine, paroxetine , sertraline or venlafaxine ) – see below for more information
Some medicines for depression or Parkinson’s disease , called MAO inhibitors (such as isocarboxazide, phenelzine, selegiline or tranylcypromine). You should not take Matrifen within 14 days of stopping these medicines – see below for more information
Some antihistamines , especially those that make you sleepy (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine or hydroxyzine)
Some antibiotics used for infection (such as erythromycin or clarithromycin)
Medicines for fungal infections (such as itraconazole, ketoconazole , fluconazole or voriconazole)
Drugs for HIV – infection ‘s (such as ritonavir)
Drugs for irregular heartbeat (such as amiodarone , diltiazem or verapamil)
Medicines for tuberculosis (such as rifampicin)
Some medicines for epilepsy (such as carbamazepine, phenobarbital or phenytoin )
Some medicines for nausea or motion sickness (such as phenothiazines)
Some medicines for heartburn or stomach ulcers (such as cimetidine)
Some medicines for angina (chest pain) or high blood pressure (such as nicardipine)
Some medicines used to treat blood cancer (such as idelalisib).

Matrifen with sedatives
Concomitant use of Matrifen and sedatives or medicines for sleep disorders such as benzodiazepines or similar medicines increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and can be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible. If your doctor prescribes Matrifen at the same time as sedatives, your dose and treatment time should be limited by your doctor.

Tell your doctor if you are taking any sedatives and follow your doctor’s close

dose recommendations. It may be helpful to inform friends or relatives about paying attention to the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.

Matrifen with antidepressants

The risk of side effects is increased if you take medications such as certain antidepressants. Matrifen can interact with these drugs and you may experience that your mental status changes so that you, for example, feel anxious or see, feel, hear or smell the smell of something that does not exist (hallucinations) and experience other effects such as altered blood pressure, rapid heartbeat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhea.

Operations

If you think you are going to be anesthetized/anesthetized, tell your doctor or dentist that you are using Matrifen.

Matrifen and alcohol

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

Matrifen can make you sleepy and you can breathe more slowly. If you drink alcohol, these effects will be aggravated.

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 taking this medicine.

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

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

Do not use Matrifen if you are breastfeeding. You should not breastfeed for 3 days after removing the Matrifen transdermal patch. The reason for this is that the drug can pass into breast milk.

Driving and using machines

Matrifen can affect your ability to drive and use machines or tools as it may make you drowsy or dizzy. If this happens, do not drive or use any tools or machines. Do not drive while using this medicine until you know how it affects you.

If you are not sure if it is safe for you to drive while you are taking this medicine, talk to your doctor or pharmacist.

How to use Matrifen

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will decide which strength of Matrifen is most suitable for you. The doctor bases his assessment on how severe your pain is, your general condition, and the type of pain treatment you have received so far.

Use and change patches

• There is enough medicine in each patch to last for 3 days (72 hours).

You should change your patch every three days unless your doctor tells you otherwise.

• Always remove the old patch before applying the new one.

• Always change patches at the same time of day every three days (72 hours).

• If you use more than one patch, change all patches at once.

Write down the day, date, and time you put on the patch, so you know when you need to change your patch.

• The following table shows you when it is time to change the patch:

Put on your patch at	Change your patch on
Monday	→ Thursday
Tuesday	→ Friday
Wednesday	→ Saturday
Thursday	→ Sunday
Friday	→ Monday
Saturday	→ Tuesday
Sunday	→ Wednesday

Here you put on the patch

Adults

Apply the patch on a flat part of your upper body or arm (not over a joint).

Children

Always put the patch on the upper back so that the child does not have access to or remove the patch.
Check from time to time if the patch remains on the skin.
It is important that your child does not remove the patch and put it in his mouth as it can be life threatening and even fatal.
Observe your child very closely for 48 hours after:- The first patch has been applied- A patch with a higher dose has been applied.
It may take some time for the patch to take full effect. Therefore, your child may also need to take other painkillers before the patches take effect. Your doctor will talk to you about this.

Adults and children:

Do not attach the patch

The same place twice in a row
Skin surfaces that move a lot (joints), skin that is irritated or has sores
Skin with a lot of hair. If there is hair, do not shave it off (shaving irritates the skin). Instead, cut the hair as close to the skin as possible.

Put on a patch

Step 1: Prepare the skin

Make sure the skin is completely dry, clean and cool before applying the patch.
If you need to clean your skin, use only cold water
Do not use soap or other detergents, creams , moisturizing lotions, oils or talcum powder before applying the patch.
Do not apply a patch immediately after a hot bath or shower.

Step 2: Open the bag

Each patch is enclosed in a sealed bag.
Tear or cut the bag into the notch that the arrow points to.
Carefully tear or cut off the edge of the bag completely (if you use scissors, cut close to the sealed edge of the bag so that the patch is not damaged).

Hold both sides of the opened bag and pull them apart.
Take out the patch and apply it immediately.
Save the empty bag so that you can put your used patch in the latter when the patch is to be thrown away.
Each patch should only be used once.
Do not remove the patch from the bag until you are ready to use it.
Check that the patch is not damaged.
Do not use the patch if it has been split, cut or looks damaged.
Never divide or cut the patch.

Step 3: Pull off and press firmly

Make sure that the patch will be covered by loose clothing and that it will not sit under a tight or elastic band.
Carefully pull one half of the glossy protective film away from the center of the patch. Avoid touching the adhesive side of the patch.
Press the adhesive side of the patch onto the skin.
Remove the second protective film and press the entire patch onto the skin using the palm of your hand.
Press for at least 30 seconds. Make sure it fits well, especially at the edges.

Step 4: Discard the patch

As soon as you remove the patch, fold it carefully in the middle so that the adhesive side sticks together.
Put it back in its original bag and discard the bag according to the instructions of the pharmacy staff.
Keep used patches out of the reach and sight of children – even used patches contain some medicines that can harm children and can even be fatal.

Step 5: Wash

Always wash your hands with clean water only after handling the patch.

More about using Matrifen

Everyday activities when the patch is used

The patches are water resistant.
You can shower or bathe while wearing the patch, but do not rub on the patch itself.
If your doctor agrees, you can train and participate in sports activities while wearing the patch.
You can also swim while wearing the patch, but:- Do not bathe in hot whirlpool baths.- Do not put tight or elastic bands over the patch.
When 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 sun lamps. You should not sunbathe, take long hot baths or take a sauna. If you do this, you may get an increased amount of medication from the patch.

How quickly do the patches take effect?

It may take some time for your first patch to take full effect.
Your doctor may also give you other painkillers for the first day.
After that, the patch should relieve the pain continuously so that you can stop taking other painkillers, but it is possible that your doctor will prescribe other painkillers from time to time.

How long will you use the patches?

Matrifen patches are intended for long-term pain. Your doctor can tell you how long you can expect to use the patches.

If your pain worsens

If your pain worsens while you are using the patches, your doctor may try to give you patches with higher strength or additional painkillers (or both).

If it does not help to increase the strength of the patches, your doctor may stop using the patches.

If you use too many patches or patches with the wrong strength

If you or your child have applied too many patches or patches with the wrong strength, remove the patches and contact a doctor immediately. If a child accidentally puts on a patch

Signs of overdose are, for example, difficulty breathing or shallow breathing, fatigue, extreme drowsiness, inability to think clearly, walk or speak normally, lethargy, dizziness, and confusion.

If you forget to change your patch

If you forget to change your patch, do it as soon as you can and write down the day and time. Change the patch again after 3 days (72 hours) as usual.

If you are very late in changing your patch, talk to your doctor, as you may need more painkillers, but do not put on an extra patch.

If a patch comes off

If a patch comes off before it is time to change it, apply a new one immediately and write down the day and time. Apply a new skin surface on:

Your upper body or arm
The upper part of your baby’s back.

Let your doctor know that this has happened and leave the patch on for another 3 days (72 hours), or the time specified by your doctor, before switching to a new patch as usual.

If your patches come off constantly, talk to a doctor, pharmacist, or nurse.

If you want to stop using the patches

Talk to your doctor before stopping using these patches.

If you have been using them for a long time, your body may have become accustomed to them. If you suddenly stop, you may start to feel unwell.

If you stop using the patches, do not start again without first asking your doctor. You may need a different strength of the patches when you start again.

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

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you or your partner or caregiver notices any of the following in the person using the patch, remove the patch and call a doctor or go to the nearest hospital immediately. The person may need immediate medical attention.

Unusual drowsiness, slower or shallower breathing than expected.Follow the advice above and make sure the person who used the patch moves and talks as much as possible. In very rare cases, these breathing difficulties can be life-threatening or even fatal, especially in people who have never before used strong painkillers with opioids (such as Matrifen or morphine) (less common, may occur in up to 1 in 100 users ).
Sudden swelling of the face or neck, severe irritation, redness or blistering of your skin. This may be a sign of an allergic reaction (has been reported, occurs in an unknown number of users).
Seizures (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 user in 10 )

• Nausea, vomiting, constipation

• Sleepiness ( somnolence )

• Dizziness

• Headache.

Common (may affect up to 1 in 10 people )

• Allergic reaction

• Loss of appetite

• Difficulty sleeping

• Depression

• Feeling of anxiety and confusion

• To see, feel, hear or smell something that does not exist (hallucinations)

• Shaking or muscle twitching

• Abnormal sensation in the skin, such as tingling or tingling sensation ( paresthesias )

• Dizziness (fraud)

• Rapid or irregular heartbeat ( palpitation, tachycardia )

• High blood pressure

• Shortness of breath ( dyspnoea )

• Diarrhea

• Dry mouth

• Abdominal pain or indigestion

• Significantly increased sweating

• pruritus, rash, or erythema

Inability to urinate or empty bladder properly

• Severe fatigue, weakness, or general malaise

• To feel frozen

• Swollen hands, ankles, or feet (peripheral edema ).

Uncommon (may affect up to 1 in 100 people )

• Anxiety or confusion

• Strong feeling of happiness ( euphoria )

• Decreased sensation or sensitivity, especially in the skin ( hypoesthesia )

• Memory loss

• Blurred vision

• Slow heartbeat ( bradycardia ) or low blood pressure

• Blue skin caused by low oxygen content in the blood (cyanosis)

Intestinal cramps ( ileus )

Itchy rash ( eczema ), allergic reaction, or other skin conditions where the patch is located

• Flu-like illness

The feeling of change in body temperature

• Fever

• Muscle twitching

• Difficulty getting and maintaining an erection ( impotence ) or problems having sex.

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

• Contracted pupils are ( mios )

• Temporary respiratory arrest ( apnea ).

Has been reported (occurs in an unknown number of users)

• Lack of male sex hormone (androgen deficiency)

• Delirium (symptoms may include a combination of anxiety, restlessness, disorientation, confusion, fear, seeing and hearing things that are not, sleep disturbance, nightmares).

You may notice a rash, redness, or slight itching in the skin where the patch is located. This is usually mild and disappears once you have removed the patch. If it does not disappear or if the patch irritates the skin very much, tell your doctor.

Repeated, long-term treatment with the patches may make the medicine less effective (you will become “tolerant” of it) or make you addicted to it.

If you switch from another painkiller to Matrifen or if you suddenly stop using Matrifen, you may experience withdrawal symptoms such as nausea, diarrhea, anxiety, or shaking. Tell your doctor if you get any of these symptoms.

There are also reports of newborns experiencing withdrawal symptoms after their mothers have used Matrifen for a long time during pregnancy.

How to store the Matrifen

Storage space

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

Storage time

Use Matrifen before the expiry date which is stated on the carton and bag. The expiration date is the last day of the specified month (after EXP). If the patches have passed their expiry date, take them to your pharmacist.

The medicine does not require any special storage instructions.

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

If a used or unused patch is accidentally stuck on another person, especially a child, it can be fatal.

Used patches should be folded so that the adhesive side of the patch is glued together. It must then be put back in the original bag and stored out of sight and reach of other persons, especially children until it is disposed of safely. Ask your pharmacist how to dispose of medicines no longer required.

Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is fentanyl.

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

Patch name:	Each patch contains:	Each patch provides a dose of:	The active surface of each patch is:
Matrifen 12 micrograms / hour transdermal patch	1.38 mg	12 micrograms/hour	4.2 cm ²
Matrifen 25 micrograms / hour transdermal patch	2.75 mg	25 micrograms/hour	8.4 cm ²
Matrifen 50 micrograms / hour transdermal patch	5.5 mg	50 micrograms/hour	16.8 cm ²
Matrifen 75 micrograms / hour transdermal patch	8.25 mg	75 micrograms/hour	25.2 cm ²
Matrifen 100 micrograms / hour transdermal patch	11 mg	100 micrograms/hour	33.6 cm ²

The other ingredients are propylene glycol, hydroxypropyl cellulose, dimethicone, silicone adhesive (amine resistant), ethylene-vinyl acetate (EVA, release-regulating membrane ), polyethylene terephthalate (PET, outer plastic film), fluoropolymerized polyester (protective film), and printing ink.

What the medicine looks like and contents of the pack

Matrifen is a transparent and rectangular patch, each patch is packaged in a heat-sealed bag consisting of paper, aluminum, and acrylonitrile-methyl acrylate-butadiene (AMAB).

The transdermal patches are marked with the name and strength printed in the following colors:

Matrifen 12 micrograms/hour transdermal patch: brown marking

Matrifen 25 micrograms/hour transdermal patch: red marking

Matrifen 50 micrograms / hour transdermal patch: green label

Matrifen 75 micrograms/hour transdermal patch: light blue marking

Matrifen 100 micrograms / hour transdermal patch: gray label

The patches are provided in boxes of 1, 2, 3, 4, 5, 8, 10, 16, and 20 patches. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

LTS Lohmann Therapie-Systeme AG

Lohmannstrasse 2

D-56626 Andernach

Germany

Takeda GmbH

Robert-Bosch-Strasse 8

D-78224 Singen