Matrifen 100 micrograms/hour transdermal system

Package leaflet: Information for the patient

Matrifen, 12 micrograms/hour, transdermal system, patch
Matrifen, 25 micrograms/hour, transdermal system, patch
Matrifen, 50 micrograms/hour, transdermal system, patch
Matrifen, 75 micrograms/hour, transdermal system, patch
Matrifen, 100 micrograms/hour, transdermal system, patch
fentanyl
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Matrifen is and what it is used for
2. Important information before using Matrifen
3. How to use Matrifen
4. Possible side effects
5. How to store Matrifen
6. Contents of the pack and other information

1. What Matrifen is and what it is used for

The name of this medicine is Matrifen.
Matrifen is indicated for the treatment of chronic moderate to severe pain:

• in adults requiring continuous opioid therapy
• in children over 2 years of age who have already been treated with opioid analgesics and require continuous opioid therapy.

Matrifen contains, as the active substance, fentanyl, which is a strong pain-relieving medicine belonging to the group of opioids.

2. Important information before using Matrifen

When not to use Matrifen

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• in case of acute, sudden or postoperative pain,
• if the patient has severe respiratory depression (marked slowing and shallowing of breathing).

Do not use this medicine if any of the above situations apply to the patient. In case of
doubt, consult a doctor or pharmacist before using Matrifen.
Warnings and precautions

• Matrifen may cause life-threatening adverse effects in people who do not regularly use opioid-containing medicines.
• Matrifen is a medicine that may be life-threatening to children. This also applies to used patches. Consider that the appearance of the patch (used or unused) may encourage a child to touch it, stick it to the body, put it in the mouth, etc., which may lead to death.
• The medicine should be stored in a safe and secure place inaccessible to others – for more information see section 5.

In case of accidental adhesion of the Matrifen patch to another person's skin
Patches should only be applied to the skin of the person for whom they have been prescribed.
There have been several reports of accidental adhesion of the patch to another person's skin during
close physical contact or while sleeping in the same bed with a person using patches.
Accidental adhesion of the patch to another person's skin (especially a child) may
lead to drug absorption through the skin and cause severe adverse effects such as
respiratory disorders with slow and shallow breathing, which may be life-threatening.
If such a situation occurs, remove the patch immediately and contact a doctor.
Special caution is required when using Matrifen
Before using this medicine, consult a doctor or pharmacist if any of the following situations apply:

• the patient has ever had lung disease or breathing difficulties,
• the patient has ever had heart, liver, or kidney function disorders or low blood pressure,
• the patient has ever had a brain tumor,
• the patient has ever had headaches or head injury,
• the patient is elderly – they may be more sensitive to the effects of this medicine,
• the patient has myasthenia gravis, a condition characterized by muscle weakness and fatigue.

If any of the above situations apply to the patient (or the patient is unsure), consult a
doctor or pharmacist before using Matrifen.
While using the patches, inform the doctor if the patient experiences breathing problems
during sleep.
Opioids, such as Matrifen, may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and nocturnal hypoxemia (low oxygen levels in the blood). Inform the doctor if the patient, their partner, or caregiver notices any of the following symptoms:

• pauses in breathing during sleep
• nocturnal awakenings due to breathlessness
• difficulty maintaining sleep
• excessive daytime sleepiness. The doctor may decide to change the dose of the medicine.

While using the patches, inform the doctor if the patient notices any change in
pain perception. If the patient feels that:

• pain no longer subsides after applying the patch
• pain worsens
• there is a change in the way pain is perceived (e.g., the patient feels pain in another part of the body)
• pain occurs on touch where it should not. Do not change the dose independently. The doctor may decide to adjust the dose or treatment.

Adverse effects of Matrifen

• Matrifen may cause unusual fatigue and slowed, shallow breathing. Very rarely, these respiratory disorders may be life-threatening or lead to death, particularly in people who have not previously used opioid pain medicines (such as Matrifen or morphine). If the patient, partner, or caregiver notices that the person using the patches is excessively drowsy and has slow or shallow breathing, they should:
• remove the patch
• contact a doctor or go immediately to the nearest hospital
• encourage the patient to move and speak as much as possible.
• If fever occurs during treatment with Matrifen, consult a doctor – increased body temperature may significantly increase drug absorption through the skin.
• Matrifen may cause constipation; consult a doctor or pharmacist on how to prevent or relieve constipation.

For a complete list of adverse effects, see section 4.
Do not heat the area where the patch is applied with external heat sources such as: heated pads, electrically heated blankets, hot water bottles (thermophores), heated beds, heating or tanning lamps. Do not sunbathe or use prolonged warming baths, saunas, or warming hydrotherapy baths. In these situations, there is a risk of increased drug release from the patch.
Long-term use and tolerance
This medicine contains fentanyl, which is an opioid. Repeated use of opioid pain medicines may lead to reduced effectiveness of the medicine (the patient becomes accustomed to it, known as tolerance). During treatment with Matrifen, the patient's sensitivity to pain may also increase. This phenomenon is known as hyperalgesia. Increasing the dose of patches may temporarily further reduce pain intensity, but it may also be harmful. If the patient notices reduced effectiveness of the medicine, they should consult a doctor.
The doctor will decide whether increasing the dose or gradually reducing the use of Matrifen is a better solution for the patient.
Dependence and addictive use
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 addictive use, which may result in life-threatening overdose. The risk of these adverse effects may increase with increasing dose and prolonged duration of use. Dependence or addictive use may cause the patient to lose control over how much medicine to use or how often to use it. The patient may feel the need to continue using the medicine, even if it does not help relieve their pain.
The risk of dependence or addictive use varies among individuals. The risk of dependence on or addictive use of Matrifen may be higher if:

• the patient or anyone in their family has ever abused or been dependent on alcohol, prescription medicines, or illegal substances ("addiction");
• the patient smokes tobacco;
• the patient has ever had mood disorders (depression, anxiety disorders, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If any of the following symptoms occur during treatment with Matrifen, they may
indicate dependence or addictive use.

• The patient must use this medicine for longer than recommended by the doctor.
• The patient must use a higher dose than recommended.
• The patient uses this medicine for reasons other than those for which the doctor prescribed it, e.g., "to calm down" or "to be able to sleep".
• The patient has made several unsuccessful attempts to stop or control the use of this medicine.
• After stopping the use of this medicine, the patient feels unwell and experiences improved well-being when using the medicine again ("withdrawal effect").

If the patient notices any of these symptoms, they should discuss with the doctor the best treatment strategy for them, including when it is appropriate to discontinue treatment and how to safely stop treatment.
Withdrawal symptoms after stopping Matrifen
Do not abruptly stop using this medicine. Withdrawal symptoms may occur, such as
anxiety, difficulty falling asleep, irritability, restlessness, anxiety, palpitations, increased
blood pressure, nausea or vomiting, diarrhea, loss of appetite, tremors, chills, or sweating. If
the patient wishes to stop using this medicine, they should first consult a doctor. The doctor
will advise how to do it; usually, this is done by gradually reducing the dose to minimize any unpleasant withdrawal symptoms.
Matrifen and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.
This also includes all over-the-counter medicines or herbal remedies taken by the patient. When purchasing other medicines at the pharmacy, inform the pharmacist that Matrifen is being used.
The treating doctor knows which medicines can be safely used with Matrifen. The patient will
require close monitoring when using certain medicines listed below or when stopping certain medicines listed below, as this may affect the required strength of Matrifen.
In particular, inform the doctor or pharmacist if the patient is taking:

• Other opioid pain medicines (such as buprenorphine, nalbuphine, or pentazocine) and certain nerve pain medicines (gabapentin and pregabalin).
• Sleeping medicines (such as temazepam, zaleplon, or zolpidem).
• Sedatives (tranquilizers such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and antipsychotics (such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
• Medicines reducing muscle tension (such as cyclobenzaprine or diazepam).
• Certain antidepressants known as SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine) – see below.
• Certain antidepressants or medicines used in the treatment of Parkinson's disease known as MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). Do not use Matrifen for 14 days after stopping these medicines – see below.
• Certain antihistamines, especially those causing drowsiness (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine).
• Certain antibiotics (such as erythromycin or clarithromycin).
• Antifungal medicines (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
• Medicines used in HIV therapy (such as ritonavir).
• Antiarrhythmic medicines (such as amiodarone, diltiazem, or verapamil).
• Antituberculosis medicines (such as rifampicin).
• Certain antiepileptic medicines (such as carbamazepine, phenobarbital, or phenytoin).
• Certain medicines used to treat nausea and motion sickness (such as phenothiazines).
• Certain medicines used to treat heartburn and stomach ulcers (such as cimetidine).
• Certain medicines used to treat coronary heart disease (angina pectoris) or hypertension (such as nicardipine).
• Certain medicines used to treat blood cancers (such as idelalisib).

Using Matrifen with antidepressants
The risk of adverse effects increases when used concomitantly with certain antidepressants.
An interaction between Matrifen and these medicines may occur, leading to changes in mental state, e.g., restlessness, hallucinations (seeing, feeling, hearing, or smelling things that do not exist), and other effects such as blood pressure fluctuations, rapid heart rate, high temperature, excessive reflexes, coordination disorders, muscle stiffness, nausea, vomiting, and diarrhea (these may be symptoms of serotonin syndrome). When using these medicines together, the doctor may wish to closely monitor the patient for such adverse effects, especially when starting treatment or changing the dose.
Use with central nervous system depressants, including alcohol and certain narcotic medicines
Concomitant use of Matrifen with sedative medicines such as benzodiazepines or other medicines with similar effects increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible.
If the doctor prescribes Matrifen together with sedative medicines, the dose and duration of concomitant treatment should be limited by the doctor.
Inform the doctor about all sedative medicines being taken and strictly follow the doctor's recommended dose. It may be helpful to inform friends or family members to be aware of the symptoms listed above. If such symptoms occur, contact the doctor.
Surgical procedures
If the patient suspects they may undergo anesthesia, inform the doctor or dentist that they are using Matrifen.
Using Matrifen with alcohol
Do not drink alcohol before consulting the treating doctor.
Matrifen may cause fatigue and slowed breathing. Alcohol may worsen these effects.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Matrifen should not be used during pregnancy unless discussed with a doctor.
Matrifen should not be used during the perinatal period, as it may cause respiratory disorders in the newborn.
Long-term use of Matrifen during pregnancy may cause withdrawal symptoms in the newborn (such as loud crying, tremors, seizures, inadequate feeding, and diarrhea), which may be life-threatening if not recognized and treated. If withdrawal symptoms in the child are suspected, contact a doctor immediately.
Do not use Matrifen during breastfeeding. Do not breastfeed for 3 days after removing the Matrifen patch. The medicine may pass into human milk.
Driving and operating machinery
Matrifen may affect the ability to drive and operate machinery or tools as it may cause drowsiness and dizziness. If such symptoms occur, do not drive or operate any machinery or use any tools. Do not drive until the patient's reaction to the medicine is known.
Consult a doctor or pharmacist if the patient is unsure whether they can safely drive while using this medicine.

3. How to use Matrifen

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.
The doctor will decide which strength of Matrifen is appropriate for the patient, based on an assessment of pain intensity, the patient's general condition, and previous pain treatment.
Before starting and regularly during treatment, the doctor will also discuss with the patient what to expect from using Matrifen, when and for how long it should be used, when to contact the doctor, and when to discontinue the medicine (see also section 2 "Withdrawal symptoms after stopping Matrifen").

Application and changing of patches

• Each patch contains enough medicine for 3 days (72 hours).
• The patch should be changed every third day, unless otherwise instructed by the doctor.
• Always remove the old patch before applying a new one.
• Always change the patch at the same time of day, every 3 days (72 hours).
• If the patient uses more than one patch, all patches must be changed simultaneously.
• It is advisable to record the date and time of patch application to remember when to change it.
• The table below shows when to change the patch:

Patch applied on: Change patch on:
Monday Thursday
Tuesday Friday
Wednesday Saturday
Thursday Sunday
Friday Monday
Saturday Tuesday
Sunday Wednesday

Where to apply the patch
Adults

• Apply patches to a flat area of the upper body or on the arm (avoiding joint areas).

Children

• To minimize the risk of the child touching or removing the patch, apply it to the upper back.
• Frequently check whether the patch is properly adhered to the skin.
• It is essential that the child does not remove the patch and put it in their mouth, as this may be life-threatening or fatal.
• The child should be closely observed for 48 hours after:
• Application of the first patch
• Application of a patch with higher strength.
• The effect of the patch may be delayed after the first dose. Therefore, until the full effect of the medicine is evident, the child may receive additional pain-relieving medicines. The doctor will advise on this.

Adults and children
Do not apply the patch:

• To the same site consecutively
• To mobile areas (near joints), irritated or damaged skin.
• To heavily hairy skin. If hair is present, do not shave (shaving may irritate the skin). Instead, trim the hair as close to the skin as possible.

Applying the patch
Step 1: Skin preparation

• Ensure the skin is completely dry, clean, and cool before applying the patch.
• If the skin needs cleaning, use cool water only.
• Do not use soap or other cleansing agents, oils, creams, balms, or talcum powder before applying the patch.
• Do not apply the patch immediately after a hot bath or shower.

Step 2: Opening the pouch

• Each patch is individually packaged in a sealed pouch.
• Cut the pouch along the dotted line with scissors.
• Carefully and completely cut the edge of the pouch to avoid damaging the patch inside.

• Hold both sides of the opened pouch and gently pull apart.
• Remove the patch and apply it immediately.
• Keep the empty pouch for later use in the disposal of used patches.
• Each patch may be used only once.
• Do not remove the patch from the pouch until ready to apply.
• Check whether the patch is damaged.
• Do not use patches that are cut, torn, or otherwise damaged.
• Never divide or cut patches.

Step 3: Unfolding the patch and applying it to the skin

• Ensure clothing over the application site is loose; do not wear tight elastic bands or bandages.
• Carefully peel off one half of the shiny protective liner from the center of the patch. Avoid touching the adhesive surface of the patch.
• Apply the adhesive side of the patch to the skin.
• Remove the second half of the protective liner and press the entire patch firmly onto the skin with the palm of the hand.
• Hold in place for at least 30 seconds. Ensure the patch adheres completely, especially at the edges.

Step 4: Removing the patch

• Immediately after removing the patch, fold it in half so the adhesive sides stick together.
• Place it in the original pouch and dispose of it according to the pharmacist's instructions.
• Store used patches out of sight and out of reach of children—used patches still contain active medicine that may be harmful or life-threatening to children.

Step 5: Washing hands

• Always wash hands with clean water only after applying or removing the patch.

Additional information on using Matrifen
Daily activities while using patches

• Patches are water-resistant.
• Showers or baths are allowed, but do not rub the patch.
• With the doctor's approval, physical exercise or sports may be performed during patch use.
• Swimming is also permitted while wearing the patch, but:
• Avoid prolonged hot baths or sauna use.
• Do not wear tight elastic bands or bandages over the patch site.
• Do not heat the patch application site with external heat sources such as heating pads, electric blankets, hot water bottles (heat packs), heated beds, heating or tanning lamps, or sunbathing. Avoid prolonged hot baths or sauna use. In such situations, there is a risk of increased drug release from the patch.

How quickly will the patch work?

• Maximum effect from the first patch may be delayed.
• During the initial treatment period, the doctor may prescribe additional pain-relieving medicines.
• After the initial treatment phase, the patch should provide consistent pain relief, allowing discontinuation of other pain medicines. However, the doctor may occasionally recommend additional pain-relieving medicines.

How long will the patient use the patches?

• Matrifen patches are used to treat chronic pain. The treating doctor will inform the patient about the expected duration of therapy.

In case of increased pain

• If pain suddenly worsens after applying the last patch, check the patch. If it is no longer adhering properly or has fallen off, replace it (see also section In case of patch detachment).
• If pain increases over time during patch use, the treating doctor may recommend a patch with higher strength and/or additional pain-relieving medicines.
• If increasing the patch strength does not improve pain control, the doctor may decide to discontinue patch treatment.

In case of applying more Matrifen patches than recommended or a patch with an incorrect dose
If too many patches are applied or a patch with an incorrect dose is used, remove the patches immediately and contact a doctor as soon as possible.
Symptoms of overdose include breathing difficulties or shallow breathing, fatigue, excessive drowsiness, inability to think clearly, walk, or speak normally, and feelings of faintness, dizziness, or confusion. Overdose may also cause brain disorders known as toxic leukoencephalopathy.

If the patient forgets to change the patch

• Change the patch as soon as remembered and record the date and time. The next patch should be changed after 3 days (72 hours) as usual.
• If a long time has passed since the last patch change, consult the doctor, as additional pain-relieving medicines may be needed; however, do not apply an extra patch.

In case of patch detachment

• If the patch detaches before the required change time, apply a new patch immediately and record the date and time. Apply the new patch to a different site:
• On the upper body or arm.
• On the upper back—in children.
• Inform the doctor and leave the new patch in place for 3 days (72 hours) or as directed by the doctor, until the next scheduled change.
• If early detachment occurs repeatedly, contact the doctor, pharmacist, or nurse.

Stopping the use of patches

• Do not abruptly stop using this medicine. If the patient wishes to discontinue treatment, they should first consult the doctor. The doctor will advise on how to do this—usually by gradually reducing the dose to minimize any unpleasant withdrawal symptoms. See also section 2 "Withdrawal symptoms after stopping Matrifen".
• After stopping patch treatment, do not restart therapy without consulting the doctor. In such cases, a different dose of medicine may be required.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient, their partner or caregiver notices any of the following symptoms in a person using the patches,
the patch should be removed immediately and the doctor contacted, or immediate medical attention sought at the nearest hospital. Intensive medical care may be required.

• Feeling of excessive tiredness, abnormally slow or shallow breathing. Follow the advice above and encourage the patient, as much as possible, to move and speak. Very rarely, these breathing disturbances may be life-threatening or lead to death, particularly in people who have not previously been treated with strong opioid painkillers (such as Matrifen or morphine). (Uncommon, may occur in 1 out of 100 people).
• Sudden swelling of the face or throat, severe irritation, redness or blisters on the skin. These may be signs of a severe allergic reaction. (Frequency cannot be estimated from available data.)
• Seizures. (Uncommon, may occur in 1 out of 100 people).
• Reduced level of consciousness or loss of consciousness. (Uncommon, may occur in 1 out of 100 people).

The following adverse reactions have also been reported

Very common adverse reactions (may occur in more than 1 out of 10 people):

• nausea, vomiting, constipation,
• drowsiness,
• dizziness,
• headache.

Common adverse reactions (may occur in less than 1 out of 10 people):

• allergic reaction,
• loss of appetite,
• insomnia,
• depression,
• feeling of anxiety or confusion,
• seeing, feeling, hearing, or smelling things that are not real (hallucinations),
• muscle tremors or spasms,
• disturbances of sensation, tingling, burning of the skin (paresthesia),
• dizziness,
• fast heartbeat or palpitations,
• high blood pressure,
• shortness of breath,
• diarrhoea,
• dry mouth,
• abdominal pain or indigestion,
• excessive sweating,
• itching, rash, redness of the skin,
• difficulty passing urine or completely emptying the bladder,
• feeling of fatigue, weakness, malaise,
• feeling cold,
• peripheral swelling in the limbs.

Uncommon adverse reactions (may occur in less than 1 out of 100 people):

• restlessness or disorientation,
• unnatural state of euphoria and increased activity (euphoria),
• reduced sensation, especially of the skin (hypoesthesia),
• memory loss,
• blurred vision,
• slow heartbeat or low blood pressure,
• lack of oxygen (cyanosis),
• intestinal obstruction (ileus),
• itchy rash, allergic reaction or other skin disorders at the site of patch application,
• influenza-like symptoms,
• sensation of body temperature changes,
• fever,
• muscle twitching,
• erectile dysfunction (impotence) or disturbances of sexual function,
• difficulty swallowing.

Rare adverse reactions (may occur in less than 1 out of 1000 people):

• constricted pupils,
• periodic breathing pauses (apnoea).

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

• deficiency of male sex hormones (androgen deficiency),
• delirium (symptoms may include restlessness, anxiety, disorientation, confusion, fear, seeing or hearing things that are not real, sleep disturbances, nightmares),
• dependence on Matrifen (see section 2).

At the site where the patch is applied to the skin, rash, redness or mild itching may occur.
These reactions are usually mild and resolve after removal of the patch. If they do not resolve, or if the patch causes significant skin irritation, inform the doctor.
Repeated use of patches may reduce the effectiveness of the medicine (tolerance or increased sensitivity to pain) or may lead to dependence.
When switching from other painkillers to Matrifen, or upon sudden discontinuation of Matrifen treatment, the patient may experience withdrawal symptoms such as nausea, vomiting, diarrhoea, restlessness and chills. The doctor should be informed immediately if such symptoms occur.
Withdrawal symptoms have been observed in newborns whose mothers used Matrifen chronically during pregnancy.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Matrifen 100 micrograms/hour transdermal system

Where to store the patches
Unused and used Matrifen patches should be stored in a place that is out of sight and out of reach of children.
The medicine should be kept in a secure and protected place inaccessible to others. This medicine may cause serious harm and even death in a person who uses it accidentally or intentionally, but for whom it was not prescribed.

How long can Matrifen be stored
Do not use this medicine after the expiry date stated on the outer packaging and protective pouch. The expiry date (abbreviated EXP) refers to the last day of the stated month.
If the medicine has expired, return any unused patches to a pharmacy.
There are no special storage requirements.

How to dispose of used and unused patches
Accidental application of a patch—unused or used—to another person's body, especially a child, may result in death.
A used patch should be folded in half with the adhesive sides pressed together, placed back into the original protective pouch, and then stored in a secure place out of sight and reach of others, especially children, until it can be disposed of. Ask your pharmacist for advice on how to dispose of medicines no longer in use.

Do not dispose of medicines via wastewater or household waste. Doing so helps protect the environment.

6. Contents of the pack and other information

What Matrifen contains
The active substance is fentanyl.
Patches are available in 5 different strengths (see table below).

Other ingredients are: dipropylene glycol, hydroxypropyl cellulose 10 mPas, dimethicone 350 cSt,
silicone adhesive (amine resistant, medium tack), silicone adhesive (amine resistant, high tack),
rate-controlling membrane (ethylene-vinyl acetate copolymer EVA), outer layer
(polyethylene terephthalate, PET), protective layer (polyethylene terephthalate, fluoropolymer), ink.
What Matrifen looks like and contents of the pack
Matrifen transdermal system is a transparent, rectangular patch. Each patch is individually packed in a heat-sealed, child-resistant pouch made of paper, aluminium and polyethylene terephthalate (PET). The patches have a coloured print with the brand name, active substance and strength indication:
Matrifen, 12 micrograms per hour: brown print.
Matrifen, 25 micrograms per hour: red print.
Matrifen, 50 micrograms per hour: green print.
Matrifen, 75 micrograms per hour: light blue print.
Matrifen, 100 micrograms per hour: grey print.
Patches are supplied in cartons containing 1, 2, 3, 4, 5, 8, 10, 16 and 20 systems.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Istituto Gentili S.r.l.
Via San Giuseppe Cottolengo 15
20143 Milan
Italy
e-mail: [email protected]
Manufacturer
LTS Lohmann Therapie-Systeme AG
Lohmannstrasse 2
D – 56626 Andernach
Germany