MATRIFEN 12 MCG/ORA Трансдермальный пластырь

Содержание инструкции

1. MATRIFEN 12 micrograms/hour transdermal patch, 25 micrograms/hour transdermal patch, 50 micrograms/hour transdermal patch, 75 micrograms/hour transdermal patch, 100 micrograms/hour transdermal patch
   1. What is MATRIFEN and what it is used for
   2. Cosa deve sapere prima di usare MATRIFEN
   3. How to use MATRIFEN
   4. Possible side effects
   5. How to store MATRIFEN
   6. Contents of the pack and other information

MATRIFEN 12 micrograms/hour transdermal patch, 25 micrograms/hour transdermal patch, 50 micrograms/hour transdermal patch, 75 micrograms/hour transdermal patch, 100 micrograms/hour transdermal patch

Equivalent Medicinal Product only for dosages from 25 mcg/h to 100 mcg/h
Fentanil

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What MATRIFEN is and what it is used for
• 2. What you need to know before you use 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 is MATRIFEN and what it is used for

The name of this medicine is MATRIFEN
The patches help to relieve very strong and long-lasting pain:

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

MATRIFEN contains a medicine called fentanyl, which belongs to a group of powerful pain relievers
called opioids.

2. Cosa deve sapere prima di usare MATRIFEN

Non usi MATRIFEN
If you are allergic to fentanyl or to any of the other ingredients of this medicine (listed in section
6).
If the pain is of short duration, such as sudden pain or post-operative pain.
If you have difficulty breathing, with slow or shallow breathing.
Do not use this medicine if any of the above points apply to you or your child. If you have any doubts
consult your doctor, pharmacist or nurse before using MATRIFEN.

Warnings and precautions

• MATRIFEN may have life-threatening adverse effects in people who are not already regularly using prescribed opioid medicines.
• MATRIFEN is a medicine that could be life-threatening for children, even if the patches have already been used. It is important to remember that a sticky patch (new or used) may be attractive to a child, and if it were to stick to the child's skin or if the child were to put it in their mouth the result could be fatal.
• Keep this medicine in a safe and secure place, out of reach of others - see section 5 for more information.

Transfer of the patch to another person
The patch must only be used on the skin of the person to whom it has been prescribed. Cases of
accidental adhesion of the patch to a family member while in close physical contact or sharing the same bed
with the person using the patch have been reported. A patch that accidentally sticks to another person
(especially a child) may result in the medicine contained in the patch passing through the other person's skin
and causing serious adverse effects, such as difficulty breathing, with slow and
shallow breathing, which can be fatal. If the patch sticks to another person's skin, remove the patch
immediately and consult a doctor.

Special precautions with MATRIFEN
Consult your doctor or pharmacist before usingthis medicine if any of the conditions
listed below apply to you, as your doctor may need to monitor you more closely.

• If you have ever had lung or breathing problems.
• If you have ever had heart, liver, kidney problems, or have/have had 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’ in which the muscles become weak and easily fatigued.

If any of the above conditions apply to you (or you are unsure) consult your doctor, pharmacist or nurse before using MATRIFEN.

During the use of 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
(pauses in breathing during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood).
Inform your doctor if you, your partner or the person who cares for you notices any of the following conditions:

• pauses in breathing during sleep
• nighttime awakenings due to shortness of breath
• difficulty falling asleep
• excessive daytime sleepiness The doctor may decide to adjust the dose.

During the use of the patch, inform your doctor if you notice a change in the pain you feel:if you feel

• that the pain is no longer relieved by the patch
• an increase in pain
• a change in how you feel the pain (for example, you feel pain in another part of your body)
• pain when someone touches you in a way that shouldn't hurt. Do not change the dose on your own. The doctor may decide to adjust the dose or treatment.

Undesirable effects and MATRIFEN

• MATRIFEN may make you feel unusually sleepy, and may make your breathing slower and shallower. Very rarely, these breathing problems can be life-threatening or even fatal, especially in people who have never used strong opioid painkillers before (such as MATRIFEN or morphine). If you or someone else notices that the person using the patch is unusually sleepy, with slow or shallow breathing:
• Remove the patch
• Make sure the person moves and talks as much as possible
• If you develop a fever while using MATRIFEN, tell your doctor, as fever can increase the amount of medicine that passes through the skin.
• MATRIFEN can cause constipation, ask your doctor or pharmacist for advice on how to prevent or relieve constipation.

See section 4 for a complete list of possible side effects.
When wearing the patch, do not expose yourself to direct heat sources, such as hot water bottles, electric blankets,
hot water bags, heated waterbeds or heat lamps or tanning beds. Avoid sunbathing and taking long hot baths or saunas or hot tubs. Doing so may increase the amount of medicine absorbed by
the patch.
For those who play sports: the use of the drug without a therapeutic need constitutes doping and may
still result in positive doping tests.

Long-term use and tolerance
This medicine contains fentanyl, an opioid medicine. Repeated use of opioid painkillers can
make the medicine less effective (you get used to it, a phenomenon known as drug tolerance). You may also become more sensitive to pain during the use of MATRIFEN. This is known as hyperalgesia.
Increasing the dose of the patches may help to further reduce pain for a while, but it may
also be harmful. If you notice that the medicine is becoming less effective, consult your doctor. The doctor
will decide whether it is better to increase the dose or gradually reduce the use of MATRIFEN.

Dependence and drug addiction
Repeated use of MATRIFEN can also lead to dependence, abuse and drug addiction, which can
cause a potentially fatal overdose. The risk of these adverse effects may increase with
a higher dose and prolonged use. Dependence or drug addiction may make you feel
that you no longer have control over the amount of medicine you need or how often you have to
use it. You may feel the need to continue using the medicine, even if it does not help to relieve the pain.
The risk of developing dependence or drug addiction varies from person to person. You may be at a
higher risk of becoming dependent or addicted to MATRIFEN if:

• You or a family member has suffered in the past from alcohol, prescription drug or illegal substance abuse («drug addiction »);
• You are a smoker;
• You have had mood problems in the past (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

The appearance of any of the following signs during the use of MATRIFEN may be a sign of
dependence or drug addiction.

• You need to use the medicine for a longer period than indicated by the doctor
• You need to use a higher dose than recommended
• You use the medicine for reasons other than those prescribed, for example «to stay calm» or «to help you sleep»
• You have repeatedly tried to stop or control the use of this medicine, without success
• When you stop treatment with the medicine you feel unwell, and when you start using it again you feel better («withdrawal effects»).

If you notice any of these signs, consult your doctor to discuss the best therapeutic course
for you, including cases where it is appropriate to stop treatment and how to stop it
safely.

Withdrawal symptoms when stopping MATRIFEN
Do not suddenly stop taking this medicine. Withdrawal symptoms may occur
such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat
(palpitations), increased blood pressure, feeling unwell, diarrhea, loss of appetite,
doctor. The doctor will tell you how to do this, usually by gradually reducing the dose in order to minimize
any unpleasant withdrawal effects.

Other medicines and MATRIFEN
Tell your doctor or pharmacist if you are taking, have recently taken or may take any
other medicines.
These include medicines you buy without a prescription and herbal remedies.
You should also inform the pharmacist that you are using MATRIFEN when you purchase any medicine in
the pharmacy.
The doctor will know which medicines are safe to take with MATRIFEN. If you are taking or if
you stop taking any of the types of medicines listed below, close monitoring may be necessary, as this may affect the dose of MATRIFEN you need.

• Other medicines for pain, such as other opioid painkillers (such as buprenorphine, nalbuphine or pentazocine) and some painkillers for nerve pain (gabapentin and pregabalin).
• Medicines that help you sleep (such as temazepam, zaleplon or zolpidem)
• Medicines for anxiety (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 muscles (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 used to treat depression or Parkinson's disease called MAOIs (such as isocarboxazide, phenelzine, selegiline or tranylcypromine). You should not use MATRIFEN for 14 days after stopping these medicines - see below for more information
• 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 heartbeat (arrhythmia) (such as amiodarone, diltiazem and verapamil)
• Some 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 motion sickness (such as phenothiazines)
• Some medicines used to treat heartburn or ulcers (such as cimetidine)
• Some drugs used to treat angina (chest pain) or high blood pressure (such as nicardipine)
• Some drugs used to treat blood cancer (such as idelalisib).

MATRIFEN with antidepressants
The risk of side effects increases if you are taking medicines such as some antidepressants. MATRIFEN
can interact with these medicines and may cause changes in mental status, such as feeling
agitated, seeing things or hearing sounds or smells that do not exist (hallucinations) and experiencing other effects such as
changes in blood pressure, rapid heartbeat, high body temperature, exaggerated reflexes,
lack of coordination, muscle stiffness, nausea, vomiting and diarrhea (these may be
signs of serotonin syndrome). If used together, your doctor may monitor you closely for these
side effects, especially when starting treatment or when changing the dose of the medicine.

Use with central nervous system depressants, including alcohol and some narcotic drugs
The concomitant use of MATRIFEN and sedatives such as benzodiazepines or related drugs increases the
life. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes MATRIFEN together with sedatives, the dose and duration of concomitant therapy
must be limited by the doctor.
Please inform your doctor of all sedatives you are taking and carefully follow
the doctor's recommendations on dosage. It may be helpful to inform friends or family to pay
attention to the signs and symptoms above. Contact your doctor when these symptoms occur.

Surgery
If you think you will need anesthesia, tell your doctor or dentist that you are using MATRIFEN.

MATRIFEN and alcohol
Do not drink alcohol while using MATRIFEN unless you have discussed it with your doctor first.
MATRIFEN can make you feel sleepy or slow down your breathing. Drinking alcohol can worsen these
effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with breast milk,
ask your doctor or pharmacist for advice 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 labour as the medicine may affect the newborn's breathing.
Prolonged use of MATRIFEN during pregnancy may cause withdrawal symptoms in the newborn (such as
acute crying, agitation, convulsions, difficulty eating and diarrhoea) which may be potentially fatal if not
recognised and treated. Inform your doctor immediately if you think your child may have withdrawal symptoms.
Do not use MATRIFEN if you are breastfeeding with breast milk. Do not breastfeed for the 3 days following
removal of the MATRIFEN patch. This is because the medicine may pass into breast milk.

Driving and operating machinery
MATRIFEN may interfere with the ability to drive vehicles or operate machinery or tools as it may
cause drowsiness or dizziness. If this happens, do not drive and do not use any tools or machinery.
Do not drive vehicles while using this medicine until you know what effect it will have on you.
Ask your doctor or pharmacist if you have doubts about safety when driving while using this medicine.
You are responsible for assessing your fitness to drive a motor vehicle or perform work that requires increased
attention. One of the factors that can affect your ability in this regard is the use of medicines due to their effects
and/or side effects. Descriptions of these effects and side effects can be found in other sections.
Read all the information in this leaflet as a guide.
If you have any doubts, ask your doctor or pharmacist.

3. How to use MATRIFEN

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor or
pharmacist.
The doctor will decide which dosage of MATRIFEN is most suitable for you, taking into account the intensity of the pain,
your general health conditions and the type of pain treatment you have received so far.
Before starting treatment and regularly during treatment, the doctor will also discuss with you your
expectations regarding the use of MATRIFEN, when and for how long it is necessary to use it, when to contact the
doctor and when you should stop treatment (see also paragraph 2, Withdrawal symptoms when stopping MATRIFEN).

Application and replacement of the patch

• Each patch contains enough medicine for 3 days (72 hours).
• You should change the patch every three days, unless otherwise indicated by your doctor.
• Always remove the old patch beforeapplying a new one.
• Always change the patch at the same time of dayevery 3 days (72 hours).
• If you are using more than one patch, change them all at the same time.
• Note the day, date and time when you apply a patch, so you can remember when you need to replace it.
• The following table shows when to change the patch:

Where to apply the patch
Adults

• Apply the patch to a flat part of the trunk or arm (not on a joint).

Children

• Always apply the patch to the upper back to make it difficult for the child to touch or remove it.
• However, check frequently that the patch remains firmly attached to the skin.
• It is important that the child does not remove the patch or put it in their mouth, as this would be life-threatening or even fatal.
• Carefully observe the child for 48 hours after:
• the first patch has been applied
• a patch with a higher dose has been applied
• The patch may take some time to reach its maximum effect. Therefore, the child may also need to use other pain relievers until the patch becomes effective. The doctor will discuss this with you.

Adults and children:
Do not apply the patch

• To the same place twice in a row.
• To areas that move a lot (joints), irritated skin or with wounds.
• To areas with a lot of hair. Existing hair should not be shaved (shaving irritates the skin), but cut with scissors as close to the skin as possible.

How to put on the 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 the skin, use only cold water.
• Do not use soap or any other detergent, or creams, moisturizers, oils or talcum powder before applying the patch.
• Do not apply a patch immediately after a hot bath or shower.

Step 2: Open the sachet

• Each patch is sealed in its own sachet.
• Cut with scissors to open the sachet along the dotted line.
• Gently cut completely around the edge of the sachet to avoid damaging the patch inside.

• Grasp both sides of the open sachet and peel them apart.
• Remove the patch and use it immediately.
• Keep the empty sachet to dispose of the used patch later.
• Use each patch only once.
• Do not remove the patch from the sachet until you are ready to use it.
• Inspect the patch to see if it is damaged.
• Do not use the patch if it is split, cut or appears damaged.
• Never split or cut the patch

Step 3: Peel and press

• Make sure the patch will be covered by comfortable clothing and not blocked under tight or elastic bandages.
• Carefully peel off one half of the shiny plastic backing starting from the center of the patch. Try not to touch the adhesive side of the patch.
• Press this adhesive part of the patch onto the skin.
• Remove the other half of the plastic backing and press the entire patch onto the skin with the palm of your hand.
• Hold the pressure for at least 30 seconds, making sure the patch adheres well, especially along the edges.

Step 4: Dispose of the patch

• As soon as you remove a patch, fold it firmly in half, so that the adhesive side sticks to itself.
• Put it back in the original sachet and dispose of the sachet according to the pharmacist's instructions.
• Keep used patches out of the sight and reach of children, as even used patches contain some medicine, which can be dangerous and even fatal for children.

Step 5: Wash

• After touching the patch, always wash your hands using only running water.

Other information for using MATRIFEN
Daily activities when using the patch

• The patch is waterproof.
• You can shower or bathe while wearing the patch, but do not rub it.
• If your doctor allows it, you can exercise or play sports while wearing the patch.
• You can also swim while wearing the patch, but:
• do not use hot thermal whirlpools
• do not put tight or elastic bandages over the patch
• While wearing the patch, do not expose it to direct heat sources such as hot water bottles, thermal blankets, hot water bags, heated waterbeds, heat lamps or tanning beds. Do not sunbathe, take hot baths or saunas for prolonged periods, otherwise the amount of medicine released from the patch may increase.

How long does it take for the patch to work?

• The first patch may take some time to reach its maximum effect.
• The doctor will provide you with other pain relievers for the first day or as needed
• After this period, the patch should help relieve pain continuously, so you can stop the other pain relievers. However, your doctor may still prescribe additional pain relievers from time to time

How long will you have to use the patches?

• MATRIFEN patches are indicated for long-term pain. The doctor will be able to tell you how long they expect you to use the patches.
• If the pain suddenly worsens after applying your last patch, you should check your patch. If it is not attached well or has come off, you should replace the patch (see also the paragraph If a patch comes off).
• If the pain worsens over time while you are using these patches, the doctor may try a patch with a higher dose, or prescribe additional pain relievers (or both).
• If increasing the patch dosage does not help, the doctor may decide to stop using the patches.

If you use too many patches or a patch with the wrong dosage
If you have applied too many patches or a patch with the wrong dosage, remove the patch and immediately inform your
doctor.
Signs of overdose include: difficulty breathing or shallow breathing, fatigue, extreme
drowsiness, inability to think clearly, walk or speak normally, and feeling
faint, dizzy or confused. An overdose can also cause a brain disorder known as
toxic leukoencephalopathy.

If you forget to change the patch

• If you forgot, change the patch as soon as you remember and note the day and time. Change again after 3 days (72 hours)as usual.
• If it is long overdue to change the patch, contact your doctor as you may need additional pain relievers, but do notapply an extra patch.

If the patch comes off

• If a patch comes off before you need to change it, apply a new one immediately and note the day and time. Use a new part of skin on:
• trunk or arm
• upper back (in a child).
• Tell your doctor what happened and leave the patch in this position for 3 days (72 hours)or as directed by your doctor, before changing the patch as usual.
• If the patches continue to fall off, talk to your doctor, pharmacist or nurse.

If you want to stop using the patches

• Do not suddenly stop taking this medicine. If you want to stop taking this medicine, talk to your doctor first. The doctor will tell you how to do this, usually by gradually reducing the dose in order to minimize any unpleasant effects due to withdrawal. See also section 2 "Withdrawal symptoms when stopping MATRIFEN".
• If you stop using the patches, do not start again without first consulting your doctor, as you may need a patch with a different dosage. If you have any other questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you, or someone else, notices that the person using the patch shows any of the following symptoms,
remove the patch and immediately call a doctor, or go to the nearest hospital, because they may
need urgent medical attention.

• Unusual drowsiness, with slower or shallower breathing than expected. Follow the recommendations above and keep the person who was using the patch as active as possible and make them talk. Very rarely, these breathing difficulties can be life-threatening or even fatal, especially in people who have never used strong opioid analgesics before (such as MATRIFEN or morphine). (Uncommon, may affect up to 1 in 100 people)
• Sudden redness of the face or throat, severe irritation, redness or blistering of the skin.

These may be signs of a serious allergic reaction. (frequency cannot be estimated from available clinical data)

• Convulsions (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)
• 100.)

The following side effects have also been reported.
Very common (may affect more than 1 in 10 people)

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

Common (may affect up to 1 in 10 people)

• Allergic reaction
• Loss of appetite
• Difficulty sleeping
• Depression
• Anxiety or confusion
• Seeing things, hearing sounds or smelling odors that are not there (hallucinations)
• Tremors or muscle spasms
• Unusual skin sensations, such as tingling or numbness (paresthesia)
• Feeling of spinning (vertigo)
• Fast 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 to completely empty the bladder
• Feeling tired, weak or generally unwell
• 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 sensitivity, especially to the skin (hypoesthesia)
• Memory loss
• Blurred vision
• Slow heartbeat (bradycardia) or low blood pressure
• Bluish discoloration of the skin caused by lack of oxygen in the blood (cyanosis)
• Loss of bowel contractions (ileus)
• Itchy skin rash (eczema), allergic reaction or other skin disorder where the patch is located
• Flu-like illness
• Feeling of change in body temperature
• Fever
• Muscle spasm
• Difficulty swallowing

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

• Constriction of the pupils (miosis)
• Interruption of breathing from time to time (apnea) The following side effects have also been reported, but their exact frequency is unknown:
• Lack of male sex hormones (androgen deficiency)
• Delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not there, sleep disturbances, nightmares)
• You may become dependent on MATRIFEN (see section 2)

You may notice a rash, redness or mild itching of the skin at the patch site. These disorders are usually mild and disappear after you remove the patch. If this does not happen, or if the patch severely irritates the skin, tell your doctor.
Repeated use of the patches may make the medicine less effective (you get used to it or may become more sensitive to pain), or you may become dependent on it.
If you switch to MATRIFEN from a different pain reliever or if you suddenly stop using MATRIFEN,
you may experience withdrawal effects, such as vomiting, nausea, diarrhea, anxiety or chills. Tell your doctor if
you experience any of these effects.
Withdrawal effects have also been reported in newborns after mothers have used MATRIFEN for
a long time during pregnancy.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through
the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store MATRIFEN

Where to store the patches
Keep all patches (used and unused) out of sight and reach of children.
Store in the original packaging to protect from light. This medicine does not require particular
temperature conditions for storage.
Keep this medicine in a safe and secure place, inaccessible to other people. Accidental or intentional
intake of this medicine by other people to whom it has not been prescribed can
cause serious harm and be fatal.

For how long to store MATRIFEN
Do not use MATRIFEN after the expiry date stated on the box and sachet. The expiry date refers to
the last day of that month (after Exp.). If the patches are expired, they must be taken to
the pharmacy.

How to dispose of used patches or patches you no longer use
A used or unused patch that accidentally sticks to another person, especially a child, can
be fatal.
Used patches must be firmly folded in half so that the adhesive part of the patch sticks to
itself. Subsequently, they must be stored securely in their original sachet and kept out of
sight and reach of other people, especially children, until their safe disposal. Ask
your pharmacist how to dispose of medicines you no longer use.
Do not dispose of any medicine in wastewater and household waste. These measures will help protect
the environment.

6. Contents of the pack and other information

What MATRIFEN contains
The active ingredient is: fentanyl.
There are 5 different dosages of patches available (see the table below)

Other ingredients are: Dipropylene glycol, hydroxypropyl cellulose, dimethicone, adhesive silicone (amino-
resistant), ethylene vinyl acetate (EVA, release membrane), polyethylene terephthalate (PET, backing film),
polyester coated with fluoropolymer (protective film) and printing ink.

Description of the appearance of MATRIFEN and contents of the pack
Matrifen is a transparent and rectangular patch. Each patch is packaged in a child-resistant heat-sealed
sachet, composed of paper, aluminum and polyethylene terephthalate (PET). The transdermal patches are
printed in colour with denomination, active substance name and dosage:
patch 12 micrograms/hour: brown printing
patch 25 micrograms/hour: red printing
patch 50 micrograms/hour: green printing
patch 75 micrograms/hour: light blue printing
patch 100 micrograms/hour: grey printing
The patches are supplied in a pack containing 1, 2, 3, 4, 5, 8, 10, 16 and 20 patches.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Istituto Gentili S.r.l. - Via San Giuseppe Cottolengo 15, 20143 Milan (MI)

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