Matrifen 25 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 this leaflet carefully 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 reactions, including any not listed in this leaflet, tell 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. What you need to know 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 pain requiring continuous opioid therapy:

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

Matrifen contains fentanyl as the active substance, a potent analgesic 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 (markedly slowed or shallow breathing).

Do not use this medicine if any of the above situations apply to the patient. In case of
doubt, speak with 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, including used patches. Consider that the appearance of the patch (used or unused) may attract a child to touch it, stick it to the body, or put it in the mouth, etc., which may lead to death.
• The medicine must be stored in a safe and secure place inaccessible to others – for more information see section 5.

If the Matrifen patch adheres to another person's skin
Patches must be applied only to the skin of the person for whom they were prescribed.
There have been 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 result in
drug absorption through the skin and cause severe adverse effects such as breathing
difficulties with slow and shallow breathing, which may be life-threatening.
If this occurs, remove the patch immediately and contact a doctor.
Exercise special caution when using Matrifen
Before using this medicine, speak with 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, kidney problems or low blood pressure,
• the patient has ever had a brain tumour,
• 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 causing muscle weakness and fatigue.

If any of the above situations apply to the patient (or the patient is unsure), speak with a
doctor or pharmacist before using Matrifen.
While using patches, inform the doctor if the patient develops breathing problems
during sleep.
Opioids such as Matrifen may cause breathing disturbances during sleep, such as sleep apnoea (pauses in breathing during sleep) and nocturnal hypoxia (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
• waking up at night due to breathlessness
• difficulty maintaining sleep
• excessive daytime sleepiness. The doctor may decide to adjust the dose of the medicine.

While using 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 felt (e.g., the patient feels pain in another part of the body)
• touch causes pain that should not be present. Do not change the dose independently. The doctor may decide to adjust the dose or treatment.

Adverse effects of Matrifen

• Matrifen may cause unusual tiredness and slowed or shallow breathing. Very rarely, these breathing disturbances may be life-threatening or fatal, especially 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, speak with a doctor – increased body temperature may significantly increase drug absorption through the skin.
• Matrifen may cause constipation; speak with a doctor or pharmacist about how to prevent or relieve constipation.

For a full list of adverse effects, see section 4.
Do not heat the patch application site with external heat sources such as: heated pads, electrically heated blankets, hot water bottles (thermophores), heated beds, heating or tanning lamps. Avoid sunbathing or prolonged warm baths, saunas, or 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, an opioid. Repeated use of opioid pain medicines may lead to reduced effectiveness (the patient becomes accustomed to the medicine, known as tolerance). During treatment with Matrifen, the patient's sensitivity to pain may also increase. This phenomenon is known as hyperalgesia. Increasing the patch dose may temporarily further reduce pain intensity but 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 the better solution for the patient.
Dependence and compulsive use
This medicine contains fentanyl, an opioid. It may cause dependence and/or addiction.
Repeated use of Matrifen may also lead to dependence, abuse, and compulsive use, which may result in life-threatening overdose. The risk of these adverse effects may increase with higher doses and longer duration of use. Dependence or compulsive use may cause the patient to lose control over how much medicine to use or how often to use it. The patient may feel a need to continue using the medicine even if it does not help relieve their pain.
The risk of dependence or compulsive use varies between individuals. The risk of dependence on or compulsive 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 compulsive use:

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

If the patient notices any of these symptoms, they should discuss with their doctor the best treatment strategy, including when it is appropriate to stop treatment and how to safely discontinue the medicine.
Withdrawal symptoms after stopping Matrifen
Do not suddenly stop using this medicine. Withdrawal symptoms may occur, such as
restlessness, difficulty falling asleep, irritability, agitation, anxiety, rapid heartbeat (palpitations), increased
blood pressure, nausea or vomiting, diarrhoea, loss of appetite, tremors, chills, or sweating. If
the patient wishes to stop using this medicine, they should first speak with their doctor. The doctor
will advise how to do so; usually, this is done by gradually reducing the dose to minimize
any unpleasant withdrawal symptoms.
Matrifen and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, and any medicines the patient plans to take.
This also includes all over-the-counter medicines or herbal remedies the patient is taking. When purchasing other medicines at a pharmacy, inform the pharmacist that Matrifen is being used.
The treating doctor knows which medicines can be safely used with Matrifen. Close monitoring may be required if the patient uses or stops using any of the medicines listed below, as this may affect the required strength of Matrifen.
In particular, tell 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 (tranquillisers such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and antipsychotic medicines (such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
• Medicines that reduce 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 to treat 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) or high blood pressure (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 together with certain antidepressants. An interaction between Matrifen and these medicines may occur, leading to changes in mental state such as agitation, hallucinations (seeing, feeling, hearing, or smelling things that are not there), and other effects such as blood pressure fluctuations, rapid heart rate, high temperature, exaggerated reflexes, coordination disturbances, muscle stiffness, nausea, vomiting, and diarrhoea (these may be symptoms of serotonin syndrome). When used together, the doctor may wish to closely monitor the patient for such adverse effects, especially when starting treatment or changing the dose.
Use with medicines that depress the central nervous system, including alcohol and
certain narcotic medicines
Concurrent use of Matrifen with sedatives 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, concurrent use should only be considered if no other treatment options are possible.
If the doctor prescribes Matrifen together with sedatives, the dose and duration of combined treatment should be limited by the doctor.
Inform the doctor about all sedative medicines being taken and strictly follow the prescribed 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 anaesthesia, inform the doctor or dentist that they are using Matrifen.
Using Matrifen with alcohol
Do not drink alcohol without first speaking with the treating doctor.
Matrifen may cause tiredness and slowed breathing. Alcohol may worsen these effects.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning 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.
Do not use Matrifen around the time of delivery, as it may cause breathing problems in the newborn.
Long-term use of Matrifen during pregnancy may cause withdrawal symptoms in the newborn (such as loud crying, tremors, seizures, poor feeding, and diarrhoea), which may be life-threatening if not recognised and treated. If withdrawal symptoms in the baby are suspected, contact a doctor immediately.
Do not use Matrifen while 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 knows how they react to the medicine.
Speak with 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 directed 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 the severity of pain, 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 stop using 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

• Patches should be applied to a flat area of the upper body or upper 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 crucial 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:
  • Applying the first patch
  • Applying a patch of higher strength
• The effect of the patch may be delayed after the first dose. Therefore, until the full effect of the medicine becomes apparent, 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 skin site consecutively
• To mobile areas (near joints), or to 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: Preparing the skin

• 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 talc before applying the patch.
• Do not apply the patch immediately after a hot bath or shower.

Step 2: Opening the sachet

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

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

Step 3: Unfolding and applying the patch 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.
• 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 sachet and dispose of it according to the pharmacist's instructions.
• Store used patches out of sight and out of reach of children — even used patches still contain 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

• The patches are water-resistant.
• Showering or bathing is permitted, but avoid rubbing the patch.
• With the doctor's approval, physical exercise or sports may be performed while using the patch.
• Swimming is allowed during patch use, 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, electrically heated blankets, hot water bottles (hot water bags), heated beds, heat lamps, or tanning lamps. Do not sunbathe or use prolonged hot baths or saunas. 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 recommend additional pain-relieving medicines.
• After the initial treatment phase, the patch should provide consistent pain relief, allowing other pain medicines to be discontinued. 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 worsening 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 If the patch detaches).
• If pain increases over time during patch use, the treating doctor may recommend a higher-strength patch 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 using more patches than recommended or a patch with an incorrect dose

If too many patches are used or a patch with an incorrect dose is applied, remove the patches immediately and contact the doctor without delay.

Symptoms of overdose include breathing difficulties or shallow breathing, fatigue, excessive drowsiness, inability to think, walk, or speak clearly, and feelings of faintness, dizziness, or confusion. Overdose may also cause brain disturbances known as toxic leukoencephalopathy.

If the patient forgets to change the patch

• Change the patch as soon as remembered and note 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.

If the patch detaches

• If the patch detaches before the scheduled 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 upper 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 premature detachment occurs repeatedly, contact the doctor, pharmacist, or nurse.

Stopping the use of patches

• Do not stop using this medicine abruptly. 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 from the previous one may be required.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If the patient, their partner or caregiver notices any of the following symptoms in a person using the patches, the patch must be removed immediately and the doctor contacted, or the person must go immediately to the nearest hospital. Intensive medical care may be required.

• Feeling of excessive tiredness, excessive slowing or shallowing of breathing. Follow the advice above and encourage the patient to move and speak as much as possible. Very rarely, these breathing disturbances may be life-threatening or lead to death, particularly in people who have not previously used strong opioid pain medicines (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 symptoms of a severe allergic reaction. (Frequency cannot be estimated from available data.)
• Seizures. (Uncommon, may occur in 1 out of 100 people).
• Reduced consciousness or loss of consciousness. (Uncommon, may occur in 1 out of 100 people).

The following side effects have also been reported

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

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

Common side effects (may affect up to 1 in 10 people):

• allergic reaction,
• loss of appetite,
• insomnia,
• depression,
• feeling of anxiety or confusion,
• seeing, feeling, hearing, or smelling things that are not there (hallucinations),
• muscle tremors or spasms,
• sensory disturbances, tingling, burning skin (paraesthesia),
• dizziness,
• fast heartbeat or palpitations,
• high blood pressure,
• shortness of breath,
• diarrhoea,
• dry mouth,
• stomach 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 of cold,
• peripheral swelling in the limbs.

Uncommon side effects (may affect up to 1 in 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,
• flu-like symptoms,
• sensation of body temperature changes,
• fever,
• muscle twitching,
• erectile dysfunction (impotence) or sexual dysfunction,
• difficulty swallowing.

Rare side effects (may affect up to 1 in 1,000 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 there, 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 disappear 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 on the medicine.
When switching from other pain medicines to Matrifen, or when Matrifen is suddenly discontinued, the patient may experience withdrawal symptoms such as nausea, vomiting, diarrhoea, restlessness and chills. Inform the doctor immediately if such symptoms occur.
Cases of withdrawal symptoms have been observed in newborns whose mothers chronically used Matrifen during pregnancy.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform the doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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. Side effects can also be reported to the marketing authorisation holder. By reporting side effects, more information can be gathered on the safety of medicine use.

5. How to store Matrifen 25 micrograms/hour transdermal system

Where to store the patches
Unused and used Matrifen patches must 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 to which others do not have access. It may cause serious harm or result in death to a person who uses this medicine accidentally or intentionally, when it has not been prescribed for them.

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 (marked as 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 requirements for storage.

How to dispose of used and unused patches
Accidental adhesion of a patch—unused or used—to another person’s body, especially in children, 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 place out of sight and out of reach of others, especially children, until disposal. Ask your pharmacist how to dispose of medicines no longer in use.
Medicines must not be disposed of via wastewater or household waste. Proper disposal 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).

The other ingredients are: dipropylene glycol, hydroxypropylcellulose 10 mPas, dimethicone 350 cSt,
silicone adhesive (amine resistant, medium tack), silicone adhesive (amine resistant, high tack),
release-controlling membrane (ethylene-vinyl acetate copolymer EVA), outer film (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 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