m a t r i f e nTM
Matrifen 12 micrograms/hour transdermal patch
Matrifen 25 micrograms/hour transdermal patch
Matrifen 50 micrograms/hour transdermal patch
Matrifen 75 micrograms/hour transdermal patch
Matrifen 100 micrograms/hour transdermal patch
Fentanyl
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Matrifen is and what it is used for
- 2. Before you use Matrifen
- 3. How to use Matrifen
- 4. Possible side effects
- 5. Storing Matrifen
- 6. Further information
What Matrifen Is And What It Is Used For
Matrifen belongs to a group of strong painkillers called opioids and acts through blocking the pain signals to the brain.
In Matrifen transdermal patch the active substance fentanyl is deposited. Fentanyl is gradually released from the patch, passes through the skin and into the body, where it relieves severe and long-lasting pain, which can only be relieved by opioids. One transdermal patch relieves pain for 72 hours (3 days).
Before You Use Matrifen
WARNING
Matrifen is a drug that could be life-threatening to children. This is also the case with used transdermal patches. Bear in mind that the design of this medicinal product could be tempting to a child.
Matrifen can have life-threatening side-effects in persons that are not using prescribed opioid drugs on a regular basis.
Do not use Matrifen:
- if you are hypersensitive (allergic) to fentanyl or any of the ingredients of the product
- If you suffer from short-term pain (e.g. after a surgical procedure)
- if your central nervous system is severely impaired, for instance by brain injury
- if you concomitantly take MAO-inhibitors (e.g. moclobemide against depression or selegiline against Parkinson’s disease) or have taken such medicine during the last 14 days.
Take special care with Matrifen
Before starting to use Matrifen you should inform your doctor if you suffer from any of the following disorders:
- asthma, respiratory depression or any lung disease
- irregular heartbeat
- low blood pressure
- impaired liver function
- impaired kidney function
- if you have had a head injury or brain disease (e.g. a tumour)
- if you suffer from a disease causing fatigue and weakness of the muscles (myasthenia gravis).
Inform your doctor if you develop a fever during the treatment, as the increased body temperature may cause too much medicine to pass through the skin. For the same reason you should avoid exposing the patch on the skin to direct heat such as electric blankets, hot-water bottles, sauna, solarium or hot baths. It is acceptable to stay outside in the sun, but you must protect the patch with a piece of clothing during hot summer days.
The transdermal patches should not be divided or cut. Decreasing relief of pain (tolerance), physical or psychological dependence may develop if you use Matrifen for a longer period. However, this is rarely seen during treatment of pain due to cancer.
Elderly patients should be monitored when using Matrifen.
Matrifen should not be given to children under 2 years of age or to children who have not previously been treated with strong painkillers such as morphine.
Taking other medicines:
Certain other medicines may affect or be affected by Matrifen. Some of these medicines are:
- Painkillers (e.g. opioids such as pen-tazocin, buprenorphine morphine and codeine), medicines to treat anxiety and tranquilisers, sleeping medicines, general anaesthetics, phenothiazines (medicine against psychosis), sedating antihistamines (certain medicines for allergy and travel sickness causing drowsiness) and muscle relaxants
- Barbituric acid derivatives (medicine for epilepsy)
- Ritonavir (for HIV)
- Itraconazole and ketoconazole (for fungal infections)
- MAO-inhibitors (e.g. moclobemide for depression or selegiline for Parkinson’s disease)
- Macrolide antibiotics (e.g. azithromycin and erythromycin).
Please inform your doctor or pharmacist if you are taking or have recently been taking any other medicines, including medicines obtained without a prescription.
Using Matrifen with food and drink
Alcohol may increase the risk of breathing problems.
Pregnancy and breast-feeding
Do not use Matrifen if you are pregnant or breastfeeding unless your doctor has weighed the risks of not using to be greater than using Matrifen. Safe use during pregnancy has not been established.
Long-term treatment during pregnancy may cause withdrawal symptoms in the newborn child. If you become pregnant during treatment with Matrifen, consult your doctor.
Driving and using machines:
Fentanyl transdermal patch may impair your mental and/or physical ability to perform potentially hazardous tasks such as driving or operating machinery. During treatment with Matrifen certain undesirable effects may occur (for example drowsiness, apathy or sickness). This should be kept in mind when doing things that require your full attention, for instance during driving a car. You alone are responsible to decide if you are in a fit condition to drive a motor vehicle or perform other tasks that demands increased concentration. Because of their effects or side effects, one of the factors that can reduce your ability to these things safely is your use of medicines. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure about anything.
Used transdermal patches
High quantities of drug remain in the transdermal patches even after use. Used transdermal patches, as well as any unused transdermal patches should therefore be kept out of reach and sight of children and pets, and discarded according to local requirements or returned to the pharmacy.
How To Use Matrifen
Always use Matrifen exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The dose is determined by your doctor, who will adjust it for you individually. Always follow your doctor’s instructions.
The normal dose is usually one patch every three days. According to your reaction the strength of the patch or the number of patches may need to be adjusted. The effect is reached within 24 hours after the first patch has been applied. Do not discontinue treatment without consulting your doctor.
How to apply Matrifen transdermal patch
- Find a flat part of your upper body (trunk) or upper arm, where the skin is without hair, cuts, spots or other skin blemishes. The body part must not have been irradiated in connection with radiation therapy.
- The patch should be applied to the upper back when the product is used by children. This reduces the possibility of the removal by the child.
- If the skin is hairy, then cut the hair with scissors. Do not shave, as shaving irritates the skin. If the skin needs washing, wash with water. Do not use soap, oil, lotions, alcohol or other cleansers that may irritate the skin. The skin must be completely dry before applying the patch.
- The patch must be stuck on immediately after opening the package. When the protective plastic has been removed, the patch is applied by pressing it firmly onto the skin with the palm of the hand for approximately 30 seconds to make sure that the patch sticks well to the skin. Pay special attention to see that the patch sticks properly at the edges.
- A Matrifen transdermal patch is used for 72 hours (3 days). On the outer package you can write the date and time you applied the patch. This may help you remember when to change your patch.
- The patch should not be divided or cut.
How to change the transdermal patch
- After 72 hours (3 days) you can remove the patch. Usually the patch does not come off by itself.
- Fold the used patch in half so that the sticky edges adhere to each other. Put back used patches in the outer package and hand in to your pharmacist or discard according to local requirements.
- Apply a new patch as described above but on another part of the skin. At least 3 days should go by before the same part is used again.
If you use more Matrifen than you should:
If you have stuck on more patches than prescribed, remove the patches and contact your doctor, hospital or Poisons Information Service for their opinion of the risk.
The most common sign of overdose is reduced ability to breathe. Symptoms are that the person breathes abnormally slowly or weakly. If this should occur – remove the patches and contact a doctor immediately. While waiting for the doctor, keep the person awake by talking to or shaking her/him now and then.
Other signs and symptoms of overdose are drowsiness, low body temperature, slow heart rate, decreased muscle tone, deep sedation, loss of muscle co-ordination, constriction of the pupils and convulsions.
If you forget to use or change your patch:
You should change your patch at the same time every three days, if not otherwise instructed by your doctor. If you forget to change your patch, change it as soon as you remember.
If you are very late changing your patch, you should contact your doctor because you might need some extra painkillers.
Matrifen Side Effects
Like all medicines, Matrifen can have side effects, although not everybody gets them.
If any of the following serious, very rare side effects occur, you should discontinue treatment and immediately contact your doctor or go to a hospital: severe respiratory depression (severe breathlesness, rattling breath) or complete block of the digestion channel (convulsive pain, vomiting, flatulence).
Other side effects
Very common (occur in more than 1 of 10 patients):
Drowsiness, headache, feeling sick, vomiting, constipation, sweating, itching.
Common (occur in more than 1 of 100 patients):
Apathy, confusion, depression, anxiety, nervousness, hallucinations, reduced appetite, dry mouth, stomach upset, skin irritation at the application site.
Uncommon (occur in less than 1 of 100 patients):
Unnatural feeling of happiness, loss of memory, difficulties in sleeping, restlessness, shivering, feelings of stinging in the skin (like ants are crawling on the skin called paraesthesia), speech disturbances, irregular heartbeat, high or low blood pressure, difficulty in breathing, diarrhoea, rash, blushing, difficulties in passing urine.
Rare (occur in less than 1 of 1000 patients): Hazy vision, dilated blood vessels, hiccups, serious allergic reaction (difficulty in breathing, wheeze while breathing, rash), swelling, feeling cold.
Very rare (occur in less than 1 of 10,000 patients):
Delusions, loss of physical strength, disorder in the sexual functions disorders, loss of muscle co-ordination, convulsions, slow or weak breath, difficulty breathing, blood in the mouth due to unusual accumulation of blood in the lungs, sore throat, stomach pain due to block of the digestion channel (ileus), feeling bloated due to painful gases in the stomach or the guts, unusually low production of urine, pain in the urine bladder.
Other adverse reactions Decreasing relief of pain (tolerance), physical and psychological dependence can develop during longterm use of fentanyl.
Opioid withdrawal symptoms (for instance: nausea, vomiting, diarrhoea, anxiety and shivering) may occur in patients after switching from previously prescribed opioid analgesics to Matrifen transdermal patch.
The side effects observed in children and adolescents treated with fentanyl are similar to those observed in adults. However some side effects are more common in children and adolescents (fever, being or feeling sick and nausea).
Please inform your doctor if any of the side effects are serious or if you experience disturbing side effects or notice any side effects not mentioned in this leaflet.
How To Store Matrifen
Keep out of the reach and sight of children, even after use. High quantities of the drug remain in the transderm al patches even after use.
Do not use Matrifen after the expiry date stated on the package. The expiry date refers to the last day of that month.
For environmental and safety reasons, used as well as unused and out of date patches must be discarded to local requirements or returned to the pharmacy for disposal. Used patches should be folded in half with the sticky sides together and kept in the outer package until discarded or delivered to the pharmacy.
Further Information
What Matrifen transdermal patch contains
The active substance is: Fentanyl. Each transdermal patch contains 1.38 mg, 2.75 mg, 5.5 mg, 8.25 mg or 11 mg in a patch of 4.2, 8.4, 16.8, 25.2 or 33.6 cm2 and releases 12, 25, 50, 75 or 100 micrograms/hour.
Other ingredients are: Dipropylene glycol, hydroxypropyl cellulose, dimeticone, silicone adhesives (amine resistant), ethylenvinylacetate (EVA, release membrane), polyethylene terephthalate (PET, backing film), fluoropolymercoated polyester (protective film) and printing ink.
What Matrifen looks like and contents of the pack
Matrifen is a transparent and rectangular transdermal patch. The transdermal patches are equipped with a coloured imprint with the trade name, active substance and strength:
- Matrifen 12 micrograms/hour patch: brown imprint
- Matrifen 25 micrograms/hour patch: red imprint
- Matrifen 50 micrograms/hour patch: green imprint
- Matrifen 75 micrograms/hour patch: light blue imprint
- Matrifen 100 micrograms/hour patch: grey imprint
The patches are supplied in cartons containing 1, 2, 3, 4, 5, 8, 10, 16 and 20 patches. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer:
This medicinal product is authorised in the Member States of the EEA under the following names:
Matrifen: Belgium, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, The Netherlands, Norway, Poland, Slovak Republic, Slovenia, Sweden, United Kingdom
Fentanilo, Matrifen: Portugal.
This leaflet was last approved in November 2008
GBR/IRL-5
650XXXX
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