PACKAGE LEAFLET: INFORMATION FOR THE USER

Matrifen"

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

IMPORTANT INFORMATION ABOUT YOUR MEDICINE

•    These patches contain a strong pain killer.

•    Ensure that old patches are removed before applying a new one.

•    Patches must not be cut.

•    Do not expose the patches to a heat source (such as a hot water bottlej.

•    If you develop a fever tell your doctor immediately.

•    Follow the dosage instructions carefully and only change your patch every 72 hours.

•    If your breathing becomes shallow and weak take the patch off and seek medical help.

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 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 gets 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.    How to store Matrifen

6.    Further information

1.    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 longlasting pain, which can only be relieved by opioids. One transdermal patch relieves pain for 72 hours (3 days).

2.    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 other ingredients of the product.

•    If you suffer from short-term pain (e.g. after a surgical procedure)

•    If you have severe difficulties in breathing.

•    If your central nervous system (e.g. your brain or spinal cord) is severely impaired, for instance by brain injury.

Take special care with Matrifen Before starting to use Matrifen you should inform your doctor if you suffer from any of the below disorders

•    asthma, respiratory depression (reduced ability to breathe) 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 tumor)

•    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 this may affect the way the medicine passes through your skin.

Do not expose the patch on your skin to a direct heat source such as heating pads, electric blankets, hot-water bottles, saunas, tanning lamps, solariums or hot whirlpool spa baths. These may affect the way the medicine works. You can shower while wearing a patch and are allowed to stay outside in the sun, but you must protect the patch with some 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 pentazocin, nalbuphine, buprenorphine morphine and codeine), medicines to treat anxiety and tranquilisers, sleeping medicines, general anaesthetics, phentiazines (medicine against psychosis), sedating antihistamines (certain medicines against allergy and travel sickness causing drowsiness) and muscle relaxants.

•    Barbituric acid derivatives (medicine against epilepsy)

•    Ritonavir and nelfinavir (against HIV)

•    Itraconazole, ketoconazol, fluconazol and voriconazol

(against fungal infections)

•    MAO-inhibitors (e.g. moclobemide against depression or selegiline against Parkinson's disease).You should not take Matrifen within

14 days of stopping these medicines.

•    Macrolide Antibiotics (e.g. azithromyzin, erythromycin, troleandomycin and clarithromycin

•    Nefazodone (against depression)

•    Medicines to treat an irregular heartbeat, such as amiodarone, diltiazem or verapamil.

Please inform your doctor or pharmacist if you are taking or have recently taken 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

Safe use during pregnancy has not been established. Fentanyl should not be used during childbirth since fentanyl may cause difficulties in breathing in the newborn child. Fentanyl is excreted into breast milk and may cause sedation and respiratory depression (reduced ability to breathe) in the breast-fed child. Breast-feeding should therefore be discontinued for at least 72 hours after removal of the patch. Do not use Matrifen if you are pregnant or breast-feeding unless your doctor has weighed the risks of not using to be greater than using Matrifen. Long-term treatment during pregnancy may cause withdrawal symptoms in the newborn child. If you get pregnant during treatment with Matrifen, consult your doctor.

Driving and using machines:

Fentanyl transdermal patch can make you drowsy; if this happens do not drive, use tools or machinery.

3. 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.

Do not discontinue treatment without consulting your doctor.

Using and changing the patch

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

•    You should change your patch every third day, unless your doctor has told you otherwise

•    Always remove the old patch before applying the new one

•    Always change your patch at the same time of day every 3 days (72 hours)

•    Make a note of the day, date and time you apply a patch, to remind you when you need to change your patch. On the outer package you can write the date and time you applied the patch to help you remember

•    The following table shows you which day of the week to change your patch:

Where to apply Matrifen transdermal patch

Adults - Find a flat part of your upper body (trunk) or upper arm.

Children -

•    Always apply the patch to the upper back to make it difficult for your child to reach it or take it off. Every so often check that the patch remains stuck to the skin.

•    It is important your child does not remove the patch and put it in their mouth as this could be life-threatening or even fatal.

•    It may take some time before the patch becomes fully effective. Therefore, your child might need additional painkillers until the patches become effective. Your doctor will advise you on this if it is needed.

•    Children need to be monitored very closely for 48 hours after:

-    The first patch has been put on

-    A higher dose patch has been put on.

Do not apply the patch on:

•    The same place twice in a row.

•    Sensitive areas that you move a lot, cuts, spots or other skin blemishes.

•    Body parts that have been irradiated in connection with radiation therapy.

•    Skin that is very hairy, if there is hair, do not shave it (shaving irritates the skin). Instead, clip the hair as close to the skin as possible.

You should allow 7 days to pass before you put a new patch on the same area of skin.

Putting a patch on Step 1: Preparing the skin

•    Make sure your skin is completely clean, dry and cool before applying the patch

•    If you need to clean the skin, just use cold water

•    Do not use soap or any other cleansers, creams, moisturisers, oils, powders or talc before applying the patch

•    Do not stick the patch on straight after a hot bath or shower.

Step 2: Open the pouch

•    Each patch is sealed in its own pouch

•    Tear or cut off the edge of the pouch completely (if you use scissors, cut close to the sealed edge of the pouch to avoid damaging the patch)

•    Grasp both sides of the opened pouch and pull apart

•    Take the patch out and use it straight away

•    Keep the empty pouch to dispose of the used patch later

•    Use each patch once only

•    Do not take the patch out of its pouch until you are ready to use it

•    Inspect the patch for any damage

•    Do not use the patch if it has been divided, cut or looks damaged

•    Never divide or cut the patch.

Step 3: Peel and Press

•    Make sure that the patch will be covered by loose clothing and not stuck under a tight or elasticated band

•    Carefully peel one half of the shiny plastic backing away from the centre of the patch. Try not to touch the sticky side of the patch

•    Press this sticky part of the patch onto the skin

•    Remove the other part of the backing and press the whole patch onto the skin with the palm of your hand

•    Hold for at least 30 seconds. Make sure it sticks well, especially the edges

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

Step 4: Disposing of the Patch

•    As soon as you take the patch off, fold the used patch firmly in half so that the sticky side sticks to itself

•    Put the used patch in the original pouch and discard according to local requirements or hand in to your pharmacist

•    Even used patches contain some medicine which may harm children, so keep your used patches out of the reach and sight of children.

Step 5: Wash

Wash your hands afterwards with clean water.

More about using Matrifen patches:

How quickly will the patches work?

•    It may take up to a day before your first patch is working completely

•    Your doctor may give you extra painkillers for your first day or so

•    After this, the patch should help to relieve pain continuously so that you can stop taking other painkillers However, your doctor may still prescribe extra painkillers from time to time.

If you use more Matrifen than you should

If you or someone you know has stuck on too many patches or the wrong strength patch, take the patches off and contact the doctor or the nearest hospital straight away. While waiting for the doctor, keep the person awake by talking to or shaking her/him now and then.

Signs of an overdose include trouble breathing or shallow breathing,

tiredness, extreme sleepiness, being unable to think clearly, walk or talk normally and feeling faint, dizzy or confused.

If you forget to use or change your patch

•    If you forget, change your patch as soon as you remember and make a note of the day and time. Change the patch again after 3 days (72 hours) as usual

•    If you are very late changing your patch, you should contact your doctor because you might need extra painkillers, but do not apply an extra patch.

If the patch falls off

•    If the patch falls off before it needs changing, stick a new one on straight away and make a note of the day and time. Use a new area on:

-    Your upper body or arm

-    Your child's upper back Leave another 3 days (72 hours) before changing the new patch as usual

•    If your patch keeps falling off, talk to your doctor, nurse or pharmacist.

If a patch sticks to another person

•    Only use the patch on the skin of the person who it is prescribed for

•    Make sure the patch does not get rubbed off and stick to your partner, especially in bed

•    If a patch accidentally sticks to another person, take it off straight away and talk to your doctor.

If your pain gets worse

•    If your pain gets worse while you are using these patches, your doctor may try a higher strength patch, or give you extra painkillers (or both)

•    If increasing the strength of the patch does not help, your doctor may stop the patches.

If you want to stop using the patches

•    Talk to your doctor before you stop using these patches

•    If you have been using them for some time your body may have got used to them. Stopping suddenly may make you feel unwell

•    If you stop using the patches, don't start again without asking your doctor first. You might need a different strength patch when you restart.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Matrifen can have side effects, although not everybody gets them.

Take the patch off and tell your doctor or go to your nearest hospital straight away if you notice or suspect any of the following.You may need urgent medical treatment.

•    Feeling unusually drowsy, breathing more slowly or weakly than expected. Very rarely these breathing difficulties can be life threatening or even fatal especially in people who have not used strong opioid painkillers before.

•    Sudden swelling of the face or throat, severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction. This only happens in a small number of people.

If you notice any of the above, follow the guidance above and keep moving as much as possible.

Other side effects

Very common (affects more than 1 user in 10):

Drowsiness, dizziness, headache, feeling sick, being sick (vomiting), constipation.

Common (affects 1 to 10 users in 100): Hypersensitivity, anorexia, difficulties in sleeping, confusion, depression, anxiety, hallucinations, shivering, feelings of stinging in the skin (paraesthesia), feeling giddy, irregular heartbeat, high blood pressure, breathlessness, diarrhoea, dry mouth, stomach troubles, sweating, itching,

rash, blushing, muscle spasm, difficulties in passing urine, tiredness, swelling of hands, ankles or feet, weakness, feeling of discomfort, feeling cold.

Uncommon (affects 1 to 10 users in 1,000):

Disorientation, unnatural feeling of happiness, loss of memory, restlessness, decreased feeling of sensitivity in the skin, convulsions (fits), slow heart rate, bluish colouration of the skin, low blood pressure, difficulty in breathing, obstruction of the bowel, eczema and/or other skin disorders including skin reactions where the patch is placed, muscle twitching, disorders of sexual function, flu-like symptoms, body temperature changes, drug withdrawal effects (being sick, feeling sick, diarrhoea, anxiety or shivering).

Rare (affects 1 to 10 users in 10,000):

Tiny pupils, difficulty in breathing, partial obstruction of the small or large bowel, eczema and dermatitis (inflammation of the skin) where the patch is placed.

Other adverse reactions Decreasing relief of pain (tolerance), physical and psychological dependence can develop during long-term use of fentanyl.

Opioid withdrawal symptoms (such as: feeling sick, being sick, diarrhoea, anxiety and shivering) are possible in some patients after conversion from their previous opioid analgesics to Matrifen transdermal patch.

The side effects observed in children and adolescents treated with fentanyl are similar to those observed in adults. Side effects reported as very common in clinical trials in children were fever, being or feeling sick.

Please inform your doctor if any of the side effects gets serious, or if you experience disturbing side effects or notice any side effects not mentioned in this leaflet.

5.    HOW TO STORE MATRIFEN

Keep out of the reach and sight of children, even after use. High quantities of the drug remain in the transdermal 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.

This medicinal product does not require any special storage conditions.

For environmental and safety reasons, used as well as unused and out of date patches must be discarded according 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.

6.    FURTHER INFORMATION What Matrifen, transdermal patch contains

The active substance is: Fentanyl.

1 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 respectively.

Other ingredients are: Dipropylene glycol, hydroxypropyl cellulose, dimeticone, silicone adhesives (amine resistant), ethylene vinyl acetate (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, each patch is packed in a heat-sealed pouch made of paper, aluminium and polyacrylonitrile (PAN). The transdermal patches are equipped with a coloured imprint with trade name, active substance and strength:

12 micrograms/hour patch: brown imprint 25 micrograms/hour patch: red imprint 50 micrograms/hour patch: green imprint 75 micrograms/hour patch: light blue imprint

100 micrograms/hour patch: grey imprint

The patches are supplied in carton containing 1, 2, 3, 4, 5, 8, 10, 16, and 20 patches. Not all pack sizes may be marketed

Marketing Authorisation Holder

Nycomed UK Ltd.,

Three Globeside Business Park, Fieldhouse Lane, Marlow, Bucks,

SL7 1HZ, UK

Manufacturer:

Nycomed Danmark ApS,

PO Box 88, Langebjerg 1,

DK-4000 Roskilde, Denmark

Nycomed GmbH,

Robert-Bosch-Strasse 8,

78224 Singen, Germany

This leaflet was last approved in 03/2011.

GBR-7

650XXXX