Package leaflet: Information for the user

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 things you need to know about Matrifen transdermal patches.

•    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 bottle)

•    If you develop a fever tell your doctor immediately

•    Follow the dosage instructions carefully and only change your patch every 3 days (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 because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, please ask your doctor, pharmacist or nurse.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in 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 further information

OWhat Matrifen is and what it is used for

Matrifen transdermal patch contains the active substance fentanyl. Fentanyl belongs to a group of strong painkillers called opioids and acts through blocking the pain signals to the brain. Fentanyl is gradually released from the patch, passes through the skin and into the body.

Matrifen is used for:

Adults:

Long term pain that can only be adequately controlled by strong analgesics.

Children:

Long term management of severe chronic pain in children receiving opioid therapy from 2 years of age.

One transdermal patch relieves pain for 72 hours (3 days).

©What you need to know before you use Matrifen

Matrifen patches can be used in children aged 2 to 16 years who have previously used opioid painkillers. If the patches have been prescribed for your child, the 'you' stated everywhere below should be read as 'your child'.

Do not use Matrifen:

• If you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6)

• 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.

Warnings and precautions

•    Ritonavir and nelfinavir (against HIV)

•    Itraconazole, ketoconazole, fluconazole and voriconazole (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

•    Some medicines used to treat depression (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine)

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

•    Nefazodone (against depression)

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

Matrifen with alcohol

You should not drink alcohol whilst using Matrifen patches, as this may increase the risk of serious side effects and cause breathing difficulties, a fall of blood pressure, extreme drowsiness and coma.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while taking this medicine until you know how it affects you

•    It is an offence to drive if this medicine affects your ability to drive

•    However, you would not be committing an offence if:

•    The medicine has been prescribed to treat a medical or dental problem and

•    You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

•    It was not affecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

How to use Matrifen

WARNING

Matrifen is a medicinal product 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 which in cases may lead to a fatal outcome. Matrifen can have life-threatening side effects in persons that are not using prescribed opioid drugs on a regular basis.

Patch sticking to another person

The patch should be used only on the skin of the person for whom it was ordered by the doctor. Cases have been reported where a patch was accidentally stuck to a family member while in close physical contact or sharing the same bed as the patch wearer. A patch sticking to another person (particularly a child) may result in an overdose. In case the patch sticks to the skin of another person, take the patch off immediately and seek medical attention.

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 tumour)

•    if you suffer from a disease causing fatigue and weakness of the muscles (myasthenia gravis)

•    Matrifen may cause constipation, talk to your doctor or pharmacist for advice on how to prevent constipation.

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 heating pads, electric blankets, hot-water bottles, heated water beds, sauna, tanning lamps, solarium, hot baths or hot water whirlpool spa baths. You can shower while wearing a patch and it is 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.

Children

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.

Other medicines and Matrifen

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Certain other medicines may affect or be affected by Matrifen. Some of these medicines are:

•    Painkillers (e.g. opioids such as morphine and codeine, as well as pentazocine, nalbuphine and buprenorphine)

•    Medicines to treat anxiety and tranquillisers, sleeping medicines and general anaesthetics, phenothiazines (medicine against psychosis)

•    Sedating antihistamines (certain medicines against allergy and travel sickness causing drowsiness)

•    Medicines used as muscle relaxants

•    Some medicines used to treat epilepsy (such as carbamazepine, phenobarbital or phenytoin)

•    Rifampicin (for treatment of tuberculosis)

Always use this medicine exactly as your doctor has told you. 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 recommended dose is 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.

Using and changing the patches

•    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 differently. Always remove the old patch before applying a new one. Always change your patch at the same time of day every 3 days (72 hours). If you are using more than one patch, change all your patches at the same time.

•    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:

Apply your patch on:

Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Sunday

Change your patch at the same time on:

Thursday

Friday

Saturday

Sunday

Monday

Tuesday

Wednesday

Where to apply the patch

Adults

•    Apply the patch on a flat part of your upper body 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 that 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 should be monitored very closely for 48 hours after:

•    The first patch has been put on

•    A higher dose patch has been put on.

For you or your child, do not apply the patch

on:

•    The same place twice in a row

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

•    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 several 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 dry, clean and cool before you put the patch on

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

•    Do not use soap or any other cleansers, creams, moisturisers, oils 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 open the pouch at the notch, shown by the arrow

•    Gently 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.

Step 4: Disposing of the Patch

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

•    Put it back in its original pouch and discard according to local requirements or hand in to your pharmacist

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

Step 5: Wash

•    Wash your hands afterwards with clean water.

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 the 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 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 a patch sticks to another person (See also section 2 above)

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

•    Make sure the patch does not get rubbed off and stick to your partner or child, especially while sharing a bed or in close contact

•    If a patch accidentally sticks to another person, take it off straight away and seek immediate medical attention.

How long will you use the patches for ?

•    Matrifen patches are for long-term pain. Your doctor will be able to tell you how long you can expect to use the patches.

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 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, 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 you stop using Matrifen

•    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 different patch strength when you restart.

Everyday activities while using the patches

•    The patches are waterproof.

•    You can shower or bathe while wearing a patch, but do not scrub the patch itself.

•    You can also swim while wearing the patch, but:

•    Don't use hot whirlpool spa baths.

•    Don't put a tight or elasticated band over the patch.

•    Don't expose the patch to direct heat such as heating pads, hot-water bottles, electric blankets, heated water beds, heat or tanning lamps, intensive sun bathing, prolonged hot baths or saunas. These may affect the way the medicine is absorbed through the skin.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the following serious side effects occur, you should remove the patch and immediately contact your doctor or visit a hospital. 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 (like Matrifen or morphine) before. If you, or your partner or carer, notice that you or your child are breathing much more slowly or weakly, keep moving and talking as much as possible.

•    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.

•    Convulsions, fits or seizures. This affects fewer than 1 in 100 people.

•    Reduced consciousness or loss of consciousness. These affect fewer than 1 in 100 people.

Other side effects

Very common: may affect more than 1 in 10 people

•    drowsiness

•    dizziness

•    headache

•    feeling sick, being sick (vomiting)

•    constipation.

Common: may affect up to 1 in 10 people

•    hypersensitivity

•    loss of appetite, difficulties in sleeping

•    confusion, depression, anxiety hallucinations

•    shivering

•    feelings of stinging in the skin (paraesthesia)

•    feeling giddy

•    irregular heartbeat, fast heart rate

•    high blood pressure

•    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: may affect up to 1 in 100 people

loss of memory

feeling agitated, disorientated, excited or unusually carefree

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

Rare: may affect up to 1 in 1,000 people

•    tiny pupils

•    partial obstruction of the small or large bowel.

Additional side effects in children and adolescents:

Very common: may affect more than 1 in 10 people

headache

feeling or being sick constipation, diarrhoea itching.

Common: may affect up to 1 in 10 people

allergic reaction loss of appetite, stomach pain not being able to sleep, drowsiness, tiredness, feeling weak feeling worried or depressed, hallucinations (seeing, feeling or hearing things that are not there) dizziness

shaking, decreased feeling or sensitivity, especially in the skin dry mouth

rash, excessive sweating, redness of the skin

muscle spasms difficulty passing urine swelling of hands, ankles or feet skin reactions where the patch is placed.

Uncommon: may affect up to 1 in 100 people

confusion

sensation of pins and needles tiny pupils feeling giddy

bluish colouration of the skin, eczema and/or other skin disorders including dermatitis where the patch is placed

•    drug withdrawal effects (such as sickness, feeling sick, diarrhoea, anxiety or shivering), flu-like symptoms.

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. Skin rashes, itching or sweating (affects less than 1 in 10 people). You may notice rashes, redness or slight itching of the skin at the site of the patch. This is usually mild and disappears after you have removed the patch. If it does not, or if the patch irritates your skin badly, tell your doctor.

Reporting of side effects

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

How to store Matrifen

Keep unused and used patches out of the sight and reach of children. 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.

Handling the patch

Accidental exposure to used and unused patches particularly in children may lead to a fatal outcome. Used patches should be folded so that the adhesive side of the patch adheres to itself and then they should be safely discarded. Unused patches should be returned to the hospital or pharmacy.

Do not throw away any medicines via wastewater or household waste. These measures will help protect the environment.

©Contents of the pack and other information

What Matrifen, transdermal patch contains

The active substance is: Fentanyl.

The patches come in 5 different strengths (see table below).

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

Takeda UK Limited, Building 3, Glory Park, Glory Park Avenue, Wooburn Green, BUCKS, HP10 0DF.

Manufacturer:

Takeda Pharma A/S, Dybendal Alle 10, DK-2630 Taastrup, Denmark.

Takeda GmbH

Robert-Bosch-Strasse 8, D-78224 Singen, Germany

This leaflet was last revised in 04/2015.    ^

GBR-8    6509787