Package leaflet: Information for the user

Quatrofen 12 micrograms/hour transdermal patch

Quatrofen 25 micrograms/hour transdermal patch

Quatrofen 50 micrograms/hour transdermal patch

Quatrofen 75 micrograms/hour transdermal patch

Quatrofen 100 micrograms/hour transdermal patch

Fentanyl

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 Quatrofen is and what it is used for

2. What you need to know before you use Quatrofen

3. How to use Quatrofen

4. Possible side effects

5. How to store Quatrofen

6. Contents of the pack and further information

1. What Quatrofen is and what is used for

Quatrofen 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.

Quatrofen 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).

2. What you need to know before you use Quatrofen

Quatrofen 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 Quatrofen:

• 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

WARNING

Quatrofen 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. Quatrofen 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 Quatrofen 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)

• Quatrofen 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 Quatrofen for a longer period. However, this is rarely seen during treatment of pain due to cancer.

Elderly patients should be monitored when using Quatrofen.

Children

Quatrofen 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 Quatrofen

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

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

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

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

• Medicines used as muscle relaxants.

• Some medicines used to treat epilepsy (such as carbamazapine, Phenobarbital or phenytoin)

• Rifampicin (for treatment of tuberculosis)

• 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 Quatrofen 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.

Quatrofen with alcohol

You should not drink alcohol whilst using Quatrofen 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 Quatrofen if you are pregnant or breast-feeding unless your doctor has weighed the risks of not using to be greater than using Quatrofen. Long-term treatment during pregnancy may cause withdrawal symptoms in the newborn child. If you get pregnant during treatment with Quatrofen, 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 Quatrofen

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 recommendeddose 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.

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

Where to apply the patch

Adults

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:

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.

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 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 <dispose according to local requirements>.

• 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

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

If you use more Quatrofen than you should:

If you have stuck on more patches than prescribed, remove the patches and contact your doctor or hospital immediately 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 (tiny pupils) and convulsions (fits).

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?

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 you stop using Quatrofen

• 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.

4. 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:

Very rarely these breathing difficulties can be life-threatening or even fatal, especially in people who have not used strong opioid painkillers (like Quatrofen 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.

• 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 spasms,

• 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 coloration 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 Quatrofen 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

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Quatrofen

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 Quatrofen 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.

6. Contents of the pack and other information

What Quatrofen transdermal patch contains

The active substance is: Fentanyl.

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

Name of patch:	Each patch contains:	Each patch gives a dose of:	Active surface area of each patch is:
Quatrofen 12 micrograms/hour transdermal patch	1.38 mg	12 micrograms/hour	4.2 cm2
Quatrofen 25 micrograms/hour transdermal patch	2.75 mg	25 micrograms/hour	8.4 cm2
Quatrofen 50 micrograms/hour transdermal patch	5.5 mg	50 micrograms/hour	16.8 cm2
Quatrofen 75 micrograms/hour transdermal patch	8.25 mg	75 micrograms/hour	25.2 cm2
Quatrofen 100 micrograms/hour transdermal patch	11 mg	100 micrograms/hour	33.6 cm2

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 Quatrofen looks like and contents of the pack

Quatrofen 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, 3, 5, 10 and 20 patches. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

Matrifen: Cyprus

Quatrofen: Italy and Sweden

Fendivia: Spain

This leaflet was last revised in 2015-04-17