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Quatrofen


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.


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:


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


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:

sedating antihistamines (certain medicines against allergy and travel sickness causing drowsiness),


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

Apply the patch on a flat part of your upper body or arm


Children


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 a patch on straight after a hot bath or shower.


Step 2: Open the pouch




Grasp both sides of the opened pouch and pull apart.


Step 3: Peel and press


Step 4: Disposing of the patch


Step 5: Wash

Wash your hands afterwards with clean water.


How quickly will the patches work?

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 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)



How long will you use the patches for?

Quatrofen 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 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


Everyday activities while using the patches



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:

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 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.

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.


Other side effects


Very common: may affect more than 1 in 10 people


Common: may affect up to 1 in 10 people


Uncommon: may affect up to 1 in 100 people


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


Additional side effects in children and adolescents:


Very common: may affect more than 1 in 10 people


Common: may affect up to 1 in 10 people


Uncommon: may affect up to 1 in 100 people


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