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FENTALIS RESERVOIR 50 MICROGRAM/HOUR TRANSDERMAL PATCHES

Active substance(s): FENTANYL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Fentalis Reservoir 25 microgram/hour transdermal patches
Fentalis Reservoir 50 microgram/hour transdermal patches
Fentalis Reservoir 75 microgram/hour transdermal patches
Fentalis Reservoir 100 microgram/hour transdermal patches
fentanyl

Important things you need to know about Fentalis Reservoir 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)
• Do not soak in a hot bath or take a hot shower whilst wearing a patch.
• If you develop a fever tell your doctor immediately
• Follow the dosage instructions carefully and only change your patch at the same time of day 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 any further questions, 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 Fentalis Reservoir transdermal patches are and what they are used for
2. What you need to know before you use Fentalis Reservoir transdermal patches
3. How to use Fentalis Reservoir transdermal patches
4. Possible side effects
5. How to store Fentalis Reservoir transdermal patches
6. Contents of the pack and other information

1. WHAT FENTALIS RESERVOIR TRANSDERMAL PATCHES ARE AND WHAT THEY ARE
USED FOR
The name of your medicine is Fentalis Reservoir transdermal patches
The patches help relieve pain that is very bad and long-lasting:
• in adults who need continuous pain treatment
• in children above 2 years of age who are already using opioid medicines and who need continuous pain treatment.
Fentalis Reservoir transdermal patches contains an active substance called fentanyl. It belongs to a group of strong painkillers called opioids.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE FENTALIS RESERVOIR
TRANSDERMAL PATCHES
Do not use Fentalis Reservoir transdermal patches if:
• You are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6)
• You have pain which lasts only for a short period, such as sudden pain or pain after having an operation
• You have breathing difficulties, with slow or shallow breathing
Do not use this medicine if any of the above apply to you or your child. If you are not sure, talk to your doctor or pharmacist before using
Fentalis Reservoir transdermal patches.
Warnings and precautions
• Fentalis Reservoir transdermal patches can have life-threatening side effects in people who are not already regularly using
prescribed opioid medicines.
• Fentalis Reservoir transdermal patches is a medicine that could be life-threatening to children, even if the patches have been used.
Bear in mind that a sticky patch (unused or used) could be tempting to a child and if it sticks to a child’s skin or they put it in their
mouth, the result may be fatal.
Patch sticking to another person
The patch should be used only on the skin of the person for whom it has been prescribed. There have been reports of patches accidentally
sticking to a family member while in close physical contact or sharing the same bed as the person wearing the patch. A patch accidently
sticking to another person (particularly a child) can cause the medicine in the patch to go through the skin of the other person and cause
serious side effects such as breathing difficulties, with slow or shallow breathing which may be fatal. In case the patch sticks to the skin of
another person, take the patch off right away and get medical attention.
Take special care with Fentalis Reservoir transdermal patches
Talk to your doctor or pharmacist before using this medicine if any of the following apply to you - your doctor may need to check you more
closely if:
• You have ever had problems with your lungs or breathing
• You have ever had problems with your heart, liver, kidneys, or low blood pressure
• You have ever had a brain tumour
• You have ever had persistent headaches or a head injury
• You are elderly - you may be more sensitive to the effects of this medicine.
• You have a condition called ‘myasthenia gravis’ in which muscles become weak and tire easily.
• You have ever abused or been dependent on alcohol, prescription medicines or illegal drugs. If any of the above apply to you (or you are
not sure), talk to your doctor or pharmacist before using Fentalis Reservoir transdermal patches.
Side effects and Fentalis Reservoir transdermal patches
• Fentalis Reservoir transdermal patches may make you unusually drowsy, and make your breathing more slow or shallow.
Very rarely these breathing problems can be life-threatening or even fatal, especially in people who have not used strong opioid painkillers
(like Fentalis Reservoir transdermal patches or morphine) before. If you, or your partner or carer, notice that the person wearing the patch is
unusually drowsy, with slow or shallow breathing:
- Take the patch off
- Call a doctor, or go to your nearest hospital straight away
- Keep the person moving and talking as much as possible
• If you get a fever while using Fentalis Reservoir transdermal patches, tell your doctor - this may increase the amount of medicine that
passes through your skin
• Fentalis Reservoir transdermal patches may cause constipation, talk to your doctor or pharmacist for advice on how to prevent or relieve
constipation.
• Repeated, long term use of the patches may make the medicine less effective (you become ‘tolerant’ to it) or you may become
dependent on it. See section 4 for a full list of possible side effects.
When you are wearing the patch do not expose it to direct heat such as heating pads, electric blankets, hot-water bottles, heated water beds
or heat or tanning lamps. Do not sunbathe, have long hot baths or saunas or use hot whirlpool spa baths. If you do, you may increase the
amount of medicine you get from the patch.
Other medicines and Fentalis Reservoir transdermal patches
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy
without a prescription or herbal medicines. You should also tell your pharmacist that you are using Fentalis Reservoir transdermal patches if
you buy any medicines from your pharmacy.
Your doctor will know which medicines are safe to take with Fentalis Reservoir transdermal patches. You may need to be closely monitored
if you are taking some of the types of medicines listed below or if you stop taking some of the types of medicines listed below, as this may
affect the strength of Fentalis Reservoir transdermal patches you need.
In particular, tell your doctor or pharmacist if you are taking:
• Other medicines for pain, such as other opioid painkillers (such as buprenorphine, nalbuphine, or pentazocine).
• Medicines for helping you sleep (such as temazepam, zaleplon, or zolpidem).
• Medicines to help you calm down (tranquillisers, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines
for mental conditions (anti-psychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
• Medicines for relaxing your muscles (such as cyclobenzaprine or diazepam).
• Some medicines used to treat depression called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine,
fluvoxamine, paroxetine, sertraline, or venlafaxine). - see below for more information
• Some medicines used to treat depression or Parkinson’s disease called MAOIs (such as isocarboxazid, phenelzine, selegiline or
tranylcypromine). You should not take Fentalis Reservoir transdermal patches within 14 days of stopping these medicines. - see below for
more information
• Some antihistamines, especially ones that make you sleepy (such as chlorphenamine, clemastine, cyproheptadine, diphenhydramine or
hydroxyzine).
• Some antibiotics used to treat infection (such as erythromycin or clarithromycin).
• Medicines used to treat fungal infection (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
• Medicines used to treat HIV infection (such as ritonavir).
• Medicines used to treat an irregular heart beat (such as amiodarone, diltiazem or verapamil).
• Medicines to treat tuberculosis (such as rifampicin).
• Some medicines used to treat epilepsy (such as carbamazepine, phenobarbital or phenytoin).
• Some medicines used to treat nausea or motion sickness (such as phenothiazines).
• Some medicines used to treat heartburn or ulcers (such as cimetidine).
• Some medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
• Some medicines used to treat cancer of the blood (such as idelalisib).
Fentalis Reservoir transdermal patches with antidepressants
The risk of side effects increases if you are taking medicines such as certain antidepressants. Fentalis Reservoir transdermal patches
may interact with these medicines and you may experience changes to mental status such as feeling agitated, seeing, feeling, hearing, or
smelling things that are not there (hallucinations) and other effects such as changing blood pressure, fast heartbeat, high body temperature,
overactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting and diarrhoea.
Operations
If you think that you are going to receive anaesthesia tell your doctor or dentist that you are using Fentalis Reservoir transdermal patches.
Fentalis Reservoir transdermal patches and alcohol
Do not drink alcohol while using Fentalis Reservoir transdermal patches unless you have talked to your doctor first.
Fentalis Reservoir transdermal patches can make you drowsy or breathe more slowly. Drinking alcohol may make these effects worse.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice
before using this medicine.
Fentalis Reservoir transdermal patches should not be used during pregnancy unless you have discussed this with your doctor.
Fentalis Reservoir transdermal patches should not be used during childbirth as the medicine can affect the breathing of the newborn child.
Do not use Fentalis Reservoir transdermal patches if you are breastfeeding. You should not breastfeed for 3 days after removing your
Fentalis Reservoir transdermal patches patch. This is because the medicine may pass into breast milk.
Driving and using machines
Fentalis Reservoir transdermal patches can affect your ability to drive and use machines or tools as it may make you sleepy or dizzy. If this
happens, do not drive or use any tools or machines. Do not drive while using this medicine until you know how it affects you.
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.

3.

HOW TO USE FENTALIS RESERVOIR TRANSDERMAL PATCHES

Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Your doctor will decide which strength of Fentalis Reservoir transdermal patches is most suitable for you, taking into
account the severity of your pain, your general condition and type of pain treatment that you have received so far.
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 when to change your patch:
Apply your patch on

Change your patch on

Monday



Thursday

Tuesday



Friday

Wednesday



Saturday

Thursday



Sunday

Friday



Monday

Saturday



Tuesday

Sunday



Wednesday

Where to apply the patch
Adults
• Apply the patch on a flat part of your upper body or arm (not over a joint).
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.
• Watch your child very closely for 48 hours after:
- The first patch has been put on
- A higher dose patch has been put on
• It may take some time for the patch to have its maximum effect. Therefore, your child might need to use other painkillers as well
until the patches become effective. Your doctor will talk to you about this.
Adults and Children:
Do not apply the patch on
• The same place twice in a row.
• Areas that you move a lot (joints), skin that is irritated or with cuts.
• 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.
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

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Step 2: Open the sachet
• Each patch is sealed in its own sachet
• Tear open the sachet at the notch
• Gently tear off the edge of the sachet completely
• Grasp both sides of the opened sachet and pull apart
• Take the patch out and use straight away
• Keep the empty sachet to dispose of the used patch later
• Use each patch once only
• Do not take the patch out of its sachet 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 the first part 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 sachet and dispose of the sachet as instructed by your pharmacist
• Keep used patches out of sight and reach of children - even used patches contain some medicine which may harm children and may even
be fatal
Step 5: Wash
• Always wash your hands after you have handled the patch using clean water only
More about using Fentalis Reservoir transdermal patches
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
• If your doctor agrees, you can exercise or play sport while wearing the patch
• You can also swim while wearing the patch, but:
- Do not use hot whirlpool spa baths
- Do not put a tight or elasticated band over the patch
• While you are wearing the patch do not expose it to direct heat such as heating pads, electric blankets, hot-water bottles, heated water
beds, heat or tanning lamps. Do no sunbathe, have long hot baths or saunas. If you do, you may increase the amount of medicine you get
from the patch.
How quickly will the patches work?
• It may take some time for your first patch to have its maximum effect.
• Your doctor may give you other painkillers as well 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.
How long will you use the patches for?
• Fentalis Reservoir transdermal 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 additional
painkillers (or both)
• If increasing the strength of the patch does not help, your doctor may decide to stop the use of the patches
If you use too many patches or the wrong strength patch
If you have stuck on too many patches or the wrong strength patch, take the patches off and contact a doctor straight away.
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 you forget to change your patch
• If you forget, change your patch as soon as you remember and make 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 talk to your doctor because you might need some extra painkillers, but do not apply
an extra patch.
If a patch falls off
• If a patch falls off before it needs changing, stick a new one on straight away and make note of the day and time. Use a new area of skin on:
- Your upper body or arm
- Your child’s upper back
• Let your doctor know this has happened and leave the patch on for another 3 days (72 hours) or as directed by
your doctor, before changing the new patch as usual
• If your patches keep falling off, talk to your doctor, pharmacist or nurse
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 patch
strength when you restart
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you or your partner, or carer, notice any of the following about the person wearing the patch, take the patch off and call a doctor,
or go to your nearest hospital, straight away. You may need urgent medical treatment.
• Feeling unusually drowsy, breathing that is more slow or shallow than expected. Follow the advice above and keep the person who was
wearing the patch moving and talking as much as possible. Very rarely these breathing difficulties can be life-threatening or even fatal,
especially in people who have not used strong opioid painkillers (like Fentalis Reservoir transdermal patches or morphine) before.
(Uncommon, this may affect up to 1 in 100 people)
• Sudden swelling of the face or throat, severe irritation, reddening or blistering of your skin.
These may be signs of a severe allergic reaction. (frequency cannot be estimated from the available data.)
• Fits (seizures). (Uncommon, this may affect up to 1 in 100 people.)
• Reduced consciousness or loss of consciousness. (Uncommon, these may affect up to 1 in 100 people.)
The following side effects have also been reported
Very common (may affect more than 1 in 10 people)
• Nausea, vomiting, constipation
• Feeling sleepy (somnolence)
• Feeling dizzy
• Headache
Common (may affect up to 1 in 10 people)
• Allergic reaction
• Loss of appetite
• Difficulty sleeping
• Depression
• Feeling anxious or confused
• Seeing, feeling, hearing or smelling things that are not there (hallucinations)
• Muscle tremors or spasms
• Unusual feeling in the skin, such as tingling or crawling feelings (paraesthesia)
• Spinning sensation (vertigo)
• Heart beat feels fast or uneven (palpitations, tachycardia)
• High blood pressure
• Being short of breath (dyspnoea)
• Diarrhoea
• Dry mouth
• Stomach pain or indigestion
• Excessive sweating
• Itching, skin rash or redness of the skin
• Being unable to pass urine or empty bladder completely
• Feeling very tired, weak or generally unwell
• Feeling cold
• Swollen hands, ankles or feet (peripheral oedema)
Uncommon (may affect up to 1 in 100 people)
• Feeling agitated or disoriented
• Feeling extremely happy (euphoria)
• Decreased feeling or sensitivity, especially in the skin (hypoaesthesia)
• Loss of memory
• Blurred vision
• Slow heart beat (bradycardia) or low blood pressure
• Blue colour to the skin caused by low oxygen in the blood (cyanosis)
• Loss of contractions of the gut (ileus)
• Itchy skin rash (eczema), allergic reaction or other skin disorders where the patch is placed
• Flu-like illness
• Feeling of body temperature change
• Fever
• Muscle twitching
• Difficulty getting and keeping an erection (impotence) or problems having sex
Rare side effects (may affect up to 1 in 1000 people)
• Constricted pupils (miosis)
• Stopping breathing from time to time (apnoea)
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.
Repeated use of the patches may make the medicine become less effective (you become ‘tolerant’ to it) or become dependent on it.
If you switch from a different painkiller to Fentalis Reservoir transdermal patches or if you suddenly stop using Fentalis Reservoir transdermal
patches, you may notice withdrawal effects such as sickness, feeling sick, diarrhoea, anxiety or shivering. Tell your doctor if you notice any of
these effects.
There have been reports also of newborn infants experiencing withdrawal effects after their mothers have used Fentalis Reservoir
transdermal patches for a long time during pregnancy.
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 Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide
more information on the safety of this medicine.

5.

HOW TO STORE FENTALIS RESERVOIR TRANSDERMAL PATCHES

Keep all patches (used and unused) out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and sachet after “EXP”. The expiry date refers to the last day of
that month. If the patches are out of date, take them to your pharmacy.
Store in the original package. Do not refrigerate or freeze!
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
A used or unused patch accidentally sticking to another person, especially a child, may be fatal. Used patches should be folded firmly in half
so that the sticky side of the patch sticks to itself. Then they should be safely discarded by putting them back into the original sachet and
stored out of sight and reach of other people, especially children, until safely disposed.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Fentalis Reservoir transdermal patches contain
The active substance is fentanyl.
Fentalis Reservoir 25 microgram/hour transdermal patches:
• Each transdermal patch (active surface area 10 cm2) contains: 2.5 mg fentanyl (which corresponds to a release rate of
25 microgram/hour of fentanyl)
Fentalis Reservoir 50 microgram/hour transdermal patches:
• Each transdermal patch (active surface area 20 cm2) contains: 5 mg fentanyl (which corresponds to a release rate of 50 microgram/hour
of fentanyl)
Fentalis Reservoir 75 microgram/hour transdermal patches:
• Each transdermal patch (active surface area 30 cm2) contains: 7.5 mg fentanyl (which corresponds to a release rate of
75 microgram/hour of fentanyl)
Fentalis Reservoir 100 microgram/hour transdermal patches:
• Each transdermal patch (active surface area 40 cm2) contains: 10 mg fentanyl (which corresponds to a release rate of
100 microgram/hour of fentanyl)
• The other ingredients are:
Occlusive backing: polyethylene-terephthalate/ethylenvinylacetate-copolymer
Drug reservoir: ethanol 96 %, hydroxyethylcellulose, purified water
Release membrane: ethylenvinylacetate-copolymer 91:9
Adhesive surface: silicone medical adhesive
Protective layer (removed before the patch is stuck onto the skin) polyethylene-terephthalate, release coated.
What Fentalis Reservoir transdermal patches look like and contents of the pack
Fentalis Reservoir transdermal patches are transparent oblong transdermal patches packed in a sachet which consists of a protective layer
(removed before the patch is stuck onto the skin), and four functional lavers: an occlusive backing, a drug reservoir, a release membrane and
an adhesive surface. With the adhesive surface Fentalis Reservoir transdermal patches can be stuck onto the skin. The transdermal patch
slowly releases fentanyl which is absorbed through the skin.
Fentalis Reservoir transdermal patches are available in packs with 3, 5, 7, 10, 14 and 20 transdermal patches.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR. UK.
Manufacturer: Hexal AG, Industriestrasse 25, 83601 Holzkirchen, Germany
This leaflet was last revised in 01/2017.

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