Fentanyl Sandoz®

fentanyl transdermal patches

Consumer Medicine Information (CMI)
Return unused patches to the Tell your doctor if you have
pharmacy (see Disposal at the end of allergies to any other medicines,
WHAT IS IN THIS this leaflet). foods, preservatives or dyes.
LEAFLET
Keep used and unused patches where Tell your doctor if you have or have
children cannot reach them. had any of the following medical
This leaflet answers some common conditions:
questions about Fentanyl Sandoz.
• liver or kidney disease
It does not contain all the available BEFORE YOU USE
information. It does not take the FENTANYL SANDOZ • lung disease
place of talking to your doctor or
pharmacist. • brain lesions or head injuries
When you must not use it
All medicines have risks and • heart disease
benefits. Your doctor has weighed Do not use this medicine if you
have an allergy to: • medical conditions which lower
the risks of you taking this medicine your resistance to diseases.
against the benefits they expect it • fentanyl, the active ingredient, or
will have for you. Unless you are being treated for
to any of the other ingredients
listed at the end of this leaflet cancer pain, you must tell your
If you have any concerns about doctor if you have not used any
using this medicine, ask your under Product description.
opioid analgesics in the past.
doctor or pharmacist. • any other similar medicines.
You may be more likely to
Keep this leaflet with the medicine. Some of the symptoms of an allergic
experience some of the side effects.
You may need to read it again. reaction may include:
Tell your doctor if you (or a family
• shortness of breath
member) have ever abused or been
• wheezing or difficulty breathing
WHAT FENTANYL • swelling of the face, lips, tongue
dependent on alcohol, prescription
medicines, or illegal drugs.
SANDOZ IS USED or other parts of the body
Tell your doctor if you are
FOR • rash, itching or hives on the
pregnant, plan to become
skin.
pregnant, are breastfeeding or
This medicine is used to relieve Do not use this medicine if you wish to breastfeed.
chronic or long-lasting pain, which have or have had any of the
requires strong painkillers. following medical conditions: Your doctor can discuss with you the
risks and benefits involved.
It contains the active ingredient • acute pain or pain following
fentanyl. surgery If you have not told your doctor
about any of the above, tell him/her
Fentanyl belongs to a group of • mild or intermittent pain. before you start taking Fentanyl
medicines called opioid analgesics. Sandoz.
Do not use any Fentanyl Sandoz
It works by blocking the nerves that strength other than the 12.5 Taking other medicines
recognise pain messages from the microgram/hour patch if you have
body. never had opioid analgesics for Tell your doctor or pharmacist if
pain relief before. you are taking any other
Ask your doctor if you have any medicines, including any that you
questions about why this medicine Do not use this medicine after the get without a prescription from
has been prescribed for you. expiry date printed on the pack or your pharmacy, supermarket or
Your doctor may have prescribed it if the packaging is torn or shows health food shop.
for another reason. signs of tampering.
Some medicines and Fentanyl
This medicine may be addictive. If it has expired or is damaged, Sandoz may interfere with each
return it to your pharmacist for other.
This medicine is available only with disposal.
a doctor's prescription.
If you are not sure whether you
Warning should start using this medicine,
talk to your doctor.
Fentanyl Sandoz patches may be
retrieved and abused by addicts.
Before you start to use it
Please ensure that used patches are
concealed and disposed of carefully.

190725-fentanyl-sandoz-cmi Page 1
These include: • certain medicines used to treat of patches, is suitable to control your
fungal infections such as pain.
• other strong analgesics used to
ketoconazole and itraconazole
manage pain such as morphine, Each patch is applied onto the skin
codeine, methadone, oxycodone, • sedating antihistamines and lasts for three days (72 hours).
pethidine or buprenorphine After three days, remove the patch
• certain medicines that act on the and apply a new patch to the skin at a
• ritonavir and nelfinavir, heart and blood vessels such as different place.
medicines used to treat HIV calcium-channel blockers like
infections. Do not take ritonavir or verapamil and diltiazem You should not use more than one
nelfinavir while using Fentanyl patch at a time, unless your doctor
Sandoz, unless you are closely • certain medicines used to treat authorises otherwise (for example
monitored by your doctor. arrhythmias such as amiodarone. to obtain a dose that cannot be
These medicines may be affected by achieved with a single patch). The
• antidepressant medicines old patch should be removed
belonging to the class monoamine Fentanyl Sandoz or may affect how
well it works. You may need before the new patch is applied.
oxidase inhibitors (MAOIs) including
moclobemide, phenelzine sulfate and different amounts of your medicines, Fentanyl Sandoz should not be used
tranylcypromine sulphate, selective or you may need to take different in children under 12 years of age or
serotonin re-uptake inhibitors medicines. in adolescents under 18 years of age
(SSRIs), or serotonin norepinephrine Your doctor and pharmacist have who weigh less than 50 kg.
re-uptake inhibitors (SNRIs). more information on medicines to be The first patch may take up to a day
Fentanyl Sandoz should not be used careful with or avoid while using this to take effect after it is applied onto
concurrently with these medicines. medicine. the skin. This is because fentanyl is
Fentanyl Sandoz should be initiated slowly absorbed through the skin
14 days after cessation of MAOIs. Tolerance
into the blood. Your doctor may
Combination of these medicines with As with all opioid analgesics, prescribe additional medicines to
Fentanyl Sandoz patches may Fentanyl Sandoz may lead to control your pain for the first day.
increase the risk of serotonin tolerance with continued use. Your
syndrome, a potentially life- doctor may, therefore, prescribe a Applying the patch
threatening condition. higher dose of Fentanyl Sandoz after 1. Find an intact and hairless
• certain medicines used to treat some time to continue to give you spot of skin on the upper part of
depression such as nefazodone pain relief. your body or on your upper arm.
Do not place the patch onto skin
• medicines that slow down your that is red, burnt or damaged.
central nervous system (for example HOW TO USE
medicines that makes you sleepy, FENTANYL SANDOZ In young children or persons with
reduce anxiety or decrease cognitive impairment, the patch
awareness, such as sedatives, Follow all directions given to you should be put on the upper back to
hypnotics, sleeping tablets, by your doctor or pharmacist lower the chances that the patch
tranquillisers, strong pain killers carefully. will be removed and placed in the
(opioids), medicines used for surgery mouth.
They may differ from the
(anesthetics), muscle relaxants, information contained in this leaflet. The skin should be healthy and
allergy medicine that makes you undamaged.
drowsy, alcohol or some illegal If you do not understand the
drugs). Combination of these instructions, ask your doctor or 2. Trim any excess hair with
medicines with Fentanyl Sandoz may pharmacist for help. scissors. Do not shave the hair off
increase the sedative effect of these since this may affect the skin. If
drugs or slow down your ability to
How much to use you need to wash the skin before
react, breathing difficulties with slow Ask your doctor or pharmacist if applying the patch, use clean water
or shallow breathing, coma and you are unsure of the correct dose only. Do not use soap, oils or
death. A change in dose by your for you. lotions.
doctor may be required if Fentanyl The skin should be completely
Sandoz is used with these medicines. They will tell you exactly which
patch or patches to use. dry before applying the patch.
• medicines used to treat mental 3. Open the pouch and remove
Follow the instructions they give
illness or psychotic conditions the Fentanyl Sandoz patch. Do not
you.
• medicines used to relieve severe apply the patch if it looks damaged
If you use the wrong dose, Fentanyl in any way. Never cut or divide the
nausea and vomiting
Sandoz may not work as well in patch.
• certain antibiotics used to treat controlling your pain.
infections such as clarithromycin and 4. Remove the protective film.
Fentanyl Sandoz is available in five
troleandomycin different sizes. Your doctor will 5. Apply the patch to the skin
decide which patch, or combination and press with the palm of the
hand for about 30 seconds. Make

190725-fentanyl-sandoz-cmi Page 2
sure all of the patch is in contact This may increase the chance of you At high temperatures, the amount of
with skin and the corners are stuck getting an unwanted side effect. fentanyl absorbed by the skin
tightly. increases. Your doctor may need to
If you are not sure what to do, ask
adjust your Fentanyl Sandoz dose.
6. Wash your hands after your doctor or pharmacist.
applying or removing the patch. If you experience any of the
If you have trouble remembering to
following you should seek medical
You can now leave the patch on the use your medicine, ask your
attention immediately:
skin for three days (72 hours). pharmacist for some hints.
• Trouble breathing or slow or
You may have a bath, shower or If you use too much shallow breathing
swim. (overdose) • Slow heartbeat
Always write the date and time Immediately telephone your doctor • Severe sleepiness
you applied the patch on the pack. or the Poisons Information Centre • Cold, clammy skin
It will help you to use Fentanyl (telephone 0800 POISON or 0800 • Trouble walking or talking
Sandoz correctly and remember 764766) for advice, or go to • Feeling faint, dizzy or confused
when the next patch is due. Accident and Emergency at the
nearest hospital, if you think that Things you must not do
Changing the patch you or anyone else may have used Do not expose the patch to direct
too much Fentanyl Sandoz. Do this heat from electric blankets, heat
1. After three days (72 hours),
even if there are no signs of pads, heated water beds, heat or
remove the patch.
discomfort or poisoning. tanning lamps, intensive
2. Fold the used patch in half so sunbathing, hot water bottles, long
You may need urgent medical
that the adhesive side sticks to hot baths, saunas or hot spa baths
attention.
itself. Wrap the folded patch and while you are using Fentanyl
carefully dispose of it in the The most important symptom of an Sandoz.
garbage. overdose is difficulty in breathing.
Direct exposure to such heat may
3. Apply a new patch straight If a person using Fentanyl Sandoz cause an increase in the amount of
away to a different area of the has abnormally slow or weak fentanyl absorbed by the skin.
skin, following the steps under breathing, remove the patch. Keep
'Applying the patch'. the person awake by talking to Do not use Fentanyl Sandoz to treat
them or gently shaking them every any other complaints unless your
If you do not understand the doctor tells you to.
now and then.
instructions provided with this
medicine, ask your doctor or Do not give the patches to anyone
pharmacist for help. else, even if they have the same
WHILE YOU ARE condition as you.
If your pain continues, see your
doctor who may prescribe additional
USING FENTANYL Do not stop using your medicine or
medicines to help control the pain or SANDOZ lower the dosage without checking
change the dose of Fentanyl Sandoz. with your doctor.
Your doctor may advise you initially Things you must do Your doctor may want you to
to change the patch every two days gradually reduce the amount you are
(48 hours) instead of every three If you are about to be started on
any new medicine, remind your using before stopping completely.
days (72 hours) to achieve adequate This may help reduce the possibility
pain relief. doctor and pharmacist that you
are using Fentanyl Sandoz. of withdrawal symptoms such as:
How long to use Fentanyl • nausea, loss of appetite,
Tell any other doctors, dentists,
Sandoz vomiting, diarrhoea
and pharmacists who treat you
Continue using your medicine for that you are using this medicine. • anxiety, depression
as long as your doctor tells you.
If you become pregnant while • sweating, shivering.
If you forget to use it using this medicine, tell your
doctor immediately. Things to be careful of
Apply a new patch as soon as you
remember, and continue to use If your pain continues or returns, Be careful driving or operating
Fentanyl Sandoz as you would see your doctor. machinery until you know how
normally. Fentanyl Sandoz affects you.
You may need additional medicines
If it is almost time for your next dose, to control the pain or a change in the This medicine may affect your
skip the dose you missed and apply strength of the Fentanyl Sandoz alertness and cause dizziness in some
your next dose when you are meant patch. people. Do not drive, operate
to. machinery or do anything else that
Tell your doctor if you develop a
could be dangerous until your doctor
Do not use a double dose to make fever.
tells you that it is safe.
up for the dose that you missed.

190725-fentanyl-sandoz-cmi Page 3
Avoid drinking alcohol while you • swelling of hands, ankles or feet Tell your doctor or pharmacist if
are taking this medicine. you notice anything else that is
• skin rash (local redness and itch making you feel unwell.
If you drink alcohol, drowsiness may at the site of the patch is usually mild
be worse. and resolves when the patch is Other side effects not listed above
removed). may also occur in some people.
If the patch accidentally adheres to
another person (for example a • involuntary muscle contractions Some of the side effects (for example
family member sharing the same high blood pressure) can only be
bed), remove the patch and contact • irregular heart beat found when your doctor does tests
your doctor. Do this even if there • unusual tiredness or weakness, from time to time to check your
are no signs of discomfort or feeling of body temperature change. progress.
drowsiness.
Tell your doctor as soon as possible
if you notice any of the following: AFTER USING
SIDE EFFECTS • convulsions, fits or seizures FENTANYL SANDOZ
Tell your doctor or pharmacist as • slow heart beat
Storage
soon as possible if you do not feel • fast heart beat.
well while you are taking Fentanyl Keep your medicine in the original
Sandoz. The above list includes serious side sealed pouch.
effects that may require medical
All medicines can have side effects. attention. Serious side effects are If you take it out of its original
Sometimes they are serious, most of rare. container it may not keep well.
the time they are not. You may need
If any of the following happen, Keep your medicine in a cool dry
medical attention if you get some of
remove the Fentanyl Sandoz patch place where the temperature stays
the side effects.
and tell your doctor immediately below 25°C.
Do not be alarmed by the following or go to Accident and Emergency Do not store Fentanyl Sandoz or any
lists of side effects. You may not at your nearest hospital: other medicine in the bathroom or
experience any of them.
• breathing slows or weakens near a sink. Do not leave it on a
Ask your doctor or pharmacist to window sill or in the car.
answer any questions you may • temporarily stopped breathing
Heat and dampness can destroy some
have.
• difficulty in breathing medicines.
Tell your doctor or pharmacist if
Make sure that you are with Keep it where children cannot
you notice any of the following and
someone who can keep you awake reach it.
they worry you:
by talking to you or gently shaking
A locked cupboard at least one-and-
• nausea, vomiting, constipation, you every now and then.
a-half metres above the ground is a
stomach pain or discomfort, dry
• sudden life-threatening allergic good place to store medicines.
mouth, diarrhoea, uncomfortable
feeling in stomach or belching after reaction. Symptoms of an allergic
Disposal
eating, indigestion, blockage in the reactions are rash, itching or hives on
bowel the skin, swelling of the face, lips, The contents of Fentanyl Sandoz
tongue or other parts of the body, patches may be retrieved and
• low blood pressure, headache, shortness of breath, wheezing or abused by addicts.
light-headedness, weakness or trouble breathing.
Fold used patches so that the
dizziness, fainting, high blood
The above list includes very serious adhesive side of the patch sticks to
pressure
side effects. You may need urgent itself, wrap and dispose of
• drowsiness, sleepiness, trouble medical attention or hospitalisation. carefully in the garbage.
sleeping, confusion, hallucinations, These side effects are very rare.
If your doctor tells you to stop using
euphoria, depression, loss of
Nausea, vomiting, diarrhoea, anxiety this medicine or the expiry date has
appetite, anxiety, trouble sleeping,
and shivering may occur initially passed, ask your pharmacist what to
agitation, loss of memory, tingling or
when you are switched from other do with any medicine that is left over
numbness of the hands or feet,
opioid analgesics to Fentanyl Sandoz
tremor or shaking
or if therapy is stopped suddenly.
• sweating or trouble in urinating Tell your doctor if you experience
PRODUCT
any of these effects. DESCRIPTION
• runny or blocked nose, flu-like
symptoms, generally feeling unwell Medicines like Fentanyl Sandoz can
lead to addiction. This is unlikely What it looks like
• discharge with itching of the when this medicine is used correctly. Fentanyl Sandoz patches are
eyes and crusty eyelids
transparent rounded oblong patches.
(conjunctivitis)
They are individually packed in

190725-fentanyl-sandoz-cmi Page 4
sachets and are available in packs
containing 5 sachets.
Ingredients
Active ingredients:
• Fentanyl Sandoz 12.5mcg/h -
12.5 microgram fentanyl released per
hour
• Fentanyl Sandoz 25mcg/h - 25
microgram fentanyl released per
hour
• Fentanyl Sandoz 50mcg/h - 50
microgram fentanyl released per
hour
• Fentanyl Sandoz 75mcg/h - 75
microgram fentanyl released per
hour
• Fentanyl Sandoz 100mcg/h - 100
microgram fentanyl released per hour
Inactive ingredients:
• polyethylene terephthalate
• acrylic-vinylacetate copolymer
• siliconised polyethylene
terephthalate.

This medicine does not contain

lactose, sucrose, gluten, tartrazine or
any other azo dyes.
Distributor
Fentanyl Sandoz is supplied in New
Zealand by:
Sandoz New Zealand Limited
12 Madden Street
Auckland 1010
New Zealand

Tel: 0800 726 369

This leaflet was revised in May 2023.

190725-fentanyl-sandoz-cmi Page 5