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RELEVTEC 35 MICROGRAM/HOUR TRANSDERMAL PATCH

Active substance(s): BUPRENORPHINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Relevtec 35 microgram/hour transdermal patch
Relevtec 52.5 microgram/hour transdermal patch
Relevtec 70 microgram/hour transdermal patch
Buprenorphine
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 or pharmacist.
• 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 or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Relevtec is and what it is used for
2. What you need to know before you use
Relevtec
3. How to use Relevtec
4. Possible side effects
5. How to store Relevtec
6. Contents of the pack and other information

1

What Relevtec is and what it is
used for

Relevtec contains the active substance
buprenorphine which is a strong painkiller and
belongs to a group of medicines called opioids. It
acts on specific nerve cells in the spinal cord and
in the brain.
Relevtec is used to treat
• moderate to severe cancer pain and severe
pain that has not responded to other types of
painkillers.
This medicine is not suitable for treating shortlasting pain.








breast-feeding
Buprenorphine, the active substance contained
in the transdermal patch, inhibits milk formation
and passes into breast milk. Therefore, you
should not use Relevtec if you are

breast-feeding.

Driving and using machines
Relevtec may influence your ability to drive or
use machines particularly when
• treatment starts
• switching from another preparation
• dose is changed
• you also use other medicines that act on the
brain
• you drink alcohol
• treatment ends

Do not drive or use machines:
• if you feel dizzy, drowsy, experience blurred
or double vision, or other effects that affect
your reactions
Do not use Relevtec if you:
• for at least 24 hours after the transdermal
• are allergic to buprenorphine or any of the other patch has been removed
ingredients of this medicine (listed in section 6)
The medicine can affect your ability to drive as it
• are dependent on opioids Relevtec must not
may make you sleepy or dizzy.
be used to treat withdrawal symptoms of
• Do not drive while taking this medicine until
addicted persons.
you know how it affects you.
• have serious breathing problems
• It is an offence to drive if this medicine affects
• are being treated or have been treated during
your ability to drive.
the last 2 weeks with medicines known as
• However, you would not be committing an
monoamine oxidase (MAO) inhibitors
offence if:
These types of medicines are used to treat
- The medicine has been prescribed to treat a
depression or Parkinson’s disease.
medical or dental problem and
• have myasthenia gravis (a certain type of
- You have taken it according to the instructions
severe muscle weakness)
given by the prescriber or in the information
• have delirium tremens (confusion and
provided with the medicine and
trembling caused by abstinence from alcohol
- It was not affecting your ability to drive safely
following habitual excessive drinking or
Details regarding a new driving offence concerning
occurring during an episode of heavy alcohol
driving after drugs have been taken in the UK may
consumption)
be found here: https://www.gov.uk/drug-driving-law.
Warnings and precautions
Talk to your doctor or pharmacist if you are not
Talk to your doctor or pharmacist before using
sure whether it is safe for you to drive while
Relevtec if you:
taking this medicine.
• have recently drunk a lot of alcohol
• have convulsive disorders (fits)
Consult your doctor or pharmacist if you are
• have unexplained loss of consciousness
unsure about anything.
• have a shock
• have increased pressure inside the skull such
as after head injury
How to use Relevtec
• have reduced breathing function
• are using medicines that reduce breathing
listed under “Other medicines and Relevtec”
Always use this medicine exactly as your doctor
• have reduced liver function
or pharmacist has told you. Check with your
Patients with reduced liver function require
doctor or pharmacist if you are not sure.
careful monitoring by the doctor during
Your doctor chooses the appropriate strength of
treatment.
• have fever or exposure to external heat Fever Relevtec for you and decides upon any changes
to this, where necessary. The lowest possible
and external heat increase skin permeability,
dose providing adequate pain relief will be given.
which may cause a higher buprenorphine
blood level. Therefore, consult your doctor if
The recommended dose is:
you have fever. External heat - such as sauna,
• one transdermal patch every 3 to 4 days
infrared lamp, electric blanket, hot water bottle
(maximum 96 hours)
- may prevent the transdermal patch from
For convenience of use you can change your
sticking properly. Do not expose yourself to
transdermal patch twice weekly - always on
external heat.
the same days - such as always on Monday
• are inclined to abuse medicines or drugs
mornings and Thursday evenings. Please make
Please see “Do not use Relevtec”.
a note on the outer pack to help you remember
• are an athlete
when to change your patch. Should your doctor
This medicine may cause positive results in
advise you to use any additional painkiller, follow
sports doping control tests.
the doctor’s instructions strictly. Otherwise you
Some people may become dependent on strong
will not benefit fully from treatment with Relevtec.
painkillers such as Relevtec when using them
This dose applies to all adults regardless of age,
over a long period. They may have side effects
when they stop using them. See section 3, “If you including patients with kidney diseases. Patients
with liver disease require close monitoring by the
stop using Relevtec”.
doctor.
Children and adolescents
Contact your doctor or pharmacist if you think that
Relevtec should not be used in children and
the effect of Relevtec is too weak or too strong.
adolescents below the age of 18 years, because
no experience has so far been gained in this age
Method of administration
group.
Transdermal use.
Other medicines and Relevtec
After application, the active substance passes
Tell your doctor or pharmacist if you are using,
through the skin into the blood.
have recently used or might use any other
1. Before using a transdermal patch
medicines.
• Choose an area of skin on your upper body
The following medicines can affect or be affected
that is flat, clean and hairless. Preferably, use
by Relevtec:
the chest below the collar-bone, or the upper
• certain medicines used to treat depression
part of the back. See pictures 1a) and 1b).
or Parkinson’s disease known as monoamine Ask for assistance if you cannot apply the
oxidase (MAO) inhibitors
transdermal patch yourself.
Do not use Relevtec if you are being treated,
1a) 1b)
or have been treated in the last 2 weeks, with
monoamine oxidase inhibitors.
• medicines which calm and/or induce sleep
• anaesthetics
• medicines to treat depression
• medicines to treat mental or anxiety
disorders, with sedative effects
Chest
Back
• other strong painkillers (opioids)
• certain medicines to treat bacterial infections, • If the chosen area has hair, cut it off with a pair
such as erythromycin
of scissors. Do not shave it off.
• certain medicines to treat fungal infections,
• Avoid skin which is red, irritated or has any
such as ketoconazole
other blemishes, for instance large scars.
• certain medicines to treat HIV infections, such • The area of skin you choose must be dry and
as ritonavir, indinavir, saquinavir
clean. If necessary, wash it with cold or
• dexamethasone, a medicine to treat many
lukewarm water. Do not use soap or other
conditions including inflammation
detergents. After a hot bath or shower, wait
• certain medicines to treat epilepsy or certain
until your skin is completely dry and cool.
pain conditions, such as carbamazepine or
Do not apply lotion, cream or ointment to the
phenytoin
chosen area. This might prevent your
• rifampicin, a medicine to treat tuberculosis or transdermal patch from sticking properly.
certain other infections
Sticking on the transdermal patch
Relevtec with food, drink and alcohol
Each patch is marked with “Buprenorphinum
Avoid alcohol and products containing grapefruit
35 µg/h”, “Buprenorphinum 52.5 µg/h” or
while using Relevtec as they may intensify
“Buprenorphinum 70 µg/h”.
effects of buprenorphine.
2. Just before use, tear open the sachet where
Pregnancy and breast-feeding
indicated, as seen in the picture. Remove the
If you are pregnant or breast-feeding, think you
transdermal patch.
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
using this medicine.

2

What you need to know before
you use Relevtec

3








pregnancy
There is not sufficient experience regarding
use of Relevtec in pregnant women. Therefore,
Relevtec transdermal patches should not be
used if you are pregnant or if you could
become pregnant during treatment.

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Continued on next page >>

3. The sticky side of the patch is protected with
a transparent foil. Carefully peel off half the
foil. Try not to touch the sticky part of the patch.






nettle rash
decreased erection
withdrawal symptoms
administration site reactions

Very rare, may affect up to 1 in 10,000 people
• dependence on the medicine
• mood swings
• muscle twitching
• taste disturbance
• pinpoint pupils
• ear or chest pain
4. Stick the patch onto the area of skin you have
• breathing faster than normal
chosen in step 1 and remove the remaining foil.
• hiccups, retching
• pustules, small blisters

5. Press the patch against your skin with the
palm of your hand. Ensure that the whole
patch is in contact with your skin, especially
the edges.

Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. 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 Relevtec

Keep this medicine out of the sight and reach of
children.

Wearing the transdermal patch
Provided that you have applied the patch correctly,
there is little risk of it coming off. You may shower,
bathe or swim while wearing it. However, do not
expose the patch to extreme heat, such as sauna,
infrared lamp, electric blanket or hot water bottle.
In the unlikely event that your patch falls off
before it needs changing, do not reuse it. Stick a
new one on straight away.
Changing the transdermal patch
Take the old transdermal patch off and fold it in
half with the sticky side inwards. Dispose of the
used patch carefully.
Always use a new appropriate site for a new
patch, following steps 1 to 8 above. Wait at least
one week before using the same site again.
Duration of use
This will be decided by your doctor. See also
under “If you stop using Relevtec”.
If you use more Relevtec than you should
Remove the excess patches and consult a doctor
immediately.
Signs of overdose are:
• drowsiness
• nausea, vomiting
• pinpoint pupils
• reduced breathing
• blood circulation collapse
If you forget to use Relevtec
Stick a new transdermal patch on as soon as you
remember and make a note of the day. Amend
your patch change routine. For example, if you
usually change your patch on Mondays and
Thursdays, but you forget and don’t renew your
patch until Wednesday. In this case, change your
patches on Wednesdays and Saturdays from then
on. If you are very late changing your transdermal
patch, pain may return. Contact your doctor if this
occurs.
Never apply extra patches to make up for a
forgotten application.
If you stop using Relevtec
If you interrupt or finish treatment too soon, pain
may return and you may feel unwell. Contact
your doctor who will decide upon the necessary
steps should you wish to stop treatment.
The risk of side effects after ending Relevtec
transdermal patches use is very low. Consult
your doctor if you feel excited, anxious, nervous,
shaky, overactive, or have sleeping difficulties or
digestion problems.
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.
Serious allergic reactions (very rare, may affect
up to 1 in 10,000 people)
Remove the transdermal patch and contact
your doctor immediately if you develop any
allergic reaction symptoms such as:
• swelling of the face, lips, mouth, neck, eyes or
throat
• wheezing or difficulty in swallowing or breathing
• skin rash, redness or itching covering most of
the body
• yellowing of the skin and eyes
• collapse, feeling faint
In some cases delayed allergic reactions occur
with signs of inflammation. In such a case,
remove the transdermal patch and contact
your doctor.
Other side effects can occur with the following
frequencies:
Very common, may affect more than 1 in 10
people
• nausea
• skin reddening, itching

Do not use this medicine after the expiry date
which is stated on the carton and on the sachet.
The expiry date refers to the last day of that
month.
This medicine does not require any special
storage conditions.
Do not throw away any medicines via wastewater
or household waste. Used transdermal patches
should be folded with the adhesive surfaces
inwards. Ask your pharmacist how to throw away
medicines you no longer use. These measures
will help protect the environment.

6

Contents of the pack and other
information

What Relevtec contains
The active substance is buprenorphine.
Relevtec 35 microgram/hour transdermal patch:
Each transdermal patch contains 20 mg of
buprenorphine in a patch size of 25 cm2
releasing 35 micrograms of buprenorphine per
hour.
Relevtec 52.5 microgram/hour transdermal
patch: Each transdermal patch contains 30 mg
of buprenorphine in a patch size of 37.5 cm2
releasing 52.5 micrograms of buprenorphine per
hour.
Relevtec 70 microgram/hour transdermal patch:
Each transdermal patch contains 40 mg of
buprenorphine in a patch size of 50 cm2
releasing 70 micrograms of buprenorphine per
hour.
The other ingredients are:
Release liner (to be removed before applying
the patch): poly(ethylene terephthalate) foil,
siliconized
Adhesive matrix (containing buprenorphine):
levulinic acid, oleyl oleate, povidone K90,
poly[butylacrylate-co-(2-ethylhexyl)acrylate-comethylmethacrylate-co-N-tert-octylacrylamid]
(32:32:15:20), poly[acrylic acid-co-butylacrylateco-(2-ethylhexyl)acrylate-co-vinylacetate]
(5:15:75:5)
Separating film (between the adhesive matrices
with and without buprenorphine): poly(ethylene
terephthalate) foil
Adhesive matrix (without buprenorphine):
acrylate adhesive
Backing layer (printed): polyurethane backing foil,
printing ink
What Relevtec looks like and contents of the
pack
Relevtec is a pale yellowish-brown, rectangular
transdermal patch with rounded edges,
containing the following imprint:
Buprenorphinum 35 µg/h
Buprenorphinum 52.5 µg/h
Buprenorphinum 70 µg/h
Each transdermal patch is individually packed in
a child resistant sachet.
Carton containing 2, 3, 4, 5, 6, 8, 9, 10, 11, 12,
16, 18, 19, 20, 21 or 24 transdermal patches.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sandoz Limited
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR,
UK
Manufacturer
Hexal AG
Industriestraße 25,
83607 Holzkirchen,
Germany
This leaflet was last revised in 06/2016

Common, may affect up to 1 in 10 people
• dizziness
• headache
• shortness of breath
• vomiting, constipation
• skin changes
• sweating
• tissue swelling caused by excess fluid
• tiredness
Uncommon, may affect up to 1 in 100 people
• confusion
• sleep disorder, restlessness
• sedation, sleepiness
• blood circulation disorders such as low blood
pressure and, rarely, fainting
• dry mouth
• rash
• difficulties in passing urine, urine retention
• weariness
Rare, may affect up to 1 in 1,000 people
• loss of appetite
• hallucinations, anxiety, nightmares
• decreased sexual drive
• reduced concentration
• speech or balance disorder
• drowsiness
• abnormal skin sensation such as numbness,
prickling, tingling or burning
• visual disturbance such as blurred vision
• swelling of the eyelid
• hot flushes
• breathing difficulties
• heartburn

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44068784
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Date prepared:
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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