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RELETRANS 20 MICROGRAM/HOUR TRANSDERMAL PATCH

Active substance(s): BUPRENORPHINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Reletrans 5 microgram/hour transdermal patch
Reletrans 10 microgram/hour transdermal patch
Reletrans 15 microgram/hour transdermal patch
Reletrans 20 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 Reletrans is and what it is used for
2. What you need to know before you use
Reletrans
3. How to use Reletrans
4. Possible side effects
5. How to store Reletrans
6. Contents of the pack and other information

1

What Reletrans is and what it is
used for

Reletrans transdermal patches contain the active
ingredient buprenorphine which belongs to a
group of medicines called strong analgesics or
‘painkillers’.
Reletrans is used in adults to relieve moderate,
long-lasting pain that requires the use of a strong
painkiller.
Reletrans should not be used to relieve acute
pain.

2

What you need to know before
you use Reletrans

Do not use Reletrans if you
• are allergic to buprenorphine or any of the other
ingredients of this medicine (listed in section 6)
• have breathing problems
• are addicted to drugs
• are taking a type of medicine known as a
monoamine oxidase (MAO) inhibitor (examples
include tranylcypromine, phenelzine,
isocarboxazid, moclobemide and linezolid), or
you have taken this type of medicine in the last
two weeks
• suffer from myasthenia gravis (a condition in
which the muscles become weak)
• have previously suffered from withdrawal
symptoms such as agitation, anxiety, shaking
or sweating upon stopping taking alcohol
Reletrans must not be used to treat symptoms
associated with drug withdrawal.
Warnings and precautions
Talk to your doctor or pharmacist before using
Reletrans if you:
• recently drunk a lot of alcohol
• suffer from seizures, fits or convulsions
• have a severe headache or feel sick due to a
head injury or increased pressure in your skull
(for instance due to brain disease). This is
because buprenorphine may make symptoms
worse or hide the extent of a head injury.
• are feeling light-headed or faint
• have severe liver problems
• have ever been addicted to drugs or alcohol
• have a high temperature, as this may lead to
larger quantities of the active ingredient being
absorbed into the blood than normal
• are an athlete: This medicine may cause
positive results in sports doping control tests.
If you have recently had an operation, please
speak to your doctor before using these
transdermal patches.
Children and adolescents
Reletrans should not be used in patients below
the age of 18 years.
Other medicines and Reletrans
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
• Reletrans must not be used together with a
type of medicine known as a monoamine
oxidase (MAO) inhibitor (examples include
tranylcypromine, phenelzine, isocarboxazid,
moclobemide and linezolid), or if you have
taken this type of medicine in the last two weeks.
• If you take some medicines such as
phenobarbital or phenytoin (medicines
commonly used to treat seizures, fits or
convulsions), carbamazepine (a medicine to
treat seizures, fits or convulsions and certain
pain conditions), or rifampicin (a medicine to
treat tuberculosis) the effects of Reletrans may
be reduced.
• Reletrans may make some people feel
drowsy, sick or faint or make them breathe
more slowly or weakly. These side effects may
be made worse if other medicines that produce
the same effects are taken at the same time.
These include certain medicines to treat pain,
depression, anxiety, psychiatric or mental
disorders, medicines to help you sleep,
medicines to treat high blood pressure such as
clonidine, other opioids (which may be found in
painkillers or certain cough mixtures e.g.
morphine, dextropropoxyphene, codeine,
dextromethorphan, noscapine), antihistamines
which make you drowsy, or anaesthetics such
as halothane.
• Reletrans must be used with caution if you
are also taking benzodiazepines (medicines
used to treat anxiety or to help you sleep).
This combination may cause serious breathing
problems which could be fatal in case of
overdose. Tell your doctor if you are taking this
combination.
Reletrans with alcohol
Alcohol may make some of the side effects worse
and you may feel unwell if you drink alcohol whilst
using Reletrans. Drinking alcohol whilst using
Reletrans may also affect your reaction time.
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.
You should not use Reletrans if you are pregnant,
likely to become pregnant or are breast-feeding.
Driving and using machines
Reletrans may affect your reactions to such an
extent that you may not react adequately or
quickly enough in the event of unexpected or
sudden occurrences. This applies particularly:
• at the beginning of treatment
• if you are taking medicines to treat anxiety or
help you sleep
• if your dose is increased

If you are affected (e.g. feel dizzy, drowsy or
have blurred vision) you should not drive or
operate machinery whilst using Reletrans, or
for 24 hours after removing the transdermal patch.
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
Details regarding a new driving offence
concerning driving after drugs have been taken
in the UK may be found here: https://www.gov.uk/
drug-driving-law.
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 Reletrans

Always use this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
Different strengths of Reletrans are available.
Your doctor will decide which strength of
Reletrans will suit you best.
During treatment, your doctor may change the
transdermal patch you use to a smaller or larger
one if necessary, or tell you to use a combination
of up to two patches. You should not apply
more than two transdermal patches at the
same time up to a maximum total dose of
40 micrograms/hour.
If you feel that the effect of the buprenorphine
transdermal patch is too weak or too strong,
talk to your doctor or pharmacist.
Adults
Unless your doctor has told you differently, attach
one Reletrans transdermal patch (as described
in detail below) and change it every seventh day,
preferably at the same time of day. Your doctor
may wish to adjust the dose after 3-7 days until
the correct level of pain control has been found.
If your doctor has advised you to take other
painkillers in addition to the transdermal patch,
strictly follow the doctor’s instructions, otherwise
you will not fully benefit from treatment with the
buprenorphine patch. The transdermal patch
should be worn for 3 full days before increasing the
dose, this is when the maximum effect of a given
dose is established.
Patients with liver disease
In patients with liver disease, the effects and
period of action of the buprenorphine transdermal
patch may be affected and your doctor will
therefore check on you more closely.
Use in children and adolescents
Reletrans transdermal patches should not be
used in patients below the age of 18 years.
Method of administration
Reletrans transdermal patch is for transdermal
use.
The transdermal patches act through the skin.
After application, buprenorphine passes through
the skin into the blood.
Before applying Reletrans
• Choose an area of non-irritated, intact skin on
your upper arm, outer arm, upper chest, upper
back or side of the chest (see illustrations
below). Ask for assistance if you cannot apply
the transdermal patch yourself.

















The buprenorphine transdermal patch should
be applied to a relatively hairless or nearly
hairless skin site. If no suitable hair free sites
are available the hairs should be cut off with a
pair of scissors. Do not shave them off.
Avoid skin which is red, irritated or has any
other blemishes, for instance large scars.
The area of skin you choose must be dry and
clean. If necessary, wash it with cold or
lukewarm water. Do not use soap, alcohol, oil,
lotions or other detergents. After a hot bath or
shower, wait until your skin is completely dry
and cool. Do not apply lotion, cream or
ointment to the chosen area. This might prevent
your transdermal patch from sticking properly.

Applying the transdermal patch
Step 1: Each transdermal patch is sealed in a
sachet. Just before use, open the sachet by
tearing where indicated. Take out the transdermal
patch. Do not use the transdermal patch if the
sachet seal is broken.

Step 2: The sticky side of the transdermal patch
is covered with a transparent foil. Carefully peel
off half the foil. Try not to touch the sticky part of
the transdermal patch.
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For use in adults

Step 3: Stick the transdermal patch on to the
area of skin you have chosen and remove the
remaining foil.

Step 4: Press the transdermal patch against your
skin with the palm of your hand and count slowly
to 30. Make sure that the whole transdermal patch
is in contact with your skin, especially at the edges.

Wearing the transdermal patch
You should wear the transdermal patch for seven
days. Provided that you have applied the
transdermal patch correctly, there is little risk of it
coming off. If the edges of the transdermal patch
begin to peel off, they may be taped down with a
suitable skin tape. You may shower, bathe or
swim whilst wearing it.
Do not expose the transdermal patch to extreme
heat (e.g. heating pads, electric blanket, heat
lamps, sauna, hot tubs, heated water beds, hot
water bottle, etc) as this may lead to larger
quantities of the active ingredient being absorbed
into the blood than normal. External heat may
also prevent the transdermal patch from sticking
properly. If you have a high temperature this may
alter the effects of Reletrans (see “Warnings and
precautions” section above).
In the unlikely event that your transdermal patch
falls off before it needs changing, do not use the
same patch again. Stick a new one on straight away
(see “Changing the transdermal patch” below).
Changing the transdermal patch
• Take the old transdermal patch off.
• Fold it in half with the sticky side inwards.
• Open and take out a new transdermal patch.
Use the empty sachet to dispose of the old
transdermal patch. Now discard the sachet
safely.
• Stick a new transdermal patch on a different
appropriate skin site (as described above). You
should not apply a new transdermal patch to
the same site for 3-4 weeks.
• Remember to change your transdermal patch
at the same time of day. It is important that you
make a note of the time of day.
Duration of treatment
Your doctor will tell you how long you should be
treated with Reletrans. Do not stop treatment
without consulting a doctor, because your pain
may return and you may feel unwell (see also
“If you stop using Reletrans” below).
If you use more Reletrans than you should
As soon as you discover that you have used
more transdermal patches than you should,
remove all transdermal patches and call your
doctor or hospital straight away. People who
have taken an overdose may feel very sleepy
and sick. They may also have breathing
difficulties or lose consciousness and may need
emergency treatment in hospital. When seeking
medical attention make sure that you take this
leaflet and any remaining transdermal patches
with you to show to the doctor.
If you forget to apply Reletrans
Stick a new transdermal patch on as soon as you
remember. Also make a note of the date, as your
usual day of changing may now be different.
If you are very late changing your transdermal
patch, your pain may return. In this case, please
contact your doctor.

Uncommon (may affect up to 1 in 100 people):
• dehydration
• mood swings, restlessness, agitation, anxiety,
feeling detached from oneself, a feeling of
extreme happiness, hallucinations, nightmares
• changes in taste, difficulty in speaking, reduced
sensitivity to pain or touch, loss of memory,
migraine, fainting, shaking, problems with
concentration or co-ordination
• dry eyes, blurred vision
• a ringing or buzzing sound in the ears
• a feeling of dizziness or spinning
• high or low blood pressure, angina pectoris
(severe chest pain associated with heart
disease), fast or irregular heart beat
• worsening of breathing problems associated
with asthma, cough, hiccups, over breathing,
reduced oxygen in the blood, runny nose,
wheezing
• wind
• weight loss
• dry skin, swelling of the face
• muscle cramps, spasms, aches and weakness
• difficulty in beginning the flow of urine
• inability to fully empty the bladder
• a flu like illness, high temperature, shivering,
generally feeling unwell
• an increase in accidental injuries (e.g. falls)
• withdrawal symptoms such as agitation,
anxiousness, sweating or shaking upon
stopping using Reletrans
• a feeling of faintness, especially on standing up
If you need to have blood tests remind your doctor
that you are using Reletrans. This is important
because Reletrans may change the way your
liver works and this could affect the results of
some blood tests.
Rare (may affect up to 1 in 1,000 people):
• decreased sexual drive, mental disorder
• difficulties with balance
• swelling of the eyelids or face, a reduction in
size of the pupils in the eye
• difficulty in breathing
• diverticulitis (inflammation of the intestine),
difficulty in swallowing
• local allergic reaction with marked signs of
swelling (in such cases treatment should be
stopped)
• decreased erection, sexual dysfunction
• colicky abdominal pain or discomfort
Very rare (may affect up to 1 in 10,000 people):
• muscle twitching
• ear pain
• blisters
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
Website: 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 Reletrans

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the carton and on the sachet after EXP.
The expiry date refers to the last day of that month.
Do not store it above 25°C.
Do not use the transdermal patch if you notice
that the sachet seal is already broken.
Used transdermal patches must be folded over
on themselves with the adhesive layer inwards,
and discarded safely.
Do not throw away any medicine via wastewater
or household waste. 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

Do not apply additional transdermal patches to
make up for the forgotten application.

What Reletrans contains

If you stop using Reletrans
If you stop using Reletrans too soon or you
interrupt your treatment your pain may return.
If you wish to stop treatment please consult your
doctor. They will tell you what can be done and
whether you can be treated with other medicines.

Reletrans 5 microgram/hour transdermal
patch:
Each transdermal patch contains 5 mg of
buprenorphine per 6.25 cm2, releasing
5 micrograms of buprenorphine per hour.

Some people may have side effects when they
have used strong painkillers for a long time and
stop using them. The risk of having effects after
stopping Reletrans is very low. However, if you
feel agitated, anxious, nervous or shaky, if you
are overactive, have difficulty sleeping or
digestive problems, tell your doctor.
The pain relieving effect of Reletrans is
maintained for some time after removal of the
transdermal patch. You should not start another
opioid analgesic (strong painkiller) within
24 hours after removal of the transdermal patch.
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 side effects that may be associated with
Reletrans are similar to those seen with other
strong painkillers and include difficulty in
breathing and low blood pressure.
This medicine can cause allergic reactions,
although serious allergic reactions are rare.
Remove the transdermal patch and tell your doctor
immediately if you get any sudden wheeziness,
difficulties in breathing, swelling of the eyelids,
face or lips, rash or itching especially those
covering your whole body.
There is a risk that you may become addicted or
reliant on Reletrans.
In patients treated with Reletrans, the following
other side effects have been reported:
Very common (may affect more than 1 in
10 people):
• headache, dizziness, drowsiness
• constipation, dry mouth, feeling or actually
being sick
• itching, redness, itching at application site
Common (may affect up to 1 in 10 people):
• loss of appetite
• confusion, depression, difficulty in sleeping,
nervousness
• tingling or numbness
• flushing of the skin
• shortness of breath
• abdominal pain or discomfort, diarrhoea,
indigestion
• sweating, rash, skin eruptions
• tiredness, a feeling of unusual weakness, pain,
chest pain, swelling of hands, ankles or feet,
redness or rash at the application site

• The active substance is buprenorphine.

Reletrans 10 microgram/hour transdermal
patch:
Each transdermal patch contains 10 mg of
buprenorphine per 12.5 cm2, releasing
10 micrograms of buprenorphine per hour.
Reletrans 15 microgram/hour transdermal
patch:
Each transdermal patch contains 15 mg of
buprenorphine per 18.75 cm2, releasing
15 micrograms of buprenorphine per hour.
Reletrans 20 microgram/hour transdermal
patch:
Each transdermal patch contains 20 mg of
buprenorphine per 25 cm2, releasing
20 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 K 90, poly
[acrylic acid-co-butylacrylate-co-(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 Reletrans looks like and contents of the
pack
Reletrans is a pale yellowish-brown, rectangular
transdermal patch with rounded edges,
containing the following imprint:
Buprenorphinum 5 µg/h
Buprenorphinum 10 µg/h
Buprenorphinum 15 µg/h
Buprenorphinum 20 µg/h
Each transdermal patch is individually packed in
a child resistant sachet.
Carton containing 1, 2, 3, 4, 5, 8, 10, 12 or 20
transdermal patches.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Limited, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR. United Kingdom
Manufacturer
Hexal AG, Industriestrasse 25
D-83607 Holzkirchen, Germany
This leaflet was last revised
in 07/2016

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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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