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PRENOTRIX 35 MICROGRAM /H TRANSDERMAL PATCH

Active substance(s): BUPRENORPHINE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Prenotrix
35 / 52.5 / 70 micrograms/h
transdermal patch
Buprenorphine
Read all of this leaflet carefully before
you start using this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.

• if you are dependent on strong pain relievers
(opiods);
• if you suffer from a disease in which you have
or may have great difficulty breathing;

• The use of the medicinal product can lead to
positive results in the event of a doping test.

• if you are taking monoamine oxidase (MAO)
inhibitors (certain medicines used to treat
depression) or you have taken this type of
medicines in the last two weeks (see “Other
medicines and Prenotrix”);

Other medicines and Prenotrix

• if you suffer from myasthenia gravis (a certain
type of severe muscle weakness);
• if you suffer from delirium tremens ( confusion
and trembling caused by abstinence from
alcohol following habitual excessive drinking or
occurring during an episode of heavy alcohol
consumption)

• 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.

Prenotrix must not be used to treat withdrawal
symptoms in drug-dependent persons.

• If you get any of the side effects, talk to your
doctor of pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.

Talk to your doctor or pharmacist before using
Prenotrix

WHAT IS IN THIS LEAFLET:
1. WHAT PRENOTRIX IS AND WHAT IT IS USED
FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
PRENOTRIX
3. HOW TO USE PRENOTRIX
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE PRENOTRIX
6. CONTENTS OF THE PACK AND OTHER
INFORMATION

Warnings and precautions

• if you have recently drunk a lot of alcohol;
• if you suffer from seizures or convulsions (fits);
• if your consciousness is disturbed (feeling
light-headed or faint) for an unknown reason;
• if you are in a state of shock (cold sweat might
be a sign of it);
• if the pressure in your skull is increased (for
instance after head injury or in brain disease),
and artificial respiration is not possible;
• if you have difficulty breathing or are taking
other medicines that may make you breathe
more slowly or weakly (see "Other medicines
and Prenotrix");
• if your liver does not work properly;

1

WHAT PRENOTRIX IS AND WHAT
IT IS USED FOR

Prenotrix is an analgesic (a pain-relieving
medicine) intended to relieve moderate to severe
cancer pain and severe pain that has not
responded to other types of painkillers.
Buprenorphine is an opioid (strong pain reliever),
which reduces pain by acting on the central
nervous system (specific nerve cells in the spinal
cord and in the brain). Prenotrix is not suitable for
the treatment of acute (short-lasting) pain.

2

WHAT YOU NEED TO KNOW BEFORE
YOU USE PRENOTRIX

Do not use Prenotrix
• if you are allergic (hypersensitive) to the active
substance buprenorphine, soy, peanut or any
of the other ingredients of this medicine (listed
in section 6.);

product has not been studied in this age
group.

• if you are inclined to abuse medicines or drugs.
Please consult your doctor if any of these
statements apply to you or were applicable to you
at any time in the past.
Also, please
precautions:

be

aware

of

the

following

Please tell your doctor or pharmacist if you are
taking/using, have recently taken/used or might
take/use or have recently taken any other
medicines, including medicines obtained without
a prescription.
• Prenotrix must not be used together with
monoamine oxidase (MAO) inhibitors (certain
medicines used to treat depression and
parkinson’s disease), or if you have taken this
type of medicine for the last 2 weeks.
• Prenotrix may make some people feel drowsy,
sick, or faint or make them breathe more
slowly or weakly. These side effects may be
intensified if other medicines that may produce
the same effects are taken at the same time.
These other medicines include other strong
pain relievers (opioids), certain sleeping pills,
anaesthetics, and medicines used to treat
certain psychological diseases such as
tranquillizers, anti-depressants, and
neuroleptics. Some of these combinations in
higher doses may cause serious problems with
the breathing regulation in the brain - which
may get life-threatening.
• If Prenotrix is used together with some
medicines, the effects of the transdermal patch
may be increased. These medicines include e.g.
certain anti-infectives/anti-fungals (e.g.
containing erythromycin or ketoconazole) or
HIV medicines (e.g. containing ritonavir).
• If Prenotrix is used together with other
medicines, the effects of the transdermal patch
may be reduced. These medicines include
certain products, e.g. dexamethasone;
medicines to treat epilepsy (e.g. containing
carbamazepine, or phenytoin) or medicines for
tuberculosis (e.g. rifampicin).
Prenotrix with food and drink

• Some people may become dependent on
strong pain relievers such as Prenotrix when
they use them over a long period of time. They
may have withdrawal effects when they stop
using them (see “If you stop using Prenotrix”).

You should not drink alcohol while using
Prenotrix. Alcohol may intensify certain side
effects of the transdermal patch and you may feel
unwell. Drinking grapefruit juice may intensify the
effects of Prenotrix.

• Fever and external heat may lead to larger
quantities of buprenorphine in the blood than
normal. Also, external heat may prevent the
transdermal patch from sticking properly.
Therefore, do not expose yourself to external
heat (e.g. sauna, infra-red lamps, electric
blankets, hot water bottles) and consult your
doctor if you have fever

Pregnancy and breast-feeding

• Prenotrix is not recommended for persons
below the age of 18 years, because the

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
using this medicine.
Pregnancy
There is not sufficient experience regarding the
use of Prenotrix in pregnant women. Therefore
you should not use Prenotrix if you are pregnant.

Breast-feeding

Route of administration

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

This patch is for transdermal use. Prenotrix acts
through the skin. When transdermal patch is
applied to the skin, the active substance
buprenorphine passes through the skin into the
blood.

Ask your doctor or pharmacist for advice before
taking any medicine.

The recommended dose is:

Driving and using machines

Adults

Prenotrix can affect your ability to drive and use
machines as it may make you sleepy or dizzy.

Unless your doctor has told you differently, attach
one Prenotrix transdermal patch (as described in
detail below) and change it after 3 days at the
latest. To help you remember when to change
your transdermal patch, you should make a note
on the calendar on the outer packaging. If your
doctor has advised you to take other pain relievers
in addition to the transdermal patch, strictly
follow the doctor's instructions, otherwise you will
not fully benefit from treatment with Prenotrix.

During treatment with Prenotrix do not drive or
use machines, nor do so for at least 24 hours after
the end of treatment.
• It is an offence to drive if this medicine affects
your ability to drive.
• However, you would not be committing an
offence if:
• Prenotrix 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
The effect on your ability to drive applies
particularly:
• at the beginning of treatment,
• when you switch to Prenotrix from another
pain reliever,
• if you also use other medicines that act on the
brain,
• if you drink alcohol.
Talk to your doctor or pharmacist if you are not
sure whether it is safe for you to drive while taking
this medicine.
Prenotrix contains soya oil
If you are allergic to peanut or soya, do not use
this medicinal product.

3

HOW TO USE PRENOTRIX

Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Prenotrix is available in three strengths:
Prenotrix 35 micrograms/h transdermal patch,
Prenotrix 52.5 micrograms/h transdermal patch
and Prenotrix 70 micrograms/h transdermal patch.
The choice of which strength of Prenotrix will suit
you best will be made by your doctor. During
treatment your doctor may change which
transdermal patch you use to a smaller or larger
one if necessary.
Always use Prenotrix exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.

not apply lotion, cream or ointment to the
chosen area. This might prevent your
transdermal patch from sticking properly
Applying the transdermal patch:
1. Please do not open the
sachet, before you actually
intend
to
use
the
transdermal patch. Each
transdermal patch is sealed
in a sachet.
2. Start with peel off the
loose separation foil.

Patients under 18 years of age
Prenotrix should not be used in persons below the
age of 18 years, because no experience has so far
been gained in this age group.
Elderly patients
No dosage adjustment is needed for elderly
patients.
Patients with kidney disease / dialysis patients
In patients with kidney disease and in dialysis
patients, no dosage adjustment is necessary.

3. Peel off one half of the
strip-foil of the transdermal
patch and try not to touch
the sticky part .

4. Stick the transdermal patch
onto the area of skin you
have chosen and remove
the remaining foil.

Patients with liver disease
In patients with liver disease, the intensity and
duration of action of Prenotrix may be affected. If
this applies to you, your doctor will check on you
more closely.
Instruction for opening of child resistant
pouch
1. Incise up to markings / arrowheads at each side
2. Rip at both notches along the heat-sealed joint
3. Open the pouch and take the patch
Method of administration
Before applying the transdermal patch
• Choose an area of skin which is flat, clean and
hairless on your upper body, preferably on the
chest below the collar-bone or on the upper
part of the back. Call assistance if you cannot
apply the transdermal patch yourself.
• If the chosen area has hairs, cut them 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 or other
detergents. After a hot bath or shower, wait
until your skin is completely dry and cool. Do

5. Press
the
transdermal
patch against your skin
with the palm of your hand
for 30 to 60 seconds. Make
sure that the whole
transdermal patch is in
contact with your skin,
especially at the edges.
6. Wash your hands after
using the transdermal
patch. Do not use any
cleansing products.

Wearing the transdermal patch
You may wear the transdermal patch for up to 3
days. Provided that you have applied the
transdermal patch correctly, there is little risk of it
coming off. You may shower, bathe or swim while
wearing it. However, do not expose the
transdermal patch to extreme heat (e.g. sauna
baths, infra-red lamps, electric blankets, hot water
bottles).
In the unlikely event that your transdermal patch
falls off before it needs changing, do not use the
same transdermal 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 sides inwards.
• Throw it away carefully,
• Stick a new transdermal patch on a different
skin site (as described above). Wait at least one
week before using the same skin site

side effects, please consult your doctor. He/she
will tell you what can be done and whether you
can be treated with other medicines.
Some people may experience withdrawal-effects
when they have used strong pain relievers for a
long time and stop using them. The risk of having
effects after you stop using Prenotrix is very low.
However, if you feel agitated, anxious, nervous or
shaky, if you are overactive, have difficulty
sleeping or digestion problems, tell your doctor.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Prenotrix can cause side effects,
although not everybody gets them
Side effects are classified as follows:
very common: may affect more than 1 in 10
people
common:

may affect up to 1 in10 people

Your doctor will tell you how long you may use
Prenotrix. Do not stop using Prenotrix on your
own account, because pain may return and you
may feel unwell (see also “If you stop using
Prenotrix” below).

uncommon:

may affect up to 1 in 100
people

If you have the impression that the effect of the
Prenotrix transdermal patch is too weak or too
strong, tell your doctor or pharmacist.

very rare:

Duration of treatment

rare:

not known:

As soon as you discover that you have used more
transdermal patch than you should, remove the
excess transdermal patch and talk to a doctor or
pharmacist.
If you forget to use Prenotrix
If you forgot an application, stick a new
transdermal patch on as soon as you remember. If
you are very late changing your transdermal
patch, pain may return. In this case please contact
your doctor.
Never apply twice the number of transdermal
patches to make up for the forgotten application!
If you stop using Prenotrix
If you interrupt or finish using Prenotrix too soon,
pain may return.
If you wish to stop use on account of unpleasant

may affect up to 1 in 10,000
people
frequency cannot be
estimated from the available
data

difficulty concentrating, speech
disorder, muzziness, disturbed
balance, abnormal skin sensations
(numbness, prickling or burning
sensations)

General disorders
Common:

oedema (e.g. swelling of the
legs), tiredness

Uncommon:

weariness

Rare:

withdrawal symptoms (see
below), administration site
reactions

Eye disorders

Very rare:

chest pain

Rare:

visual disturbance, blurred vision,
swollen eyelids

If you notice any of the side effects listed above,
tell your doctor as soon as possible.

Very rare:

pin-point pupils

In some cases delayed allergic reactions occurred
with marked signs of inflammation. In such a case
you should stop using Prenotrix after you have
talked to your doctor.

Very rare:

muscle twitching, taste disorders

Ear disorders
Very rare:

ear pain

Heart and blood circulation disorders
Uncommon: circulation disorders (such as low
blood pressure or, rarely, even
circulatory collapse)
Rare:

hot flushes

Chest and lung disorders
Common:

shortness of breath

Rare:

difficulty breathing (respiratory
depression)

Very rare:

abnormally rapid breathing,
hiccups

Digestive system disorders
Very common: nausea (feeling sick)

If you experience swelling of the hands, feet,
ankles, face, lips, mouth or throat with may
cause difficulty in swallowing and breathing,
hives, fainting, yellowing of the skin and
eyes (also called jaundice), remove the
transdermal patch and call your doctor
immediately or seek help at the casualty
department of the nearest hospital. These
can be symptoms of a very rare serious
allergic reaction.
Some people may have withdrawal symptoms
when they have used strong pain relievers for a
long time and stop using them. The risk of having
withdrawal effects when you stop using Prenotrix
is low. However, if you feel agitated, anxious,
nervous or shaky, if you are overactive, have
difficulty sleeping or digestion problems, tell your
doctor.

Uncommon:

dry mouth

If any of the side effects gets serious, or if you
notice any side effects not mentioned in this
leaflet, please tell your doctor or pharmacist.

The following side effects have been reported:

Rare:

heartburn

Reporting of side effects

Immune system disorders

Very rare:

retching

If you get any side effects, talk to your doctor or
pharmacist. This includes any possiblie side effects
not listed in this leaflet. You can also report any
side effects directly via Yellow Card Scheme
[www.mhra.gov.uk/yellowcard].

If you use more Prenotrix than you should
If this happens there may be signs of an overdose
of the substance buprenorphine. An overdose
may intensify the side effects of buprenorphine
such as drowsiness, nausea and vomiting. You
may get pin-point pupils and breathing may
become slow and weak. You may also get
cardiovascular collapse.

may affect up to 1 in1,000
people

Rare:

Very rare:

Common:

vomiting, constipation

severe allergic reactions

Metabolism and nutrition disorders

Skin disorders (generally at the site of
application)

Rare:

Very common: redness, itching

loss of appetite

Common:
Psychiatric disorders

skin changes (exanthema,
generally on repeated use),
sweating

Uncommon: confusion, sleep disorder,
restlessness

Uncommon:

rash

Rare:

illusions such as hallucinations,
anxiety and nightmares, reduced
sex drive

Rare:

hives

Very rare:

pustules, small blisters

dependence, mood swings

Urinary system disorders

Very rare:

Uncommon:
Nervous system disorders
Common:

dizziness, headache

Uncommon: various degrees of sedation
(calmness), ranging from tiredness
to muzziness

difficulty in passing water,
urinary retention (less urine than
normal)

By reporting side effects you can help provide
more information on the safety of this medicine.

5

HOW TO STORE PRENOTRIX

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 the sealsachet
(sealed bag). The expiry date refers to the last day
of that month.
Open the sachet only in order to use the patch
immediately.

Reproductive system disorders

Storage conditions: Do not store above 25°C.

Rare:

Do not freeze.

erection difficulties

Disposal of used or non-used transdermal
patch

sealed sachets of 4, 5, 8, 10, 16, 20, 24 (6 x 4)
transdermal patches.

Used transdermal patches should be folded with
the adhesive surface inwards and discarded or
whenever possible returned to the pharmacy. Any
unused medicinal product should be discarded or
returned to the pharmacy.

Prenotrix 52.5 micrograms/h is available in single
sealed sachets of 4, 5, 8, 10, 16, 20, 24 (6 x 4)
transdermal patches.

6

CONTENTS OF THE PACK AND
OTHER INFORMATION

What Prenotrix contains
The active substance is: Buprenorphine

Prenotrix 70 micrograms/h is available in single
sealed sachets of 4, 5, 8, 10, 16, 20, 24 (6 x 4)
transdermal patches.
Not all pack sizes may be marketed.
The following strengths of the patches are
available:
Prenotrix 35 micrograms/h
Prenotrix 52.5 micrograms/h

Prenotrix 35 micrograms/h transdermal
patch: Each transdermal patch contains 20 mg
buprenorphine and releases about 35 micrograms
of buprenorphine per hour. The area of the
transdermal patch containing the active substance
is 25 cm2.

Prenotrix 70 micrograms/h

Prenotrix 52.5 micrograms/h transdermal
patch: Each transdermal patch contains 30 mg
buprenorphine and releases about 52.5
micrograms per hour. The area of the transdermal
patch containing the active substance is 37.5 cm2.

Manufacturer:
Acino AG,
Am Windfeld 35,
83714 Miesbach, Germany

Prenotrix 70 micrograms/h transdermal
patch: Each transdermal patch contains 40 mg
buprenorphine releases about 70 micrograms per
hour. The area of the transdermal patch
containing the active substance is 50 cm2.
The other ingredients in Prenotrix are:
Drug
containing
adhesive
matrix:
styrene-butadiene-styrene
(SBS)
and
styrene-butadiene
block
co-polymers,
colophonium
resin,
antioxidants
(2,4-Bis(1,1-Dimethylethyl)phenyl phosphite (3:1);
Tris(2,4-Di-Tert-Butylphenyl)phosphate), aloe vera
leaf extract oil (also contains refined soya-bean oil
and alpha tocopherol acetate).
Backing
foil:
pigmented
polyethylene,
thermoplastic resin and aluminium vapour coated
polyester, blue printing colour.
Release liner with pull of aid: polyester film, one
side siliconised (to be removed prior application).
What Prenotrix looks like and contents of the
pack
The patches are tan coloured, rectangular with
four rounded edges and topped off corners and
labeled with Buprenorphin 35 µg/h.
The patches are tan coloured, rectangular with
four rounded edges and topped off corners and
labeled with Buprenorphin 52.5 µg/h.
The patches are tan coloured, rectangular with
four rounded edges and topped off corners and
labeled with Buprenorphin 70 µg/h.
Each patch is packed in single sealed sachets.
Prenotrix 35 micrograms/h is available in single

Marketing Authorisation Holder:
Activase Pharmaceuticals Ltd,
11 Boumpoulinas, 3rd floor,
P.C. 1060 Nicosia, Cyprus

This medicinal product is authorised in the
Member States of the EEA under the
following names:
DE Buprenorphin Acino 35 Mikrogramm/Stunde
transdermales Pflaster
Buprenorphin Acino 52,5
Mikrogramm/Stunde transdermales Pflaster
Buprenorphin Acino 70 Mikrogramm/Stunde
transdermales Pflaster
UK Prenotrix 35 microgram/h transdermal patch
Prenotrix 52.5 microgram/h transdermal
patch
Prenotrix 70 microgram/h transdermal patch
ES Canur 35 µg/h Parche transdérmico
Canur 52,5 µg/h Parche transdérmico
Canur 70 µg/h Parche transdérmico
This leaflet was last revised in 07/2015.
A0130-0131-0132/O/PIL/G2

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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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