TRANSTEC 70 MICROGRAM/H TRANSDERMAL PATCHES

Active substance: BUPRENORPHINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Transtec® 35 micrograms/h Transdermal Patches
Transtec® 52.5 micrograms/h Transdermal Patches
Transtec® 70 micrograms/h Transdermal Patches
(buprenorphine)
This medicine is available using any of the above names but will be referred to as Transtec
throughout the following leaflet.
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.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Transtec is and what it is used for
2. Before you use Transtec
3. How to use Transtec
4. Possible side effects
5. How to store Transtec
6. Further information
1. What Transtec is and what it is used for
Transtec 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. Transtec
acts through the skin. When the transdermal patch is applied to the skin, the active
substance buprenorphine passes through the skin into the blood. 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). The effect of the transdermal patch
lasts for up to four days.
Transtec is not suitable for the treatment of acute (short-lasting) pain.
2. Before you use Transtec
Do not use Transtec,
if you are allergic (hypersensitive) to the active substance buprenorphine or any of the
other ingredients of Transtec;
■ if you are dependent on strong pain relievers (opioids);
■ if you suffer from a disease in which you have or may have great difficulty breathing
■ if you are taking monoamine oxidase (MAO) inhibitors (certain medicines used to treat
depression) or you have taken this type of medicine in the last two weeks (see "Taking
other medicines");
■ 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);
■ if you are pregnant.
Transtec must not be used to treat withdrawal symptoms in drug-dependent persons.


Take special care with Transtec,









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 "Taking other medicines");
if your liver does not work properly;
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 be aware of the following precautions:
■ Some people may become dependent on strong pain relievers such as Transtec 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 Transtec”).
■ 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.
■ Transtec should not be used in persons below the age of 18 years, because no
experience has so far been gained in this age group.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
■ Transtec must not be used together with monoamine oxidase (MAO) inhibitors (certain
medicines used to treat depression), or if you have taken this type of medicine for the
last 2 weeks.
■ Transtec 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.
■ If Transtec 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 Transtec 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).
Using Transtec with food and drink
You should not drink alcohol while using Transtec. Alcohol may intensify certain side
effects of the transdermal patch and you may feel unwell. Drinking grapefruit juice may
intensify the effects of Transtec.

Pregnancy
There is not sufficient experience regarding the use of Transtec in pregnant women.
Therefore do not use Transtec if you are pregnant.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Buprenorphine, the active substance contained in the transdermal patch, inhibits milk
formation and passes into the breast milk. Therefore, do not use Transtec if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Transtec may make you feel dizzy or drowsy or experience blurred or double vision and
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,
■ when your dosage is changed,
■ when you switch to Transtec from another pain reliever,
■ if you also use other medicines that act on the brain,
■ if you drink alcohol.
If you are affected, you should not drive or operate machinery whilst using Transtec. This
applies also at the end of treatment with Transtec. Do not drive or operate machinery for at
least 24 hours after the patch has been removed.
Discuss with your doctor or pharmacist if you are unsure about anything.
3. How to use Transtec
Transtec is available in three strengths: Transtec 35 micrograms/h transdermal patch,
Transtec 52.5 micrograms/ h transdermal patch and Transtec 70 micrograms/h transdermal
patch.
The choice of which strength of Transtec 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 Transtec exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
The usual dose is:
Adults
Unless your doctor has told you differently, attach one Transtec transdermal patch (as described
in detail below) and change it after 4 days at the latest. For convenience of use, you can change
the transdermal patch twice a week at the same days, e.g. always on Monday mornings and
Thursday evenings. 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 Transtec.
Patients under 18 years of age
Transtec 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.
Patients with liver disease
In patients with liver disease, the intensity and duration of action of Transtec may be
affected. If this applies to you, your doctor will check on you more closely.
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
(see adjacent illustrations). Call
assistance if you cannot apply
the transdermal patch yourself.
Chest Back

Chest
Back
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 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 at the notch. Take out the transdermal patch.

Step 2:
The sticky side of the transdermal patch is covered with a silvery
protective foil. Carefully peel off half the foil. Try not to touch the
sticky part of the transdermal patch.
Step 3:
Stick the transdermal patch onto 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 for about 30 seconds.
Make sure that the whole transdermal patch is in contact with your
skin, especially at the edges.

Wearing the transdermal patch
You may wear the transdermal patch for up to 4 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 side inwards.
■ Throw it away carefully, out of the reach and sight of children.
■ Stick a new transdermal patch on a different skin site (as described above). Wait at least
one week before using the same site again.
Duration of treatment
Your doctor will tell you how long you may use Transtec. Do not stop using Transtec on
your own account, because pain may return and you may feel unwell (see also "If you stop
using Transtec" below).
If you have the impression that the effect of the Transtec transdermal patch is too weak or
too strong, tell your doctor or pharmacist.
If you use more Transtec 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.
As soon as you discover that you have used more transdermal patches than you should,
remove the excess transdermal patches and talk to a doctor or pharmacist.
If you forget to use Transtec
If you forget an application, stick a new transdermal patch on as soon as you remember.
You will then need to change your routine, e.g. if you usually apply your transdermal
patches on Mondays and Thursdays, but you forget and don’t stick on a new transdermal
patch until Wednesday, you will need to change your transdermal patches on Wednesdays
and Saturdays from then on. Make a note of the new pair of days on the calendar on the
outer packaging. 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!

Skin disorders (generally at the site of application)
Very common:
redness, itching
Common:
skin changes (exanthema, generally on repeated use), sweating
Uncommon:
rash
Rare:
hives
Very rare:
pustules, small blisters
Urinary system disorders
Uncommon:
difficulty in passing water, urine retention (less urine than normal)
Reproductive system disorders
Rare:
erection difficulties
General disorders
Common:
oedema (e.g. swelling of the legs), tiredness
Uncommon:
weariness
Rare:
withdrawal symptoms (see below), administration site reactions
Very rare:
chest pain
If you notice any of the side effects listed above, tell your doctor as soon as possible.
In some cases delayed allergic reactions occurred with marked signs of inflammation. In
such a case you should stop using Transtec after you have talked to your doctor.
If you experience swelling of the hands, feet, ankles, face, lips, mouth, or throat
which may cause difficulty in swallowing or 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 Transtec is low. However, if you feel agitated, anxious, nervous or shaky, if you are
overactive, have difficulty sleeping or digestion problems, tell your doctor.
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.
5. How to store Transtec






If you stop using Transtec
If you interrupt or finish using Transtec too soon, pain may return. If you wish to stop use on
account of unpleasant 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
Transtec 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, Transtec can cause side effects, although not everybody gets them.
Side effects are classified as follows:
Very common:
more than 1 out of 10 persons
Uncommon:
more than 1 out of 1000 persons
and less than 1 out of 100 persons
very rare:
less than 1 out of 10,000 persons

Common:
more than 1 out of 100 persons
and less than 1 out of 10 persons
Rare:
more than 1 out of 10000 persons
and less than 1 out of 1000 persons

The following side effects have been reported:
Immune system disorders
Very rare:
serious allergic reactions (see below)
Metabolism and nutrition disorders
Rare:
loss of appetite
Psychiatric disorders
Uncommon:
confusion, sleep disorder, restlessness
Rare:
illusions such as hallucinations, anxiety and nightmares, reduced sex
drive
Very rare:
dependence, mood swings
Nervous system disorders
Common:
dizziness, headache
Uncommon:
various degrees of sedation (calmness), ranging from tiredness to
muzziness
Rare:
difficulty concentrating, speech disorder, muzziness, disturbed balance,
abnormal skin sensations (numbness, prickling or burning sensations)
Very rare:
muscle twitching, taste disorders
Eye disorders
Rare:
Very rare:

visual disturbance, blurred vision, swollen eyelids
pin-point pupils

Ear disorders
Very rare:

ear pain

Heart and blood circulation disorders
Uncommon:
circulatory 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)
Common:
vomiting, constipation
Uncommon:
dry mouth
Rare:
heartburn
Very rare:
retching



Keep out of the reach and sight of children.
Do not use after the expiry date printed on the carton or label.
There are no storage precautions for this product.
Please dispose of the used patches carefully and out of the reach of children, as they
will still contain some medication.
If the patches become brittle or discoloured you should seek the advice of your
pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.

6. Further information
What is in your patch?
Your patch is called Transtec. Each self-adhesive patch contains the active ingredient
buprenorphine.
Transtec® 35 microgram/h Transdermal Patch contains 20mg of buprenorphine with a
release rate of 35 microgram of buprenorphine per hour. The area of the patch containing
2
the active substance is 25 cm . Each patch is square skin coloured with rounded corners
and marked ‘Transtec 35μg/h buprenorphinum 20mg’ in blue ink.
Transtec® 52.5 microgram/h Transdermal Patch contains 30mg of buprenorphine with a
release rate of 52.5 microgram of buprenorphine per hour. The area of the patch containing
2
the active substance is 37.5 cm . Each patch is rectangle shaped skin coloured with
rounded corners and marked ‘Transtec 52.5μg/h buprenorphinum 30mg’ in green ink.
Transtec® 70 microgram/h Transdermal Patch contains 40mg of buprenorphine with a
release rate of 70 microgram of buprenorphine per hour. The area of the patch containing
the active substance is 50 cm2. Each patch is rectangle shaped skin coloured with rounded
corners and marked ‘Transtec 70μg/h buprenorphinum 40mg’ in red ink.
Transtec also contains the following excipients:
(z)-octadec-9-en-1-yl oleate, povidone K90, 4-oxopentanic acid, poly [acrylic acid-cobutylacrylate-co-(2-ethylhexyl)
acrylate-co-vinylacetate]
(5:15:75:5),
cross-linked;
poly(ethyleneterephthalate) foil; poly(ethyleneterephthalate) tissue.
Each patch last for up to 4 days (96 hours).
Transtec is available in packs of 4, 5 and 10.
POM
PL No: 15814/0820
PL No: 15814/0821
PL No: 15814/0822

Transtec® 35 microgram/h Transdermal Patches
Transtec® 52.5 microgram/h Transdermal Patches
Transtec® 70 microgram/h Transdermal Patches

These products are manufactured by Grunenthal GmbH Zieglerstrasse 6 Aachen D-52078
Germany and are procured from within the EU and repackaged by the Product Licence
holder: O.P.D. Laboratories Ltd., Unit 6, Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 06.03.2012
Transtec® is a registered Trade Mark of Grünenthal GmbH, Germany.

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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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