TRANSTEC 52.5 MICROGRAMS/H TRANSDERMAL PATCH

Active substance: BUPRENORPHINE

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CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

TRANSTEC PATCHES

ARTWORKER:

DT

Q.A.
APPROVED:

CODE:

6464 2356 2357 2358 E

DATE OF PROOF:

05/10/09

DATE:

DATE:

Chest and lung disorders
Common:
shortness of breath
Rare:
difficulty breathing (respiratory depression)
Very rare:
abnormally rapid breathing, hiccups

Pg 4

Digestive system disorders
Very common:
nausea (feeling sick)
Common:
vomiting, constipation
Uncommon:
dry mouth
Rare:
heartburn
Very rare:
retching

Urinary system disorders
Uncommon:
difficulties in passing water, urine retention (less urine than normal)
Reproductive disorders
Rare:
erection difficulties
General disorders
Common:
Uncommon:
Rare:
Very rare:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

Pg 1

000-0000E

TRANSTEC® 35 µg/h Transdermal Patch
TRANSTEC® 52.5 µg/h Transdermal Patch
TRANSTEC® 70 µg/h Transdermal Patch
(Buprenorphine)
Patient information leaflet
This product is available in three different strengths 35 µg/h, 52.5 µg/h and 70 µg/h.
Throughout this leaflet these products will be collectively referred to as Transtec.

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

oedema (e.g. swelling of the legs), tiredness
weariness
withdrawal symptoms (see below), administration site reactions
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 get serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor
or pharmacist.

5. How to store Transtec:
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not use after the expiry date shown on the sachet or carton.
There are no special storage conditions for Transtec transdermal patches.
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.
If the patches become discoloured or show any other signs of deterioration, you should seek the advice of your
pharmacist before using them.

6. Further Information:
What Transtec contains:
The active substance in Transtec is Buprenorphine.
Transtec come in three sizes:
Transtec 35µg/h contains 20 mg buprenorphine, contained in each self-adhesive patch. The patch will deliver
about 35 micrograms of buprenorphine per hour. The area of the patch containing the active substance is 25 cm2.
Transtec 52.5µg/h contains 30 mg buprenorphine, contained in each self-adhesive patch. The patch will deliver
about 52.5 micrograms of buprenorphine per hour. The area of the patch containing the active substance is
37.5 cm2.
Transtec 70µg/h contains 40 mg buprenorphine, contained in each self-adhesive patch. The patch will deliver
about 70 micrograms of buprenorphine per hour. The area of the patch containing the active substance is 50 cm2.
The other ingredients in Transtec are:
[(Z)-octadec-9-en-1-yl] oleate; povidone K90; 4-oxopentanic acid; poly [acrylic acid-co-butylacrylate-co(2-ethylhexyl) acrylate-co-vinylacetate] (5:15:75:5), cross-linked; poly (ethyleneterephthalate) foil and poly
(ethyleneterephthalate) tissue. The release liner which is removed before applying the transdermal patch consists
of siliconised poly (ethyleneterephthalate)-foil coated on one side with aluminium.
What Transtec looks like and contents of the pack.
Transtec 35µg/h transdermal patch is marked ‘Transtec 35µg/h/ buprenorphinum 20 mg’
Transtec 52.5µg/h transdermal patch is marked ‘Transtec 52.5µg/h/ buprenorphinum 30 mg’
Transtec 70µg/h transdermal patch is marked ‘Transtec 70µg/h/ buprenorphinum 40 mg’
Transtec is available in packs of 4 and 5 transdermal patches. Transtec patches are square-shaped patches with a
self-adhesive backing.
POM

PROOF HISTORY:
v.1 - waymade - 05/10/09

CUSTOMER
APPROVED:

PL No: 6464/2356 Transtec 35µg/h transdermal patch
PL No: 6464/2357 Transtec 52.5µg/h transdermal patch
PL No: 6464/2358 Transtec 70µg/h transdermal patch

This product is manufactured by LTS Lohmann Therapie-System GmbH, Andernach, Germany and is procured
from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 5.10.2009
Transtec is a registered trademark of GRÜNENTHAL GmbH

Read all of this leaflet carefully before you start taking 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 get 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 is it 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 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 ingredient, buprenorphine or any of the other ingredients of
Transtec. (See Section 6 " Other ingredients")

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 if 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 example, 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 also “Taking other medicines” section).

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 the patches (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 a 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 consult 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, which 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).

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

PRE-PRESS NO.:

02-1808

PRODUCT:

TRANSTEC PATCHES

ARTWORKER:

DT

Q.A.
APPROVED:

CODE:

6464 2356 2357 2358 E

DATE OF PROOF:

05/10/09

DATE:

DATE:

Using Transtec with food and drink:
Pg 2
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 medicines.
Breast feeding
Buprenorphine, the active substance contained in the transdermal patch, inhibits milk formation and passes into breast
milk.Therefore, do not use Transtec if you are breast feeding. Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and operating machinery:
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 µg/h patch, Transtec 52.5 µg/h patch, and Transtec 70 µg/h patch.
The choice of which strength of Transtec will suit you best will be made by your doctor. During your treatment, your
doctor may change which transdermal patch you use to a smaller or larger one if necessary.
Always use the Transtec patches exactly as your doctor has instructed 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 otherwise, attach one Transtec transdermal patch (as detailed below) and change it after
4 days at the latest. For convenience of use, you can change the transdermal patch twice a week on 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 that is flat, clean and hairless on your upper body, preferably on the chest below the
collar-bone or the upper part of the back (see illustrations). Call assistance if you cannot apply the transdermal
patch yourself.

CHEST





PROOF HISTORY:
v.2 - waymade - 05/10/09

CUSTOMER
APPROVED:

CUSTOMER: Waymade

Leaflet Flat Size = 296 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

Pg 3

Wearing the 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 on a new one straight away (see “Changing the transdermal patch” section).
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 patches 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 your
breathing may become slow and weak. You may have 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 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!
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, ifyou 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

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

Very rare:
less than 1 out of 10000 persons

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.

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

Step 2. The sticky side of the transdermal patch is covered with a silvery protective foil.
Carefully peel off half of the foil. Try not to touch the sticky side of the patch
otherwise it will not stick properly.

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

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

Eye disorders
Rare:
Very rare:

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

Ear disorders
Very rare:

ear pain

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.

Heart and blood circulation disorders
Uncommon:
circulatory disorders (such as low blood pressure or, rarely even circulatory collapse)
Rare:
hot flushes
Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

Expand view ⇕

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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