TRANSTEC 35 MICROGRAM/H TRANSDERMAL PATCHES

Active substance: BUPRENORPHINE

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Using Transtec with food and drink

Transtec® 35 microgram/h Transdermal Patches
(buprenorphine)

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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

Your medicine is available using the name Transtec 35 microgram/h Transdermal Patches but will be
referred to as Transtec throughout this leaflet.
Read all of this leaflet carefully before you start using this 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 breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Keep this leaflet in a safe place. 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 effect not listed in this leaflet,
please tell your doctor or pharmacist.

In
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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 also applies
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.

this leaflet:
What Transtec is and what it is used for
Before you use Transtec
How to use Transtec
Possible side effects
How to Store Transtec
Further information

3. HOW TO USE TRANSTEC

1. WHAT TRANSTEC IS AND WHAT IT IS USED FOR

The choice of which Transtec patch 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:

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 painkiller. 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.

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.

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.

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

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 blanket, hot water bottle)
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.

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 for assistance if you cannot
apply the patch yourself.
If the chosen area has hairs, cut them off with a pair of
scissors. Do not shave them off!
Chest
Back
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 patch is sealed in a sachet. Just before use, open the sachet by tearing at
the notch. Take out the transdermal patch.

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 effect 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).

Step 2:
The sticky side of the 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.

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Wearing the patch

Chest and lung disorders

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 blanket, hot water bottles).

Common:
Rare:
Very rare:

shortness of breath
difficulty breathing (respiratory depression)
abnormally rapid breathing, hiccups

Digestive system disorders

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).

Very common:
Common:
Uncommon:
Rare:
Very rare:

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 patch on a different skin site (as described above). Wait at least one week before using
the same site again.

nausea (feeling sick)
vomiting, constipation
dry mouth
heartburn
retching

Skin disorders (generally at the site of application)
Very common:
Common:
Uncommon:
Rare:
Very rare:

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.

redness, itching
skin changes (exanthema, generally on repeated use), sweating
rash
hives
pustules, small blisters

Urinary system disorders
Uncommon:

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

Reproductive system disorders
Rare:

If you use more Transtec than you should

erection difficulties

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 pinpoint 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.

General disorders

If you forget to use Transtec

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 you notice any side effects not mentioned in this leaflet, please
tell your doctor or pharmacist.

Common:
Uncommon:
Rare:
Very rare:

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!

If you stop using Transtec

If you interrupt or finish treatment 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.

5. HOW TO STORE TRANSTEC
Do not use Transtec after the expiry date which is stated on the carton and on the sachets after
‘Expiry date (month/year)’. The expiry date refers to the last day of that month.
After the expiry date, take any unused patches you have left to a pharmacy.
Keep out of the reach and sight of children
If your medicine shows any signs of deterioration, return it to your pharmacist for advice.
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.

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

6.

Rare:
More than 1 out of 10000 persons
and less than 1 out of 1000 persons

The active substance contained in Transtec patches is buprenorphine.
Each patch contains 20mg buprenorphine and releases about 35 micrograms of buprenorphine per
hour. The area of the patch containing the active substance is 25cm2.
The other ingredients 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) and
crosslinked; poly(ethyleneterephthalate) foil; poly(ethyleneterephthalate) tissue.

The following side-effects have been reported:

Immune system disorder

What Transtec looks like and contents of the pack

serious allergic reactions (see below)

Each patch lasts for up to 4 days (96 hours).

Metabolism and nutrition disorders
Rare:

Transtec comes in cartons containing 4, 5 or 10 individually sealed patches. They are skin coloured
square patches with rounded corners, printed ‘Transtec 35ug/h buprenorphinum 20mg’ in dark blue
ink.

loss of appetite

Psychiatric disorder
Uncommon:
Rare:
Very rare:

Manufacturer

confusion, sleep disorder, restlessness
illusions such as hallucinations, anxiety and nightmares, reduced sex drive
dependence, mood swings

Your medicine is made by: Grünenthal GmbH, Aachen, Germany.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd, Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd, Kirk Sandall, Doncaster, DN3 1QR.

Nervous system disorders
Common:
Uncommon:
Rare:
Very rare:

Eye disorders
Rare:
Very rare:

Ear disorders
Very rare:

dizziness, headache
various degrees of sedation (calmness), ranging from tiredness to muzziness
difficulty concentrating, speech disorder, muzziness, disturbed balance, abnormal
skin sensations (numbness, prickling or burning sensations)
muscle twitching, taste disorders

POM

Rare:

PL No: 08929/0466

Leaflet revision and issue date (Ref): 09.10.09
Transtec® is a registered trademark of Grünenthal GmbH.

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

ear pain

Heart and blood circulation disorder
Uncommon:

FURTHER INFORMATION

What Transtec contains

Very rare:
Less than 1 out of 10,000 persons

Very rare:

oedema (swelling of the legs), tiredness
weariness
withdrawal symptoms (see below), administration site reactions
chest pain

circulatory disorders (such as low blood pressure or, rarely, even circulatory
collapse)
hot flushes
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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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