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TRANSTEC 70MICROGRAM/H TRANSDEMAL PATCHES

Active substance(s): BUPRENORPHINE

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Package Leaflet: Information For The User

Transtec® 35micrograms/h Transdermal Patch
Transtec® 52.5micrograms/h Transdermal Patch
Transtec® 70micrograms/h 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.
®

The name of your medicine is Transtec 35 micrograms/h transdermal patch or Transtec® 52.5 micrograms/h transdermal patch or
Transtec® 70 micrograms/h transdermal patch but it will be referred as Transtec throughout in this leaflet.
What is in this leaflet
1. What Transtec is and what it is used for
2. What you need to know before you use Transtec
3. How to use Transtec
4. Possible side effects
5. How to store Transtec
6. Contents of the pack and other 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. What you need to know before you use Transtec
Do not use Transtec:
if you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6);
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 ‘Other medicines and Transtec’);
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.
Warnings and precautions
Talk to your doctor or pharmacist before using 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 ‘Other
medicines and Transtec’);
if your liver does not work properly;
if you are inclined to abuse medicines or drugs.
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.
Athletes should be aware that this medicine may cause a positive reaction to sports doping control tests.
Children and adolescents
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.
Other medicines and Transtec
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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).

Transtec with food, drink and alcohol
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, breast-feeding and fertility
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.
There is not sufficient experience regarding the use of Transtec in pregnant women. Therefore do not use Transtec if you are pregnant.
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.
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
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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.
The recommended 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.
Use in children and adolescents
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
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 sight and reach 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!
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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are classified as follows:
Common:
Very common:
more than 1 out of 100 persons
more than 1 out of 10 persons
and less than 1 out of 10 persons
Uncommon:
more than 1 out of 1000 persons
and less than 1 out of 100 persons

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

very rare:
less than 1 out of 10,000 persons

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
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:
Uncommon:
Rare:
Very rare:

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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at: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 Transtec
Keep out of the sight and reach of children.
Do not use after the expiry date which is stated on the carton label after ‘Exp’. The expiry date refers to the last day of that month.
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 your patches become discoloured or show any signs of deterioration, seek the advice of your pharmacist.
6. Contents of the pack and other information
What Transtec contains
The active ingredient in Transtec is Buprenorphine.
Transtec 35micrograms/h contains 20mg buprenorphine, contained in each self-adhesive patch. The patch will deliver about
35micrograms of burprenorphine per hour. The area of the patch containing the active substance is 25cm2.

The following side effects have been reported:

Transtec 52.5micrograms/h contains 30mg buprenorphine, contained in each self-adhesive patch. The patch will deliver about
52.5micrograms of buprenorphine per hour. The area of the patch containing the active substance is 37.5cm2.

Immune system disorders
Very rare:
serious allergic reactions (see below)

Transtec 70micrograms/h contains 40mg buprenorphine, contained in each self-adhesive patch. The patch will deliver about
70micrograms of buprenorphine per hour. The area of the patch containing the active substance is 50cm2.

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

The other ingredients in Transtec are:
[(Z)-octadec-9-en-1-yl] oleate; povidone K90; 4-oxopentanoic 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 35micrograms/h transdermal patch is marked ‘Transtec 35μg/h/ buprenorphinum 20mg’ in blue ink.
Transtec 52.5micrograms/h transdermal patch is marked ‘Transtec 52.5μg/h/ buprenorphinum 30mg’ in green ink.
Transtec 70micrograms/h transdermal patch is marked ‘Transtec 70μg/h/ buprenorphinum 40mg’ in red ink.
Transtec is available in packs of 3, 4 and 5 transdermal patches. Transtec patches are square-shaped patches with a self-adhesive
backing.
Manufactured by: LTS Lohmann Therapie-System GmbH, Andernach, Germany.

Eye disorders
Rare:
Very rare:

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

Ear disorders
Very rare:

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, UK.
POM
®
CD
Transtec 35micrograms/h Transdermal Patch PL No: 18799/2621

ear pain

Transtec 52.5micrograms/h Transdermal Patch PL No: 18799/2622
®
Transtec 70micrograms/h Transdermal Patch PL No: 18799/2647

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

®

Leaflet date: 29/07/2015

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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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