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TRANSTEC 52.5 MICROGRAMS/H TRANSDERMAL PATCHES

Active substance: BUPRENORPHINE

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CUSTOMER: Waymade
PRODUCT: TRANSTEC PATCHES

PRE-PRESS NO.:

02 1808

ARTWORKER:

DT

DATE OF PROOF:

23/05/14

CODE:

TVT CHECKED

6464 2327 2328 2329 G

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

PROOF HISTORY:
v.1 - waymade - 23/05/14

DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED JULY 2011 REPORTING OF SIDE EFECTS DRUG DRIVING TEXT

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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 ALL MEDICINES OUT OF THE SIGHT AND REACH 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 comes in three sizes:
Transtec 35 micrograms/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 52.5 micrograms/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 70 micrograms/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-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 35 micrograms/h transdermal patch is marked ‘Transtec 35µg/h/ buprenorphinum 20 mg’ in blue ink.
Transtec 52.5 micrograms/h transdermal patch is marked ‘Transtec 52.5µg/h/ buprenorphinum 30 mg’ in
green ink.
Transtec 70 micrograms/h transdermal patch is marked ‘Transtec 70µg/h/ buprenorphinum 40 mg’ 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.
POM

CD

PL No: 6464/2327 Transtec 35 micrograms/h transdermal patch
PL No: 6464/2328 Transtec 52.5 micrograms/h transdermal patch
PL No: 6464/2329 Transtec 70 micrograms/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.) 23.05.2014
Transtec is a registered trademark of GRÜNENTHAL GmbH

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

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CUSTOMER:Waymade

PRE-PRESS NO.:

02 1808

PRODUCT: TRANSTEC PATCHES

ARTWORKER:

DT

DATE OF PROOF:

23/05/14

CODE:

TVT CHECKED

6464 2327 2328 2329 G

Q.A.
APPROVED:
DATE:

PROOF HISTORY:
v.1 - waymade - 23/05/14

CUSTOMER
APPROVED:
DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED JULY 2011 REPORTING OF SIDE EFECTS DRUG DRIVING TEXT

Pg 2

Pg 3

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.

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").

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.

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

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

Do not drive while taking this medicine until you know how it affects you.

It is an offence to drive if this medicine affects your ability to drive.

However, you would not be committing an offence if:
• The medicine 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
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this
medicine

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.

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 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

Common:
more than 1 out of 100 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

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.

The following side effects have been reported:
Immune system disorders
Very rare:
serious allergic reactions (see below)

Method of administration

Metabolism and nutrition disorders
Rare:
loss of appetite

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 illustrations). Call assistance if you cannot
apply the transdermal patch yourself.

Chest




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

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:

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

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.

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

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.

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

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

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

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” section
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.

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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.

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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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