Transtec.pdf

PACKAGE LEAFLET: INFORMATION FOR THE USER

Transtec ® 35 micrograms/h / 52.5 micrograms/h / 70 micrograms/h transdermal patch

Buprenorphine

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 :

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

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.

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. 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

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!

Plik z chomika:

Inne pliki z tego folderu:

Inne foldery tego chomika: