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 questons, ask your doctor or pharmacist.

- This medians has teen prescribed for you only.    i if their sgns of illness are the same as yours.

-    If you get any sde effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See secton 4.

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.    Howto use Transtec

5. How to store Transt

1.    What TRANSTK is aidwhat it is used for

Transtec is an anagesic (a Fain-relieving medicine) intended to relieve moderate to severe cancer pain and severe pain that has not responded to other types of painkillers. Transtec arts through the skin. When the transdermal patch is appled to the skin, the active substance buprenorphine passes through the skin into the bood. Buprenorphine is an opod (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 allergc to buprenorphine or any of the other ingredents of this medicine (listed in secton 6);

-    if you are dependent on strong pain relevers (opiods);

-    if you suffer from a disease in whch you have or may haw great difficulty breathing

-    f pu are tedng monoamine oxdarse (MAO) inhibto ' the last two weeks (see 'Taking other medcines");

-    if you suffer from myasthena gravis (a certain type of severe m

-    if you suffer from delirium tremens (confuson and trembling occurring during an episode of heavy afcohol oonsumpton);

-    if you are pregnant.

Tran

i) or you have taten this type of medicine in from acohol following habitual excessive drinking or

rc must not be used to treat withdrawal symptoms in drug-dependent persons.

-    if your conscousness is disturbed (feeling lght-headed or faint) for an unknown reason;

-    if you are in a state of shock (cod sweat mght be a sgn of it);

-    if the pressure in your skull is increased (for instance after head injury or in brain disease), and artfcal respiraton is not possible;

-    if you haw diffculty breathing or are taking other medcines that may make you breathe more slowly orweakly (see "Other medcines and Transtec");

-    if your liver does not work properly;

-    if you are inclined to abuse medicines or drugs.

Also, please be aware of the folowing precautions:

-    Some people may become dependent on strong pain relievers such as Transtec when they use them over a long perod of time. They may have wthdrawal effects when they stop using them (see "If you stop using Transtec").

-    Fever and external heat may lead to larger quantites of buprenorphine in the blood than normal. Also, external heat may prevent the transdermal patch from sticking proper^. Therefore, do not expose purse# to external heat (e.g. sauna, infra-red amps, electric blankets, hot water bottles) and consut your doctor if you have fever.

Athletes should be aware that this medicine may cause a postive region to sports doping control tests.

Children and adolescents

Transtec shoud not be used in persons below the age of 18 years, because no experence has so far been

gained in this aje group.

Other medicines and Transtec

Tell your doctor or pharmacist f you are taking have recently taken or might tale any other medcines.

-    Transtec must not be used together with monoamine oxidase (MAO) inhibtors (certain medcines used to treat depresson), or f you have taken this type of medcine for the ast 2 weeks.

-    Transtec may make some people feel drowsy, sck, or faint or mate them breathe more slowly or weakly. These side effects may be intensifed f other medcines that may produce the same effects are taten at the same time. These other medcines include other strong pain relevers (opiods), certain sleeping pills, anaesthetics, and medcines used to treat certain psychologcsl diseases such as tranquillizers, anti-depressants, and neuroleptcs.

-    f Transtec is used together with some medicines, the effects of the transdermal patch may be increased. These medcines include e.g. certain anti-infectes/anti-fungals (e.g. containing eiythrompin or ketoconazole) or HIV medcines (e.g. containing rtonavir)

-    If Transtec is used together with other medcines, the effects of the transdermal patch may be reduced. These medcines include certain products, e.g. dexamethasone; redcines to treat epidpsy (e.g. containing tarbamatepine, or phenytoin) or medicines for tubercuosis (e.g. rfampcin).

Drinking grapefrut juce may intensify the effects of Tran

If you are pregnant or breast-feeding, think you may be pregnant or are panning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

before taking There is not s

not use Transtec f you are breast-feeding.

Driving and using machines

Transtec may mate you feel dzzy or drowsy or experience blurred or double vision and affect your reactons to such an extent that you may not react adequately or quckly enough in the event of unexpected or sudden occurrences. This apples particularly

-    at the beginning of treatment,

-    when your dosage is chafed,

-    when you switch to Transtec from another pain relever,

-    f you also use other medcines that act on the brain,

-    f you drink acohol.

If you are affected, you shoud not drive or operate machinery whilst using Transtec. This applies also at the end of treatment wth 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.

mrnl rformaton for UKpatents only

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

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

• It is an offence to drive while you haw this medcine in your body owr a specfed limit unless you have a defence (called the 'statutory defence').

•    This defence applies when:

•    The medicine has been prescribed to treat a medical or dental problem; and

•    You haw taten it according to the instructions given by the prescriber and in the information provded with the medcine.

•    Please note that t is still an offence to drive f you are unfit because of the medcine (i.e. your ability to drive is being affected).

Details regarding a new drving offence concerning driving after drugs have been taten in the UK may be found here:

Talk to your doctor or pharmacist f you are not sure whether t is safe for you to drive while taking this medcine.

3. How to use TRANSTEC

Always use this medcine exactly as your doctor has told you. Check with your doctor or pharmacist f you are not sure.

igths: Transtec 35 micrograms/h transdermal patch, Transtec 52.5 micrograms/h transdermal patch and rmal patch.

ranstec will suit you best will be male by your doctor. During treatment your doctor may change which transdermal patch you use to a smaller or larger one f necessary.

Always use Transtec exactly as your doctor has told you. You should check wth your doctor or pharmacist if you are not sure.

The recommended dose is:

Aduts

Unless your doctor has tod you differently, attach one Transtec transdermal patch (as described in detail below) and change t after 4 days at the latest. For convenence of use, you can change the transdermal patch twce 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 shoud mate a note on the calendar on the outer pacteging. If your doctor has advised you to take other pain relevers in addtion to the transdermal patch, strctly folow the doctor's instructions, otherwise you will not fully benefit from treatment wth Transtec.

Use in children and adolescents

Transtec shoud not be used in persons below the age of 18 years, because no experence has so far been gained in this age group.

Elderly patents

No dosage adjustment is needed for ederly patients.

Patents with kdney disease / dialysis patients

In patients wth kidney disease and in dialysis patients, no dosage adjustment is necessary.

Patents with liver disease

In patents wth liver disease, the intensity and duraton of acton of Transtec may be affected. If this apples to you, your doctor will check on pu more closey.

Method of administration Before apphrinq the transdemial patch , - Choose an area of skin which is Hat, clean arid tailless on you

or on the upper part of the back (see adjacent illustrations) Call assistance f pu cannot apply the transdermal patch purself.

Chest

Back

-    f the chosen area has hairs, cut them off with a pair of scissors. Do not shave them off!

-    Avod skin whch is red, irritated or has any other blemishes, for instance large scars.

- The area of skin you choose must be dry and clean. f necessary, wash t with cod or lutewarm water. Do not use soap or other detergents. After a hot bath or shower, wat until your skin is completely dry and cool. Do not apply oton, cream or ointment to the chosen area. This mght prevent pur transdermal patch from stcking property.

Each transdermal patch is sealed in a sachet. Just before use, open the sachet by tearing at the notch. late out the transdermal patch.

d

Step 2:

The stcky sde of the transdermal patch is covered wth a silwy protective foil. Carefully peel off half the foil. Try not to touch the stcky 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 wth 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 appled the transdermal patch correctly, there is little risk of t coming off. You may shower, bathe or swim while wearing t. However, do not expose the transdermal patch to extreme heat (e.g. sauna baths, infra-red amps, edct^ bantets, hot water bottles).

In the unlitely event that your transdermal patch falls off before t needs changing, do not use the same transdermal patch again. Stick a new one on straght away (see 'Changing the transdermal patch" below).

Changing the transdermal patch

-    Take the od transdermal patch off.

-    Fod t in half wth the stcky sde inwards.

<#

-    Throw it away carefully, out of the sight and reach of children.

-    Stck a new transdermal patch on a different skin site (as described above). Wat at feast one week before using the same ste again.

Duration of treatment

Your doctor will tell you how long you may use Transtec. Do not stop using Transtec on yourown account, because pain may return and you may feel unwell (see also "If you stop using Transtec" below).

If you haw the impresson that the effect of the Transtec transdermal patch is too weak or too strong, tell your doctor or pharmacist.

If yoi 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 sde effects of buprenorphine such as drowsiness, nausea, and vomtng. Ybu may get pin-point pupils and breathing may become stw and weak. You may also get

As soon as you discover that you have used more transdermal patches than you should, remove the excess transdermal patches and talk to a

If you forget to use Transtec

If you forget an applcaton, stck 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 patcheson Mondays and Thursdays, but you forget and don't stil mi a lew tran d-nml pat.h until w-din- day, yu will M to change your transdermal patches on Wednesdays and Saturdays from then on. Mate a note of the new pair of days on the calendar on the outer packaging. f you are wry late changing pur transderma patch, pan may return. In this case pfease oontect pur doctor.

Newr appy me 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 sde effects, please consut our doctor. He/she will tell you what can be done and whether you can be treated with other medicines.

your doctor. He/she wil

Some people may ex.    ...

The risk of having effects after you stop using Transtec is very low. However, f you feel agitated, an have difficulty sleeping or dgeston probfems, tell pur doctor.

If you haw any furtherquestons on the use of this medicine, ask your doctor or pharmscist.

ius, nervous or shaky, if you are overactive,

4. POSSIBLE SIDE EFFECTS

Lite all medcines, this medcine can cause side effects, athough not everybody gets them. Sde effects are classfied as follows:

The awing ide effet haveI-h|ireported:

Vey rare:    serous altergc reactons (see bebw)

Rare:    loss of appette

Psychiatric disorders

Uncommon:    confuson, sleep disorder, restlessness

Rare:    illusons such as hallucinatons, anxety and nightmares, reduced sex drive

Nervous system disorders

Common:    dizziness, headache

Uncommon:    varous degrees of sedaton (calmness), ranging from tiredness to muzziness

Rare:    difficulty concentrating, speech disorder, muzziness, disturbed balance, abnormal skin sensations (numbness, prckling

or burning sensatons)

Very rare:    muscle twitching, taste disorders

Eye disorders

Rare:    visual disturbance, blurred vision, swollen eyelids

Vey rare:    pin-point pupils

Ear disorders

Vey rare:    ear pain

Heart and blood circulation disorders

Uncommon:    circulatory disorders (such as low btod pressure or, rarely, even circulatory colapse)

Rare:    hot flushes

Chest and lung disorders

Common:    shortness of breath

Rare:    difficulty breathing (respirator depressor)

Vey rare:    abnormal^ rapid breathing, hccups

Jsssmor sck

Common:    vomiting, constipaton

Uncommon:    dry mouth

Very common:

Common:

Uncommon:

(generally at the site of application)

redness, itching

d use), sweating

Very rare:    pustules, small blisters

Uncommon:    difficulty in passing water, urine retenton (less urine than normal)

Fteprodujiiiire ^ectiondiijjicutBs

General disorders

Common:    oedema (e.g. swelling of the legs), tiredness

Uncommon:    weariness

Rare:    wthdrawl symptoms (see below), administration site reactons

If you notice any of the side effects listed above, tell your doctor as soon as possible.

In some cases delayed allergc reactions occurred wth marted sgns of infammaton. In such a case you should stop using Transtec after you haw talked to your doctor.

If you experience sweling of the hands, feet, ankles, face, ips, mouth, or throat whfch may cause difficulty in swaflowing or breathing, hives, fainting, yellowing of the skin and eyes (akso caled jauidce), remove the transdermal patch and call you doctor immediately or seek help at the casualty department of the nearest hospital . These can be symptoms of a very rare serious allergic

Some people may have withdrawal symptoms when they have used strong pain relevers for a long time and stop using them. The risk of having withdrawal effects when you stop using Transtec is low. However, f you feel agitated, anxous, nervous or shaky, f you are overactive, have difficulty sleeping or dgeston problems, tell your doctor.

If any of the side effects gets serous, or if you notice any sde effects not mentoned in this leaflet, please tell your doctor or pharmacist. Reporting of tide effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible sde effects not listed in this leaflet.

You can also report side effects directly via;

Yellow Card Scheme

By reporting sde effects you can help provde more informaton on the safety of this medcine.

5. Howto store TRANSTEC

Keep this medche ait of the si^it and reach of children.

Do not use this medcine after the expiry date which is stated on the carton and on the sachet after "Expiry date (month/year):". The expiry date refers to the last day of that month.

This medcinal product does not require any special storage conditions.

Do not throw awy medicines va wastewater or household waste. Ask your pharmacist how to throw away medcines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Transtec contains

The active substance is buprenorphine.

The other ingredents in Transtec are:

Adhesive matrix: i(t)-octadec-»-en-1 -yl] oeate, povddoie nau, 4-oxo (2-ethylh^xyl)acrylate-co-vinylacetate] (5:15:755), cross-linked (buprenophine-cont foil separating both matrx areas: pdy(ethyfeneterepNhaate)-fal; backing a^n po removed before app^ing the transderma patch consists of silconised poy(ethyfenete What Transtec looks like and contents of the pack Transtec transdermal patches are skin-coloured wth rounded corners and are imprinted Transtec 35 pg/h, buprenorphinum 20 mg

. tastec 70 pf/h, buprenorphinum30mg⁹^    ^    ^    ^ ^    ^    ^

ed (area without buprenorphine); issue. The release liner which is

on one sde wth

“ Ktha! Gmb^ⁱ53C^ionA^Hdh^d!^erGe^m^Many"^fact"^rer

NappPharmaceutdalsLmited.Cambrdge Science Park, Miton Road, Cambrdge CB4CGW, UK._

This leaflet is also available in large print, Braille or as an audio CD.

To request a copy, please call the RNIB Medicine Information line (free of charge) on:

08001985000

You will need to give details of the product name and reference number. These are as follows:

Product name: Transtec

Reference number: 04539/41_

This medcinal product is authorised in the Members States of the EEA under the following names:

This leaflet was last revised in

October 2015

® TRANSTEC is a registered trade mark of Grunenthal GmbH and is used under licence.

NAPP and the 'NAPP' logo are registered trade marks of the Napp Pharmaceutical Group. © 2007-2014 Napp Pharmaceuticals Limited.

6510918 93021030 50/000/23

SCHWARZ

<#

#