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500934/PL1f

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Buprenorphine

The name of your medicine is Transtec 35 micrograms/h Transdermal Patch, Transtec 52.5 micrograms/h Transdermal Patch or Transtec 70 micrograms/h Transdermal Patch. Throughout this leaflet your medicine will be referred to as Transtec.

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 “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 “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).

Using 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.

Additional information for UK patients only

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 while you have this medicine in your body over a specified 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 have taken it according to the instructions given by the prescriber and in the information provided with the medicine.

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

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law

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

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.

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

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 on 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.

-    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.

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.    Continued overleaf

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:

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:	Rare:
more than 1 out of 1000 persons	more than 1 out of 10000 persons
and less than 1 out of 100 persons	and less than 1 out of 1000 persons
Very rare:
less than 1 out of 10,000 persons

The following side effects have been reported:

Immune system disorders

Very rare:    serious allergic reactions (see below)

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

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

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

ear pain

Heart and blood circulation disorders

Uncommon:    circulatory disorders (such as low blood pressure or, rarely, even circulatory collapse)

Rare:    hot flushes

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

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.

If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

Yellow Card Scheme

Website: 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 this medicine 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 medicinal product does not require any special storage conditions.

If you notice any sign of deterioration or discolouration of the medicine, please tell your pharmacist immediately.

Do not throw away unused medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines 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 in Transtec is buprenorphine.

Transtec 35 micrograms/h transdermal patch	Each transdermal patch contains 20 mg of buprenorphine and releases about 35 micrograms of buprenorphine per hour. The area of the transdermal patch containing the active substance is 25 cm2.
Transtec 52.5 micrograms/h transdermal patch	Each transdermal patch contains 30 mg of buprenorphine and releases about 52.5 micrograms of buprenorphine per hour. The area of the transdermal patch containing the active substance is 37.5cm2.
Transtec 70 micrograms/h transdermal patch	Each transdermal patch contains 40 mg of buprenorphine and releases about 70 micrograms of buprenorphine per hour. The area of the transdermal patch containing the active substance is 50cm2.

- The other ingredients in Transtec are:

[(Z)-octadec-9-en-1-yl] oleate; povidone K90; 4-oxopentanoic acid; poly[acrylic acid-co-butyl-acrylate-co-(2 ethylhexyl)acrylate-co-vinylacetate] (5:15:75:5), cross-linked/not cross linked, poly(ethyleneterephthalate) tissue, poly(ethyleneterephthalate) foil.

What Transtec looks like and contents of the pack

Each Transtec 35 micrograms/h Transdermal Patch is rectangle in shape, with rounded corners and is skin coloured and sits on an aluminized rigid removable protective layer. Transtec 35 pg/h buprenorphinum 20 mg is printed in blue ink on the front of the patch. In the centre of the patch a drug reservoir is posted.

Each Transtec 52.5 micrograms/h Transdermal Patch is rectangle in shape, with rounded corners and is skin coloured and sits on an aluminized rigid removable protective layer. Transtec 52.5 pg/h buprenorphinum 30 mg is printed in green ink on the front of the patch. In the centre of the patch a drug reservoir is posted.

Each Transtec 70 micrograms/h Transdermal Patch is rectangle in shape, with rounded corners and is skin coloured and sits on an aluminized rigid removable protective layer. Transtec 70 pg/h buprenorphinum 40 mg is printed in red ink on the front of the patch. In the centre of the patch a drug reservoir is posted.

Transtec comes in cartons containing 3 or 4 transdermal patches individually sealed in sachets.

Product Licence Holder

Procured from within the EU by the Product Licence Holder Ginova Ltd and repackaged by Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.

Manufacturer

LTS Lohmann Therapie-Systeme GmbH, Lohmannstrasse 2, D-56626, Andernach, Germany.

Transtec® 35 micrograms/h Transdermal Patch

PL 18067/0312

Transtec® 52.5 micrograms/h Transdermal Patch

PL 18067/0313

Transtec® 70 micrograms/h Transdermal Patch

PL 18067/0314    | POM|

This leaflet was last approved on 8^th September 2016.

Transtec® is a registered trademark of Grunenthal GmbH.

To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.

500934/PL1f