• 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.

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. Further information

• 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.

Tolerance, dependence, and addiction

This medicine contains buprenorphine which is an opioid medicine. Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Transtec can also lead to dependence, abuse, and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Transtec if:

• You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs whilst taking Transtec, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You might feel that you need to carry on taking your medicine, even when it doesn’t help to relieve your pain.
• You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’)

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking 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 you have depression or other conditions that are treated with antidepressants.
  The use of these medicines together with Transtec can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Transtec");
• if your liver does not work properly;

Also, please be aware of the following precautions:

• 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.

Transtec can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

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.

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, and gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain),

Please inform your doctor or pharmacist if you are taking:

• medicines to treat allergies, travel sickness or nausea (antihistamines or antiemetics);
• medicines to treat psychiatric disorders (antipsychotics or neuroleptics);
• muscle relaxants;
• medicines to treat Parkinson’s disease.

Concomitant use of Transtec and sedating medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor prescribes Transtec together with sedating medicines the dose and the duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedating medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

• 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).
• Some medicines may increase the side effects of Transtec and may sometimes cause very serious reactions. Do not take any other medicines whilst taking Transtec without first talking to your doctor, especially antidepressants, such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepine, or trimipramine. These medicines may interact with Transtec and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.

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.

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.

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.

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.

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.

Applying the transdermal patch:

Step 1:

Each transdermal patch is sealed in a sachet. Cut the child-re resistant sachet along the dotted line with scissors. Be careful not to damage the transdermal patches.

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.

How long will you use the patch for

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 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 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 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.

Very rare: serious allergic reactions (see below)

Rare: loss of appetite

Uncommon: confusion, sleep disorder, restlessness

Rare: illusions such as hallucinations, anxiety and nightmares, reduced sex drive

Very rare: dependence, mood swings

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

Rare: visual disturbance, blurred vision, swollen eyelids

Very rare: pin-point pupils

Very rare: ear pain

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

Rare: hot flushes

Common: shortness of breath

Rare: difficulty breathing (respiratory depression)

Very rare: abnormally rapid breathing, hiccups

Very common: nausea (feeling sick)

Common: vomiting, constipation

Uncommon: dry mouth

Rare: heartburn

Very rare: retching

Very common: redness, itching

Common: skin changes (exanthema, generally on repeated use), sweating

Uncommon: rash

Rare: hives

Very rare: pustules, small blisters

Not known: dermatitis contact (skin rash with inflammation which may include burning sensation, skin discolouration).

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

Rare: erection difficulties

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

Uncommon: weariness

Rare: withdrawal symptoms (see below), administration site reactions

Very rare: 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.

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;

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is buprenorphine.

Transtec 35 micrograms/h transdermal patch

Each transdermal patch contains 20 mg 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 buprenorphine and releases about 52.5 micrograms of buprenorphine per hour.

The area of the transdermal patch containing the active substance is 37.5 cm².

Transtec 70 micrograms/h transdermal patch

Each transdermal patch contains 40 mg buprenorphine and releases about 70 micrograms of buprenorphine per hour.

The area of the transdermal patch containing the active substance is 50 cm².

The other ingredients in Transtec are:

Adhesive matrix: [(Z)-octadec-9-en-1-yl] oleate; povidone K90; 4-oxopentanic acid; poly[acrylic acid-cobutylacrylate- co-(2-ethylhexyl)acrylate-co-vinylacetate] (5:15:75:5), cross-linked (buprenorphine-containing area) or not cross-linked (area without buprenorphine); foil separating both matrix areas: poly(ethyleneterephthalate)-foil; backing layer: 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.

Transtec transdermal patches are skin-coloured with rounded corners and are imprinted

Transtec 35 μg/h, buprenorphinum 20 mg

Transtec 52.5 μg/h, buprenorphinum 30 mg

Transtec 70 μg/h, buprenorphinum 40 mg

Transtec comes in cartons containing 4 transdermal patches individually sealed in child-resistant sachets.