Read all of this leaflet carefully before you start using tills medicine because it contains important information for you.

*    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist or

*    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even i f their signs of illness are the same

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

4.

Wliat is in this leaflet:

1.    What Butec patches are and what they are used for

2.    What you need to know before you use Butec patches

3.    How to use Butec patches

4.    Possible side effects

5.    How to store Butec patches

6.    Content ofthe pack and other information

1. What Butec patches are and what they are used for

Butec patches contain the active ingredient buprenorphine which belongs to a group of medicines called strong analgesics or ‘painkillers’.

They have been prescribed for you by your doctor to relieve moderate, long-lasting pain that requires the use of a strong painkiller.

Butec patches should not be used to relieve acute pain.

Butec patches act through the skin.

After application, buprenorphine

passes through the skin into the blood.

Each patch lasts for seven days.

2. What you need to know before you use Butec patches

Do not use Butec patches:

•    if you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6);

•    if you have breathing problems;

•    if you are addicted to drugs;

•    if you are taking a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid, modobamide and linezolid), or you have taken this type of medicine in the last two

•    if you suffer from myasthenia gravis (a condition in which the muscles become weak);

•    if you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping taking alcohol.

Butec patches must not be used to

treat symptoms associated with drug

withdrawal.

War nings and precautions

Talk to your doctor, pharmacist or nurse

before using Butec patches:

•    if you suffer from seizures, fits or convulsions;

•    if you have a severe headache or feel sick due to a head injury or increased pressure in your skull (for instance due to brain disease). This is because the patches may make symptoms worse or hide the extent of a head injury;

•    if you are feeling light-headed or

•    if you have severe liver problems;

•    if you have ever been addicted to drugs or alcohol;

•    if you have a high temperature, as this may lead to larger quantities of the active ingredient being absorbed into the blood than nonnal.

If you have recently had an operation, please speak to your doctor before using these patches.

Children and adolescents

Do not give this medicine to children

below 18 years.

Other medicines and Butec patches Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

*    Butec patches must not be used together with a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid, moclobamide and linezolid), or if you have taken this type of medicine in the last two

*    If you take some medicines such as phenobarbital or phenytoin (medicines commonly used to treat seizures, fits or convulsions), carbamazepine (a medicine to treat seizures, fits or convulsions and certain pain conditions), or rifampicin (a medicine to treat tuberculosis) the effects of Butec patches may be reduced.

*    Butec patches may make some people feel drowsy, sick or faint or make them breathe more slowly’ or weakly. These side effects may be made worse if other medicines that produce the same effects are taken at the same time. These include certain medicines to treat pain, depression, anxiety, psychiatric or mental disorders, medicines to help you sleep, medicines to treat high blood pressure such as clonidine, other opioids (which may be found in painkillers or certain cough mixtures e.g. morphine, dextropropoxyphene,

codeine, dextromethorphan, noscapine). antihistamines which make you drowsy, or anaesthetics such as halothane.

* Butee patches must be used with caution if you are also taking benzodiazepines (medicines used to treat anxiety or to help you sleep). This combination may cause serious breathing problems.

Using Butee patches with food, drink and alcohol

Alcohol may make some of the side effects worse and you may feel unwell if you drink alcohol whilst wearing Butee patches. Drinking alcohol whilst using Butee patches may also affect your reaction time.

Pregnancy breast-feeding and fertility

You should not use Butee patches if you are pregnant, or are 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. Driving and using machines Butee patches may 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;

•    if you are taking medicines to treat anxiety or help you sleep;

•    if your dose is increased.

If you are affected (e.g. feel dizzy, drowsy or have blurred vision), you should not drive or operate machinery whilst using Butee patches, or for 24 hours after removing the patch.

Ihe medicine can affect your ability to drive as it may make you sleepy or

•    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:

o Ihe medicine has been prescribed to treat a medical or dental problem; and

o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine.

•    Hease 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 Butee patches

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist

Three different strengths of Butee patches are available. Your doctor will decide which strength of Butee patch will suit you best.

During treatment, your doctor may change the patch you use to a smaller or larger one if necessary. Do not cut or divide the patch or use a higher dose than recommended. You should not apply more than two patches at the same time, rqr to a maximum total dose of 40 micrograms hour.

Adults and elderly patients Unless your doctor has told you differently, attach one Butee patch (as described in detail below) and change it eveiy seventh day, preferably at the same time of day. Your doctor may wish to adjust the dose after 3-7 days until the correct level of pain control has been found. If your doctor has advised you to take other painkillers in addition to the patch, strictly follow the doctor’s instructions, otherwise you will not fully benefit from treatment with the Butee patch. The patch should be worn for 3 full days before increasing the dose, this is when the maximum effect of a given dose is established.

Patients under 18 years of age Butee patches should not be used in patients below the age of 18 years. Patients with kidney disease/dialysis patients

In patients with kidney disease, no change in dose is necessary.

Patients with liver disease In patients with liver disease, the effects and period of action of the Butee patch may be affected and your doctor will therefore check on you more closely. Before applying the Butee patch • Choose an area of non-initated, intact skin on your upper arm, outer arm, upper chest, upper back or side of the chest. (See illustrations below). Ask for assistance if you cannot apply the patch yourself.

•    Ihe Butee patch should be applied to a relatively hairless or nearly hairless skin site. If no suitable hair free sites are available the hairs should be cut 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

•    Ihe area of skin you choose must be dry and clean. If necessary, wash it with cold or lukewarm water. Do not use soap, alcohol, oil, lotions 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 patch from sticking properly.

Applying the patch

Step 1: Each patch is sealed in a pouch. Just before use, open the pouch by tearing where indicated. Take out the patch. Do not use the patch if the pouch seal is broken.

Step 2: The sticky side ofthe patch is covered with a silvery protective foil. Carefully peel off half the foil. Tty not to touch the sticky part of the patch

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

Step 4: Press the patch against your skin with the palm of your hand and count slowly to 30. Mike sure that the whole patch is in contact with your skin, especially at the edges.

Wearing the patch You should wear the patch for seven days. Rovided that you have applied the patch conectly, there is little risk of it coming off. If the edges of the patch begin to peel off, they may be taped down with a suitable skin tape. You may shower, bathe or swim whilst wearing it. Do not expose the patch to extreme heat (e.g. heating pads, electric blanket, heat lamps, sauna, hot tubs, heated water beds, hot water bottle, etc) as this may lead to larger quantities of the active ingredient being absorbed into the blood than normal. External heat may also prevent the patch from sticking properly. If you have a high temperature this may alter the effects of Butee patches (see “Take special care” section above).

In the unlikely event that your patch falls off before it needs changing, do not use the same patch again. Stick a new

6511207 22*07/2016

one on straight away (see “Changing ihe patch” below).

Changing the patch

•    Take the old patch off.

•    Fold it in half with the sticky side inwards.

•    Open and take out a new patch. Use the empty pouch to dispose of the old patch. Now discard the pouch safely.

•    Even used patches contain some active ingredient that may harm children or animals, so make sure your used patches are always kept out of the sight and reach of them.

•    Stick a new patch on a different appropriate skin site (as described above). You should not apply a new patch to the same site for 3-4 weeks.

•    Remember to change your patch at the same time of day. It is important that you make a note of the lime of

Duration of treatment

Your doctor will tell you how long you should be treated with the patch. Do not stop treatment without consulting a doctor, because your pain may return and you may feel unwell (see also “If you stop using patches” below).

If you feel that the effect of the Butec patch is too weak or too strong, talk to your doctor or pharmacist.

If you use more Butec patches than you should

As soon as you discover that you have used more patches than you should, remove all patches and call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy and sick. They may also have breaking difficulties or lose consciousness and may need emergency treatment in hospital. When seeking medical attention make sure that you take Ihis leaflet and any remaining patches with you to show to the doctor. If you forget to apply the Butec patch Stick a new patch on as soon as you remember. Also make a note of the date, as your usual day of changing may now be different. If you are very late changing your patch, your pain may return. In this case, please contact your doctor.

Do not apply additional patches to make up for the forgotten application. If you stop using Butec patches If you stop using Butec patches too soon or you interrupt your treataent your pain may return. If you wish to stop treatment please consult your doctor. They will tell you what can be done and whether you can be treated wilh other medicines.

Some people may have side effects when they have used strong painkillers for a long time and stop using them.

The risk of having effects after stopping Butec patches is very low. However, if you feel agitated, anxious, nervous or shaky, if you are overactive, have difficulty sleeping or digestive problems, tell your doctor.

The pain relieving effect of Butec patch is maintained for some time after removal of Ihe patch. You should not start another opioid analgesic (strong painkiller) within 24 hours after removal of the patch.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines Butec patches can have side effects, although not everybody gets them.

Serious side effects that may be associated with Butec patches are similar to those seen with olher strong painkillers and include difficulty in breathing and low blood pressure.

This medicine can cause allergic reactions, although serious allergic reactions are rare. Remove the patch and tell your doctor immediately if you get

any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body.

As with all strong painkillers, there is a risk that you may become addicted or reliant on Butec patches.

In patients treated with Butec patches, the following other side effects have been reported:

Very common (probably occurring in more than 1 in 10 people)

•    Headache, dizziness, drowsiness.

•    Constipation, feeling or actually being sick.

•    Itchy skin

•    Rash, redness, itching, inflammation or swelling of the skin at the application site.

Common (probably occurring in between 1 and 10 out of every 100 people)

•    Loss of appetite.

•    Confusion, depression, anxiety, difficulty in sleeping, nervousness, shaking (tremors).

•    Shortness of breath.

•    Abdominal pain or discomfort, diarrhoea, indigestion, dry mouth.

•    Sweating, rash, skin eruptions.

•    Tiredness, a feeling of unusual weakness, muscle weakness, swelling of hands, ankles or feet.

Uncommon (probably occurring in

between 1 and 10 out of every 1,000

people)

•    Mood swings, restlessness, agitation, a feeling of extreme happiness, hallucinations, nightmares, decreased sexual drive, aggression.

•    Changes in taste, difficulty in speaking, reduced sensitivity to pain or touch, tingling or numbness.

•    Loss of memory, migraine, fainting, problems with concentration or co-ordination.

•    Dry eyes, blurred vision.

•    A ringing or buzzing sound in the ears, a feeling of dizziness or spinning.

•    High or low blood pressure, chest pain, fast or irregular heart beat.

•    Cough, hiccups, wheezing.

•    Wind.

•    Weight loss.

•    Spasms, aches and pains.

•    Difficulty in beginning the flow of urine, loss of bladder control.

•    Inability to fully empty the bladder.

•    An increase in accidental injuries (e.g. falls).

•    Withdrawal symptoms such as agitation, anxiousness, sweating or shaking upon stopping using Butec patches.

If you need to have blood tests remind your doctor that you are using Butec patches. This is important because Butec patches may change the way your liver works and this could affect the results of some blood tests.

Rare (probably occurring in between 1 and 10 out of every 10,000 people)

•    Angina (chest pain associated with heart disease).

•    Mental disorder.

•    Difficulties with balance.

•    Swelling of Ihe eyelids or face, a reduction in size of the pupils in the eye.

•    Difficulty in breathing, worsening of asthma, over breathing.

•    A feeling of faintness, especially on standing up.

•    Difficulty in swallowing.

•    Local allergic reaction with marked signs of swelling (in such cases treatment should be stopped).

•    Swelling and irritation inside the nose.

•    Decreased erection, sexual dysfunction.

•    A flu like illness.

•    Flushing of the skin.

•    Dehydration.

Very rare (probably occurring in fewer than 1 out of every 10,000 people)

•    Muscle twitching.

•    Blisters.

Not known (frequency cannot be estimated from the available data)

•    Seizures, fits or convulsions

•    Inflammation of the bowel wall. Symptoms may include fever, vomiting and stomach pain or discomfort.

•    Colicky abdominal pain or discomfort.

•    Feeling detached from oneself.

•    Withdrawal symptoms in babies born to mothers who have been given Butec in pregnancy may include high-pitched crying, irritability and restlessness, shaking (tremor), feeding difficulties, sweating and not putting on weight.

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 Ihe Yellow Card Scheme at: www.mhra.gov.uk/vellowcard By reporting side effects you can help provide more information on the safety of this medicine.

| 5. How to store ’Butec patches |

Keep this medicine out of the sight and reach of children.

Do not use Butec patches after the expiry date which is stated on the carton and on the pouch. The expiry date refers to

Ihe last day of that month. After Ihe expiry date, take any unused patches to a pharmacy.

Do not store Butec patches above 25°C.

Do not use the patch if the pouch seal is broken.

Used patches must be folded over on themselves with the adhesive layer inwards, and discarded safely out of sight and reach of children.

6. Contents of the pack and other information What Butec patches contain

The active ingredient is buprenorphine.

Butec 5 microgram/hour transdermal

Each transdermal patch contains 5 mg of buprenorphine in a patch size of 6.25 cm² and releases about 5 micrograms ofbuprenorphine per hour (over a period of 7 days).

Butec 10 microgram/hour transdermal patch Each transdermal patch contains 10 mg of buprenorphine in a patch size of 12.5 cm² and releases about 10 micrograms of buprenorphine per hour (over a period of 7 days).

Butec 20 microgram/hour transdermal

Each transdermal patch contains 20 mg of buprenorphine in a patch size of 25 cm² and releases about 20 micrograms of buprenorphine per hour (over a period of 7 days).

The other ingredients are:

•    Polyacrylate (Durotak 387-2051 & 387-2054)

•    Levulinic acid

•    Oleyl oleate

•    Povidone

•    Polyethyleneterephthalate What Butec patches look like and contents of the pack

Transdermal patch Three sizes are available.

5 microgram/hour: square, beige coloured patch with rounded corners marked Butec 5 pg/h 10 microgram/hour: rectangular, beige coloured patch with rounded corners marked Butec 10 pg/h 20 microgram/hour: square, beige coloured patch with rounded corners marked Butec 20 pg/h Butec patches are available in cartons containing 4 pouches each containing a single patch.

BUTEC PAT PIL UK 6511207 V3.indd 3