Butec 15 Microgram/Hour Transdermal Patch

(bard) Packaging Artwork Team

BARD Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road. Cambridge CB4 0GW, UK

TO: +44 (0)1223 424-M4

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22/07 £016


Package leaflet: Information for the patient

Butec® 15 microgram/hour transdermal patches Buprenorphine

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 questions, ask your doctor, phajmacist or nurse.

•    This medicine has been prescribed for you only. Do not pass it on to olhers. 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, phajmacist or nurse. This includes any possible effects not listed in this leaflet. See section 4.

What 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.    Contents of the 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 tranylcypromine, phenelzine, isocarboxazid, moclobemide 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.

Warnings 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 normal.

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 tranylcypromine, phenelzine, isocarboxazid, moclobemide 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.

Butec 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 which could be fatal in case of overdose. Tell your doctor if you are taking this combination.

Using Butec 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 Butec patches. Drinking alcohol whilst using Butec patches may also affect your reaction time.

Pregnancy, breast-feeding and fertility

You should not use Butec 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 Butec 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 occurences. 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 Butec patches, or for 24 hours after removing the patch.

The 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 The 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.

•    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: 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 Butec patches_

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or phajmacist if you are not sure.

Different strengths of Butec patches are available. Your doctor will decide which strength of Butec patch will suit you best.

When people first start using Bulec, they often experience some nausea and vomiting (see section 4). This usually passes after the first week of treatment. It’s a good idea to book a follow-up appointment with your doctor a week or two after you first start using Butec patches to ensure that you are taking the correct dose and to manage any side effects.

During treatment, your doctor may change the patch you use to a smaller or larger one if necessary, or tell you to use a combination of up to two patches. 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 up to a maximum total dose of 40 micrograms/hour.

Adults and elderly patients

Unless your doctor has told you differently, attach one Butec patch (as described in detail below) and change it every 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 Butec 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 Butec 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 Butec patch may be affected and your doctor will therefore check on you more closely.

Before applying the Butec patch • Choose an area of non-irritated, 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.

•    The Butec patch should be applied to a relatively hairiess 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 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, 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 of the patch is covered with a silvery protective foil. Carefully peel off half the foil. Try 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. Make 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. Provided that you have applied the patch correctly, 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. healing pads, electric blanket, heat lamps, sauna, hot (ubs, 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 pr operly. If you have a high temper ature this may alter the effects of Butec 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 one on straight away (see “Changing the 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

•    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 reach and sight 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 o f the time o f

Duration of treatment

Your doctor will tell you how long you should be treated with the Butec 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 Butec 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 mere 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 breathing difficulties or lose consciousness and may need emergency treatment in hospital. When seeking medical attention make sure that you take this 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. Ifyou are very late changing your patch, your pain may return. In this ease, 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 treatment 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 with 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 the 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 cause side effects, although not eveiybody gets them.

Serious side effects that may be associated with Butec patches are similar to those seen with other 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 (may affect 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 (may affect up to 1 in 10


•    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 (may affect up to 1 in 100


•    Mood swings, restlessness, agitation, a feeling of extreme happiness, hallucinations,'

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

•    Loss of memory1, migraine, fainting, problems with concentration or coordination.

•    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.

•    Dry skin.

•    Spasms, aches and pains.

•    Difficulty in beginning the flow of

•    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 (may affect up to 1 in 1,000 people)

•    Angina (chest pain associated with heart disease).

•    Decreased sexual drive, mental disorder.

•    Difficulties with balance.

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


•    Di fficulty 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

•    Decreased erection, sexual dysfunction.

•    A flu-like illness.

•    Flushing of the skin.

•    Dehydration.

Very rare (may affect up to 1 in 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. 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 the

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

| S. 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 the last day of that month. After the 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.

Do not throw away any 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 Butec patches contain The active ingredient is buprenorphine. Each transdermal patch contains 15 mg of buprenorphine in a patch size of 18.75 cm2 and releases about 15 micrograms of buprenorphine per hour (over a period of 7 days).

The other ingredients are:

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

•    Levulinic acid

•    Oleyl oleate

•    Povidone

•    Polyethyleneterephthal ate What Butec patches look like and contents of the pack

A rectangular, beige coloured patch with rounded comers marked Butec 15 pg/h

Butec patches are available in cartons containing 4 pouches, each containing a single patch.

Marketing Authorisation Holder

Qdem Pharmaceuticals Limited, Cambridge Science Park,

Milton Road,

Cambridge CB4 OAB,


Manufacturers Bard Pharmaceuticals Limited, Cambridge Science Park, Milton Road,

Cambridge CB4 OGW,


Mundipharma DC B.V.. Leusderend 16,

3832 RC' Leusden,

The Netherlands.

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: 0800 198 5000

You will need to give details of the product name and reference number.

These are as follows:

Product name: Butec patches Reference number: 40431/0027

This leaflet was last revised in July 2016

® BUTEC, QDEM and the ‘Qdem Pharmaceuticals’ logo are registered trade

© 2015 Qdem Pharmaceuticals Limited.

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