PACKAGE LEAFLET: INFORMATION FOR THE USER SZ00000LT000

Reletrans 5 microgram/hour transdermal patch Reletrans 10 microgram/hour transdermal patch Reletrans 15 microgram/hour transdermal patch Reletrans 20 microgram/hour transdermal patch

Buprenorphine

For use in adults

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 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.

What is in this leaflet

1.    What Reletrans is and what it is used for

2.    What you need to know before you use Reletrans

3.    How to use Reletrans

4.    Possible side effects

5.    How to store Reletrans

6.    Contents of the pack and other information

Reletrans transdermal patches contain the active ingredient buprenorphine which belongs to a group of medicines called strong analgesics or 'painkillers'.

Reletrans is used in adults to relieve moderate, long-lasting pain that requires the use of a strong painkiller.

Reletrans should not be used to relieve acute pain.

Do not use Reletrans if you

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

•    have breathing problems

•    are addicted to drugs

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

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

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

Reletrans must not be used to treat symptoms associated with drug withdrawal.

Warnings and precautions

Talk to your doctor or pharmacist before using Reletrans if you:

•    recently drunk a lot of alcohol

•    suffer from seizures, fits or convulsions

•    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 buprenorphine may make symptoms worse or hide the extent of a head injury.

•    are feeling light-headed or faint

•    have severe liver problems

•    have ever been addicted to drugs or alcohol

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

•    are an athlete: This medicine may cause positive results in sports doping control tests.

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

Children and adolescents

Reletrans should not be used in patients below the age of 18 years.

Other medicines and Reletrans

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

•    Reletrans must not be used together with a type of medicine known as a monoamine oxidase (MAO) inhibitor (examples include tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid), or if you have taken this type of medicine in the last two weeks.

•    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 Reletrans may be reduced.

•    Reletrans 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.

•    Reletrans 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.

Reletrans with alcohol

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

Pregnancy and breast-feeding

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.

You should not use Reletrans if you are pregnant, likely to become pregnant or are breast-feeding.

Driving and using machines

Reletrans 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 Reletrans, or for 24 hours after removing the transdermal patch.

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 if this medicine affects your ability to drive.

•    However, you would not be committing an offence if:

-    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 or in the information provided with the medicine and

-    It was not affecting your ability to drive safely

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.

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

Different strengths of Reletrans are available. Your doctor will decide which strength of Reletrans will suit you best.

During treatment, your doctor may change the transdermal patch you use to a smaller or larger one if necessary, or tell you to use a combination of up to two patches. You should not apply more than two transdermal patches at the same time up to a maximum total dose of 40 micrograms/hour.

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

Adults

Unless your doctor has told you differently, attach one Reletrans transdermal 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 transdermal patch, strictly follow the doctor's instructions, otherwise you will not fully benefit from treatment with the buprenorphine patch. The transdermal 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 with liver disease

In patients with liver disease, the effects and period of action of the buprenorphine transdermal patch may be affected and your doctor will therefore check on you more closely.

Use in children and adolescents

Reletrans transdermal patches should not be used in patients below the age of 18 years.

Method of administration

Reletrans transdermal patch is for transdermal use.

The transdermal patches act through the skin. After application, buprenorphine passes through the skin into the blood.

Before applying Reletrans

• 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 transdermal patch yourself.

•    The buprenorphine transdermal 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 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 transdermal patch from sticking properly.

Applying the transdermal patch

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

Step 2: The sticky side of the transdermal patch is covered with a transparent foil. Carefully peel off half the foil. Try not to touch the sticky part of the transdermal patch.

Step 3: Stick the transdermal patch on to 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 and count slowly to 30. Make sure that the whole transdermal patch is in contact with your skin, especially at the edges.

Wearing the transdermal patch

You should wear the transdermal patch for seven days. Provided that you have applied the transdermal patch correctly, there is little risk of it coming off. If the edges of the transdermal 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 transdermal 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 transdermal patch from sticking properly. If you have a high temperature this may alter the effects of Reletrans (see “Warnings and precautions” section above).

In the unlikely event that your transdermal patch falls off before it needs changing, do not use the same 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.

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

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

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

Duration of treatment

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

If you use more Reletrans than you should

As soon as you discover that you have used more transdermal patches than you should, remove all transdermal 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 transdermal patches with you to show to the doctor.

If you forget to apply Reletrans

Stick a new transdermal 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 transdermal patch, your pain may return. In this case, please contact your doctor.

Do not apply additional transdermal patches to make up for the forgotten application.

If you stop using Reletrans

If you stop using Reletrans 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 Reletrans 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 Reletrans is maintained for some time after removal of the transdermal patch. You should not start another opioid analgesic (strong painkiller) within 24 hours after removal of the transdermal patch.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects that may be associated with Reletrans 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 transdermal 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.

There is a risk that you may become addicted or reliant on Reletrans.

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

Very common (may affect more than 1 in 10 people):

•    headache, dizziness, drowsiness

•    constipation, dry mouth, feeling or actually being sick

•    itching, redness, itching at application site

Common (may affect up to 1 in 10 people):

•    loss of appetite

•    confusion, depression, difficulty in sleeping, nervousness

•    tingling or numbness

•    flushing of the skin

•    shortness of breath

•    abdominal pain or discomfort, diarrhoea, indigestion

•    sweating, rash, skin eruptions

•    tiredness, a feeling of unusual weakness, pain, chest pain, swelling of hands, ankles or feet, redness or rash at the application site

Uncommon (may affect up to 1 in 100 people):

•    dehydration

•    mood swings, restlessness, agitation, anxiety, feeling detached from oneself, a feeling of extreme happiness, hallucinations, nightmares

•    changes in taste, difficulty in speaking, reduced sensitivity to pain or touch, loss of memory, migraine, fainting, shaking, 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, angina pectoris (severe chest pain associated with heart disease), fast or irregular heart beat

•    worsening of breathing problems associated with asthma, cough, hiccups, over breathing, reduced oxygen in the blood, runny nose, wheezing

•    wind

•    weight loss

•    dry skin, swelling of the face

•    muscle cramps, spasms, aches and weakness

•    difficulty in beginning the flow of urine

•    inability to fully empty the bladder

•    a flu like illness, high temperature, shivering, generally feeling unwell

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

•    withdrawal symptoms such as agitation, anxiousness, sweating or shaking upon stopping using Reletrans

•    a feeling of faintness, especially on standing up

If you need to have blood tests remind your doctor that you are using Reletrans. This is important because Reletrans 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):

•    decreased sexual drive, mental disorder

•    difficulties with balance

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

•    difficulty in breathing

•    diverticulitis (inflammation of the intestine), difficulty in swallowing

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

•    decreased erection, sexual dysfunction

•    colicky abdominal pain or discomfort

Very rare (may affect up to 1 in 10,000 people):

•    muscle twitching

•    ear pain

•    blisters

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 the 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.

Keep this medicine 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 EXP The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not use the transdermal patch if you notice that the sachet seal is already broken.

Used transdermal patches must be folded over on themselves with the adhesive layer inwards, and discarded safely.

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

draft: 44068799, 44068800, 44069447, 44068801 laetus code: 00 mat.no.: 00000000

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