PATIENT INFORMATION LEAFLET

Tilofyl 25 microgram/hour transdermal patches Tilofyl 50 microgram/hour transdermal patches Tilofyl 75 microgram/hour transdermal patches Tilofyl 100 microgram/hour transderma patches (Fentanyl)

Important things you need to know about Tilofyl

*    These patches contain a strong painkiller

*    Ensure that old patches are removed before applying a new one

*    Patches must not be cut

*    Do not expose the patches to a heat source (such as a hot water bottle)

*    If you develop a fever tell your doctor immediately

*    Follow the dosage instructions carefully and only change your patch every 72 hours

*    If your breathing becomes shallow and weak take the patch off and seek medical help

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 further questions, please ask your doctor or your 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:

9	What Tilofyl Patch is and what it is used for		Possible side effects
2	What you need to know before you use Tilofyl Patch		How to store Tilofyl Patch
3	How to use Tilofyl Patch	|6	Contents of the pack and
			other information

What Tilofyl Patch is and what it is used for

Tilofyl Patch is a strong pain-killing medicine

that belongs to the opioid group.

Tilofyl Patch relieves prolonged severe pain requiring treatment with strong pain-killing medicines (e.g. cancer pain).

Children:

Tilofyl Patch can be used in children aged 2 to 16 years who have previously used opioid painkillers.

What you need to know before you use Tilofyl Patch

Do not use Tilofyl Patch:

*    if you are allergic to fentanyl, or any of the other ingredients of this medicine (listed in section 6)

*    if you have acute pain or pain after an operation

*    if the functioning of your nervous system is greatly reduced

*    if you suffer from severe breathing problems

*    for children in pain under 2 years of age

*    for children which have not been treated before with strong painkillers such as morphine

Warnings and precautions

*    Tilofyl Patch is a medicinal product that could be life-threatening to children, even if the patches have been used. Bear in mind that a sticky patch could be tempting to a child and in some cases may lead to a fatal outcome.

*    Tilofyl Patch can have life-threatening side effects in persons who are not using prescribed opioid medicines on a regular basis.

Patch sticking to another person

The patch should be used only on the skin of the person for whom it has been prescribed. Cases have been reported where a patch was accidentally stuck to a family member while in close physical contact or sharing the same bed as the patch wearer. A patch sticking to another person (particularly a child) may result in an overdose. In case the patch sticks to the skin of another person, take the patch off immediately and seek medical attention (see also section 3 below).

Talk to your doctor before using Tilofyl Patch if you have:

*    asthma, any other lung disease or breathing difficulties

*    disturbances of heart rhythm

*    low blood pressure or blood volume

*    reduced liver function

*    reduced kidney function

*    had a brain injury, brain tumour, signs of increased intracranial pressure (e.g. headache, visual disturbances), reduced consciousness or coma

*    myasthenia gravis (a disease characterised by muscle weakness)

*    chronic constipation

If you are very ill, very thin or elderly, you may be more sensitive to the effects of the patches.

If you develop fever you should contact your doctor. The dosage may have to be adjusted.

Avoid exposing the Tilofyl patch to direct heat source such as heating pads, hot water bottles, electric blankets, heated water beds, heat or tanning lamps, intensive sun bathing, prolonged hot baths, saunas or hot whirlpool spa baths, while wearing the patch. It is possible that more fentanyl is released from the patch at higher temperature.

Tilofyl Patch may cause constipation, talk to your doctor or pharmacist for advice on how to prevent constipation.

Like many other strong painkillers, repeated use of the patches may make you become tolerant to the medicine or become dependent on it.

Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or illegal drugs.

Children

The use of Tilofyl Patch is not recommended in children under 2 years of age. Do not use in children which have not been treated before with strong painkillers such as morphine.

Other medicines and Tilofyl Patches

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

Some other medicines can affect or be affected by Tilofyl Patch. These medicines include:

*    Medicines that have a sedative effect, such as

-    opioids (e.g. morphine and codeine)

-    sedatives

-    sleeping pills

-    anaesthetic agents

-    phenothiazides (antipsychotic agents)

-    medicines to relieve anxiety

-    muscle relaxants

-    sedative antihistamines

-    alcohol

*    Inhibitors of the enzyme CYP3A4 (enzyme in the liver, which mainly metabolises fentanyl in the body), e.g.

-    ritonavir and nelfinavir (antiviral agents)

-    ketoconazole, itraconazole, fluconazole and voriconazole (anti-fungal agents),

-    verapamil, diltiazem and amiodarone (e.g. used for treating irregular heart beat)

-    some macrolide antibiotics (e.g. clarithromycin, erythromycin, troleandomycin)

-    nefazodone (used to treat depression)

*    Inductors of the enzyme CYP3A4, such as

-    rifampicin (antibiotic)

-    carbamazepine, phenobarbital or phenytoin (medicines used to treat epilepsy)

*    Pentazocine, nalbuphine and buprenorphine (strong painkillers)

*    Some medicines used to treat depression

-    Selective Serotonin Re-uptake Inhibitor (SSRI),

-    Serotonin Norepinephrine Re-uptake Inhibitors (SNRI) or

-    Monoamine Oxidase Inhibitors (MAOI)

(such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, tranylcypromine).

Your doctor needs to know if you are taking any of the above medicines, since concomitant use may increase the risk of serotonin syndrome, a potentially life-threatening condition.

You should not use Tilofyl Patch during treatment and within 14 days of stopping MAOI (medicines used to treat depression or Parkinson's disease).

Tilofyl Patch with alcohol

You should not consume alcohol during Tilofyl Patch treatmet. Alcohol increases the side effects of the medicine.

Pregnancy and breast-feeding

You should not use Tilofyl Patch if you are pregnant unless your doctor considers the treatment essential. Experience is limited - ask your doctor for advice. If you become pregnant during treatment with Tilofyl Patch you should contact your doctor.

It is not recommended to use Tilofyl Patch if you are breast-feeding. Ask your doctor for advice. You should not breast-feed for at least 3 days after removing your patch.

Driving or using machines

You should not drive or use machines without first asking your doctor for advice. Tilofyl patch greatly affects reaction capacity, especially at the beginning of treatment and after increasing the dose.

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:

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 or in the information provided with the medicine and

o It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

How to use Tilofyl Patch

The dose is determined by your doctor, who adjusts it individually for you. Always use Tilofyl Patch exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Using and changing the patches

*    There is enough medicine in each patch to last 3 days (72 hours)

*    You should change your patch every third day, unless your doctor has told you otherwise

*    Always remove the old patch before applying the new one

*    Always change your patch at the same time of day every 3 days (72 hours)

*    Make a note of the day, date and time you apply a patch, to remind you when you need to change your patch

*    The following table shows you which day of the week to change your patch

Adults

*    Apply the patch on a flat part of your upper body or arm.

Children

*    Always apply the patch to the upper back to make it difficult for your child to reach it or take it off

*    Every so often check that the patch remains stuck to the skin

*    It is important your child does not remove the patch and put it in their mouth as this could be life threatening or even fatal

*    It may take some time before the patch becomes fully effective. Therefore, your child might need additional painkillers until the patches become effective. Your doctor will advise you on this if it is needed

*    Children need to be monitored very closely for 48 hours after:

-    The first patch has been put on

-    A higher dose patch has been put on

For you and your child, do not apply the patch

on:

*    The same place twice in a row

*    Sensitive areas that you move a lot, cuts, spots or other skin blemishes

*    Skin that is very hairy, if there is hair, do not shave it (shaving irritates the skin). Instead clip the hair as close to the skin as possible

continued....

You should allow several days to pass before you put on a new patch on the same area of skin.

Putting a patch on

Step 1: Preparing the skin

•    Make sure your skin is completely clean, dry and cool before you put the patch on

•    If you need to clean the skin, just use cold water

•    Do not use soap or any other cleansers, creams, moisturisers, oils or talc before applying the patch

•    Do not stick a patch on straight after a hot bath or shower

Step 2: Open the pouch

•    Each patch is sealed in its own pouch

•    Tear or cut off the edge of the pouch completely (if you use scissors, cut close to the sealed edge of the pouch to avoid damaging the patch)

•    Grasp both sides of the opened pouch and pull apart

•    Take the patch out and use it straight away

•    Keep the empty pouch to dispose of the used patch later

•    Use each patch once only

•    Do not take the patch out of its pouch until you are ready to use it

•    Inspect the patch for any damage

•    Do not use the patch if it has been divided, cut or looks damaged

•    Never divide or cut the patch

Step 3: Peel and press

•    Make sure that the patch will be covered by loose clothing and not stuck under a tight or elasticated band

•    Carefully peel one half of the shiny plastic backing away from the centre of the patch. Try not to touch the sticky side of the patch

•    Press this sticky part of the patch onto the skin.

•    Remove the other part of the backing and press the whole patch onto the skin with the palm of your hand

•    Hold for at least 30 seconds. Make sure it sticks well, especially the edges

Step 4: Disposing of the Patch

•    As soon as you take the patch off, fold it firmly in half so that the sticky side sticks to itself

•    Put it back in its original pouch and put the pouch in the bin with your household rubbish

•    Even used patches contain some medicine which may harm children, so keep your used patches out of the reach and sight of children

Step 5: Wash

Wash your hands afterwards with clean water.

More about using Tilofyl patches How quickly will the patches work?

•    It may take up to a day before your first patch is working completely

•    Your doctor may give you extra painkillers for your first day or so

•    After this, the patch should help to relieve pain continuously so that you can stop taking other painkillers. However, your doctor may still prescribe extra painkillers from time to time

If you forget to change the patch

•    If you forget, change your patch, as soon as you remember and make a note of the day and time. Change the patch again after 3 days (72 hours) as usual

•    If you are very late changing your patch, you should talk to your doctor because you might need extra painkillers, but do not apply an extra patch

If you use too many patches or the wrong strength patch

•    If you have stuck on too many patches or the wrong strength patch, take the patches off and contact a doctor or the nearest hospital straight away

Signs of an overdose include trouble breathing or shallow breathing, tiredness, extreme sleepiness, being unable to think clearly, walk or talk normally and feeling faint, dizzy or confused.

If the patch falls off

•    If the patch falls off before it needs changing, stick a new one on straight away and make a note of the day and time. Use a new area on:

-    On your upper body or arm

-    Your child's upper back

•    Leave another 3 days (72 hours) before changing the new patch as usual

•    If your patch keeps falling off, talk to your doctor, nurse or pharmacist

If the patch sticks to another person (see also section 2 above)

•    Only use the patch on the skin of the person who it is prescribed for

•    Make sure the patch does not get rubbed off and sticks to your partner, especially in bed

•    If a patch accidently sticks to another person, take it off straight away and seek immediate medical attention.

If your pain gets worse

•    If your pain gets worse while you are using these patches, your doctor may try a higher strength patch, or give you extra painkillers (or both)

•    If increasing the strength of the patch does not help, your doctor may stop the patches

If you want to stop using the patches

•    Talk to your doctor before you stop using these patches

•    If you have been using them for some time your body may have got used to them. Stopping suddenly may make you fell unwell

•    If you stop using the patches, don't start again without asking your doctor first. You might need a different strength patch when you restart

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

Possible side effects

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

Serious side effects

Take the patch off and tell your doctor or go to your nearest hospital straight away if you notice or suspect any of the following. You may need urgent medical treatment.

•    Feeling unusually drowsy, breathing more slowly or weakly than expected. Very rarely these breathing difficulties can be life threatening or even fatal especially in people who have not used strong opioid painkillers before. If you notice any of the above, follow the guidance above and keep moving as much as possible.

•    Cramp-like pain, vomiting, feeling of bloating (intestinal paralysis)

•    Breathlessness, rash, wheezing (acute allergic reaction)

•    Reduced consciousness or loss of consciousness

Side effects

Very common, affects more than 1 per 10 users

•    Feeling sick or being sick, constipation

•    Dizziness, sleepiness

•    Headache

Common, affects 1 to 10 per 100 users

•    Feeling your heartbeat, fast heart rate

•    Muscle spasms

•    Shaking, sensation of pins and needles

•    Feeling breathless

•    Diarrhoea

•    Dry mouth, loss of appetite

•    Stomach ache, indigestion

•    Difficulty passing urine

•    Excessive sweating, feeling cold

•    Itchy skin, rashes or redness of the skin

•    High blood pressure

•    General feeling of discomfort, tiredness, weakness

•    Swelling of hands, ankles or feet

•    Allergic reaction

•    Feeling nervous, worried or depressed

•    Not able to sleep

•    Confusion, seeing, feeling or hearing things that are not there (hallucinations)

•    A feeling of dizziness or "spinning"

Uncommon, affects 1 to 10 per 1,000 users

•    Slow heart rate

•    Bluish colouration of the skin

•    Decreased feeling of sensitivity, especially in the skin

•    Fits

•    Blurred vision

•    Muscle twitching

•    Loss of memory

•    Severe breathing difficulties

•    Complete blockage of the gut

•    Disorders of sexual function

•    Eczema and/or other skin disorders including dermatitis where the patch is placed

•    Low blood pressure

•    Flu-like symptoms

•    Fever, body temperature changes

•    Drug withdrawal effects (such as sickness, feeling sick, diarrhoea, anxiety or shivering)

•    Feeling agitated, disorientated, excited or unusually carefree

Rare, occurs in 1 to 10 per 10,000 users

•    Tiny pupils

•    Incomplete blockage of the gut

•    Transient cessation of breathing, reduced breathing

•    Irregular heart beat

Frequency not known, according to the available data

•    Abnormal slow breathing

•    Severe and sometimes fatal allergic reaction affecting the whole body

Like many other strong painkillers, repeated use of the patches may make you become tolerant to the medicine or become dependent on it.

Children and adolescents

The side effect profile in children and adolescents was similar to that observed in adults. Very common side effects reported were fever, headache, vomiting, feeling sick, constipation, diarrhea and pruritus.

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 internet at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Tilofyl Patch

Keep all patches (used and unused) out of the sight and reach of children.

Store in the original package. Do not refrigerate or freeze!

Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Handling the patch

Used patches should be folded firmly in half so that the sticky side of the patch sticks to itself and then they should be safely discarded after putting them back into the original pouch. Accidental exposure to used and unused patches particularly in children may be fatal. Unused patches should be returned to the pharmacy.

E Contents of the pack and other information

What Tilofyl Patches contains:

•    The active substance is fentanyl.

Each transdermal patch (active surface area 10, 20, 30 and 40 cm²) contains: 2.5 mg, 5 mg, 7.5 mg or 10 mg fentanyl (which corresponds to a release rate of 25, 50, 75 or 100 micrograms/hour of fentanyl)

•    The other ingredients are:

Outer membrane: polyethylene-terephthalate / ethylenvinylacetate-copolymer.

Medicinal product container: ethanol 96%, hydroxyethylcellulose, purified water.

Control membrane: ethylenvinylacetate-copolymer.

Adhesive membrane: silicon medical adhesive.

Protective membrane: (removed before the patch is stuck onto the skin) polyethylene-terephthalate, release coated

What Tilofyl Patches looks like and contents of the pack:

Tilofyl Patch is a transparent oblong transdermal patch packed in a sachet which consists of a protective membrane (removed before the patch is stuck onto the skin), and four functional layers: an outer membrane, a medicinal product container, a control membrane and an adhesive membrane. With the adhesive membrane Tilofyl Patch can be stuck onto the skin.

Tilofyl Patch is available in packs with 3, 5, 7, 10, 14 and 20 transdermal patches.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Tillomed Laboratories Ltd 3 Howard Road,

Eaton Socon, St Neots, Cambridgeshire PE19 8ET, UK

Manufacturer:

Hexal AG,

Industriestrasse 25,

D-83607 Holzkirchen, Germany

Product Licence Numbers:

Tilofyl 25 microgram/hour Patches:

PL 11311/0311

Tilofyl 50 microgram/hour Patches:

PL 11311/0312

Tilofyl 75 microgram/hour Patches:

PL 11311/0313

Tilofyl 100 microgram/hour Patches:

PL 11311/0314

This leaflet was last revised in May 2015.

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