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A SANDOZ PACKAGE LEAFLET: INFORMATION FOR THE USER    SZ00000LT000

Fentalis Reservoir 25 microgram/hour transdermal patches Fentalis Reservoir 50 microgram/hour transdermal patches Fentalis Reservoir 75 microgram/hour transdermal patches Fentalis Reservoir 100 microgram/hour transdermal patches

Fentanyl

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 Fentalis Reservoir transdermal patches are and what they are used for

2.    What you need to know before you use Fentalis Reservoir transdermal patches

3.    How to use Fentalis Reservoir transdermal patches

4.    Possible side effects

5.    How to store Fentalis Reservoir transdermal patches

6.    Contents of the pack and other information

1. WHAT FENTALIS RESERVOIR TRANSDERMAL PATCHES ARE AND WHAT THEY ARE USED FOR

Fentalis Reservoir transdermal patches are strong pain-killing medicines that belongs to the opioid group.

Fentalis Reservoir transdermal patches relieve prolonged severe pain requiring treatment with strong pain-killing medicines (e.g. cancer pain).

Children:

Fentanyl transdermal patches can be used in children aged 2 to 16 years who have previously used opioid painkillers.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE FENTALIS RESERVOIR TRANSDERMAL PATCHES

Do not use Fentalis Reservoir transdermal patches

•    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

•    Fentalis Reservoir transdermal patches 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.

•    Fentalis Reservoir transdermal patches 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 Fentalis Reservoir transdermal patches, 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.

•    myasthenia gravis (a disease characterised by muscle weakness)

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

•    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 Fentalis Reservoir transdermal patches to direct heat 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.

Fentalis Reservoir transdermal patches 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 Fentalis Reservoir transdermal patches are 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.

Doping warning

This medicine may cause a positive reaction to ‘anti-doping’ tests.

Other medicines and Fentalis Reservoir transdermal 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 Fentalis Reservoir transdermal patches.

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

-    musclerelaxants

-    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 Fentalis Reservoir transdermal patches during treatment and within 14 days of stopping MAOI (medicines used to treat depression or Parkinson’s disease).

Fentalis Reservoir transdermal patches with alcohol

You should not consume alcohol during Fentalis Reservoir transdermal patches treatment. Alcohol increases the side effects of the medicine.

Pregnancy and breast-feeding

You should not use Fentalis Reservoir transdermal patches 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 Fentalis Reservoir transdermal patches, you should contact your doctor.

It is not recommended to use Fentalis Reservoir transdermal patches 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 and using machines

You should not drive or use machines without first asking your doctor for advice. Fentalis Reservoir transdermal patches greatly affect your 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:

-    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

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 FENTALIS RESERVOIR TRANSDERMAL PATCHES

The dose is determined by your doctor, who will adjust it individually for you. Always use Fentalis Reservoir

transdermal patches exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults and children aged 16 years and above:

The recommended starting dose is one transdermal patch every three days (72 hours). Depending on your

response your doctor may adjust the dosage (additional patch or patch with another strength).

Older patients:

The dose is determined by your doctor, who may adjust it individually for you.

Children and adolescents under 16 years of age:

Your doctor will adjust the dose individually according to the age of your child.

Reduced liver or kidney function:

The dose is determined by your doctor, who will adjust it individually for you.

How to use Fentalis Reservoir transdermal patches

1.    Apply the patch to a smooth area on the upper body or upper arm. The area of skin must not be hairy or have sores, pimples or other skin wounds.

2.    You should cut off any hair with scissors (but it is advisable to use a hairless area). Do not shave off the hair, as this causes skin irritation. If necessary, the skin may be cleansed with water. Do not use soap, oils, skin creams, alcohol or other substances that can irritate the skin. The skin must be completely dry before the patch is applied.

3.    Apply Fentalis Reservoir transdermal patch as soon as the pack has been opened. After removing the protective membrane, apply the patch to the skin by pressing lightly with the flat of the hand for approximately 30 seconds. Ensure that the patch has stuck properly to the skin. It may be necessary to correct the adhesion to the skin.

•    Fentalis Reservoir transdermal patches have a waterproof protective film so that you can leave it in place even when you take a shower.

•    The Fentalis Reservoir transdermal patch is used for 3 days (72 hours).

•    You must not divide or cut the Fentalis Reservoir transdermal patch into pieces, as this results in the medicine

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4. Wash your hands afterwards with clean water.

Especially for use in children:

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

2.    Every so often check that the patch remains stuck to the skin.

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

4.    Children should be monitored very closely for 48 hours after:

-    the first patch has been put on

-    a higher dose patch has been put on

How to change the Fentalis Reservoir transdermal patch

•    After 3 days you should change the patch. Usually the patch does not come off by itself.

•    Always remove the old patch before applying a new one.

•    Fold the used patch in half with the sticky sides together. Replace the used patch in its packaging. Put the package in the bin used for household waste.

•    Apply a new patch in accordance with the instructions “How to use Fentalis Reservoir transdermal patches”. Do not apply the patch on the same area of skin as the last one. The same application site may only be used again after at least 7 days.

•    If a residue is left on the skin after removing the patch, use soap and water to remove. Do not use alcohol or any other solvent.

If the Fentalis Reservoir transdermal patch is damaged and leaks out onto the skin, rinse the skin immediately with water. Do not use soap or any other cleansing product, because this can accelerate the absorption of the active substance through the skin.

Fold the leaking patch carefully in two with the adhesive sides together and put it in the bin used for household waste. 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 the 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 a patch sticks to another person (see also section 2 above)

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

•    Make sure the patch does not get rubbed off and sticks to your partner or child, especially while sharing a bed or in close contact.

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

If you use more Fentalis Reservoir transdermal patches than you should

If you have applied more transdermal patches than prescribed you should remove the patch(es) and contact a doctor or hospital immediately.

If you forget to apply or change the Fentalis Reservoir transdermal patch

The transdermal patch should be changed at the same time every 3 days unless the doctor has instructed otherwise.

If you forget to change the Fentalis Reservoir transdermal patch, you should change it as soon as you remember.

If you forget for a long period to change the patch you should contact your doctor, because you may need additional pain-killing medicine. Do not apply an extra patch to make up for the forgotten patch.

If you stop using Fentalis Reservoir transdermal patches

Do not suddenly stop using Fentalis Reservoir transdermal patches without first discussing this with your doctor. It is very important that you use your medicine in accordance with the doctor’s instructions.

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

4. POSSIBLE SIDE EFFECTS

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

Serious side effects

If you develop any of the following serious side effects, you should stop using the medicine and immediately contact your doctor or go to the Accident and Emergency Department of your hospital:

•    Significant restricted breathing (respiratory paralysis)

•    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 Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE FENTALIS RESERVOIR TRANSDERMAL PATCHES

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 . 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Fentalis Reservoir transdermal patches contain

The active substance is fentanyl.

Fentalis Reservoir 25 microgram/hour transdermal patches:

•    Each transdermal patch (active surface area 10 cm2) contains: 2.5 mg fentanyl (which corresponds to a release rate of 25 microgram/hour of fentanyl)

Fentalis Reservoir 50 microgram/hour transdermal patches:

•    Each transdermal patch (active surface area 20 cm2) contains: 5 mg fentanyl (which corresponds to a release rate of 50 microgram/hour of fentanyl)

Fentalis Reservoir 75 microgram/hour transdermal patches:

•    Each transdermal patch (active surface area 30 cm2) contains: 7.5 mg fentanyl (which corresponds to a release rate of 75 microgram/hour of fentanyl)

Fentalis Reservoir 100 microgram/hour transdermal patches:

•    Each transdermal patch (active surface area 40 cm2) contains: 10 mg fentanyl (which corresponds to a release rate of 100 microgram/hour of fentanyl)

•    The other ingredients are:

Occlusive membrane: polyethylene-terephthalate/ethylenvinylacetate-copolymer Medicinal product container: ethanol 96 %, hydroxyethylcellulose, purified water Control membrane: ethylenvinylacetate-copolymer Adhesive surface: silicone medical adhesive

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

What Fentalis Reservoir transdermal patches look like and contents of the pack

Fentalis Reservoir transdermal patches are transparent oblong transdermal patches packed in a sachet which consists of a protective membrane (removed before the patch is stuck onto the skin), and four functional lavers: an outer membrane, a medicinal product container, a control membrane and an adhesive membrane. With the adhesive membrane Fentalis Reservoir transdermal patches can be stuck onto the skin. The transdermal patch slowly releases fentanyl which is absorbed through the skin.

Fentalis Reservoir transdermal patches are available in packs with 3, 5, 7, 10, 14 and 20 transdermal patches.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR. UK.

Manufacturer

Hexal AG, Industriestrasse 25, 83601 Holzkirchen, Germany This leaflet was last revised in 06/2015.

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