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PACKAGE LEAFLET: INFORMATION FOR THE USER

OSMANIL 12 MICROGRAMS/H TRANSDERMAL PATCH

(fentanyl)

Important things you need to know about Osmanil transdermal patch

•    These patches contain a strong pain killer.

•    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 3 days (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 any further questions, ask your doctor, nurse 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Osmanil transdermal patch is and what it is used for

2.    What you need to know before you use Osmanil transdermal patch

3.    How to use Osmanil transdermal patch

4.    Possible side effects

5.    How to store Osmanil transdermal patch

6.    Contents of the pack and other information

1. WHAT OSMANIL TRANSDERMAL PATCH IS AND WHAT IT IS USED FOR

The name of your medicine is Osmanil 12 micrograms/h transdermal patch. It is called Osmanil transdermal patch or just ‘patch’ in this leaflet.

The patches help relieve pain that is very bad and long-lasting.

Osmanil transdermal patch contains a medicine called fentanyl. It belongs to a group of strong painkillers called opioids.

The medicine passes slowly into your body through your skin.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE OSMANIL TRANSDERMAL PATCH

Osmanil transdermal patches can be used in children aged 2 to 16 years who have previously used opioid painkillers. If the patches have been prescribed for your child, the ‘you’ stated everywhere below should be read as ‘your child’.

Do not use Osmanil transdermal patch if:

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

•    You have pain which lasts only for a short period

•    Your child who is in pain is under 2 years old

•    Your child has not been treated with strong painkillers such as morphine

•    Your central nervous system (brain and spinal cord) is severely impaired, for instance by brain injury.

•    You suffer from breathing difficulties (breathe more slowly and weakly) and feel unusually drowsy

Do not use this medicine if any of the above applies to you or your child. If you are not sure, talk to your doctor or pharmacist before using Osmanil transdermal patch. Warnings and precautions

Talk to your doctor or pharmacist before using Osmanil transdermal patch

•    Like some other strong painkillers, Osmanil transdermal patch may make you unusually drowsy, and breathe more slowly or weakly. Very rarely these breathing difficulties can be life-threatening or even fatal in people who have not used strong morphine-related painkillers (like Osmanil transdermal patch) or morphine before. If you, or your partner or carer, notice that you or your child are breathing much more slowly or weakly then:

o Take the patch off

o Call a doctor, or go to your nearest hospital, straight away o Keep moving and talking as much as possible

•    If you develop a fever while wearing Osmanil transdermal patch tell your doctor as this may affect the way the medicine passes through your skin

•    Don’t expose the patch to direct heat such as heating pads, electric blankets, hot-water bottles, heated water beds, heat or tanning lamps, intensive sun bathing, prolonged hot baths, saunas or hot whirlpool spa baths. These may affect the way the medicine is absorbed through the skin.

•    Check with your doctor or pharmacist before using this medicine if you have ever had:

o Problems with your lungs or breathing

o Problems with your heart or blood pressure and blood volume, liver or kidneys o Brain tumours

o Persistent headaches or a head injury

Your doctor might need to check you more closely.

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

•    If you suffer from a condition in which muscles become weak and tire easily, known as myasthenia gravis, talk to your doctor or pharmacist before using Osmanil transdermal patch.

•    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

•    Osmanil transdermal patch may cause constipation, talk to your doctor or pharmacist for advice on how to prevent constipation.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Osmanil transdermal patch.

Other makes of patch

There are other makes of fentanyl transdermal patch available, but they are not all the same. If your patch looks different from one you have used before you should check with your doctor or pharmacist before using it.

Other medicines and Osmanil transdermal patch

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines

In particular, tell your doctor or pharmacist if you are taking:

•    Other medicines for pain, such as other opioid painkillers (buprenorphine, nalbuphine or pentazocine)

•    Medicines for helping you sleep

•    Medicines to help you calm down (tranquilisers) and medicines for mental conditions

•    Medicines for relaxing your muscles

•    Some medicines used to treat depression (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine)

•    Some medicines used to treat depression (called MAOIs). You should not take Osmanil transdermal patch within

14 days of stopping these medicines.

•    Nefazodone, a medicine used to treat depression

•    Some antihistamines (especially ones that make you sleepy)

•    Some antibiotics used to treat infection, such as erythromycin, clarithromycin or troleandomycin

•    Medicines used to treat fungal infection, such as itraconazole, ketoconazole, fluconazole or voriconazole

•    Medicines used to treat HIV infection, such as ritonavir or nelfinavir

•    Medicines used to treat an irregular heartbeat, such as amiodarone, diltiazem or verapamil

•    Rifampicin (for treatment of TB)

•    Some medicines used to treat epilepsy (such as carbamazepine, phenobarbital or phenytoin)

Please tell your doctor, if you use certain drugs for the treatment of depression, known as serotonin reuptake inhibitors (SSRI), serotonin noradrenalin reuptake inhibitors (SNRI) or MAO-inhibitors. Your doctor needs to know about any use of these drugs, as the concomitant use with Osmanil transdermal patch may increase the risk of the development of a serotonin syndrome, a potentially life-threatening condition.

Your doctor will know which medicines are safe to take with Osmanil transdermal patch. You may need to be closely monitored if you are taking some of the types of medicines listed above or if you stop taking some of the types of medicines listed above, as this may affect the strength of Osmanil transdermal patch you need.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Osmanil transdermal patch.

Operations or tests

If you think that you are going to have an anaesthetic, tell your doctor or dentist that you are using Osmanil transdermal patch.

Using Osmanil transdermal patch with food, drink and alcohol

Do not drink alcohol unless you have talked to your doctor first.

Osmanil transdermal patch can make you drowsy or breathe more slowly. Drinking alcohol may make these effects worse.

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. Osmanil transdermal patch should not be used during childbirth as the medication can affect the breathing of the newborn child.

Do not breast-feed whilst using Osmanil transdermal patch. You should not breast-feed for 3 days after removing your Osmanil transdermal patch. This is because small amounts of the medicine may pass into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

Osmanil transdermal patch can make you drowsy. If this happens, do not drive or use any tools or machines.

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.

3. HOW TO USE OSMANIL TRANSDERMAL PATCH

Always use this medicine exactly as your doctor or pharmacist 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 differently.

•    Always remove the old patch before applying a 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.

Where to apply the 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 that 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 should 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, skin with 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.

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

Putting a patch on Step 1: Preparing the skin

•    Make sure your skin is completely dry clean, 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 open the pouch

•    Gently 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 damages

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

•    Never divide or cut the patch

Please turn over

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 Osmanil transdermal 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 relive 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 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 some 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 a patch falls off

•    If a 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 of skin on:

o Your upper body or arm o Your child’s upper back

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

•    If your patches keep falling off, talk to your doctor, nurse or pharmacist

If a patch sticks to another person

•    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 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 talk to your doctor.

How long will you use the patches for?

Osmanil transdermal patches are for long-term pain. Your doctor will be able to tell you how long you can expect to use the patches.

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 feel 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.

Everyday activities while using the patches

•    The patches are waterproof

•    You can shower or bathe while wearing a patch, but do not scrub the patch itself

•    If your doctor agrees, you can exercise or play sport while wearing the patch

•    You can also swim while wearing the patch, but: o Don’t use a hot whirlpool spa bath

o Don’t put a tight or elasticated band over the patch Don’t expose the patch 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 or saunas. These may affect the way the medicine is absorbed through the skin.

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

4. POSSIBLE SIDE EFFECTS

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

gets them.

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 (like Osmanil transdermal patch or morphine) before. If you, or your partner or carer, notice that you or your child are breathing much more slowly or weakly, follow the guidance above and keep moving and talking as much as possible.

•    Sudden swelling of the face or throat, severe irritation, reddening or blistering of your skin.

These may be signs of a severe allergic reaction. This only happens in a small number of people.

•    Convulsions, fits or seizures. This affects less than 1 in 100 people.

The following side effects have also been reported:

Very common (affects more than 1 in 10 people):

•    Feeling sick (nausea) or being sick (vomiting), constipation.

•    Dizziness, drowsiness or not being able to sleep

•    Headache

Common (affects less than 1 in 10 people):

•    Allergic reaction

•    Awareness of unusual heart beats (also called palpitations), fast heart rate

•    High blood pressure

•    Loss of appetite or dry mouth

•    Sedation, feeling nervous, worried or depressed.

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

•    Sensation of pins and needles, shaking, feeling giddy

•    Muscle spasms

•    Stomach ache, indigestion, difficulty passing urine

•    Diarrhoea

•    Feeling cold, excessive sweating

•    General feelings of discomfort, tiredness, weakness

•    Swelling of hands, ankles or feet

•    Itchy skin, rashes or redness of the skin

Uncommon (affects less than 1 in 100 people ):

•    Flu-like symptoms

•    Slow heart rate

•    Low blood pressure

•    Decreased feeling of sensitivity, especially in the skin

•    Bluish colouration of the skin

•    Feeling agitated, disorientated, excited or unusually carefree

•    Loss of memory, speech problems

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

•    Disorders of sexual function

•    Complete obstruction of the intestine

•    Muscle twitching

•    Fever, body temperature changes

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

Rare side effects (probably affecting less than 1 in 1000 people):

•    Blurred vision due to the pupil of the eye becoming smaller

•    Hiccups

•    Incomplete obstruction of the small or large intestine.

•    Irregular heartbeat

•    Dilation of blood vessels

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

•    Painful bloating

•    Lack of coordination or balance

•    Lazy eye

•    Bladder pain, passing less urine than usual over the day

The following side effects have been reported during clinical trials in children (up to 18 years of age):

Very common side effects (probably affecting more than 1 in 10 people):

•    Headache

•    Feeling or being sick

•    Constipation, diarrhoea

•    Itching

Common side effects (probably affecting up to 1 in 10 people):

•    Allergic reaction

•    Loss of appetite, stomach pain

•    Not being able to sleep, drowsiness, tiredness, feeling weak

•    Feeling worried or depressed, hallucinations (seeing, feeling or hearing things that are not there), dizziness

•    Shaking, decreased feeling or sensitivity, especially in the skin

•    Dry mouth

•    Rash, excessive sweating, redness of the skin

•    Muscle spasms

•    Difficulty passing urine

•    Swelling of hands, ankles or feet

•    Skin reactions where the patch is placed

Uncommon side effects (probably affecting less than 1 in 100 people):

•    Confusion

•    Sensation of pins and needles

•    Tiny pupils

•    Feeling giddy

•    Bluish colouration of the skin, eczema and/or other skin disorders including dermatitis where the patch is placed

•    Drug withdrawal effects (such as sickness, feeling sick, diarrhoea, anxiety or shivering), flu-like symptoms.

If you get any of these side effects, tell your doctor, nurse or pharmacist.

Skin rashes, itching or sweating (affects less than 1 in 10 people). You may notice rashes, redness or slight itching of the skin at the site of the patch. This is usually mild and disappears after you have removed the patch. If it does not, or if the patch irritates your skin badly, tell your doctor.

There have been reports of newborn infants experiencing withdrawal effects after their mothers have used Osmanil transdermal patch for a long time during pregnancy.

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

If you get any of these side effects, tell your doctor, nurse or pharmacist.

If you switch from a different painkiller to Osmanil transdermal patches, you may notice effects such as sickness, feeling sick, diarrhoea, anxiety or shivering. Tell your doctor if you notice any of these effects.

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 at 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 OSMANIL TRANSDERMAL PATCH

Keep this medicine out of the sight and reach of children, even after use. High quantities of the active substance remain in the transdermal patches even after use.

Do not use this medicine after the expiry date which is stated on the package.

The expiry date refers to the last day of that month.

Do not store above 30 °C.

For environmental and safety reasons, used as well as unused and out of date patches must be discarded or returned to the pharmacy for disposal. Used patches should be folded in half with the sticky sides together. Put back used patches in the outer package and discard or whenever possible hand in to your pharmacist.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Osmanil transdermal patch contains

•    The active substance is fentanyl.

Each patch releases 12.5 micrograms fentanyl per hour. Each patch of 3.75 cm² contains 2.063 mg fentanyl.

•    The other ingredients are:

Adhesive layer : Polyacrylate adhesive layer Backing film: Polypropylene foil, blue printing ink Release liner: Polyethylene terephthalate foil (siliconised)

What Osmanil transdermal patch looks like and contents of the pack

Osmanil transdermal patch is a transparent transdermal patch with an adhesive surface so that it can be stuck on the skin. The patches have a blue imprint stating their strength.

Osmanil transdermal patch is supplied in packs containing 5, 7 10, 14 or 20 transdermal patches.

Not all pack sizes may be marketed.

Note

Not all fentanyl dosages can be achieved with the Osmanil 12 micrograms/h transdermal patch. There are other patches containing fentanyl available which will deliver these different doses.

Marketing Authorisation Holder

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Manufacturer

Acino AG, Am Windfeld 35, 83714 Miesbach, Germany

This leaflet was last revised in February 2014

©2014 Zentiva

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