FENYLAT 12 MICROGRAMS / HOUR TRANSDERMAL PATCH - patient leaflet, side effects, dosage

Fenylat™

if you get side effects talk to your doctor, pharmacist or nurse. this includes any possible side effects not listed in this leaflet. see section 4.

What is in this leaflet

• 1. What Fenylat is and what it is used for

• 2. What you need to know before you use Fenylat

• 3. How to use Fenylat

• 4. Possible side effects

• 5. How to store Fenylat

• 6. Contents of the pack and other information

1. what fenylat is and what it is used for

The name of your medicine is Fenylat

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

• in adults who need continuous pain treatment
• in children above 2 years of age who are already using opioid medication and who need continuous pain treatment.

Fenylat contains a medicine called fentanyl. It belongs to a group of strong painkillers called opioids.

2. what you need to know before you use fenylatdo not use fenylat if: you are allergic to fentanyl, peanut, soya or any of the other ingredients of this medicine (listed in section 6)

• You have pain which lasts only for a short period, such as sudden pain or pain after having an operation
• You have breathing difficulties, with slow or shallow breathing

Do not use this medicine if any of the above apply to you or your child. If you are not sure, talk to your doctor or pharmacist before using Fenylat.

Warnings and precautions

• Fenylat can have life-threatening side effects in people who are not already regularly using prescribed opioid medicines.
• Fenylat is a medicine that could be life-threatening to children, even if the patches have been used. Bear in mind that a sticky patch (unused or used) could be tempting to a child and if it sticks to a child’s skin or they put it in their mouth, the result may be fatal.
• Store this medicine in a safe and secure place, where other people cannot access it – see section 5 for more information.

Patch sticking to another person

The patch should be used only on the skin of the person for whom it has been prescribed. There have been reports of patches accidentally sticking to a family member while in close physical contact or sharing the same bed as the person wearing the patch. A patch accidently sticking to another person (particularly a child) can cause the medicine in the patch to go through the skin of the other person and cause serious side effects such as breathing difficulties, with slow or shallow breathing which may be fatal. In case the patch sticks to the skin of another person, take the patch off right away and get medical attention.

Take special care with Fenylat

Talk to your doctor or pharmacist before using this medicine if any of the following apply to you – your doctor may need to check you more closely if:

• You have ever had problems with your lungs or breathing
• You have ever had problems with your heart, liver, kidneys, or low blood pressure
• You have ever had a brain tumour
• You have ever had persistent headaches or a head injury
• You are elderly – you may be more sensitive to the effects of this medicine.
• You have a condition called ‘myasthenia gravis’ in which muscles become weak and tire easily.
• You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”)
• You are a smoker
• You have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illness

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Fenylat.

While using the patch, tell your doctor if you have breathing problems while sleeping. Opioids like <invented name> can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep-related hypoxaemia (low oxygen level in the blood). Tell your doctor if you, your partner or carer notice you have any of the following:

• breathing pauses during sleep
• night awakening due to shortness of breath
• difficulties staying asleep
• excessive drowsiness during the day

Your doctor may decide to change your dose.

While using the patch, tell your doctor if you notice a change in the pain you are feeling. If you feel:

• your pain is no longer relieved by the patch
• an increase in pain
• there is a change in how you feel the pain (for example, you feel pain in another part of your body)
• pain when something touches your body that you wouldn’t expect to hurt you.
• Do not change the dose yourself. Your doctor may decide to change your dose or treatment.

Side effects and Fenylat

• Fenylat may make you unusually drowsy, and make your breathing more slow or shallow. Very rarely these breathing problems can be life-threatening or even fatal, especially in people who have not used strong opioid painkillers (like Fenylat or morphine) before. If you, or your partner or carer, notice that the person wearing the patch is unusually drowsy, with slow or shallow breathing:

• – Take the patch off

• – Call a doctor, or go to your nearest hospital straight away

• – Keep the person moving and talking as much as possible

• If you develop a fever while wearing Fenylat, tell your doctor as this may affect the way the medicine passes through your skin.
• Fenylat may cause constipation, talk to your doctor or pharmacist for advice on how to prevent or relieve constipation.
• Repeated, long-term use of the patches may make the medicine less effective (you get used to it, or you may become more sensitive to pain), or you may become dependent on it. Increasing the dose of your patches may help to further reduce your pain for a while, but it may also be harmful. If you notice that your medicine becomes less effective, talk to your doctor. Your doctor will decide whether it is better for you to increase the dose or to gradually decrease your use of <invented name>. Also if you have concern that you may become dependent, you can consult your doctor on this.

See section 4 for a full list of possible side effects.

Do not expose the patch to a direct heat such as j-l ,, n a heating pads , hot-water bottles, electric blankets ,

UOInTl] piislKO heat lamps, saunas and hot whirlpool spa baths.

11 ■ 111111 This may affect the medicine works.

Withdrawal symptoms when stopping <invented name>

Do not suddenly stop taking this medicine. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating may occur. If you want to stop taking this medicine, talk to your doctor first. Your doctor will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum.

Other medicines and Fenylat

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription or herbal medicines. You should also tell your pharmacist that you are using Fenylat if you buy any medicines from your pharmacy.

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

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

• Other medicines for pain, such as other opioid painkillers (such as buprenorphine, nalbuphine, or pentazocine).
• Medicines for helping you sleep (such as temazepam, zaleplon, or zolpidem).
• Medicines to help you calm down (tranquillisers, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental conditions (anti-psychotics, such as arip-iprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
• Medicines for relaxing your muscles (such as cyclobenzaprine or diazepam).
• Some medicines used to treat depression called SSRIs or SNRIs (such as citalopram, duloxe-tine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). – see below for more information
• Some medicines used to treat depression or Parkinson’s disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromi­ne).You should not take Fenylat within 14 days of stopping these medicines. – see below for more information
• Some antihistamines, especially ones that make you sleepy (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine).
• Some antibiotics used to treat infection (such as erythromycin or clarithromycin).
• Medicines used to treat fungal infection (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
• Medicines used to treat HIV infection (such as ritonavir).
• Medicines used to treat an irregular heart beat (such as amiodarone, diltiazem, or verapamil).
• Medicines to treat tuberculosis (such as rifampicin).
• Some medicines used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin). Some medicines used to treat nausea or motion sickness (such as phenothiazines).
• Some medicines used to treat heartburn or ulcers (such as cimetidine).
• Some medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
• Some medicines used to treat cancer of the blood (such as idelalisib).

<invented name> with antidepressants

The risk of side effects increases if you are taking medicines such as certain antidepressants. <invented name> may interact with these medicines and you may experience changes to mental status such as feeling agitated, seeing, feeling, hearing, or smelling things that are not there (hallucinations) and other effects such as changing blood pressure, fast heart beat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomitting and diarrhoea (these could be signs of Serotonin Syndrome). If used together, your doctor may want to closely monitor you for such side effects in particular when starting treatment or when the dose of your medicine is changed.

Use with central nervous system depressants, including alcohol and some narcotic drugs Concomitant use of Fenylat and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor does prescribe Fenylat together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

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

Operations

If you think that you are going to receive anaesthesia tell your doctor or dentist that you are using Fenylat.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Fenylat should not be used during pregnancy unless you have discussed this with your doctor.

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

Prolonged use of <invented name> during pregnancy can cause withdrawal symptoms (such as highpitched cry, jitteriness, fits, poor feeding and diarrhoea) in your newborn baby that could be life-threatening if not recognised and treated. Talk to your doctor immediately if you think your baby may have withdrawal symptoms.

Do not use Fenylat if you are breastfeeding. You should not breastfeed for 3 days after removing your Fenylat patch. This is because the medicine may pass into breast milk.

Driving and using machines

Fenylat can affect your ability to drive and use machines or tools as it may make you sleepy or dizzy. If this happens, do not drive or use any tools or machines. Do not drive while using this medicine until you know how it affects you.

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

Fenylat contains soya oil

If you are allergic to peanut or soya, do not use this medicinal product.

3. how to use fenylat

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

Your doctor will decide which strength of Fenylat is most suitable for you, taking into account the severity of your pain, your general condition and type of pain treatment that you have received so far.

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:

Where to apply the patch

Adults

• Apply the patch on a flat part of your upper body or arm.
• 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 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 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 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
• To open the pouch, first cut two notches, as indicated by the arrows
• Next, gently tear off both edges of the pouch completely (or, if you use scissors, cut close to the sealed edge of the sachet 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 a 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 that may harm children, so keep your used patches out of the reach and sight of children.

Step 5: Wash

• Wash your hands afterwords with clean water.
• 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:

– Don’t use hot whirlpool spa baths

– Don’t put a tight or elasticated band over the patch

• While you are wearing the patch do not expose it to direct heat such as heating pads, electric blankets, hot-water bottles, heated water beds, heat or tanning lamps. Do no sunbathe, have long hot baths or saunas. If you do, you may increase the amount of medicine you get from the patch.

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.

How long will you use the patches for?

• Fenylat 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 additional painkillers (or both)
• If increasing the strength of the patch does not help, your doctor may stop the patches

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 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 you forget to change your 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 a patch falls off

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

• 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 accidentally sticks to another person, take it off straight away and talk to your doctor.

If you want to stop using the patches

• Do not suddenly stop taking this medicine. If you want to stop taking this medicine, talk to your doctor first. Your doctor will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. See also section 2 ‘Withdrawal symptoms when stopping <invented name>
• If you stop using the patches, don’t start again without asking your doctor first. You might need a different patch strength when you restart

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.

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.

• Sudden swelling of the face or throat, severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction. (Frequency cannot be estimated from the available data.)
• Fits (seizures). (Uncommon, this may affect up to 1 in 100 people.)
• Reduced consciousness or loss of consciousness. (Uncommon, these may affect up to 1 in 100 people.)

The following side effects have also been reported

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

• Nausea, vomiting, constipation
• Feeling sleepy (somnolence)
• Feeling dizzy
• Headache
• Allergic reaction
• Loss of appetite
• Difficulty sleeping
• Depression
• Feeling anxious or confused
• Seeing, feeling, hearing, or smelling things that are not there (hallucinations)
• Muscle tremors or spasms
• Unusual feeling in the skin, such as tingling or crawling feelings (paraesthesia)
• Spinning sensation (vertigo)
• Heart beat feels fast or uneven (palpitations, tachycardia)
• High blood pressure
• Being short of breath (dyspnoea)
• Diarrhoea
• Dry mouth
• Stomach pain or indigestion
• Excessive sweating
• Itching, skin rash or redness of the skin
• Being unable to pass urine or empty bladder completely
• Feeling very tired, weak or generally unwell
• Feeling cold
• Swollen hands, ankles or feet (peripheral oedema)

Uncommon (may affect up to 1 in 100 people)

• Feeling agitated or disoriented
• Feeling extremely happy (euphoria)
• Decreased feeling or sensitivity, especially in the skin (hypoaesthesia)
• Loss of memory
• Blurred vision
• Slow heart beat (bradycardia) or low blood pressure
• Blue colour to the skin caused by low oxygen in the blood (cyanosis)
• Loss of contractions of the gut (ileus)
• Itchy skin rash (eczema), allergic reaction or other skin disorders where the patch is placed
• Flu-like illness
• Feeling of body temperature change
• Fever
• Muscle twitching
• Difficulty getting and keeping an erection (impotence) or problems having sex

Rare side effects (may affect up to 1 in 1,000 people)

• Constricted pupils (miosis)
• Stopping breathing from time to time (apnoea)

The following side effects have also been reported, but their exact frequency is unknown:

• Lack of male sex hormones (androgen deficiency)
• Delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not really there, sleep disturbance, nightmares)

5. how to store fenylatwhere you should keep the patcheskeep all patches (used and unused) out of the sight and reach of children.

Store in the original pouch in order to protect from light. This medicinal product does not require any special temperature storage conditions.

Store this medicine in a safe and secure place, where other people cannot access it. It can cause serious harm and be fatal to other people who may take this medicine by accident, or intentionally when it has not been prescribed for them.

How long to keep Fenylat for

Do not use Fenylat after the expiry date which is stated on the carton and sachet. The expiry date refers to the last date of that month. If the patches are out of date, take them to your pharmacy.

How to dispose of used patches or patches you no longer use

A used or unused patch accidentally sticking to another person, especially a child, may be fatal.

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 by putting them back into the original sachet and stored out of sight and reach of other people, especially children, until safely disposed. Ask your pharmacist how to throw away medicines you no longer use.

6. contents of the pack and other informationwhat fenylat containsthe active substance is fentanyl.

Fenylat 12 pg/h: 1 transdermal patch contains 2.55 mg fentanyl in a patch size of 4.25 cm2 and releases 12.5 micrograms fentanyl per hour.

Fenylat 25 pg/h: 1 transdermal patch contains 5.1 mg fentanyl in a patch size of 8.5 cm2 and releases 25 micrograms fentanyl per hour.

Fenylat 50 pg/h: 1 transdermal patch contains 10.2 mg fentanyl in a patch size of 17 cm2 and releases 50 micrograms fentanyl per hour.

Fenylat 75 pg/h: 1 transdermal patch contains 15.3 mg fentanyl in a patch size of 25.5 cm2 and releases 75 micrograms fentanyl per hour.

Fenylat 100 pg/h: 1 transdermal patch contains 20.4 mg fentanyl in a patch size of 34 cm2 and releases 100 micrograms fentanyl per hour.

The other ingredients are:

Matrix components: Aloe vera leaf extract oil (on the basis of soya oil tocopherol acetate), colophonium resin, poly(2-ethylhexylacrylate, vinylacetate) (50:50)

Release liner: Polyethylene terephtalate, polyester, siliconized

Backing foil with imprint: polyethylene terephthalate foil, printing ink

What Fenylat looks like and contents of the pack

Transdermal patch

Opaque, colourless, rectangular shaped patch with round corners and imprint on the backing foil “Fentanyl 12 pg/h” in single sealed sachets.

Opaque, colourless, rectangular shaped patch with round corners and imprint on the backing foil: “Fentanyl 25 pg/h” in single sealed sachets.

Opaque, colourless, rectangular shaped patch with round corners and imprint on the backing foil: “Fentanyl 50 pg/h” in single sealed sachets.

Opaque, colourless, rectangular shaped patch with round corners and imprint on the backing foil: “Fentanyl 75 pg/h” in single sealed sachets.

Opaque, colourless, rectangular shaped patch with round corners and imprint on the backing foil: “Fentanyl 100 pg/h” in single sealed sachets.

Fenylat is available in packs containing 5, 10 and 20 transdermal patches.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Luye Pharma Ltd

Surrey Technology Centre

40 Occam Road

Surrey Research Park

Guildford, GU2 7YG

Manufacturer

Luye Pharma AG Am Windfeld 35 83714 Miesbach Germany

This leaflet was last revised in 07/2021.