Fenylat 12 Micrograms/Hour Transdermal Patch
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Fenylat 12 / 25 / 50 / 75 / 100 |jg/h ro uc ' Transdermal patch MA Holder: Activase PL No.: 28444/0125-0129 |
Printing Colours: | Black |
Non-Printing Colours: | Profile |
0PL Final Preparation Date For Submission: 07/11/2014 Packing Site Technical Approval: 10/11/2014 Authority Approval Date: 00/00/0000 |
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Pack Size: All |
Dimensions: 480 x 280 mm | ||
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Livery: Activase |
Created By: DTawde |
Latest Implementation Deadline: 00/00/0000 Print Proof Approval: 00/00/0000 | |
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Manufacturer: -Market: UK Component: Leaflet |
Artwork Code: A0125-0129/O/PIL/A3 Bar Code: - Font Type: Fruitiger Roman Font Size: 9 pt | ||
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you
start using this medicine.
• 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 symptoms 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.
Fenylat
12 /25/ 50/75/ 100 micrograms/hour Transdermal Patch
Fentanyl
Important things you need to know about
Fenylat Transdermal Patches
• 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 72 hours
• If your breathing becomes shallow and weak take the patch off and seek medical help
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
WHAT FENYLAT IS AND WHAT IT IS USED FOR
Fenylat is a strong painkiller; its painkilling activity is mediated through the central nervous system.
Adults:
Fenylat is used for long-term management of severe and long-lasting pain that can only be managed adequately with strong pain relievers (opioid analgesics).
Children:
Fenylat is used for long-term management of severe chronic pain that can only be managed adequately with strong pain relievers (opioid analgesics) in children aged 2 years or older who have previously been treated with opioid analgesics.
WHAT YOU NEED TO KNOW BEFORE YOU USE FENYLAT
Do not use Fenylat:
• if you are hypersensitive (allergic) to fentanyl, peanut, soya or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from pain which lasts only for a short period, e. g. after a surgical procedure.
• if your central nervous system is severely impaired, for instance by brain injury.
• if your breathing function is severely impaired.
Warnings and precautions
Talk to your doctor before using Fenylat Warning
Fenylat is a medicinal product that could be life-threatening to children.
This is also the case with used transdermal patches.
Bear in mind that the design of this medicinal product could be tempting to a child which in some cases may lead to a fatal outcome.
Fenylat can have life-threatening side-effects in persons that are not using prescribed opioid medicines on a regular basis.
This medicine should only be used under the supervision of a doctor who is experienced in the treatment of pain.
Your doctor will use treatment with Fenylat as a part of an integrated management of pain and will assess you for your individual response to Fenylat at regular intervals.
As strong pain relievers may cause breathing problems, Fenylat should be used with caution, under special supervision and at low doses in patients with
• existing breathing problems (respiratory depression), asthma. Breathing difficulties may continue or re-occur following removal of the transdermal patch, therefore, you must be monitored for these signs. The probability of these side-effects increases with increasing doses and may be increased by medicines affecting brain function (see section "Using other medicines")
• diseases of the lungs, e.g. chronic pulmonary disease (CPD), as breathing may be reduced
• impaired liver and/or kidney function as excretion of fentanyl may be delayed
• Take special care if you develop a fever while wearing Fenylat, tell your doctor as this may affect the way the medicine passes through your skin.
• Do not expose the patch to a direct heat source such as heating pads, hot water bottles, electric blankets, heat lamps, saunas and hot whirlpool spa baths. These may affect the way the medicine works.
Check with your doctor or pharmacist before using this medicine:
• If you have severe side-effects. Following removal of Fenylat you should be monitored
for at least 24 hours or longer, depending on your symptoms.
• If you have had a head injury, a brain tumour, signs of increased intracranial pressure, changes in your state of consciousness or loss of consciousness or coma. Strong pain relievers (opioids) may mask the course of head injury.
• If you have a too slow, irregular heartbeat (bradyarrhythmia)
• If you have low blood pressure or lack of fluid (hypovolaemia). This should be treated prior to initiation of treatment with Fenylat.
• If you are at an advanced age.
• If you suffer from long-lasting constipation.
• If you have existing or suspected loss of muscle function of the bowel: treatment with Fenylat must be stopped.
• If you suffer from myasthenia gravis (a disease causing tiredness and weakness of the muscles).
• If you are addicted to medicines or alcohol or have a history of drug abuse.
Repeated use of strong pain relievers (opioids) may lead to physical or psychological dependence. However, this is rarely seen when opioids are prescribed by a doctor (see section "Possible side effects").
Do not cut Fenylat patches. The patches should be checked before use. A divided, cut or in any way damaged patch should not be used.
Patch sticking to another person The patch should only be used on the skin of the person for whom it was ordered by the doctor. 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.
Children and adolescents
Fenylat should not be administered to children, who have not been treated with opioids before. Patients may experience with a significant or life-threating respiratory depression.
Fentanyl Transdermal Patch has not been studied in children under 2 years of age. Fenylat should be administered only to opioid-tolerant children age 2 years or older (please see "How to use Fenylat"). Fenylat should not be used in children under 2 years of age.
To minimise the potential of young children removing and consuming the patch, the site of administration should be chosen carefully. The adhesion of the patch should be monitored carefully and if necessary the patch should be reapplied. The patch should be applied, removed and disposed of by a clinical person, a doctor or by an adult attending the child and not by the child. Fenylat should be stored out of the sight and reach of children before and after administration.
Misuse for doping (cheating at competitive events)
The use of Fenylat can lead to positive results in doping tests. Using Fenylat for doping reasons can result in a risk to your health.
HOW TO USE FENYLAT
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Apply your patch on |
Change your patch at the same time on |
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Other medicines and Fenylat
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This includes medicines that you buy without a prescription.
If you take any of the following medicines, an interactive increase of the central depression is to be expected and side effects like difficulty in breathing, low blood pressure, severe sleepiness/coma and death are possible:
• strong painkillers
• depressants and hypnotics
• medicines used to put you to sleep or for relaxation of your muscles (in the case of a planned medical or dental procedures with anaesthesia/narcosis, please inform your doctor or dentist that you are using Fenylat
• phenothiazines (medicines to treat neuroleptic disease)
• medicines used for treating anxiety
• medicines used for treating allergies (antihistamines that make you feel tired)
• alcohol
The concomitant use with specific medicines (CYP3A4 inhibitors) may reduce the breakdown of fentanyl in the liver which could increase or prolong the therapeutic effects and side effects, e.g.:
• ritonavir, nefinavir (medicines to treat viruses)
• ketoconazole, itraconazole, fluconazole, voriconazole (medicines to treat fungal diseases)
• troleandomycin, clarithromycin (antibiotics)
• nefazodone (medicine to treat depression)
• verapamil, diltiazem (medicines to treat heart disease and high blood pressure)
• amiodarone (medicine to treat a heart problem called arrhythmia)
Concomitant use of specific medicines (CYP3A4 inducers) may increase breakdown of fentanyl in the liver, which could decrease the therapeutic effects, e.g.
• rifampicin (antibiotic)
• carbamazepine, phenobarbital, phenytoin (for treatment of epilepsy)
Once you stop these medicines (CYP3A4 inducers) it may increase or prolong the therapeutic effects and side-effects of fentanyl which can affect your breathing. In this situation you will require special monitoring and your dose will be adjusted.
You should not use Fenylat if you are taking Monoamine Oxidase Inhibitors (MAOI) (for treatment of depression or Parkinson's disease) or have taken them within the last 14 days.
Please tell your doctor if you are taking special medicines against depression, known as Selective Serotonin Re-uptake Inhibitor (SSRI), or Serotonin Noradrenaline Re-uptake Inhibitor (SNRI) or a Monoamine Oxidase Inhibitor (MAOI).
Your doctor should know of any treatment with these medicines as the concomitant use with Fenylat may increase the risk for the potentially life-threatening serotonin syndrome.
If you are using Fenylat you should not take other painkillers like buprenorphine, nalbuphine or pentazocine, because they could counteract the effects of fentanyl (e.g. analgesic effect) and may cause withdrawal symptoms in people who are dependent on opioids.
Fenylat with food, drink and alcohol
Patients treated with Fenylat should not drink alcohol.
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.
Pregnancy
There is no adequate data from the use of fentanyl, the active ingredient of Fenylat in pregnant women. Therefore you should not use Fenylat during pregnancy unless your doctor decides it is necessary. There is a risk of neonatal withdrawal syndrome in new-born infants where the mother has used transdermal fentanyl a lot during pregnancy.
Use of Fenylat during childbirth is not recommended because fentanyl passes through the placenta and may cause breathing problems in the new-born child.
Breast-feeding
Fentanyl passes into the breast-milk. Therefore breast-feeding should be stopped during treatment with Fenylat and for at least 72 hours after removal of the patch.
Driving and using machines
Fenylat can affect your ability to drive and use machines as it may make you feel sleepy or dizzy. In patients on a stable fentanyl dose, a significant impairment of the ability to drive and use machines is not expected. However at the beginning of treatment, upon increase of dose or upon combination with other medicinal products, some people's reactions may be affected, leading to impairment of the ability to drive or use machines. Such situations should be handled with caution.
During treatment with Fenylat do not drive or use machines, nor do so for at least 24 hours after the end of treatment.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
• Fenylat 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.
Fenylat contains soya oil
If you are allergic to peanut or soya, do not use this medicinal product.
Always use this medicine 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:
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 patch becomes effective. Your doctor will advise you on this if it is needed.
POSSIBLE SIDE EFFECTS
• 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 or 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 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 damages.
• 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 sight and reach of children.
Step 5: Wash
• Wash your hands afterwards with clean water.
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 you forget to change your 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 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 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:
• 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 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 stick to your partner or child, especially while sharing a bed in close contact.
• If a patch accidentally 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 feel unwell.
• 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 product, ask your doctor or pharmacist
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 the 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.
If any of the following side effects occur you should discontinue treatment and immediately contact your doctor or visit a hospital.
Very common: may affect more than 1 in 10 people
• sleepiness, dizziness, headache
• nausea, vomiting, constipation
Common: may affect up to 1 in 10 people
• hypersensitivity of the immune system
• loss of appetite
• not able to sleep, depression, anxiety, feeling confused, hallucinations
• tremor, pins and needles
• conjunctivitis (an eye infection)
• vertigo (feeling sick and dizzy)
• palpitations and an increase in heart rate
• increase in blood pressure
• shortness of breath
• diarrhoea, dry mouth, stomach pain, indigestion
• increased sweating, itching, rash, skin reddening
• muscle spasms
• difficulty passing urine
• tiredness, swelling, particularly in feet ankles and hands (peripheral oedema), rapid tiredness (asthenia), a feeling of discomfort and uneasiness (malaise), feeling cold
Uncommon: may affect up to 1 in 100 people
• agitation, disorientation. Unnatural feeling of happiness,
• reduced sensation to touch (hypaesthesia), convulsions (including clinic and Grand Mai seizures), memory gaps, speech disturbances
• decreased heart rate, blue colouration of the skin (cyanosis)
• low blood pressure
• difficulties in breathing and breathlessness
• blockage of the intestine
• eczema, allergic rashes, skin disorders, contact dermatitis
• muscle twitching
• erectile dysfunction, sexual dysfunction
• application site reaction flu-like illness, feeling of body temperature change, application site hypersensitivity, withdrawal symptoms
• fever
Rare: may affect up to 1 in 1,000 people
• "pin-point" like pupils (miosis)
• irregular heartbeat (arrhythmia)
• flushing from dilation of blood vessels (vasodilatation)
• stopping breathing, shallow or too slow breathing (hypoventilation)
• partial blockage of the intestine
• skin inflammation and itching at the site where the patch was applied
Very rare: may affect up to 1 in 10,000 people
• painful gas
• less urine being passed and pain in the bladder
Not known: frequency cannot be estimated from the available data
• life threatening allergic reactions (anaphylactic shock), allergic reactions of different causes (anaphylactic or anaphylactoid reactions)
• slowed breathing (bradypnoea)
Other possible side effect
Tolerance of the medicine, leading to a physical dependence and psychological dependence can develop with repeated use of Fenylat (see section "Take special care with Fenylat").
Opioid withdrawal symptoms (such as nausea, vomiting, diarrhoea, anxiety, and shivering) are possible in some patients after conversion from their previous opioid analgesic to Fenylat or if therapy is stopped suddenly (see section "Take special care with Fenylat").
There have been very rare reports of new-born infants experiencing neonatal withdrawal syndrome when mothers used Fenylat a lot during pregnancy (see section "Take special care with Fenylat").
In very rare cases soya oil may cause allergic reactions.
Additional side effects in children and adolescents
The side-effects in children and adolescents treated with Fenylat Transdermal Patches is similar to the side effects observed in adults. Apart from side-effects that can usually be expected during treatment of pain in severely ill children, no additional risks are known when Fenylat is given to children aged 2 years or older at 100 pg/hour as directed.
Very common side-effects reported in the clinical trials performed in severely ill children were fever, headaches, vomiting, nausea, constipation, diarrhoea and itching.
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 any 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.
HOWTO STORE FENYLAT
Keep this medicine out of the sight and reach of children both before and after use.
Do not use this medicine after the expiry date which is stated on the label and outer packaging. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Disposal information
Do not throw away any medicines via wastewater or household waste. Please fold the used transdermal patch with the adhesive surfaces inwards and discard it according to your national requirement and out of reach of children safely. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
E CONTENTS OF THE PACK AND OTHER INFORMATION
What Fenylat contains
The active substance isfentanyl.
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, vinyl acetate) (50:50)
Release liner: polyethylene terephthalate, polyester foil, 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.
Marketing Authorisation Holder:
Activase Pharmaceuticals Ltd.,
11 Boumpoulinas, 3rd Floor,
P.C. 1060 Nicosia, Cyprus
Manufacturer:
Acino AG,
Am Windfeld 35,
83714 Miesbach
This leaflet was last revised in 11/2014
A0125-0129/0/PIL/A3