Package leaflet: Information for the user. Fetanex 12.5 microgram/hour Transdermal Patch Fetanex 37.5 microgram/hour Transdermal Patch.

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1 Package leaflet: Information for the user Fetanex 12.5 microgram/hour Transdermal Patch Fetanex 37.5 microgram/hour Transdermal Patch 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 Fetanex is and what it is used for 2. What you need to know before you use Fetanex 3. How to use Fetanex 4. Possible side effects 5. How to store Fetanex 6. Contents of the pack and other information 1. What Fetanex is and what it is used for Fetanex belongs to a group of strong painkillers called opioids. The painkiller, fentanyl, slowly passes from the patch, through the skin and into the body. Fetanex relieves severe long-lasting pain, that can only adequately be managed with strong painkillers (opioids). Children: Fetanex 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 Fetanex Do NOT use Fetanex if you are allergic to fentanyl 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, e.g. by brain injury 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 WARNING: Fetanex 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. Fetanex can have life-threatening side-effects in persons that are not using prescribed opioid medicines on a regular basis. Talk to your doctor before using Fetanex if you suffer from any of the following disorders, because the risk of side effects is higher and/or your doctor may need to prescribe a lower dose of Fetanex. asthma, breathing difficulties or any lung disease

2 low blood pressure or blood volume impaired liver function impaired kidney function if you have had a head injury, brain tumour, signs of increased intracranial pressure (e.g. headache, visual disturbances), reduced consciousness or coma slow irregular heartbeat if you suffer from a disease causing tiredness and weakness of the muscles (myasthenia gravis) chronic constipation Increased body temperature may cause too much medicine to pass through the skin. Therefore inform your doctor if you develop a fever during treatment avoid exposing the patch on the skin 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 If you are an older patient or if you are in a very bad physical condition (cachectic) your doctor will monitor you more carefully, because it may be necessary to prescribe a lower dose. Fetanex may cause constipation, talk to your doctor or pharmacist for advice on how to prevent constipation. Decreasing relief of pain (tolerance), physical or psychological dependence may develop if you use Fetanex for a longer period. However, this is rarely seen during treatment of pain. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or illegal drugs. The patches should not be cut into smaller parts, because the quality, efficacy and safety of such divided patches have not been demonstrated. Children The use of Fetanex is not recommended in children under 2 years of age. Do not use in children who have not been treated before with strong painkillers such as morphine. Other medicines and Fetanex Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you take concomitantly medicines that affect brain function it is more likely that you ll have side effects especially difficulty in breathing. This applies, for example, to: medicines used for treating anxiety (anxiolytics) and uneasiness (tranquillizers) medicines used for treating psychological disorders (neuroleptics, antipsychotics) anaesthetics, if you think you are going to have an anaesthetic, tell the doctor or dentist that you are using Fetanex medicines used for treating sleep disorders (hypnotics, sedatives) medicines used for treating allergies or travel sickness (sedating antihistamines/antiemetics) other strong-acting painkillers (opioids) medicines for relaxing your muscles, e.g. used to treat back pain (skeletal muscle relaxants) alcohol You should not take the medicines listed below at the same time as you are using Fetanex, unless you are closely monitored by your doctor. These medicines are inhibitors of the enzyme CYP3A4 in the liver and may increase the effects and side effects of Fetanex. This applies, for example, to: ritonavir and nelfinavir (used to treat HIV infection) ketoconazole, itraconazole, fluconazole and voriconazole (used to treat fungal infections) verapamil, diltiazem and amiodarone (used to treat heart disease) some macrolide antibiotics (used to treat infections; e.g. erythromycin, clarithromycin, troleandomycin)

3 naphazodone (used to treat depression) Inductors of the enzyme CYP3A4 may reduce the effects of Fetanex. This applies, for example, to: rifampicin (antibiotic) carbamazepine, phenobarbital or phenytoin (medicines used to treat epilepsy) If you stop treatment with the above medicines, your doctor will monitor you carefully, since effects of Fetanex may increase. Tell your doctor if you are using certain medicines to treat depression known as Selective Serotonin Re-uptake Inhibitors (SSRI) Serotonin Norepinephrine Re-uptake Inhibitors (SNRI) 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 Fetanex if you are taking Monoamine Oxidase Inhibitors (MAOI; medicines used to treat depression or Parkinson s disease) or have taken them within the last 14 days. Please tell your doctor if you use buprenorphine, nalbuphine or pentazocine (other strong painkillers). It is not recommended to use those together with Fetanex. Fetanex with alcohol You should not consume alcohol during Fetanex treatment. Alcohol increases the risk of severe side effects of Fetanex. 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 using this medicine. Do not use Fetanex during labour and delivery (including caesarean section) because fentanyl may cause breathing problems in the new-born child. If you get pregnant during treatment with Fetanex, consult your doctor. Do not use Fetanex if you are pregnant unless your doctor considers the treatment essential ask your doctor for advice. Safe use during pregnancy has not been established. Fentanyl passes into the breast milk and may cause sedation and respiratory depression in the breast-fed infant. Discard any breast milk produced during treatment or within 72 hours after the removal of the last patch. Driving and using machines Fetanex has major influence on the ability to drive and use machines. This has to be expected especially at the beginning of treatment, at any change of dosage as well as in connection with alcohol or tranquillizers. If you have been using the same dose of Fetanex for a longer period of time, your doctor may decide that you are permitted to drive and use dangerous machines. Do not drive or operate dangerous machines while using Fetanex, unless your doctor has told you that such is permitted. 3. How to use Fetanex Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide which strength of Fetanex is most suitable for you. Your doctor will base his judgement on the severity of your pain your general condition and

4 the type of pain treatment that you have received so far. According to your reaction the strength of the patch or the number of patches may need to be adjusted. The effect is reached within 24 hours after the first patch has been applied and its effects lessen gradually after the patch is removed. Do not discontinue treatment without consulting your doctor. Your first patch will start to work slowly, this may take as long as one day, so your doctor may give you extra painkillers until your Fetanex transdermal patch starts working completely. After this, Fetanex should help to relieve pain continuously and you should be able to stop taking these extra painkillers. However sometimes you may still need extra painkillers. How to apply Fetanex 1. Find a flat part of your upper body (trunk) or upper arm, where the skin is without hair, cuts, spots or other skin blemishes. The area must not have been treated with radiotherapy. To prevent young children removing and ingesting the patch, be careful in the selection of the application site (see below). Carefully check correct adhesion of the patch and, if necessary, additionally fix the patch in place. Every so often check that the patch remains stuck to the skin. Children In young children, the patch should be attached to the child s upper back, so that the child cannot remove the transdermal patch. The patch should be applied, removed and disposed of by hospital personnel, the doctor or an accompanying adult, and never by the child itself. 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 2. If the skin is hairy, cut the hair with scissors. Do not shave, as shaving irritates the skin. If the skin needs washing, wash with water. Do not use soap, oil, lotions, alcohol or other cleansers that may irritate the skin. The skin must be completely dry before applying the patch. 3. Apply the patch immediately after opening the package. When the release liner has been removed, apply the patch by pressing it firmly onto the skin with the palm of the hand for approximately 30 seconds to make sure that the patch sticks well to the skin. Make sure that the patch sticks properly at the edges. - Fetanex is usually used for 72 hours (3 days). - Do not expose the patch application site to heat from external sources (see in section 2. Warnings and precautions ). - As Fetanex is protected by an outer waterproof backing film you can also wear it while showering. How to change Fetanex Remove the patch after the period your doctor has told you. In most cases this is after 72 hours (3 days), in some patients after 48 hours (2 days). Usually the patch does not come off by itself. If traces of the transdermal patch remain on the skin after its removal, you can clean them off using plenty of soap and water. Do not use alcohol or any other solvent. Fold the used patch in half with the sticky sides together. Put back used patches in the outer package and discard safely or whenever possible hand in to your pharmacist. Apply a new patch as described above but on another part of the skin. At least 7 days should elapse before the same part is used again. If a patch sticks to another person 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 talk to a doctor.

5 If you use more Fetanex than you should If you have applied more patches than prescribed, remove the patches and contact your doctor or hospital on their opinion of the risk. The most serious sign of an overdose is reduced ability to breathe. Symptoms are that the person breathes abnormally slowly or weakly. If this should occur remove the patches and contact a doctor immediately. While waiting for the doctor, keep the person awake by talking to or shaking her/him now and then. If you forget to use or change Fetanex Do not under any circumstances use a double dose. You should change your patch at the same time of day every three days (every 72 hours) unless directed otherwise by your doctor. If you forget to change your patch, change it as soon as you remember. If you are very late changing your patch, you should contact your doctor because you might need some extra painkillers. If you stop using Fetanex If you wish to interrupt or stop the treatment, you should always talk to your doctor about the reasons for discontinuation and your continued treatment. Prolonged use of Fetanex can cause physical dependence. If you do stop using the patches you may feel unwell. As the risk of withdrawal symptoms is greater when the treatment is stopped suddenly, you should never stop treatment with Fetanex independently but always consult your doctor first. 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 effect If any of the following serious side effects occur you should discontinue treatment and immediately contact your doctor or visit a hospital: severe breathlessness, rattling breath (severe respiratory depression) convulsive pain, vomiting, flatulence (complete block of the digestion channel) 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

6 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 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 If you have been using Fetanex for some time, it might happen that Fetanex will become less effective for you so that a dose adjustment will be necessary (tolerance may develop). Physical and psychological dependence may develop as well and you might experience withdrawal symptoms, if you do suddenly stop using the patches. Withdrawal symptoms may be nausea, vomiting, diarrhoea, anxiety and shivering. 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, diarrhoea and pruritus. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: ; Fax: Website: imbpharmacovigilance@imb.ie. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Fetanex

7 Keep this medicine out of the sight and reach of children. Significant 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 pack. The expiry date refers to the last day of that month. Store in the original package. For environmental and safety reasons, used as well as unused and out of date patches must be discarded safely 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 safely or whenever possible hand in to your pharmacist. 6. Contents of the pack and other information What Fetanex contains The active substance is fentanyl. Each patch releases 12.5, 37.5 micrograms fentanyl per hour. Each patch of 5.25, cm² contains 2.1, 6.3 mg fentanyl. The other ingredients are: Release liner (removed before the patch is stuck onto the skin): Poly(ethylene terephthalate) foil, siliconised Self-adhesive matrix layer: Acrylic-vinylacetate copolymer Backing film: Poly(ethylene terephthalate) foil Printing ink What Fetanex looks like and contents of the pack Fetanex is a transparent rounded oblong imprinted patch with an adhesive membrane and covered with a release liner (to be removed prior to the application of the patch) so that it can be stuck onto the skin. Fetanex is available in packs with 1, 2, 3, 4, 5, 7, 8, 10, 14, 16 and 20 transdermal patches. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Rowex Ltd., Bantry, Co. Cork, Ireland. Manufacturer HEXAL AG, Industriestr. 25, Holzkirchen, Germany. This medicinal product is authorised in the Member States of the EEA under the following names: Germany: Fentanyl-HEXAL 12 Mikrogramm/h Fentanyl-HEXAL S 37,5 µg/h Ireland: Fetanex 12.5 microgram/hour Transdermal Patch Fetanex 37.5 microgram/hour Transdermal Patch This leaflet was last revised in 08/2013.