OSMANIL 25, 50, 75 AND 100 MICROGRAMS/H TRANSDERMAL PATCH
(fentanyl)
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Osmanil transdermal patch is and what it is used for
- 2. 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. Further information
What Osmanil Transdermal Patch Is And What It Is Used For
Fentanyl is one of a group of strong painkillers called opioids.
The painkiller, fentanyl, slowly passes from the patch, through the skin and into the body.
Osmanil transdermal patch is used for treatment of severe and long-lasting pain that can only adequately be managed with strong pain relievers.
Before You Use Osmanil Transdermal Patch
Do not use Osmanil transdermal patch
- if you are hypersensitive (allergic) to fentanyl or any of the other ingredients of the product.
- 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.
Take special care with Osmanil transdermal patch
WARNING:
Osmanil transdermal patch 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.
Osmanil transdermal patch can have life-threatening side-effects in persons that are not using prescribed opioid medicines on a regular basis.
Before starting to use Osmanil transdermal patch you should inform your doctor if you suffer from any of the below disorders, because the risk of side effects is higher and/or your doctor may need to prescribe a lower dose of fentanyl.
- asthma, respiratory depression or any lung disease
- low blood pressure
- impaired liver function
- impaired kidney function
- if you have had a head injury, a brain tumour, signs of increased intracranial pressure (e.g. headache, visual disturbances), changes in your state of consciousness or loss of consciousness or coma
- slow irregular heartbeat (bradyarrhythmias)
- myasthenia gravis (a disease causing tiredness and weakness of the muscles)
Inform your doctor if you develop a fever during the treatment, as the increased body temperature may cause too much medicine to pass through the skin. For the same reason you should avoid exposing the patch on the skin to direct heat such as electric blankets, hot-water bottles, sauna, solarium or hot baths. It is allowed to stay outside in the sun, but you must protect the patch with some piece of clothing during hot summer days.
Tolerance, physical or psychological dependence may develop if you use Osmanil transdermal patch for a longer period. However, this is rarely seen during treatment of pain due to cancer.
If you are an elderly 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.
The patches should not be cut into smaller parts, because the quality, efficacy and safety of such divided patches have not been demonstrated.
Use in children and adolescents
Osmanil transdermal patch should only be used in children and adolescents aged 2 years or older who have previously been treated with other opioids (e.g. morphine). Osmanil transdermal patch should not be used in infants and toddlers under 2 years of age.
Using other medicines
Please tell your doctor if you use barbiturates (used for treating sleep disorders), buprenorphine, nalbuphine or pentazocine (other strong painkillers). It is not recommended to use those together with Osmanil transdermal patch.
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 (tranquillisers)
- medicines used for treating depression (antidepressants)
- medicines used for treating psychological disorders (neuroleptics)
- anaesthetics, if you think you are going to have an anaesthetic, tell the doctor or dentist that you are using Osmanil transdermal patch
- medicines used for treating sleep disorders (hypnotics, sedatives)
- medicines used for treating allergies or travel sickness (antihistamines/antiemetics)
- other strong-acting painkillers (opioids)
- alcohol
You should not take the medicines listed below at the same time as you are using Osmanil transdermal patch, unless you are closely monitored by your doctor.
These medicines may increase the effects and side effects of Osmanil transdermal patch.
This applies, for example, to:
- ritonavir, saquinavir (used to treat AIDS)
- ketoconazole, itraconazole, voriconazole (used to treat fungal diseases)
- diltiazem (used to treat heart disease)
- cimetidine (used to treat gastrointestinal diseases)
- macrolide antibiotics (used to treat infections), e.g. clarithromycin, erythromycin, telithromycin
Please tell your doctor if you are taking MAO inhibitors (e.g. moclobemide against depression or selegiline against Parkinson’s disease) or have taken them within the last 14 days. If these medicines are taken together this may enhance their toxicity.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Using Osmanil transdermal patch with food and drink
Simultaneous use of Osmanil transdermal patch and alcoholic beverages increases the risk of severe adverse effects, and may cause breathing difficulties, a fall of blood pressure, profound sedation and coma.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. It is advised not to use Osmanil transdermal patch during labour and delivery (including caesarean section) because fentanyl may cause breathing problems in the newborn infant. If you get pregnant during treatment with Osmanil transdermal patch, consult your doctor. Osmanil transdermal patch should not be used during pregnancy and breast-feeding unless clearly necessary. Safe use during pregnancy has not been established. Fentanyl passes into the breast-milk and may cause side effects in the breast-fed infant as sedation and respiratory depression. Any breast milk produced during treatment or within 72 hours after the removal of the last patch should be discarded.
Driving and using machines
Osmanil transdermal patch 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 tranquillisers. If you have been using the same dose of Osmanil transdermal patch 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 Osmanil transdermal patch, unless your doctor has told you that such is permitted.
How To Use Osmanil Transdermal Patch
Always use Osmanil transdermal patch 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 Osmanil transdermal patch is most suitable for you, based upon the severity of your pain, your general condition and 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 fall 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 Osmanil transdermal patch starts working completely. After this, the Osmanil transdermal patch 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 Osmanil transdermal patch
- Find a flat, non-irritated part of your upper body (trunk) or upper arm, where the skin is without hair, cuts, spots or other skin blemishes.
- If the skin is hairy, then 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. - The patch must be stuck on immediately after opening the package. When the release liner has been removed, the patch is applied 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. Pay special attention to see that the patch sticks properly at the edges.
- An Osmanil transdermal patch is usually used for 72 hours (3 days). On the outer package you can write the date and time you applied the patch. This may help you remember when to change your patch.
- The patch application site should not be exposed to heat from external heat sources (see “Take special care with Osmanil transdermal patch”).
- As the transdermal patch is protected by an outer waterproof backing film, it can also be worn while showering.
- In children, the upper back is the preferred location to apply the patch, to minimize the potential of the child removing the patch.
How to change the transdermal patch
- 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, these can be cleaned off using copious amounts of soap and water.
- Fold the used patch in half so that the sticky edges adhere to each other. Put back used patches in the outer package and discard 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.
Use in children and adolescents
Osmanil transdermal patch should only be used in children and adolescents aged 2 years or older who have previously been treated with other opioids (e.g. morphine). Osmanil transdermal patch should not be used in infants and toddlers under 2 years of age.
If you use more Osmanil transdermal patch than you should
If you have stuck on more patches than prescribed, remove the patches and contact your doctor or hospital on their opinion of the risk.
The most common sign of 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.
Other signs and symptoms of overdose are drowsiness, low body temperature, slow heart rate, decreased muscle tone, deep sedation, loss of muscle co-ordination, constriction of the pupils and convulsions.
If you forget to use Osmanil transdermal patch
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, then change your patch as soon as you remember. If you are very late changing your patch then you should contact your doctor because you might need some extra painkillers.
If you stop using Osmanil transdermal patch
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 Osmanil transdermal patch 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 Osmanil transdermal patch independently but always consult your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Osmanil transdermal patch can cause side effects, although not everybody gets them.
The assessment of side effects is based on the following frequency data:
Very common: more than 1 in 10 patients
Common: less than 1 in 10, but more than 1 in 100 patients
Uncommon: less than 1 in 100, but more than 1 in 1000 patients
Rare: less than 1 in 1000, but more than 1 in 10,000 patients
Very rare: less than 1 in 10,000 patients, including isolated reports
If any of the following serious, very rare side effects occur you should discontinue treatment and immediately contact your doctor or visit a hospital: severe respiratory depression (severe breathlessness, rattling breath) or complete block of the digestion channel (convulsive pain, vomiting, flatulence).
Other side effects
Very common: Somnolence, headache, dizziness, nausea, vomiting, constipation, sweating, fever, itching. Itching will usually disappear within one day after the patch has been removed.
Common: Feeling unusually drowsy or tired (depressant effect on brain function), nervousness, loss of appetite, dry mouth, stomach pain, skin reactions at the attachment site.
Uncommon: Unnatural feeling of happiness, memory loss, difficulties in sleeping, hallucinations, agitation, tremor sensitivity disturbances, speech disorders, fall or rise in the blood pressure and heart rate, difficulties in breathing, diarrhoea, difficulty in passing urine, skin rash, skin reddening (erythema). Skin rash and skin reddening will usually disappear within one day after the patch has been removed.
Rare: Irregular heartbeat, dilated blood vessels, hiccup, water retention in the tissues, feeling cold.
Very rare: Generalised acute allergic reactions with a fall in the blood pressure and/or difficulty in breathing (anaphylactic reactions), delusional ideas, states of excitement, loss of physical strength, depression, anxiety, confusion, sexual dysfunction, withdrawal symptoms, coordination disturbances, seizures (including clonic and grand mal seizures), diminished visual acuity, impaired respiration (respiratory depression), respiratory arrest (apnoea), painful bloating, block of the digestion channel, urinary bladder pain, passing water less than normal (reduced urine excretion).
If you have been using Osmanil transdermal patch for some time, it might happen that Osmanil transdermal patch will become less effective for you so that a dose adjustment will be necessary (tolerance may develop).
Physical 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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Osmanil Transdermal Patch
Keep out of the reach and sight of children, even after use.
High quantities of the drug remain in the transdermal patches even after use.
Do not use Osmanil transdermal patch 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 25°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.
Further Information
What Osmanil 25 micrograms/h contains
- The active substance is fentanyl.
Each patch releases 25 micrograms fentanyl per hour. Each patch of 7.5 centimetres squared contains 4.125mg fentanyl.
What Osmanil 50 micrograms/h contains
- The active substance is fentanyl.
Each patch releases 50 micrograms fentanyl per hour. Each patch of 15 centimetres squared contains 8.25mg fentanyl.
What Osmanil 75 micrograms/h contains
- The active substance is fentanyl.
Each patch releases 75 micrograms fentanyl per hour. Each patch of 22.5 centimetres squared contains 12.375mg fentanyl.
What Osmanil 100 micrograms/h contains
- The active substance is fentanyl.
Each patch releases 100 micrograms fentanyl per hour. Each patch of 30 centimetres squared contains 16.5mg 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 a sticky back so that it can be stuck onto the skin. The transdermal patches are equipped with a blue imprint with the strength.
Osmanil transdermal patch is available in packs of 5 transdermal patches.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in August 2009.
‘Winthrop’ is a registered trademark.
© 2009 Winthrop Pharmaceuticals.
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