PACKAGE LEAFLET: INFORMATION FOR THE USER

Osmach 25 micrograms/h transdermal patch Osmach 50 micrograms/h transdermal patch Osmach 75 micrograms/h transdermal patch Osmach 100 micrograms/h 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 Osmach Transdermal Patch is and what it is used for

2.    What you need to know before you use Osmach Transdermal Patch

3.    How to use Osmach Transdermal Patch

4.    Possible side effects

5.    How to store Osmach Transdermal Patch

6.    Contents of the pack and other information

1.    What Osmach 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.

Adults:

Osmach Transdermal Patch is used for treatment of severe and long-lasting pain that can only adequately be managed with strong pain relievers.

Children:

Osmach Transdermal Patch is used for the long term treatment of severe and long-lasting pain in children aged 2 years or older who have previously been treated with other strong pain relievers.

2.    What you need to know before you use Osmach Transdermal Patch Do not use Osmach Transdermal Patch

-    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 (brain and spinal cord) is severely impaired, for instance by brain injury.

-    if you suffer from severe respiratory depression.

Warnings and precautions

Talk to your doctor or pharmacist before using Osmach Transdermal Patch

Your doctor will use the treatment with Osmach Transdermal Patch as a part of an integrated treatment of pain and will regularly monitor you for your individual response to Osmach Transdermal Patch.

Before starting to use Osmach 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 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 heating pads, electric blankets, heated water beds, heat or tanning lamps, intensive sunbathing, hot water bottles, prolonged hot baths, saunas and hot whirlpool spa 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.

If you have allergic reactions (including anaphylaxis and anaphylactic shock) please inform you doctor immediately.

Tolerance, physical or psychological dependence may develop if you use Osmach 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.

Patch sticking to another person

The patch should be used only 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

In general, Osmach 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). Osmach Transdermal Patch should not be used in infants and toddlers under 2 years of age.

To guard against accidental ingestion by children, caution should be used when choosing the application site for Fentanyl transdermal patch (see section 3. “HOW TO USE Osmach Transdermal Patch”) and the adhesion of the patch should be monitored closely.

The use of fentanyl patches may lead to a positive doping test. The use of fentanyl patches as a doping agent may be hazardous to the health.

Other medicines and Osmach Transdermal Patch

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.

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 Osmach Transdermal Patch.

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 if you are taking drugs against depression or Parkinson’s disease as Selective Serotonin Re-uptake Inhibitors (SSRIs) or Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs) or Monoamine Oxidase Inhibitors (MAOIs). When these drugs are coadministered with fentanyl a potentially life-threatening syndrome called serotonin syndrome may occur.

Serotonin syndrome may include mental-status changes (eg. agitation, hallucination, coma), autonomic instability (eg. abnormally rapid heartbeat, labile blood pressure, greatly increased body temperature) and/or gastrointestinal symptoms (e.g, nausea, vomiting, diarrhoea). If serotonin syndrome is suspected, the treatment with fentanyl should be discontinued.

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 Osmach 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)

-    some medicines for back pain or other painful musculoskeletal conditions (skeletal muscle relaxants)

-    alcohol

You should not take the medicines listed below at the same time as you are using Osmach Transdermal Patch, unless you are closely monitored by your doctor.

These medicines may increase the effects and side effects of Osmach Transdermal Patch. This applies, for example, to:

-    ritonavir (used to treat AIDS)

-    ketoconazole, itraconazole, voriconazole (used to treat fungal diseases)

-    diltiazem (used to treat heart disease)

-    macrolide antibiotics (used to treat infections), e. g. clarithromycin, erythromycin, telithromycin

Osmach Transdermal Patch with food, drink and alcohol

Simultaneous use of Osmach Transdermal Patch and alcoholic beverages increases the risk of severe adverse reactions, and may cause breathing difficulties, a fall of blood pressure, profound sedation and coma. During the treatment with Osmach Transdermal Patch do not drink alcoholic beverages.

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, ask your doctor or pharmacist for advice before taking any medicine.

It is advised not to use Osmach 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 Osmach Transdermal Patch, consult your doctor. Osmach Transdermal Patch should not be used during pregnancy 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

Osmach 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 tranquilizers. If you have been using the same dose of Osmach 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 Osmach Transdermal Patch, unless your doctor has told you that such is permitted.

3. How to use Osmach Transdermal Patch

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 Osmach Transdermal Patch is most suitable for you. Your doctor will base his judgement on: 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 fentanyl transdermal patch starts working completely. After this, the Osmach 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.

Use in children and adolescents

Osmach 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). Osmach Transdermal Patch should not be used in infants and toddlers under 2 years of age.

How to apply Osmach Transdermal Patch

-    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 body part must not have been irradiated in connection with radiation therapy.

-    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. Then wash hands with clean water.

-    A fentanyl 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 Osmach 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). 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. Several days should elapse before the same part is used again.

If you use more Osmach 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 Osmach 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 Osmach 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 Osmach Transdermal Patch may cause physical dependence. If you do stop using the patches you may feel unwell.

As the risk of withdrawal symptoms (nausea, vomiting, diarrhoea, anxiety and muscular tremor) is greater when the treatment is stopped suddenly, you should never stop treatment with Osmach Transdermal Patch 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.

The assessment of side effects is based on the following frequency data:

Very common	may affect more than 1 in 10 people
Common	may affect up to 1 in 10 people
Uncommon	may affect up to 1 in 100 people
Rare	may affect up to 1 in 1,000 people
Not known	frequency cannot be estimated from the available data

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 blockage of the gut (convulsive pain, vomiting, flatulence).

Other side effects

Very common: Somnolence, dizziness, headache, feeling sick (nausea) or being sick (vomiting), constipation.

Common:    Hypersensitivity, loss of appetite, difficulties in sleeping, depression, anxiety, confusion,

hallucination (seeing, feeling or hearing things that are not there), sedation, nervousness, trembling, pins and needles, vertigo, unpleasant sensations of irregular and/or forceful beating of the heart, rise in the blood pressure and heart rate, difficulties in breathing, diarrhoea, dry mouth, stomach pain, indigestion, sweating, itching, skin rash, skin reddening (erythema), skin reactions under the patch, muscle spasms, passing water less than normal (reduced urine excretion), feeling unusually tired, water retention in the tissues, loss of physical strength, general discomfort (malaise), feeling cold.

Skin rash, skin reddening and itching will usually disappear within one day after the patch has been removed.

Uncommon:    Agitation, disorientation, unnatural feeling of happiness, reduced sense of touch or sensation,

seizures (including clonic and grand mal seizures), memory loss, difficulties in speaking, fall in the blood pressure and heart rate, blue coloration of the skin, impaired breathing (respiratory depression), respiratory distress, blockage of the gut, skin disorders (eczema, allergic dermatitis, dermatitis, contact dermatitis, exanthema), muscle twitching, erectile dysfunction, sexual dysfunction, skin reactions and hypersensitivity where the patch is placed, influenza like illness, feeling of body temperature change.

If you have been using Osmach Transdermal Patch for some time, it might happen that Osmach Transdermal Patch 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 muscular tremor.

Rare:    Tiny pupils, irregular heartbeat, dilated blood vessels, stopping breathing (apnoea), too

shallow or too slow breathing, which does not meet the needs of the body (hypoventilation), obstruction of the gut (subileus), hiccup, skin reactions under the patch (dermatitis, eczema).

Very rare:    Delusional ideas, states of excitement, difficulties with coordination, diminished visual

acuity, painful bloating, urinary bladder pain, passing water less than normal (reduced urine excretion).

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

Not known:    Generalised acute allergic reactions with a fall in the blood pressure and/or difficulty in

breathing (anaphylactic shock, anaphylactic reaction, anaphylactoid reaction), abnormally slow breathing.

Additional side effects in children and adolescents

Children and adolescents treated with fentanyl transdermal patch experience side effects similar to the side effects observed in adults.

There is no specific risk for children and adolescent, when used as directed.

Very common side effects in children observed in clinical trials were fever, being sick (vomiting) and feeling sick (nausea).

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 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 Osmach Transdermal Patch

Keep unused and used Osmach Transdermal patches out of children’s reach. 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.

This medicinal product does not require any special storage conditions.

Handling the patch

Used patches should be folded so that the adhesive side of the patch adheres to itself and then they should be safely discarded. Accidental exposure to used and unused patches particularly in children may lead to a fatal outcome. Unused patches should be returned to the (hospital) pharmacy.

6. Contents of the pack and other information

What Osmach Transdermal Patch contains

-    The active substance is fentanyl.

Fentanyl 25 micrograms/h transdermal patch Each patch releases 25 micrograms fentanyl per hour. Each Fentanyl 50 micrograms/h transdermal patch Each patch releases 50 micrograms fentanyl per hour. Each Fentanyl 75 micrograms/h transdermal patch Each patch releases 75 micrograms fentanyl per hour. Each Fentanyl 100 micrograms/h transdermal patch Each patch releases 100 micrograms fentanyl per hour. Each patch of 30 cm² contains 16.5 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 Osmach Transdermal Patch looks like and contents of the pack

Osmach 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.

Osmach Transdermal Patch is available in packs of 3, 5, 10 or 20 transdermal patches.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ratiopharm GmbH, Graf-Arco-Str.3, 89079 Ulm, Germany Manufacturer

Merckle GmbH, Ludwig-Merckle-Str.3, 89143 Blaubeuren, Germany

This leaflet was last revised in July 2014.