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OSMACH 75 MICROGRAMS/H TRANSDERMAL PATCH

Active substance(s): FENTANYL

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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










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)
Do not soak in a hot bath or take a hot shower whilst wearing a patch.
If you develop a fever tell your doctor immediately
Follow the dosage instructions carefully and only change your patch at the same time of
day every 3 days (72 hours)
If your breathing becomes shallow and weak take the patch off and seek medical help

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, pharmacist or nurse.
• This medicine has been prescribed for you (or your child) 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 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 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

The name of your medicine is Osmach Transdermal Patch.
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.
Osmach Transdermal Patch contains a medicine called fentanyl. It belongs to a group of strong painkillers called
opioids.

2.

What you need to know before you use Osmach Transdermal Patch

Do not use Osmach Transdermal Patch
• you are allergic to fentanyl 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 Osmach Transdermal Patch
Warnings and precautions

• Osmach Transdermal Patch can have life-threatening side effects in people who are not already regulary using
prescribed opioid medicines.
• Osmach Transdermal Patch 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.

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 Osmach Transdermal Patch
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 have ever abused or been dependent on alcohol, prescription medicines or illegal drugs.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Osmach
Transdermal Patch

Side effects and Osmach Transdermal Patch
• Osmach Transdermal Patch 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 Osmach Transdermal Patch 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 get a fever while using Osmach Transdermal Patch, tell your doctor - this may increase the amount of
medicine that passes through your skin
• Osmach Transdermal Patch 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 become ‘tolerant’ to it) or you
may become dependent on it.
See section 4 for a full list of possible side effects.
When you are wearing the patch do not expose it to direct heat such as heating pads, electric blankets, hot-water bottles,
heated water beds or heat or tanning lamps. Do not sunbathe, have long hot baths or saunas or use hot whirlpool spa
baths. If you do, you may increase the amount of medicine you get from the patch.
The patches should not be cut into smaller parts, because the quality, efficacy and safety of such divided patches have
not been demonstrated.
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 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 Osmach Transdermal Patch if you buy any medicines from your pharmacy.

Your doctor will know which medicines are safe to take with Osmach Transdermal Patch. 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 Osmach Transdermal Patch 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 aripiprazole, 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, duloxetine, 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 Osmach Transdermal Patch 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).
Osmach Transdermal Patch with antidepressants
The risk of side effects increases if you are taking medicines such as certain antidepressants. Osmach Transdermal
Patch 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.
Operations
If you think that you are going to receive anaesthesia tell your doctor or dentist that you are using Osmach Transdermal
Patch.
Osmach Transdermal Patch and alcohol
Do not drink alcohol while using Osmach Transdermal Patch unless you have talked to your doctor first.
Osmach Transdermal Patch can make you drowsy or breathe more slowly. Drinking alcohol may make these effects
worse.
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.
Osmach Transdermal Patch should not be used during pregnancy unless you have discussed this with your doctor.
Osmach Transdermal Patch should not be used during childbirth as the medication can affect the breathing of the
newborn child.
Do not use Osmach Transdermal Patch if you are breastfeeding. You should not breastfeed for 3 days after removing
your Osmach Transdermal Patch patch. This is because the medicine may pass into breast milk.

Driving and using machines
Osmach Transdermal Patch 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.

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, 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 differently.

Always remove the old patch before applying a new one.

Always change your patch at the same time of day every 3 Days (72 hours).

If you are using more than one patch, change all your patches at the same time.

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 when to change your patch:

Apply your patch on
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday









Change your patch on
Thursday
Friday
Saturday
Sunday
Monday
Tuesday
Wednesday

Where to apply the patch
Adults
• Apply the patch on a flat part of your upper body or arm (not over a joint).
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.
• Watch your child very closely for 48 hours after:
- The first patch has been put on
- A higher dose patch has been put on
• It may take some time for the patch to have its maximum effect. Therefore, your child might need to use other
painkillers as well until the patches become effective. Your doctor will talk to you about this.
Adults and Children:
Do not apply the patch on
• The same place twice in a row.
• Areas that you move a lot (joints), skin that is irritated or with cuts.
• 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.
Putting a patch on

Step 1: Preparing the skin
Make sure your skin is completely dry, clean 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 sachet
• Each patch is sealed in its own sachet
• Tear open the sachet at the notch
• Gently tear off the edge of the sachet completely









Grasp both sides of the opened sachet and pull apart
Take the patch out and use straight away
Keep the empty sachet to dispose of the used patch later
Use each patch once only
Do not take the patch out of its sachet 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 transparent 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 sachet and dispose of the sachet as instructed by your pharmacist
• Keep used patches out of sight and reach of children – even used patches contain some medicine which may
harm children and may even be fatal
Step 5: Wash
• Always wash your hands after you have handled the patch using clean water only
More about using Osmach Transdermal Patch
Everyday activities while using the patches
• 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 some time for your first patch to have its maximum effect.
• Your doctor may give you other painkillers as well 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

How long will you use the patches for?
• Osmach Transdermal Patch 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 decide to stop the use of 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 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
• Let your doctor know this has happened and leave the patch on for another 3 days (72 hours) or as directed by
your doctor, before changing the new patch as usual
• If your patches keep falling off, talk to your doctor, pharmacist or nurse
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 medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you or your partner, or carer, notice any of the following about the person wearing the patch, take the patch
off and call a doctor, or go to your nearest hospital, straight away. You may need urgent medical treatment.

Feeling unusually drowsy, breathing that is more slow or shallow than expected.
Follow the advice above and keep the person who was wearing the patch moving and talking as much as
possible. Very rarely these breathing difficulties can be life-threatening or even fatal, especially in people who
have not used strong opioid painkillers (like Osmach Transdermal Patch or morphine) before. (Uncommon, this
may affect up to 1 in 100 people)



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
Common (may affect up to 1 in 10 people)

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 1000 people)

Constricted pupils (miosis)

Stopping breathing from time to time (apnoea)

You may notice rashes, redness or slight itching of the skin at the site of the patch. This is usually mild and
disappears after you have removed the patch. If it does not, or if the patch irritates your skin badly, tell your doctor.
Repeated use of the patches may make the medicine become less effective (you become ‘tolerant’ to it) or become
dependent on it.
If you switch from a different painkiller to Osmach Transdermal Patch or if you suddenly stop using Osmach
Transdermal Patch, you may notice withdrawal effects such as sickness, feeling sick, diarrhoea, anxiety or shivering.
Tell your doctor if you notice any of these effects.
There have been reports also of newborn infants experiencing withdrawal effects after their mothers have used
Osmach Transdermal Patch for a long time during pregnancy.

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

Where you should keep the patches

Keep all patches (used and unused) out of the sight and reach of children.
How long to keep Osmach Transdermal Patch for

Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP. The expiry
date refers to the last day of that month. If the patches are out of date, take them to your pharmacy.
This medicinal product does not require any special storage conditions.
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.
Do not throw away any medicines via wastewater or household waste. These measures will help protect the
environment.

6.

Contents of the pack and other information

What Osmach Transdermal Patch contains
- The active substance is fentanyl.
Osmach 25 micrograms/h transdermal patch
Each patch releases 25 micrograms fentanyl per hour. Each patch of 7.5 cm2 contains 4.125 mg fentanyl.
Osmach 50 micrograms/h transdermal patch
Each patch releases 50 micrograms fentanyl per hour. Each patch of 15 cm2 contains 8.25 mg fentanyl.
Osmach 75 micrograms/h transdermal patch
Each patch releases 75 micrograms fentanyl per hour. Each patch of 22.5 cm2 contains 12.375 mg fentanyl.
Osmach 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 December 2016.

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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