Document: leaflet MAH BRAND_PL 32019-0008 change

• leaflet MAH BRAND_PL 11311-0536
• leaflet MAH BRAND_PL 32019-0008

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PATIENT INFORMATION LEAFLET

Tilotrans 25 microgram/hour transdermal patches Tilotrans 50 microgram/hour transdermal patches Tilotrans 75 microgram/hour transdermal patches Tilotrans 100 microgram/hour transdermal patches

(Fentanyl)

What Tilotrans Patch is and what it is used for

Tilotrans Patch is a strong pain-killing medicine that belongs to the opioid group.

Tilotrans Patch relieves prolonged severe pain requiring treatment with strong pain-killing medicines (e.g. cancer pain).

Children:

Tilotrans Patch can be used in children aged 2 to 16 years who have previously used opioid painkillers.

What you need to know before you use Tilotrans Patch

Do not use Tilotrans Patch:

•    If you are allergic to fentanyl, or any of the other ingredients of this medicine (listed in section 6)

•    If you have acute pain or pain after an operation

•    If the functioning of your nervous system is greatly reduced

•    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

•    Tilotrans Patch is a medicinal product that could be life-threatening to children, even if the patches have been used. Bear in mind that a sticky patch could be tempting to a child and in some cases may lead to a fatal outcome.

•    Tilotrans Patch can have life-threatening side effects in persons who are not using prescribed opioid medicines on a regular basis.

Patch sticking to another person

The patch should be used only on the skin of the person for whom it has been prescribed. 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 (see also section 3 below).

Talk to your doctor before using Tilotrans Patch if you have:

•    asthma, any other lung disease or breathing difficulties

•    disturbances of heart rhythm

•    low blood pressure or blood volume

•    reduced liver function

•    reduced kidney function

•    had a brain injury, brain tumour, signs of increased intracranial pressure (e.g. headache, visual disturbances), reduced consciousness or coma

•    myasthenia gravis (a disease characterised by muscle weakness)

•    chronic constipation

If you are very ill, very thin or elderly, you may be more sensitive to the effects of the patches.

If you develop fever you should contact your doctor. The dosage may have to be adjusted.

Avoid exposing the Tilotrans patch to direct heat source such as heating pads, hot water bottles, electric blankets, heated water beds, heat or tanning lamps, intensive sun bathing, prolonged hot baths, saunas or hot whirlpool spa baths, while wearing the patch. It is possible that more fentanyl is released from the patch at higher temperature.

Tilotrans Patch may cause constipation, talk to your doctor or pharmacist for advice on how to prevent constipation.

Like many other strong painkillers, repeated use of the patches may make you become tolerant to the medicine or become dependent on it.

Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or illegal drugs.

Children

The use of Tilotrans Patch is not recommended in children under 2 years of age. Do not use in children which have not been treated before with strong painkillers such as morphine.

Other medicines and Tilotrans Patches

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some other medicines can affect or be affected by Tilotrans Patches. These medicines include:

•    Medicines that have a sedative effect, such as

-    opioids (e.g. morphine and codeine)

-    sedatives

-    sleeping pills

-    anaesthetic agents

-    phenothiazides (antipsychotic agents)

-    medicines to relieve anxiety

-    muscle relaxants

-    sedative antihistamines

-    alcohol

•    Inhibitors of the enzyme CYP3A4 (enzyme in the liver, which mainly metabolises fentanyl in the body), e.g.

-    ritonavir and nelfinavir (antiviral agents)

-    ketoconazole, itraconazole, fluconazole and voriconazole (anti-fungal agents)

-    verapamil, diltiazem and amiodarone (e.g. used for treating irregular heart beat)

-    some macrolide antibiotics (e.g. clarithromycin, erythromycin, troleandomycin)

-    nefazodone (used to treat depression)

•    Inductors of the enzyme CYP3A4, such as

-    rifampicin (antibiotic)

-    carbamazepine, phenobarbital or phenytoin (medicines used to treat epilepsy)

•    Pentazocine, nalbuphine and buprenorphine

(strong painkillers)

•    Some medicines used to treat depression

-    Selective Serotonin Re-uptake Inhibitor (SSRI)

-    Serotonin Norepinephrine Re-uptake Inhibitors (SNRI) or

-    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 Tilotrans Patch during treatment and within 14 days of stopping MAOI (medicines used to treat depression or Parkinson's disease).

Tilotrans Patches with alcohol

You should not consume alcohol during Tilotrans

Patch treatmet. Alcohol increases the side effects

of the medicine.

Pregnancy and breast-feeding

You should not use Tiloftrans Patch if you are pregnant unless your doctor considers the treatment essential. Experience is limited - ask your doctor for advice. If you become pregnant during treatment with Tilotrans Patch you should contact your doctor.

It is not recommended to use Tilotrans Patch if you are breast-feeding. Ask your doctor for advice. You should not breast-feed for at least 3 days after removing your patch.

Driving or using machinery

You should not drive or use machines without first asking your doctor for advice. Tilotrans patch greatly affects reaction capacity, especially at the beginning of treatment and after increasing the dose.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while taking this medicine until you know how it affects you.

•    It is an offence to drive if this medicine affects your ability to drive.

•    However, you would not be committing an offence if:

o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

o 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.

How to use Tilotrans Patch

The dose is determined by your doctor, who adjusts it individually for you. Always use Tilotrans Patch 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 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 patches become effective. Your doctor will advise you on this if it is needed

•    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 and your child, do not apply the patch

on:

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