Active ingredient
- fentanyl
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 01883/0314.
Fencino 25 micrograms/hour transdermal patch
INFORMATION FOR THE USER
Fencino®25 micrograms/hour transdermal patch
fentanyl
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Fencino is and what it is used for
2. What you need to know before you use Fencino
3. How to use Fencino
4. Possible side effects
5. How to store Fencino
6. Contents of the pack and other information
1. WHAT FENCINO IS AND WHAT IT IS USED FOR
The name of your medicine is Fencino.
The patches help relieve pain that is very bad and long-lasting:
Fencino contains a medicine called fentanyl. It belongs to a group of strong painkillers called opioids.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FENCINO
Do not use Fencino if:
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 Fencino.
Warnings and precautions
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 Fencino
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:
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Fencino.
While using the patch, tell your doctor if you have breathing problems while sleeping. Opioids like Fencino can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep-related hypoxaemia (low oxygen level in the blood). Tell your doctor if you, your partner or carer notice you have any of the following:
Your doctor may decide to change your dose.
While using the patch, tell your doctor if you notice a change in the pain you are feeling.
If you feel:
Do not change the dose yourself. Your doctor may decide to change your dose or treatment.
Side effects and Fencino
Withdrawal symptoms when stopping Fencino
Do not suddenly stop taking this medicine. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating may occur. If you want to stop taking this medicine, talk to your doctor first. Your doctor will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum.
Other medicines and Fencino
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 Fencino if you buy any medicines from your pharmacy.
Your doctor will know which medicines are safe to take with Fencino. 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 Fencino you need.
In particular, tell your doctor or pharmacist if you are taking:
Fencino with antidepressants
The risk of side effects increases if you are taking medicines such as certain antidepressants. Fencino 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 heartbeat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting and diarrhoea (these could be signs of serotonin syndrome). If used together, your doctor may want to closely monitor you for such side effects in particular when starting treatment or when the dose of your medicine is changed.
Use with central nervous system depressants, including alcohol and some narcotic drugs
Concomitant use of Fencino and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However if your doctor does prescribe Fencino together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
Do not drink alcohol while using Fencino unless you have talked to your doctor first.
Operations
If you think that you are going to receive anaesthesia tell your doctor or dentist that you are using Fencino.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Fencino should not be used during pregnancy unless you have discussed this with your doctor.
Fencino should not be used during childbirth as the medication can affect the breathing of the newborn child.
Do not use Fencino if you are breastfeeding. You should not breastfeed for 3 days after removing your Fencino patch. This is because the medicine may pass into breast milk.
Prolonged use of Fencino during pregnancy can cause withdrawal symptoms (such as high-pitched cry, jitteriness, fits, poor feeding and diarrhoea) in your newborn baby that could be life-threatening if not recognised and treated. Talk to your doctor immediately if you think your baby may have withdrawal symptoms.
Driving and using machines
Fencino 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.
It is an offence to drive if this medicine affects your ability to drive. However, you would not be committing an offence if:
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Fencino contains soya oil
In very rare cases, soya oil may cause allergic reactions.
3. HOW TO USE FENCINO
Always use this medicine 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 Fencino 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
Apply your patch on Change your patch on
Monday Thursday
Tuesday Friday
Wednesday Saturday
Thursday Sunday
Friday Monday
Saturday Tuesday
Sunday Wednesday
Where to apply the patch
Adults
Children
Adults and Children:
Do not apply the patch on
Putting a patch on
Step 1: Preparing the skin
Step 2: Open the sachet
Step 3: Peel and press
Step 4: Disposing of the patch
Step 5: Wash
More about using Fencino
Everyday activities while using the patches
How quickly will the patches work?
How long will you use the patches for?
If your pain gets worse
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 a patch falls off
If you want to stop using the patches
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.
The following side effects have also been reported
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 side effects (may affect up to 1 in 1000 people)
Not known: frequency cannot be estimated from the available data
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 get used to it, or you may become more sensitive to pain), or you may become dependent on it.
If you switch from a different painkiller to Fencino or if you suddenly stop using Fencino, 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 Fencino 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE FENCINO
Where you should keep the patches
Keep all patches (used and unused) out of the sight and reach of children.
This medicinal product does not require any special storage conditions. Store this medicine in a safe and secure place, where other people cannot access it. It can cause serious harm and be fatal to people who may take this medicine by accident, or intentionally when it has not been prescribed for them.
How long to keep Fencino for
Do not use Fencino after the expiry date which is stated on the carton and sachet. The expiry date refers to the last date of that month. If the patches are out of date, take them to your pharmacy.
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 Fencino contains
The active substance is fentanyl.
Fencino 25 μg/h:
1 transdermal patch contains 5.1 mg fentanyl in a patch size of 8.5 cm2 and releases 25 micrograms fentanyl per hour.
The other ingredients are:
Matrix components: Aloe vera leaf extract oil (on the basis of soya oil tocopherol acetate), colophonium resin, poly(2-ethylhexylacrylate, vinylacetate) (50:50)
Release liner: polyethylene terephtalate, polyester, siliconized
Backing foil with imprint: polyethylene terephthalate foil, printing ink
What Fencino looks like and contents of the pack
Transdermal patch.
Opaque, colourless, rectangular shaped patch with round corners and imprint on the backing foil “Fentanyl 25μg/h” in single sealed sachets.
Fencino is available in packs containing 5, 10 and 20 transdermal patches.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Manufacturer:
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany: Fentavera 12/25/50/75/100 Mikrogramm/Stunde transdermales Pflaster
Spain: Fentanilo Matrix Aristo 12/25/50/75/100 microgramos/hora parches transdérmicos EFG
United Kingdom: Fencino 12/25/50/75/100 micrograms/h transdermal patch
This leaflet was last revised in March 2022.
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