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Fentanyl Grünenthal

Document: Fentanyl Grünenthal sublingual tablet ENG PL change

Package leaflet: Information for the user


Fentanyl Grünenthal 67 micrograms, sublingual tablets

Fentanyl Grünenthal 133 micrograms, sublingual tablets

Fentanyl Grünenthal 267 micrograms, sublingual tablets

Fentanyl Grünenthal 400 micrograms, sublingual tablets

Fentanyl Grünenthal 533 micrograms, sublingual tablets

Fentanyl Grünenthal 800 micrograms, sublingual tablets

Fentanyl


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


What is in this leaflet

1. What Fentanyl Grünenthal is and what it is used for

2. What you need to know before you take Fentanyl Grünenthal

3. How to take Fentanyl Grünenthal

4. Possible side effects

How to store Fentanyl Grünenthal

6. Contents of the pack and other information


What Fentanyl Grünenthal is and what it is used for


Fentanyl Grünenthal contains the active ingredient fentanyl, which belongs to a group of strong pain-relieving medicines called opioids.


Fentanyl Grünenthal is used to treat breakthrough pain in adult patients with cancer who are already taking other opioid pain medicines for their persistent (around-the-clock) cancer pain.


Breakthrough pain is additional, sudden pain that occurs even though you have taken your usual opioid pain-relieving medicines.


What you need to know before you take Fentanyl Grünenthal


Do not take Fentanyl Grünenthal:


Warnings and precautions

Fentanyl Grünenthal contains an active ingredient in an amount that can be fatal to a child, and therefore keep all tablets out of the sight and reach of children and non-patients at all times.

Keep the tablets in a locked storage space and do not store the tablets once removed from the blister package.


Talk to your doctor or pharmacist before taking Fentanyl Grünenthal.


Tell your doctor before treatment if you have or have recently had any of the following, as your doctor will need to take account of these when prescribing your dose:


Children and adolescents

Fentanyl Grünenthalshall not be used by children and adolescents below 18 years.


Other medicines and Fentanyl Grünenthal

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

psycho-stimulating medicines (such as modafinil).


Certain types of strong pain killers, called partial agonist/antagonists e.g. buprenorphine, nalbuphine and pentazocine (medicines for treatment of pain). You could experience symptoms of withdrawal syndrome (nausea, vomiting, diarrhoea, anxiety, chills, tremor and sweating) while using these medicines.


Fentanyl Grünenthalwith food, drink and alcohol


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 taking this medicine.


Fentanyl Grünenthal should not be used during pregnancy unless you have discussed this with your doctor. You should not use Fentanyl Grünenthal during childbirth because fentanyl may cause respiratory depression and withdrawal symptoms in the foetus or in the new-born child.

Fentanyl can get into breast milk and may cause side effects in the breast-fed infant. Do not use Fentanyl Grünenthal if you are breast-feeding. You should not start breast-feeding until at least 5 days after the last dose of Fentanyl Grünenthal.


Driving and using machines

You should discuss with your doctor whether it is safe for you to drive, or operate machinery after taking Fentanyl Grünenthal. Do not drive or operate machinery if you: are feeling sleepy or dizzy; have blurred or double vision; or have difficulty in concentrating. It is important you know how you react to Fentanyl Grünenthal before driving or operating machinery.


Fentanyl Grünenthalcontains sodium

This medicinal product contains 0.651 mg sodium per tablet. To be taken into consideration by patients on a controlled sodium diet.


How to take Fentanyl Grünenthal


This medicine should be taken by placing the tablet under your tongue (sublingual use).


Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.


If your doctor switched you to Fentanyl Grünenthal, you must not use the previous medicine containing fentanyl concurrently for the treatment of your breakthrough pain. Dispose of the previous medicine. However, keep using the opioid pain medicine you take for your persistent (around-the-clock) cancer pain during your Fentanyl Grünenthaltreatment.


Initial Phase – Finding the most appropriate dose

For Fentanyl Grünenthal to work successfully, your doctor will need to identify the most appropriate dose for treating a single episode of breakthrough pain. Fentanyl Grünenthal sublingual tablets are available in a range of strengths. You may need to try different strengths of Fentanyl Grünenthal sublingual tablets over a number of episodes of breakthrough pain to find the most appropriate dose. Your doctor will help you do this and will work with you to find the best strength of tablet to use.


If you do not get adequate pain relief from one tablet your doctor may ask you to take two tablets to treat an episode of breakthrough pain. Do not take a second tablet unless your doctor tells you to as this may result in overdose. Your doctor will advise you which strength of tablet to use.


You must always use the dose of Fentanyl Grünenthalas prescribed by your doctor – this may be a different dose from that which you have used with other medicines for breakthrough pain.


Maintenance Phase - Once you have found the most appropriate dose

Once you and your doctor have found a dose of Fentanyl Grünenthal tablets that controls your breakthrough pain you should not take this dose more than four times a day. A dose of Fentanyl Grünenthal may consist of more than one tablet.


If you think that the dose of Fentanyl Grünenthal that you are using is not controlling your breakthrough pain satisfactorily tell your doctor, as he may need to adjust your dose.


You must not change your dose of Fentanyl Grünenthal unless directed by your doctor.


Taking the medicine

Fentanyl Grünenthal should be used sublingually. This means that the tablet should be placed under the tongue where it dissolves rapidly in order to allow fentanyl to be absorbed across the lining of the mouth.


When you get an episode of breakthrough pain, take the dose advised by your doctor as follows:

  • If your mouth is dry, take a sip of water to moisten it. Spit out or swallow the water.

  • Remove the tablet(s) from the blister pack immediately before use.

  • Peel back the tab of the foil top of one blister and gently remove the tablet. Do not try to push Fentanyl Grünenthal sublingual tablets through the foil top.

  • Place the tablet under your tongue as far back as you can and let it dissolve completely.

  • Fentanyl Grünenthal will dissolve rapidly under the tongue and be absorbed in order to provide pain relief. It is therefore important that you do not suck, chew or swallow the tablet.

  • After 30 minutes, if pieces of the tablet remain, they may be swallowed.

  • You should not drink or eat anything until the tablet has completely dissolved under your tongue.


If you take more Fentanyl Grünenthal than you should

Symptoms of overdose include altered mental status, loss of consciousness, extreme drowsiness, slow and shallow breathing. If these occur, seek emergency medical help immediately.


Note to caregivers

While waiting for the doctor:


If you think someone has taken Fentanyl Grünenthal by accident seek emergency medical help immediately.


If you forget to takeFentanyl Grünenthal

Do not take a double dose to make up for a forgotten tablet.


If you stop using Fentanyl Grünenthal

You should discontinue Fentanyl Grünenthal when you no longer have any breakthrough pain. You must however continue to take your usual opioid pain relieving medicine to treat your persistent cancer pain as advised by your doctor. You may experience withdrawal symptoms similar to the possible side effects of Fentanyl Grünenthal when discontinuing Fentanyl Grünenthal. If you experience withdrawal symptoms or if you are concerned about your pain relief you should contact your doctor. Your doctor will evaluate if you need medicine to reduce or eliminate the withdrawal symptoms.


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 most serious side effects are


If you become very sleepy and/or experience any of the above mentioned side effects, you should stop taking Fentanyl Grünenthal and you or your caregiver should contact your doctor immediately and call for emergency help.


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):


Not known (frequency cannot be estimated from the available data):


Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via [to be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Fentanyl Grünenthal


The pain-relieving medicine in Fentanyl Grünenthal is very strong and could be life-threatening if taken accidentally by a child. Keep this medicine out of the sight and reach of children.


Do not use this medicineafter the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.


This medicine does not require any special temperature storage conditions.

Store in the original blister package, in order to protect from light.

Keep Fentanyl Grünenthalin a locked storage space.


Do not store the tablet once removed from the blister package.

Unused or partially used remaining products must not be disposed of via wastewater or household waste. It should be taken, if possible, to your pharmacist to be disposed of safely. This is a safety precaution and it will also help protect the environment.


6. Contents of the pack and other information


What Fentanyl Grünenthal contains

The active substance is: fentanyl.

Each sublingual tablet contains 67, 133, 267, 400, 533 or 800 micrograms of fentanyl (as citrate).


The other ingredients (exipients) are: calcium hydrogen phosphate anhydrous, microcrystalline cellulose, disodium phosphate anhydrous, hypromellose, macrogol, magnesium stearate, maltodextrin, titanium dioxide (E171), triacetin, printing ink (shellac, iron oxide black (E172)).


What Fentanyl Grünenthal looks like and contents of the pack

Fentanyl Grünenthal 67 micrograms is a white, convex, triangular tablet, height of 5.6 mm, printed with ‘0’ in black ink on one face.

Fentanyl Grünenthal 133 micrograms is a white, convex, triangular tablet, height of 5.6 mm, printed with ‘1’ in black ink on one face.

Fentanyl Grünenthal 267 micrograms is a white, convex, triangular tablet, height of 5.6 mm, printed with ‘2’ in black ink on one face.

Fentanyl Grünenthal 400 micrograms is a white, convex, triangular tablet, height of 5.6 mm, printed with ‘4’ in black ink on one face.

Fentanyl Grünenthal 533 micrograms is a white, convex, triangular tablet, height of 5.6 mm, printed with ‘5’ in black ink on one face.

Fentanyl Grünenthal 800 microgramsis a white, convex, triangular tablet, height of 5.6 mm, printed with ‘8’ in black ink on one face.


The Fentanyl Grünenthalsublingual tablets are available in a peelable, child resistant blister, with pack sizes of 3, 4, 15 or 30 tablets.

Not all pack sizes may be marketed.


Marketing Authorisation Holder

[To be completed nationally]


Manufacturer

Grünenthal GmbH

Zieglerstraße 6

52078 Aachen

Germany


This medicinal product is authorised in the Member States of the EEA under the following names:

Sweden: Fentanyl Grünenthal 67 mikrogram / 133 mikrogram / 267 mikrogram / 400 mikrogram / 533 mikrogram / 800 mikrogramsublinguala resoribletter

Belgium: Recivit, 67 microgram /133 microgram /267 microgram /400 microgram /533 microgram /800 microgram, tabletten voor sublinguaal gebruik

Ireland: Recivit 67 micrograms / 133 micrograms / 267 micrograms / 400 micrograms / 533 micrograms / 800 micrograms, sublingual tablets

The Netherlands: Recivit 67 microgram / 133 microgram / 267 microgram / 400 microgram /
533 microgram / 800microgram, tabletten voor sublinguaal gebruik

United Kingdom: Recivit 67 micrograms / 133 micrograms / 267 micrograms / 400 micrograms / 533 micrograms / 800 micrograms, sublingual tablets


This leaflet was last revised in 2015-10-28