TABFYL is a medicine for the treatment of adults who already need to use strong painkillers (opioids) regularly to relieve persistent cancer pain, but who need treatment for severe episodic pain. If you are not sure, talk to your doctor.

Breakthrough pain is pain that comes on suddenly, even if you have taken or used regular opioid pain medications.

The active substance in TABFYL sublingual tablets is fentanyl. Fentanyl belongs to a group of strong painkillers called opioids.

Do not use Tabfyl:
- if you are allergic to fentanyl or any of the other ingredients of this medicine.

Talk to your doctor or pharmacist before using Tabfyl.

Pregnancy and breastfeeding:
If you are pregnant, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

You should not use TABFYL during pregnancy unless your doctor specifically recommends it.

Fentanyl can pass into breast milk and may cause side effects in a nursing infant. Do not use TABFYL if you are breast-feeding. You should not start breast-feeding until at least 5 days have passed since your last dose of TABFYL.

Driving and using machines:
TABFYL may impair your mental and/or physical abilities to perform potentially hazardous activities such as driving or using machinery.

Do not drive or use machines if you feel sleepy, dizzy or have blurred vision while taking TABFYL.

Before you use TABFYL for the first time, your doctor will explain to you how you should use TABFYL to effectively treat severe episodic pain.

Always use this medicine exactly as your doctor has told you. Talk to your doctor or pharmacist if you are not sure.

You should use this medicine ONLY as directed by your doctor.
The medicine should not be used by other people as it may pose a SERIOUS risk to their health and in particular to the health of children.

TABFYL is a different type of medication from other medicines you may have used to treat breakthrough pain. You should always take the dose of TABFYL prescribed by your doctor – this may be different from the doses of other medicines you have used to treat breakthrough pain before.

If you have any further questions on this medicine, ask your doctor or pharmacist.

- The active substance is fentanyl. One sublingual tablet contains:
100 micrograms fentanyl (as citrate)
200 micrograms fentanyl (as citrate)
300 micrograms fentanyl (as citrate)
400 micrograms fentanyl (as citrate)
600 micrograms fentanyl (as citrate)
800 micrograms fentanyl (as citrate)
- The other ingredients are: mannitol (E421), microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium and magnesium stearate.

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

10 sublingual tablets