Patient leaflet - Effentora 800 micrograms buccal tablets
1. What Effentora is and what it is used for
The active substance of Effentora is fentanyl citra is a pain-relieving medicine known as an opioid, to treat breakthrough pain in adult patients with are already taking other opioid pain medicines f persistent (around-the-clock) cancer pain.
te. Effentora which is used cancer who or their
Breakthrough pain is additional, sudden pain tha spite of you having taken your usual opioid pain medicines.
t occurs in -relieving
2. What you need to know before you use E
ffentora
Do NOT use Effentora if you:
are not regularly using a prescribed opioid m
edicine (e.g , oxycodone, or at least a ave not been ntora,
codeine, fentanyl, hydromorphone, morphine pethidine), every day on a regular schedule, f week, to control your persistent pain. If you h using these medicines you must not use Effe because it may increase the risk that breathin become dangerously slow and/or shallow, or
g could
even stop.
are allergic to fentanyl or any of the other ing
redients of
this medicine (listed in section 6)
suffer from severe breathing problems or sev
ere
obstructive lung conditions
suffer from short-term pain other than breakt
hrough pain oxybate.
- are taking a medicine which contains sodium
Warnings and precautions
Keep using the opioid pain medicine you take fo persistent (around-the-clock) cancer pain during Effentora treatment.
r your
your
Whilst you are being treated with Effentora, do n fentanyl treatments previously prescribed for yo breakthrough pain. If you still have some of thes
ot use other ur
e fentanyl
treatments at home, contact your pharmacist to dispose of them.
check how to
Store this medicine in a safe and secure place, w people cannot access it (see section 5. How to st for more information).
here other ore Effentora
Talk to your doctor or pharmacist BEFORE using
Effentora if: ur persistent d yet
your other opioid pain medicine taken for yo
(around-the-clock) cancer pain is not stabilise
you are suffering from any condition that has
an effect on
your breathing (such as asthma, wheezing, or short breath)
ness of
- you have a head injury
you have an exceptionally slow heart rate or other
heart
problems
you have liver or kidney problems, as these organs
have an n the
effect on the way in which your system breaks dow medicine
you have low amount of fluid in the circulation or l
ow
blood pressure
you are over 65 years old - you may need a lower d
ose and your
any dose increase will be reviewed very carefully by doctor
you have problems with your heart especially slow
heart
rate
you use benzodiazepines (see section 2 under “Oth
er
medicines and Effentora”). Using benzodiazepines increase the chances of getting serious side effects including death
can
you use antidepressants or antipsychotics (selectiv
e
serotonin reuptake inhibitors [SSRIs], serotonin norepinephrine reuptake inhibitors [SNRIs], monoa oxidase (MAO) inhibitors; see section 2 under “Do n Effentora” and “Other medicines and Effentora”). Th these medicines with Effentora can lead to a serot syndrome a potentially life-threatening condi
mine ot use e use of onin tion
(see section 2 under “Other medicines and Effentor
a”)
you have ever developed adrenal insufficiency, a c
ondition h
in which the adrenal glands do not produce enoug hormones or lack of sex hormones (androgen defic with opioid use (see section 4 under “Serious side e
iency) ffects”) ds or
you have ever abused or been dependent on opioi
any other drug, alcohol or illegal drugs
you drink alcohol; please refer to section Effentora
with
food, drink and alcohol.
Consult your doctor WHILE using Effentora if:
you experience pain or increased sensitivity to pain
(hyperalgesia) which does not respond to a higher of your medicine as prescribed by your doctor
dosage
you experience a combination of the following sym
ptoms: ness and y be a
nausea, vomiting, anorexia, fatigue, weakness, dizzi low blood pressure. Together these symptoms ma sign of a potentially life-threatening condition calle adrenal insufficiency, a condition in which the adre glands do not produce enough hormones
d
nal
sleep-related breathing disorders: Effentora can cau
se
sleep-related breathing disorders such as sleep apn (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The sy can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties t maintain sleep or excessive drowsiness during the you or another person observe these symptoms, c
oea
mptoms
o
day. If ontact
your doctor. A dose reduction may be considered doctor.
by your
Long-term use and tolerance
This medicine contains fentanyl which is an opioid me Repeated use of opioid painkillers can result in the dru less effective (you become accustomed to it, known a tolerance). You may also become more sensitive to pa using Effentora. This is known as hyperalgesia. Increas dose of Effentora may help to further reduce your pai
dicine. g being s drug in while ing the n for a
while, but it may also be harmful. If you notice that your medicine becomes less effective, talk to your doctor. Your doctor will decide whether it is better for you to increase th dose or to gradually decrease your use of Effentora.
e
Dependence and addiction
This medicine contains fentanyl, which is an opioid. It can
cause dependence and/or addiction.
Repeated use of Effentora can also lead to dependence, ab
use
and addiction which may result in life-threatening overdose The risk of these side effects can increase with a higher dos and longer duration of use. Dependence or addiction can make you feel that you are no longer in control of how muc medicine you need to use or how often you need to use it. You might feel that you need to carry on using your medici even when it doesn’t help to relieve your pain. The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent or addicted on Effentora if you:
.
e
h
ne,
or anyone in your family have ever abused or been
dependent on alcohol, prescription medicines or illegal drugs (“addiction”)
- are a smoker
have ever had problems with your mood (depression,
anxiety or a personality disorder) or have been treated by psychiatrist for other mental illness.
a
If you notice any of the following signs whilst using Effentor it could be a sign that you have become dependent or addicted.
a,
you need to use the medicine for longer than advised by
your doctor
- you need to use more than the recommended dose
you are using the medicine for reasons other than
prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
you have made repeated, unsuccessful attempts to quit
or
control the use of the medicine
when you stop taking the medicine you feel unwell (e.g.
nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating), and you feel better once using the medicine again (‘withdrawal effects’).
If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when is appropriate to stop and how to stop safely.
it
Seek URGENT medical advice if:
you experience symptoms such as difficulty in breathing
or
dizziness, swelling of the tongue, lip or throat while using Effentora. These might be early symptoms of a serious allergic reaction (anaphylaxis, hypersensitivity; see sectio
n 4
under “Serious side effects”).
What to do if someone accidentally takes Effentora
If you think someone has accidentally taken Effentora pleas seek immediate medical assistance. Try to keep the person awake until emergency help arrives.
e
If someone has accidentally taken Effentora, they may have the same side effects as described in the section 3 “If you us more Effentora than you should”.
e
Children and adolescents
Do not give this medicine to children and adolescents below18 years of age.
Other medicines and Effentora
Tell your doctor or pharmacist before starting Effentora if yo are taking or have recently taken or might take any of the following medicines:
u
Concomitant use of Effentora and sedative medicines su
ch
as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depressi coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
on),
However if your doctor does prescribe Effentora 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 (such as sleeping pills, medicines to treat anxiety, some medicines to treat allergic reactions (antihistamines), or tranquillisers) and follow your doctor’s dose 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.
- Some muscle relaxants - such as baclofen, diazepam (see also section “Warnings and precautions”.
- Any medicines that might have an effect on the way in which your body breaks down Effentora, such as ritonavir, nelfinavir, amprenavir, and fosamprenavir (medicines that help control HIV infection) or other so-called CYP3A4 inhibitors such as ketoconazole, itraconazole, or fluconazole (used for treatment of fungal infections), troleandomycine, clarithromycine, or erythromycine (medicines for treatment of bacterial infections), aprepitant (used for severe nausea) and diltiazem and verapamil (medicines for treatment of high blood pressure or heart diseases).
Medicines called monoamine-oxidase (MAO) inhibitors
(used for severe depression) or have done so in the past 2 weeks.
- Certain type 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 syndrom (nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating) while using these medicines.
- Some painkillers for nerve pain (gabapentin and pregabalin).
- The risk of side effects increases if you are taking medicines such as certain antidepressants or antipsychotics. Effentora may interact with these medicines and you may experience mental status changes (e.g. agitation, hallucinations, coma), and other effects such as body temperature above 38°C, increase in heart rate, unstable blood pressure, and exaggeration of reflexes, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g nausea, vomiting, diarrhoea). Your doctor will tell you whether Effentora is suitable for you.
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Effentora with food, drink and alcohol
- Effentora may be used before or after, but not during, meals. You may drink some water before using Effentora to help moisten your mouth, but you should not drink or eat anything while taking the medicine.
- You should not drink grapefruit juice while using Effentora because it may affect the way your body breaks down Effentora.
- Do not drink alcohol while using Effentora. It can increase the risk of experiencing serious side effects including death.
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.
Pregnancy
Effentora should not be used during pregnancy unless you have discussed this with your doctor.
If Effentora is used for a long time during pregnancy, there is also a risk of the new-born child having withdrawal symptoms which might be life-threatening if not recognized and treated by a doctor.
You should not use Effentora during childbirth because fentanyl may cause respiratory depression in the new-born child.
Breast-feeding
Fentanyl can get into breast milk and may cause side effects in
500 mm
the breast-fed infant. Do not use Effentora if you are breast-feeding. You should not start breast-feeding until at least 5 days after the last dose of Effentora.
Driving and using machines
You should discuss with your doctor whether it is safe for you to drive, or operate machinery after taking Effentora. 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
Effentora before driving or operating machinery.
Effentora contains sodium
This medicine contains less than 1 mmol sodium ( buccal tablet, that is to say essentially ‘sodium-free
23 mg) per ’.
3. How to use Effentora
Always use this medicine exactly as your doctor ha Check with your doctor or pharmacist if you are no
s told you. t sure.
Before starting treatment and regularly during trea doctor will also discuss with you what you may ex using Effentora, when and how long you need to t to contact your doctor, and when you need to sto section 2).
tment, your pect from ake it, when p it (see also
Dosage and frequency
When you first start using Effentora, your doctor w you to find the dose that will relieve your breakthr is very important that you use Effentora exactly as tells you. The initial dose is 100 micrograms. Durin determination of your right dose, your doctor may you to take more than one tablet per episode. If yo breakthrough pain is not relieved after 30 minutes 1 more tablet of Effentora during the titration peri
ill work with ough pain. It the doctor g instruct ur
, use only od.
Once the right dose has been determined with yo use 1 tablet for an episode of breakthrough pain a rule. In the further course of treatment your requir
ur doctor, s a general ement for analgesic therapy may change. Higher doses may necessary. If your breakthrough pain is not relieved minutes, use only
be after 30
1 more tablet of Effentora during this dose-readjus period.
tment
Contact your doctor if your right dose of Effentora relieve your breakthrough pain. Your doctor will d dose needs to be changed.
does not ecide if your
Wait at least 4 hours before treating another episo breakthrough pain with Effentora.
de of
You must let your doctor know immediately if you Effentora more than four times per day, as a chang
are using e may be required to your treatment regimen. Your doctor the treatment for your persistent pain; when your pain is controlled again, your doctor may need to dose of Effentora. If your doctor suspects Effentora increased sensitivity to pain (hyperalgesia), a reduc Effentora dose may be considered (see section 2 u “Warnings and precautions”). For the most effectiv your doctor know about your pain and how Effent working for you, so that the dose can be changed
may change persistent change the -related tion of your nder e relief, let ora is if needed.
Do not change doses of Effentora or your other pa medicines on your own. Any change in dosage m prescribed and monitored by your doctor.
in ust be
If you are not sure about the right dose, or if you h
ave questions about taking this medicine, you should doctor.
contact your
Method of administration
Effentora buccal tablets are for oromucosal use. W place a tablet in your mouth, it dissolves and the m absorbed through the lining of your mouth, into t system. Taking the medicine in this way allows it t absorbed quickly to relieve your breakthrough pai
hen you edicine is he blood
o be n.
Taking the medicine
Open the blister only when you are ready to use the tablet.
The tablet must be used immediately once removed from the blister.
Separate one of the blister units from the blister card by
tearing apart at the perforations.
- Bend the blister unit along the line where indicated.
Peel the blister backing to expose the tablet. Do NOT
attempt to push the tablet through the blister, because this can damage the tablet.
Remove the tablet from the blister unit and immediately
place the entire tablet near a molar tooth between the gum and the cheek (as shown in the picture). Sometimes, your doctor may tell you to place the tablet under your tongue instead.
- Do not attempt to crush or split the tablet.
Do not bite, suck, chew, or swallow the tablet, as this will
result in less pain relief than when taken as directed.
The tablet should be left between the cheek and gum until
dissolved, which usually takes approximately 14 to 25 minutes.
You may feel a gentle bubbling sensation between your
cheek and gum as the tablet dissolves.
In case of irritation, you may change the placement of the
tablet on the gum.
After 30 minutes, if pieces of the tablet remain, they may be
swallowed with a glass of water.
If you use more Effentora than you should
The most common side effects are feeling sleepy, sick or
dizzy. If you begin to feel very dizzy, or very sleepy before the tablet is completely dissolved, rinse your mouth with water and spit the remaining pieces of the tablet into a sink or toilet right away.
A serious side effect of Effentora is slow and/or shallow
breathing. This can occur if your dose of Effentora is too high or if you take too much Effentora. In severe cases taking too much Effentora may also lead to coma. If you feel very dizzy, very sleepy or have slow or shallow breathing, If this occurs, please seek immediate medical assistance.
An overdose may also result in a brain disorder known as
toxic leukoencephalopathy.
If you forget to use Effentora
If the breakthrough pain is still ongoing, you may take Effentora as prescribed by your physician. If the breakthrough pain has stopped, do not take Effentora until the next breakthrough pain episode.
If you stop using Effentora
You should discontinue Effentora 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 Effentora when discontinuing Effentora. 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.
EFFENTORA PATIENT INFO LFLT Flat:
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 notice any of these, contact your doctor.
Serious side effects
The most serious side effects are shallow breathing,
low blood pressure and shock. Effentora like other fentanyl products can cause very severe breathing problems which can lead to death. If you become very sleepy or have slow and/or shallow breathing, you or your carer should contact your doctor immediately and call for emergency help.
Contact your doctor immediately if you experience a combination of the following symptoms
Nausea, vomiting, anorexia, fatigue, weakness, dizziness
and low blood pressure
Together these symptoms may be a sign of a potentially
life-threatening condition called adrenal insufficiency. A condition in which the adrenal glands do not produce
enough hormones.
Other side effects
Very common: may affect more than 1 in 10 people
- dizziness, headache
- feeling nauseous, vomiting
at the site of tablet application: pain, ulcer, irritation, bleeding,
numbness, loss of sensation, redness, swelling or spots.
Common: may affect up to 1 in 10 people
- feeling anxious or confused, depression, insomnia
- abnormal taste, weight decreased
sleepiness, sedation, excessive tiredness, weakness,
migraine, numbness, swelling of arms or legs, drug
withdrawal syndrome (may manifest by the occurrence of the following side effects nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating), shaking, falls, chills
constipation, inflammation of the mouth, dry mouth,
diarrhoea, heartburn, loss of appetite, stomach pain, uncomfortable stomach, indigestion, toothache, oral thrush
- itching, excessive sweating, rash
- shortness of breath, painful throat
decrease in white cells in the blood, decrease in red blood cells,
decreased or raised blood pressure, unusually fast heart rate
- muscle pain, back pain
fatigue.
Rar
e: may affect up to 1 in 1,000 people
d
isturbance in thinking, movements disturbance listers in the mouth, dry lips, collection of pus under the kin in the mouth
b
s
l
ack of testosterone, abnormal sensation in eye, observing ashes of light, brittle nails
fl
a
llergic reactions such as rash, redness, swollen lip and face, ives.
h
Not
known: frequency cannot be estimated from the
avai
lable data
l
oss of consciousness, stop in breathing, convulsion (fits) ack of sex hormones (androgen deficiency)
- l
d
rug tolerance (see section 2)
d
rug dependence (addiction) (see section 2)
d
rug abuse (see section 2)
d
elirium (symptoms may include a combination of gitation, restlessness, disorientation, confusion, fear, seeing r hearing things that are not really there, sleep isturbance, nightmares)
a o d
p
rolonged treatment with fentanyl during pregnancy may ause withdrawal symptoms in the newborn which can be fe-threatening (see section 2).
c li
Rep
orting of side effects
If yo This You Sch Yell By r info
u get any side effects, talk to your doctor or pharmacist. includes any possible side effects not listed in this leaflet. can also report side effects directly via the Yellow Card eme at: www.mhra.gov.uk/yellowcard or search for MHRA ow Card in the Google Play or Apple App Store. eporting side effects you can help provide more rmation on the safety of this medicine.
5.
How to store Effentora
The and chil rea
pain-relieving medicine in Effentora is very strong could be life-threatening if taken accidentally by a d. This medicine must be kept out of the sight and ch of children.
D
o not use this medicine after the expiry/use before date hich is stated on the blister package label and the carton. he expiry date refers to the last day of that month. tore this medicine in a safe and secure place, where other eople cannot access it. It can cause serious harm and be atal to people who may take this medicine by accident, or ntentionally when it has not been prescribed for them. tore in the original package in order to protect from moisture. Do not throw away any medicines via wastewater or ousehold waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help rotect the environment.
w T
S
p f
i
- S
•
h
p
Each blist 4 or 28 b Not all pa
er contains 4 buccal tablets, supplied in cartons of uccal tablets.
ck sizes may be marketed.
Marketi
ng Authorisation Holder:
Phoenix Suite 12, County M
Labs Unlimited Company
Bunkilla Plaza, Bracetown Business Park, Clonee, eath, Ireland.
Manufa
cturer:
Merckle
GmbH,
Ludwig-89143Bla Germany
Merckle-Straße 3,
ubeuren,
This leafl
et was last revised in 12/2025
PL 35104 and PL 3
/0060, PL 35104/0061, PL 35104/0062, PL 35104/0063 5104/0064.
Uncommon: may affect up to 1 in 100 people
- sore throat
- decrease in cells that help the blood to clot,
feeling elated, nervous, abnormal, jittery or slow; seeing or
hearing things that are not really there (hallucinations), reduced consciousness, change in mental state, dependence (reliance on the medicine, addiction), disorientation, lack of concentration, loss of balance, vertigo, problem with speaking, ringing in the ear, ear discomfort
- disturbed or blurred vision, red eye
- unusually low heart rate, feeling very warm (hot flushes),
- severe breathing problems, trouble breathing during sleep,
one or more of the following problems in the mouth: ulcer,
loss of sensation, discomfort, unusual colour, soft tissue
disorder, tongue disorder, painful or blistered or ulcerated tongue, gum pain, chapped lips, tooth disorder
inflammation of the oesophagus, paralysis of the gut, gall
bladder disorder
cold sweat, swollen face, generalised itching, hair loss, muscle
twitching, muscular weakness, feeling unwell, chest discomfort, thirst, feeling cold, feeling hot, difficulty passing urine
- malaise
- flushing.
6. C
ontents of the pack and other information
Wh
at Effentora contains
The
active substance is fentanyl.
E
ach Effentora 100 micrograms Buccal Tablet contains 00 micrograms fentanyl (as citrate).
1
E
ach Effentora 200 micrograms Buccal Tablet contains 00 micrograms fentanyl (as citrate).
2
E
ach Effentora 400 micrograms Buccal Tablet contains 00 micrograms fentanyl (as citrate).
4
E
ach Effentora 600 micrograms Buccal Tablet contains 00 micrograms fentanyl (as citrate).
6
E
ach Effentora 800 micrograms Buccal Tablet contains 00 micrograms fentanyl (as citrate).
8
The typ
other ingredients are mannitol, sodium starch glycolate e A, sodium hydrogen carbonate, sodium carbonate, citric , magnesium stearate.
acid
Wh
at Effentora looks like and contents of the pack
The emb Effe with 600
buccal tablets are flat-faced, round bevelled-edge tablet, ossed one side with a “C” and on the other side with “1” for ntora 100 micrograms, with “2” for Effentora 200 micrograms, “4” for Effentora 400 micrograms, with “6” for Effentora micrograms, with “8” for Effentora 800 micrograms.
500 mm