Abstral 200 mikrogram Resoriblett, sublingual

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

fentanylcitrat

Available from:

Medartuum AB

ATC code:

N02AB03

INN (International Name):

fentanyl citrate

Dosage:

200 mikrogram

Pharmaceutical form:

Resoriblett, sublingual

Composition:

mannitol Hjälpämne; fentanylcitrat 314,2 mikrog Aktiv substans

Prescription type:

Receptbelagt

Product summary:

Förpacknings: Blister, 30 resoribletter

Authorization status:

Avregistrerad

Authorization date:

2017-09-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ABSTRAL 100 MICROGRAM SUBLINGUAL TABLETS
ABSTRAL 200 MICROGRAM SUBLINGUAL TABLETS
ABSTRAL 300 MICROGRAM SUBLINGUAL TABLETS
ABSTRAL 400 MICROGRAM SUBLINGUAL TABLETS
ABSTRAL 600 MICROGRAM SUBLINGUAL TABLETS
ABSTRAL 800 MICROGRAM SUBLINGUAL TABLETS
fentanyl
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Abstral is and what it is used for
2.
What you need to know before you take Abstral
3.
How to take Abstral
4.
Possible side effects
5.
How to store Abstral
6.
Contents of the pack and other information
1.
WHAT ABSTRAL IS AND WHAT IT IS USED FOR
Abstral
_ _
is a treatment for adults
WHO MUST ALREADY REGULARLY BE TAKING STRONG PAIN-RELIEVING
MEDICINE (OPIOIDS)
for their persistent cancer pain, but require treatment for their
breakthrough pain.
If you are not sure, talk to your doctor.
Breakthrough pain is pain which occurs suddenly, even though you have
taken or used your usual
opioid pain-relieving medicine.
The active substance in Abstral sublingual tablets is fentanyl.
Fentanyl belongs to a group of strong
pain-relieving medicines called opioids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ABSTRAL
DO NOT TAKE ABSTRAL

if you are allergic to fentanyl or any of the other ingredients of
this medicine (listed in section 6)

if you have severe breathing problems

if you are not regularly using a prescribed opioid medicine (e.g
codeine, fentanyl,
hydromorphone, morphine, oxycodone, pethidine), every day on a regular
schedule, for at least
a we

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Abstral 100 microgram sublingual tablets
Abstral 200 microgram sublingual tablets
Abstral 300 microgram sublingual tablets
Abstral 400 microgram sublingual tablets
Abstral 600 microgram sublingual tablets
Abstral 800 microgram sublingual tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 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)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sublingual tablet
100 microgram sublingual tablet is a white round tablet
200 microgram sublingual tablet is a white oval-shaped tablet
300 microgram sublingual tablet is a white triangle-shaped tablet
400 microgram sublingual tablet is a white diamond-shaped tablet
600 microgram sublingual tablet is a white “D”-shaped tablet
800 microgram sublingual tablet is a white capsule-shaped tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Management of breakthrough pain in adult patients using opioid therapy
for chronic cancer pain.
Breakthrough pain is a transient exacerbation of otherwise controlled
chronic background pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Abstral should only be administered to patients who are considered
tolerant to their opioid therapy for
persistent cancer pain. Patients can be considered opioid tolerant if
they take at least 60 mg of oral
morphine daily, at least 25 micrograms of transdermal fentanyl per
hour, at least 30 mg of oxycodone
daily, at least 8 mg of oral hydromorphone daily or an equianalgesic
dose of another opioid for a week
or longer.
Method of administration:
Abstral sublingual tablets should be administered directly under the
tongue at the deepest part. Abstral
sublingual tablets should not be swallowed, but allowed to completely
dissolve in the sublingual
cavity without chewing or suck