Apeneta 100 mg prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tapentadol maleate hemihydrate

Available from:

KRKA, d.d., Novo mesto

ATC code:

N02AX06

INN (International Name):

Tapentadol maleate hemihydrate

Dosage:

100 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Therapeutic area:

tapentadol

Authorization status:

Marketed

Authorization date:

2021-10-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
APENETA 50 MG PROLONGED-RELEASE TABLETS
APENETA 100 MG PROLONGED-RELEASE TABLETS
APENETA 150 MG PROLONGED-RELEASE TABLETS
APENETA 200 MG PROLONGED-RELEASE TABLETS
APENETA 250 MG PROLONGED-RELEASE TABLETS
tapentadol
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 Apeneta is and what it is used for
2.
What you need to know before you take Apeneta
3.
How to take Apeneta
4.
Possible side effects
5.
How to store Apeneta
6.
Contents of the pack and other information
1.
WHAT APENETA IS AND WHAT IT IS USED FOR
The full name of your medicine is ‘Apeneta 50 mg, 100 mg, 150 mg,
200 mg or 250 mg prolonged-
release tablets’. It is referred to as ‘Apeneta’ in the rest of
this leaflet. Prolonged-release means that
the active substance releases slowly but equaly into the blood.
Therefore the medicine works for a
longer time and you can take the medicine only twice a day.
Tapentadol - the active substance in Apeneta - is a strong painkiller
which belongs to the class of
opioids. Apeneta is used in adults for the treatment of severe
long-term pain that can only be
adequately managed with an opioid painkiller.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE APENETA
DO NOT TAKE APENETA
-
if you are allergic to tapentadol or any of the other ingredients of
this medicine (listed in section
6)
-
if you have asthma or if your breathing is dangerously slow or shallow
(respiratory depression,
hypercapnia (abnormally elevated carbon dioxide levels in the blood))
-
if you have

Summary of Product characteristics

Health Products Regulatory Authority
26 January 2023
CRN00D7CR
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Apeneta 100 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains tapentadol maleate hemihydrate
equivalent to 100 mg tapentadol.
Excipient with known effect: lactose monohydrate
Each prolonged-release tablet contains 3.3 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet (tablet)
Pale brownish yellow, oval, biconvex, film-coated tablets with mark T2
on one side of the tablet.
Tablet dimensions: approx. 16 mm x 8.5 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Apeneta is indicated for the management of severe chronic pain in
adults, which can be adequately managed only with opioid
analgesics.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosing regimen should be individualised according to the severity
of pain being treated, the previous treatment
experience and the ability to monitor the patient.
Apeneta should be taken twice daily, approximately every 12 hours.
_Initiation of therapy_
Initiation of therapy in patients currently not taking opioid
analgesics
Patients should start treatment with single doses of 50 mg tapentadol
as prolonged-release tablet administered twice daily.
_Initiation of therapy in patients currently taking opioid analgesics_
When switching from opioids to Apeneta and choosing the initial dose,
the nature of the previous medicinal product,
administration and the mean daily dose should be taken into account.
This may require higher initial doses of Apeneta for
patients currently taking opioids compared to those not having taken
opioids before initiating therapy with Apeneta.
_Titration and maintenance_
After initiation of therapy the dose should be titrated individually
to a level that provides adequate analgesia and minimises
undesirable effects under the close supervision of the prescribing
physician.
Experience from