Tapimio 200 mg prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tapentadol Phosphate

Available from:

Neuraxpharm Ireland Limited

ATC code:

N02AX06

INN (International Name):

Tapentadol Phosphate

Pharmaceutical form:

Prolonged-release tablet

Therapeutic area:

tapentadol

Authorization status:

Not marketed

Authorization date:

2022-11-04

Patient Information leaflet

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
TAPIMIO25 MG PROLONGED-RELEASE TABLETS
TAPIMIO 50 MG PROLONGED-RELEASE TABLETS
TAPIMIO 100 MG PROLONGED-RELEASE TABLETS
TAPIMIO 150 MG PROLONGED-RELEASE TABLETS
TAPIMIO 200 MG PROLONGED-RELEASE TABLETS
TAPIMIO 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 Tapimio is and what it is used for
2.
What you need to know before you take Tapimio
3.
How to take Tapimio
4.
Possible side effects
5.
How to store Tapimio
6.
Contents of the pack and other information
1.
WHAT TAPIMIO IS AND WHAT IT IS USED FOR
Tapentadol - the active substance in Tapimio - is a strong painkiller
which belongs to the class of
opioids. Tapimio is used for the treatment of severe chronic pain in
adults that can only be adequately
managed with an opioid painkiller.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAPIMIO
DO NOT TAKE TAPIMIO
•
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)
•
if you have paralysis of the gut
•
if you have acute poisoning with alcohol, sleeping pills, pain
relievers or other psychotropic
medicines (medicines that affect mood and emotions) (see “Other
medicines and Tapimio”)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Tapimio if you:
•
have slow or shallow breathing,
•
suffer from increased pressure in the brai

Summary of Product characteristics

Health Products Regulatory Authority
24 November 2022
CRN00D70R
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tapimio 200 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains tapentadol phosphate equivalent
to 200 mg tapentadol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
Yellow, oblong, biconvex prolonged-release tablets (8 mm x 16 mm) with
score lines on both sides.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tapimio 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.
Tapimio 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 Tapimio
administered twice daily.
_Initiation of therapy in patients currently taking opioid analgesics_
When switching from opioids to Tapimio 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 Tapimio for
patients currently taking opioids compared to those not having taken
opioids before initiating therapy with Tapimio.
_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 clinical trials has shown that a titration regimen in
increments of 50 mg prolonged release tapentadol twice
daily every 3 days was appropriate to ac