Tapentadol Liconsa 250 mg prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tapentadol Tartrate

Available from:

Laboratorios LICONSA, S.A.

ATC code:

N02AX06

INN (International Name):

Tapentadol Tartrate

Pharmaceutical form:

Prolonged-release tablet

Therapeutic area:

tapentadol

Authorization date:

2022-08-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TAPENTADOL LICONSA 25 MG PROLONGED-RELEASE TABLETS
TAPENTADOL LICONSA 50 MG PROLONGED-RELEASE TABLETS
TAPENTADOL LICONSA 100 MG PROLONGED-RELEASE TABLETS
TAPENTADOL LICONSA 150 MG PROLONGED-RELEASE TABLETS
TAPENTADOL LICONSA 200 MG PROLONGED-RELEASE TABLETS
TAPENTADOL LICONSA 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 your 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 Tapentadol Liconsa is and what it is used for
2.
What you need to know before you takeTapentadol Liconsa
3.
How to take Tapentadol Liconsa
4.
Possible side effects
5.
How to store Tapentadol Liconsa
6.
Contents of the pack and other information
1. WHATTAPENTADOL LICONSA IS AND WHAT IT IS USED FOR
Tapentadol the active substance in Tapentadol Liconsa, is a strong
painkiller which belongs to the
class of opioids. Tapentadol Liconsa is used for the treatment of
severe long-term pain in adults that
can only be adequately managed with an opioid painkiller.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKETAPENTADOL LICONSA
DO NOT TAKE TAPENTADOL LICONSA IF YOU
•
are allergic to tapentadol or any of the other ingredients of this
medicine (listed in section 6),
•
have asthma or if your breathing is dangerously slow or shallow
(respiratory depression,
hypercapnia),
•
have no bowel movement as shown by severe constipation and bloating
which may be
accompanied by pain or discomfort in the lower stomach,
•
have acute poisoning with alcohol, sleeping pills, pain relievers or
other psychotro

Summary of Product characteristics

Health Products Regulatory Authority
13 January 2023
CRN00D6TS
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tapentadol Liconsa 250 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains tapentadol tartrate equivalent
to 250 mg of tapentadol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
Red brown, oblong and biconvex prolonged-release tablet, with a length
of approximately 21 mm and a width of
approximately 7.5 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tapentadol Liconsa 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
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.
Tapentadol Liconsa 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 Tapentadol Liconsa 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
Tapentadol Liconsa for patients currently taking opioids compared to
those not having taken opioids before initiating therapy
with Tapentadol Liconsa.
_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