Dolten retard 100 mg prolonged-release tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC code:

N02AX06

INN (International Name):

TAPENTADOL 100 mg

Pharmaceutical form:

PROLONGED-RELEASE TABLET

Composition:

TAPENTADOL 100 mg

Prescription type:

POM

Therapeutic area:

ANALGESICS

Authorization status:

Authorised

Authorization date:

2023-12-01

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOLTEN RETARD 50 MG PROLONGED-RELEASE TABLETS
DOLTEN RETARD 100 MG PROLONGED-RELEASE TABLETS
DOLTEN RETARD 150 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 Dolten Retard is and what it is used for
2.
What you need to know before you take Dolten Retard
3.
How to take Dolten Retard
4.
Possible side effects
5.
How to store Dolten Retard
6.
Contents of the pack and other information
1.
WHAT DOLTEN RETARD IS AND WHAT IT IS USED FOR
Tapentadol, the active substance in Dolten Retard , is a strong
painkiller which belongs to the class
of opioids. Dolten Retard 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 DOLTEN RETARD
DO NOT TAKE DOLTEN RETARD
-
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 Dolten Retard
”)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Dolten Retard if you
-
have slow or shallow breathing,
-
suffer from increased pressure in the brain or disturbed consciousness
up to coma

Summary of Product characteristics

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dolten Retard 50 mg prolonged-release tablets
Dolten Retard 100 mg prolonged-release tablets
Dolten Retard 150 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 58.24mg tapentadol
hydrochloride equivalent to 50 mg
tapentadol.
Each prolonged-release tablet contains 116.48mg tapentadol
hydrochloride equivalent to 100 mg
tapentadol.
Each prolonged-release tablet contains 174.72mg tapentadol
hydrochloride equivalent to 150 mg
tapentadol.
Excipients with known effect: lactose monohydrate.
Each prolonged-release tablet contains 2.825 mg of lactose anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
_50 mg_
: Peach, oval shaped, biconvex, film-coated tablets, debossed “D”
on one side and plain on the
other side with dimensions 15 x 7mm
_100 mg_
: Yellow, oval shaped, biconvex, film-coated tablets debossed ‘C’
on one side and plain on
the other side with dimensions 15 x 7mm
_150 mg_
: Brown, oval shaped, biconvex, film-coated tablets, debossed “E”
on one side and plain on
the other side with dimensions 15 x 7mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dolten Retard 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.
Dolten Retard should be taken twice daily, approximately every 12
hours.
Page 2 of 13
Dolten Retard is only available as 50 mg, 100 mg and 150 mg
prolonged-release tablets. For doses
not achievable with these strengths, other tapentadol
prolonged-release products are available.
_Initiation of therapy _
_Initiation of therapy in patients currently not taking opioid
analgesics _
Patients should start trea