Dolten 100 mg film-coated 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:

FILM-COATED TABLET

Composition:

TAPENTADOL 100 mg

Prescription type:

POM

Therapeutic area:

ANALGESICS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2023-02-13

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DOLTEN 50 MG FILM-COATED TABLETS
DOLTEN 75 MG FILM-COATED TABLETS
DOLTEN 100 MG FILM-COATED 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 is and what it is used for
2.
What you need to know before you take Dolten
3.
How to take Dolten
4.
Possible side effects
5.
How to store Dolten
6.
Contents of the pack and other information
1.
WHAT DOLTEN IS AND WHAT IT IS USED FOR
Tapentadol, the active substance in Dolten, is a strong painkiller
which belongs to the class of opioids.
Dolten is used for the treatment of moderate to severe acute pain in
adults that can only be adequately
managed with an opioid painkiller.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOLTEN
DO NOT TAKE DOLTEN
-
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”).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Dolten
-
If you have slow or shallow breathing.
-
If you suffer from increased pressure in the brain or disturbed
consciousness up to coma.
-
If you have had a head injury or brain tumors.
-
If you suffer from a liver or kidney disease (see

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dolten 50 mg film-coated tablets
Dolten 75 mg film-coated tablets
Dolten 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Dolten 50 mg film-coated tablet contains 58.24 mg Tapentadol
hydrochloride equivalent to 50
mg Tapentadol.
Each Dolten 75 mg film-coated tablet contains 87.36 mg Tapentadol
hydrochloride equivalent to 75
mg Tapentadol.
Each Dolten 100 mg film-coated tablet contains 116.48 mg Tapentadol
hydrochloride equivalent
to100 mg Tapentadol.
Excipients with known effect:
Dolten 50 mg film-coated tablet contains 25.00 mg lactose monohydrate.
Dolten 75 mg film-coated tablet contains 37.50 mg lactose monohydrate.
Dolten 100 mg film-coated tablet contains 50.00 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Dolten 50 mg appears white, round, convex, film-coated tablets,
debossed with “Medochemie logo”
on one side and plain on the other side, with diameter 7.0 mm.
Dolten 75 mg appears yellow, round, convex, film-coated tablets plain
on both sides, with diameter
8.0 mm.
Dolten 100 mg appears dark pink, round, convex, film-coated tablets,
debossed “MC” on one side and
plain on the other side, with diameter 9.0 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dolten is indicated for the relief of moderate to severe acute 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.
Patients should start treatment with single doses of 50 mg tapentadol
as film-coated tablet
administered every 4 to 6 hours. Higher starting doses may be
necessary depending on the pain
intensity and the patient’s previous history of analgesic
requirements.
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On the first day of dosing, an additional dose