ULTRACET TABLET

Šalis: Pietų Afrika

kalba: anglų

Šaltinis: South African Health Products Regulatory Authority (SAHPRA)

Prieinama:

Janssen Pharmaceutica (Pty) Ltd

Dozė:

See ingredients

Vaisto forma:

TABLET

Sudėtis:

EACH TABLET CONTAINS PARACETAMOL 325,0 mg TRAMADOL HYDROCHLORIDE 37,5 mg

Autorizacija statusas:

Registered

Leidimo data:

2014-03-08

Pakuotės lapelis

Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name:
ULTRACET® (44/2.9/0931)
Dosage form and strength:
37,5 mg tramadol hydrochloride and 325 mg paracetamol per tablet
___________________________________________________________________________________
Page 1 of 16
PATIENT INFORMATION LEAFLET
.
_ _
_ _
_ _
ULTRACET Film coated tablets
Each tablet contains 37,5 mg tramadol hydrochloride and 325 mg
paracetamol.
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ULTRACET
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other
health care provider.
•
ULTRACET has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same
as yours.
WHAT IS IN THIS LEAFLET
1.
What ULTRACET is and what it is used for
2.
What you need to know before you take ULTRACET
3.
How to use ULTRACET
4.
Possible side effects
5.
How to store ULTRACET
6.
Contents of the pack and other information
SCHEDULING STATUS
Schedule 5
Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name:
ULTRACET® (44/2.9/0931)
Dosage form and strength:
37,5 mg tramadol hydrochloride and 325 mg paracetamol per tablet
___________________________________________________________________________________
Page 2 of 16
1. WHAT ULTRACET IS AND WHAT IT IS USED FOR_ _
Tramadol and paracetamol are the active substances in ULTRACET. They
are
painkillers that act on the brain and spinal cord to control pain.
ULTRACET is used
for the management of moderate to moderately severe pain in adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ULTRACET
DO NOT TAKE ULTRACET IF:
•
if you are hypersensitive (allergic) to tramadol or paracetamol or to
any other opioid or
any
of the other ingredients of ULTRACET
(listed in section 6);
•
if you take other medicines containing paracetamol or tramadol;
•
if you have a moderate to severe liver disease;
•
if you are taking alcohol;
•
if

Prekės savybės

_JANSSEN PHARMACEUTICA (PTY) LTD. _
_ULTRACET® (_44/2.9/0931_) _
_37,5 MG TRAMADOL HYDROCHLORIDE AND 325 MG PARACETAMOL PER TABLET _
_PROFESSIONAL INFORMATION (PI) _
_ _
_ _
_PAGE 1 OF 26 _
PROFESSIONAL INFORMATION
1
NAME OF THE MEDICINE
ULTRACET Film coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 37,5 mg tramadol hydrochloride and 325 mg
paracetamol.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Light yellow, film-coated capsule-shaped tablet engraved “J-C” on
one side and “T/P” on
the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ULTRACET is indicated for the management of moderate to
moderately-severe pain in
adults.
ULTRACET is not recommended for minor pain that may be treated
adequately through
lesser means.
SCHEDULING STATUS
Schedule 5
_JANSSEN PHARMACEUTICA (PTY) LTD. _
_ULTRACET® (_44/2.9/0931_) _
_37,5 MG TRAMADOL HYDROCHLORIDE AND 325 MG PARACETAMOL PER TABLET _
_PROFESSIONAL INFORMATION (PI) _
_ _
_ _
_PAGE 2 OF 26 _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
To be used in adults and children over 16 years of age.
DO NOT EXCEED THE RECOMMENDED DOSE.
For the management of pain, the recommended maximum single dose of
ULTRACET
is 1 or 2 tablets every 4 to 6 hours as needed for pain relief up to a
maximum of 8
tablets per day. The lowest effective dose should be used for the
shortest period of
time.
A titration period of several days with gradual dose increases at the
initiation of
ULTRACET therapy may be beneficial for some patients. Clinical studies
with tramadol
in patients with moderate to moderately severe chronic pain indicate
that the tolerability
of tramadol can be improved by starting tramadol at a low dose with
gradual upward
dose titration to reach doses that provide sufficient pain relief.
SPECIAL POPULATIONS
Children below 16 years of age
The use of ULTRACET is contraindicated in children below 12 years of
age (see section 4.3,
Contraindications).
The safety and effectiveness of ULTRACET