ULTRACET TABLET

Krajina: Malajzia

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktívna zložka:

Acetaminophen; TRAMADOL HYDROCHLORIDE

Dostupné z:

JOHNSON & JOHNSON SDN BHD

INN (Medzinárodný Name):

Acetaminophen; TRAMADOL HYDROCHLORIDE

Počet v balení:

10Tablet Tablets; 30Tablet Tablets

Výrobca:

JANSSEN CILAG SPA

Príbalový leták

ULTRACET TABLET
®
Tramadol hydrochloride / acetominophen (37.5mg/325mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What ULTRACET
®
is used for
2.
How ULTRACET
®
works
3.
Before you use ULTRACET
®
4.
How to use ULTRACET
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
ULTRACET
®
8.
Product description
9.
Manufacturer and product
registration holder
10.
Date of revision
WHAT ULTRACET
®
IS USED FOR
ULTRACET
®
is used to treat moderate
pain to severe pain.
HOW ULTRACET
®
WORKS
ULTRACET
®
tablets have a
combination of two pain relievers –
tramadol hydrochloride (an opioid
analgesic) and acetaminophen (same as
paracetamol).
BEFORE YOU USE ULTRACET
®
-
_When you must not use it _
•
You are less than 12 years old;
•
You have slow or shallow breathing,
or other breathing problems;
•
You are pregnant;
•
You are breastfeeding.
You must not take ULTRACET
®
if you
have previously had an allergic reaction
(hypersensitivity) to tramadol
hydrochloride or acetaminophen, or to
any other opioid pain relievers. Please
tell your doctor if this applies to you.
Hypersensitivity can be recognized for
instance by skin rash, itching, shortness
of breath or swollen face. If any of these
occur, contact your doctor right away.
Do not give ULTRACET
®
to a child
under 18 years of age that has just an
operation to remove their tonsils or
adenoids.
Do not take ULTRACET
®
if you are
taking:
•
Sleeping pills e.g. hypnotics;
•
Medicines that affect your mood or
emotions e.g. narcotics and
psychotropic drugs;
•
Pain relievers that affect your central
nervous system e.g. centrally acting
analgesics and opioids;
•
Antidepressants such as Monoamine
Oxidase Inhibitors (MAO inhibitors)
currently or within the last 14 days.
_ _
_Pregnancy and lactation _
If you are, or think you may be,
pregnant, you should inform your doctor,
who will decide if you can take
ULTRACET
®
. Opioid medicines can
slow the breathing of a newborn child.
Prolonged use of ULTRACET
®
during

Súhrn charakteristických

PRODUCT NAME
ULTRACET
®
(tramadol and paracetamol)
DOSAGE FORMS AND STRENGTHS
Light yellow, film-coated capsule-shaped tablet debossed:
“J-C” on one side and “T/P” on the other side.
Each tablet contains 37.5 mg tramadol hydrochloride and 325 mg
paracetamol.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
ULTRACET is indicated for the management of moderate to severe pain.
DOSAGE AND ADMINISTRATION
DOSAGE
ADULTS AND CHILDREN 16 YEARS OF AGE AND OVER_ _
The maximum single dose of ULTRACET is 1 to 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.
ADULTS AND ADOLESCENTS (12 YEARS AND OLDER)
ULTRACET is not approved for use in patients below 12 years old.
PAEDIATRIC POPULATION
The safety and efficacy of ULTRACET has not been studied in the
paediatric population. Therefore,
use of ULTRACET is not recommended in patients under 12 years of age.
TREATMENT WITHDRAWAL
Do not stop use of ULTRACET abruptly. Withdrawal symptoms may be
relieved by tapering the
medication (see
_Warnings and Precautions – Treatment withdrawal_
).
SPECIAL POPULATIONS
_CHILDREN BELOW 16 YEARS OF AGE _
The
use
of
ULTRACET
is
contraindicated
in
children
below
12
years
of
age
(see
_Contraindications_
).
_ _
The safety and effectiveness of ULTRACET in children aged 12 to below
16 years of age has not
been established(see
_Contraindications and Warnings and Precautions - Other risk factors
for life-_
_threatening respiratory depression in children_
).
_ELDERLY (65 YEARS OF AGE AND OLDER) _
No overall differences with regard to safety or pharmacokinetics were
noted between subjects
≥65 years of age and younger subjects. However, dose selection for
an elderly patient should be
cautious, reflecting the greater frequency of decreased hepatic, renal
or cardiac function, of
concomitant disease and multiple drug therapy.
_RENAL IMPAIRMENT _
In patients with creatinine clearances of less than 30 mL/min, i