Utraphen Film Coated Tablet 37.5mg325mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TRAMADOL HYDROCHLORIDE; PARACETAMOL/ACETAMINOPHEN

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

TRAMADOL HYDROCHLORIDE; PARACETAMOL/ACETAMINOPHEN

Unit dalam pakej:

10x10 Tablets

Dikeluarkan oleh:

STANDARD CHEM & PHARM CO LTD

Risalah maklumat

UTRAPHEN FILM COATED TABLETS 37.5MG/325MG
Tramadol Hydrochloride/ Paracetamol (37.5mg/325mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Utraphen is used for
2.
How Utraphen works
3.
Before you use Utraphen
4.
How to use Utraphen
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Utraphen
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT UTRAPHEN IS USED FOR
Utraphen is used to treat moderate pain
to severe pain.
HOW UTRAPHEN WORKS
Utraphen Tablets have a combination of
two
pain
relievers
–
tramadol
hydrochloride (an opioid analgesic) and
acetaminophen
(same
as
paracetamol).
BEFORE YOU USE UTRAPHEN
-
_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 Utraphen 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 Utraphen to a child under 18
years of age that has just an operation to
remove their tonsils or adenoids.
Do not take Utraphen 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 Utraphen. Opioid
medicines can slow the breathing of a
newborn
child.
Prolonged
use
of
Utraphen
during
pregnancy
can
cause
withdr

Ciri produk

PRODUCT NAME
Utraphen Film Coated Tablets 37.5mg/325mg
DOSAGE FORMS AND STRENGTHS
It occurs as a light yellow capsular shaped, biconvex film-coated
tablet, branded “755” on one side and “STD” on the other side.
Each film coated tablet contains 37.5 mg tramadol hydrochloride and
325 mg paracetamol.
CLINICAL INFORMATION
INDICATIONS
Utraphen 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 Utraphen 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)
Utraphen is not approved for use in patients below 12 years old.
PAEDIATRIC POPULATION
The safety and efficacy of Utraphen has not been studied in the
paediatric population. Therefore, use of Utraphen is not recommended
in patients under 12 years of
age.
TREATMENT WITHDRAWAL
Do not stop use of Utraphen 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 Utraphen is contraindicated in children below 12 years of
age (see
_Contraindications_
).
The safety and effectiveness of Utraphen 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 patients ≥65 years of age and younger patients.
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, it is
recom