ULTRADOL F.C. TABLETS 37.5MG325MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Acetaminophen; Tramadol hydrochloride

Available from:

MIRACO NUTRIPHARM PTE. LTD.

ATC code:

N02AJ13

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Acetaminophen 325mg; Tramadol hydrochloride 37.5mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Standard Chem. & Pharm. Co., Ltd.

Authorization status:

ACTIVE

Authorization date:

2022-05-19

Summary of Product characteristics

ULTRADOL F.C. TABLETS 37.5MG/325MG (TRAMADOL HCL + ACETAMINOPHEN)
COMPOSITION
Each ULTRADOL F.C. Tablet contains Tramadol HCl 37.5mg and
Acetaminophen 325mg.
PHARMACEUTICAL FORM
ULTRADOL occurs as a light yellow capsular shaped, biconvex
film‐coated tablet, branded "775"
one side and "STD" on the other side.
CLINICAL INFORMATION
INDICATIONS
ULTRADOL is indicated for the treatment of moderate to severe pain.
DOSAGE AND ADMINISTRATION
The tablets should be taken orally, whole, not divided or chewed, with
sufficient liquid, without
regard to food. ULTRADOL should under no circumstances be administered
for longer than
absolutely necessary. If long-term pain treatment with ULTRADOL is
necessary in view of the nature
and severity of the illness, then careful and regular monitoring
should be carried out (if necessary,
with breaks in treatment) to establish whether and to what extent
further treatment is necessary.
DOSAGE – ADULTS AND CHILDREN 16 YEARS OF AGE AND OVER
The maximum single dose of ULTRADOL 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.
TREATMENT WITHDRAWAL
Do not stop use of ULTRADOL abruptly. Withdrawal symptoms may be
relieved by tapering the
medication (see
_Warnings and Precautions – Treatment Withdrawal_
).
CHILDREN BELOW 16 YEARS OF AGE
The use of ULTRADOL is contraindicated in children below 12 years of
age (see
_Contraindications_
).
The safety and effectiveness of ULTRADOL 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_
). Therefore, treatment is not recommended in this
population.
ELDERLY (75 YEARS OF AGE AND OLDER)
Elimination of the active components may be prolonged in elderly
patients over 75 years of age.
Therefore, if necessary, the dosage interval may be extended according
to the patients requirements.