HORGESIC TABLET 35MG450MG

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

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Prenos Lastnosti izdelka (SPC)
07-01-2022

Aktivna sestavina:

Orphenadrine Citrate; Paracetamol

Dostopno od:

GOLDPLUS UNIVERSAL PTE LTD

Koda artikla:

M03BC51

Farmacevtska oblika:

TABLET

Sestava:

Orphenadrine Citrate 35 mg; Paracetamol 450 mg

Pot uporabe:

ORAL

Tip zastaranja:

Prescription Only

Izdeluje:

Hovid Berhad

Status dovoljenje:

ACTIVE

Datum dovoljenje:

2022-01-07

Lastnosti izdelka

                                VIHORxx-0 (SIN)
HORGESIC TABLET 35MG/450MG
077
COMPOSITION
Each tablet contains orphenadrine citrate 35mg, paracetamol
450mg
DESCRIPTION
Round,
white
uncoated
tablet,
bevel-edged,
flat
faces,
"HD"
embossed and scored on the same face. The score line serves to
facilitate breaking for ease of swallowing and does not divide the
tablet into equal half-doses.
_EXCIPIENTS:_
Colloidal
Silicon
Dioxide,
Partially
Pregelatinised
Starch, Microcrystalline Cellulose M200D+, Crospovidone, Stearic
Acid
ACTIONS
Orphenadrine is a skeletal muscle relaxant. Paracetamol is an
analgesic and antipyretic.
INDICATIONS
Tension headache, occipital headaches associated with spasm of
skeletal muscles in the region of the head and neck. Acute and
traumatic conditions of the limbs and trunk: sprains, strains,
whiplash injuries, acute torticollis, prolapsed intervertebral disc.
CONTRAINDICATIONS
Orphenadrine shows some anticholinergic activity and should not
be
used
in
patients
with
glaucoma,
prostatic
hypertrophy
or
obstruction at the bladder neck, or myasthenia gravis.
PRECAUTIONS
•
Orphenadrine may impair the ability of the patient to engage in
potentially hazardous activities such as operating machinery or
driving a motor vehicle; ambulatory patients should therefore
be cautioned accordingly.
•
Orphenadrine citrate should be used with caution in patients
with
tachycardia,
cardiac
decompensation,
coronary
insufficiency, cardiac arrhythmias.
•
Safety of continuous long-term therapy with orphenadrine has
not been established. Therefore, if orphenadrine is prescribed
for prolonged use, periodic monitoring of blood, urine and liver
function is recommended.
SERIOUS SKIN REACTIONS
Rarely, PARACETAMOL may cause serious skin reactions such as
acute
generalised
exanthematous
pustulosis
(AGEP),
Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis
(TEN), which can be fatal.
PATIENTS SHOULD BE INFORMED ABOUT THE SIGNS OF SERIOUS SKIN
REACTIONS, AND USE OF THE DRUG SHOULD BE DISCONTINUED AT THE
FIRST
APPEARANCE
OF
SKIN
RASH
OR
ANY
OTHER

                                
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