SUNITON TABLET

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
20-04-2023
Ciri produk Ciri produk (SPC)
10-01-2023

Bahan aktif:

Paracetamol; ORPHENADRINE CITRATE

Boleh didapati daripada:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

Paracetamol; ORPHENADRINE CITRATE

Unit dalam pakej:

1000 Tablet Tablets; 100 Tablet Tablets; 1000 Tablet Tablets; 500 Tablet Tablets

Dikeluarkan oleh:

SUNWARD PHARMACEUTICAL SDN. BHD.

Risalah maklumat

                                SUNITON TABLET
Orphenadrine Citrate / Paracetamol
(35mg / 450mg)
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET
1. What Suniton Tablet is used for
2. How Suniton Tablet works
3. Before you use Suniton Tablet
4. How to use Suniton Tablet
5. While you are using it
6. Side effects
7. Storage and disposal of Suniton Tablet
8. Product description
9. Manufacturer and Product Registration
Holder
10. Date of revision
WHAT SUNITON TABLET IS USED FOR
Suniton Tablet is used for the relief of painful
muscle ache and headache.
HOW SUNITON TABLET WORKS
Orphenadrine is a skeletal muscle relaxant
that acts in the nervous system to produce
muscle
relaxant
effects.
Paracetamol
is
an
analgesic (pain killer) and antipyretic (relieve
fever).
BEFORE YOU USE SUNITON TABLET
_- When you must not use it _
Do not take Suniton Tablet if you:

are
hypersensitive
to
chlorpheniramine
citrate,
paracetamol
or
any
of
the
other
ingredients
of
this
medicine
(listed
in
Product Description).
_ _

have glaucoma (increase pressure in eyes).

have gastric outflow obstruction.

have ulcer in stomach.

have
enlargement
of
prostate
or
bladder
neck obstruction.

have severe muscle weakness.

have liver problem or kidney problem.
_- Before you start to use it _
Tell your doctor before taking this medicine
if you have:

rapid heart rate or other heart disease.

impaired liver or kidney function.
This preparation contains Paracetamol.
Do not take any other paracetamol containing
medicines at the same time.
_Pregnancy and breastfeeding _
You should check with your doctor if you are
or think you may be pregnant, planning to
become pregnant or if you are breastfeeding.
_ _
_Laboratory _
Tell your doctor that you are taking Suniton
Tablet before doing any medical tests.
_- Taking other medicines _
Tell your doctor if you are taking any other
medicines, including any that you buy without
a prescription from a pharmacy, supermarket
or health food shop. You should talk to your
doctor or pharmacist if you are ta
                                
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                                INTERACTIONS WITH OTHER MEDICAMENTS:
Orphenadrine has been shown to induce enzymatic systems involving the
metabolism of aminopyrine,
steroidal contraceptives, griseofulvin, hexobarbital and
phenylbutazone. Orphenadrine will potentiate
other anticholinergic agents.
Paracetamol should also be given with care to patients taking other
drugs that affect the liver.
Paracetamol hepatotoxicity has been reported to be enhanced by
phenobarbitone, alcohol and doxorubicin.
PREGNANCY AND LACTATION:
Orphenadrine has been taken by only a limited number of pregnant women
and women of childbearing
age, without an increase in the frequency of malformations or other
direct or indirect harmful effects on
the human fetus having been observed.
Since safety of the use of this preparation in pregnancy and during
lactation has not been established,
use of the drug in such patients requires that the potential benefits
of the drug be weighed against its
possible hazard to the mother and child.
SIDE EFFECTS:
Adverse effects are mainly due to the mild anticholinergic action of
orphenadrine, and are usually
associated with higher dosage. Dryness of the mouth is usually the
first adverse effect to appear. When
the daily dose is increased, possible adverse effects include:
tachycardia, palpitation, urinary hesitancy
or retention, blurred vision, dilatation of pupils, increased ocular
tension, weakness, nausea, vomiting,
headache,
dizziness,
constipation,
drowsiness,
hypersensitivity
reactions,
pruritus,
hallucinations,
agitation, tremor, gastric irritation, and rarely urticaria and other
dermatoses.
Side-effects of paracetamol are usually mild, though haematological
reactions such as agranulocytosis,
thrombocytopenia and pancytopenia have been reported. Cutaneous
hypersensitivity reactions including
skin rashes, angioedema, Stevens Johnson Syndrome/ Toxic Epidermal
Necrolysis have been reported.
Other allergic reactions occur occasionally.
SYMPTOMS AND TREATMENT OF OVERDOSE:
Symptoms of orphenadrine overdosage are excitement, confusion and
d
                                
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