DYCOSIC TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Paracetamol; ORPHENADRINE CITRATE

Boleh didapati daripada:

DYNAPHARM (M) SDN BHD

INN (Nama Antarabangsa):

Paracetamol; ORPHENADRINE CITRATE

Unit dalam pakej:

50x10'stablet Tablets

Dikeluarkan oleh:

DYNAPHARM (M) SDN BHD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DYCOSIC TABLET
Orphenadrine citrate (35 mg) and Paracetamol (450 mg)
What is in this leaflet
1.
What _DYCOSIC_ is used for
2.
How _DYCOSIC_ works
3.
Before you use _DYCOSIC_
4.
How to use _DYCOSIC_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of _DYCOSIC_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
1.
WHAT DYCOSIC IS USED FOR
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.
2.
HOW DYCOSIC WORKS
Orphenadrine is a skeletal muscle relaxant.
Paracetamol is an analgesic and antipyretic.
Orphenadrine, which is a congener of
diphenhydramine without sharing its
soporific effect, is an antimuscarinic agent.
It also has weak antihistaminic and local
anaesthetic properties.
Paracetamol is a centrally acting
analgesic and antipyretic with minimal
anti-inflammatory properties.
3.
BEFORE YOU USE DYCOSIC
-
_When you must not use it_
_ _
Glaucoma, prostatic hypertrophy or
obstruction at the bladder neck,
myasthenia gravis, oesophageal spasm and
pyloric or duodenal obstruction.
Hypersensitivity to paracetamol or
orphenadrine citrate.
_Pregnancy and lactation _
Use in pregnancy
DYCOSIC is not recommended for use
during pregnancy.
Use in lactation
DYCOSIC should not be taken during
lactation as orphenadrine and paracetamol
are excreted into breast milk.
-
_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.
Interactions have been reported between
orphenadrine and phenothiazines and
other drugs with anti-muscarinic
properties.
Concomitant use with alcohol or other
CNS depressants should be avoided.
Anticoagulant dosage may require
reduction if paracetamol medication is
prolonged.
Par

Ciri produk

MAL18056180AZ
CONTENT
Orphenadrine citrate 35 mg
Paracetamol 450 mg.
PHARMACODYNAMICS
Orphenadrine, which is a congener of diphenhydramine without sharing
its soporific effect, is a tertiary amine antimuscarinic with actions
and uses similar to those of
trihexyphenidyl. It also has weak antihistaminic and local anaesthetic
properties.
Paracetamol is a centrally acting analgesic and antipyretic with
minimal anti-inflammatory properties.
PHARMACOKINETICS
Orphenadrine is readily absorbed from the gastro-intestinal tract, and
very readily absorbed following intramuscular injection. It is rapidly
distributed in tissues and most of a
dose is metabolised and excreted in the urine along with a small
proportion of unchanged drug. A half-life of 14 hours has been
reported.
Paracetamol is rapidly absorbed following oral administration.
Paracetamol absorption takes place mainly in the small intestine and
therefore the rate of absorption depends on the rate of gastric
emptying.
The presence of food in the stomach has also been reported to reduce
the rate of absorption of paracetamol. Alterations in gastric pH have
no appreciable effect on
paracetamol absorption.
Peak plasma concentrations are reached 1 hour after absorption. The
plasma half-life is 1 to 3 hours.
Paracetamol penetrates the brain and is present in breast milk of
human.
Paracetamol is metabolized by the microsomal enzyme system of the
liver. This metabolism is mainly to the glucuronide and sulphate
conjugates, accounting for
approximately 49% and 26% of the ingested dose respectively. About 4%
is excreted as free paracetamol. Other minor pathways include the
production of catechol
derivatives and cysteine conjugates (via glutathione). Paracetamol
excretion is rapid and occurs via the urine.
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.
DOSAGE