DHACOPAN SYRUP 5MG5ML

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

HYOSCINE BUTYLBROMIDE

Boleh didapati daripada:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

HYOSCINE BUTYLBROMIDE

Unit dalam pakej:

100 ml

Dikeluarkan oleh:

PT Actavis Indonesia

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DHACOPAN TABLET/SYRUP
Hyoscine butylbromide (10mg, 5mg/5ml)
__________________________________________________________________________________________
__________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What Dhacopan is used for
2.
How Dhacopan work
3.
Before you use Dhacopan
4.
How to take Dhacopan
5.
While
you
are
using
Dhacopan
6.
Side Effects
7.
Storage
and
Disposal
of
Dhacopan
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT
DHACOPAN IS USED FOR
Dhacopan
is
used
to
relieve
cramps in the smooth muscles
of your:
• Stomach
• Gut (intestine)
• Bladder and gallbladder
• abdomen during menstruation
HOW
DHACOPAN WORK
Dhacopan
contain
a
medicine
called “hyoscine butylbromide”.
This
belongs
to
a
group
of
medicines
called
antispasmodics.
BEFORE YOU USE DHACOPAN
_-When you must not take it _
Do not take Dhacopan if:
•
You
are
allergic
(hypersensitive)
to
hyoscine
butylbromide or any of the other
ingredients
•
You
have
glaucoma
(an
increase in pressure inside eye)
• You have stomach or small
intestine ulcer
•
You
have
enlarged
prostate
glands
•
You
have
paralytic
ileus
(paralysis of the intestine)
• You have urinary retention
•
You
have
pyloric
stenosis
(narrowing of the opening from
the
stomach
to
the
small
intestine)
• You are pregnant, likely to get
pregnant, or are breast-feeding
unless
the
potential
advantage
justifies the possible risk to the
foetus.
• you are consuming alcohol
_-Before you start to take it _
You
should
check
with
your
doctor
or
pharmacist
before
taking Dhacopan if:
• You have a very fast heart rate
or other heart problems
Dhacopan
may
cause
drowsiness, if affected do not
drive or operate machinery.
If you are not sure if any of the
above apply to you, talk to your
doctor
or
pharmacist
before
taking Dhacopan.
_-Taking other medicines_
Please
tell
your
doctor
or
pharmacist if you are taking or
have
rece

Ciri produk

DHACOPAN
PRODUCT DESCRIPTION:
Tablet :
Orange film-coated tablets, round and deep convex, 8mm
diameter without score-line and logo.
Syrup :
Clear yellow syrup, sweet taste with banana flavour.
COMPOSITION:
1) Each tablet contains
: Hyoscine Butylbromide BP 10mg
2) Each 5ml contains
: Hyoscine Butylbromide BP 5mg/5ml
Excipients:
_Dhacopan Tablet 10mg :_ Corn Starch, Lactose mesh 200, Polyvidone
30, Magnesium stearate, Titanium Dioxide, Methocel E15, Sunset
Yellow No.6 Alum lake, Propylene Glycol.
_Dhacopan Syrup 5mg/5ml :_ Granulated Fine White Sugar, Sodium
Saccharin, Propyl Hydroxybenzoate, Methyl Hydroxybenzoate,
Propylene Glycol, Sodium Citrate Dihydrate, Citric Acid
Monohydrate, FDC Yellow No. 6 Water Soluble (40-44%), Quinoline
Yellow E104 Water Soluble 70-72%, Banana Flavour PCA 5639,
Alcohol 96%, Purified Water.
PHARMACOLOGY:
Dhacopan contains Hyoscine Butylbromide which is a quaternary
ammonium anticholinergic agent with both central and peripheral
actions. The peripheral effects include decreased production of
saliva, sweat, bronchial, lachrymal, nasal, gastric and intestinal
secretions, decreased intestinal motility and inhibition of
micturition.
INDICATION:
For relief of gastrointestinal and colonic spasm, acute spasm in renal
or biliary colic; dysmenorrhoea.
RECOMMENDED DOSAGE:
Tablets :
Adults and Children more than 12 years: 1 to 2 tablets, 3 or 4 times
a day.
Syrup :
Children: 6 to 12 years: 2 teaspoonful 3 times a day.
SIDE EFFECTS:
Dry mouth with difficulty in swallowing and thirst, increased
intraocular pressure, flushing, dry skin, difficulty in micturition,
constipation, palpitations and arrhythmias.
CONTRAINDICATIONS:
Contraindicated in patients with glaucoma; with gastric or duodenal
ulcer, with urinary retention; prostatic enlargement; paralytic ileus;
pyloric stenosis.
CAUTION:
Tachycardia and cardiac insufficiency. May cause drowsiness, if
affected do not drive or operate machinery. Avoid alcohol.
USE IN PREGNANCY AND LACTATION:
There are no adequate studies in pregnant and lactating wome