DENZOL 200mg Film Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
29-03-2023
Ciri produk Ciri produk (SPC)
20-09-2021

Bahan aktif:

Albendazole

Boleh didapati daripada:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

Albendazole

Unit dalam pakej:

100 Tablets; 2Tablet Tablets

Dikeluarkan oleh:

Egyptian International Pharmaceutical Industries Co. (EIPICO.)

Risalah maklumat

                                DENZOL SUSPENSION/TABLET
Albendazole (20 mg/ml, 200 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Denzol is used for
2.
How Denzol works
3.
Before you use Denzol
_ _
4.
How to use Denzol
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Denzol
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DENZOL IS USED FOR
Denzol is used to treat worm infection
such
as
Threadworm/
Pinworm,
Roundworm,
Whipworm,
Hookworm,
Tapeworm and others.
HOW DENZOL WORKS
It works by killing the worms, eggs or
larval stage of the worms
BEFORE YOU USE DENZOL
-
_When you must not use it _
Do not take Denzol if:
•
You are allergic to Albendazole or any
of the ingredients in this medicine
•
You are pregnant or suspected to be
pregnant
Ask your doctor or pharmacist for advice
before taking any medicine.
_ _
-
_Before you start use it _
It may cause fetal harm; therefore, women
of childbearing age should only begin the
treatment after a negative pregnancy test.
-
_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.
Tell your doctors if you are taking these
medicines:
•
Dexamethasone (a type of steroid)
•
Praziquantel (anti-worm medication)
•
Cimetidine (medicine to treat stomach
ulcer and heartburn)
HOW TO USE DENZOL_ _
-
_How much to use _
Follow all directions given to you by
your doctor and pharmacist carefully.
They may differ from the information
contained in this leaflet. If you do not
understand the instructions on the label,
ask your doctor or pharmacist for help.
Denzol is for oral administration and
should be taken with meals.
_Enterobiasis, ascariasis, ancylostomiasis _
or
_ trichuriasis: _
ADULTS & CHILDREN ABOVE 2 YEARS OF
AGE:
400 mg as a single dose.
CHILDREN UP TO 2 YEARS OF AGE:
200
mg as a single dose.
The dose may be repeated in 3 weeks.
_Taeniasis, strongyloidiasis_
:
400 mg /day for
                                
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Ciri produk

                                DENZOL 200MG FILM COATED TABLET
DENZOL 20MG/ML SUSPENSION
ALBENDAZOLE
PRODUCT DESCRIPTION
DENZOL FILM COATED TABLET:
White, round, biconvex smooth film coated tablets, engraved E1A3 from
one side.
DENZOL SUSPENSION:
Homogenous syrupy suspension, white to off white colour with a banana
like
odour. Each 1ml contains Albendazole 20 mg.
COMPOSITION
DENZOL FILM COATED TABLET:
Each tablet contains Albendazole 200 mg.
DENZOL SUSPENSION
: Each 1ml contains Albendazole 20 mg.
PHARMACODYNAMICS
Albendazole is a broad spectrum antithelmintic with activity against
most nematodes and some cestodes.
Albendazole acts by destruction of cytoplasmic microtubules in the
worm’s intestinal or absorptive cells
and inhibition of glucose uptake and other nutrients in susceptible
helminthes, resulting in death of the
worm.
PHARMACOKINETICS
Albendazole is poorly absorbed from GI tract, and is rapidly
metabolized in the liver to
the active
albendazole
sulphoxide,
which
is
approximately 70%
bound
to
the
plasma
protein. Peak plasma
concentrations occur in 2-5 hours after dosing. It has a plasma
half–life of about 8.5 hours and is primarily
eliminated in the bile.
INDICATION
Albendazole
is
use
in
patient
with
Enterobiasis
_, _
Ascariasis
_, _
Ancylostamiasis
_, _
trichuriasis,
Strongyloidiasis,
Taeniasis,
Capillariasis,
_ _
Neurocysticerosis,
Trichostrongyliasis,
Hydatid
Disease
(
_Echinococcus granulosus_
), and Filariasis, in combination with other
Anthelmintics.
RECOMMENDED DOSAGE
DENZOL is for oral administration and should be taken with meals.
_Enterobiasis, ascariasis, ancylostomiasis, or trichuriasis: _
_ _
Adults & children above 2 years of age: 400 mg as a single.
Children up to 2 years of age: 200 mg as a single dose.
The dose may be repeated in 3 weeks.
_Taeniasis, strongyloidiasis_
: 400 mg /day for 3 days.
_Capillariasis_
: 400 /day for 10 days.
_Neurocysticerosis: _
15 mg /kg/day for 30 days.
_Trichostrongyliasis_
: 400 mg single dose
_Hydatid disease_
:
Patients over 60 kg body weight: 400 mg twice daily for 28 days
followed
                                
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