Prevacid FDT 15mg Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LANSOPRAZOLE

Boleh didapati daripada:

Takeda Malaysia Sdn Bhd

INN (Nama Antarabangsa):

LANSOPRAZOLE

Unit dalam pakej:

28Tablet Tablets

Dikeluarkan oleh:

Kokando Co., Ltd.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PREVACID FDT TABLETS
_ _
Lansoprazole (15mg, 30mg)
__________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What Prevacid is used for
2.
How Prevacid works
3.
Before you use Prevacid
4.
How to use Prevacid
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Prevacid
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT PREVACID IS USED FOR
Prevacid is used in children 12
to 17 years old:
-
Short-term treatment
of symptomatic gastro-
esophageal reflux
disease (GERD) and
erosive esophagitis
(disease with
symptoms caused by
return flow of gastric
acid)
In adults:
-
Treatment of gastric,
intestinal,
gastrointestinal ulcers
and reflux esophagitis
(inflammation of the
esophagus caused by
the return flow of fluid
from stomach)
-
Relief of heartburn and / or
upper epigastric pain
associated with acid-related
indigestion
-
Treatment and prevention
of Non-Steroidal Anti-
inflammatory Drugs
(NSAIDs) - associated
gastric and intestinal ulcer
and relief of symptoms
-
Hormone producing tumor
in the pancreas causing
excess acid in the stomach
(Zollinger-Ellison-
Syndrome) and other
pathological hypersecretory
conditions
-
Eradication of H. pylori in
people with gastric and
intestinal ulcer in
combination with two
appropriate antibiotics
HOW PREVACID WORKS
Prevacid belongs to a group
known as Proton Pump
Inhibitors (PPIs). Prevacid
reduces the amount of acid in
your stomach.
Prevacid may help your acid-
related symptoms, but you
could still
have serious
stomach problems. Talk with
your doctor.
BEFORE YOU USE PREVACID
-
_When you must not use it _
You should not take Prevacid if
you are allergic to lansoprazole
or any of the other ingredients
of this medicine.
-
_Before you start to use it _
Before you take Prevacid, tells
your doctor if you
:
•
have liver problems
•
have kidney problems
•
Are pregnant or plan to
become pregnant. It
should be used by
pre

Ciri produk

PREVACID
®
FDT
(Lansoprazole Fast Disintegrating Tablets)
_PREVACID® FDT _is a preparation of lansoprazole, a proton pump
inhibitor.
_PREVACID® FDT _displays strong and sustained inhibition of gastric
acid secretion by suppressing the activity of (H
+
-
K
+
)-ATPase which exists locally in the parietal cells of gastric mucosa
and plays an important role as a proton pump.
Clinically, _PREVACID® FDT _attains a rapid and high healing ratio
against gastric ulcer and duodenal ulcer, and the
usefulness of the drug has been proven. It has also been proven to be
a useful drug for treatment of stomal ulcer,
reflux esophagitis and Zollinger-Ellison syndrome.
COMPOSITION
_PREVACID® FDT _ are white to yellowish white uncoated tablets with
orange to dark brown speckles for oral
administration containing the active ingredient, lansoprazole in the
form of enteric-coated microgranules and are
available in two dosages strengths. _PREVACID® FDT _15mg Tablets
contains lansoprazole 15mg and _PREVACID® FDT _
30mg Tablets contains lansoprazole 30mg.
INDICATIONS
•
Gastric ulcer, duodenal ulcer, stomal ulcer and reflux esophagitis.
•
Relief of reflux-like symptoms (e.g. heartburn) and / or ulcer-like
symptoms (e.g. upper epigastric pain)
associated with acid-related dyspepsia.
•
Treatment and prophylaxis of NSAID-associated benign gastric ulcer,
duodenal ulcers and relief of symptoms
in patients requiring continued NSAID treatment.
•
Eradication of _H. pylori _from the upper gastrointestinal tract in
patients with peptic ulcer (duodenal or benign
gastric ulcer) when used in combination with appropriate antibiotics.
•
Zollinger-Ellison syndrome (and other Pathological hypersecretory
conditions)
•
Short-term treatment of symptomatic GERD and erosive esophagitis for
children (12-17 years of age)
DOSAGE AND ADMINISTRATION
Usually for adults, administer one tablet (30mg of lansoprazole)
orally once a day.
In duodenal ulcer, 30mg once daily for 4 weeks. In gastric ulcer and
stomal ulcer, 30mg once daily for 8 weeks. In
refl