SUNPEPCIN 40 TABLET

Country: Малезија

Језик: Енглески

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

Активни састојак:

FAMOTIDINE

Доступно од:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Међународно име):

FAMOTIDINE

Јединице у пакету:

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

Произведен од:

SUNWARD PHARMACEUTICAL SDN. BHD.

Информативни летак

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ 1
SUNPEPCIN TABLET
Famotidine (20mg, 40mg)
WHAT IS IN THIS LEAFLET
1. What Sunpepcin Tablet is used for
2. How Sunpepcin Tablet works
3. Before you use Sunpepcin Tablet
4. How to use Sunpepcin Tablet
5. While you are using it
6. Side effects
7. Storage and Disposal of Sunpepcin Tablet
8. Product Description
9. Manufacturer and Product Registration
Holder
10.Date of revision
WHAT SUNPEPCIN TABLET IS USED FOR

Treatment of active duodenal ulcer.

Treatment of active benign gastric ulcer.

Maintenance therapy of duodenal ulcer

Short-term treatment to relieve gastroesoph-
ageal reflux symptoms caused by the back-
flow of stomach acid into the esophagus
channels.

Treatment
of
Pathological
Hypersecretory
condition where the body produces excess
stomach
acid.
For
example
Zollinger-
Ellison
syndrome
(tumor
cells
in
the
pancreas causes excess production of gas-
tric acid) and Multiple Endocrine adenomas
(tumors of the endocrine glands)
HOW SUNPEPCIN TABLET WORKS
The active ingredient in the medicine is fa-
motidine. Famotidine belongs to a group of
medicines called H2 antagonists or H2 block-
ers. It works by reducing the amount of acid
made by the stomach. This helps to reduce the
pain and also allows the ulcer and/or reflux
disease to heal.
BEFORE YOU USE SUNPEPCIN TABLET
_- When you must not use it _

If
you
have
exhibited
hypersensitivity
to
this product or other similar medicines.
_-Before you start to use it _
You should check with your doctor:-

If you have renal insufficience.

If
you
are
pregnant
or
breastfeeding.
Famotidine should not be used during
pregnancy
unless the potential benefits
outweigh the potential risks to the fetus.
Famotidine
is
detectable
in
human
milk.
Hence, a decision should be made whether
to discontinue nursing or discontinue the
medicine.

The doctor may arrange additional tests to
diagnose
stomach
cancer
before
starting
Sunpepcin
tablet
because
famotidine
can
mask the symptoms and delay the diagnosis.
_- Takin

Карактеристике производа

Sunpepcin 20 Tablet
Sunpepcin 40 Tablet
Each tablet contains:
Famotidine 20mg
Famotidine 40mg
ACTIONS AND MODE OR MECHANISM OF ACTION:
Famotidine is a competitive inhibitor of histamine H
2
-receptors. It inhibits gastric secretion , that is both the
acid concentration and volume of basal and stimulated gastric
secretion suppresses , while changes in
pepsin secretion are proportional to volume output.
Famotidine had little or no effect on fasting or postprandial serum
gastrin levels. Gastric emptying and
exocrine pancreatic function were not affected by famotidine .
PHARMACOKINETICS:
Famotidine is incompletely absorbed. The bioavailability of oral doses
is 40-45% and is not significantly affected
by the presence of food . Famotidine undergoes minimal first-pass
metabolism. After oral doses, peak plasma
levels occur in 1-3 hours. Plasma level after multiple doses are
similar to those after single doses. Fifteen to
20% of famotidine in plasma is protein bound. Famotidine has an
elimination half-life of 2.5-3.5 hours and is
prolonged in renal impairment. Famotidine is eliminated by renal
(65-70%) and metabolic (30-35%) routes .
Twenty five to 30% of an oral dose is recovered in the urine as
unchanged compound. The only metabolite
identified in man is the S-oxide.
INDICATIONS:
a)
Treatment of active duodenal ulcer
b)
Treatment of active benign gastric ulcer
c)
Maintenance therapy for duodenal ulcer
d)
Short term treatment for symptomatic relief of gastroesophageal reflux
disease
e)
Treatment of pathological hypersecretory conditions (eg.
Zollinger-Ellison syndrome, multiple endocrine adenomas).
SIDE EFFECTS / ADVERSE REACTIONS:
Famotidine is generally well-tolerated with side-effects such as
headache, dizziness, constipation and diarrhea
reported rarely.
Other side effects which are reported infrequently includes:
Gastrointestinal
:
Nausea, cholestatic jaundice, liver enzyme abnormalities, vomiting,
abdominal discomfort,
anorexia, dry mouth
Hematologic
:
Leukopenia, agranulocytosis, thrombocytopenia, pancytopenia.
Ca