APO-FAMOTIDINE famotidine 20mg tablet blister pack

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

famotidine

Հասանելի է:

Apotex Pty Ltd

Լիազորման կարգավիճակը:

Registered

Տեղեկատվական թերթիկ

GENRX FAMOTIDINE
_Contains the active ingredient famotidine_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about famotidine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is GenRx
Famotidine Tablets. It contains the
active ingredient famotidine.
Famotidine belongs to a group of
medicines called H2-antagonists. It is
used to:
It is used to:
•
Treat peptic ulcers.
Depending on the position of the
ulcer it is called a gastric or
duodenal ulcer. A gastric ulcer
occurs in the stomach and a
duodenal ulcer occurs in the
duodenum, which is the tube
leading from the stomach. These
ulcers usually cause pain and
indigestion which is felt between
the navel and the breast bone. The
pain may occur before or after
meals, or in the middle of the
night. Famotidine also helps to
stop duodenal ulcers coming
back.
•
Treat Zollinger Ellison
Syndrome, a rare condition
caused by too much acid
production in the stomach.
•
Treat and relieve symptoms of
Gastro-Oesophageal Reflux
Disease.
This is caused by the reflux, or
washing back, o

Ապրանքի հատկությունները

1
AUSTRALIAN PRODUCT INFORMATION
APO- FAMOTIDINE (FAMOTIDINE) TABLETS
1
NAME OF THE MEDICINE
Famotidine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20mg or 40mg famotidine, as the active
ingredient.
The tablets contain no excipients with a known effect.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO- FAMOTIDINE 20 MG TABLETS
A beige, film coated, round, biconvex tablet engraved “20” on one
side and plain on the
other.
APO- FAMOTIDINE 40 MG TABLETS
A brown, film coated, round, biconvex tablet engraved “40” on one
side and plain on the
other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
The treatment of duodenal ulcer; benign gastric ulcer;
Zollinger-Ellison syndrome;
prevention of relapses of duodenal ulceration.
•
Short-term (no more than 12 weeks) symptomatic relief of
gastro-oesophageal reflux
not responsive to conservative measures.
•
Healing of oesophageal erosion or ulceration associated with
gastro-oesophageal
reflux disease.
•
Prevention of relapses of symptoms and erosions or ulcerations
associated with
gastro-oesophageal reflux disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
DUODENAL ULCER
Initial Therapy
The recommended dose of famotidine is one 40 mg tablet daily, taken at
night. Treatment
should be given for four to eight weeks, but the duration of treatment
may be shortened if
endoscopy reveals that the ulcer has healed. In most cases, duodenal
ulcer healing occurs
within four weeks on this regimen. In those patients whose ulcers have
not healed completely
after four weeks, treatment should be continued for a further four
week period.
2
Maintenance Therapy
For the prevention of recurrence of duodenal ulceration, it is
recommended that therapy with
famotidine be continued with a dose of one 20 mg tablet daily, taken
at night. In ongoing
clinical studies this regimen has been continued for twelve months.
BENIGN GASTRIC ULCER
The recommended dose of famotidine is one 40 mg tablet daily, taken at
night. Treatment
sh