AUSFAM 20 famotidine 20mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

famotidine, Quantity: 20 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; pregelatinised maize starch; purified talc; magnesium stearate; purified water; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; iron oxide black; macrogol 400

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Duodenal ulcer; Benign gastric ulcer; Zollinger-Ellison syndrome; Prevention of relapses of duodenal ulceration; Short-term (no more than 12 weeks) symptomatic relief of gastroesophageal reflux not responsive to conservative measures; Healing of oesophageal erosion or ulceration associated with gastroesophageal reflux disease; Prevention of relapses of symptoms and erosions or ulcerations associated with gastroesophageal reflux disease.

Product summary:

Visual Identification: Tan, square tablet debossed with "FO" over "20" on one side and plain on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2003-04-08

Patient Information leaflet

AUSFAM- Consumer Medicine Information
Page 1 of 4
AUSFAM
famotidine
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AUSFAM. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking AUSFAM against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO
YOUR DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT AUSFAM IS USED
FOR
AUSFAM is used to:
•
treat peptic ulcers (gastric and
duodenal ulcers)
•
treat reflux oesophagitis (reflux
disease)
•
treat a rare condition called
Zollinger-Ellison syndrome
•
prevent duodenal ulcers and
reflux disease from coming back.
PEPTIC ULCERS:
AUSFAM is used to heal peptic
ulcers. Depending on the position
of the ulcer it is called a gastric or
duodenal ulcer. A gastric ulcer
occurs in the stomach. A duodenal
ulcer occurs in the duodenum,
which is the tube leading out of the
stomach. These ulcers usually
cause pain and discomfort
(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.
AUSFAM is also used to help stop
duodenal ulcers from coming back.
REFLUX DISEASE:
AUSFAM is used to treat reflux
oesophagitis, also called reflux
disease, and stop it from coming
back. This condition is caused by
the washing back, or reflux, of food
and acid from the stomach into the
food pipe, also called the
oesophagus. This causes a painful
burning sensation in the chest rising
up to the throat (heartburn), and
usually occurs after eating or at
night.
ZOLLINGER-ELLISON SYNDROME:
AUSFAM is used to treat a rare
condition called Zollinger-Ellison
syndrome, where the stomach
produces very large amounts of
acid, much more than in ulcers and
reflux disease.
AUSFAM belongs to a group of
medicines called histamine H

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – AUSFAM (FAMOTIDINE)
TABLETS
1
NAME OF THE MEDICINE
Famotidine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ausfam tablets come in two strengths and contain either 20 mg or 40 mg
of famotidine.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Ausfam 20,
20 mg tablet: tan, square, marked “FO over 20” on one side and
plain on the other
side.
Ausfam 40,
40 mg tablet: brown, square, marked “FO over 40” on one side and
plain on the
other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
Duodenal ulcer
•
Benign gastric ulcer
•
Zollinger-Ellison syndrome
•
Prevention of relapses of duodenal ulceration.
•
Short-term (no more than 12 weeks) symptomatic relief of
gastroesophageal reflux not
responsive to conservative measures.
•
Healing of oesophageal erosion or ulceration associated with
gastroesophageal reflux
disease.
•
Prevention of relapses of symptoms and erosions or ulcerations
associated with
gastroesophageal reflux disease
4.2
D
OSE 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 of
duodenal ulcer, healing occurs within
2
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.
_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 12
months.
BENIGN GASTRIC ULCER
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
reveal