PEMZO omeprazole 20 mg capsules bottle

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

omeprazole, Quantity: 20 mg

Предлага се от:

Pharmacor Pty Ltd

INN (Международно Name):

Omeprazole

Лекарствена форма:

Capsule

Композиция:

Excipient Ingredients: purified water; Gelatin; quinoline yellow; titanium dioxide; sodium lauryl sulfate; dibasic sodium phosphate; mannitol; hypromellose; macrogol 6000; purified talc; polysorbate 80; methacrylic acid copolymer; maize starch; sucrose

Начин на приложение:

Oral

Броя в опаковка:

5,7,14,15,28,30,50,56,60,90,100&500

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

The relief of heartburn and other symptoms associated with GORD. The treatment and prevention of relapse in erosive oesophagitis. The treatment of duodenal and gastric ulcer. Combination therapy for the treatment of peptic ulcer disease associated with H. pylori infection. The treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs.The prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. Long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be H. pylori negative, or in whom eradication is inappropriate, e.g. the elderly or ineffective. The treatment of Zollinger-Ellison syndrome.

Каталог на резюме:

Visual Identification: Opaque yellow cap and body No 2 hard gelatin capsules containing off-white (ivory) to cream-white spherical microgranules; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Статус Оторизация:

Licence status A

Дата Оторизация:

2010-04-09

Листовка

October 2019
PEMZO OMEPRAZOLE CAPSULES
OMEPRAZOLE
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Pemzo Omeprazole. It does not
contain all the information that is
known about Pemzo Omeprazole.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor will have weighed the
risks of you taking Pemzo Omeprazole
against the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PEMZO OMEPRAZOLE
IS USED FOR
REFLUX OESOPHAGITIS
Pemzo Omeprazole is used to treat the
symptoms of reflux oesophagitis or
reflux disease. This can be caused by
"washing back" (reflux) of food and
acid from the stomach into the food
pipe (oesophagus).
Reflux can cause a burning sensation
in the chest rising up to the throat, also
known as heartburn.
Pemzo Omeprazole is also taken to
help stop reflux oesophagitis coming
back or relapsing.
PEPTIC ULCERS
Pemzo Omeprazole 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. A
duodenal ulcer occurs in the
duodenum which is the tube leading
out from the stomach.
These ulcers can be caused by too
much acid being made in the stomach.
Pemzo Omeprazole is also used to
help stop gastric or duodenal ulcers
coming back.
PEPTIC ULCERS ASSOCIATED WITH
_HELICOBACTER PYLORI_ INFECTION
Most people who have a peptic ulcer
also have a bacterium called
_Helicobacter pylori_
in their stomach.
When Pemzo Omeprazole is taken
with antibiotics, they work to kill the
bacterium and let your ulcer heal. You
may need further treatment with
antibiotics.
PEPTIC ULCERS ASSOCIATED WITH NON-
STEROIDAL ANTI-INFLAMMATORY DRUGS
(NSAIDS)
Some peptic ulcers are caused by
taking medicines called non-steroidal
anti-inflammatory drugs (NSAIDs), a
type of medicine u

Данни за продукта

1
AUSTRALIAN PRODUCT INFORMATION –
PEMZO OMEPRAZOLE (OMEPRAZOLE) CAPSULE
1
NAME OF THE MEDICINE
Omeprazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains omeprazole 20mg
Excipients with known effect
Gelatin, sucrose
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Opaque yellow cap and body No 2 hard gelatin capsules containing
enteric coated off-white (ivory) to
cream-white spherical microgranules.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
PEMZO OMEPRAZOLE is indicated for:
Gastro-Oesophageal Reflux Disease (GORD) 1.
Symptomatic GORD
The relief of heartburn and other symptoms associated with GORD.
2.
Erosive oesophagitis
The treatment and prevention of relapse.
Peptic Ulcers
1.
The treatment of duodenal and gastric ulcer.
2.
Combination therapy for the treatment of peptic ulcer disease
associated with Helicobacter
pylori infection.
3.
The treatment of gastric and duodenal ulcers and erosions associated
with non-steroidal
antiinflammatory drugs.
4.
The prevention of gastric and duodenal ulcers and erosions associated
with non-steroidal
antiinflammatory drugs in patients assessed as being at high risk of
gastroduodenal ulcer or
complications of gastroduodenal ulcer.
2
5.
Long-term prevention of relapse in gastric and duodenal ulceration, in
patients proven to be
Helicobacter pylori negative, or in whom eradication is inappropriate,
e.g. the elderly or
ineffective.
Zollinger-Ellison Syndrome
The treatment of Zollinger-Ellison Syndrome.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Dosage
PEMZO OMEPRAZOLE should be swallowed whole (not broken or chewed) with
liquid. It should be
noted that PEMZO OMEPRAZOLE is only available in 20 mg.
Symptomatic GORD
Recommended dose for symptom relief:
Omeprazole 10 mg to 20 mg once daily for a maximum of four weeks.
In most patients, symptom relief is rapid. If symptom control has not
been achieved after four weeks
treatment with PEMZO OMEPRAZOLE 20 mg daily, further investigation is
recommended.
Erosive oesophagitis