OMEPRAZOLE SANDOZ omeprazole (as magnesium) 20 mg enteric-coated tablet blister pack

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

omeprazole magnesium, Quantity: 20.6 mg

Доступно од:

Sandoz Pty Ltd

INN (Међународно име):

Omeprazole magnesium

Фармацеутски облик:

Tablet, enteric coated

Састав:

Excipient Ingredients: colloidal anhydrous silica; magnesium stearate; propylene glycol; simethicone; stearic acid; macrogol 6000; crospovidone; titanium dioxide; methacrylic acid - ethyl acrylate copolymer (1:1); glyceryl monostearate; microcrystalline cellulose; copovidone; polysorbate 80; hypromellose; purified talc; povidone; iron oxide red; maize starch; sucrose; hydrolysed maize starch

Пут администрације:

Oral

Јединице у пакету:

30

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

Gastro-oesophageal reflux disease (GORD). ,Symptomatic GORD. ,The relief of heartburn and other symptoms associated with GORD.,Erosive oesophagitis. ,The treatment and prevention of relapse.,Peptic ulcers. ,The treatment of duodenal and gastric ulcer.,Combination therapy for the treatment of peptic ulcer disease associated with Helicobacter 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 Helicobacter pylori negative, or in whom eradication is inappropriate, e.g. the elderly, or ineffective.,Zollinger-Ellison syndrome. ,The treatment of Zollinger-Ellison syndrome.

Резиме производа:

Visual Identification: Pink, oval, biconvex film-coated tablet with a breaking notch on both sides.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Статус ауторизације:

Registered

Датум одобрења:

2012-03-08

Информативни летак

OMEPRAZOLE SANDOZ
®
1
OMEPRAZOLE SANDOZ
®
_omeprazole (as magnesium) enteric-coated tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Omeprazole Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risk of you taking this medicine
against the benefits it is expected to
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 OMEPRAZOLE
SANDOZ IS USED
FOR
REFLUX OESOPHAGITIS
This medicine 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.
Omeprazole Sandoz is also taken to
help stop reflux oesophagitis coming
back or relapsing.
PEPTIC ULCERS
Omeprazole Sandoz 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 of the stomach. This can
be caused by too much acid being
made in the stomach.
This medicine is also used to help
stop gastric and duodenal ulcers from
coming back.
PEPTIC ULCERS ASSOCIATED WITH
HELICOBACTER PYLORI INFECTION
Most people who have peptic ulcer
also have a bacterium called
Helicobacter pylori in their stomach.
When Omeprazole Sandoz 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 these NSAIDs, a type of
medicine used to treat pain or
inflammation. Omeprazole Sandoz is
used to heal an

Карактеристике производа

_Product Information _
_ _
_Page 1 _
_Omeprazole Sandoz 10 mg and 20 mg enteric-coated tablets _
_07/2021 _
_Version 18 _
AUSTRALIAN PRODUCT INFORMATION
OMEPRAZOLE SANDOZ
® (OMEPRAZOLE) ENTERIC-COATED TABLETS
1.
NAME OF THE MEDICINE
Omeprazole magnesium
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Omeprazole Sandoz enteric-coated tablets contains 10.3 mg and
20.6 mg omeprazole
magnesium equivalent to 10 mg and 20 mg omeprazole, respectively.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Omeprazole Sandoz 10 mg enteric-coated tablets - light pink, oval,
biconvex film-coated
tablets.
Omeprazole Sandoz 20 mg enteric-coated tablets - pink, oval, biconvex
film-coated tablets with
a breaking notch on both sides.
4.
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Omeprazole Sandoz enteric-coated tablets are indicated for:
GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
_Symptomatic GORD _
The relief of heartburn and other symptoms associated with GORD.
_Erosive oesophagitis _
The treatment and prevention of relapse.
PEPTIC ULCERS
The treatment of duodenal and gastric ulcer.
Combination therapy for the treatment of peptic ulcer disease
associated with
_Helicobacter _
_pylori_
infection.
The treatment of gastric and duodenal ulcers and erosions associated
with non-steroidal anti-
inflammatory drugs (NSAIDs).
The prevention of gastric and duodenal ulcers and erosions associated
with NSAIDs 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.
_ _
_Product Information _
_ _
_Page 2 _
_Omeprazole Sandoz 10 mg and 20 mg enteric-coated tablets _
_07/2021 _
_Version 18 _
ZOLLINGER-ELLISON SYNDROME
The treatment of Zollinger-Ellison syndrome.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS _
_SYMPTOMATIC GORD _
Recommended dose for sy