ESOMEPRAZOLE AMNEAL esomeprazole (as magnesium dihydrate) 20mg enteric capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

esomeprazole magnesium dihydrate, Quantity: 21.69 mg

Available from:

Medis Pharma Pty Ltd

INN (International Name):

esomeprazole magnesium dihydrate

Pharmaceutical form:

Capsule, enteric

Composition:

Excipient Ingredients: methacrylic acid - ethyl acrylate copolymer (1:1); triethyl citrate; titanium dioxide; mannitol; hypromellose; Gelatin; stearoyl macrogolglycerides; maize starch; polysorbate 80; purified talc; iron oxide yellow; sucrose; diacetylated monoglycerides; purified water; dimeticone 350; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

30 or 98 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Gastro-Oesophageal Reflux Disease (GORD),? treatment of erosive reflux oesophagitis,? long-term management of patients with healed oesophagitis to prevent relapse,? symptomatic treatment of gastro-oesophageal reflux disease (GORD),Patients requiring NSAID therapy,? short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy.,? healing of gastric ulcers associated with non-steroidal anti-inflammatory,drug NSAID (non-selective and COX-2 selective) therapy,? prevention of gastric and duodenal ulcers associated with non-steroidal anti inflammatory drug NSAID (non-selective and COX-2 selective) therapy in patients at risk.,Prevention of rebleeding of gastric or duodenal ulcers following treatment with IV Esomeprazole solution by intravenous infusion.,Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion,In combination with appropriate antibiotics for:,? healing of duodenal ulcer associated with Helicobacter pylori,? eradication of Helicobacter pylori in patients with active or healed peptic ulcer

Product summary:

Visual Identification: 20 mg capsule, hard, size 4 capsules, opaque yellow cap and opaque white body printed with a black inscription "20 mg" on the cap and on the body; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2014-03-21

Patient Information leaflet

Version 01
1
ESOMEPRAZOLE ACTAVIS_ _
ESOMEPRAZOLE MAGNESIUM DIHYDRATE_ _
(ES-oh-MEP-ra-zole)
enteric
capsules
_ _
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS
LEAFLET
This leaflet answers some of the
common questions people ask about
ESOMEPRAZOLE ACTAVIS. It does
not contain all the information that is
known about ESOMEPRAZOLE
ACTAVIS.
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 ESOMEPRAZOLE
ACTAVIS 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
ESOMEPRAZOLE
ACTAVIS IS USED FOR
_REFLUX OESOPHAGITIS _
_ _
ESOMEPRAZOLE ACTAVIS is taken
to treat reflux oesophagitis. 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.
ESOMEPRAZOLE ACTAVIS is also
taken to help stop reflux oesophagitis
coming back or relapsing.
_ _
_UPPER GASTROINTESTINAL SYMPTOMS _
_ASSOCIATED WITH NON-STEROIDAL ANTI-_
_INFLAMMATORY DRUGS (NSAIDS) _
_THERAPY _
_ _
ESOMEPRAZOLE ACTAVIS is taken
to treat the symptoms of pain or
discomfort, in the stomach caused by
NSAIDs, a type of medicine for pain or
inflammation.
ESOMEPRAZOLE ACTAVIS is also
taken to help heal and
prevent ulcers caused by NSAIDs.
_PEPTIC ULCERS ASSOCIATED _
_WITH HELICOBACTER PYLORI _
_INFECTION _
_ _
Most people who have a peptic
(gastric and duodenal) ulcer also
have a bacterium called Helicobacter
pylori in their stomach.
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.
If you have a peptic ulcer, your
doctor will prescribe
ESOMEPRAZOLE ACTAVIS with
antibiotics. When ESOMEPRAZOLE
ACT

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION -
ESOMEPRAZOLE AMNEAL (ESOMEPRAZOLE (AS MAGNESIUM DIHYDRATE)) 20MG
AND 40MG ENTERIC CAPSULES
1.
NAME OF THE MEDICINE
Esomeprazole (as magnesium dihydrate)
2.
QUANTITATIVE AND QUALITATIVE COMPOSITION
ESOMEPRAZOLE AMNEAL 20 mg and 40 mg capsules contain enteric coated
granules which
contain esomeprazole (as magnesium dihydrate).
Excipients of known effect: propyl-p-hydroxybenzoate (E216),
methyl-p-hydroxybenzoate (E218)
and sodium benzoate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
ESOMEPRAZOLE AMNEAL 20 mg gastro-resistant hard capsules, are size 4
capsules containing
off-white to greyish spherical microgranules. The capsules have opaque
yellow cap and opaque
white body printed with a black inscription “20 mg” on the cap and
on the body.
ESOMEPRAZOLE AMNEAL 40 mg gastro-resistant hard capsules, are size 3
capsules containing
off-white to greyish spherical microgranules. The capsules have opaque
yellow cap and body
printed with a black inscription “40 mg” on the cap and on the
body.
4.
CLINICAL PARTICULARS
4.1
INDICATIONS
ESOMEPRAZOLE AMNEAL is indicated for:
GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)

treatment of erosive reflux oesophagitis

long-term management of patients with healed oesophagitis to prevent
relapse

symptomatic treatment of gastro-oesophageal reflux disease (GORD)
PATIENTS REQUIRING NSAID THERAPY

short-term treatment of upper gastrointestinal symptoms associated
with non-steroidal anti-
inflammatory drug NSAID (non-selective and COX-2 selective) therapy.

healing of gastric ulcers associated with non-steroidal
anti-inflammatory drug NSAID (non-
selective and COX-2 selective) therapy

prevention of gastric and duodenal ulcers associated with
non-steroidal anti inflammatory drug
NSAID (non-selective and COX-2 selective) therapy in patients at risk.
PREVENTION OF REBLEEDING OF GASTRIC OR DUODENAL ULCERS FOLLOWING
TREATMENT WITH IV
ESOMEPRAZOLE SOLUTION BY INTRAVENOUS INFUSION.
PATHOLOGICAL HYP