NOXICID CAPS esomeprazole 40mg (as magnesium) enteric capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

esomeprazole, Quantity: 40 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

Esomeprazole

Pharmaceutical form:

Capsule, enteric

Composition:

Excipient Ingredients: crospovidone; glyceryl monostearate; triethyl citrate; methacrylic acid - ethyl acrylate copolymer (1:1); polysorbate 80; purified talc; hyprolose; mannitol; sodium hydroxide; sucrose; titanium dioxide; purified water; iron oxide yellow; iron oxide red; Gelatin; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; maize starch

Administration route:

Oral

Units in package:

30, 100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

NOXICID is indicated for: 1. 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) 2. 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. 3. Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion 4. 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: White to cream coloured pellets filled in hard gelatin capsule with brown cap and brown body, imprinted with 'MYLAN' over 'EM 40' in black ink on cap and body; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-10-16

Patient Information leaflet

NOXICID CAPS
_Esomeprazole (as magnesium)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about Noxicid. 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 risks of you taking Noxicid
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 NOXICID IS USED
FOR
_REFLUX OESOPHAGITIS_
Noxicid 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.
Noxicid is also taken to help stop
reflux oesophagitis coming back or
relapsing.
_UPPER GASTROINTESTINAL_
_SYMPTOMS ASSOCIATED WITH_
_NON-STEROIDAL ANTI-_
_INFLAMMATORY DRUGS_
_(NSAIDS) THERAPY_
Noxicid is taken to treat the
symptoms of pain or discomfort, in
the stomach caused by NSAIDs, a
type of medicine for pain or
inflammation.
Noxicid 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 Noxicid with
antibiotics. When Noxicid and
antibiotics are taken together, they
work to kill the bacterium and let
your ulcer heal. You may need
further treatment with antibiotics.
_ZOLLINGER-ELLISON SYNDROME_
Noxicid is also used to treat a rare
condition called Zollinger-Ellison
syndrome, wher

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
NOXICID
CAPS
_Esomeprazole (as magnesium) capsule _
1
NAME OF THE MEDICINE
Esomeprazole magnesium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in NOXICID is esomeprazole magnesium, a
substituted benzimidazole. The NOXICID
CAPS 20 mg and 40 mg enteric capsules are comprised of enteric coated
pellets containing esomeprazole (as
magnesium).
List of excipients with known effect: sugars and traces of sulfites.
For the full list of excipients, see
SECTION
6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Noxicid 20 mg enteric capsule are white to cream coloured pellets
filled in hard gelatin capsule with pink cap
and pink body, imprinted with 'Mylan' over 'EM 20' in black ink on cap
and body.
Noxicid 40 mg enteric capsule are white to cream coloured pellets
filled in hard gelatin capsule with brown
cap and brown body, imprinted with 'Mylan' over 'EM 40' in black ink
on cap and body.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NOXICID CAPS are 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.
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 o