NOXICID CAPS HEARTBURN RELIEF esomeprazole 20mg (as magnesium) enteric capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

esomeprazole magnesium, Quantity: 22.252 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Capsule, enteric

Composition:

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

Administration route:

Oral

Units in package:

7, 14

Prescription type:

(S2) Pharmacy Medicine

Therapeutic indications:

For relief of frequent heartburn and other symptoms of gastro-oesophageal reflux disease.

Product summary:

Visual Identification: 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.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-05-08

Patient Information leaflet

NOXICID
® CAPS
HEARTBURN RELIEF
_Esomeprazole (as magnesium)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
NOXICID CAPS HEARTBURN
RELIEF. It does not contain all the
information that is known about
NOXICID CAPS HEARTBURN
RELIEF.
It does not take the place of talking to
your pharmacist or doctor.
All medicines have risks and
benefits. Your pharmacist or doctor
will have weighed the risks of you
taking NOXICID CAPS
HEARTBURN RELIEF against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE.
YOU MAY NEED TO READ IT AGAIN.
WHAT NOXICID CAPS
HEARTBURN RELIEF
IS USED FOR
NOXICID CAPS HEARTBURN
RELIEF is used for the relief of
frequent heartburn and stomach acid
complaints due to gastro-oesophageal
reflux disease (GORD).
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.
Frequent heartburn is when you have
heartburn for two or more times a
week. Heartburn that occurs
frequently is a typical symptom of
GORD.
_HOW NOXICID CAPS_
_HEARTBURN RELIEF WORKS_
NOXICID CAPS HEARTBURN
RELIEF is a type of medicine called
a proton-pump inhibitor. It works by
decreasing the amount of acid made
by the stomach, to give relief of
symptoms and allow healing to take
place. This does not stop food being
digested in the normal way.
FOLLOW ALL DIRECTIONS GIVEN TO YOU
BY YOUR PHARMACIST OR DOCTOR
CAREFULLY.
They may differ from the
information contained in this leaflet.
ASK YOUR PHARMACIST OR DOCTOR IF
YOU WANT MORE INFORMATION.
There is no evidence that NOXICID
CAPS HEARTBURN RELIEF is
addictive.
THIS MEDICINE CAN BE PURCHASED
DIRECTLY FROM YOUR PHARMACY
WITHOUT A DOCTOR’S PRESCRIPTION.
BEFORE YOU TAKE
NOXICID CAPS
HEARTBURN RELIEF
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE NOXICID CAPS
HEARTBUR

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
NOXICID
®
CAPS
HEARTBURN RELIEF
_Esomeprazole (as magnesium) _
1
1
NAME OF THE MEDICINE
Esomeprazole magnesium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in NOXICID CAPS HEARTBURN RELIEF is esomeprazole
magnesium, a
substituted benzimidazole. The NOXICID CAPS HEARTBURN RELIEF 20 mg
enteric capsules
are comprised of enteric coated pellets containing esomeprazole (as
magnesium).
Each capsule contains esomeprazole magnesium 22.252 mg (equivalent to
esomeprazole 20 mg).
List of excipients with known effect: NOXICID CAPS HEARTBURN RELIEF
also contains
traces of sulfites.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
NOXICID CAPS HEARTBURN RELIEF 20 mg enteric capsule: 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.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NOXICID CAPS HEARTBURN RELIEF are indicated for:
The symptomatic relief of frequent heartburn and other symptoms of
gastro-oesophageal reflux
disease (GORD).
4.2
DOSE AND METHOD OF ADMINISTRATION
Esomeprazole magnesium enteric capsules should be swallowed whole with
liquid.
For patients who cannot swallow, the enteric capsules can be opened
and pellets mixed in non-
carbonated water and administered via a large syringe through a
gastric tube. To ensure
appropriate dosing and to avoid clogging, the gastric tube should be
flushed with non-carbonated
water following administration.
ADULTS
Relief of heartburn and other symptoms of gastro-oesophageal reflux
disease (GORD).
The recommended dose for symptomatic relief of GORD is one NOXICID
CAPS HEARTBURN
RELIEF 20 mg capsule once daily for 7 – 14 days, depending on the
severity and persistence of
symptoms.
Patients should be referred to their doctor if symptoms persist or
worsen while taking this course,
or if symptoms persist or recur within two weeks of completing the
course. If symptom control
AUSTRALI