ESOMEPRAZOLE SZ esomeprazole (as magnesium trihydrate) 20 mg enteric-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

esomeprazole magnesium trihydrate, Quantity: 22.264 mg (Equivalent: esomeprazole, Qty 20 mg)

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: glyceryl monostearate; povidone; purified water; crospovidone; polysorbate 80; silicon dioxide; hypromellose phthalate; microcrystalline cellulose; pregelatinised maize starch; hyprolose; iron oxide red; purified talc; methacrylic acid - ethyl acrylate copolymer (1:1); macrogol 6000; light magnesium oxide; macrogol 400; titanium dioxide; hypromellose; iron oxide yellow; maize starch; sucrose

Administration route:

Oral

Units in package:

Al/Al blister pack (PVC/OPA/Al/PVC/Peelable child resistance PET/Al foil) of 7, 14, 30, 100's, Al/Al blister pack (PVC/OPA/Al/PV

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Esomeprazole enteric-coated tablet 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] Prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole solution administered by intravenous infusion.,4] Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypers

Product summary:

Visual Identification: Light pink coloured, oblong, biconvex, coated tablets debossed with '20' on one side and 'CE' on the other.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2018-11-02

Patient Information leaflet

ESOMEPRAZOLE SZ
1
ESOMEPRAZOLE SZ
_esomeprazole (as magnesium trihydrate) enteric-coated tablet _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Esomeprazole SZ. It does not contain
all the information that is known
about Esomeprazole SZ.
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 SZ 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
SZ IS USED FOR
_REFLUX OESOPHAGITIS _
Esomeprazole SZ 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 SZ 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 SZ 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 SZ 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
SZ with antibiotics. When
Esomeprazole SZ and antibiotics are
taken together, they work to kill the
bacterium and let you

Summary of Product characteristics

210610-Esomeprazole SZ-pi
Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION
ESOMEPRAZOLE SZ
® (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)
ENTERIC COATED TABLETS
1.
NAME OF THE MEDICINE
Esomeprazole magnesium trihydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Esomeprazole SZ
20 mg: Each tablet contains 20 mg of esomeprazole.
Esomeprazole SZ
40 mg: Each tablet contains 40 mg of esomeprazole.
Esomeprazole SZ (esomeprazole enteric-coated 20 mg and 40 mg tablets)
is comprised of
enteric-coated pellets containing esomeprazole (as magnesium
trihydrate).
_List of excipients with known effect:_
sugars
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Esomeprazole SZ
20 mg: Light pink coloured, oblong, biconvex, coated tablets debossed
with
'20' on one side and ‘CE’ on the other.
Esomeprazole SZ
40 mg: Pink coloured, oblong, biconvex, coated tablets debossed with
'40'
on one side and ‘CE’ on the other side.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Esomeprazole SZ (esomeprazole enteric-coated 20 mg and 40 mg tablet)
is indicated for:
•
_GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD): _
o
treatment of erosive reflux oesophagitis.
o
long-term management of patients with healed oesophagitis to prevent
relapse.
o
symptomatic treatment of gastro-oesophageal reflux disease (GORD).
•
_PATIENTS REQUIRING NSAID THERAPY: _
o
short-term treatment of upper gastrointestinal symptoms associated
with non-steroidal
anti-inflammatory drug NSAID (non-selective and COX-2 selective)
therapy.
o
healing of gastric ulcers associated with non-steroidal
anti-inflammatory drug NSAID
(non-selective and COX-2 selective) therapy.
o
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 _
_ESOMEPRAZOLE SOLUTION ADMINISTERED BY INTRAVENOUS INFUSION. _
210610-Esomeprazole SZ-pi
Page 2 of 27
•
_PATHOLOGICAL HYP