ESOMEPRAZOLE SANDOZ Hp7 amoxicillin (as trihydrate) 500mg capsule, clarithromycin 500 mg tablet, esomeprazole (as magnesium trihydrate) 20 mg tablet Composite 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: purified water; methacrylic acid - ethyl acrylate copolymer (1:1); crospovidone; hypromellose phthalate; iron oxide red; light magnesium oxide; pregelatinised maize starch; polysorbate 80; silicon dioxide; hyprolose; macrogol 6000; glyceryl monostearate; microcrystalline cellulose; povidone; macrogol 400; purified talc; maize starch; sucrose; titanium dioxide; hypromellose; iron oxide yellow

Administration route:

Oral

Units in package:

14 esomeprazole 20mg tablets, 14 clarithromycin 500mg tablets, 28 amoxicillin 500 mg capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Healing of duodenal ulcer associated with Helicobacter pylori. ,Eradication of Helicobacter pylori in patients with active or healed peptic ulcers.

Product summary:

Visual Identification: light pink, oblong, biconvex film coated tablets debossed with '20' on one side and 'CE' on the other side; Container Type: Carton; Container Material: Cardboard; 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:

2019-10-17

Patient Information leaflet

ESOMEPRAZOLE SANDOZ
®
HP7
1
ESOMEPRAZOLE
SANDOZ
® HP7
_COMPOSITE PACK _
_Esomeprazole (as magnesium), amoxicillin (as trihydrate) and
clarithromycin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Esomeprazole Sandoz Hp7. It does
not contain all the available
information about Esomeprazole
Sandoz Hp7.
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 Sandoz Hp7 against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THESE MEDICINES, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINES.
You may need to read it again.
WHAT ESOMEPRAZOLE
SANDOZ HP7 IS USED
FOR
Esomeprazole Sandoz Hp7 is a
composite pack, which contains three
different medicines. When taken
together in the right doses, they will
kill the bacteria in your stomach
called Helicobacter pylori and let
your peptic ulcer heal.
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.
Most people who have a peptic ulcer
also have a bacterium called
Helicobacter pylori in their stomach.
If the bacteria are killed it is unlikely
that your ulcer will come back.
Esomeprazole SZ is the brand name
of esomeprazole (E), and it is given
with amoxicillin (A), brand name
Amoxycillin Sandoz and
clarithromycin (C), brand name
Clarithromycin Sandoz. Amoxycillin
Sandoz and Clarithromycin Sandoz
are both types of antibiotic.
_HOW ESOMEPRAZOLE SANDOZ _
_HP7 WORKS _
Esomeprazole SZ is a type of
medicine called a proton-pump
inhibitor.
Esomeprazole SZ 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.
Amoxicillin and clarithromycin are
both antibiotics that

Summary of Product characteristics

211201-Esomeprazole Sandoz Hp7-pi
Page 1 of 34
AUSTRALIAN PRODUCT INFORMATION
ESOMEPRAZOLE SANDOZ
® HP7 (ESOMEPRAZOLE MAGNESIUM
TRIHYDRATE, AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN)
This
document
refers
to
the
use
of
esomeprazole,
amoxicillin
and
clarithromycin
in
combination for the healing of patients with duodenal ulcer associated
with
_Helicobacter pylori _
and for the eradication of
_Helicobacter pylori _
in patients with active or healed peptic ulcer.
The components of this therapy are frequently used to treat other
conditions. For information
about the treatment of other conditions, refer to full Product
Information for the appropriate
component.
1.
NAME OF THE MEDICINE
The active ingredient in Esomeprazole SZ is esomeprazole magnesium
trihydrate.
The active ingredient in Amoxicillin Sandoz
is amoxicillin trihydrate.
The active ingredient in Clarithromycin Sandoz
is clarithromycin.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ESOMEPRAZOLE SZ TABLETS
Esomeprazole is a proton pump inhibitor. The active ingredient is
esomeprazole magnesium
trihydrate,
a
substituted
benzimidazole.
Esomeprazole
SZ
tablets
contain
esomeprazole
magnesium trihydrate equivalent to esomeprazole 20 mg as the active
ingredient.
AMOXICILLIN SANDOZ CAPSULES
Amoxicillin trihydrate is a semisynthetic antibiotic and is a member
of the penicillinase-stable
group of penicillins derived from the penicillin nucleus,
6-aminopenicillanic acid. Amoxicillin
Sandoz capsule contain amoxicillin trihydrate equivalent to
amoxicillin 500 mg as the active
ingredient.
CLARITHROMYCIN SANDOZ TABLETS
Clarithromycin is a semi-synthetic macrolide antibiotic.
Clarithromycin Sandoz tablets
contain clarithromycin 500 mg as the active ingredient.
_Excipient with known effect_
: Lactose
For the full list of excipients, see Section 6.1
_ _
List of excipients
_. _
3.
PHARMACEUTICAL FORM
Esomeprazole Sandoz Hp7 consists of:
-
Esomeprazole SZ 20 mg tablets – light pink, oblong, biconvex film
coated tablets debossed
with ‘20’ on one side and ‘CE’ on the other si