OMEZ 20 CAPSULES

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Dr ReddyÆs Laboratories (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

CAPSULES

Composition:

EACH CAPSULE CONTAINS OMEPRAZOLE 20,0 mg

Authorization status:

Registered

Authorization date:

2002-03-06

Patient Information leaflet

DR REDDY’S LABORATORIES (PTY) LTD
OMEZ 10/20/40
APPROVED PATIENT INFORMATION LEAFLET
28/01/2021
_ _
Ome10/20/40- 28/01/2021_ _
_PAGE 1 OF 10 _
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
OMEZ 10/20/40, CAPSULES
OMEPRAZOLE
CONTAINS SUGAR (MANNITOL)
Each 10 mg capsule contains 59 mg of mannitol.
Each 20 mg capsule contains 118 mg of mannitol.
Each 40 mg capsule contains 236 mg of mannitol.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING OMEZ

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare provider.

OMEZ has been prescribed for you personally and you should not share
your medicine with other people. It
may harm them, even if their symptoms are the same as yours.
WHAT IS IN THIS LEAFLET:
1. What OMEZ is and what it is used for
2. What you need to know before you take OMEZ
3. How to take OMEZ
4. Possible side effects
5. How to store OMEZ
6. Contents of the pack and other information
1. WHAT OMEZ IS AND WHAT IT IS USED FOR
OMEZ belongs to a group of medicines called “proton pump
inhibitors”. OMEZ works by reducing the amount of
acid that your stomach produces.
DR REDDY’S LABORATORIES (PTY) LTD
OMEZ 10/20/40
APPROVED PATIENT INFORMATION LEAFLET
28/01/2021
_ _
Ome10/20/40- 28/01/2021_ _
_PAGE 2 OF 10 _
OMEZ is used to treat the following conditions:
Adults:

Reflux oesophagitis and gastro-oesophageal reflux disease (GORD),
where acid from the stomach
escapes into the gullet (a tube which connects your throat to your
stomach) causing pain, inflammation
and heartburn.

Indigestion (dyspepsia).

Zollinger-Ellison Syndrome, when excess stomach acids are produced due
to a growth in the pancreas.

Ulcers in the upper part of the intestine (duodenal ulcer) or stomach
(gastric ulcer).

Duodenal ulcers which are infected with bacteria called
“_Helicobacter pylori”_.
If you have this condition, your doctor may also prescribe antibiotics
to treat the infection.

Gastric and/or duod

Summary of Product characteristics

DR REDDY’S LABORATORIES (PTY) LTD
OMEZ 10/20/40
APPROVED PACKAGE INSERT
28/01/2021
OME 10/20/40 – 28/01/2021_ _
_ _
_PAGE 1 OF 15 _
SCHEDULING STATUS
1
NAME OF THE MEDICINE
OMEZ 10, 10 mg, capsule
OMEZ 20, 20 mg, capsule
OMEZ 40, 40 mg, capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
OMEZ 10: Each capsule contains omeprazole 10 mg
OMEZ 20: Each capsule contains omeprazole 20 mg
OMEZ 40: Each capsule contains omeprazole 40 mg
Contains sugar (mannitol).
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Capsule.
OMEZ 10: Off-white to pale yellow elliptical to spherical
enteric-coated pellets, filled in a hard gelatin capsule with
opaque lavender coloured cap and opaque yellow coloured body.
“Omeprazole 10 mg” imprinted with black ink on
cap and “R157” imprinted with black ink on body.
OMEZ 20: Off-white to pale yellow elliptical to spherical
enteric-coated pellets, filled in a hard gelatin capsule with
opaque lavender coloured cap and opaque iron grey coloured body.
“Omeprazole 20 mg” imprinted with black ink on
cap and “R158” imprinted with black ink on body.
OMEZ 40: Off-white to pale yellow elliptical to spherical
enteric-coated pellets, filled in a hard gelatin capsule with
opaque yellow coloured cap and opaque purple coloured body.
“Omeprazole 40 mg” imprinted with black ink on cap
and “R159” imprinted with black ink on body.
S4
DR REDDY’S LABORATORIES (PTY) LTD
OMEZ 10/20/40
APPROVED PACKAGE INSERT
28/01/2021
OME 10/20/40 – 28/01/2021_ _
_ _
_PAGE 2 OF 15 _
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
OMEZ is indicated in:
Adults

Treatment of duodenal ulcer, including prevention of relapse, gastric
ulcer and reflux oesophagitis.

Long-term management of reflux oesophagitis and Zollinger-Ellison
Syndrome.

Symptomatic relief of heartburn in patients with gastro-oesophageal
reflux disease (GORD) and the short-term
relief of functional dyspepsia.

_Helicobacter pylori_-positive duodenal ulcers as part of an
eradication programme with appr