SANDOZ OMEPRAZOLE 20 CAPSULES

Land: Sør-Afrika

Språk: engelsk

Kilde: South African Health Products Regulatory Authority (SAHPRA)

Tilgjengelig fra:

Sandoz South Africa (Pty) Ltd

Dosering :

See ingredients

Legemiddelform:

CAPSULES

Sammensetning:

EACH CAPSULE CONTAINS OMEPRAZOLE 20,0 mg

Autorisasjon status:

Registered

Autorisasjon dato:

2005-11-07

Informasjon til brukeren

Applicant
:
Sandoz SA (Pty) Ltd
V6 (04.07.2022)
Proprietary name (dosage form)
:
Sandoz Omeprazole 20 (capsules)
Strength
:
Each capsule contains Omeprazole 20 mg
Page 1 of 14
Submission date: 04 July 2022
CLEAN PROPOSED PIL FOR SANDOZ OMEPRAZOLE 20
SCHEDULING STATUS: S4
SANDOZ OMEPRAZOLE 20 (CAPSULES)
Omeprazole
Contains sugar (sucrose 108,04 mg) and mannitol 7,91 mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING SANDOZ
OMEPRAZOLE 20
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
•
SANDOZ OMEPRAZOLE 20 capsules 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 SANDOZ OMEPRAZOLE 20 is and what it is used for
2. What you need to know before you take SANDOZ OMEPRAZOLE 20
3. How to take SANDOZ OMEPRAZOLE 20
4. Possible side effects
5. How to store SANDOZ OMEPRAZOLE 20
6. Contents of the pack and other information
1. WHAT SANDOZ OMEPRAZOLE 20 IS AND WHAT IT IS USED FOR
Applicant
:
Sandoz SA (Pty) Ltd
V6 (04.07.2022)
Proprietary name (dosage form)
:
Sandoz Omeprazole 20 (capsules)
Strength
:
Each capsule contains Omeprazole 20 mg
Page 2 of 14
Submission date: 04 July 2022
The active ingredient in SANDOZ OMEPRAZOLE 20 belongs to the group of
medicines called
inhibitors of the gastric proton pump. They work by reducing the
amount of acid that your
stomach produces.
SANDOZ OMEPRAZOLE 20 is used for the treatment of conditions
associated with over
production of acid in the stomach or acid moving into the oesophagus
(throat).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SANDOZ OMEPRAZOLE 20
DO NOT TAKE SANDOZ OMEPRAZOLE 20 CAPSULES IF:
•
You are hypersensitive (allergic) to omeprazole or any of the other
ingredients of
SANDOZ OMEPRAZOLE 20 capsules (listed in section 6).
•
If you are allergic to medicines containing other proton pump
inhibitors (eg pantopr

Preparatomtale

Applicant
:
Sandoz SA (Pty) Ltd
V6 (04.07.2022)
Proprietary name (dosage form)
:
Sandoz Omeprazole 20 (capsules)
Strength
:
Each capsule contains Omeprazole 20 mg
Page 1 of 27
Submission date: 04 July 2022 PROPOSED PI FOR SANDOZ OMEPRAZOLE 20
SCHEDULING STATUS S4
1. NAME OF THE MEDICINE
SANDOZ OMEPRAZOLE 20 (capsules)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Sandoz Omeprazole 20 capsule contains 20 mg omeprazole in a
gastro-resistant
formulation.
Contains sugar (sucrose 108,04 mg) and mannitol 7,91 mg.
3. PHARMACEUTICAL FORM
A capsule with opaque yellow body and cap, containing off-white to
cream-white spherical
pellets.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SANDOZ OMEPRAZOLE 20 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.
Applicant
:
Sandoz SA (Pty) Ltd
V6 (04.07.2022)
Proprietary name (dosage form)
:
Sandoz Omeprazole 20 (capsules)
Strength
:
Each capsule contains Omeprazole 20 mg
Page 2 of 27
Submission date: 04 July 2022
-
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 program with
appropriate antibiotics.
-
Treatment
of
non-steroidal
anti-inflammatory
drugs
(NSAIDs)-associated
gastric
and/or duodenal ulcers and erosions.
-
Reduction of the risk to develop gastric and/or duodenal
ulcer/erosions, and reduction
of the risk of relapse for previously healed gastric and/or duodenal
ulcer/erosions in
patients on NSAIDs treatment.
CHILDREN_: _
Short-term (up to 3 months) treatment of severe ulcerative reflux
oesophagitis resistant to
previous medical treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
SANDOZ OMEPRAZOLE 20 is recommended to be given in the morning and
swallowed
whole with a half glass of liquid. The SANDOZ OMEPRAZOLE 20 capsules
should not be
c