Apo-Omeprazole 20mg capsules delayed-release

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

omeprazole

Available from:

Apotex Inc.

ATC code:

A02BC01

INN (International Name):

omeprazole

Dosage:

20mg

Pharmaceutical form:

capsules delayed-release

Units in package:

(100) plastic container

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-04-16

Patient Information leaflet

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INFORMATION FOR THE CONSUMER
IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT
PR
APO-OMEPRAZOLE
OMEPRAZOLE DELAYED-RELEASE CAPSULES
APOTEX STANDARD
Read this leaflet carefully. It contains general points about
APO-OMEPRAZOLE and should add
to more specific advice from your doctor or pharmacist.
WHAT IS APO-OMEPRAZOLE USED FOR AND HOW DOES IT WORK?
APO-OMEPRAZOLE is the brand name for a drug called omeprazole.
The most common uses of APO-OMEPRAZOLE are:
for stomach ulcers or for duodenal ulcers, including ulcers caused by
infection with a
bacterium called _Helicobacter pylori_;
for ulcers caused by your medicine for pain and joint problems
(NSAID-associated gastric
and duodenal ulcers);
for reflux esophagitis (tissue damage caused by stomach contents
flowing back up the
food pipe);
and for symptoms of reflux disease such as heartburn and
regurgitation.
APO-OMEPRAZOLE may also be used in rare conditions like
"Zollinger-Ellison syndrome",
where the stomach produces large amounts of acid. APO-OMEPRAZOLE works
by reducing
the amount of acid made in your stomach. This helps in treating
acid-related and bacteria-
related stomach problems.
Your doctor will have explained why you are being treated with
APO-OMEPRAZOLE and will
have told you what dose to take. Follow those directions carefully.
They may differ from the
information contained in this leaflet.
WHAT IS IN APO-OMEPRAZOLE?
Each APO-OMEPRAZOLE capsule contains omeprazole as the active
ingredient. In addition, it
contains the following non-medicinal ingredients (listed in
alphabetical order): eudragit, gelatin,
magnesium hydroxide, mannitol, povidone, red iron oxide, titanium
dioxide and triethyl citrate.
Check with your doctor if you think you might be allergic to any of
the above ingredients.
WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING APO-OMEPRAZOLE?
Tell your doctor
Tell your doctor
about ALL health problems you have now or have had in the past;
about severe liver problems you have now or have had in the past;
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about other medicines you tak

Summary of Product characteristics

APPENDIX 1.9
THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC)
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1. NAME OF THE MEDICINAL PRODUCT
Apo-Omeprazole Capsules 20 mg
(Omeprazole Delayed-Release Capsules 20 mg)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsules contain 20 mg of active component – Omeprazole.
Detailed composition
is presented below:
STRENGTH (LABEL CLAIM)
FUNCTION
20 MG
12% uncoated pellets
INGREDIENT AND TEST STANDARD
QUANTITY PER UNIT
12% UNCOATED OMEPRAZOLE PELLETS
MG/100 MG
Omeprazole USP (micronized)
Active
12
Mannitol USP
Bulking Agent
81
Povidone USP
Disintegrant
5
Magnesium Hydroxide USP
Suspension
2
Purified Water USP
Solvent
-
SUBTOTAL (EXCLUDING WATER)
100
8% ENTERIC COATED OMEPRAZOLE
PELLETS
-
MG/G OF 12% PELLETS
Purified Water USP
Solvent
1500
Triethyl Citrate NF
Plasticizer
45
Methacrylic Acid Copolymer
Dispersion NF
Enteric Coating
Polymer
1500
TOTAL (COATING SUSPENSION)
-
3045
12% Uncoated Omeprazole Pellets
-
1000
THEORETICAL YIELD (SOLIDS)
-
1495
ENCAPSULATION
MG/CAPSULE
8% Enteric Coated Omeprazole
Pellets
-
250
**Capsule shell #2 (pink opaque cap
and reddish-brown body, imprinted
“APO 020” with black ink)
Encasement
61*
TOTAL FILLED CAPSULE (THEORETICAL)
311
*Capsule shell weight is determined on a batch by batch basis
APPENDIX 1.9
THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC)
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**COMPOSITION OF CAPSULE
Capsule shell composition - cap: gelatin (97.3326%), red iron oxide
(0.6862%) and titanium
dioxide (1.9812%).
Capsule shell composition - body: gelatin (97.5701%), red iron oxide
(0.0943%) and titanium
dioxide (2.3356%).
Black ink: shellac NF, dehydrated alcohol USP, isopropyl alcohol USP,
butyl alcohol NF,
propylene glycol USP, purified water USP, strong ammonia solution NF,
potassium hydroxide
NF and black iron oxide NF.
3. PHARMACEUTICAL FORM
Delayed-Release Capsules
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
APO-OMEPRAZOLE (omeprazole) is indicated in the treatment of
conditions where a
reduction of gastric acid secretion is required, such as:
•
Duodenal u