Apo-Rabeprazole 20mg tablets enteric-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

rabeprazole (rabeprazole sodium)

Available from:

Apotex Inc.

ATC code:

A02BC04

INN (International Name):

rabeprazole (rabeprazole sodium)

Dosage:

20mg

Pharmaceutical form:

tablets enteric-coated

Units in package:

(100) plastic container

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-04-16

Patient Information leaflet

IMPORTANT: PLEASE READ
PART III: CONSUMER INFORMATION
Pr
APO-RABEPRAZOLE
rabeprazole sodium
This leaflet is Part III of a three-part "Product Monograph"
published when APO-RABEPRAZOLE was approved for sale
in Canada and is designed specifically for Consumers. This
leaflet is a
summary and will not tell you everything about Apo-
Rabeprazole. Contact your doctor or pharmacist if you have
any questions about the drug. ABOUT THIS MEDICATION
Read this leaflet carefully. It contains general information
about Apo-Rabeprazole tablets that you should know in
addition to the specific advice from your doctor or pharmacist.
instructions regarding how and when to take Apo-Rabeprazole
tablets.
WHAT THE MEDICATION IS USED FOR:
APO-RABEPRAZOLE IS THE BRAND NAME FOR A DRUG CALLED
RABEPRAZOLE SODIUM.
The most common uses of Apo-Rabeprazole tablets are:
symptomatic relief and healing of duodenal ulcers;
symptomatic relief and healing of stomach ulcers;
healing of gastroesophageal reflux disease (GERD) and
relief of its symptoms such as burning sensation rising from
the chest towards the neck (heartburn) and the flow of
bitter/sour juice into the mouth (regurgitation);
treatment of symptoms (i.e. heartburn and regurgitation) of
non-erosive reflux disease (NERD);
maintenance treatment of gastroesophageal reflux disease
(GERD).
Apo-Rabeprazole tablets may also be used in rare conditions
-
produces large amounts of acid.
When used with certain antibiotics, Apo-Rabeprazole is also
used for the treatment of ulcers caused by infection with a
bacterium called
_Helicobacter pylori _
(
_H. pylori_
), and to help
reduce the risk of these ulcers from coming back. If the doctor
is prescribing therapy with a combination of Apo-Rabeprazole
and antibiotics (amoxicillin and clarithromycin) the
pharmacist should provide you with information on the
antibiotics.
WHAT IT DOES:
Apo-Rabeprazole is a medicine called a proton pump inhibitor
(PPI).
Apo-Rabeprazole works by reducing the amount of acid made
in your stomach.
WHEN IT SHOULD NOT BE USED:
If you

Summary of Product characteristics

APPENDIX 1.9
THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC)
_ _
Page 1 of 22
1. NAME OF THE MEDICINAL PRODUCT
Apo-Rabeprazole Tablets 10 mg and 20 mg
(Rabeprazole Tablets 10 mg and 20 mg)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
STRENGTH (LABEL CLAIM):
%W/W
10 MG
20 MG
COMPONENT
FUNCTION
QUANTITY
MG /TABLET
QUANTITY MG
/TABLET
CORE TABLET:
Rabeprazole Sodium*
Active
14.3
10.01
20.02
Anhydrous Lactose NF**
Diluent/Filler
83.5
58.45
116.9
Colloidal Silicon Dioxide NF
Glidant
0.2
0.14
0.28
Magnesium Stearate NF
Lubricant
2.0
1.4
2.8
TOTAL CORE WEIGHT
100.0
70.0
100.0
COATING SOLUTION:
Methacrylic Acid Copolymer
Dispersion NF
†
Binder
60
50.0
†
80
†
Red Ferric Oxide NF Orange Shade
Colorant
2.0
0.5
N/A
Yellow Ferric Oxide NF
Colorant
--
N/A
0.8
Titanium Dioxide USP
Opacifier/
Pigment
18.0
4.5
7.2
Talc USP 500 Mesh
Lubricant
14.0
3.5
5.6
Triethyl Citrate NF
Plasticizer
6.0
1.5
2.4
Purified Water USP***
Solvent
--
100.0
160.0
TOTAL COATING SOLUTION
160
256
TOTAL COATING SOLIDS
25.0
40.0
TOTAL COATED TABLET WEIGHT
100.0
95.0
180.0
* Potency adjustment, based on 100% active assay
** Varies according to potency, based on 100% active assay
*** Water is evaporated off during the manufacturing process
† Contains 30% solids
3. PHARMACEUTICAL FORM
Film-Coating Tablets
APPENDIX 1.9
THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC)
_ _
Page 2 of 22
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
APO-RABEPRAZOLE (Rabeprazole sodium) is indicated for:
• Treatment of conditions where a reduction of gastric acid
secretion is required, such as:
1.
Symptomatic relief and healing of erosive or ulcerative gastro
esophageal reflux
disease (GERD).
2.
Long-term maintenance of healing of erosive or ulcerative gastro
esophageal reflux
disease (GERD).
3. Treatment of symptoms (i.e. heartburn and regurgitation) in
symptomatic gastro
esophageal reflux disease (GERD), also called non-erosive reflux
disease (NERD).
4.
Symptomatic relief and healing of duodenal ulcers.
5.
Symptomatic relief and healing of gastric ulcers.
6.
Lon