Apo-Lansoprazole 30mg capsules delayed-release

Ország: Örményország

Nyelv: angol

Forrás: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktív összetevők:

lansoprazole

Beszerezhető a:

Apotex Inc.

ATC-kód:

A02BC03

INN (nemzetközi neve):

lansoprazole

Adagolás:

30mg

Gyógyszerészeti forma:

capsules delayed-release

db csomag:

(100) plastic container

Recept típusa:

Prescription

Engedélyezési státusz:

Registered

Engedély dátuma:

2015-04-16

Betegtájékoztató

IMPORTANT:
PLE
ASE READ
PART III:
CONSUMER
INFORMATION
Pr
APO­LANSOPRAZOLE LANSOPRA
Z
O
LE
DELAYED­RELEASE CAPSULES USP
THIS LEAFLET IS PART III OF A THREE­PART “PRODUCT MONOGRAPH”
PUBLISHED WHEN APO­LANSOPRAZOLE 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
LANSOPRAZOLE. CONTACT YOUR DOCTOR OR PHARMACIST IF YOU HAVE
ANY QUESTIONS ABOUT THE DRUG.
ABOUT THIS MEDICATION
WHAT THE MEDICATION IS USED FOR:
APO-LANSOPRAZOLE is a medicine that is indicated in the treatment
of conditions where the reduction of gastric acid secretion is
required,
such as:
· DUODENAL ULCER
A duodenal ulcer is a sore on the lining of the duodenum, which is the
beginning of the small intestine.
·
GASTRIC ULCER
A gastric ulcer is a sore on the lining of the stomach.
· REFLUX ESOPHAGITIS
A reflux esophagitis is an inflammation of the swallowing tube
(esophagus) resulting from regurgitation of gastric contents into the
esophagus. Because stomach contents are acidic, this may result in
irritation of the esophagus.
· HEALING OF NON­STEROIDAL ANTI­INFLAMMATORY DRUGS (NSAID)­
ASSOCIATED GASTRIC ULCER
· REDUCTION OF RISK OF NSAID­ASSOCIATED GASTRIC ULCER
· SYMPTOMATIC GASTROESOPHAGEAL REFLUX DISEASE (SGERD)
sGERD is a disorder that results from stomach acid moving backward
from the stomach into the esophagus.
· PATHOLOGICAL HYPERSECRETORY CONDITIONS
Pathological hypersecretory conditions are conditions in which the
stomach produces too much acid which comes up into the esophagus
and causes heartburn.
·
TREATMENT OF THE BACTERIAL INFECTION CAUSED BY HELICOBACTER
PYLORI (H.PYLORI) IN COMBINATION WITH OTHER MEDICATIONS (E.G., THE
ANTIBIOTICS CLARITHROMYCIN AND AMOXICILLIN) TO TREAT STOMACH
ULCERS.
WHAT IT DOES:
APO-LANSOPRAZOLE is a type of medication called a proton pump
inhibitor, commonly known as PPI.
There are cells in the lining of your stomach that produce the acid
your
body uses during digestion. The burning pain from acid ref

Termékjellemzők

APPENDIX 1.9
THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC)
_ _
1. NAME OF THE MEDICINAL PRODUCT
APO-LANSOPRAZOLE Capsules 15 mg and 30 mg
(Lansoprazole Delayed-Release Capsules USP 15 mg and 30 mg)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
COMPONENT
FUNCTION OF
COMPONENT
%W/W
QUANTITY (MG/CAPSULE)
15 MG
30 MG
GRANULES
Lansoprazole USP
Active
18.68
15.00
30.0
Magnesium Hydroxide USP
Alkalizing agent
1.067
0.857
1.714
Methylcellulose USP A15LV
Filler
23.0
18.47
36.9
Poloxamer 407 NF/EP (Micro)
Binder
10.67
8.57
17.14
FILM COATING (SUB-COATING) SOLUTION
Purified Water USP*
Carrier vehicle
-
171.4
317.7
Hydroxypropyl Methylcellulose 2910 USP
E5
Film-forming
polymer
11.67
9.37
18.74
Polyethylene Glycol NF 8000
Plasticizer
1.67
1.34
2.68
Enteric coating solution
Purified Water USP*
Carrier vehicle
-
34.3
68.6
Triethyl Citrate NF
Plasticizer
2.56
2.06
4.11
Talc USP 500 Mesh
Glidant or anti-
caking agent
5.12
4.11
8.22
Methacrylic Acid Copolymer Dispersion
NF**
Polymer
resistant to
gastric fluid
25.62
68.6
137.1
TOTAL (EXCLUDING WATER)
100.0
80.3
160.6
ENCAPSULATION
#4 caps, pink opaque cap and green
opaque body imprinted “APO L15” in white
ink
Encasement
-
38
$
-
#3 caps, pink opaque cap and black
opaque body, imprinted “APO L30” in white
ink
Encasement
-
-
48
$
TOTAL CAPSULE WEIGHT
118.3
208.6
* Purified water is excluded from the total; evaporated during the
coating process.
** 30% solids
$
Individual average capsule shell weight
Note: Fill weights of 80.3 mg and 160.6 mg are theoretical fill
weights for the 15 mg and 30 mg
capsules, respectively, and will be adjusted based on assay results
for the FC/EC granules.
APPENDIX 1.9
THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC)
_ _
3. PHARMACEUTICAL FORM
Delayed Release Capsules
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NOTE: WHEN USED IN COMBINATION WITH ANTIMICROBIALS FOR THE ERADICATION
OF
HELICOBACTER PYLORI (_H. PYLORI_), THE PRODUCT MONOGRAPH FOR THOSE
AGENTS
SHOULD BE CONSULTED.
ADULTS
APO-LANSOPRAZOLE (Lansoprazole delayed-release capsule