Apo-Clopidogrel tablets

Land: Armenien

Sprog: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv bestanddel:

clopidogrel (clopidogrel bisulfate)

Tilgængelig fra:

Apotex Inc.

ATC-kode:

B01AC04

INN (International Name):

clopidogrel (clopidogrel bisulfate)

Dosering:

75mg

Lægemiddelform:

tablets

Enheder i pakken:

(30/3x10/) in blister

Recept type:

Prescription

Autorisation status:

Registered

Autorisation dato:

2018-05-07

Indlægsseddel

210 mm
35 mm
280 mm
420 mm
NOTE: Pharmacode is vendor-specific information and may vary.
Page 1 of 2
New Material
Code:
SAP Ref #:
N/A
419951
136437 Clopidogrel Film Coated Tablets Insert Canada
N/A
ECL Common
Text#:
Description:
2
C of A:
414960
Old Material
Code:
Minimum
Font Size:
Pantone
Colours:
Dimensions/Dieline#:
Version No:
Change Control #:
963164
PKGP-CA-INSERT
Flat: 420 mm x 280 mm (16,54” x 11,02”)
Folded: 210 mm x 35 mm (8,27” x 1,38”)
BLACK
DIELINE
9 PT
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects may include:
•
joint pain and/or muscle pain
•
abdominal pain, diarrhea, indigestion (heartburn)
•
nausea, vomiting, constipation, loss of taste, taste disturbance
•
dizziness, headache
•
tingling sensation in the arms and/or legs
•
rash, itching
•
bruising
•
enlargement of breast tissue in men
If you cut or injure yourself, it may take slightly longer than usual
for bleeding
to stop. For minor cuts and injuries, e.g. cutting yourself shaving,
this is of no
concern. However, if you are in any doubt at all, you should contact
your
doctor immediately.
IF ANY OF THESE AFFECTS YOU SEVERELY, TELL YOUR DOCTOR OR PHARMACIST.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect
Talk with your
healthcare
professional
Stop taking
drug and
seek
immediate
medical
help
Only if
severe
In all
cases
Common
Nose bleeds
ü
BLEEDING DISORDERS: blood in the
stool, urine or eye, vomiting blood,
coughing up blood, purple spotted
rash
ü
ALLERGIC REACTION: rash, hives,
swelling of the face, lips, tongue or
throat, difficulty swallowing or
breathing
ü
Uncommon
Fever, signs of infection, extreme
tiredness
ü
LIVER DISORDER: yellowing of the skin
or eyes, dark urine, abdominal pain,
nausea, vomiting, loss of appetite
ü
BLEEDING IN THE BRAIN: sudden, severe
headache, weakness, loss of speech
or vision, confusion, nausea,
vomiting, seizures, loss of
consciousness
ü
Very rare
EOSINOPHILIC PNEUMONIA: cough,
fever, difficulty breathing, and
sweating at night
ü
KOUNIS

Produktets egenskaber

APPENDIX 1.9
THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC)
_ _
Page
1
of
23
1. NAME OF THE MEDICINAL PRODUCT
Apo-Clopidogrel
(Clopidogrel Bisulfate Tablets USP 75 mg)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
*98.0mg of Clopidogrel Bisulfate USP is equivalent to 75.0 mg of
Clopidogrel.
** Evaporates during manufacturing process and does not contribute to
the final weight of the tablet
3. PHARMACEUTICAL FORM
Tablets
COMPONENT AND QUALITY STANDARD
(AND GRADE, IF APPLICABLE)
FUNCTION OF
COMPONENT
75 MG
% W/W
QUANTITY
(MG/TABLET)
CORE
Clopidogrel Bisulfate USP*
Active
53.38
98.0
Anhydrous Lactose NF
Filler
26.58
48.8
Methyl Cellulose USP 15 CPS
Tablet Binder
9.26
17.0
Crospovidone NF
Disintegrant
6.54
12.00
Colloidal Silicon Dioxide NF
Glidant
0.22
0.400
Zinc Stearate USP
Lubricant
2.07
3.80
TOTAL CORE
98.05
180.0
COATING
Hydroxypropyl Cellulose NF (LF)
Film-forming polymer
0.65
1.20
Hydroxypropyl Methyl Cellulose 2910
USP E5
Film-forming polymer
0.22
0.40
Polyethylene Glycol 8000 NF
Plasticizer
0.44
0.80
Titanium Dioxide USP
Pigment/Opaquant
0.64
1.17
Red Ferric Oxide NF- Orange Shade
#34690
Tablet Pigment
0.02
0.03
Purified water USP**
Solvent/suspension
medium
-
-
TOTAL COATING
-
40.0
TOTAL COATING (EXCLUDING WATER)
-
3.60
TOTAL (FILM COTED TABLET)
100.0
183.60
APPENDIX 1.9
THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC)
_ _
Page
2
of
23
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MI, STROKE OR ESTABLISHED PERIPHERAL ARTERIAL DISEASE
APO-CLOPIDOGREL (Clopidogrel bisulfate) is indicated for the secondary
prevention of
atherothrombotic events (myocardial infarction, stroke and vascular
death) in patients
with
atherosclerosis
documented
by
stroke,
myocardial
infarction,
or
established
peripheral arterial disease.
ACUTE CORONARY SYNDROME
APO-CLOPIDOGREL (Clopidogrel bisulfate), in combination with
acetylsalicylic acid
(ASA), is indicated for the early and long-term secondary prevention
of atherothrombotic
events (myocardial infarction, ischemic stroke, cardiovascular death
and/or refractory
ischemia) i