Apo-Clopidogrel 75mg tablets

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

clopidogrel (clopidogrel bisulfate)

Доступна с:

Apotex Inc.

код АТС:

B01AC04

ИНН (Международная Имя):

clopidogrel (clopidogrel bisulfate)

дозировка:

75mg

Фармацевтическая форма:

tablets

Штук в упаковке:

(30/3x10/) blisters

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2015-03-25

тонкая брошюра

210 mm
35 mm
280 mm
420 mm
Flat:
420 mm x 280 mm
(16,54” x 11,02”)
Folded:
210 mm x 35 mm
(8,27” x 1,38”)
NOTE: Pharmacode is vendor specific information and may vary.
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BLACK
DIELINE
PKGP-CA-INSERT
Ravindra Degozu
Oct 25, 2018
QA
Rev#:
C of A:
347693
Previous
Code:
Minimum
Font Size:
Pantone
Colours:
Dimensions/Dieline#:
Prepared by:
Date:
Material
Code:
Material
Code REF:
N/A
410351
INS APO-CLOPIDOGREL FCT 75MG/300MG
N/A
ECL Common
Text#:
Description:
Change Control #:
797371
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
s

Характеристики продукта

_PR_
_APO-CLOPIDOGREL PRODUCT MONOGRAPH PAGE 3 OF 52_
_JULY, 2018_
PR
APO-CLOPIDOGREL
Clopidogrel Tablets USP
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
NONMEDICINAL INGREDIENTS
Oral
tablet
75 mg and 300 mg
Anhydrous lactose, colloidal silicon dioxide,
crospovidone, ferric oxide red, hydroxypropyl
cellulose, hydroxypropyl methylcellulose,
methylcellulose, polyethylene glycol, titanium
dioxide and zinc stearate.
INDICATIONS AND CLINICAL USE
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) in patients with acute coronary syndromes - without ST
segment elevation (i.e.
unstable angina or non-Q-wave myocardial infarction). These benefits
of clopidogrel
bisulfate have been shown only when these patients were concomitantly
treated with
ASA in addition to other standard therapies. These benefits were also
seen in patients
who were managed medically and those who were managed with
percutaneous coronary
intervention (with or without stent) or CABG (coronary artery bypass
graft).
PEDIATRICS (< 18 YEARS OF AGE):
The safety and efficacy of clopidogrel bisulfate in pediatric patients
have not been established
(see WARNINGS AND PRECAUTIONS, SPECIAL POPULATIONS, PEDIATRICS (<18
YEARS OF AGE)).
CONTRAINDICATIONS
APO-CLOPIDOGREL (clopidogrel bisulfate) is contraindicated in:

Patients who are hypersensitive to this drug or to any ingredient in
the formulation or
component of the co