ETOPAN 400

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ETODOLAC

متاح من:

TARO PHARMACEUTICAL INDUSTRIES LTD

ATC رمز:

M01AB08

الشكل الصيدلاني:

TABLETS

تركيب:

ETODOLAC 400 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

TARO PHARMACEUTICAL INDUSTRIES LTD

المجموعة العلاجية:

ETODOLAC

المجال العلاجي:

ETODOLAC

الخصائص العلاجية:

For the management of signs and symptoms of osteoarthritis and rheumatoid arthritis. For the management of pain.

تاريخ الترخيص:

2021-06-30

نشرة المعلومات

Etopan PIL
_–_
_ final September 2023 _
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
ETOPAN
200
ETOPAN
300
ETOPAN
400
ETOPAN
500
Capsules
Capsules
Tablets
Tablets
ACTIVE INGREDIENT
Each capsule
contains:
Each capsule
contains:
Each tablet
contains:
Each tablet
contains:
etodolac 200 mg
etodolac 300 mg
etodolac 400 mg
etodolac 500 mg
Inactive ingredients and allergens
in this medicine: see section 2
‘Important information about
some of this medicine’s ingredients’, and section 6 ‘Additional
information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
1
. WHAT IS THIS MEDICINE INTENDED FOR?
For the management of signs and symptoms of osteoarthritis and
rheumatoid arthritis.
For the management of pain.
THERAPEUTIC GROUP:
Non-steroidal anti-inflammatory drugs (NSAIDs).
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient (etodolac) or to
any of the other
ingredients in this medicine (see section 6).
•
You have SEVERE HEART FAILURE.
•
You have an ulcer (a peptic ulcer, a small lesion or hole in the
stomach or duodenum) or
bleeding in the stomach, or have had two or more episodes of ulcers,
stomach bleeding or
perforation.
•
You have had an ALLERGIC REACTION OR ASTHMATIC REACTION (wheezing,
itching or skin rash)
after taking aspirin, Etopan or another NSAID.
•
You have severe liver failure and kidney failure.
•
YOU ARE IN THE LAST TRIMESTER OF PREGNANCY.
•
You have previously had bleeding from the stomach or bowel due to
taking a NSAID.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE USING ETOPAN, TELL YOUR D

خصائص المنتج

1.
Name of the medicinal product
Etopan 200
Etopan 300
Etopan 400
Etopan 500
2.
Qualitative and quantitative composition
Etopan 200
Etopan 300
Etopan 400
Etopan 500
Each capsule
contains:
etodolac 200 mg
Each capsule
contains:
etodolac 300 mg
Each tablet
contains:
etodolac 400 mg
Each tablet
contains:
etodolac 500 mg
Excipients with known effect
Each Etopan 200 mg capsule contains 22.87 mg of lactose monohydrate.
Each Etopan 300 mg capsule contains 34.30 mg of lactose monohydrate.
Each Etopan 400 mg tablet contains 121.30 mg of lactose monohydrate,
0.7-1.05 mg sodium.
Each Etopan 500 mg tablet contains 151.60 mg of lactose monohydrate,
0.88-1.31 mg sodium.
For the full list of excipients, see section 6.1.
3.
Pharmaceutical form
Capsules (200, 300 mg)
Tablets (400, 500 mg)
Etopan 200: dark pink, gelatine capsule with black imprint "ETO 200
MG" on cap and body, white to
off white powder filling.
Etopan 300: light pink, gelatine capsule with black imprint "ETO 300
MG" on cap and body, white to
off white powder filling.
Etopan 400: peach colored, film coated, capsule shaped tablet. One
side is engraved with "T88",
other side is smooth.
Etopan 500: blue, oval shaped, film coated tablet. One side is
engraved with "Taro", other side is
engraved with "89".
4.
Clinical particulars
4.1
Therapeutic indications
Etodolac is indicated for the: Treatment of osteoarthritis and
rheumatoid arthritis - acute and long
term use in the management of signs and symptoms. Management of
pain-relief of mild to
moderate pain, especially when anti-inflammatory actions may also be
desired, e.g., following
dental, obstetric or orthopedic surgery, and for the relief of
musculoskeletal pain due to soft tissue
athletic injuries. Relief of mild to moderate bone pain caused by
metastatic neoplastic disease.
Treatment of acute gouty arthritis or calcium pyrophosphate deposition
disease - uricosuric
activity, relief of acute attacks, long-term prophylactic use may
decrease the incidence or severity
of recurrent acute gout attacks, especially during t