COUMADIN 5 MG

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

WARFARIN SODIUM

Tersedia dari:

TARO PHARMACEUTICAL INDUSTRIES LTD

Kode ATC:

B01AA03

Bentuk farmasi:

TABLETS

Komposisi:

WARFARIN SODIUM 5 MG

Rute administrasi :

PER OS

Jenis Resep:

Required

Diproduksi oleh:

TARO PHARMACEUTICAL INDUSTRIES LTD

Kelompok Terapi:

WARFARIN

Area terapi:

WARFARIN

Indikasi Terapi:

Coumadin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonar embolis. Coumadin is indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. Coumadin is indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.

Tanggal Otorisasi:

2023-06-30

Selebaran informasi

Page 1 of 7
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
COUMADIN 1 MG TABLETS
COUMADIN 2 MG TABLETS
Active ingredient and its quantity:
Active ingredient and its quantity:
Each tablet contains:
Each tablet contains:
warfarin sodium 1 mg
warfarin sodium 2 mg
COUMADIN 2.5 MG TABLETS
COUMADIN 5 MG TABLETS
Active ingredient and its quantity:
Active ingredient and its quantity:
Each tablet contains:
Each tablet contains:
warfarin sodium 2.5 mg
warfarin sodium 5 mg
Inactive ingredients and allergens: see section 2 under ‘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 for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Prophylaxis and treatment of thrombosis.
THERAPEUTIC GROUP:
Anticoagulants, vitamin K antagonists.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient (warfarin
sodium) or to any of
the other ingredients in this medicine (listed in section 6).
•
You are pregnant, may become pregnant or gave birth within the last 48
hours.
•
You have or have ever had any bleeding problems.
•
You recently had a stroke caused by bleeding in the brain.
•
You had surgery within the last 72 hours or are going to have surgery
within the
next 72 hours.
•
You are taking non-steroidal anti-inflammatory drugs (NSAIDs), aspirin
or
anticoagulants, since using them in combination with Coumadin may
increase the
risk of bleeding (see section ‘Drug interactions’).
If any of these conditions applies to you, do not take this medicine
and go back

Karakteristik produk

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PRESCRIBING INFORMATION
COUMADIN TABLETS
1. NAME OF THE MEDICINAL PRODUCT
COUMADIN 1 mg
COUMADIN 2 mg
COUMADIN 2.5 mg
COUMADIN 5 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Coumadin 1 mg contains 1 mg warfarin sodium.
Each tablet of Coumadin 2 mg contains 2 mg warfarin sodium.
Each tablet of Coumadin 2.5 mg contains 2.5 mg warfarin sodium.
Each tablet of Coumadin 5 mg contains 5 mg warfarin sodium.
Excipients with known effect:
Lactose: Each tablet contains 196.5-198.6 mg lactose per tablet. For
the full list of excipients,
see section 6.1.
3. PHARMACEUTICAL FORM
Tablets.
Presentation:
COUMADIN 1 mg tablets are pink, flat capsule shaped, beveled tablets,
one side engraved
with “WARFARIN” and "TARO", and other side scored and engraved
with “1”.
COUMADIN 2 mg tablets are lavender, flat capsule shaped, beveled
tablets, one side
engraved with “WARFARIN” and "TARO", and other side scored and
engraved with “2”.
COUMADIN 2.5 mg tablets are green, flat capsule shaped, beveled
tablets, one side
engraved with “WARFARIN” and "TARO", and other side scored and
engraved with “2½”.
COUMADIN 5 mg tablets are peach, flat capsule shaped, beveled tablets,
one side engraved
with “WARFARIN” and "TARO", and other side scored and engraved
with “5”.
The tablet can be divided into equal halves.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
COUMADIN is indicated for the prophylaxis and/or treatment of venous
thrombosis and its
extension, and pulmonary embolism.
COUMADIN is indicated for the prophylaxis and/or treatment of the
thromboembolic
complications associated with atrial fibrillation and/or cardiac valve
replacement.
COUMADIN is indicated to reduce the risk of death, recurrent
myocardial infarction, and
thromboembolic events such as stroke or systemic embolization after
myocardial infarction.
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4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage and administration of COUMADIN must be individualized for
each patient
according to the particular patient's