Marevan 5mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Warfarin sodium

Sẵn có từ:

Advanz Pharma

Mã ATC:

B01AA03

INN (Tên quốc tế):

Warfarin sodium

Liều dùng:

5mg

Dạng dược phẩm:

Oral tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 02080200; GTIN: 5021691700128

Tờ rơi thông tin

PACKAGE LEAFLET: INFORMATION FOR THE USER
MAREVAN
®
0.5MG TABLETS
WARFARIN SODIUM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-Keep this leaflet. You may need to read it again. If you have any
questions, ask your
doctor, pharmacist or nurse.
-This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. WHAT MAREVAN 0.5MG TABLETS ARE AND WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAREVAN 0.5MG TABLETS
3. HOW TO TAKE MAREVAN 0.5MG TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE MAREVAN 0.5MG TABLETS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT MAREVAN 0.5MG TABLETS ARE AND WHAT THEY ARE USED FOR
Marevan contains warfarin. Warfarin belongs to a group of medicines
called anticoagulants. It is
used to reduce the clotting ability of the blood. (It is sometimes
called a ‘blood thinner’, but it
does not actually thin the blood.) Warfarin is used to prevent and
treat blood clots forming in the
legs, lungs, brain and heart.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAREVAN 0.5MG TABLETS
DO NOT TAKE MAREVAN 0.5MG TABLETS IF YOU:
• are ALLERGIC to Warfarin or to any of the other ingredients of
this medicine (listed in section 6)
• are PREGNANT or may become pregnant or have had a BABY IN THE LAST
48 HOURS
• have or have ever had any BLEEDING PROBLEMS
• have recently had a STROKE caused by bleeding in the brain
• have had SURGERY within the last 72 hours or are going to have
surgery in the next 72 hours
• are taking non-steroidal anti-inflammatory drugs (NSAIDS), ASPIRIN
or ANTI-CLOTTING
MEDICINES as this may increase the risk of bleeding. (See Section 2
Other medicines and
Marevan 0.5mg Tablets).
If any of these apply to you, do not tak

Đặc tính sản phẩm

1.
NAME OF THE MEDICINAL PRODUCT
Marevan 0.5mg Tablets
Warfarin 0.5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.5mg Warfarin Sodium.
Excipients with known effect:
Lactose: contains 48.350 mg lactose per tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, flat, circular, bevel-edged uncoated tablets having ‘M’
breakline ‘0.5’ on one side
and plain on other side.
The score line is not intended for breaking the tablet.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Prophylaxis of systemic embolism in patients with rheumatic heart
disease and atrial
fibrillation.
Prophylaxis after insertion of prosthetic heart valves.
Prophylaxis and treatment of venous thrombosis and pulmonary embolism.
Transient attacks of cerebral ischaemia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults:_ The typical induction dose is 10mg daily for 2 days but this
should be tailored to
individual requirements. The daily maintenance dose is usually 3 to
9mg taken at the same
time each day. The exact maintenance dose depends on the prothrombin
time or other
appropriate coagulation tests.
Control tests should be made at regular intervals and the maintenance
dose should be
adjusted according to the results obtained. Once the maintenance dose
is established, it is
rarely necessary to alter it.
In
emergencies,
anticoagulant
therapy
should
be
initiated
with
heparin
and
warfarin
together.
Concomitant
therapy
with
heparin
affects
the
results
of
control tests,
and
should
be
discontinued at least six hours before the first test is carried out.
_Elderly:_ As for adults, but dosage may need to be lowered.
_Paediatric population: _ No data are available.
Method of administration
Oral.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
• Haemorrhagic stroke (see section 4.4 for further details)
• Clinically significant bleeding
• Within 72 hours of major surgery with risk of severe bleed