Tranexamic acid 500mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Tranexamic acid

Tersedia dari:

Kent Pharma (UK) Ltd

Kode ATC:

B02AA02

INN (Nama Internasional):

Tranexamic acid

Dosis:

500mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 02110000

Selebaran informasi

PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER
TRANEXAMIC ACID 500MG TABLETS
TRANEXAMIC ACID
_(continued overleaf)_
WIP URN
080317-GT07C-PIL-03
APPROVED URN
JOB
Tranexamoc Acid Creo PIL
SIZE
210 x 140mm
DATE
8 March 2017
BOH APPROVAL DATE
SAVED AS
14212_03 PIL.ai M1X
PRINTS
1 Colour - Black
WIP URN: 080317-GT07C-PIL-03
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 further questions, ask
your doctor or pharmacist.
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 or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. WHAT TRANEXAMIC ACID IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRANEXAMIC ACID
3. HOW TO TAKE TRANEXAMIC ACID
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE TRANEXAMIC ACID
6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT TRANEXAMIC ACID IS AND WHAT IT IS USED FOR
Tranexamic Acid 500mg Tablets (hereinafter referred
to as Tranexamic Acid) are an antifibrinolytic agent
used to reduce bleeding. When you bleed your body
forms clots or plugs as part of healing. In some
people these plugs do not stay in place long enough.
This can cause too much bleeding. Tranexamic acid
helps these plugs to stay in place.
Tranexamic acid can be used to prevent or reduce
bleeding for a short period of time in many different
conditions. You could have been prescribed this
medicine for one of the following reasons:
following prostate surgery
heavy periods
nose bleeds
surgery to the cervix in women
bleeding inside the eye
tooth removal in haemophiliacs
a hereditary disease called angioneurotic oedema
(HANO). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRANEXAMIC ACID
DO NOT TAKE TRANEXAMIC ACID IF YOU HAVE OR HAVE
HAD:
an allergic (hypersensi

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tranexamic Acid 500mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg Tranexamic Acid.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White, capsule shaped tablet embossed with ‘T500’ on one side and
a break
line on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tranexamic
Acid
500mg
Tablets
are
indicated
for
short
term
use
for
haemorrhage or risk of haemorrhage in those with increased
fibrinolysis or
fibrinogenolysis. Local fibrinolysis as occurs in the following
conditions:
1.
a) Prostatectomy and bladder surgery
b) Menorrhagia
c) Epistaxis
d) Conisation of the cervix
e) Traumatic hyphaema
2.
Management of dental extraction in haemophiliacs.
3.
Hereditary angioneurotic oedema.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS
Local Fibrinolysis: The recommended standard dose is 15-25mg/kg
bodyweight (i.e. 2-3 tablets) two to three times daily. For the
indications listed
below the following doses may be used:
1a
Prostatectomy: Prophylaxis and treatment of haemorrhage in high risk
patients should commence pre- or post-operatively with tranexamic
acid injection; thereafter 2 tablets three to four times daily until
macroscopic haematuria is no longer present.
1b
Menorrhagia: Recommended dosage is 2 tablets 3 times daily as long
as needed for up to 4 days. If very heavy menstrual bleeding, dosage
may be increased. A total dose of 4g daily (8 tablets) should not be
exceeded. Treatment with Tranexamic acid should not be initiated
until menstrual bleeding has started.
1c
Epistaxis: When repeated bleeding is anticipated oral therapy (2
tablets
three times daily) should be administered for 7 days.
1d
Cervix Conisation: 3 tablets three times daily.
1e
Traumatic Hyphaema: 2-3 tablets 3 times daily. The dose is based on
25mg/kg three times a day.
2.
Haemophilia: In the management of dental extractions 2-3 tablets
every eight hours. The dose is based on 25mg/kg.
3.