Tranexamic acid 500mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Tranexamic acid

Beschikbaar vanaf:

Manx Healthcare Ltd

ATC-code:

B02AA02

INN (Algemene Internationale Benaming):

Tranexamic acid

Dosering:

500mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 02110000; GTIN: 5035559026114

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRANEXAMIC ACID
Tranexamic Acid 500mg Tablets
_(continued overleaf)_
a blood clot, for example in your leg or lungs
kidney failure
fits
any condition which has caused you to have a
blood clot or means that you are at risk of
developing a blood clot.
WARNINGS AND PRECAUTIONS
Tell your doctor if you have or have had:
kidney disease
blood in your urine
any uncontrollable bleeding including menstrual
bleeding
If you take this medicine for hereditary angioneurotic
oedema your doctor may arrange for you to have
regular blood tests to check that your liver is working
properly and may suggest that you have regular eye
tests.
Children under 15 years of age with heavy menstrual
bleeding should consult their doctor before use.
OTHER MEDICINES AND TRANEXAMIC ACID
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
YOU MUST TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE
ALREADY TAKING ANY OF THE FOLLOWING MEDICINES:
fibrinolytics, drugs which help to dissolve blood
clots, such as streptokinase
medicines that may affect the ability of your blood
to clot, or that may increase the risk of clots
forming, such as oestrogens which may be
present in some oral contraceptives and some
hormone replacement therapies.
TAKING TRANEXAMIC ACID WITH FOOD AND DRINK
The tablets should be taken with a glass of water.
The tablets should be swallowed whole. Do not crush
or chew them.
PREGNANCY AND BREAST-FEEDING
Ask your doctor or pharmacist for advice before
taking any medicine.
DRIVING AND USING MACHINES
Tranexamic Acid should not have an effect on your
ability to drive or use machinery. 3. HOW TO TAKE TRANEXAMIC ACID
Always take this medicine exactly as described in this
leaflet or as your doctor has told you. You should
check with your doctor or pharmacist if you are not
sure.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Keep thi

Productkenmerken

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
Description: White caplet shaped tablets marked TXA 26 on one face and
blank on
the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term use for haemorrhage or risk of haemorrhage in increased
fibrinolysis or
fibrinogenolysis.
•
Local fibrinolysis occurs in the following conditions:
Prostatectomy
Menorrhagia
Epistaxis
Conisation of the cervix
Traumatic hyphaema
Management of dental extraction in haemophiliacs
•
Hereditary angioneurotic oedema
4.2
Posology and method of administration
_Posology _
_Adults_:
The recommended standard dose is 15-25 mg / kg body weight (which
generally equates to 2
to 3 tablets), two to three times a day.
The following doses are also suggested for the listed indications:
PROSTATECTOMY:
Prophylaxis and treatment of haemorrhage in high-risk patients should
commence pre or post
operatively with tranexamic acid injection. Thereafter 2 tablets
should be dosed three to four
times a day until macroscopic haematuria is no longer present.
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.
EPISTAXIS:
2 tablets should be dosed three times a day for seven days where
recurrent bleeding is
anticipated.
CONISATION OF THE CERVIX:
3 tablets should be dosed three times a day.
TRAUMATIC HYPHAEMA:
2 to 3 tablets should be dosed three times a day. This dose should be
based on a dose of 25
mg / kg body weight three times a day.
HEREDITARY ANGIONEUROTIC OEDEMA:
2 to 3 tablets should generally be dosed two to three times a day. In
some patients this dosing
should be continuous, b