Tranexamic Acid 500mg film-coated Tablets

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

TRANEXAMIC ACID

Tilgængelig fra:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC-kode:

B02AA02

INN (International Name):

TRANEXAMIC ACID 500 mg

Lægemiddelform:

FILM-COATED TABLET

Sammensætning:

TRANEXAMIC ACID 500 mg

Recept type:

POM

Terapeutisk område:

ANTIHEMORRHAGICS

Autorisation status:

Authorised

Autorisation dato:

2007-04-05

Indlægsseddel

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRANEXAMIC ACID 500 MG FILM-COATED TABLETS
Tranexamic acid
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
The product Tranexamic Acid 500 mg film-coated tablets contains the
active substance
tranexamic acid and belongs to a group of medicines called
anti-fibrinolytic drugs.
These are used to stop or reduce unwanted bleeding. When you bleed
your body forms
clots to stop the bleeding. In some people these break down causing
too much bleeding.
Tranexamic acid stops these clots dissolving and so reduces unwanted
bleeding.
Tranexamic acid is used to prevent or reduce bleeding for a short
period of time in many
different conditions. You may have been prescribed it for one of the
following:
•
following prostate surgery (post-prostatectomy).
•
following bladder surgery.
•
heavy periods (menorrhagia).
•
nose bleeds (epistaxis).
•
cervical surgery (conisation of the cervix).
•
bleeding inside the eye (traumatic hyphaema).
•
tooth removal (dental extraction) in haemophiliacs (people who bleed
more easily
than normal). You will know if this refers to you.
•
a hereditary disease called angioneurotic oedema (HANO). A doctor will
have told
you if you have this. 2

Produktets egenskaber

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tranexamic Acid 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg of tranexamic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Off-white, capsule shaped, scored, film-coated tablets.
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
4.
CLINICAL PARTICULARS
_ _
4.1 THERAPEUTIC INDICATIONS
Short-term use for haemorrhage or risk of haemorrhage in increased
fibrinolysis or
fibrinogenolysis. Local fibrinolysis as occurs in the following
conditions:
•
prostatectomy and bladder surgery.
•
menorrhagia.
•
epistaxis.
•
conisation of the cervix.
•
traumatic hyphaema.
•
hereditary angioneurotic oedema.
•
management of dental extraction in haemophiliacs.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
1.
LOCAL
FIBRINOLYSIS:
The
recommended
standard
dosage
is
15-25 mg/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
per-
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 for up to 4 days.
If very heavy menstrual bleeding, dosage may be increased. A total
dose of 4 g
Page 2 of 6
(8 tablets) daily should not be exceeded. Treatment with tranexamic
acid should
not be initiated until menstrual bleeding has started.
1C. EPISTAXIS:
Where recurrent bleeding is anticipated oral therapy (2 tablets three
times daily) should be administered for 7 days.
1D. CONISATION OF THE CERVIX:
3 tablets three times daily.
1E. TRAUMATIC HYPHAEMA:
2-3 tablets three times daily. The dose is based on
25 mg/kg three times a day.
2. HEREDITARY ANGIONEUROTIC OEDEMA:
S