Tranexamic acid 500mg tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Tranexamic acid

MAH:

Sovereign Medical Ltd

ATC_code:

B02AA02

INN:

Tranexamic acid

dosage:

500mg

pharmaceutical_form:

Oral tablet

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 02110000; GTIN: 05021730009885

PIL

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PAGE 1 OF 2
Received Date:
23/05/2018
CDL JOB No. :
65458
Required By :
29/05/2018
PRODUCT NAME:
Tranexamic Acid
500 mg Tablets
PIP CODE:
GB 674-5947-APIL
COMPONENT:
Leaflet
SIZE:
148x400 mm
MARKET:
Great Britain
PRODUCT SITE:
TBC
SCALE:
100%
COLOURS:
Black
Pharma Code
DATE:
23/05/2018
FONT SIZE:
11 pt
VERSION NO:
4
AMENDED BY:
VK
PROJECT:
Sovereign Medical
GB 674-5947-APIL
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRANEXAMIC ACID 500 MG TABLETS
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 500 mg Tablets
are and what they are used for
2. What you need to know before you take
Tranexamic Acid 500 mg Tablets
3. How to take Tranexamic Acid 500 mg
Tablets
4. Possible side effects
5. How to store Tranexamic Acid 500 mg
Tablets
6. Contents of the pack and other
information
1. WHAT TRANEXAMIC ACID 500 MG
TABL

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tranexamic Acid 500 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Tranexamic acid 500 mg
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
Each film-coated tablet is white to off-white, oblong, biconvex with a
break
line and marked “TA” on one side of the break line.
The breakline is not intended for breaking the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Short-term use for haemorrhage or risk of haemorrhage in increased
fibrinolysis or fibrinogenolysis. Local fibrinolysis as occurs in the
following conditions:
a)
Prostatectomy and bladder surgery
b)
Menorrhagia
c)
Epistaxis
d)
Conisation of the cervix
e)
Traumatic hyphaema
2.
Hereditary angioneurotic oedema
3.
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:
a)
Prostatectomy: Prophylaxis and treatment of haemorrhage in high risk
patients should commence pre- or post-operatively with intravenous
tranexamic acid injection; thereafter 2 tablets three to four times
daily
until macroscopic haematuria is no longer present.
b)
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.
c)
Epistaxis: Where recurrent bleeding is anticipated oral therapy (2
tablets three times daily) should be administered for 7 days.
d)
Conisation of the cervix: 3 tablets three times daily.
e)
Traumatic hyphaema: 2-3 tablets three times daily. The dose is based
on 25 mg /kg three times a day.
2.
Hereditary angioneurotic oedema
Some patie