Tranexamic acid 500mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Tranexamic acid

Disponible des:

Rivopharm (UK) Ltd

Codi ATC:

B02AA02

Designació comuna internacional (DCI):

Tranexamic acid

Dosis:

500mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 02110000; GTIN: 5060388650186

Informació per a l'usuari

Tranexamic Acid 500 mg Film Coated Tablets Ver 12/2017
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
effect not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET:
1. What Tranexamic Acid
is and what it 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 TABLETS
IS AND WHAT THEY ARE USED FOR
Tranexamic Acid
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. WHAT YOU NEED TO KNOW BEFORE YOU

Fitxa tècnica

OBJECT 1
TRANEXAMIC ACID 500 MG FILM COATED TABLETS
Summary of Product Characteristics Updated 26-Jan-2017 | Rivopharm UK
Ltd
1. Name of the medicinal product
Tranexamic Acid 500 mg film coated tablets.
2. Qualitative and quantitative composition
Each film coated tablet contains:
Tranexamic acid 500 mg.
For a full list of excipients, see 6.1.
3. Pharmaceutical form
Tablets.
Tranexamic Acid 500 mg film coated tablets are white to off white,
capsule shaped, biconvex film-coated
tablets. They are marked with TXA 500 with a break line.
4. Clinical particulars
4.1 Therapeutic indications
Tranexamic Acid 500 mg film coated 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
Route of administration: Oral.
_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 per-
or post-operatively with an injectable form; 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. Traumat