Cyklokapron

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Tranexamic acid 100 mg/mL;  
Available from:
Pfizer New Zealand Limited
INN (International Name):
Tranexamic acid 100 mg/mL
Dosage:
100 mg/mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Tranexamic acid 100 mg/mL   Excipient: Water for injection
Units in package:
Ampoule, 5mL, 10 dose units
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Kyowa Pharma Chemical Co. Ltd.
Therapeutic indications:
Haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local fibrinolysis may occur in the following conditions: · Prostatectomy and bladder surgery · Menorrhagia · Epistaxis · Conisation of the cervix · Management of dental extraction in patients with coagulopathies · Ulcerative colitis · Haematuria · Gastrointestinal haemorrhage. General fibrinolysis as in prostatic and pancreatic cancer; after thoracic and other major surgery: · in obstetrical complications such as abruptio placentae and post-partum haemorrhage · in leukaemia and liver diseases and in connection with thrombolytic therapy with streptokinase.
Product summary:
Package - Contents - Shelf Life: Ampoule, 5mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C - Ampoule, glass, 10mL - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light
Authorization number:
TT50-2917/1
Authorization date:
1988-07-14

CYKLOKAPRON

CYKLOKAPRON

Tranexamic acid Tablets and Solution for Injection

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about CYKLOKAPRON.

It does not contain all the available

information and it does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you being treated with

CYKLOKAPRON against the

benefits it is expected to have for

you.

Please read this leaflet carefully and

follow the instructions given to you

by your doctor and the advice

contained in this leaflet.

If you have any concerns about

being treated with this medicine,

ask your doctor or pharmacist.

Keep this leaflet.

You may need to read it again.

What CYKLOKAPRON

is used for

CYKLOKAPRON Tablets are used

to prevent excessive bleeding in

patients with:

traumatic hyphaema (bleeding

into the front part of the eye)

blood clotting disorders, who are

having minor surgery

heavy periods

hereditary angioneurotic oedema

(periodic swelling of the throat)

CYKLOKAPRON Solution for

Injection is used to reduce bleeding

and the need for transfusion of blood

in patients undergoing heart surgery,

total knee replacement and total hip

replacement surgery.

How CYKLOKAPRON

works

CYKLOKAPRON contains

tranexamic acid. Tranexamic acid is

an antifibrinolytic that works by

slowing the processes that cause

bleeding.

Before treatment with

CYKLOKAPRON

When CYKLOKAPRON must

not be used

CYKLOKAPRON must not be used

if you:

have an allergy to tranexamic

acid or any of the ingredients

listed at the end of this leaflet.

are being treated for stroke

are being treated for blood clots

in your legs, lungs or anywhere

else in your body.

have a problem with colour vision

that developed after you were

born.

Do not use CYKLOKAPRON after

the expiry date (EXP) printed on

the pack.

Medicine taken after the expiry date

has passed may not work as well.

Do not use CYKLOKAPRON if

the packaging is torn or shows

signs of tampering.

Do not use CYKLOKAPRON to

treat any other complaint unless

your doctor tells you to.

Before treatment with

CYKLOKAPRON

Tell your doctor if you have any of

the following:

you, or someone in your family,

has ever suffered from blood clots

severe bruising

kidney disease with or without

blood in the urine

are pregnant or think you may be

pregnant

are breastfeeding or plan to

breastfeed

irregular periods and the reason is

not known.

Tell your doctor if you have or

have ever suffered from

convulsion, fits or seizures before

you start taking

CYKLOKAPRON.

Convulsions, fits or seizures have

been reported with

CYKLOKAPRON treatment.

Tell your doctor if you have

allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

If you have not told your doctor

about any of these things, tell

him/her before you start treatment

with CYKLOKAPRON.

Do not give this medicine to anyone

else even if they have the same

condition as you.

CYKLOKAPRON

Taking other medicines

Tell your doctor about any other

medicines you are taking including

medicines that you buy without a

prescription, in a pharmacy,

supermarket or health food shop.

Some medicines may interfere with

CYKLOKAPRON. These include:

other medicines used to prevent

bleeding

medicines used to thin the blood.

These medicines may affect the

way CYKLOKAPRON works.

Treatment with

CYKLOKAPRON

How to take CYKLOKAPRON

Tablets

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

Traumatic hyphaema

(bleeding to the front part of

the eye)

Take two or three tablets every 8

hours, for six to seven days.

Swallow the tablets with water.

Heavy periods

Take two or three tablets four times a

day for four days. Start taking the

tablets when you first notice the

bleeding. Take CYKLOKAPRON

tablets for the first four days of your

period. See your doctor for a check

up after three months of treatment. If

the bleeding is not reduced, talk to

your doctor. Swallow the tablets

with water.

Hereditary Angioneurotic

Oedema (periodic swelling

of the throat)

The usual dose is two or three tablets,

2 to 3 times a day. Your doctor will

tell you how long to take the tablets.

Swallow the tablets with water.

For those with a clotting

disorder, having minor

surgery

The usual dose is two or three tablets,

2 to 3 times a day. Your doctor will

tell you how long to take the tablets.

Swallow the tablets with water.

The directions your doctor gives you

should be strictly followed.

If you do not understand the

instructions in this leaflet, ask your

doctor or pharmacist for help.

If you forget to take it

Take your CYKLOKAPRON

Tablet(s) as soon as you remember

and then go back to taking it as you

normally would.

If it is almost time for your next

dose, skip the dose you have missed

and take your next dose when you

are meant to.

Do not try to make up for missed

doses by taking more than one dose

at a time because this may increase

the chance of you getting an

unwanted side effect.

If you have trouble remembering

when to take your medicine, ask your

pharmacist for some hints.

Cyklokapron Solution for

Injection

Cardiac Surgery and Total

Knee or Total Hip

Replacement Surgery

CYKLOKAPRON Solution for

Injection will be administered under

medical supervision to reduce blood

loss during cardiac surgery or during

your knee or hip replacement

surgery.

Your doctor will determine the dose

that you will be given, based on your

weight. The dose used in children

undergoing heart surgery may be

different to the dose used in adult

heart surgery.

The dose may vary depending on

whether you suffer from diseases

relating to the kidneys.

If you take or are given too

much CYKLOKAPRON

(overdose)

CYKLOKAPRON Solution for

Injection will be administered under

medical supervision so an overdose

is unlikely.

Symptoms from taking too much or

being given too much

CYKLOKAPRON include:

dizziness

headache

nausea

diarrhoea

low blood pressure

convulsions, fits or seizures.

Immediately telephone your doctor

or Poisons Information Centre for

advice (in Australia telephone 13

11 26, in New Zealand telephone

0800 POISON (0800 764 766) or go

to Accident & Emergency at your

nearest hospital if you think you or

anyone else has taken too much

CYKLOKAPRON, even if there

are no signs of discomfort or

poisoning.

You may need urgent medical

attention.

Have CYKLOKAPRON or this

leaflet available to give details if

needed.

Keep telephone numbers for these

places handy.

While you being

treated with

CYKLOKAPRON

Things you must do

Tell any other doctors, dentists and

pharmacists that you are being

treated with CYKLOKAPRON.

If you start on any new medicine,

tell your doctor, dentist or

CYKLOKAPRON

pharmacist that you being treated

with CYKLOKAPRON.

Side effects

Tell your pharmacist or doctor as

soon as possible if you do not feel

well while you being treated with

CYKLOKAPRON.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects.

Tell your doctor, nurse or

pharmacist if you notice any of the

following and they worry you:

nausea

vomiting

diarrhoea.

These are the more common side

effects of CYKLOKAPRON.

Mostly these are mild and short-

lived.

Following cardiac surgery, total knee

replacement or total hip replacement

surgery, tell your doctor or nurse

immediately if you experience any of

the following:

irregular and often rapid heart

beat

heart attack

slow or irregular heart beat

cardiogenic shock caused by very

low blood pressure. The

symptoms are dizziness and light

headedness, rapid, weak pulse,

white skin, sweating, restlessness,

loss of consciousness, fainting,

rapid, shallow breathing, cold

clammy skin and weakness

stroke. The symptoms of stroke

are numbness or weakness of the

arms or legs, headache, dizziness

and confusion, visual disturbance,

difficulty swallowing, slurred

speech and loss of speech

kidney problems where you pass

little or no urine, drowsiness,

nausea, vomiting and

breathlessness

difficulty breathing

a condition called deep vein

thrombosis (DVT).

symptoms of DVT are pain and

swelling in the large veins,

usually in your legs. DVT may

lead to complications such as

blood clots in your lungs

bowel infarction caused by a

restriction of blood supply to the

bowels. You may experience

severe abdominal pains and may

pass bloody stools.

These are serious side effects. You

may need urgent medical attention.

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital if you notice

any of the following:

unexpected pain

unexpected swelling in your legs

or arms

giddiness or dizziness

allergic skin reactions

changes in your eyesight

convulsions, fits or seizures

low blood pressure from rapid

administration of

CYKLOKAPRON Solution for

Injection.

These may be serious side effects.

You may need urgent medical

attention.

These side effects are rare.

Other side effects not listed above

may occur in some patients.

Tell your doctor if you notice any

other side effects while being

treated with CYKLOKAPRON.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

After treatment with

CYKLOKAPRON

Storage

Keep your CYKLOKAPRON

tablets in a cool, dry place where

the temperature stays below 30°C.

Do not store CYKLOKAPRON

Tablets or any other medicine in

the bathroom or near a sink.

Do not leave your tablets in the car

on hot days or on a window sill.

Heat and dampness can destroy some

medicines.

Keep your CYKLOKAPRON

Tablets out of reach of children.

A locked cupboard at least one and a

half metres above the ground is a

good place to store medicines.

CYKLOKAPRON Solution for

Injection will normally be stored in a

hospital. The undiluted product

should be stored in a cool, dry place

where the temperature stays below

25°C. Do not freeze. Protect from

light.

This product does not contain

antimicrobial agents. It is for single

use in one patient only.

If storage of the diluted solution is

necessary, it should be stored at 2°C-

8°C for a maximum of 24 hours.

Any unused solution should be

discarded.

Disposal

If your doctor or pharmacist tells

you to stop taking

CYKLOKAPRON Tablets or the

medicine has passed the expiry

date, ask your pharmacist what to

do with any medicine that is left

over.

Remember: this medicine is for

you. Never give it to someone else

even if they have the same

condition as you.

CYKLOKAPRON

Product Description

What it looks like

CYKLOKAPRON Tablets are white,

capsule shaped tablets. The tablets

are scored on one side and marked

with 'CY' on the other.

CYKLOKAPRON Solution for

Injection is a clear and colourless

solution.

Ingredients

The active ingredient in

CYKLOKAPRON is tranexamic

acid.

Each CYKLOKAPRON tablet

contains 500 mg of tranexamic acid.

The inactive ingredients are:

microcrystalline cellulose

hydroxypropylcellulose

talc

magnesium stearate

colloidal anhydrous silica

povidone

water.

Other ingredients that are in the

tablet coating are:

Eudragit E100

titanium dioxide

macrogol 8000

vanillin.

CYKLOKAPRON Tablets do not

contain gluten, sucrose, tartrazine or

other azo dyes.

CYKLOKAPRON Solution for

Injection each contains 100 mg/mL

tranexamic acid.

The inactive ingredient is

Sterile Water for Injections.

Pack sizes

CYKLOKAPRON Tablets are

available in bottles of 100 tablets.

CYKLOKAPRON Solution for

Injection is available in packs of

5 x 5 mL and 10 x 5 mL

ampoules each containing 500 mg

tranexamic acid and 5 mL Water

for Injections (not available in

Australia).

1 x 10 mL and 10 x 10 mL

ampoules each containing 1000

mg tranexamic acid and 10 mL

Water for Injections.

If you want to know more

If you have any questions about your

treatment with CYKLOKAPRON,

ask your doctor or pharmacist.

Supplier

In Australia by

Pfizer Australia Pty Ltd

38-42 Wharf Road

WEST RYDE NSW 2114

Australia

Toll free number: 1800 675 229.

In New Zealand by

Pfizer New Zealand Ltd

PO Box 3998

Auckland

New Zealand

Toll Free Number: 0800 736 363.

Australian Registration

Number

Tablets

500 mg tablet - AUST R 14463.

Solution for Injection

500 mg/5 mL ampoule - AUST R

160658 (not available in

Australia).

1000 mg/10 mL ampoule - AUST

R 166415.

This leaflet was prepared in

December 2013.

Registered trademark

© Pfizer Australia Pty Ltd 2013.

NEW ZEALAND DATA SHEET

1. PRODUCT NAME

CYKLOKAPRON

500 mg tablets.

CYKLOKAPRON

100 mg/mL solution for injection.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 500 mg tablet contains 500 mg tranexamic acid.

Each 5 mL ampoule contains 500 mg of tranexamic acid and 5 mL water for injections.

Each 10 mL ampoule contains 1000 mg tranexamic acid and 10 mL water for injections.

For the full list of excipients, see Section 6.1.

3. PHARMACEUTICAL FORM

CYKLOKAPRON 500 mg tablets are white, capsule shaped, film coated, engraved CY

within arcs, dimensions 8.0 mm x 18.0 mm.

CYKLOKAPRON Solution for injection is a sterile, clear and colourless solution, containing

100 mg/mL tranexamic acid.

4. CLINICAL PARTICULARS

4.1 Therapeutic Indications

Haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local

fibrinolysis may occur in the following conditions:

Prostatectomy and bladder surgery

Menorrhagia

Epistaxis

Conisation of the cervix

Management of dental extraction in patients with coagulopathies

Ulcerative colitis

Haematuria (Tranexamic acid therapy is not indicated in haematuria caused by diseases

of the renal parenchyma (also see Section 4.4)).

Gastrointestinal haemorrhage.

General fibrinolysis as in prostatic and pancreatic cancer; after thoracic and other major

surgery:

in obstetrical complications such as abruptio placentae and post-partum haemorrhage

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in leukaemia and liver diseases and in connection with thrombolytic therapy with

streptokinase.

Hereditary angioneurotic oedema.

For the reduction of peri– and post-operative blood loss and the need for blood transfusion in

adult patients undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty.

For the reduction of peri- and post-operative blood loss and the need for blood transfusion in

paediatric patients undergoing cardiac surgery.

4.2 Dose and Method of Administration

Dose

Intravenous administration is necessary only if it is difficult to give adequate doses by mouth.

The recommended standard dose is 2-3 tablets of 0.5 g, or 5-10 mL by slow intravenous

injection at a rate of 1 mL/minute, two to three times daily. For the indications listed below

the following doses are recommended.

Prostatectomy

5-10 mL by slow intravenous injection every eight hours (the first injection being given

during the operation) for the first three days after surgery; thereafter 1-1.5 g orally three to

four times daily until macroscopic haematuria is no longer present.

Menorrhagia

1-1.5 g orally three to four times daily for three to four days. CYKLOKAPRON therapy is

initiated when bleeding has become profuse.

Epistaxis

1.5 g orally three times daily for four to ten days. CYKLOKAPRON solution for injection

may be applied topically to the nasal mucosa of patients suffering from epistaxis. This can be

done by soaking a gauze strip in the solution, and then packing the nasal cavity.

Haematuria

1-1.5 g orally 2-3 times daily until macroscopic haematuria is no longer present.

Conisation of the Cervix

1.5 g orally 3 times a day for 12 to 14 days post-operatively.

Dental Surgery in Patients with Coagulopathies

Immediately before surgery, 10 mg per kg body-weight should be given intravenously. After

surgery, 25 mg per kg body-weight are given orally three to four times daily for six to eight

days. It may be necessary to administer coagulation factor concentrate. This decision should

be made after consulting a specialist on coagulation.

General Fibrinolysis

1.0 g (10 mL) by slow intravenous injection three to four times daily. With fibrinolysis in

conjunction with diagnosed, increased intravascular coagulation, i.e., defibrillation syndrome,

an anticoagulant such as heparin may be given with caution.

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Hereditary Angioneurotic Oedema

1-1.5 g orally two to three times daily as intermittent or continuous treatment depending on

whether the patient has prodromal symptoms or not.

Intravenous Administration

Adult Cardiac Surgery

After induction of anaesthesia and prior to skin incision, administer a pre-surgical loading

dose of 15 mg/kg tranexamic acid, followed by infusion of 4.5 mg/kg/h for the duration of

surgery. 0.6 mg/kg of this infusion dose may be added in the priming volume of the heart-

lung machine.

Adult Total Knee Arthroplasty

Administration of 15 mg/kg tranexamic acid prior to release of the tourniquet followed by

repeat bolus injection of 15 mg/kg at 8 hourly intervals after the initial dose. The last bolus

dose is to be administered 16 hours after the initial dose.

Adult Total Hip Arthroplasty

Administration of 15 mg/kg tranexamic acid immediately prior to skin incision, followed by a

repeat bolus of 15 mg/kg at 8 hourly intervals after the initial dose. The last bolus dose is to

be administered 16 hours after the initial dose.

Special Populations

Renal Impairment

For patients with impaired renal function, the following dosages are recommended.

Serum creatinine

(micromol/L)

eGFR

(mL/min/1.73m

2

)

Dose IV

Dose Orally

Dose frequency

120-249

60-89

10 mg/kg

15 mg/kg

twice daily

250-500

30- 59

10 mg/kg

15 mg/kg

daily

>500

< 29

5 mg/kg

7.5 mg/kg

daily

Adult Cardiac Surgery

eGFR

(mL/min/1.73m

2

)

Dosage adjustment for Cyklokapron solution for injection

Loading

Prime

Infusion

60-89

15 mg/kg

0.6 mg/kg

3.75 mg/kg/h

30- 59

15 mg/kg

0.6 mg/kg

2.5 mg/kg/h

< 29

15 mg/kg

0.6 mg/kg

1.25 mg/kg/h

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Adult Total Knee Arthroplasty

eGFR

(mL/min/1.73m

2

)

Dosage adjustment for Cyklokapron solution for injection

60-89

Administration of 15 mg/kg tranexamic acid immediately prior to

tourniquet release followed by a repeat bolus of 11.25 mg/kg at 8

hourly intervals after the initial dose. The last bolus dose is to be

administered 16 hours after the initial dose.

30-59

Administration of 15 mg/kg tranexamic acid immediately prior to

tourniquet release followed by a repeat bolus of 8.4 mg/kg at 8

hourly intervals after the initial dose. The last bolus dose is to be

administered 16 hours after the initial dose.

<29

Administration of 15 mg/kg tranexamic acid immediately prior to

tourniquet release followed by a repeat bolus of 6.3 mg/kg at 8

hourly intervals after the initial dose. The last bolus dose is to be

administered 16 hours after the initial dose.

Adult Total Hip Arthroplasty

eGFR

(mL/min/1.73m

2

)

Dosage adjustment for Cyklokapron solution for injection

60-89

Administration of 15 mg/kg tranexamic acid immediately prior to skin

incision followed by a repeat bolus of 11.25 mg/kg at 8 hourly intervals

after the initial dose. The last bolus dose is to be administered 16 hours

after the initial dose.

30-59

Administration of 15 mg/kg tranexamic acid immediately prior to skin

incision followed by a repeat bolus of 8.4 mg/kg at 8 hourly intervals

after the initial dose. The last bolus dose is to be administered 16 hours

after the initial dose.

< 29

Administration of 15 mg/kg tranexamic acid immediately prior to skin

incision followed by a repeat bolus of 6.3 mg/kg at 8 hourly intervals

after the initial dose. The last bolus dose is to be administered 16 hours

after the initial dose.

Elderly

No reduction in dosage is necessary, unless there is evidence of renal failure.

Paediatric Population

Clinical experience with CYKLOKAPRON in menorrhagic children under 15 years of age is

not available.

Paediatric Cardiac Surgery in Patients ≥ 2 Years Old

After induction of anaesthesia and prior to skin incision, administration of 10 mg/kg as an

initial pre-surgical bolus dose followed by a repeat bolus dose of 10 mg/kg during surgery or

as an infusion during surgery.

Tranexamic acid should only be used in the paediatric population ≥ 2 years old. Dose

reduction is recommended for children ≥ 2 years old with mild to moderate renal impairment.

It should not be used in children with severe renal impairment.

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Paediatric population ≥ 2 years with renal impairment

eGFR

(mL/min/1.73m2)

Dosage adjustment for Cyklokapron solution for injection

60-89

Administration of 10 mg/kg tranexamic acid after induction of

anaesthesia and prior to skin incision followed by a bolus dose of

7.5 mg/kg at CPB bypass.

30-59

Administration of 10 mg/kg tranexamic acid after induction of

anaesthesia and prior to skin incision followed by a bolus of

5.6 mg/kg at CPB bypass.

<29

Tranexamic acid should not be used in paediatrics with severe renal

impairment.

Method of Administration

Rapid intravenous injection may cause dizziness and/or hypotension (refer to Section 4.4, 4.8

and Post marketing Report).

Cyklokapron solution for injection is intended for slow intravenous injection and infusion

(see Section 6.6). The recommended rate of administration is 50 mg/min. Undiluted

Cyklokapron solution for injection (100 mg/mL) may be administered at 0.5 mL/min by

intravenous infusion or intravenous injection. Solutions diluted to 1% tranexamic acid (i.e.,

1 g in 100 mL or 10 mg/mL), may be administered at 5 mL/min or solutions diluted to 2%

tranexamic acid, may be administered at 2.5 mL/min by intravenous infusion.

For adult cardiac surgery, a loading dose is administered prior to surgery followed by a

prolonged

infusion

during

surgery.

recommended

rate

prolonged

infusion

4.5 mg/kg patient body weight per hour. For a patient who weighs 100 kg, undiluted

Cyklokapron

solution

injection

(100 mg/mL)

administered

4.5 mL/hour.

Solutions diluted to 1% tranexamic acid may be administered at 45 mL/hour and solutions

diluted to 2% tranexamic acid may be administered at 22.5 mL/hour.

4.3 Contraindications

Patients with a history or risk of thrombosis should not be given tranexamic acid, unless at

the same time it is possible to give treatment with anticoagulants.

Active thromboembolic disease such as deep vein thrombosis, pulmonary embolism and

cerebral thrombosis.

The preparation should not be given to patients with acquired disturbances of colour vision.

If disturbances of colour vision arise during the course of treatment the administration of the

preparation should be discontinued.

Patients with subarachnoid haemorrhage should not be given tranexamic acid as anecdotal

experience indicates that cerebral oedema and cerebral infarction may be caused in such

cases.

Hypersensitivity to tranexamic acid or any of its ingredients.

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4.4 Special Warnings and Precautions for Use

The dose of tranexamic acid should be reduced in patients with renal impairment because of

the risk of accumulation (see Section 4.2). Isolated cases of obstruction of the urinary tract

due to blood clots have been observed when tranexamic acid has been used to treat severe

bleeding from the upper urinary tract.

Tranexamic acid therapy is not indicated in haematuria caused by diseases of the renal

parenchyma. Intravascular precipitation of fibrin frequently occurs in these conditions and

may aggravate the disease. In addition, in cases of massive renal haemorrhage of any cause,

antifibrinolytic therapy carries the risk of clot retention in the renal pelvis.

Although clinical evidence shows no significant increase in thrombosis, possible risk of

thrombotic

complications

cannot

ruled

out.

Venous

arterial

thrombosis

thromboembolism has been reported in patients treated with Cyklokapron. In addition, cases

of central retinal artery and central retinal vein obstruction have been reported. A few

patients have developed intracranial thrombosis with tranexamic acid but further observation

is needed to assess the significance of this potential hazard.

Patients with a high risk for thrombosis (a previous thromboembolic event and a family

history of thromboembolic disease) should use Cyklokapron only if there is a strong medical

indication and under strict medical supervision.

Cyklokapron should not be administered concomitantly with Factor IX Complex concentrates

or Anti-inhibitor Coagulant concentrates, as the risk of thrombosis may be increased.

Blood in body cavities such as pleural space, joint spaces and urinary tract (e.g., renal pelvis,

bladder) may develop ‘indissoluble clots’ in these cavities due to extravascular blood clots

which may be resistant to physiological fibrinolysis.

There are no data on the use of tranexamic acid in women taking oral contraceptive agents.

Patients with irregular menstrual bleeding should not use Cyklokapron until the cause of the

irregularity

been established. If

menstrual bleeding

not adequately reduced

Cyklokapron, an alternative treatment should be considered.

Patients with disseminated

intravascular coagulation (DIC) who require treatment with

Cyklokapron must be under the strict supervision of a physician experienced in treating this

disorder.

Rapid intravenous injection of Cyklokapron solution for injection may cause dizziness and/or

hypotension (see Section 4.2 , 4.8 and Postmarketing experience

)

Convulsions have been reported in association with tranexamic acid treatment.

Renal Impairment

Patients with impaired renal function may experience an increased elimination half life for

drug.

need

dose

reduction

recommended

adult

patients

with

renal

impairment.

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Dose reduction is recommended in children ≥ 2 years old who are mildly or moderately

renally

impaired. Tranexamic acid

not recommended

children who are severely

impaired (see

Section 4.2).

For both the adult and the paediatric patient, an eGFR ≥ 90 mL/min/1.73 m

usually indicates

kidney function within a ‘normal range’, but does not exclude patients with early kidney

damage. If renal impairment is suspected, informed dose alterations decision may include

other estimates of renal function including consultation with an experienced renal physician

Paediatric Population

Clinical experience with Cyklokapron in menorrhagic females under 15 years of age is not

available.

Clinical experience in the paediatric population < 2 years old is limited and tranexamic acid

should only be used if the benefit outweighs the risk. The benefit of an antifibrinolytic drug

in neonates and infants aged < 2 year old is questionable, as bleeding under CPB in this

population is more related to the immaturity of the coagulation system than fibrinolysis.

Published efficacy and safety data is inconclusive in neonates and infants aged < 2 years old.

Due to the physiological characteristics of neonates and infants (immaturity of the blood-

brain barrier and renal function), as well as the generalised inflammatory state related to

CPB, there may be a potential risk of cerebral exposure to tranexamic acid evoking epileptic

seizure (see Section 4.2 ).

4.5 Interaction With Other Medicines and OtherForms of Interactions

Clinically

important

interactions

have

been

observed

with

tranexamic

acid

tablets.

Because of the absence of interaction studies, simultaneous treatment with anticoagulants

must take place under the strict supervision of a physician experienced in this field.

4.6 Fertility, Pregnancy and Lactation

Pregnancy

Australian Pregnancy Categorisation:

Drugs which have been taken by only a limited number or pregnant women and women of

childbearing age, without an increase in the frequency of malformation or other direct or

indirect harmful effects on the human foetus having been observed.

The long-term clinical experience is limited to 21 pregnant women, treated for one to

18 weeks, in most cases to prevent further haemorrhage in connection with ablatio placentae.

All women delivered alive and normal children except for prematurity. The short-term

experience comprises 67 women with abruptio placentae treated with a single dose just

before

delivery

caesarean

section.

deliveries

went

well

were

further

complicated by haemorrhage.

There are no adequate and well-controlled studies in pregnant women. However, tranexamic

acid is known to cross the placenta and appears in cord blood at concentrations approximately

equal to maternal

concentration. Because animal reproduction

studies are

not always

predictive of human response, Cyklokapron should be used during pregnancy only if clearly

needed.

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Lactation

Tranexamic acid is secreted in the mother's milk at a concentration of about a hundredth of

the corresponding serum levels but is not likely to influence the child at therapeutic doses.

Fertility

Reproduction studies performed in mice, rats and rabbits have not revealed any evidence of

impaired fertility or adverse effects on the foetus due to tranexamic acid.

4.7 Effects on Ability to Drive and Use Machinery

Tranexamic acid may cause dizziness and therefore may influence the ability to drive or use

machines.

4.8 Undesirable Effects

Gastrointestinal discomfort occurs in more than 30% of patients after oral administration of

6 g/day. The discomfort disappears when the dose is reduced.

Common side effects (1 to < 10%)

Gastrointestinal tract:

Nausea, vomiting, diarrhoea.

Uncommon side effects (0.1 to < 1%)

Skin and subcutaneous tissue:

Allergic skin reactions.

Intravenous Administration

The safety of tranexamic acid via intravenous administration was established by pooling

published studies comprising a total of 5736 adult tranexamic acid patients undergoing

cardiac surgery, total knee or hip arthroplasty. The adverse events are reported by system

organ class with frequencies expressed as a percentage of patients treated. These should be

interpreted within the surgical setting.

Adult Cardiac Surgery

Safety data were compiled by pooling 43 published studies comprising 2797 adult patients

undergoing low risk cardiac surgery and 1055 adult patients undergoing high risk cardiac

surgery. Low risk cardiac surgery is defined as CABG, valve replacement surgery or

multiple procedures involving both CABG and valve replacement. High risk cardiac surgery

includes repeat CABG, repeat valve replacement, atrio-septal repair or surgical repair of

aortic dissection or aneurysm.

Patients receiving tranexamic acid patients were treated with total doses that varied from

< 20 mg/kg to 100 mg/kg. Patient characteristics for the cardiac surgical demography were

similar for the control group and the tranexamic acid treated group.

The frequency of adverse events by most relevant body system for all patients undergoing

low and high risk cardiac surgery is provided in Table 1. The commonly reported (≥ 1% to

< 10%) complications in association with tranexamic acid were renal; cardiac; respiratory,

thoracic and mediastinal disorders. In low risk cardiac surgery, the adverse events were

similar

tranexamic

acid

treated

patients

control

group.

high

risk

procedures, the risk of patients experiencing an adverse event was 3 fold greater in the

tranexamic acid treated patients compared to the non-active control group.

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The marked difference in adverse events in the high risk surgical group between the non-

active control group and the tranexamic acid group was driven by the results of two published

studies which contributed 782 of the 1055 patients. These patients, described as high risk

surgical patients, had an average risk of mortality at least twice the norm for isolated primary

CABG and a risk of repeat surgery exceeding 5%. More than 45% of these patients also

presented with FC III angina and CHF. As safety data for the tranexamic acid treated high

risk patient population were collected against active comparators, the incidences of adverse

events in these patients should be interpreted compared to active comparators. Frequency of

adverse events reported for this patient population and surgical setting in tranexamic acid

treated patients versus active comparators are presented in Table 2.

Fatal events

Overall, there was a trend towards a lower risk of mortality in all cardiac surgery patients

receiving tranexamic acid compared to the control group with the rates almost halved in high

risk surgery patients.

Cardiac disorders

For patients undergoing low risk surgery, the incidence was higher in the tranexamic acid

group compared to the control group. For patients undergoing high risk surgery, the

incidence was higher. The most commonly reported adverse events were cardiogenic shock

and myocardial infarction.

Nervous System disorders

The most commonly reported Central Nervous System disorder reported in published studies

for all adult cardiac surgery patients is stroke. The incidence of stroke was higher in patients

undergoing high risk than low risk cardiac surgery in both the tranexamic acid treated group

control

group.

unknown

whether

this

increased

risk

cerebrovascular thromboembolic events.

Renal disorders

The majority of renal disorders reported in published studies for all cardiac surgery patients

were renal dysfunction and renal failure. Renal disorders occurred more frequently in

patients undergoing high risk surgery than low risk surgery. These were also reported more

frequently in the tranexamic acid treatment groups than in the control groups. The reason for

increased

incidence

renal

disorders

tranexamic

acid

treatment

groups

unknown.

Table 1: Adverse events ≥ 1%

in adult patients undergoing low and high risk cardiac

surgery as reported in published studies

Control

Tranexamic acid

Low risk

surgery

(N= 1040)

High risk

surgery

(N = 207)

Low risk

surgery

(N= 2797)

High risk

surgery

(N= 273)

High risk

surgery & high

risk patients

1

(N= 1055)

Fatal

death

0.8%

6.8%

1.0%

2.2%

3.6%

Cardiac disorders

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Control

Tranexamic acid

Low risk

surgery

(N= 1040)

High risk

surgery

(N = 207)

Low risk

surgery

(N= 2797)

High risk

surgery

(N= 273)

High risk

surgery & high

risk patients

1

(N= 1055)

arrhythmia

atrial fibrillation

cardiogenic shock

10.6

heart block

myocardial infarction

Nervous system

disorders

stroke

Respiratory, thoracic &

mediastinal disorders

respiratory failure

Renal disorders

renal dysfunction/

impairment

renal failure

13.6

renal insufficiency

Control group = Placebo or no antifibrinolytic treatment

782 of the 1055 patients are high risk cardiac surgery patients. Also refer to Table 2.

Table 2: Adverse events ≥ 1% for adult high risk patients undergoing high risk

cardiac surgery treated with tranexamic acid versus active comparator

Aprotinin

1

*

(N = 907)

EACA

1

*

(N = 780)

Tranexamic acid

(N = 1055)

1

Fatal

death

6.1%

4.0%

3.6%

Cardiac disorders

cardiogenic shock

myocardial infarction

12.4

15.3

10.6

Nervous System disorders

stroke

Vascular

DVT or pulmonary embolism

Respiratory, thoracic & mediastinal

disorders

respiratory failure

10.6

12.6

Renal disorders

renal dysfunction

renal failure

12.0

14.2

12.8

16.9

13.6

*

Aprotinin and EACA are not available in Australia; EACA = ε-aminocaproic acid

779 of 907 aprotinin, all 780 EACA and 782 of 1055 tranexamic acid patients are high risk cardiac surgery

patients.

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