Cyklokapron 500 mg Film-coated Tablets

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

TRANEXAMIC ACID PH. EUR.

Disponibbli minn:

Mylan IRE Healthcare Limited

Kodiċi ATC:

B02AA; B02AA02

INN (Isem Internazzjonali):

TRANEXAMIC ACID PH. EUR.

Dożaġġ:

500 milligram(s)

Għamla farmaċewtika:

Film-coated tablet

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

Amino acids; tranexamic acid

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

2006-08-18

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CYKLOKAPRON 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.
The name of your medicine is Cyklokapron 500 mg film-coated tablets,
which will be called
Cyklokapron tablets throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Cyklokapron tablets are and what they are used for
2. What you need to know before you take Cyklokapron tablets
3. How to take Cyklokapron tablets
4. Possible side effects
5. How to store Cyklokapron tablets
6. Contents of the pack and other information.
1. WHAT CYKLOKAPRON TABLETS ARE AND WHAT THEY ARE USED FOR
Cyklokapron tablets contain the active ingredient tranexamic acid,
which belongs to a group of
medicines called antifibrinolytic drugs.
Cyklokapron tablets are used for the short-term treatment or
prevention of haemorrhage (severe
bleeding) for the following conditions:
• Prostatectomy (removal of part or all of the prostate gland)
• Bladder surgery
• Menorrhagia (a heavy and prolonged period in women)
• Epistaxis (nosebleed)
• Conisation of the cervix (removal of part of the cervix to help
diagnosis)
• Traumatic hyphaema (bleeding behind the eye caused by injury)
Cyklokapron tablets are also used:
• Treatment of hereditary angioneurotic oedema (an inherited
condition causing swelling of the face
and hands)
• To prevent severe bleeding after tooth extraction in haemophiliacs
(people with a bleeding disorder)
• To treat severe bleeding of the upper digestive tract.
2. WHAT YOU NEED TO

Karatteristiċi tal-prodott

Health Products Regulatory Authority
30 November 2020
CRN00C21V
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cyklokapron 500 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg Tranexamic Acid.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet
White, capsule-shaped, film coated tablet with the letters CY with
arcs above and below on one side and scored on the other
side.
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
- Management of upper gastrointestinal haemorrhage
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of Administration: Oral
Local fibrinolysis: The recommended standard dosage is 15-25mg/kg body
weight (2-3tablets) 2-3 times daily. For the
indications listed below the following doses may be used:
PROSTATECTOMY: Prophylaxis and treatment of haemorrhage in high risk
patients should commence per-or-post operatively
with Cyklokapron Injection; thereafter 2 tablets (l.0g) 3-4 times
daily until macroscopichaematuria is no longer present.
- MENORRHAGIA: 2-3tablets (l.0-1.5g) 3-4 times daily for 3-4
days.Cyklokapron therapy should be initiated only after heavy
bleeding has started.
- EPISTAXIS: Where recurrent bleeding is anticipated oral therapy (2
(l.0g) tablets 3 times daily) should be administered for 7
days.
- CONISATION OF THE CERVIX: 3(1.5g) tablets 3 times daily.
- TRAUMATIC HYPHAEMA: 2-3 (l.0-1.5g) tablets 3 times a day. The dose
is based on 25mg/kg 3 times a day.
Health Products Regulatory Authority
30 November 2020
CRN00C21V
Page 2 of 5
Hereditary angioneurotic oedema: 2-3 tablets 2-3 times daily
intermittently for some days, or continuously,