CYKLOKAPRON

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TRANEXAMIC ACID

Available from:

Meda Health Sales Ireland Limited

ATC code:

B02AA02

INN (International Name):

TRANEXAMIC ACID

Dosage:

500 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

tranexamic acid

Authorization status:

Marketed

Authorization date:

1983-04-01

Patient Information leaflet

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 you 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 KNOW BEFORE YOU TAKE CYKLOK

Summary of Product characteristics

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 macroscopic haematuria 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.
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