Cyklokapron 500mg tablets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Tranexamic acid

Mevcut itibaren:

Viatris UK Healthcare Ltd

ATC kodu:

B02AA02

INN (International Adı):

Tranexamic acid

Doz:

500mg

Farmasötik formu:

Oral tablet

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 02110000; GTIN: 7317510000226

Bilgilendirme broşürü

PATIENT INFORMATION LEAFLET
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.
• In this leaflet, Cyklokapron 500 mg film-coated tablets will be
called Cyklokapron.
WHAT IS IN THIS LEAFLET:
1. What Cyklokapron is and what it is used for
2. What you need to know before you take Cyklokapron
3. How to take Cyklokapron
4. Possible side effects
5. How to store Cyklokapron
6. Contents of the pack and other information.
1. WHAT CYKLOKAPRON IS AND WHAT IT IS USED FOR
Cyklokapron contains the active substance tranexamic acid and 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.
Cyklokapron stops
these clots dissolving and so reduces unwanted bleeding.
Cyklokapron 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. WHA

Ürün özellikleri

OBJECT 1
CYKLOKAPRON TABLETS
Summary of Product Characteristics Updated 29-May-2018 | Mylan
Products Limited
1. Name of the medicinal product
Cyklokapron 500 mg Film-coated Tablets
2. Qualitative and quantitative composition
Each tablet contains Tranexamic acid 500 mg as the active ingredient.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablets.
White, oblong tablets, 8x18 mm, engraved CY with an arc above and
below the lettering, for oral use.
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
4.2 Posology and method of administration
Route of administration: Oral.
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:
1A. PROSTATECTOMY: Prophylaxis and treatment of haemorrhage in high
risk patients should
commence pre- or post-operatively with Cyklokapron Injection;
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 Cyklokapron should not be initiated
until menstrual bleeding has
started.
1C. EPISTAXIS: Where recurrent bleeding is anticipated oral therapy (2
tablets three times daily) should
be administered for 7 days.
1D. CONISATION OF THE CERVIX: 3 tablets three times daily.
1E. 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 patients