Symptoms may be nausea, vomiting, orthostatic symptoms and/or hypotension. Initiate vomiting, then stomach lavage, and charcoal therapy. Maintain a high fluid intake to promote renal excretion. There is a risk of thrombosis in predisposed individuals. Anticoagulant treatment should be considered.
3 years.
- Mild to moderate renal insufficiency
- Hypersensitivity to tranexamic acid or any of the excipients
- Active thromboembolic disease
- A previous thromboembolic event and a family history of thrombophilia.
- Haematuria
- Irregular menstrual bleeding
- Patients being administered warfarin or other anticoagulants
- Patients taking oral contraceptives
Not applicable.
Core
Microcrystalline cellulose (E460)
Hyprolose (E463)
Talc (E553b)
Magnesium stearate (E572)
Colloidal anhydrous silica
Povidone (E1201)
Coating
Methacrylate polymers
Titanium dioxide (E171)
Talc (E553b)
Magnesium stearate (E572)
Macrogol 8000
Vanillin
Film-coated Tablets (Tablets).
White, oblong tablets, 8x18 mm, engraved CY with an arc above and below the lettering.
Gastrointestinal discomfort is the most common undesirable effect that may occur but disappear when the dosage is reduced.
Frequency of undesirable effects at a dose of 4g/day (MedDRA LLT):
|
Gastrointestinal disorders Common (>1/100 to <1/10): |
Nausea, vomiting diarrhoea |
|
Skin and subcutaneous tissue disorders Uncommon (>1/1,000 to <1/100) |
Allergic skin reactions |
Adverse Events:
Other adverse events have been reported with the use of tranexamic acid but the frequency of the reports cannot be estimated from the available data: thromboembolic events, retinal/artery occlusion and impaired colour vision or other visual disturbances.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
Reduction of heavy menstrual bleeding over several cycles in women with regular, 21-35 day cycles with no more than 3 days individual variability in cycle duration.
Tranexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of the activation of plasminogen to plasmin. At much higher concentrations it is a non-competitive inhibitor of plasmin. The inhibitory effect of tranexamic acid in plasminogen activation by urokinase has been reported to be 6-100 times and by streptokinase 6-40 times greater than that of aminocaproic acid. The antifibrinolytic activity of tranexamic acid is approximately ten times greater than that of aminocaproic acid.
A 2001 study involving more than 800 women demonstrated a significant improvement in their quality of life when taking tranexamic acid.
Following oral administration, 1.13% and 39% of the administered dose were recovered after 3 and 24 hours respectively. Tranexamic acid administered parenterally is distributed in a two compartment model. Tranexamic acid crosses the placenta, and may reach one hundredth of the serum peak concentration in the milk of lactating women. Tranexamic acid crosses the blood brain barrier.
Following intravenous administration, the biological half-life of tranexamic acid has been determined to be 1.9 hours and 2.7 hours.
February 2018
Mylan Products Ltd,
Station Close,
Potters Bar,
Hertfordshire,
EN6 1TL,
United Kingdom
Do not store above 25°C.
Blister packs of PVC/PVDC with aluminium foil backing containing 18 tablets.
PL 46302/0124
Each tablet contains 500 mg Tranexamic acid as the active ingredient.
Patients should consult their doctor if menstrual bleeding is not reduced after three menstrual cycles.
Women over the age of 45 years should consult their doctor prior to taking Cyklo-f.
The following patients should consult their doctor prior to initiating treatment with Cyklo-f:
- Patients who are obese and diabetic
- Those with polycystic ovary syndrome or a history of endometrial cancer in a first-degree relative
- Women receiving unopposed oestrogen or tamoxifen
Patients who experience visual disturbance should be withdrawn from treatment.
None known.
Route of administration
Oral.
Posology
Cyklo-f therapy is initiated only once heavy bleeding has started. The recommended dosage is 2 tablets 3 times daily for as long as needed, but for a maximum of 4 days. If there is very heavy menstrual bleeding, the dosage may be increased. A total dose of 4 g daily (8 tablets) should not be exceeded.
Cyklo-f can be used as long as periods remain regular and heavy.
Children: Not for use in children under 18 years of age.
Elderly patients: Not recommended for use in the elderly.
No special requirements
31st March 2010
