SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Cyklo-f 500 mg film-coated tablets,

Cyklo-f Heavy Period Relief 500mg tablets

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Each tablet contains 500 mg Tranexamic acid as the active ingredient.

For excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Film-coated Tablets (Tablets).

White, oblong tablets, 8x18 mm, engraved CY with an arc above and below the lettering.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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.

4.2    Posology and method of administration

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.

4.3 Contraindications

•    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

4.4 Special warnings and precautions for use

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Patients who experience visual disturbance should be withdrawn from treatment.

4.5 Interaction with other medicinal products and other forms of interaction

Cyklo-f will counteract the thrombolytic effect of fibrinolytic preparations.

4.6 Pregnancy and lactation

Pregnancy

Cyklo-f is contraindicated in pregnancy. Although there studies of a teratogenic effect, the usual caution with should be observed.

Tranexamic acid crosses the placenta.

Lactation

Tranexamic acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.

Breastfeeding women should consult their doctor prior to taking Cyklo-f.

4.7    Effects on ability to drive and use machines

None known.

4.8    Undesirable effects

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

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.

4.9 Overdose

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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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.

5.3 Preclinical safety data

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.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

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

Not applicable.

6.3    Shelf life

3 years.

6.4    Special precautions for storage

Do not store above 25°C.

6.5    Nature and contents of container

Blister packs of PVC/PVDC with aluminium foil backing containing 18 tablets.

6.6 Special precautions for disposal

No special requirements

7. MARKETING AUTHORISATION HOLDER

Meda Pharmaceuticals Ltd Skyway House Parsonage Road Takeley

Bishop’s Stortford CM22 6PU

8 MARKETING AUTHORISATION NUMBER(S)

PL 15142/0131

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

31/03/2010

DATE OF REVISION OF THE TEXT

07/03/2014