This information is intended for use by health professionals

1. Name of the medicinal product

Mylan

Cyklo-f 500 mg film-coated tablets

Boots

Cyklo-f Heavy Period Relief 500mg tablets

2. Qualitative and quantitative composition

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

For a full list of 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

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.

Method of administration

Route of administration: Oral

4.3 Contraindications

• Hypersensitivity to the active substance or any of the excipients listed in section 6.1.

• Mild to moderate renal insufficiency

• 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

• Severe renal impairment (risk of accumulation)

• History of convulsions

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Patients who experience visual disturbance should be withdrawn from treatment.

Cases of convulsions have been reported in association with tranexamic acid treatment. In cardiac surgery, most of these cases were reported following intravenous (i.v.) injection of tranexamic acid in high doses.

4.5 Interaction with other medicinal products and other forms of interaction

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

4.6 Fertility, pregnancy and lactation

Pregnancy

Cyklo-f is contraindicated in pregnancy. Although there is no evidence from animal studies of a teratogenic effect, the usual caution with use of drugs in pregnancy should be observed.

Tranexamic acid crosses the placenta.

Breast-feeding

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

Cyklo-f has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/l0), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥ 1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports, not known (cannot be estimated from the available data).

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

Nervous system disorders

Not known

 

Convulsions particularly in case of misuse (refer to sections 4.3 and 4.4)

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

Signs and symptoms may include nausea, vomiting, orthostatic symptoms and/or hypotension, dizziness, headache and convulsions. 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

Pharmacotherapeutic group: Antihemorrhagics, Antifibrinolytics. ATC code: B02AA02

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.

5.2 Pharmacokinetic properties

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

6.2 Incompatibilities

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 and other handling

No special requirements

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorisation holder

Mylan Products Ltd.,

Station Close,

Potters Bar,

Herts,

EN6 1TL,

United Kingdom.

8. Marketing authorisation number(s)

PL 46302/0124

9. Date of first authorisation/renewal of the authorisation

31/03/2010

10. Date of revision of the text

February 2018