Cyklo-F Heavy Period Relief 500mg Tablets
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 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Patients who experience visual disturbance should be withdrawn from treatment.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 of 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.
Shelf life
6.3
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
Meda Pharmaceuticals Ltd Skyway House Parsonage Road Takeley
Bishop’s Stortford CM22 6PU
8 MARKETING AUTHORISATION NUMBER(S)
PL 15142/0131
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION 31/03/2010
10 DATE OF REVISION OF THE TEXT
13/09/2016