Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Consilient Health Limited, 5<sup>th</sup> Floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland
Cilostazol is indicated for the improvement of the maximal and pain-free walking distances in patients with intermittent claudication, who do not have rest pain and who do not have evidence of peripheral tissue necrosis (peripheral arterial disease Fontaine stage II).
Cilostazol is for second-line use, in patients in whom lifestyle modifications (including stopping smoking and [supervised] exercise programs) and other appropriate interventions have failed to sufficiently improve their intermittent claudication symptoms.
The recommended dosage of cilostazol is 100 mg twice a day.
Cilostazol should be initiated by physicians experienced in the management of intermittent claudication (see also section 4.4).
The physician should reassess the patient after 3 months of treatment with a view to discontinuing cilostazol where an inadequate effect is observed or symptoms have not been improved.
Patients receiving treatment with cilostazol should continue with their life-style modifications (smoking cessation and exercise), and pharmacological interventions (such as lipid lowering and antiplatelet treatment) to reduce the risk of cardiovascular events. Cilostazol is not a substitute for such treatments. Reduction of the dose to 50 mg twice daily is recommended in patients receiving medicines that strongly inhibit CYP3A4, for example some macrolides, azole antifungals, protease inhibitors, or medicines that strongly inhibit CYP2C19, for example omeprazole (see sections 4.4 and 4.5).
There are no special dosage requirements for the elderly.
The safety and efficacy of cilostazol in children have not yet been established.
No dose adjustment is necessary in patients with a creatinine clearance of >25 ml/min. Cilostazol is contraindicated in patients with a creatinine clearance of ≤25 ml/min.
No dosage adjustment is necessary in patients with mild hepatic disease. There are no data in patients with moderate or severe hepatic impairment. Since cilostazol is extensively metabolised by hepatic enzymes, it is contraindicated in patients with moderate or severe hepatic impairment.
Cilostazol should be taken 30 minutes before breakfast and the evening meal. Taking cilostazol with food has been shown to increase the maximum plasma concentrations (Cmax) of cilostazol, which may be associated with an increased frequency of adverse reactions.
Information on acute overdose in humans is limited. The signs and symptoms can be anticipated to be severe headache, diarrhoea, tachycardia and possibly cardiac arrhythmias.
Patients should be observed and given supportive treatment. The stomach should be emptied by induced vomiting or gastric lavage, as appropriate.
5 years.
This medicinal product does not require any special storage conditions.
28 (2x14) or 56 (4x14) tablets in PVC/PVdC//Aluminium blisters in carton box with package leaflet. Not all pack sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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