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SPC, UK: CILOSTAZOL Tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Cilostazol 100 mg tablets.

Qualitative and quantitative composition

One tablet contains 100 mg of cilostazol. For the full list of excipients, see section 6.1.

Pharmaceutical form

Tablet. Odourless or almost odourless, white or almost white, round, flat, bevelled edge tablets with no physical faults, no spots and no extraneous matters on the surface of tablet. The tablets are with ...

Therapeutic indications

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 ...

Posology and method of administration

Posology 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 ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe renal impairment: creatinine clearance of ≤25 ml/min Moderate or severe hepatic impairment Congestive ...

Special warnings and precautions for use

The suitability of treatment with cilostazol should be carefully considered alongside other treatment options such as revascularisation. Based on its mechanism of action, cilostazol may induce tachycardia, ...

Interaction with other medicinal products and other forms of interaction

Inhibitors of platelet aggregation Cilostazol is a PDE III inhibitor with anti-platelet activity. In a clinical study in healthy subjects, cilostazol given 150 mg b.i.d. for five days did not result in ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data in the use of cilostazol in pregnant women. Studies in animals have s hown reproductive toxicity (see Section 5.3). The potential risk for humans is unknown. Cilostazol ...

Effects on ability to drive and use machines

Cilostazol may cause dizziness and patients should be warned to exercise caution before they drive or operate machinery.

Undesirable effects

The most commonly reported adverse reactions in clinical trials were headache (in>30%), diarrhoea and abnormal stools (in>15% each). These reactions were usually of mild to moderate intensity and were ...

Overdose

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 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitor excl. heparin. ATC code: B01AC23 From data generated in nine placebo-controlled studies (where 1,634 patients were exposed ...

Pharmacokinetic properties

Absorption Following multiple doses of cilostazol 100 mg twice daily in patients with peripheral vascular disease, steady state is achieved within 4 days. Distribution Cilostazol is 95-98% protein bound, ...

Preclinical safety data

Cilostazol and several of its metabolites are phosphodiesterase III inhibitors which suppress cyclic AMP degradation, resulting in increased cAMP in a variety of tissues including platelets and blood vessels. ...

List of excipients

Cellulose, microcrystalline Maize starch Carmellose calcium Hypromellose 2910 Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

Shelf life: 5 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

28 (2x14) or 56 (4x14) tablets in PVC/PVdC//Aluminium blisters in carton box with package leaflet. Not all pack sizes may be marketed.

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.

Marketing authorization holder

Consilient Health Limited, 5<sup>th</sup> Floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

Marketing authorization number(s)

PL 24837/0048

Date of first authorization / renewal of the authorization

24/04/2014

Date of revision of the text

18/01/2018

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