Pletol tablets are indicated for increasing the maximum pain-free walking distance in patients with intermittent claudication who have no pain at rest and no signs of peripheral tissue necrosis (peripheral arterial disease, Fontaine stage II).
Composition
One tablet contains cilostazol 50 mg.
Excipients: corn starch, hydroxymethylpropylcellulose E 5, microcrystalline cellulose 101, magnesium stearate, microcrystalline cellulose 12, carmellose calcium.
Contraindication
Hypersensitivity to cilostazol or any component of the drug; severe renal failure (creatinine clearance ≤ 25 ml / minute); moderate or severe hepatic failure; congestive heart failure; pregnancy; any known tendency to bleeding (for example, active ulcer, recent hemorrhagic stroke (within 6 months), proliferative form of diabetic retinopathy, poorly controlled arterial hypertension); history of ventricular tachycardia, ventricular fibrillation or multifocal ventricular ectopy in patients who have undergone or not undergone appropriate therapy, as well as prolongation of the QT interval; history of severe tachyarrhythmia; concomitant treatment with two or more additional antiplatelet agents or anticoagulants (e.g. acetylsalicylic acid, clopidogrel, heparin, warfarin, acenocoumarol, dabigatran, rivaroxaban or apixaban); unstable angina, myocardial infarction within the last 6 months or coronary intervention within the last 6 months.
Method of application
The recommended dose is 100 mg twice a day. The tablets are taken 30 minutes before meals or 2 hours after meals in the morning and evening.
Taking the drug with food may increase its maximum plasma concentration, which increases the risk of adverse reactions. Significant improvement in the patient's condition is observed after taking the drug for 16-24 weeks, sometimes improvement was noted after treatment for 4-12 weeks. If treatment was not effective within 6 months, the doctor should prescribe another therapy.
Application features
Pregnant women
There are no confirmed data on the use of cilostazol in pregnant women, the potential risk is unknown. Cilostazol may pass into breast milk, accurate data are not available. Given the possible negative effect on the child, the use of the drug during breastfeeding is not recommended. If treatment with cilostazol is necessary, breastfeeding should be discontinued.
Children
The drug is not recommended for use in children due to the lack of data on safety and efficacy.
Drivers
Caution should be exercised, as dizziness is possible when taking the drug.
Overdose
Information on acute overdose is limited. Severe headache, diarrhea, tachycardia, and arrhythmia may occur. Patients should be monitored and treated with supportive care. The stomach should be emptied by inducing vomiting or gastric lavage.
Side effects
From the side of the circulatory and lymphatic system: often - bruising; infrequently - anemia; rarely - prolonged bleeding time, thrombocytosis; isolated cases - bleeding tendency, thrombocytopenia, granulocytopenia, agranulocytosis, leukopenia, pancytopenia, aplastic anemia.
On the part of the immune system: infrequently - allergic reactions.
From the digestive system and metabolism: often - edema (peripheral edema or facial edema); infrequently - hyperglycemia, diabetes mellitus; isolated cases - anorexia.
On the part of the psyche: infrequently - anxiety.
From the nervous system: very often - headache; often - dizziness; infrequently - insomnia, unusual dreams; isolated cases - paresis, hypesthesia.
On the part of the organs of vision: isolated cases - conjunctivitis.
On the part of the organs of hearing: isolated cases - tinnitus.
From the cardiovascular system: often - palpitations, tachycardia, angina pectoris, arrhythmia, ventricular extrasystoles; infrequently - myocardial infarction, atrial fibrillation, congestive heart failure, supraventricular tachycardia, ventricular tachycardia, loss of consciousness, ocular hemorrhages, epistaxis, gastrointestinal hemorrhages, unspecified bleeding, orthostatic hypotension; rare cases - hot flashes, hypertension, hypotension, cerebral hemorrhages, pulmonary hemorrhages, muscle hemorrhages, hemorrhages in the respiratory tract, subcutaneous hemorrhages.
From the respiratory tract: often - rhinitis, pharyngitis; infrequently - shortness of breath, pneumonia, cough; isolated cases - interstitial pneumonia.
Gastrointestinal tract: often - diarrhea, stool disorders; often - nausea, vomiting, dyspepsia, flatulence, abdominal pain; infrequently - gastritis.
On the part of the digestive system: isolated cases - hepatitis, liver dysfunction, jaundice.
Skin and subcutaneous tissue disorders: common: rash, itching; rare: eczema, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.
From the urinary system: rarely - renal failure, impaired renal function; isolated cases - hematuria, pollakiuria.
General disorders: often - chest pain, asthenia; infrequently - muscle pain, chills; rare cases - hyperthermia, malaise, pain.
An increase in the incidence of palpitations and peripheral edema has been observed when cilostazol was used in combination with other vasodilators that can cause reflex tachycardia, such as dihydropyridine calcium channel blockers.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 3 years.
