Properties
What is it?
Composition: Active substance: Nicergoline 30mg Excipients: Calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, sodium carboxymethylcellulose; Film coating: Hypromellose, titanium dioxide (E171), polyethylene glycol 6000, iron yellow oxide (E172), silicone. Pharmacological properties Pharmacodynamics: Nicergoline is an ergoline derivative. After oral administration, nicergoline is rapidly and extensively metabolized to form numerous metabolites that also affect various levels of the central nervous system. Indications: Adjunctive therapy for symptomatic treatment of chronic cerebro-organic disorders, as part of the correction of dementia syndrome (Alzheimer's type dementia, Parkinsonian dementia, vascular dementia, multi-infarct dementia and other types of dementia) with the following symptoms: memory impairment, decreased concentration, impaired thinking, rapid fatigue, lack of energy and motivation, affective disorders. Treatment of post-stroke conditions. The primary target group is dementia syndromes with primary degenerative dementia, vascular dementia, and mixed forms of these syndromes. Note: Before starting treatment with nicergoline, you should ensure that these symptoms are not a manifestation of another disease (e.g., therapeutic, psychiatric or neurological profile) and do not require specific treatment. Contraindications: Hypersensitivity to the active substance, other ergot alkaloids or any of the excipients of the preparation, recent myocardial infarction, acute bleeding, risk or tendency to collapse, severe bradycardia (<50 beats/min), orthostatic regulation disorder. Pregnancy: Nicergoline is unlikely to be prescribed to pregnant and breastfeeding women. Use of nicergoline during pregnancy is permissible only if the potential benefit outweighs the potential risk to the patient and fetus. Breastfeeding: Its use during breastfeeding is not recommended. Method of administration and dosage: - For oral administration only. - Unless otherwise prescribed, tablets should be taken during meals, with a small amount of liquid, without chewing. - If the preparation is prescribed for once-daily administration, then a total daily dose of 30 mg (1 coated tablet) is recommended at breakfast. - Since positive dynamics are usually observed 4-6 weeks after the start of treatment, it is recommended to take the preparation for a long period. - The duration of use is not limited when used according to recommendations. At certain intervals (but not less than every 6 months), the doctor should assess the advisability of continuing Sermion® treatment. Dosage: - The recommended daily dose is 30-60 mg per day and can be divided into 1-2 doses. - The dose and duration of treatment depend on the severity of symptoms and the patient's individual response to treatment. - In some cases, therapy may be initiated with parenteral administration and then switched to oral maintenance therapy. Elderly individuals (over 65 years of age): Dose adjustment of the preparation is not required in this category of patients. Patients with impaired renal function: Use of Sermion is recommended at lower doses (see paragraph "Pharmacokinetics"). Side effects: Mental disorders (uncommon): Psychomotor agitation, confusion, insomnia. Nervous system disorders: (uncommon): Somnolence, dizziness, headache; (unknown): Flushing and feeling of warmth. Vascular disorders (uncommon): Decrease in blood pressure (BP), flushing. Gastrointestinal disorders: (frequent): Abdominal discomfort; (uncommon): Diarrhea, nausea, constipation. Skin and subcutaneous tissue disorders: (uncommon): Itching; (unknown): Skin rash. General disorders and local reactions (unknown): Fibrosis, nasal congestion. Laboratory and instrumental data (uncommon): Increased concentration of uric acid in the blood. Overdose: In case of overdose, a sharp decrease in blood pressure is possible. The occurrence and severity of side effects vary among patients. The doctor should assess the severity of intoxication and the necessary measures. Specific treatment is usually not required, the patient only needs a horizontal position for a few minutes. In exceptional cases, in case of a sharp violation of blood supply to the brain and heart, it is recommended to take sympathomimetic agents under constant monitoring of blood pressure. A specific antidote is not known. Interaction with other medicinal products: Nicergoline should be used with caution with the following medications: - Antihypertensive agents: Nicergoline may enhance their therapeutic effect. Nicergoline may enhance the cardiotropic effects of beta-blockers. - Sympathomimetic agents (alpha and beta): Nicergoline reduces the vasoconstrictor effect of sympathomimetic agents, as it is an antagonist of alpha-adrenergic receptors. - Preparations metabolized by CYP 2D6: Since nicergoline is metabolized by cytochrome CYP 2D6, its interaction with preparations metabolized by the same enzyme system is not excluded. Antiplatelet agents and anticoagulants (e.g., acetylsalicylic acid): Increases the effect on hemostasis and thus may prolong bleeding time. - Medications affecting uric acid metabolism: Nicergoline can cause an asymptomatic increase in serum uric acid levels. Special instructions and precautions: - The preparation can cause a decrease in systolic and, to a lesser extent, diastolic pressure in normotensive patients and patients with high blood pressure. Other studies have not confirmed this effect. - Sympathomimetic agents (alpha or beta) should be used with caution in patients taking nicergoline. - Fibrosis (e.g., pulmonary, cardiac, valvular and retroperitoneal) has been observed with the use of certain ergot alkaloids that exhibit agonist activity at 5-HT 2β serotonin receptors. Symptoms of ergotism (including nausea, vomiting, diarrhea, abdominal pain, and peripheral vasoconstriction) have been observed after consumption of certain ergot alkaloids and their derivatives. When prescribing drugs of this class, clinicians and prescribers should be aware of the signs and symptoms of ergot overdose. - If special precautions are taken, nicergoline can be used in patients with mild bradycardia. - Cerebrovascular disorders can also be a manifestation of diseases such as heart failure, arrhythmia, or arterial hypertension. If these diseases are present, it is necessary to start their treatment. - Nicergoline inhibits platelet aggregation and reduces blood viscosity. In patients prone to bleeding disorders, blood coagulation parameters should be regularly monitored. The same monitoring should be carried out at the beginning of treatment with nicergoline in patients taking anticoagulants simultaneously. - Sermion should be used with caution if there is a history of hyperuricemia or gout and/or with drugs that may affect uric acid metabolism and excretion. - Contains less than 1 mmol of sodium (23 mg) per tablet. Patients on a low-sodium diet should be informed that this preparation is essentially sodium-free. Effect on the ability to drive vehicles and operate other potentially dangerous mechanisms: Since hypotension may develop during the administration of the preparation, patients may experience weakness, dizziness, and drowsiness. Individual reactions, mainly at the beginning of therapy or when alcohol is taken concurrently, may affect the preparation. Storage conditions: - At a temperature not exceeding 25°C. - Keep out of reach of children. Shelf life: 3 years. Do not use after the expiry date indicated on the packaging. Conditions for dispensing from pharmacies: Pharmaceutical product group II, dispensed by prescription form No. 3 Manufacturer Pfizer Italia S.R.L. Località Marino del Tronto - 63100 Ascoli Piceno (AP), Italy Marketing authorization holder Viatris Specialty LLC 3711 Collins Ferry Road, Morgantown, WV, 26505, USA