Adjuvant treatment for symptomatic therapy of chronic cerebro-organic disorders.
Composition:
Active substance: Nicergoline 30 mg
Excipients: Calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, sodium carboxymethylcellulose; film coating: hypromellose, titanium dioxide (E171), polyethylene glycol 6000, yellow iron oxide (E172), silicon.
Pharmacological properties
Pharmacodynamics:
Nicergoline is an ergoline derivative. After oral administration, nicergoline is rapidly and extensively metabolized to form several metabolites, which also exert effects at various levels of the central nervous system.
Indications:
Adjuvant treatment for symptomatic therapy of chronic cerebro-organic disorders as part of dementia syndrome management (Alzheimer-type dementia, Parkinsonian dementia, vascular dementia, multi-infarct dementia and other types of dementia) with the following symptoms: memory impairment, reduced concentration, impaired thinking, rapid fatigue, lack of energy and motivation, affective disorders. Treatment of post-stroke conditions. The primary target group includes dementia syndromes with primary degenerative dementia, vascular dementia and mixed forms of these syndromes.
Note: Before initiating nicergoline therapy, it should be ensured that these symptoms are not manifestations of another disease (e.g., therapeutic, psychiatric or neurological conditions) and do not require specific treatment.
Contraindications:
Hypersensitivity to the active substance, other ergot alkaloids or any excipient of the product; recent myocardial infarction; acute bleeding; risk or tendency to collapse; severe bradycardia (<50 beats/min); orthostatic regulation disorders.
Pregnancy: It is unlikely that nicergoline will be prescribed to pregnant or breastfeeding women. During pregnancy, nicergoline should be used only if the potential benefit outweighs the potential risk to the patient and the fetus.
Breastfeeding: its use during breastfeeding is not recommended.
Method of administration and dosage:
- For oral use only.
- Unless otherwise prescribed, tablets should be taken with meals, with a small amount of liquid, without chewing.
- If the drug is prescribed once daily, the recommended total daily dose of 30 mg (1 coated tablet) should be taken at breakfast.
- Since positive dynamics are usually observed 4–6 weeks after initiation of therapy, long-term use is recommended.
- Duration of use is not limited when used according to recommendations. At certain intervals (but at least every 6 months), the physician should assess the advisability of continuing treatment with Sermion®.
Dosage:
- The recommended daily dose is 30–60 mg per day and may be divided into 1–2 doses.
- Dose and duration of treatment depend on the severity of symptoms and the individual patient’s response to therapy.
- In some cases, therapy may begin with parenteral administration followed by transition to oral maintenance therapy.
Elderly patients (over 65 years): no dose adjustment is required in this category.
Patients with impaired renal function: use of Sermion is recommended at lower doses (see section “Pharmacokinetics”).
Side effects:
Psychiatric disorders (uncommon): psychomotor agitation, confusion, insomnia.
Nervous system disorders: (uncommon): drowsiness, dizziness, headache; (unknown): flushing and sensation of heat.
Vascular disorders (uncommon): decreased blood pressure (BP), flushing.
Gastrointestinal disorders: (common): abdominal discomfort; (uncommon): diarrhea, nausea, constipation.
Skin and subcutaneous tissue disorders: (uncommon): itching; (unknown): skin rash.
General disorders and administration site reactions (unknown): fibrosis, nasal congestion.
Laboratory and instrumental data (uncommon): increased blood uric acid concentration.
Overdose:
In case of overdose, a marked decrease in blood pressure may occur. The presence and severity of adverse effects vary among patients.
The physician should assess the severity of intoxication and take necessary measures. Specific treatment is usually not required; the patient only needs to remain in a horizontal position for several minutes. In exceptional cases, in case of severe impairment of cerebral and cardiac blood supply, sympathomimetic agents are recommended under continuous blood pressure monitoring.
No specific antidote is 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 vasoconstrictive effect of sympathomimetics, as it is an alpha-adrenergic receptor antagonist.
- Drugs metabolized by CYP 2D6: since nicergoline is metabolized by cytochrome CYP 2D6, interaction with drugs metabolized by the same enzyme system cannot be excluded. Antiplatelet agents and anticoagulants (e.g., acetylsalicylic acid): increase the effect on hemostasis and may prolong bleeding time.
- Drugs affecting uric acid metabolism: nicergoline may cause an asymptomatic increase in serum uric acid levels.
Special warnings and precautions:
- The drug may cause a decrease in systolic and, to a lesser extent, diastolic blood pressure in normotensive patients and in patients with arterial hypertension. Other studies have not confirmed this effect.
- Sympathomimetic agents (alpha or beta) should be used with caution in patients receiving nicergoline.
- Fibrosis (e.g., pulmonary, cardiac, valvular and retroperitoneal) has been reported with certain ergot alkaloids exhibiting 5-HT2β serotonin receptor agonist activity. Symptoms of ergotism (including nausea, vomiting, diarrhea, abdominal pain and peripheral vasoconstriction) have been reported following the use of certain ergot alkaloids and their derivatives. Prescribers should be aware of signs and symptoms of ergot overdose.
- With appropriate precautions, nicergoline may be used in patients with mild bradycardia.
- Cerebrovascular disorders may also be manifestations of diseases such as heart failure, arrhythmia or arterial hypertension. If these conditions are present, their treatment must be initiated.
- Nicergoline inhibits platelet aggregation and reduces blood viscosity. Patients predisposed to coagulation disorders should have coagulation parameters regularly monitored. The same monitoring should be carried out at the beginning of nicergoline therapy in patients simultaneously receiving anticoagulants.
- Sermion should be used with caution in patients with a history of hyperuricemia or gout and/or in combination with drugs that may affect uric acid metabolism and excretion.
- Contains less than 1 mmol sodium (23 mg) per tablet. Patients on a low-sodium diet should be informed that this product is essentially sodium-free.
Effects on the ability to drive vehicles and operate potentially hazardous machinery:
Since arterial hypotension may develop during treatment, patients may experience weakness, dizziness and drowsiness.
Individual reactions to the drug may occur, especially at the beginning of therapy or when taken together with alcohol.
Storage conditions:
- Store 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 package.
Dispensing conditions: Pharmaceutical product group II, dispensed by prescription form №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
