Sermion: instructions for use, indications, reviews and price

Compound

The composition of the drug Sermion differs slightly depending on the amount of active substance in the composition and on the form of release of the drug.
1 tablet of Sermion contains 5 mg / 10 mg / 30 mg of the active substance nicergoline and auxiliary components: calcium hydrogen phosphate dihydrate, sodium carboxymethylcellulose, magnesium stearate, MCC. The tablet shell consists of: talc, sucrose, sandarac resin, magnesium carbonate, carnauba wax, rosin, acacia resin, titanium dioxide (E171), sunset yellow (E110).

Lyophilisate in the form of powder or white porous mass for the preparation of injection solutions. A solvent is also included - a colorless transparent liquid. Active ingredient: 4 ml of nicergoline . Excipients: tartaric acid and lactose monohydrate. Solvent composition: benzalkonium chloride, sodium chloride, water for injection (up to 4 ml).

Sermion tablets p/o 5 mg No. 15x2

Name

Sermion tablet p/o 5 mg in blister pack. in pack No. 15x2

Main active ingredient

Nicergoline

Release form

pills

Compound

Active substance: nicergoline. One film-coated tablet contains 5, 10 or 30 mg of nicergoline. Other excipients: Tablet core: calcium hydrogen phosphate dihydrate (E341), microcrystalline cellulose (E460), magnesium stearate (E470), sodium carboxymethylcellulose (E466). Tablet shell (for 5 mg and 10 mg tablets): sucrose, talc (E553), acacia gum (E414), sandarac gum, magnesium carbonate (E504), titanium dioxide (E171), rosin, carnauba wax (E903), sunset yellow (E110, for 5 mg tablets); Tablet shell (for 30 mg tablets): hydroxypropyl methylcellulose (E464), titanium dioxide (E171), polyethylene glycol 6000 (E1521), yellow iron oxide (E172), silicone.

Description

Sermion, 5 mg - round, convex, film-coated tablets, orange in color. Sermion, 10 mg - round, convex, film-coated tablets, white. Sermion, 30 mg - round, biconvex, film-coated tablets, yellow. Film-coated tablets 5 mg; 15 tablets in a blister (PVC/PVDC - aluminum foil), 2 blisters and instructions for use in a cardboard box. Film-coated tablets 10 mg; 25 tablets in a blister (PVC/PVDC - aluminum foil), 2 blisters and instructions for use in a cardboard box. Film-coated tablets 30 mg; 15 tablets in a blister (PVC/PVDC - aluminum foil), 2 blisters and instructions for use in a cardboard box.

Dosage

5 mg; 10 mg; 30 mg;

Indications for use

The active substance contained in Sermion is a semi-synthetic derivative of ergot alkaloid, which has a beneficial effect on impaired brain metabolism in older people. The active substance (nicergoline) connects with certain binding sites of various messenger substances produced in the human body and influencing the transmission of impulses between nerve cells. An imbalance in the content of these messenger substances leads to the development of disorders. In this way, Sermion promotes recovery processes in the brain during deficient conditions. Sermion is used as an adjuvant to treat symptoms of brain dysfunction caused by the aging process and cerebrovascular accidents. These disorders may manifest as: • attention deficit disorders and memory impairment; • attention disorders; • decreased motivation; • failure to maintain personal hygiene; • fatigue or dizziness; • reduction or absence of social seclusion, self-isolation). Before starting treatment with Sermion, your attending physician will make sure that these symptoms are not a manifestation of another disease (therapeutic, psychiatric or neurological profile) and do not require specific treatment.

Contraindications

• if you have hypersensitivity (allergy) to the active substance - nicergoline, other ergot alkaloid derivatives or any other component included in the Sermion drug (listed in the Composition section); • if you have recently suffered a myocardial infarction; • in case of acute bleeding; • at risk or tendency to collapse; • with a rare heartbeat; • for dizziness and fainting that occurs in certain circumstances, for example, when standing up quickly

Use during pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Taking into account the indications for use (see section “What is Sermion and in what cases is this drug used”), the use of this drug in pregnant women and breastfeeding women is unlikely and is not intended. Sermion should not be used during pregnancy and breastfeeding.

Directions for use and doses

In all cases, you should strictly follow the doctor's instructions. If you have any doubts about using this medicine, consult your doctor or pharmacist. As a rule, the dose of the drug is 1-2 tablets per day. Accordingly, one tablet is taken during breakfast and, if necessary, the next tablet is taken at dinner. If your doctor has prescribed Sermion one 30 mg tablet per day (for example, if you have impaired kidney function), then it is best to take it with breakfast. The tablets should be taken with meals, without chewing, with a small amount of water. Due to the fact that positive dynamics are usually observed 4-6 weeks from the start of treatment, it is recommended to take the drug for a long period of time. At certain intervals (but not less than every 6 months), the doctor will evaluate the advisability of continuing treatment with Sermion. Children and adolescents under 18 years of age Sermion is not intended for use in children and adolescents under 18 years of age. Patients with impaired renal function Your doctor will prescribe the dose you need. If your kidney function is severely impaired, your doctor may prescribe the drug at a lower dose. The effect of treatment appears gradually. Because treatment is usually given over a long period of time, your doctor will determine at appropriate intervals whether you should continue treatment. If you take more tablets than you should, your blood pressure may drop suddenly or your heart rate may slow down. In this case, you should immediately consult a doctor. Special treatment is usually not required, and in most cases it is enough to take a horizontal position for a few minutes. In exceptional cases, the doctor will take the necessary measures. If you forget to take the drug Do not take a double dose of Sermion to make up for the missed dose and continue to take the drug as directed by your doctor. If you stop taking the drug You should not suddenly stop taking Sermion without first consulting your doctor. If adverse reactions occur, your doctor will discuss possible measures with you, as well as the possibility of prescribing other medications to treat them. If you have any further questions about the use of this drug, consult your doctor or pharmacist.

Side effect

As with other medicines, Sermion can sometimes cause side effects, although not everyone gets them. Common (may affect 1 in 10 people) Complains of abdominal pain. Uncommon (may occur in 1 in 100 people) Hyperactivity, confusion, insomnia, drowsiness, dizziness and weakness, headaches, decreased blood pressure, redness of the skin, constipation, diarrhea, nausea, itching, increased concentration of uric acid in the blood. Not known: frequency cannot be determined from available data Hot flushes, skin rash, painful connective tissue overgrowth (fibrosis), nasal congestion. Reporting side effects If you notice any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. By submitting information about adverse events, you are helping to collect information about the safety of this medicine.

Interaction with other drugs

Tell your doctor or pharmacist if you are currently taking, have recently taken or may take any other medicines. Taking two or more medications may cause drug interactions, even if the drugs are taken at different times. The effects and side effects of these medicines may be increased or decreased. Your doctor will check what medications you are taking and, if necessary, adjust them. Sermion may enhance the effect of medications used to reduce high blood pressure (including so-called “beta blockers”). The vasoconstrictor effect of some drugs on smooth muscles (drugs with symptomatic effect) may be weakened by Sermion. Sermion may prolong blood clotting time, which is increased by acetylsalicylic acid or certain anticoagulants. Caution must be exercised when using Sermion simultaneously with drugs that affect the metabolism and excretion of uric acid (due to the risk of developing gout). Effects of food, drinks and alcohol During treatment with Sermion (as with any other medicines), you should not drink alcohol as the effect may be unpredictable.

Precautionary measures

Before using Sermion, consult your doctor or pharmacist. Sermion should be taken with caution: • with a mild to moderate decrease in heart rate; • if you have a bleeding disorder or are taking medications that inhibit coagulation. In some cases, your doctor may do blood clotting tests more often than usual; • if you have high levels of uric acid in your blood or are taking or have previously taken medicines to treat gout. • simultaneous treatment with sympathomimetics (alpha or beta). Cases of fibrosis of the lungs, heart, heart valves and retroperitoneum have been observed with the use of certain ergot alkaloid derivatives. The following symptoms have been observed following ingestion of certain ergot alkaloids and their derivatives: nausea, vomiting, diarrhea, abdominal pain, and peripheral vasospasm.

Storage conditions

Store the drug at a temperature not exceeding 25°C. Keep the drug out of the reach of children. Do not use the drug after the expiration date indicated on the carton or blister after the word “EXP”. The expiration date is the last day of the specified month. Medicines should not be disposed of in sewers or household waste. Ask your pharmacist for instructions on how to dispose of unused medicines. These measures will help protect the environment.

Release form

5 mg tablets: convex round tablets with an orange coating in blisters of 15 pcs. A cardboard pack contains 2 blisters.
10 mg tablets: convex round tablets with a white coating in blisters of 25 pcs. A cardboard pack contains 2 blisters.
Tablets 30 mg: biconvex round tablets with a yellow coating in blisters of 15 pcs. A cardboard pack contains 2 blisters.
The lyophilisate for the preparation of injection solutions is contained in colorless glass bottles. Also included are ampoules with solvent. One cardboard box contains 4 bottles of lyophilisate and 4 ampoules with solvent.

pharmachologic effect

The medicine improves peripheral and cerebral circulation, and is also an alpha-blocker. The main active ingredient of the drug nicergoline is a derivative of ergoline and improves hemodynamic and metabolic processes occurring in the brain.

The drug reduces platelet aggregation and also improves blood rheology; in addition, it accelerates blood flow in the lower and upper extremities. The improvement in blood flow is due to the alpha 1-adrenergic blocking effect.

Sermion directly affects the cerebral neurotransmitter systems - dopaminergic, noradrenergic and acetylcholinergic, which has a beneficial effect on cognitive processes. With long-term use of the drug, patients experienced a decrease in the severity of behavioral disorders associated with dementia, and the cognitive function of the body also improved.

Nicergoline (sermion) is a hydrated semi-synthetic derivative of ergoline (contains an ergoline core and a bromine-substituted nicotinic acid residue). The pharmacotherapeutic effectiveness of this drug is determined by two main properties: an adrenergic blocking effect, leading to improved blood flow, and a direct effect on the cerebral neurotransmitter systems - noradrenergic, dopaminergic and acetylcholinergic. Nicergoline is used to treat cerebrovascular insufficiency, cognitive impairment in the elderly, including various forms of dementia, as well as a number of other disorders, mainly of a vascular nature [1-4, 9, 16, 18]. The drug was developed in the late 60s of the 20th century, and it began to be used in clinical practice in the 70s, first in Italy and then in other countries [16, 18]. Currently, nicergoline is registered in more than 50 countries (Europe, Asia, Latin America) [18].

In clinical terms, nicergoline was initially considered as a vascular drug that antagonizes α1-adrenergic receptors, and its therapeutic efficacy was associated with vasodilation, decreased vascular resistance, and increased arterial blood flow [1, 8, 16, 18]. Therefore, it was used mainly to treat dementia due to cerebrovascular insufficiency. However, further studies have shown that nicergoline has a much wider spectrum of action - at the molecular and cellular levels, acting not only on blood vessels, but also blood cells (platelets) and neurons [18]. Currently, the drug is used for dementia of various origins (Alzheimer's disease, vascular dementia), cerebrovascular disorders (including stroke, transient ischemic attacks, post-stroke disorders, migraine), peripheral vascular disorders (obliterating atherosclerosis of the vessels of the lower extremities), imbalances of vestibular origin, with glaucoma, Parkinson's disease, as well as benign prostatic hyperplasia [18].

When taken orally, the drug has linear pharmacokinetics, which is practically independent of age; it is quickly and almost completely absorbed in the gastrointestinal tract [1, 18]. Food intake does not have a significant effect on the absorption of nicergoline. Unlike another ergot derivative, hydrergine, nicergoline is excreted primarily in the urine (80%) in the form of metabolites, and only about 20% in feces [1, 18]. In healthy volunteers, it was shown that after taking a tablet drug, its maximum concentration in the blood serum is achieved within 3 hours, and the half-life is about 15 hours [18]. Nicergoline is usually prescribed at a dose of 30 mg 2 times a day, the duration of therapy ranges from 2 to 12 months or more [16, 18]. In Asian countries, nicergoline is usually used in smaller doses (however, like other drugs with similar effects) [18].

Mechanism of action

Data from numerous experimental studies indicate a wide spectrum of action of nicergoline, which explains its effectiveness in diseases of various etiologies and pathogenesis. It improves cognitive functions regardless of the etiology of the disease [6].

When administered nicergoline, there is an increase in regional cerebral blood flow, improvement in glucose utilization processes, and activation of protein synthesis [1, 2, 4, 16, 18]. The nicotinic acid residue contained in the nicergoline molecule has a direct myotropic antispasmodic effect on the muscular lining of blood vessels, especially the vessels of the brain and limbs. The experiment showed that nicergoline reduces vascular resistance of the carotid and vertebrobasilar systems and improves cerebral blood flow and metabolism [18]. A positive effect of a course of nicergoline on lipid metabolism was noted [3].

The improvement in metabolic processes in the brain parenchyma resulting from the action of nicergoline was confirmed by spectroscopy data [18]. At the same time, the literature emphasizes that this drug has a positive effect on the basic, fundamental molecular processes underlying the onset and progression of dementia [16, 18].

One of the mechanisms of action of nicergoline is a disaggregating effect caused by a decrease in platelet aggregation and an increase in the plasticity of erythrocytes, which, in combination with the effect on cerebral vessels, leads to an improvement in regional cerebral blood flow in ischemic tissue [1, 18]. Taking into account the positive effect on platelet and erythrocyte aggregation, nicergoline is considered as a drug that reduces the risk of developing thromboembolic cerebral complications [18].

A study of the state of microcirculation of the bulbar conjunctiva showed that under the influence of a course of treatment with nicergoline, there was an acceleration of blood flow and a decrease in the severity of sludge syndrome [3]. This effect was more often recorded in arterioles and capillaries and less clearly in venules. In ⅓ of the examined patients there was an expansion of conjugate arterioles, reaching 10% of the initial diameter, and in 15-30% of patients (depending on age) there was an increase in the number of functioning capillaries per unit area of the bulbar conjunctiva [3]. In 1/3 of elderly patients in this study, disappearance or reduction of perivascular edema was observed.

Recently, its influence on the processes of neuroplasticity [8, 16, 18] and the mechanisms of neuroprotection [2, 7] has been shown. It is important to note that the neuroprotective properties of nicergoline are not associated with its direct effect on noradrenergic α1 receptors and serotonergic 5-HT1A receptors, but are global in nature. This is to a large extent due to the ability of nicergoline, acting through endogenous neurotrophic factors, to provide the trophic functions of cholinergic neurons [16], which leads to their survival under pathological conditions, including aging [10]. Experimental data indicate an increase in the concentration of nerve growth factor in the frontal regions of the brain in old animals (rats) that received nicergoline [18]. These mechanisms explain the ability of sermion (nicergoline) to slow down the progression of cognitive disorders in vascular pathology of the brain and Alzheimer's disease [6]. Current evidence suggests that nicergoline can “protect” neurons from the toxic effects of beta-amyloid, thereby slowing the progression of Alzheimer’s disease [7].

Experimental studies have shown the neuroprotective effect of nicergoline during hypoxia, even under conditions of hypercapnia, when cerebral vessels are in a state of dilation, indicating its direct effect on the brain parenchyma [8]. Intraventricular administration of nicergoline has been shown to affect both blood pressure and heart rate in anesthetized dogs and also inhibit T- and L-type neuronal calcium channels [8]. The neuroprotective properties of this drug are manifested in the protection of neurons from death under conditions of oxidative stress [16, 18]. When prescribing nicergoline, the processes of lipid peroxidation are reduced and the excessive formation of free radicals is reduced. There is evidence [16] that the antioxidant effect of nicergoline is comparable to the effect of the classical antioxidant tocopherol (vitamin E). Nicergoline also acts on the process of apoptosis [2, 16].

Nicergoline increases the synthesis of acetylcholine by activating choline acetyltransferase, increases the release of acetylcholine from presynaptic terminals, reduces the breakdown of acetylcholine by inhibiting acetylcholinesterase, and also acts on postsynaptic M-cholinergic receptors in the central nervous system [18]. It increases the level of acetylcholine in the cortex and striatum of old animals (rats), while no changes in the level are observed in young animals [15, 18]. In addition, nicergoline restores the age-related decrease in acetylcholine levels in the hippocampus [15, 16, 18]. Inhibition of acetylcholinesterase when using nicergoline is quite comparable to the similar effect of physostigmine, although inferior to the effect of tacrine [16]. A decrease in acetylcholinesterase activity in the brain after intravenous and intraperitoneal administration of nicergoline was confirmed experimentally [18]. The identified changes in the acetylcholinergic system in experimental animals were accompanied by better performance in tests for mnestic functions [18]. The additional positive effect of nicergoline is due to its influence on other neurotransmitter systems (adrenergic, serotonergic) [15, 16].

Animals treated with nicergoline showed an improvement in the performance of tasks associated with mnestic activity [15]. Moreover, the degree of improvement increases with increasing duration of therapy [15].

The nootropic and antiamnestic activity of nicergoline was confirmed in models of experimental cerebral ischemia and using toxic agents that selectively disrupt mnestic functions [18].

Clinical researches

Nicergoline has been successfully used to treat dementia of various origins [1, 9, 11, 16, 18]. The positive effect of the drug in the form of a decrease in the severity of cognitive and behavioral disorders is noted, according to some data, in almost 89% of patients (when a placebo is prescribed, an improvement, usually transient in nature, is observed in 26-50% of cases) [18].

The first studies examining the effectiveness of nicergoline in dementia used the Sandoz Clinical Geriatric Scale (SCAG) and the Clinical Global Impression (CGI) scale for assessment, followed by the Mini-Mental State Examination (MMSE) and the Alzheimer's Disease Assessment Scale (ADAS). ) [18].

The difference in clinical effect between the group of patients receiving nicergoline and those receiving placebo ranges from 5 to 30%, depending on the duration of the course of therapy and the characteristics of the patients included in the study [9].

Safety and Tolerability

The drug is well tolerated [6, 11, 16, 17]. In particular, the nature, frequency of occurrence and severity of adverse reactions in patients receiving nicergoline are quite comparable to the effect of placebo [6, 16, 18]. Moreover, even if side effects occur, they tend to decrease as therapy continues [1]. Among the adverse reactions that are quite typical for the entire class of ergot derivatives, complaints of dry mouth, constipation, and diarrhea should be noted. When taking the drug orally, systolic and diastolic blood pressure do not change significantly, and only sometimes decrease slightly (without a statistically significant difference with patients receiving placebo) [18]. With a single intravenous administration of nicergoline, a decrease in blood pressure was detected already at the 5th minute, which returned to the initial level by the end of the first hour [3]. In this regard, certain caution is emphasized when administering nicergoline intravenously to patients in older age groups [3]. Patients with initially high blood pressure may experience a bursting headache after administration of the drug [3].

As found by B. Winblad et al. [17], in the group of patients receiving nicergoline, side effects requiring discontinuation of treatment were observed in 8.5% of cases, in the group receiving placebo - in 8.3% of cases. During therapy with nicergoline, there are no statistically significant changes in vital functions and laboratory parameters, with the exception of a slight increase in the level of uric acid in the blood serum in some cases, which is not accompanied by any clinical symptoms [16, 17]. However, this must be taken into account in patients with a history of gout.

Thus, nicergoline has been used in clinical practice for almost 40 years. During this time, considerable experience has been accumulated in the use of this drug in conditions of various pathogenesis. And if initially nicergoline was considered as an exclusively “vascular” drug, leading to an improvement in cerebral blood flow due to an antagonistic effect on α1-adrenergic receptors, then a significantly wider spectrum of its action was later demonstrated. Nicergoline has a positive effect on the cholinergic and catecholaminergic neurotransmitter systems, inhibits platelet aggregation, improves cerebral metabolism, increasing the utilization of oxygen and glucose, and has anti-apoptotic, antioxidant and neurotrophic activity. All this allows us to consider nicergoline not only as a symptomatic agent, but also as a drug with a neuroprotective effect. The combination of effectiveness with good tolerability makes the drug Sermion (nicergoline) very popular, especially in neurogeriatric practice.

Pharmacodynamics and pharmacokinetics

Absorption (for tablets)

Once in the human body, nicergoline is absorbed very quickly and with virtually no residue. The rate and degree of absorption of nicergoline practically does not depend on either the dosage form or food intake. When using a dosage of up to 60 mg, the pharmacokinetics of nicergoline is linear, without changing depending on the age of the drug taker.

Distribution and metabolism

The substance nicergoline binds more than 90% to plasma proteins, while the degree of its affinity for serum albumin is less than for the α-acid of the glycoprotein. Nicergoline, as well as its metabolites, can be distributed in blood cells.

The main metabolic products of the substance nicergoline are: 6-methyl-8β-hydroxymethyl-10α-methoxyergoline (MDL, the result of demethylation occurring under the action of the CYP2D6 isoenzyme) and 1,6-dimethyl-8β-hydroxymethyl-10α-methoxyergoline (MMDL, a product formed as a result of hydrolysis).

When nicergoline is administered intravenously or taken orally, the ratio of AUC values for MDL and MMDL indicates apparent first-pass metabolism through the liver. With 30 mg of the drug, Cmax MMDL (21 ± 14 ng/ml) and MDL (41 ± 14 ng/ml) were achieved after 1 and 4 hours, respectively, after which the concentration of MDL decreased with a half-life of 13-20 hours. The studies also confirmed the absence of accumulation of other metabolites in the blood (including MMDL).

Removal

The substance nicergoline is excreted from the body in the form of metabolites , mostly in the urine (about 80%), as well as in feces (about 10-20% of the total dose).

Pharmacokinetics manifested in special clinical cases

Those patients who suffered from severe renal failure

Pharmacological properties of the drug Sermion

Pharmacodynamics. After oral administration, it is quickly and extensively metabolized to form a number of metabolites, which also have an effect at various levels of the central nervous system. Sermion has a positive effect on the emotional state, ability to concentrate and level of vigor. After oral administration, Sermion causes various neuropharmacological effects: it not only increases glucose consumption by brain tissue, enhances the biosynthesis of proteins and nucleic acids, but also affects various neurotransmitter systems. Increased choline acetyltransferase activity and muscarinic receptor density were also observed after prolonged oral administration of Sermion. In addition, in both in vitro and in vivo , nicergoline significantly increased acetylcholinesterase activity. Both after single and long-term oral administration of the drug, the exchange of basal and agonist-sensitive phosphoinositide increases. Sermion also enhances the activity and translocation of Ca-dependent PKC isoforms across the membrane. These enzymes are involved in the mechanism of secretion of soluble amyloid precursor protein, which leads to increased release and decreased production of pathological beta-amyloid, as demonstrated in cultured human neuroblastoma. The antioxidant effect and activation of detoxification enzymes by Sermion protects nerve cells from death due to oxidative stress and apoptosis in experimental models in vivo and in vitro . Sermion attenuates the age-dependent decline in nitric oxide synthetase mRNA in neurons, which improves cognitive function. Pharmacokinetics. Nicergoline is rapidly and almost completely absorbed after oral administration. The peak of serum radioactivity after administration of low doses (4–5 mg) of radiolabeled nicergoline was observed after 1.5 hours. However, with oral administration of therapeutic x doses (30 mg) of 3H-labeled nicergoline, the peak of serum radioactivity in the blood serum was observed after 3 hours. The half-life of the drug is approximately 15 hours (healthy volunteers). The absolute bioavailability of nicergoline after oral administration is approximately 5%, due to high hepatic clearance and first-pass metabolism. After oral administration of nicergoline at therapeutic doses, the AUC values in radioactive serum were 81 and 6%, respectively, for the main metabolites MDL and MMDL (healthy volunteers). Peak plasma concentrations of MDL and MMDL were achieved approximately 1 and 4 hours after dosing with a half-life of 13 and 14 hours. Nicergoline is rapidly hydrolyzed due to binding with esters after intravenous administration. The drug is quickly and extensively distributed in tissues. The volume of distribution of nicergoline was 105 L, which likely reflects the metabolism of the drug in the blood and its penetration into blood cells and/or tissues. Nicergoline binds extensively to plasma proteins (90%), with greater affinity for α-acid glycoprotein than for serum albumin. Urinary excretion is the main route of excretion, since 80% of the total dose of radiolabeled nicergoline is determined in urine and only 10–20% in feces. When administered orally in doses of 30–60 mg, it has been established that the pharmacokinetics of nicergoline is linear. Nicergoline is extensively metabolized before elimination. The main route of metabolism is hydrolysis of ester bonds to form the metabolite MMDL. The following biotransformation leads to the formation of the metabolite MDL by demethylation. The demethylation process occurs with the participation of the catalytic action of the CYP 2D6 isoenzyme. The metabolite MDL is mainly formed, accounting for 50% of the total dose and 74% of the radioactivity detected in urine. As a secondary metabolic pathway, 1-dimethylnicergoline is formed by demethylation (1-DN) and then metabolized by hydrolysis of ester bonds into MDL. In patients with severe renal impairment, there is a significant reduction in urinary MDL secretion.

Indications for use of Sermion

The drug is indicated for:

chronic and acute cerebral vascular and metabolic disorders (occurring as a result of arterial hypertension , atherosclerosis , embolism or thrombosis of cerebral , including vascular dementia , acute transient cerebral circulatory disorder, as well as headache caused by vasospasm );
chronic and acute vascular and metabolic disorders (functional and organic arteriopathy of the extremities , syndromes that manifest themselves as a result of impaired peripheral blood flow, as well as Raynaud's disease );
as an additional remedy during the treatment of hypertensive crisis .

Contraindications

The drug is contraindicated in:

violation of orthostatic regulation;
recent myocardial infarction ;
severe bradycardia ;
acute bleeding;
hypersensitivity to those substances contained in the drug.

The drug should be taken with caution if there is a history of gout or hyperuricemia and/or if the drug must be combined with drugs that interfere with the excretion of uric acid and/or metabolism.

In addition to the above, indications for the use of Sermion tablets have additional restrictions:

the patient's age is under 18 years;
periods of pregnancy and lactation;
deficiency in the body of isomaltase/sucrase, glucose-galactose malabsorption, as well as fructose intolerance.

Side effects

For the nervous system: insomnia or drowsiness occasionally occurs.

For the cardiovascular system: occasionally there is a pronounced decrease in blood pressure (especially with parenteral administration of the drug), fever, dizziness.

For metabolism: an increase in the concentration of uric acid in the blood may occur. This effect does not depend on dosage or duration of treatment.

Other side effects: skin rashes and dyspeptic symptoms occur occasionally.

As a rule, the side effects of the drug are moderate.

Side effects of the drug Sermion

The following non-severe side effects have been reported rarely. From the gastrointestinal tract: constipation, nausea, vomiting, increased acidity of gastric juice, diarrhea, abdominal pain. From the cardiovascular system: arterial hypotension, dizziness, angina attacks, cold extremities, tachycardia. From the side of the central nervous system: dizziness, headache, confusion, drowsiness, insomnia. Allergic reactions: angioedema, itching, skin rash. Reproductive disorders in men: ejaculation disorders. General disorders: feeling of heat, hot flashes, sweating, pain in the limbs, increased body temperature. During clinical studies, an increase in uric acid levels in the blood was observed, which was independent of both the dose used and the duration of treatment.

Instructions for use of Sermion (Method and dosage)

Sermion tablets

The drug is prescribed orally.

For post-stroke conditions, cognitive vascular disorders and chronic cerebral circulatory disorders, Sermion tablets should be taken three times a day, 10 mg. The minimum course of treatment is 3 months, since the therapeutic effect of the drug appears gradually.

For vascular dementia, the medicine Sermion should be taken twice a day, 30 mg. It is recommended to consult with your doctor every 6 months to determine the advisability of continuing the course of treatment.

For ischemic stroke caused by thrombosis , atherosclerosis and embolism of cerebral vessels, acute as well as transient cerebral circulatory disorders (with hypertensive cerebral crises and transistor ischemic attacks ) - the course of treatment is best started with parenteral administration of the drug Nicergoline , after which Sermion is taken orally.

For peripheral circulatory disorders, the medicine should be taken three times a day, 10 mg at a time, for a long time (several months).

Patients who have impaired renal function (serum creatinine level exceeds 2 mg/dL) should take Sermion at a lower therapeutic dosage.

Instructions for use of Sermion lyophilisate

Intramuscularly: 2-4 ml of the drug is administered twice a day (2-4 mg).

Intravenously: the drug is administered slowly at a dosage of 4-8 mg in 100 ml of 5-10% dextrose solution or 0.9% sodium chloride solution. At this dosage, injections with the drug can be given up to several times a day.

sodium chloride solution is injected within 2 minutes .

It is recommended to use the reconstituted solution immediately after preparation.

The duration of therapy, dosage, and method of administration of the drug into the body depend on the disease. Sometimes it is better to start treatment with parenteral administration of the drug, and then switch to oral administration for the purpose of maintenance treatment.

Patients who have impaired renal function (serum creatinine level exceeds 2 mg/dL) Sermion should be taken at a lower therapeutic dosage.

Use of the drug Sermion

5 mg tablets: the recommended dose of the drug is 5–10 mg 3 times a day with equal intervals between doses for a long period of time. Dosage, duration and route of administration of the drug depend on the specific clinical situation. In some cases, it is advisable to begin treatment with parenteral administration of the drug with further continuation of treatment in the form of maintenance oral therapy. 30 mg tablets: the recommended dose of the drug is 1 tablet 1-2 times a day (30-60 mg). The usual daily dose for adults is 30 mg. Temporarily the daily dose can be increased to 60 mg. In case of vascular disorders of the eye or inner ear, the recommended dose is 30 mg per day. The drug should be taken before meals with a small amount of water, without chewing. If the dose is prescribed once a day, it is advisable to take the drug in the morning. Since renal excretion is the main route of elimination (80%) of nicergoline and its metabolites, it is recommended to reduce the dose in patients with impaired renal function (serum creatinine ≤20%). solution for injection : the drug is intended for parenteral use. For intramuscular administration, the recommended dose is 2–4 mg (2–4 ml) 2 times a day (using the supplied solvent). For intravenous administration, the recommended dose of Sermion is 4–8 mg, having previously dissolved it in 100 ml of 0.9% sodium chloride solution or 5% dextrose (glucose) solution. The drug should be administered intravenously slowly. At the doctor's discretion, this dose may be repeated throughout the day. If necessary, Sermion can be administered intra-arterially at a dose of 4 mg in 10 ml of 0.9% sodium chloride solution, slowly, over at least 2 minutes. The dose, duration of treatment and route of administration are determined by the doctor individually.

Interaction

Taking Sermion together with anticholinergic and antihypertensive drugs, the effect of the latter can be enhanced.

If you take the drug simultaneously with cholestyramine or non-absorbable antacids, the absorption of Sermion occurs more slowly.

The drug is metabolized with the direct participation of the CYP 2D6 enzyme, so it may interact with other drugs that are also biotransformed with the help of this enzyme ( Risperidone , Rinidine , and other antipsychotics).

Interactions of the drug Sermion drug Sermion

The drug should be used with caution in combination with:

antihypertensive drugs (nicergoline may potentiate their effects);
drugs that are also metabolized by the cytochrome CYP 2D6 system, since it is impossible to exclude interaction with these drugs (such as quinidine, most antipsychotics, including clozapine, risperidone, haloperidol, thioridazine);
acetylsalicylic acid (bleeding time may prolong);
drugs that affect the metabolism of uric acid (metabolism and excretion of uric acid may change).

Sermion should not be used simultaneously with drugs that excite the central nervous system, α- and β-adrenergic agonists. When used simultaneously with anticoagulant and antiplatelet agents, it is necessary to monitor the indicators of the lightening blood system. The drug may enhance the effects of cholinomimetic drugs.

special instructions

Typically, Sermion, used in therapeutic doses, has no effect on blood pressure. However, those patients who have arterial hypertension may experience a gradual decrease in blood pressure caused by the action of the drug.

If the drug is administered parenterally, patients are advised to lie down for a few minutes immediately after the injection, because arterial hypotension . This is especially true for those patients who have just started treatment with the drug.

The effect of the drug manifests itself gradually, so Sermion must be taken for a long time. Throughout the course of treatment, the doctor must periodically assess the effect of treatment, as well as the advisability of continuing treatment in the future.

The effect on the ability to operate machinery and drive vehicles has not been studied. Therefore, despite the ability of the drug to improve concentration, patients are advised to exercise extreme caution when driving or operating machinery, especially given the nature of the underlying disease.

Special instructions for the use of the drug Sermion

As a rule, Sermion in recommended therapeutic doses does not cause changes in blood pressure levels, however, in patients prone to hypertension (arterial hypertension), the drug can gradually reduce blood pressure levels. At the beginning of treatment, orthostatic hypotension may develop. For the treatment of patients with a history of hyperuricemia or gout and/or during concomitant treatment with drugs that affect the metabolism and excretion of uric acid, Sermion is prescribed with caution. Since approximately 80% of nicergoline metabolites are excreted in the urine, it is recommended to reduce the dose of the drug in patients with impaired renal function (serum creatinine 2 mg/dL or 175 mmol/L). The drug contains lactose, which must be taken into account when prescribing it to patients with congenital lactase deficiency, hereditary galactosemia and impaired absorption of glucose and galactose. The effect of using the drug develops gradually, so Sermion should be taken for a long time. It is advisable to evaluate the effect of therapy every 6 months to decide on the advisability of further use of the drug. While using the drug, you should refrain from drinking alcohol. Children. The drug is not used in children. Use during pregnancy and lactation. Toxicological studies have not demonstrated the teratogenic effect of nicergoline. Based on the indications, the use of the drug during pregnancy and breastfeeding is unlikely. If there are solid indications, the drug should be prescribed after considering the ratio of benefit to the mother/risk to the fetus (child). The ability to influence the reaction rate when driving a vehicle or while working with other mechanisms. Although the clinical effects of Sermion are used to improve concentration, its effect on the ability to drive vehicles and operate potentially dangerous machinery has not been studied. During treatment with the drug, and also taking into account the underlying disease, patients should be careful when driving vehicles or operating other mechanisms.

Reviews about Sermione

You can find a lot of reviews about the drug Sermion on the Internet, and almost all of them are positive. Patients taking the drug report its high effectiveness. Their blood pressure was normalized, the number of migraine attacks gradually decreased, and their headaches stopped hurting. Many reviews about Sermion contain patient reports of increased concentration and improved cognitive functions of the body.

The forum also contains warnings to patients who have taken the pills that this medicine should be taken for a long time, since it only begins to work as it accumulates in the body. In this regard, there were a few patient reviews about Sermion in a negative context - those who took the drug, without seeing the effect, quit the course of treatment.

There are also warnings that this drug is not suitable for children. It should not be taken by children and adolescents under 18 years of age.

Sermion price, where to buy

Depending on the markup of pharmacies and the form of release of the drug, the price of Sermion tablets can vary greatly:

5 mg tablets cost about 550 rubles for 30 pieces. packaged;
10 mg tablets can be found at a price of about 700 rubles per package containing 50 tablets;
the cost of 30 mg tablets is about 1200 rubles per pack of 30 pcs.;
the price of Sermion in ampoules is about 2100 rubles per package.

Online pharmacies in RussiaRussia
Online pharmacies in UkraineUkraine
Online pharmacies in KazakhstanKazakhstan

ZdravCity

Sermion tablets p.p.o.
5mg 30 pcs Phizer Italia Srl RUR 537 order
Sermion tablets p.p.o. 10 mg 50 pcs. Pfizer Italy S.r.L.
690 RUR order
Sermion tablets p.p.o. 30 mg 30 pcs. Pfizer Italy S.r.L.
RUB 1,238 order

Pharmacy Dialogue

Sermion (tab. 10 mg No. 50) Pfizer
RUR 701 order
Sermion (tab. 30 mg No. 30) Pfizer
RUB 1,174 order
Sermion (tab. 10 mg No. 50) Pfizer Italia SrL
RUR 664 order
Sermion (amp. 4 mg No. 4 + solution) Actavis
RUB 2,311 order
Sermion (5 mg tablet No. 30)Pfizer Italia SrL
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RUR 551 order

Pharmacy24

Sermion 30 mg N30 tablets Pfizer Italy S.r.l., Italy
391 UAH.order
Sermion 10 mg N50 tablets Pfizer Italy S.r.l., Italy
310 UAH. order
Sermion 4 mg 4 ml N4 powder Actavis Italy S.p.A., Italy
1101 UAH. order
Sermion 5 mg No. 30 tablets Pfizer Italy S.r.l., Italy
203 UAH order

PaniPharmacy

Sermion tablets Sermion tablets. 10 mg No. 50 Italy, Pfizer Italia
302 UAH. order
Sermion tablets Sermion tablets. 5mg No. 30 Italy, Pfizer Italia
207 UAH. order
Sermion ampoule Sermion lyophilized powder for injection 4 mg No. 4 Italy, Actavis Italia
1164 UAH. order
Sermion tablets Sermion tablets. 30 mg No. 30 Italy, Pfizer Italia
392 UAH. order