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Sermion user manual

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Composition

The composition of the drug Sermion slightly differs depending on the amount of active substance in the composition and on the form of release of the drug.
    Active substance: 5 mg of nicergoline.
    Excipients: 100 mg of calcium hydrogen phosphate dihydrate, 1.3 mg of sodium carboxymethyl cellulose, 1.3 mg of magnesium stearate, 22.4 mg of MCC.
    Sugar capsule of tablets: 10.9mg of talc, 33.35mg of sucrose, 1mg of sandaraka resin, 0.7mg of magnesium carbonate, 0.06mg of carnauba wax, 0.6mg of rosin, 2.7mg of acacia, 0.7mg of titanium dioxide (E171), 0.05 mg of yellow sanset (E110).
    Active substance: 10 mg of nicergoline.
    Excipients: 94.3 mg of calcium hydrogen phosphate dihydrate, 1.3 mg of sodium carboxymethylcellulose, 2 mg of magnesium stearate, 22.4 mg of MCC.
    Sugar capsule of tablets: 10.9mg of talc, 33.35mg of sucrose, 1mg of sandaraka resin, 0.7mg of magnesium carbonate, 0.06mg of carnauba wax, 0.6mg of rosin, 2.7mg of acacia, 0.7mg of titanium dioxide (E171).
    Active substance: 30 mg of nicergoline.
    Excipients: 72.69 mg calcium hydrogen phosphate dihydrate, 1.3 mg sodium carboxymethyl cellulose, 3.61 mg magnesium stearate, 22.4 mg MCC.
    Film coating of tablets: 0.7246 mg of titanium dioxide (E171), 0.0145 mg of silicone, 0.2899 mg of polyethylene glycols 600, 2.8985 mg of hypromellose, 0.0725 mg of yellow iron oxide (E172).
    Lyophilizate in the form of powder or white porous mass for the preparation of injection solutions. Also a solvent is applied - a colorless transparent liquid.
    Active substance: 4 ml of nicergoline.
    Excipients: tartaric acid and lactose monohydrate.
    The composition of the solvent: benzalkonium chloride, sodium chloride, water for injection (up to 4 ml).

Form of issue

    Tablets of 5 mg: convex round tablets with an orange coating in blisters for 15pcs. The cardboard pack contains 2 blisters.
    Tablets of 10 mg: convex round tablets with a white sheath in blisters of 25 pcs. The cardboard pack contains 2 blisters.
    Tablets of 30 mg: biconvex round tablets with a yellow sheath in blisters for 15pcs. The cardboard pack contains 2 blisters.
    Lyophilizate for the preparation of injection solutions is contained in glass colorless vials. Also in the kit are ampoules with a solvent. In one cardboard pack contains 4 vials of lyophilizate and 4 ampoules with a solvent.

pharmachologic effect

The medicine improves peripheral and cerebral circulation, as well as alpha-blocker. The main active substance of the drug (nicergoline) is derived from ergoline and improves the hemodynamic and metabolic processes that occur in the brain.
The drug reduces platelet aggregation, and also improves blood rheology, in addition it accelerates the blood flow in the lower and upper extremities. Improved blood flow is due to alpha 1-adrenergic blocking action.
Sermion directly affects the systems of cerebral neurotransmitters - dopaminergic, norepinephrine, and acetylcholinergic, which has a positive effect on cognitive processes. With prolonged use of the drug in patients, a decrease in the severity of behavioral disorders associated with dementia was observed, and the cognitive function of the organism was also improved.

Indications for use of Sermion

The drug is indicated for:
    chronic and acute cerebral vascular and metabolic disorders (due to arterial hypertension, atherosclerosis, embolism or thrombosis of cerebral vessels, including vascular dementia, acute transient impairment of cerebral circulation, and headache caused by vasospasm);
    chronic and acute vascular and metabolic disorders (functional and organic arteriopathies of the limbs, syndromes that are manifested as a result of peripheral blood flow disturbances, as well as Raynaud's disease);
    as an additional tool during the treatment of hypertensive crisis.

Pharmacodynamics and pharmacokinetics

Suction (for tablets)

Getting into the human body, nicergoline absorbed very quickly and almost without a trace. The speed and degree of absorption of nicergoline practically does not depend on either the dosage form or the food intake. When applying a dosage of up to 60 mg, the pharmacokinetics of nicergoline is linear, unchanged depending on the age of the drug taking.

Distribution and Metabolism

The substance nicergoline binds to more than 90% of the plasma proteins, with the degree of its affinity for serum albumin is less than that of the α-acid glycoprotein. Nicergoline, as well as its metabolites, can spread in blood cells.
The main products of metabolism of nicergoline are: 6-methyl-8β-hydroxymethyl-10α-methoxyergoline (MDL, the result of demethylation occurring under the action of the isoenzyme CYP2D6) and 1,6-dimethyl-8β-hydroxymethyl-10α-methoxyergoline (MMDL, as a result of hydrolysis).
When intravenously injected with nicergoline or taken internally, the ratio of AUC values ​​for MDL and MMDL indicates an apparent metabolism during the "first passage" through the liver. When taking 30 mg of 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. Also in the course of studies, the absence of accumulation of other metabolites in the blood (including MMDL) was confirmed.

Excretion

The substance nicergoline is excreted from the body in the form of metabolites for the most part with urine (about 80%), and with feces (about 10-20% of the total dose).
Pharmacokinetics, manifested in special clinical cases
Those patients who suffered from severe renal insufficiency isolated metabolic products along with urine much less than patients who had normal renal function.

Contraindications

The drug is contraindicated in:
    violation of orthostatic regulation;
    a recent myocardial infarction;
    severe bradycardia;
    acute bleeding;
    hypersensitivity to those substances that are 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 has to be combined with drugs that disrupt uric acid excretion and / or metabolism.
In addition to the above, the indications for the use of Sermion in tablets have additional limitations:
    age of the patient under 18;
    periods of pregnancy and lactation;
    deficiency in the body isomaltase / sugarase, glucose-galactose malabsorption, as well as intolerance to fructose.

Side effects

For the nervous system: occasionally insomnia or drowsiness 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 can occur. This effect does not depend on the dosage or duration of treatment.
Other side effects: occasionally, skin rashes and dyspeptic phenomena occur.
As a rule, the side effects of the drug are expressed moderately.

Instructions for use Sermion (Method and dosage)

Sermion Tablets

The drug is administered orally.
With post-stroke conditions, cognitive vascular disorders and chronic circulatory disorders of the brain, Sermion tablets should be taken three times a day for 10 mg. The minimum course of treatment is 3 months, because the therapeutic effect of the drug is gradually manifested.
With vascular dementia, Sermion should be taken twice a day for 30 mg. It is recommended to consult a doctor every 6 months for the advisability of continuing the course of treatment.
In ischemic stroke caused by thrombosis, atherosclerosis and embolism of cerebral vessels, acute as well as transitory circulatory disorders of the brain (with hypertensive cerebral crises and transistor ischemic attacks), the course of treatment is best started with parenteral administration of the drug Nicergoline, and then take Sermion inside.
When peripheral circulation is disturbed, the drug should be taken three times a day for 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 be taken in a smaller therapeutic dosage of the drug Sermion.

Instructions for the use of lyophilizate Sermion

Intramuscularly: 2-4ml of the drug is administered twice a day (2-4mg).
Intravenously: the drug is administered slowly in a dosage of 4-8 mg in 100ml 5-10% dextrose solution or 0.9% sodium chloride solution. In this dosage, injections of the drug can be made up to several times a day.
Intraarterially: within 2 minutes, 4 mg of the drug in 10 ml of 0.9% sodium chloride solution is injected.
It is recommended to use the reconstituted solution immediately after its preparation.
The duration of therapy, dosage, and the way the drug is administered to the body depends on the disease. Sometimes it is better to start treatment with the parenteral administration of the drug, and then go to the reception inside for the purpose of maintenance treatment.
Patients who have impaired renal function (serum creatinine level is more than 2 mg / dl), Sermion should be taken in a lower therapeutic dosage.

Overdose

Symptom of drug overdose is a pronounced transient decrease in blood pressure.
As a rule, special treatment in cases of an overdose by Sermion is not required, it is enough just to lie down for a few minutes. Infringement of blood supply of heart and brain is extremely rare. In this case it is recommended to introduce sympathomimetic drugs, constantly monitoring blood pressure.

Interaction

Taking Sermion together with anticholinolytic and antihypertensive agents, the effect of the latter can be strengthened.
If you take the drug at the same time as cholestyramine or non-absorbable antacids, Sermion's absorption is slower.
Metabolism of the drug is performed with the direct participation of the enzyme CYP 2D6, so it may interact with other drugs that are biotransformed also with this enzyme (Risperidone, Rinidine, and other antipsychotics).

Terms of sale

You don't need a prescription to buy Sermion online.

Storage conditions

Keep out of reach of children at a temperature not exceeding 25 ° C.
Shelf life - 3 years.

special instructions

Usually, Sermion, used in therapeutic doses, does not affect blood pressure. However, those patients who have arterial hypertension may experience a gradual decrease in blood pressure caused by the drug.
If the drug is administered parenterally, patients are recommended to lie down for several minutes immediately after the injection, because there may be an arterial hypotension. This is especially true for those patients who have just started treatment with the drug.
The effect of the drug appears gradually, therefore, Sermion needs to be taken for a long time. During the entire course of treatment, the physician should periodically evaluate the effect of treatment, as well as the advisability of continuing treatment in the future.
Influence on the ability to manage machinery and driving by road has not been studied. Therefore, despite the property of the drug to improve the concentration of attention, patients are advised to observe extreme caution when driving or controlling mechanisms, especially given the nature inherent in the underlying disease.

In pregnancy and lactation

Studies of the drug Sermion during pregnancy have not been conducted, so it should only be taken under the supervision of the doctor for strict indications for use.
At the time of taking this medicine, you should refrain from breastfeeding, as nicergoline and the products that are formed as a result of metabolism are excreted together with breast milk.

Reviews of Sermion

In the network, you can find many reviews about the drug Sermion, while almost all of them are positive. Patients taking the drug, say about its high efficiency. They had normalized the pressure, the number of migraine attacks gradually decreased, and the head also ceased to hurt. Many reviews of Sermion contain patient reports of increased concentration and improved cognitive functions of the body.
The forum also contains warnings from patients taking pills that this medicine should be taken for a long time, since it starts to act only as it accumulates in the body. In this regard, there were few reviews of patients about Sermion in a negative context - taking the drug, without waiting for the effect, threw a course of treatment.
There are also caveats that this drug is not suitable for children. It can not be taken by children and adolescents, whose age is under 18 years old.