Tablets: almost white or white, round, flat, with a facet, without or almost inodorous; on one of the parties an engraving (on 25/37,5/50/75 mg respectively) "Е 744", "Е 741", "Е 742" or "Е 743" (on 10 pieces in blisters, on 1-3 or 6 blisters in a cardboard pack; on 14 pieces in blisters, on 2 blisters in a cardboard pack);
Capsules of the prolonged action: gelatinous firm, self-closed, with the transparent colourless case and an orange-brown lid; contents of capsules – mix of yellow and white pellets, without or almost inodorous (on 10 pieces in blisters, on 3 blisters in a cardboard pack; on 14 pieces in blisters, on 2 blisters in a cardboard pack).

Is a part of 1 tablet:

Active agent: венлафаксин (in the form of a hydrochloride of a venlafaksin) – 25, 37,5, 50 or 75 mg;
Auxiliary components (on 25/37,5/50/75 mg respectively): monohydrate of lactose – 56,62/84,93/113,24/169,86 mg, microcrystallic cellulose – 24/36/48/72 mg, glikolit starch of sodium (type A) – 8,4/12,6/16,8/25,2 mg, anhydrous colloid silicon dioxide – 0,9/1,35/1,8/2,7 mg, magnesium stearate – 1,8/2,7/3,6/5,4 mg.

Is a part of 1 capsule:

Active agent: венлафаксин (in the form of a hydrochloride) – 75 or 150 mg;
Auxiliary components: microcrystallic cellulose, ethyl cellulose, sodium chloride, диметикон, talc, коповидон, potassium chloride, xanthane gum, anhydrous colloid silicon dioxide, iron oxide yellow.

Structure of gelatin capsules: iron oxide yellow and red, titanium dioxide, gelatin.

Indications to use

Velaksin appoint at depressions of various etiology, including a condition of alarm (treatment and prevention).

Contraindications

Absolute:

Heavy functional disturbances of kidneys (at a glomerular filtration rate <10 ml a minute);
Heavy abnormal liver functions;
Simultaneous use with monoamine oxidase inhibitors;
Age up to 18 years (safety and efficiency of use of drug for this category of patients is not studied);
The pregnancy (established or assumed) and the lactation period;
Hypersensitivity to drug components.

Relative (Velaksin it is necessary to take with caution in the presence of the following diseases / states):

Spasms in the anamnesis;
Recently postponed myocardial infarction;
Arterial hypertension;
Unstable stenocardia;
Tachycardia;
Closed-angle glaucoma;
Increase in intraocular pressure;
Predisposition to bleedings from mucous membranes and integuments;
Maniacal states in the anamnesis;
Initially low body weight.

Women of childbearing age during treatment should apply reliable methods of contraception. During the planning or approach of pregnancy it is necessary to see a doctor.

Route of administration and dosage

Tablets

Velaksin accept inside, it is more preferable – during food.

Drug is recommended to accept daily on 75 mg a day in 2 receptions. If after several weeks of therapy considerable improvement is not observed, it is possible to increase a single dose to 75 mg, without changing at the same time frequency rate of reception. At the heavy depressive frustration or other states demanding hospitalization, the doctor at the beginning of therapy can appoint a daily dose of 150 mg at once in 2 receptions then it is possible to increase it each 2-3 days by 75 mg before achievement of necessary therapeutic effect.

The maximum dose of Velaksin – 375 mg a day. After achievement of desirable therapeutic effect the daily dose should be lowered to the smallest effective level gradually.

The supporting treatment can continue 6 months and more. Velaksin appoint in the smallest effective dose applied to treatment of depressive episodes.

At a renal failure, depending on its severity, apply the following modes of dosing:

Easy degree (at a glomerular filtration rate> 30 ml a minute): correction of the mode of dosing is not required;
Average degree (at a glomerular filtration rate of 10-30 ml a minute): reduction of a dose by 25-50% is required, at the same time the daily dose needs to be accepted once a day;
Heavy degree (at a glomerular filtration rate <10 ml a minute): it is not necessary to apply Velaksin.

The patients who are on a hemodialysis after completion of a session can receive 50% of an average daily dose of a venlafaksin.

At a liver failure, depending on its severity, apply the following modes of dosing:

Easy degree (at a prothrombin time it is less than 14 seconds): correction of the mode of dosing is not required;
Moderate degree (at a prothrombin time of 14-18 seconds): reduction of a dose by 50% is required;
Heavy degree: it is not necessary to apply Velaksin.

Elderly patients need to carry out therapy with care that is connected with probability of functional disturbances of kidneys. Usually appoint the smallest effective dose. At increase in a dose of the patient has to be under careful medical observation.

After the end of treatment Velaksin's dose needs to be reduced gradually, at least, for 7 days. At this time observation of a condition of the patient is necessary to minimize the risk connected with drug withdrawal.

The period which is necessary for complete cessation of reception of Velaksin, is defined by the size of the accepted dose, duration of a course of therapy and specific features of the patient.

Capsules of the prolonged action

Capsules Velaksin accept inside, entirely (they cannot be crushed, divided, placed in water or to chew), washing down with liquid, it is more preferable – during food.

The daily dose should be accepted in 1 reception, it is desirable at the same time day (in the morning or in the evening).

The recommended initial dose – 75 mg a day. At the heavy depressive frustration or other states demanding hospitalization, the doctor can appoint 150 mg at once a day then the dose with an interval of 14 days or can be increased by 75 mg more (but is not more often than in 4 days), the necessary therapeutic effect will not be reached yet.

The maximum dose of Velaksin – 350 mg a day. After achievement of desirable therapeutic effect the daily dose can be lowered to the minimum effective level gradually.

For treatment of a depression drug should be used for not less than 6 months. At the stabilizing therapy and for prevention of a recurrence or new episodes of a depression Velaksin appoint in the doses which showed the efficiency. The doctor has to regularly, at least 1 time in 3 months, to control efficiency of the carried-out treatment.

The patients accepting Velaksin in the form of tablets can be transferred to administration of drug in the form of capsules of the prolonged action with purpose of an equivalent dose once a day. However individual dose adjustment in certain cases can be required.

The drug dosing mode in the form of capsules of the prolonged action at a renal or liver failure, and also the recommendation concerning Velaksin's use by elderly patients and cancellations of therapy correspond to that at purpose of the tableted drug form.

Side effects

The majority of side effects during Velaksin's use depends on a dose. At long therapy the frequency and weight of most of them decreases, at the same time need of cancellation of therapy does not arise.

During treatment the following disturbances can be observed (<1/10 and> 1/100 – it is frequent, <1/100 and> 1/1000 – infrequently, <1/1000 and> 1/10 000 – it is rare, <1/10 000 – it is very rare):

Cardiovascular system: expansion of blood vessels (rushes of blood), arterial hypertension, cardiopalmus; infrequently – a faint, orthostatic hypotension, tachycardia; very seldom – lengthening of an interval of QT, arrhythmia like "pirouette", fibrillation of ventricles, ventricular tachycardia;
Central and peripheral nervous system: often – dizziness, a headache, excitement, sleeplessness, drowsiness, uneasiness, unusual dreams, confusion of consciousness, increase in a muscle tone, paresthesia, a tremor; infrequently – hallucinations, apathy, a myoclonus; seldom – disturbances of the speech, an ataxy, a hypomania or a mania, a serotonergic syndrome, the symptoms reminding a malignant antipsychotic syndrome, convulsive attacks; very seldom – nonsense, extrapyramidal frustration (including dystonia, dyskinesia, late dyskinesia), an akathisia / psychomotor excitement;
System of a hemopoiesis: infrequently – hemorrhages in skin (ecchymomas) and mucous membranes; seldom – lengthening of a bleeding time, thrombocytopenia; very seldom – aplastic anemia, an agranulocytosis, a pancytopenia, a neutropenia;
Urinary system: infrequently – an ischuria;
Alimentary system: a loss of appetite, dryness in a mouth, a lock, vomiting, nausea, an abdominal pain; infrequently – reversible increase in activity of liver enzymes, a bruxism; seldom – gastrointestinal bleedings; very seldom – hepatitis;
Musculoskeletal system: mialgiya, arthralgia; infrequently – a muscular spasm; very seldom – рабдомиолиз;
Reproductive system: disturbances of an erection, ejaculation, anorgazmiya; infrequently – a menorrhagia, disturbances of a menstrual cycle, decrease in a libido; seldom – a galactorrhoea;
Metabolism: body degrowth, increase in level of cholesterol of blood serum; infrequently – disturbance of hepatic tests, a hyponatremia, a syndrome of insufficient secretion of antidiuretic hormone; very seldom – increase in level of prolactin;
Sense bodys: mydriasis, accommodation disturbances, sonitus, vision disorders; infrequently – disturbance of flavoring feelings;
Allergic reactions: rash, skin itch; infrequently – makulopapulezny rash, a Quincke's disease, a small tortoiseshell; seldom – a mnogoformny erythema, Stephens-Johnson's syndrome;
Dermatological reactions: the increased sweating; infrequently – a photosensitization; seldom – an alopecia;
Organism in general: fervescence, fatigue, weakness, fever.

At children during therapy the following side effects were noted: ecchymomas, refusal of meal, abdominal pain, stethalgia, tachycardia, decrease in body weight, nausea, lock, nasal bleeding, mydriasis, dizziness, mialgiya, emotional lability, hostility, tremor, suicide thoughts.

After a dose decline or sharp cancellation of Velaksin development of fatigue, drowsiness, a headache, vomiting, nausea, anorexia, dryness in a mouth, dizzinesses, diarrheas, concerns, sleeplessnesses, nervous irritability, alarm, a disorientation, a hypomania, paresthesias, perspiration is possible. As a rule, these symptoms are expressed poorly and pass independently. Because of probability of development of these disturbances it is very important to reduce a drug dose gradually, in particular after performing treatment in high doses.

Special instructions

Before therapy at patients with depressive frustration it is necessary to consider probability of suicide attempts. For reduction of risk of overdose and/or abuse in an initiation of treatment it is necessary to give only a small amount of capsules or tablets, and the patient has to be under careful medical observation.

There were messages on an agressive behavior during administration of drug (in particular in an initiation of treatment and after the therapy termination).

Velaksin's use can cause the psychomotor excitement which is clinically reminding an akathisia (the concern with the need to move, is frequent in combination with inability to stand or sit on site). Most often disturbance is observed for the first several weeks of therapy. At development of these symptoms increase in a dose can not have favorable effect. Besides, it is necessary to consider a question of expediency of continuation of treatment.

Patients with affective frustration during Velaksin's use can have maniacal or hypomaniacal states. Such patients should appoint drug with care, and in the course of treatment they need medical observation. Also care is demanded by Velaksin's appointment the patient with epileptic seizures in the anamnesis, at increase in frequency of epileptic seizures or their emergence therapy needs to be interrupted.

At simultaneous use with antipsychotic means development of the symptoms reminding a malignant antipsychotic syndrome is possible (the combination demands care).

At emergence of rash, urtikarny elements or other allergic reactions it is necessary to see a doctor.

When performing electroconvulsive therapy against the background of Velaksin's reception it is necessary to observe extra care (due to the lack of experience of its use in these conditions).

In certain cases during Velaksin's use dozozavisimy increase in arterial pressure in this connection it is regularly recommended to control arterial pressure, in particular during specification or increase in a dose was noted.

During therapy, especially at patients of advanced age, it is necessary to consider a possibility of development of dizziness and disturbance of sense of equilibrium.

Against the background of Velaksin's reception orthostatic hypotension can develop.

Drug can increase risk of hemorrhages in skin and mucous membranes. During treatment patients need to be careful with predisposition to such states.

Safety and efficiency of use of Velaksin with the drugs lowering body weight including phentermine, are not established therefore their combined use (as well as use of a venlafaksin for decrease in body weight as monotherapy) is not recommended.

At long therapy it is reasonable to control blood serum cholesterol level.

After the treatment termination, in particular sudden, there can be cancellation symptoms. The risk of their development depends on several factors, including duration of a course and a dose, and also speed of decrease in a dose. Symptoms of cancellation are shown in the form of dizziness, touch disturbances (including paresthesias), sleep disorders (including sleeplessness and unusual dreams), excitement or alarm, nausea and/or vomiting, the tremor, perspiration, a headache, diarrhea which is speeded up and the strengthened heartbeat and emotional lability. Usually these symptoms have average or small expressiveness, however some patients can have them heavy. As a rule, they are observed in the first days after Velaksin's cancellation though in some cases develop also at the accidental admission of a dose. Most often these phenomena pass independently within 14 days, but they can be some patients' longer (2-3 months or longer).

During therapy it is necessary to be careful at control of motor transport and the performance of work requiring special attention and bystry psychomotor reactions, it is connected with probability of deterioration in thought processes and declines in the ability to performance of motive functions. At development of such disturbances duration and extent of restrictions are established by the doctor.

Medicinal interaction

Combined use of Velaksin with monoamine oxidase inhibitors (MAO) is contraindicated. It is possible to begin therapy with drug not earlier than in 14 days after the end of use of MAO inhibitors. If it was applied моклобемид (MAO reversible inhibitor), this break can be shorter (24 hours). It is possible to begin treatment with MAO inhibitors not earlier than in 7 days after Velaksin's cancellation.

It is not recommended to take alcohol during performing therapy.

At the combined use it is necessary to be careful with drugs which are inhibitors of CYP2D6 and CYP3A4 enzymes.

At simultaneous use of Velaksin with some medicines there can be following effects:

Lithium: increase in its level;
Haloperidol: strengthening of its effects that is connected with increase in its concentration in blood;
Clozapine: development of side effects (for example, epileptic seizures) and increase in its level in a blood plasma;
Anticoagulants: strengthening of their effect.