Valdoxan 25 mg 28 pcs. film-coated tablets


Pharmacodynamics and pharmacokinetics

Agomelatine is a substance with an antidepressant effect aimed at validated models of depression and some other abnormalities in the activity of the nervous system. At the same time, drugs created on its basis do not have a strong negative effect on the activity of other body systems.

Taking agomelatine helps normalize sleep structure, lower body temperature and improve the release of melatonin . The drug can be used to treat nervous system disorders of varying degrees of complexity, therefore both short-term and long-term therapy is allowed.

As a result of internal administration, absorption occurs quite quickly and almost completely. The maximum concentration in plasma is achieved 1-2 hours after administration of the drug. When distributed within the body, the substance is almost completely bound to plasma proteins, regardless of the concentration of the drug, the age of the patient, or the presence of renal impairment. A fairly rapid elimination of the drug from the body was noted, mainly in the form of metabolites through the kidneys. A small part of the unchanged substance is also excreted in the urine.

Valdoxan 25 mg 28 pcs. film-coated tablets

Composition and release form Valdoxan 25 mg 28 pcs. film-coated tablets

Tablets - 1 tablet:

  • active substance: agomelatine 25 mg;
  • Excipients: lactose monohydrate 61.84 mg, magnesium stearate 1.3 mg, corn starch 26.0 mg, Povidone-K30 9.1 mg, colloidal silicon dioxide 0.26 mg, sodium carboxymethyl starch 3.9 mg, stearic acid 2 .6 mg;
  • Film coating: glycerol 0.19665 mg, hypromellose 3.26871 mg, iron dye yellow oxide 0.19509 mg, macrogol 6000 0.20872 mg, magnesium stearate 0.19665 mg, titanium dioxide 0.43418 mg.

The design of the company logo on the tablet is applied with blue paint, which contains shellac, propylene glycol, and indigo carmine aluminum varnish.

14 tablets per blister (PVC/Al), 1, 2, 7 blisters with instructions for medical use per cardboard pack.

Packaging for hospitals:

10 tablets per blister (PVC/Al). 10 blisters with instructions for medical use per cardboard pack.

When packaging (packing) at the Russian enterprise Serdix LLC:

14 tablets per blister (PVC/Al). 1.2 blisters with instructions for medical use per cardboard pack.

10 tablets per blister (PVC/Al). 10 blisters with instructions for medical use per cardboard pack.

Packaging for hospitals:

14 tablets per blister (PVC/Al). 7 blisters with instructions for medical use per cardboard pack.

Description of the dosage form

Oblong film-coated tablets, orange-yellow in color with a blue company logo on one side.

Directions for use and doses

Valdoxan is prescribed at a dose of 25 mg per day (1 tablet), taken in the evening. The attending physician can individually prescribe a dose of 50 mg for daily use.

Pharmacodynamics

Antidepressant, melatonin agonist (MT1 and MT2 receptors) and serotonin antagonist (5-HT2c receptors). Agomelatine is active in validated models of depression (learned helplessness test, despair test, moderate chronic stress), in models with heart rate desynchronization, as well as in experimental situations of anxiety and stress. It has been shown that agomelatine does not affect the uptake of monamines and has no affinity for alpha, beta adrenergic receptors, histamine receptors, cholinergic receptors, dopamine and benzodiazepine receptors; This explains the absence of agomelatine’s side effects on the gastrointestinal tract, sexual functions and cardiovascular system, which are characteristic of other antidepressants. Agomelatine, due to its antagonistic effect on serotonin 5-HT2c receptors, enhances the release of dopamine and norepinephrine, especially in the prefrontal cortex.

In experimental animal studies with simulated Delayed Sleep Phase Syndrome in blind and aged animals, agomelatine was shown to restore synchronization of circadian rhythms through stimulation of melatonin receptors. In case of chronic stress, agomelatine prevents the occurrence of “broken” (fragmented) sleep. In experiments on healthy volunteers, agomelatine did not disrupt the normal structure of sleep and had a beneficial effect on sleep in patients with depression. In therapeutic doses, agomelatine prevented the development of insomnia and memory impairment from the moment of taking the drug until the morning. Agomelatine is not addictive, as demonstrated in a study of healthy volunteers using a visual analogue scale or the Addiction Research Center Inventory (ARCI 49 check-list). Agomelatine has also been assessed for withdrawal symptoms in depressed patients using the Discontinuation Emergent Signs and Symptoms (DESS) Questionnaire. It has been established that withdrawal syndrome does not develop even with abrupt cessation of treatment. Agomelatine does not affect body weight.

Agomelatine's clinical development program examined its efficacy and safety in major depressive disorder. In a placebo comparative controlled study, 4500 patients were examined, of whom 2500 received the drug for 6 weeks to a year. Agomelatine was statistically significantly more effective compared to placebo, with the antidepressant effect occurring within 2 weeks (efficacy range: from 49.1 to 61% versus 34.3 to 46.3% in the placebo group). Reliable data were also obtained on the effectiveness of agomelatine in patients with more severe forms of depressive disorder (Hamilton scale scores >=25), constituting more than 2/3 of the population. Active control studies confirmed the results. Agomelatine was also effective for initially high levels of anxiety, as well as for combined anxiety and depressive disorders. The effect of agomelatine on the sexual function of patients with depression with a relapsing course of the disease was studied. The Sex Effects Scale (SEXFX) was used. Agomelatine has not been shown to cause sexual dysfunction and does not affect arousal or orgasm. In patients with depression, starting from the second week of treatment, agomelatine statistically significantly improved the process of falling asleep, without causing subsequent daytime lethargy (the Leeds Questionnaire was used).

Pharmacokinetics

Suction

After oral administration, agomelatine is quickly and well (>80%) absorbed from the gastrointestinal tract. Cmax in plasma is achieved 1-2 hours after administration. Bioavailability at a therapeutic dose taken orally is approximately 3% and varies depending on the first pass effect through the liver and individual differences in CYP1A2 activity parameters. When prescribed in therapeutic doses, the therapeutic concentration of the drug increased in proportion to the dose. Meal intake (both regular and high-fat) did not affect either bioavailability or rate of absorption.

Distribution

The volume of distribution at equilibrium was about 35 liters. Plasma protein binding is 95%, regardless of drug concentration, age or the presence of renal failure.

Metabolism

After oral administration, agomelatine undergoes rapid oxidation, mainly due to CYP1A2 (90%) and CYP2C9 (10%). The main metabolites in the form of hydroxylated and demethylated agomelatine are inactive, quickly bind and are excreted in the urine. Removal of T1/2 from plasma is from 1 to 2 hours. Removal occurs quickly. High and mostly metabolic Cl is about 1100 ml/min. Excretion occurs mainly in urine (80%) and in the form of metabolites. The amount of unchanged drug in the urine is insignificant. With repeated administration of the drug, the kinetics do not change.

Pharmacokinetics in special clinical situations

The dependence of the pharmacokinetics of the drug on age has not been identified. Since no significant changes in pharmacokinetics are observed in patients with renal failure, special selection of drug doses for this category of patients is not required. When comparing the effect of the drug in healthy volunteers (matched for age, body weight and number of cigarettes smoked) with patients with mild (Child-Pugh class A) and moderate (Child-Pugh class B) degrees of liver failure, in the latter an increase in the duration of action of the drug was observed when prescribed at a dose of 25 mg/day. No unusual adverse reactions were observed.

Indications for use Valdoxan 25 mg 28 pcs. film-coated tablets

"Valdoxan" is a drug with an antidepressant effect, used in the complex treatment of severe depressive disorder.

Contraindications

You should not take Valdoxan if you have an individual sensitivity to the components of the dietary supplement. A contraindication is considered to be severe renal failure.

Application Valdoxan 25 mg 28 pcs. film-coated tablets during pregnancy and breastfeeding

During pregnancy, Valdoxan is prescribed with caution; lactation should be stopped during the course of therapy. Persons under 18 years of age are not recommended to take the drug due to the lack of sufficient clinical studies in this group of patients.

special instructions

Liver function monitoring:

Cases of liver damage have been reported, including liver failure (leading in exceptional cases to death or requiring liver transplantation in patients with pre-existing risk factors for liver damage), elevation of liver enzymes more than 10 times the upper limit of normal, hepatitis and jaundice in patients taking Valdoxan® during the post-registration period. Most of these disorders occurred in the first months of treatment. The nature of liver damage appears to be primarily hepatocellular. As a rule, after cessation of therapy, transaminase levels returned to normal values. Caution should be exercised before starting treatment and close monitoring during treatment in all patients, especially those with risk factors for liver disease or those receiving concomitant therapy with drugs that can cause liver damage.

Before starting therapy

Treatment with Valdoxan® should be prescribed only after a careful assessment of the expected benefit to possible risk in patients with risk factors for developing liver dysfunction, such as obesity/overweight/non-alcoholic fatty liver disease, diabetes, alcohol abuse and taking drugs that can cause liver dysfunction liver functions. Before initiating therapy, liver function tests should be performed in all patients, and therapy cannot be initiated if the level of liver enzymes ALT and/or AST is more than 3 times the upper limit of normal. Caution should be exercised when prescribing Valdoxan® to patients with initially elevated transaminase activity (above the upper limit of normal, but not more than 3 times the upper limit of normal).

Frequency of liver function tests

Before starting therapy, and beyond:

  • in approximately 3 weeks,
  • after approximately 6 weeks (end of the stopping period of therapy),
  • after approximately 12 and 24 weeks (end of the maintenance period of therapy) in the future - in accordance with the clinical situation.

When increasing the dose, liver function should be monitored at the same frequency as at the beginning of therapy. If the activity of transaminases in the blood serum increases, a repeat test should be performed within 48 hours.

During treatment

Treatment with Valdoxan® should be stopped immediately if:

  • the appearance of symptoms and signs of possible liver dysfunction (such as dark urine, discolored stools, yellow skin/eyes, pain in the right upper abdomen, new persistent and unexplained fatigue);
  • an increase in transaminase levels by more than 3 times, but compared with the upper limit of normal.

After discontinuation of therapy with Valdoxan®, liver function tests should be performed regularly until transaminase levels normalize.

Elderly patients

The effectiveness of the drug in elderly patients (aged 75 years and older) has not been established. In this regard, Valdoxan® should not be prescribed to patients in this age group.

Elderly patients with dementia

Valdoxan® should not be prescribed for the treatment of major depressive episodes in elderly patients with dementia (due to the lack of data on the effectiveness and safety of the drug in this group of patients).

Patients with kidney failure

In patients with severe renal failure, no significant changes in pharmacokinetic parameters were observed. However, experience with the use of Valdoxan® for major depressive episodes in patients with moderate to severe renal failure is limited. When prescribing Valdoxan® to such patients, caution should be exercised.

Bipolar disorders/mania/hypomania

Caution should be exercised when using Valdoxan® in patients with a history of bipolar disorders, manic or hypomanic episodes. If symptoms of mania appear, you should stop taking the drug.

Suicide/suicidal behavior

People who are depressed have an increased risk of suicidal ideation, self-harm, and suicide (suicide-related events). The risk remains until a clear remission occurs. Patients should be under medical supervision until the condition improves (after starting therapy, it may take several weeks for the condition to improve). Clinical experience suggests that the risk of suicide may increase in the early stages of remission.

Patients with a history of events associated with suicide, as well as patients who had suicidal intentions before starting therapy, are at risk and should be under close medical supervision during therapy.

The results of a meta-analysis of clinical trials of antidepressants in patients with mental disorders indicate an increased risk of suicidal behavior in patients under the age of 25 years while taking antidepressants compared with placebo. During the treatment period, patients, especially those at risk, should be under close medical supervision, especially at the beginning of therapy and when changing the dose of the drug. Patients (and their caregivers) should be advised to seek immediate medical attention if their condition worsens, if they experience suicidal or unusual behavior, or if they experience suicidal thoughts.

Combined use with inhibitors of the CYPIA2 isoenzyme

Caution should be exercised when using agomelatine simultaneously with moderate inhibitors of the CYP1A2 isoenzyme (such as propranolol, enoxacin) due to the possibility of increasing the concentration of agomelatine.

Patients with lactose intolerance

The drug should not be used in patients with lactose intolerance: lactase deficiency, galactosemia and glucose-galactose malabsorption.

Impact on the ability to drive vehicles and operate machinery

No studies have been conducted to study the effect of Valdoxan® on the ability to drive a car or use other mechanisms. It should be remembered that dizziness and drowsiness are common side effects of agomelatine.

Overdose

Studies on healthy volunteers have shown that when taken orally, agomelatine is well tolerated at doses up to 800 mg/day. Cases of agomelatine overdose are rare. During clinical trials, doses of up to 300 and up to 375 mg/day were reported in combination with other psychotropic drugs. In all of these cases, no signs or symptoms of overdose were reported.

Treatment: In case of overdose, specific antidotes for agomelatine are not known. Symptomatic therapy and the usual monitoring for such cases in specialized departments are indicated.

Side effects Valdoxan 25 mg 28 pcs. film-coated tablets

"Valdoxan" can cause adverse reactions from:

  • central and peripheral nervous system: dizziness, paresthesia;
  • Gastrointestinal tract: nausea, diarrhea, dry mouth, pain in the epigastric zone, AST increase 3 times relative to normal;
  • skin: dermatitis, itching, eczema, erythematous rash;
  • eye: blurred vision.

Drug interactions

Potentially possible interaction: 90% of agomelatine is metabolized in the liver with the participation of CYP1A2 isoenzymes and 10% with the participation of CYP2C9/19. Therefore, any drugs whose metabolism depends on these isoenzymes may increase or decrease the bioavailability of agomelatine. Fluvoxamine, which is a strong inhibitor of CYP1A2 and 2C9, may significantly slow down the metabolism of agomelatine (simultaneous use is not recommended).

Paroxetine (a CYP1A2 inhibitor) and fluconazole (a strong CYP2C9 inhibitor) do not interfere with the pharmacokinetics of agomelatine. Estrogens, which are moderate inhibitors of CYP1A2, have been shown to enhance the effects of agomelatine. As long as the therapeutic concentration of the drug remains within the normal range of pharmacokinetics, no dose adjustment is required.

Smoking increases the effect of CYP1A2, but has been shown to only slightly decrease the duration of action of agomelatine. Therefore, smokers do not need to adjust their dose.

Possibility of action of agomelatine on other drugs Agomelatine does not induce or inhibit CYP450 isoenzymes and therefore does not affect the action of drugs whose metabolism is associated with these isoenzymes. In healthy volunteers, agomelatine did not change the pharmacokinetics of theophylline (CYP1A2). Agomelatine does not change the free concentration of drugs that are significantly bound to plasma proteins and, in turn, do not affect the concentration of agomelatine.

There is no pharmacokinetic or pharmacodynamic interaction between lorazepam and agomelatine. There is no pharmacokinetic or pharmacodynamic interaction between lithium preparations and agomelatine. There are no data on the use of agomelatine concomitantly with electroconvulsive therapy. Since agomelatine did not show seizure-predisposing properties in animal experiments, undesirable effects of electroconvulsive therapy when used together seem unlikely.

Side effects

As a rule, the manifestation of side effects is observed at the very beginning of treatment. Patients are especially often concerned about: nausea, dizziness, drowsiness, headache, insomnia, fatigue, anxiety, sweating, and so on. All these symptoms are not severe and usually do not require additional treatment. Gradually their manifestation decreases and completely disappears.

Instructions for Valdoxan (Method and dosage)

The tablets are intended to be taken orally, regardless of food, whole - without crushing or chewing. If the next dose of the drug was missed, then no additional medication is required, and the next tablet is taken as usual.

At the same time, the instructions for use of Valdoxan indicate that you need to take 25 mg or 1 tablet daily. If there is no improvement within 2 weeks, it is possible to increase the dosage as prescribed by the doctor.

During treatment, it is necessary to monitor liver function at the initial stage, then periodically throughout therapy. The average treatment course is 6 months or until the unwanted symptoms completely disappear.

Valdoxan®

Liver function monitoring

Cases of liver damage (including liver failure, increases in liver enzyme levels more than 10 times the ULN, hepatitis and jaundice) have been reported in patients taking Valdoxan® in the post-marketing period. Most of these disorders occurred in the first months of treatment. The nature of liver damage appears to be primarily hepatocellular. As a rule, after cessation of therapy, transaminase levels returned to normal values.

It is recommended to monitor liver function at the beginning of therapy and then periodically, after 3 weeks, after 6 weeks (end of the relief period of therapy), 12 weeks and 24 weeks (end of the maintenance period of therapy) after the start of therapy, and thereafter in accordance with the clinical situation. When increasing the dose, liver function should be monitored at the same frequency as at the beginning of the drug.

If the activity of transaminases in the blood serum increases, a repeat test should be performed within 48 hours. If the activity of transaminases is more than 3 times higher than the ULN, the drug should be discontinued. In the future, the functional state of the liver should be regularly monitored until transaminase activity normalizes.

If you experience symptoms and signs of possible liver dysfunction (such as dark urine, discolored stools, yellow skin/eyes, pain in the right upper abdomen, new persistent and unexplained fatigue), Valdoxan should be stopped immediately.

Caution should be exercised when prescribing Valdoxan® to patients with elevated transaminase activity before starting therapy (above the ULN, but not more than 3 times the ULN).

Caution should be exercised when prescribing Valdoxan® to patients with risk factors for developing liver dysfunction, such as obesity/overweight/non-alcoholic fatty liver disease, diabetes mellitus, drinking significant amounts of alcohol, or taking medications that can cause liver dysfunction.

Elderly patients

The effectiveness of the drug in elderly patients (aged 65 years and older) has not been established. There is limited data on the use of Valdoxan® for major depressive episodes in patients aged 65 years and older. When prescribing the drug to elderly patients, caution should be exercised.

Patients with kidney failure

In patients with severe renal failure, no significant changes in pharmacokinetic parameters were observed. However, experience with the use of the drug for major depressive episodes in patients with moderate or severe renal failure is limited. When prescribing Valdoxan® to such patients, caution should be exercised.

Bipolar disorders/mania/hypomania

Caution should be exercised when using Valdoxan® in patients with a history of bipolar disorders, manic or hypomanic episodes. If symptoms of mania appear, you should stop taking the drug.

Suicide/suicidal behavior

People who are depressed have an increased risk of suicidal ideation, self-harm, and suicide (suicide-related events). The risk remains until a clear remission occurs. Patients should be under medical supervision until the condition improves (after starting therapy, it may take several weeks for the condition to improve). Clinical experience suggests that the risk of suicide may increase in the early stages of remission.

Patients with a history of events associated with suicide, as well as patients who had suicidal intentions before starting therapy, are at risk and should be under close medical supervision during therapy.

The results of a meta-analysis of clinical trials of antidepressants in patients with mental disorders indicate an increased risk of suicidal behavior in patients under the age of 25 years while taking antidepressants compared with placebo.

During the treatment period, patients, especially those at risk, should be under close medical supervision, especially at the beginning of therapy and when changing the dose of the drug. Patients (and their caregivers) should be advised to seek immediate medical attention if their condition worsens, if they experience suicidal or unusual behavior, or if they experience suicidal thoughts.

Combined use with CYP1A2 isoenzyme inhibitors

Caution should be exercised when using agomelatine simultaneously with moderate inhibitors of the CYP1A2 isoenzyme (such as propranolol, grepafloxacin, enoxacin) due to the possibility of increasing the concentration of agomelatine.

Impact on the ability to drive vehicles and operate machinery

No studies have been conducted to study the effect of Valdoxan® on the ability to drive a car or use other mechanisms. It should be remembered that dizziness and drowsiness are common side effects of agomelatine.

Overdose

In practical medicine, isolated cases of agomelatine . In this case, such undesirable symptoms arise as: drowsiness , stomach pain, restlessness, anxiety, weakness, tension, dizziness , and so on.

If the overdose is insignificant, then the condition will soon normalize on its own, without deviations in the activity of the cardiovascular and nervous systems, or disturbances in laboratory parameters.

If necessary, carry out symptomatic treatment and monitor the general condition of the patient.

Agomelatine

special instructions

Use with caution during major depressive episodes in patients with moderate to severe renal impairment; when administering agomelatine with moderate inhibitors of the CYP1A2 isoenzyme (such as propranolol, grepafloxacin, enoxacin); in patients with a history of manic or hypomanic episodes; in patients with a history of events associated with suicide, as well as in patients who had suicidal intentions before starting therapy; in elderly patients (65 years and older), especially in the treatment of major depressive episodes with dementia; patients who abuse alcohol or take drugs that can cause liver dysfunction.

The effectiveness of use in elderly patients has not been established.

In patients with severe renal failure, no significant changes in pharmacokinetic parameters were observed. However, experience with major depressive episodes in patients with moderate or severe renal impairment is limited.

If symptoms of mania occur, stop taking agomelatine.

People who are depressed have an increased risk of suicidal ideation, self-harm, and suicide (suicide-related events). The risk remains until a clear remission occurs. Patients should be under medical supervision until the condition improves (after starting therapy, it may take several weeks for the condition to improve). Clinical experience suggests that the risk of suicide may increase in the early stages of remission. Patients with a history of events associated with suicide, as well as patients who had suicidal intentions before starting therapy, are at risk and should be under strict medical supervision during therapy.

During the treatment period, patients, especially those at risk, should be under strict medical supervision, especially at the beginning of therapy and when changing the dose of the drug. Patients (and their caregivers) should be advised to seek immediate medical attention if their condition worsens, if they experience suicidal or unusual behavior, or if they experience suicidal thoughts.

The results of a meta-analysis of clinical trials of antidepressants in patients with mental disorders indicate an increased risk of suicidal behavior in patients under the age of 25 years while taking antidepressants compared with placebo.

Caution should be exercised when using agomelatine simultaneously with moderate inhibitors of the CYP1A2 isoenzyme (such as propranolol, grepafloxacin, enoxacin) due to the possibility of increasing the concentration of agomelatine.

It is recommended to monitor liver function at the beginning of therapy, 6 weeks (end of the relief period of therapy), 12 weeks and 24 weeks (end of the maintenance period of therapy) after the start of therapy, and at other times in accordance with the clinical situation. If transaminase activity in the blood serum increases, a repeat determination should be made within 48 hours. If transaminase activity is more than 3 times the ULN, agomelatine should be discontinued. In the future, the functional state of the liver should be regularly monitored until transaminase activity normalizes.

If symptoms of liver dysfunction develop, liver function tests should be performed. Taking into account laboratory data and the clinical picture, a decision should be made to discontinue or continue agomelatine therapy. If jaundice develops, therapy should be discontinued.

Interaction

The simultaneous use of this drug and various isoenzyme inhibitors, for example, fluvoxamine, Ciprofloxacin , leads to a significant slowdown in the metabolism of agomelatine , and accordingly to an increase in its concentration. Therefore, simultaneous therapy with these drugs is contraindicated.

Also, Rifampicin , which takes part in the metabolism of agomelatine, can reduce its bioavailability. This can also occur in patients who abuse smoking. As for the potential effect of agomelatine on other types of drugs, it is insignificant or not fully studied.

Valdoxan tablet p/pl/o 25 mg N28 (Servier)

- Hypersensitivity to agomelatine and/or any of the excipients of the drug (see section “Composition”). - Liver failure (for example, cirrhosis or active liver disease) or an increase in transaminase levels more than 3 times the upper limit of normal (see sections “Dosage and Administration” and “Special Instructions”). - Concomitant use of potent inhibitors of the CYP1A2 isoenzyme (such as fluvoxamine, ciprofloxacin) (see section “Interaction with other drugs and other types of interactions”). — Children under 18 years of age (due to lack of sufficient experience in clinical use). In children and adolescents taking other antidepressants, suicidal behavior (suicide attempts and suicidal thoughts) and hostility (mainly aggressiveness, conflict behavior, irritation) were observed more often compared to the placebo group. The drug should not be used in patients with lactose intolerance: lactase deficiency, galactosemia and glucose-galactose malabsorption. PRECAUTIONS FOR ADMINISTRATION Patients with moderate to severe renal impairment in the treatment of major depressive episodes, while co-prescribing agomelatine with moderate inhibitors of the CYP1A2 isoenzyme (such as propranolol, enoxacin), patients with a history of manic or hypomanic episodes, patients with a history of events associated with suicide, as well as patients who had suicidal intentions before starting therapy. Caution should be exercised when prescribing the drug to patients who abuse alcohol or take drugs that can cause liver dysfunction. USE IN PREGNANCY AND BREASTFEEDING Pregnancy Data on the use of agomelatine during pregnancy are absent or limited (less than 300 pregnancy outcomes). Animal studies have not revealed direct or indirect harmful effects on pregnancy, embryonic and fetal development, labor and postnatal development. As a precaution, it is recommended to avoid prescribing Valdoxan during pregnancy. Breastfeeding It is not known whether agomelatine passes into breast milk in lactating women. In animal experiments, it was shown that agomelatine and its metabolites pass into breast milk. Risk to the newborn/child cannot be excluded. It is necessary to assess the importance of breastfeeding for the child and therapy for the mother and make a decision to stop breastfeeding or stop taking the drug. Fertility Reproduction studies in rats and rabbits have shown no effect of agomelatine on fertility.

Analogues of Valdoxan

Level 4 ATC code matches:
Pipofezin

Bethol

Incazan

Melitor

Azafen

Miaser

Velafax

Mirtazonal

Venlaxor

Remeron

Venlafaxine

Lerivon

Mirtazapine

Cymbalta

Velaxin

Coaxil

Pyrazidol

Deprim

Gelarium Hypericum

Negrustin

The main analogue is Agomelatine . There are also other analogues of Valdoxan, for example – Adaptol and Paxil .

Reviews about Valdoxan

This remedy is quite often used in clinical practice. At the same time, its mild but effective effect was noted. Some patients report that the treatment was quite successful, without unwanted symptoms or intolerance reactions.

However, there are also reviews of Valdoxan when patients were bothered by: a feeling of nausea , attacks of aggression , and a lack of appetite . Such symptoms persisted not only at the initial stage, so it was necessary to change the drug.

In any case, the choice of an antidepressant must be approached with special responsibility and only take drugs prescribed by a specialist in a certain dosage.

Valdoxan price, where to buy

This drug can be bought in Moscow, in almost any pharmacy. At the same time, the price of Valdoxan varies from 1670 to 2060 rubles.

  • Online pharmacies in RussiaRussia
  • Online pharmacies in KazakhstanKazakhstan

ZdravCity

  • Valdoxan tablets p.p.o.
    25 mg 28 pcs OOO Servier Rus 1409 rub. order

Pharmacy Dialogue

  • Valdoxan tablets 25 mg No. 28 Serdix LLC

    RUB 1,492 order

  • Valdoxan (tablet p/o 25 mg No. 28)Servier Rus LLC

    1410 rub. order

  • Valdoxan (tablet p/o 25 mg No. 28)Servier Rus LLC

    RUB 1,424 order

  • Valdoxan tablets 25 mg No. 28Servier

    RUB 1,402 order

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