Remeron - instructions for use, dose, side effects, contraindications

Excipients: corn starch 15.0 mg, giprolose 3.0 mg, magnesium stearate 0.75-1.875 mg, silicon dioxide colloid 2.25 mg, lactose monohydrate up to 150 mg.

Sheath: Fell off 04F22715 yellow (hypromellose 2.36 mg, macrogol 8000 0.47 mg, titanium dioxide 0.95 mg, iron oxide dye yellow 0.13 mg).

Tablets 30 mg

Active substance: mirtazapine 30 mg.

Excipients: corn starch 30.0 mg, giprolose 6.0 mg, magnesium stearate 1.5-3.75 mg, silicon dioxide colloid 4.5 mg, lactose monohydrate up to 300 mg.

Sheath: Fell off 04F23084 orange (hypromellose 3.58 mg, macrogol 8000 0.72 mg, titanium dioxide 1.42 mg, iron oxide dye yellow 0.30 mg, ferric oxide red oxide 0.12 mg).

Tablets 45 mg

Active substance: mirtazapine 45 mg.

Excipients: corn starch 45.0 mg, giprolose 9.0 mg, magnesium stearate 2.25-5.625 mg, silicon dioxide colloid 6.75 mg, lactose monohydrate up to 450 mg.

Sheath: Opadry OY-S-28914 white (hypromellose 5.5 mg, macrogol 8000 1.1 mg, titanium dioxide 2.2 mg).

Description:

Tablets 15 mg

Yellow, covered with a shell, oval, biconvex tablets with an embossed code TZ over 3 from both sides along the risks with one side of the pill and ORGANON from the opposite side of the tablet.

Outside, thin yellow shell. The core of the tablet is white with a homogeneous compact structure.

Tablets 30 mg

Red-brown, film-coated, oval, biconvex tablets with a squeezed out code TZ over 5 from both sides along the risks with one side of the pill and ORGANON from the opposite side of the tablet.

Outside, a thin red-brown shell. The core of the tablet is white with a homogeneous compact structure.

Tablets 45 mg

White, coated, oval, biconvex tablets with a squeezed out code TZ over 7 on one side of the tablet and ORGANON from the opposite side of the tablet. The shell does not differ in color from the core of the tablet. The core of the tablet is white with a homogeneous compact structure.

Pharmacotherapeutic group:antidepressant

ATX: & nbsp

N.06.A.X.11 Mirtazapine

Pharmacodynamics:

Pharmacological properties

The drug Remeron® (mirtazapine) is a tetracyclic antidepressant with predominantly sedative effect. The drug is effective in depressive states with the presence of clinical symptoms such as the inability to experience pleasure and joy, loss of interest (anhedonia), psychomotor retardation, sleep disturbances (especially in the form of early awakenings), and weight loss and other symptoms: suicidal thoughts and diurnal mood swings. Antidepressant effect of the drug Remeron® usually comes in 1-2 weeks of treatment.

Pharmacodynamics

Mirtazapine is an antagonist of presynaptic α₂adrenoreceptors in the central nervous system and enhances central noradrenergic and serotonergic transmission of nerve impulses.In this case, the enhancement of serotonergic transmission is realized only through serotonin 5-HT₁-receptors, since mirtazapine blocks serotonin 5-HT₂- and 5-HT₃-receptors. It is believed that both enantiomers of mirtazapine have antidepressant activity, S(+) enantiomer, blocking α₂-adreno- and serotonin 5-HT₂-receptors, a R(-) enantiomer, blocking serotonin 5-HT₃-receptors. Sedative properties of mirtazapine are due to its antagonistic activity with respect to H₁-histamine receptors.

Mirtazapine is usually well tolerated, has almost no mammolin-blocking activity, and in therapeutic doses has a limited effect (eg, orthostatic hypotension) on the cardiovascular system (see section "Side effect").

Children

Two randomized, double-blind, placebo-controlled studies were conducted in children aged 7 to 18 years with a deep depressive disordern= 259), during the first 4 weeks of receiving mirtazapine for a flexible dosing regimen (15-45 mg) and for the next 4 weeks receiving fixed doses (15, 30 or 45 mg) of mirtazapine.The data from the studies did not show significant differences between mirtazapine and placebo. In the course of the study, 48.8% of the patients receiving Remeron® showed a significant (more than 7%) increase in body weight compared with the placebo group (5.7%). Urticaria was also common (11.8% in patients treated with Remeron® and 6.8% in patients receiving placebo) and hypertriglyceridemia (2.9% in patients treated with Remeron® and 0% in patients receiving placebo) .

Pharmacokinetics:

After oral administration of the drug mirtazapine quickly absorbed (bioavailability 50%), reaching a maximum concentration in the blood plasma after about 2 hours. About 85% of mirtazapine binds to plasma proteins. The average half-life is between 20 and 40 hours (rarely up to 65 hours). A shorter half-life is observed in young people. Equilibrium concentration is achieved after 3-4 days, and in further it does not change. In the recommended dosage range, the pharmacokinetic parameters of mirtazapine are linearly dependent on the administered dose of the drug. Eating does not affect the pharmacokinetics of the drug.

Mirtazapine is actively metabolized and excreted in urine and feces for several days.The main ways of its metabolism in the body are demethylation and oxidation followed by conjugation. Isozymes of cytochrome P450 (CYP2D6 and CYP1A2) participate in the formation of 8-hydroxymetabolite mirtazapine, while isoenzyme CYP3A4, presumably, determines the formation N-detylated and Noxidized metabolites. Demethylmirtazapine is pharmacologically active.

The clearance of mirtazapine decreases with renal or hepatic insufficiency.

Indications:

Depression.

Contraindications:

Hypersensitivity to mirtazapine or to any of the excipients.

Simultaneous reception of the drug Remeron ® with monoamine oxidase (MAO) inhibitors.

Patients with such rare hereditary problems as lactose intolerance, lactase deficiency or glucose-galactose malabsorption, Remeron® should not be prescribed.

The use of Remeron® for the treatment of children under 18 years of age is not recommended, since the effectiveness of Remeron® has not been demonstrated in two short-term clinical trials, and also on the basis of safety data for the preparation (see the section "Pharmacodynamics").

Carefully:

Correction of the dosing regimen and regular medical supervision are necessary for the following categories of patients:

- patients with epilepsy and organic lesions of the brain (on the background of therapy with the drug Remeron ® in rare cases, the development of seizures);

- patients with hepatic or renal insufficiency;

- Patients with heart disease (conduction disorder, angina pectoris or recent myocardial infarction);

- patients with cerebrovascular diseases (including with an ischemic stroke in the anamnesis);

- patients with arterial hypotension and conditions predisposing to hypotension (including with dehydration and hypovolemia);

- patients who abuse drugs, who are dependent on drugs that affect the central nervous system, patients with mania, hypomania.

Like other antidepressants, Remeron® should be used with caution in the following cases:

- violation of urination, including with prostatic hyperplasia;

- acute angle-closure glaucoma and increased intraocular pressure;

- diabetes;

- while concomitant administration of benzodiazepines with the drug Remeron®.

Pregnancy and lactation:

The limited data available indicate that mirtazapine in pregnant women did not have an increased risk of congenital malformations of the fetus. In the course of studies, no clinically significant teratogenic effect was detected in animals, but a toxic effect on the fetus was noted.

According to epidemiological data, the use of serotonin reuptake inhibitors in pregnancy, especially in later periods, may increase the risk of developing persistent pulmonary hypertension in newborns (PGHN). Despite the lack of data from clinical trials confirming the relationship between the use of mirtazapine and the development of PLNG, the potential risk can not be ruled out, given the mechanism of action of mirtazapine (increased serotonin concentration). Caution should be used to prescribe Remeron® to pregnant women. If the drug Remeron ® was used immediately before birth or shortly before the birth, then in the puerperal period, the condition of the newborn should be monitored for possible manifestations of withdrawal syndrome.

The results of experiments in animals and limited data on a person indicate that with mother's milk mirtazapine is displayed in very small quantities. The use of the drug for the mother during breastfeeding should be assessed regarding the possible risks to the child.

Fertility

Studies of reproductive toxicity in animals have not shown any effect on fertility.

Dosing and Administration:

Tablets should be taken orally, if necessary, washed down with liquid, and swallowed without chewing.

Adults

The effective daily dose is usually between 15 and 45 mg; the initial dose is 15 or 30 mg.

Elderly

The recommended dose is the same as for adults. To achieve a satisfactory and safe response to treatment, in elderly patients, an increase in the dose should be made under the direct supervision of a physician.

Renal insufficiency

In patients with moderate or severe renal insufficiency (creatinine clearance <40 ml / min), the clearance of mirtazapine may be reduced. This should be considered when appointing the drug Remeron to this group of patients (see.section "SPECIAL INSTRUCTIONS").

Liver failure

In patients with hepatic insufficiency, the clearance of mirtazapine may be reduced. This should be taken into account in the appointment of the drug Remeron to this group of patients, especially patients with severe hepatic insufficiency, since the use of mirtazapine in this group of patients has not been studied (see section "SPECIAL INSTRUCTIONS").

The drug Remeron® can be taken once a day, preferably at the same time, before night sleep. The drug Remeron can also be prescribed for admission twice a day, dividing the daily dose into two doses (once in the morning and once a night, a higher dose should be taken at night).

Treatment should be continued for as long as possible within 4-6 months until the symptoms disappear completely in the patient. After this treatment can be gradually canceled. Mirtazapine usually begins after 1-2 weeks of treatment. Treatment with an adequate dose should result in a positive response in 2-4 weeks. If the response to treatment is insufficient, the dose can be increased to the maximum dose (up to 45 mg). If there is no response to treatment after another 2-4 weeks, treatment should be discontinued.

Side effects:

Patients with depression experience a number of symptoms due to the disease, so it is sometimes difficult to distinguish between symptoms associated with the disease and symptoms caused by the use of the drug.

In randomized, placebo-controlled trials, the most common adverse reactions that occurred in more than 5% of patients receiving the Remeron® drug were drowsiness, sedation, dry mouth, weight gain, increased appetite, dizziness, and fatigue.

The data on adverse reactions to the Remeron® drug were evaluated from all randomized placebo-controlled trials (including both "deep depressive disorder" and other indications). The meta-analysis included 20 studies with a planned treatment duration of up to 12 weeks involving 1501 patients (134 patient years) who received doses of mirtazapine up to 60 mg and 850 patients (79 patient-years) who received a placebo. In order to maintain comparability with the use of placebo, the extended phases of these studies were excluded from the analysis.

Below are the data reflecting the incidence of adverse reactions, obtained during clinical trials. Taking into account the data on unwanted reactions derived from spontaneous post-registration safety reports, the frequency of these undesired reactions was statistically significantly higher with the use of Remeron® than with placebo. This frequency of unwanted reactions from spontaneous reports during the use of the drug in real clinical practice is based on the incidence of these unwanted reactions according to clinical studies. The frequency of adverse reactions associated with the administration of Remeron®, which were described in spontaneous post-registration safety reports, but not observed in randomized placebo-controlled studies, is indicated as "frequency unknown."

The following classification is used to indicate the frequency of undesired reactions: Often (≥1/10), often (≥1 / 100 and <1/10), infrequently (≥1 / 1000 and <1/100), rarely (≥1 / 10000 and <1/1000), frequency is unknown.

- Violations of the blood and lymphatic system: frequency unknown - depression of bone marrow function (granulocytopenia, agranulocytosis, aplastic anemia and thrombocytopenia) (see also "Special instructions"), eosinophilia.

- Disorders from the endocrine system: frequency unknown- syndrome of inadequate secretion of antidiuretic hormone.

- Disorders from the metabolism and nutrition: Often - weight gain¹, increased appetite¹; frequency unknown - hyponatremia.

- Disorders of the psyche: often - unusual dreams, confusion, anxiety^2,5, insomnia^3,5; nightmares², mania, agitation², hallucinations, psychomotor agitation (including akathisia and hyperkinesia); rarely aggressiveness; frequency is unknown - suicidal ideation⁶, suicidal behavior⁶.

- Disturbances from the nervous system: very often - drowsiness^1,4, sedation^1,4, headache²; frequent lethargy¹, dizziness, tremor; infrequently paresthesia², restless legs syndrome, fainting; rarely - myoclonus; frequency is unknown - convulsions, serotonin syndrome, paresthesia of the oral mucosa, articulation disorder.

- Vascular disorders: often - orthostatic hypotension; infrequently - lowering blood pressure².

- Disorders from the gastrointestinal tract: very often - dry mouth; often - nausea³, diarrhea², vomiting², constipation¹; infrequent - a decrease in the sensitivity of the oral mucosa; rarely - pancreatitis; frequency unknown - edema of the oral mucosa, increased salivation.

- Disturbances from the liver and bile ducts: rarely - increased serum transaminase activity.

- Disturbances from the skin and subcutaneous tissues: often - skin rash²; frequency unknown - Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme, toxic epidermal necrolysis.

- Disturbances from musculoskeletal and connective tissue: often - arthralgia, myalgia, back pain¹; frequency is unknown - rhabdomyolysis.

- Disorders from the kidneys and urinary tract: frequency unknown - retention of urine.

- General disorders and disorders at the site of administration: often - peripheral edema¹, fatigue; the frequency is unknown, somnambulism, generalized edema, localized edema.

- Laboratory and instrumental data: frequency unknown- increased activity of creatine kinase.

¹In clinical trials, these events were statistically significantly more frequent with therapy with Remeron® than with placebo.

²In clinical trials, these events were more common with placebo than with Remeron®, but the difference was not statistically significant.

³In clinical trials, these events were statistically significantly more frequent with placebo than with therapy with Remeron®.

⁴Dose reduction usually does not lead to a reduction in drowsiness and / or excessive sedation, but may lead to a decrease in the effectiveness of the antidepressant.

⁵In the treatment of antidepressants, anxiety and insomnia (which may also be symptoms of depression) may or may become more pronounced. On the background of mirtazapine therapy, there were cases of occurrence or increase of anxiety and insomnia.

⁶There have been cases of suicidal intentions and suicidal behavior on the background of mirtazapine therapy or soon after discontinuation of therapy (see section "Special instructions").

In the evaluation of data obtained in clinical trials, there was a temporary increase in the activity of transaminase and gamma-glutamyl transpeptidase (but not reported any adverse reactions associated with taking Remeron® drug that occurred with greater frequency than with placebo).

Overdose:

The available data on an overdose of only the Remeron® drug indicate that the symptoms are usually mild. It reported the inhibition of the central nervous system, leading to disorientation and prolonged sedation in conjunction with tachycardia and a slight increase or decrease in blood pressure. However, at doses much higher than the therapeutic dose, particularly overdoses several drugs simultaneously taken, there is a possibility of more serious consequences (including death). In such cases, it was also reported on the lengthening of the interval QT and tachycardia of the type "pirouette" (torsades de pointes).

In case of an overdose, symptomatic therapy should be used to maintain vital body functions, as well as ECG monitoring (electrocardiograms). You should enter Activated carbon or perform a gastric lavage.

Interaction:

Pharmacodynamic interaction

- Mirtazapine should not be used in combination with MAO inhibitors and within two weeks after discontinuation of treatment with MAO inhibitors. Treatment with MAO inhibitors should begin no earlier than two weeks after discontinuation of treatment with mirtazapine.

- Simultaneous reception with other serotonergic drugs (L-tryptophan, triptans, tramadol, linezolid, methylene blue, selective serotonin reuptake inhibitors, venlafaxine, lithium preparations and preparations of St. John's wort perfumed (Hypericum perforatum)) can lead to the development of serotonin syndrome (see section "Special instructions").

- Mirtazapine can enhance the sedative properties of benzodiazepines and other sedatives (in particular, most antipsychotics, H antagonists₁histamine receptors, opioids).

Caution should be exercised when prescribing the above medicines together with mirtazapine and conducting more thorough clinical monitoring.

- Mirtazapine can increase the depressive effect of alcohol on the central nervous system, so patients should be warned about the need to avoid drinking alcohol when taking mirtazapine.

- Mirtazapine when administered at a dose of 30 mg once daily, produced a small but statistically significant increase in the international normalized ratio (INR) in patients treated with warfarin. You can not exclude a more pronounced effect with a higher dose of mirtazapine. It is recommended to monitor INR in case of treatment with warfarin in combination with mirtazapine.

- With the simultaneous use of mirtazapine with other drugs that can cause lengthening of the interval QTc (eg, some antipsychotics or antibiotics), as well as an overdose of mirtazapine, the risk of prolonging the QT interval on the ECG and / or the occurrence of ventricular arrhythmias, for example, pirouette tachycardia, increases.

Pharmacokinetic interaction

- Carbamazepine and phenytoin (inducers of isoenzyme CYP3A4) increased the clearance of mirtazapine by approximately half, which resulted in a decrease in plasma mirtazapine concentrations of 60% and 45%, respectively. When adding carbamazepine or another inducer of liver metabolism (eg rifampicin) to mirtazapine therapy, if necessary, increase the dose of mirtazapine.If you stop taking inducers of liver metabolism, you may need to reduce the dose of mirtazapine.

- Application in combination with a potent inhibitor of isoenzyme CYP3A4 ketoconazole resulted in an increase in the maximum plasma concentration and AUC (area under the concentration versus time curve) of mirtazapine by approximately 40% and 50%, respectively.

- When used in conjunction with cimetidine (a weak inhibitor of isoenzymes CYP1A2, CYP2D6 and CYP3A4) the average concentration of mirtazapine in plasma increases by more than 50%. Caution should be exercised when using mirtazapine in combination with potent inhibitors of isoenzyme CYP3A4, HIV protease inhibitors, azole antifungal drugs, erythromycin or nefazodone. If necessary, reduce the dose of mirtazapine.

- In studies on the study of interactions mirtazapine did not affect the pharmacokinetics of paroxetine, amitriptyline, risperidone, or lithium preparations.

Special instructions:

Patients of childhood

The drug Remeron® should not be used in children and adolescents under 18 years of age.Suicidal symptoms (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behavior and anger) in clinical trials were significantly more frequent in the group of children and adolescents treated with antidepressants compared with a group of patients of the same age who took the placebo. If, based on clinical need, after all, taken the decision to use the drug should be carefully monitored the appearance of suicidal symptoms in patients. In addition, there are no data regarding long-term safety studies of growth, maturation, and cognitive and behavioral development in children and adolescents.

Suicide / suicidal thoughts or clinical worsening of the course of the disease

Any depressive disorder in itself increases the risk of suicidal thoughts and suicidal behavior. This risk persists until then, until a significant remission. Because the improvement may not occur during the first few weeks of therapy (or longer), the condition of the patients should be carefully monitored before the onset of improvement.Clinical observations show that the risk of suicide may increase in the early stages of recovery.

Patients who had a history of suicidal behavior, as well as patients who had marked suicidal intent prior to therapy, are at increased risk of suicidal thoughts or suicide attempts and should be closely monitored. A meta-analysis of results from placebo-controlled clinical studies on the use of antidepressants in adult patients with mental disorders revealed a higher risk of suicidal behavior in patients receiving antidepressants compared with the placebo group in the age group under 25 years.

Patients receiving antidepressant therapy (especially those at high risk) should be closely monitored, especially at the beginning of therapy, and also in case of dose adjustment. Patients (and also caregivers) should be warned about the need to timely identify any signs of clinical deterioration, suicidal behavior,suicidal thoughts or unusual behavior, as well as the need to immediately inform the doctor about the appearance of these symptoms.

Given the possibility of suicide, especially at the beginning of therapy, the patient should be given the least amount of tablets to reduce the risk of overdose.

Oppression of bone marrow function

When using the drug Remeron ®, there were cases of oppression of bone marrow, usually manifested in the form of granulocytopenia or agranulocytosis. In the course of clinical studies of the drug Remeron ® in rare cases, reversible agranulocytosis was noted. During the post-marketing observation, agranulocytosis was recorded in very rare cases, and in most cases it was also reversible, but several deaths were noted, which were registered mainly in patients older than 65 years. The doctor should carefully consider (and inform the patient) symptoms such as fever, sore throat, stomatitis and other signs of flu-like syndrome; When such symptoms appear, discontinue treatment and make a blood test.

Jaundice

When there are signs of jaundice, treatment should be discontinued.

States, requiring medical supervision

It should be prescribed with caution, as well as regular and careful monitoring of patients with the following conditions / diseases.

- Epilepsy and organic lesions of the brain. Although clinical experience shows that epileptic seizures occur rarely both in the treatment of mirtazapine and in the treatment of other antidepressants, the Remeron® drug should be used with extreme caution in patients with epileptic seizures in the anamnesis. Treatment should be discontinued in the event of a development or an increase in the frequency of epileptic seizures.

- Liver failure. With oral administration of mirtazapine at a dose of 15 mg, the clearance of mirtazapine decreased by approximately 35% in patients with hepatic insufficiency of mild or moderate severity compared with patients with normal liver function. The average concentration of mirtazapine in blood plasma increased by approximately 55%.

- Renal failure. With oral administration of mirtazapine at a dose of 15 mg in patients with moderate renal insufficiency (clearancecreatinine 10-40 ml / min) or severe (creatinine clearance less than 10 ml / min) mirtazapine clearance decreased by approximately 30% and 50%, respectively, compared with healthy volunteers. The average concentration of mirtazapine in blood plasma increased by 55% and 115%, respectively. In patients with mild renal insufficiency (creatinine clearance 40-80 ml / min), there were no significant differences in comparison with the control group.

- Heart diseases such as conduction disorders, angina pectoris and recent myocardial infarction. In these cases, the usual precautions are necessary when prescribing Remeron® and concomitant therapy.

- Low blood pressure.

- Diabetes. In patients with diabetes, antidepressants can affect blood glucose levels. You may need to adjust the dose of insulin and / or a dose of oral hypoglycemic drugs. Careful observation is recommended.

As with the use of other antidepressants, the following conditions can occur with the use of Remeron®.

- Possible worsening of psychotic symptoms in the use of antidepressants fortreatment of patients with schizophrenia or other psychotic disorders; Paranoid ideas can intensify.

- The depressive phase of bipolar disorder on the background of treatment can be transformed into a manic phase. Patients with a history of mania / oligomania should be closely monitored. The drug Remeron® should be discontinued if the patient has a transition to the manic phase.

- Although the drug Remeron® is not addictive, the post-marketing experience of the drug shows that a sharp cessation of treatment after prolonged use can sometimes cause symptoms of "cancellation." Most of the "cancellation" reactions are weak and self-limiting. The most commonly reported symptoms of "withdrawal": dizziness, agitation, anxiety, headache and nausea. Although they have been reported as symptoms of "withdrawal", it should be borne in mind that these symptoms can be associated with a major disease. Treatment with mirtazapine is recommended to be discontinued gradually (see section "Method of administration and dose").

- The drug Remeron® should be used with caution in patients with impaired urination,with hypertrophy of the prostate, as well as patients with acute angle-closure glaucoma and increased intraocular pressure (however, the adverse effect of taking Remeron® is unlikely due to the fact that the anticholinergic activity of the drug is very poorly expressed).

- Akathisia / psychomotor agitation: the use of antidepressants is associated with the development of akathisia, which is characterized by a subjectively unpleasant or disturbing arousal with increased motor activity. Most likely, the appearance of such symptoms during the first few weeks of treatment. Increasing the dose in this case can have a negative impact on the patient's health.

- In the postmarketing use of mirtazapine, cases of lengthening of the interval QT on the ECG, ventricular tachycardia (including tachycardia of the type "pirouette") and sudden death. However, in most cases, these symptoms were noted against an overdose or in patients with other risk factors for lengthening the interval QTc, including the simultaneous administration of two or more drugs that cause lengthening of the interval QT (cm.sections "Interaction with other medicinal products" and "Side effect"). Caution should be exercised when prescribing Remeron to patients with cardiovascular disease, and if there is an extended history in the family history QT or with concomitant therapy with other drugs that may cause lengthening of the interval QTc.

Hyponatremia

When using mirtazapine, extremely rare cases of hyponatremia are described. Patients at risk (elderly patients or patients taking drugs that can cause hyponatraemia) mirtazapine should be administered with caution.

Serotonin syndrome

With the simultaneous use of selective serotonin reuptake inhibitors and other serotonergic drugs, serotonin syndrome may occur (see section "Interaction with Other Drugs"). Symptoms of serotonin syndrome may include fever, rigidity, myoclonus, autonomic nervous system disorder with possible rapid fluctuations in vital signs of a person's functional state, changes in mental state, including confusion,irritability and strong arousal, progressing into a disorder of consciousness and to whom. Care should be taken and careful clinical monitoring is carried out while taking these drugs with mirtazapine. If such symptoms appear, discontinue treatment with Remeron® and begin symptomatic treatment. Post-registration experience of the drug shows that serotonin syndrome in patients who receive monotherapy with the drug Remeron ®, appears very rarely (see the section "Side effect").

Application in elderly patients

Elderly patients are usually more sensitive, especially with regard to the side effects of antidepressants. In clinical studies of the drug Remeron ® it was not noted that in elderly patients unwanted reactions occur more often than in other age groups.

When treating with Remeron®, avoid drinking alcohol.

Effect on the ability to drive transp. cf. and fur:

The drug Remeron ® can reduce the concentration of attention. In the course of treatment with antidepressants, patients should avoid performing potentially hazardous activities,requiring high speed of psychomotor reactions, such as driving vehicles or controlling mechanisms.

Form release / dosage:Tablets, film-coated, 15, 30 and 45 mg.

Packaging:

10 tablets in a blister pack.

1 or 3 blisters are placed in a cardboard box together with an instruction for use.

Storage conditions:

At a temperature of 2-30 ° C, in a place protected from light and moisture.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N016242 / 01

Date of registration:22.11.2010

Expiration Date:Unlimited

The owner of the registration certificate:Organon, N.V.Organon, N.V. Netherlands

Manufacturer: & nbsp

ORGANON, N.V. Netherlands

Representation: & nbspMSD Pharmaceuticals Ltd.MSD Pharmaceuticals Ltd.

Information update date: & nbsp06.09.2016

Illustrated instructions

Instructions

Remeron® (Remeron®)