Expiration date: 06/2025

Active substance: Mirtazapine.

Release form, composition and packing

Tablets, film-coated brownish-pink, oblong, with risk on one party.

Excipients: lactose monohydrate - 88.8 mg maize starch - 56 mg, giproloza - 30 mg microcrystalline cellulose - 30 mg pregelatinized starch - 30 mg Talc - 2.8 mg magnesium stearate - 1.4 mg of silicon dioxide - 1 mg.

Cover structure: Risk 5 CPS - 4.8 mg Macrogol 6000 - 0.4 mg titanium dioxide - 0.5 mg dye iron oxide yellow (E172) - 0.15 mg dye iron red oxide (E172) - 0.05 mg talc - 0.1 mg.

15 pcs. - Blisters (2) - packs cardboard.

Clinico-pharmacological group: Antidepressant

Pharmaco-therapeutic group: Antidepressant

Testimony

Depression.

Dosage

The tablets should be taken orally, if necessary with some liquid, and swallowed without chewing.

Adults:

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

Elderly patients:

The recommended dose is the same as that of adults. In elderly patients, in order to achieve a satisfactory and safe response to treatment, increasing the dose should be carried out under the supervision of a physician neposredstvennm.

Violations of the liver and kidney function:

In patients with renal or hepatic impairment the clearance of mirtazapine may be decreased. This should be considered when assigning Calixta drug in these patients.

Calixta drug may be administered one time / day, preferably in the same time before bedtime. Calixta The drug can also be assigned to receive 2 times / day by dividing the daily dose in half (once in the morning and once at night, the higher dose should be taken at night).

Treatment should be possible to continue for 4-6 months to complete disappearance of symptoms in a patient. Thereafter, treatment can be gradually phased out. Mirtazapine begins to exert its effect usually after 1-2 weeks of treatment. Treatment appropriate dose should lead to a positive result in 2-4 weeks. If necessary, the dose may be increased to a maximum dose (45 mg). In the absence of positive dynamics of treatment in another 2-4 weeks, treatment should be discontinued.

Side effect

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

To indicate the frequency of side effects, use the following classification: very common (?1 / 10), common (> 1/100 and ?1 / 10), uncommon (> 1/1000 and ?1 / 100), rare (> 1/10000 and ?1 / 1000), the frequency is not set (?1 / 10000)

From the blood and lymphatic system: the frequency has not been established - Bone marrow depression (granulocytopenia, agranulocytosis, aplastic anemia and thrombocytopenia), eosinophilia.

From the nervous system: very often - drowsiness (which can lead to impaired concentration), generally occurring during the first weeks of treatment. (NB dose reduction generally does not lead to less sedation but can reduce the effectiveness of antidepressant), sedation, headache, often - lethargy, dizziness, tremor, rarely - paresthesia, syndrome of "restless legs", syncope, rarely - myoclonus, very rare - seizures (stroke), serotonin syndrome, paresthesia oral mucosa.

On the part of the digestive tract: often - dry mouth, often - nausea, diarrhea, vomiting, infrequently - the oral mucosa decrease the sensitivity of the mouth, the frequency has not been established - swelling of the oral mucosa.

Skin and subcutaneous tissue disorders: often - skin rash.

On the part of the musculoskeletal system and connective tissue disorders: often - arthralgia, myalgia, back pain.

From endocrine system: the frequency has not been established - a violation of secretion of antidiuretic hormone.

On the part of metabolism and nutrition: very often - increased appetite.

Since the cardiovascular system: often - orthostatic hypotension, rarely - lowering blood pressure.

General disorders and administration in place: often - local edema, rarely - fatigue.

On the part of the liver and biliary tract: rarely - increased activity of serum transaminases.

Mental disorders: often - unusual dreams, confusion, anxiety *, insomnia *, infrequently - nightmares, delusions, agitation, hallucinations, agitation (including akataziyu and hyperkinesia), the frequency has not been established - suicidal ideation, suicidal behavior.

* In most antidepressant anxiety and insomnia which may be symptoms of depression, may develop or worsen. In the treatment of drug Calixta on the development or worsening of anxiety and insomnia were reported very rarely.

Contraindications

• Increased sensitivity of mirtazapine or any of the excipients,
  
• Patients with rare hereditary problems such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption, Calixta drug should not be prescribed,
  
• Because the safety and efficacy of the drug for pediatric Calixta are not installed, used Calixta drug for the treatment of children under 18 years of age is not recommended.
  

Carefully

Correction of dosage and regular medical monitoring regime required for the following categories of patients:

• Epilepsy and organic brain damage (on the background of therapy with Calixta , in rare cases, seizures may develop)
  
• Patients with hepatic or renal insufficiency,
  
• Patients with diseases of the heart (conduction disturbances, angina or recent myocardial infarction)
  
• Patients with cerebrovascular disease (including ischemic stroke in history),
  
• Patients with hypotension and with conditions predisposing to hypotension (including dehydration and hypovolemia)
  
• Patients who abuse drugs, dependence on drugs that affect the central nervous system, with mania, hypomania.
  

Like other antidepressants, Calixta drug should be used with caution in the following cases:

• Violation of urination, including hyperplasia of the prostate,
  
• Acute angle-closure glaucoma, and increased intraocular pressure,
  
• Diabetes,
  
• When concomitant use of benzodiazepines to drug Calixta.
  

Pregnancy and breast-feeding

Safety of Calixta the drug during pregnancy in humans has not been established, but in animals revealed no teratogenic effects, and the drug can be used during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus.

Application Calixta during lactation is not recommended due to lack of data on its excretion with breast milk in humans.

Application for violations of liver function

Use with caution in patients with hepatic insufficiency.

Application for violations of renal function

Use with caution in patients with renal insufficiency.

Use in children

Since the safety and efficacy of the drug for pediatric Calixta are not installed, used Calixta drug for the treatment of children under 18 years of age is not recommended.

Use in elderly patients

In elderly patients, in order to achieve a satisfactory and safe response to treatment, increasing the dose should be carried out under the supervision of a physician neposredstvennm.

Special instructions

Calixta In applying the drug should be kept in mind:

• Worsening of psychotic symptoms can occur when use of antidepressants in the treatment of patients with schizophrenia or other psychotic disorders, can worsen paranoid ideas.
  
• The depressive phase of manic-depressive psychosis during treatment can transform into the manic phase.
  
• Young people (under 24 years) with depression and other mental disorders, antidepressants compared to placebo, increased the risk of suicidal thoughts or suicidal behavior. Therefore, the appointment of Calixta drug among young people (under 24 years) should be related to the risk of suicide and the use of the drug. In short-term studies in people older than 24 years, the risk of suicide did not increase, and in people over 65 years - is somewhat reduced. Any depressive disorder in itself increases the risk of suicide. Therefore, during treatment the patient should be monitored in order to detect irregularities or changes in behavior, and suicidal tendencies.
  
• Despite the fact that the drug is not addictive Calixta , based on their post-marketing experience it proved that the abrupt cessation of treatment after prolonged use can sometimes cause withdrawal symptoms. Most of cancellation of the reactions are mild and self-limiting. The most frequently reported the following withdrawal symptoms: dizziness, agitation, anxiety, headache and nausea. Although they are reported as withdrawal symptoms, it should be understood that these symptoms may be related to the primary disease. It is recommended to stop treatment mirtazapine gradually.
  
• Elderly patients are generally more sensitive, especially in relation to side effects. In clinical studies, the drug is not Calixta noted that elderly patients the side effects are more likely than other age groups, but they may be more pronounced, but the data are still limited.
  
• If signs of jaundice, treatment should be discontinued.
  
• Patients recommend avoiding the use of alcohol in the treatment of drug Calixta.
  
• Suppression of bone marrow function, usually appearing as granulocytopenia or agranulocytosis, rarely seen with Calixta drug. It appears mostly after 4-6 weeks of treatment and is reversible after discontinuation of treatment. The physician should pay attention to symptoms such as fever, sore throat, stomatitis, and other signs of influenza-like syndrome, and to inform the patient, with the appearance of these symptoms should stop treatment and a blood test.
  

Effects on ability to drive vehicles and mechanisms

Calixta drug can reduce the concentration of attention. In the treatment of patients with antidepressants should avoid the performance of potentially hazardous activities that require high speed of psychomotor reactions, such as driving a car or operating machinery.

Overdose

Experience regarding drug overdose only Calixta indicates that symptoms are usually mild. It has been reported about the oppression of the central nervous system, accompanied by disorientation and prolonged sedation in combination with tachycardia and a slight increase or decrease in blood pressure. However, there is the likelihood of heavier results (including death) at doses much higher than the therapeutic dose, particularly multiple drug overdose taken simultaneously.

In case of overdose should be symptomatic therapy to maintain vital body functions. You must enter the activated charcoal or gastric lavage.

Drug interactions

Pharmacokinetic interactions

Mirtazapine is extensively metabolized with the participation of isoenzymes CYP2D6 and CYP3A4, and to a lesser extent with the participation of isoenzyme CYP1A2. Interaction study in healthy volunteers showed that paroxetine isoenzyme inhibitor of CYP2D6, has no effect on the pharmacokinetics of mirtazapine at equilibrium. Administering in combination with a potent inhibitor of isozyme CYP3A4, ketoconazole increased maximum plasma concentration and AUC mirtazapine by approximately 40% and 50% respectively. Caution should be exercised when applying mirtazapine in combination with potent inhibitors isoenzyme CYP3A4, HIV protease inhibitors, azole

Antifungal drugs nefazodone or erythromycin.

Carbamazepine and phenytoin, inducers of CYP3A4 isoenzyme, increased mirtazapine clearance about twofold, resulting in a 45-60% decrease in plasma mirtazapine concentrations. When adding carbamazepine or another inducer of microsomal liver enzymes (eg, rifampin) to mirtazapine therapy, mirtazapine dose it should be increased as needed. Upon termination of the treatment of such a drug may be necessary to reduce the mirtazapine dose.

In the application of mirtazapine in combination with cimetidine bioavailability of mirtazapine may increase more than 50%. Mirtazapine dose should be reduced if necessary at the beginning of treatment in combination with cimetidine or increase with cimetidine treatment cessation.

In studies on interactions conducted in vivo, mirtazapine did not influence the pharmacokinetics of risperidone or paroxetine (a substrate of CYP2D6 isoenzyme), carbamazepine (a substrate of CYP3A4 isoenzyme), amitriptyline, cimetidine or phenytoin.

There were no significant clinical effects or changes in pharmacokinetics in man for the treatment mirtazapine in combination with lithium.

Pharmacodynamic interactions

Mirtazapine should not be used in combination with MAO inhibitors or within two weeks after discontinuation of MAO inhibitor therapy.

Mirtazapine may potentiate the sedative properties of benzodiazepines and other sedatives. Caution should be exercised in the appointment of these medicines together with mirtazapine.

Mirtazapine may potentiate the depressive effects of alcohol on the central nervous system. Therefore, patients should be warned to avoid drinking.

In the case of other serotonergic drugs (e.g., selective serotonin reuptake inhibitors and venlafaxine) in combination with mirtazapine, there is a risk of interaction which can lead to serotonin syndrome.

Mirtazapine 30 mg 1 time / day caused a small but statistically significant increase in the MHO (International Normalized Ratio) in subjects treated with warfarin. We can not exclude a more pronounced effect at a higher dose of mirtazapine. Recommended MHO control treatment in the case of warfarin in combination with mirtazapine.

Conditions of supply of pharmacies

The drug prescription.

Terms and Conditions of storage

Keep out of the reach of children at or above 25 ° C.

Shelf life - 2 years. Do not use after the expiration date.

Characteristics:

Manufacturer: Belupo, medications and Kosmet HR

Expiration date: 01/09/2017