Calixta, 45 mg 30 pcs

Depression.

Indications

Depression.

Special instructions

When using the drug Calixta, you should keep in mind:

Worsening of psychotic symptoms may occur when antidepressants are used to treat patients with schizophrenia or other psychotic disorders; Paranoid ideas may increase.
The depressive phase of manic-depressive psychosis during treatment can transform into a manic phase.
In young people (under 24 years of age) with depression and other mental disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and behavior. Therefore, when prescribing Calixta to young people (under 24 years of age), the risk of suicide should be weighed against the benefits of using the drug. In short-term studies, the risk of suicide did not increase in people over 24 years of age, and the risk of suicide decreased slightly in people over 65 years of age. Any depressive disorder itself increases the risk of suicide. Therefore, during treatment, the patient should be monitored to identify disturbances or changes in behavior, as well as suicidal tendencies.
Although Calixta is not addictive, post-marketing experience has shown that abrupt cessation of treatment after prolonged use may sometimes cause withdrawal symptoms. Most withdrawal reactions are mild and self-limiting. The most commonly reported withdrawal symptoms were dizziness, agitation, anxiety, headache and nausea. Although these have been reported as withdrawal symptoms, it should be understood that these symptoms may be related to an underlying medical condition. It is recommended that treatment with mirtazapine be discontinued gradually.
Elderly patients are usually more sensitive, especially to side effects. In clinical studies of Calixta, it was not noted that side effects were more common in elderly patients than in other age groups, but they may be more pronounced, but data are still limited.
If signs of jaundice appear, treatment should be stopped.
Patients are advised to avoid alcohol while being treated with Calixta.
Bone marrow suppression, usually appearing as granulocytopenia or agranulocytosis, is rarely observed with Calixta. Appears mostly after 4-6 weeks of treatment and is reversible after cessation of treatment. The doctor should pay close attention to symptoms such as fever, sore throat, stomatitis, and other signs of influenza-like syndrome and inform the patient about this; If such symptoms appear, you should stop treatment and do a blood test.

Impact on the ability to drive vehicles and machinery

Calixta may reduce concentration. During treatment with antidepressants, patients should avoid performing potentially dangerous activities that require high speed psychomotor reactions, such as driving a car or operating machinery.

Active ingredient

Mirtazapine

Composition

1 film-coated tablet contains:

active ingredient:

mirtazapine 45 mg,

excipients:

lactose monohydrate – 133.2 mg;

corn starch – 84 mg;

hyprolose – 45 mg;

MCC – 45 mg;

pregelatinized starch – 45 mg;

talc – 4.2 mg;

magnesium stearate – 2.1 mg;

silicon dioxide – 1.5 mg

film shell:

hypromellose-5 CPS – 7.2 mg;

macrogol 6000 – 0.6 mg;

titanium dioxide – 1.05 mg.

Contraindications

hypersensitivity to mirtazapine or to any of the excipients;
patients with rare hereditary problems such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption should not be prescribed Calixta;
Since the safety and effectiveness of Calixta for children have not been established, the use of Calixta for the treatment of children under 18 years of age is not recommended.

With caution

Correction of the dosage regimen and regular medical monitoring are necessary for the following categories of patients:

patients with epilepsy and organic brain lesions (during treatment with Calixta, in rare cases, seizures may develop);
patients with liver or kidney failure;
patients with heart disease (conduction disorders, angina pectoris or recent myocardial infarction);
patients with cerebrovascular diseases (including a history of ischemic stroke);
patients with arterial hypotension and with conditions predisposing to arterial hypotension (including dehydration and hypovolemia);
patients who abuse drugs, are dependent on drugs that affect the central nervous system, with mania, hypomania.

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

urinary disorders, incl. with prostatic hyperplasia;
acute angle-closure glaucoma and increased intraocular pressure;
diabetes mellitus;
with simultaneous use of benzodiazepines with the drug Calixta.

Side Effects

People with depression experience a range of symptoms related to the disease, so it can sometimes be difficult to distinguish between symptoms related to the disease and symptoms caused by the drug.

From the blood and lymphatic system: frequency not established – bone marrow suppression (granulocytopenia, agranulocytosis, aplastic anemia and thrombocytopenia), eosinophilia.

From the nervous system: very often – drowsiness (which can lead to impaired concentration), usually occurring during the first weeks of treatment. (N.B. dose reduction does not usually result in less sedation, but may reduce the effectiveness of the antidepressant), sedation, headache; often – lethargy, dizziness, tremor; infrequently – paresthesia, restless legs syndrome, fainting; rarely – myoclonus, very rarely – convulsions (stroke), serotonin syndrome, paresthesia of the oral mucosa.

From the gastrointestinal tract: very often – dry mouth; often – nausea, diarrhea, vomiting; infrequently – decreased sensitivity of the oral mucosa; frequency not established – swelling of the oral mucosa.

From the skin and subcutaneous tissues: often – skin rash.

From the musculoskeletal system and connective tissue: often – arthralgia, myalgia, back pain.

From the endocrine system: frequency not established – impaired secretion of antidiuretic hormone.

Metabolism and nutrition: very often – increased appetite.

From the cardiovascular system: often – orthostatic hypotension; infrequently – decreased blood pressure.

General disorders and disorders at the injection site: often – local edema; infrequently – fatigue.

From the liver and biliary tract: rarely – increased activity of serum transaminases.

Mental disorders: often – unusual dreams, confusion, anxiety*, insomnia*, infrequently – nightmares, mania, agitation, hallucinations, psychomotor agitation (including akatasia and hyperkinesia); frequency not established – suicidal ideation, suicidal behavior.

*usually with antidepressant treatment, anxiety and insomnia, which can be symptoms of depression, may develop or worsen. The development or worsening of anxiety and insomnia has been reported very rarely during treatment with Calixta.

Interaction

Pharmacokinetic interaction

Mirtazapine is extensively metabolized by the CYP2D6 and CYP3A4 isoenzymes, and to a lesser extent by the CYP1A2 isoenzyme. An interaction study in healthy volunteers showed that paroxetine, an inhibitor of the CYP2D6 isoenzyme, has no effect on the pharmacokinetics of mirtazapine at steady state. Administration in combination with a strong CYP3A4 inhibitor, ketoconazole, increased the maximum plasma concentration and AUC of mirtazapine by approximately 40% and 50%, respectively. Caution should be exercised when mirtazapine is used in combination with strong CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals, erythromycin, or nefazodone.

Carbamazepine and phenytoin, inducers of the CYP3A4 isoenzyme, increased the clearance of mirtazapine by approximately twofold, which led to a 45-60% decrease in plasma concentrations of mirtazapine. When carbamazepine or another liver microsomal enzyme inducer (eg, rifampicin) is added to mirtazapine therapy, the dose of mirtazapine should be increased if necessary. If treatment with this drug is stopped, the dose of mirtazapine may need to be reduced.

When mirtazapine is used in combination with cimetidine, the bioavailability of mirtazapine may increase by more than 50%. The dose of mirtazapine should be reduced if necessary when starting treatment in combination with cimetidine or increased when treatment with cimetidine is discontinued.

In in vivo interaction studies, mirtazapine had no effect on the pharmacokinetics of risperidone or paroxetine (CYP2D6 substrate), carbamazepine (CYP3A4 substrate), amitriptyline, cimetidine, or phenytoin.
No important clinical effects or changes in pharmacokinetics were observed in humans when treated with mirtazapine in combination with lithium.

Pharmacodynamic interaction

Mirtazapine should not be used in combination with MAO inhibitors or within two weeks of stopping treatment with a MAO inhibitor.
Mirtazapine may enhance the sedative properties of benzodiazepines and other sedatives. Caution should be exercised when prescribing these drugs with mirtazapine.

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

When other serotonergic medicinal products (eg selective serotonin uptake inhibitors and venlafaxine) are used in combination with mirtazapine, there is a risk of interaction which may lead to the development of serotonin syndrome.

Mirtazapine at a dose of 30 mg 1 time / day caused a small but statistically significant increase in INR (international normalized ratio) in subjects treated with warfarin. A more pronounced effect with a higher dose of mirtazapine cannot be excluded. It is recommended to monitor MHO in case of treatment with warfarin in combination with mirtazapine.

Overdose

Current experience with overdose with Calixta alone indicates that symptoms are usually mild. CNS depression has been reported, accompanied by disorientation and prolonged sedation in combination with tachycardia and a slight increase or decrease in blood pressure.

However, there is a potential for more severe results (including death) at doses much higher than the therapeutic dose, particularly in overdoses of multiple drugs taken at the same time.

In case of overdose, symptomatic therapy should be carried out to maintain vital body functions. Activated charcoal should be administered or the stomach should be rinsed.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Manufacturer

Belupo, medicines and cosmetics d.d., Croatia