Ixel capsules 25mg №56

Release form, composition and packaging

Capsules gelatinous (solid), size No. 4, with a lid of an orange-pink color with a black imprint "IXEL" and a case of an orange-pink color with a black imprint "25"; the contents of the capsules are white to almost white powder, conglomerates (lumps) are allowed, which easily turn into powder when pressed with a glass rod.

Excipients: Calcium hydrophosphate dihydrate, calcium carmellose, povidone K30 (polyvidone K30), anhydrous colloidal silicon dioxide, Magnesium stearate, talc.

The composition of the shell of the capsule: titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), gelatin.

Indications

- depressive disorders of varying severity.

Dosage and administration

Ixel is intended for ingestion.

The average daily dose is 100 mg; The drug should be taken in 2 divided doses in the morning. Depending on the severity of symptoms, the dose may be increased to 250 mg / day.

The drug is preferably taken with meals.

The duration of therapy is determined individually.

Have patients with renal insufficiency (CC 50-10 ml / min) recommended to reduce the daily dose depending on the values ​​of QC.

Adverse effects

From the side of the central nervous system: possible - anxiety, dizziness; rarely - tremor, headache.

Gastrointestinal: rarely, dry mouth, nausea, vomiting, constipation; in some cases, a moderate increase in transaminase activity without clinical manifestations.

Other: possible - increased sweating, hot flashes, difficulty urinating; rarely - palpitations, rash; in some cases - serotonin syndrome.

Side effects are rare, mainly during the first 2 weeks of therapy, are mild, usually stop themselves as the depression symptoms regress and do not require discontinuation of the drug. Reducing the severity and number of side effects can be with a gradual increase in the dose of the drug during treatment.

Contraindications

Absolute

- children's and teenage age up to 15 years (due to the lack of clinical data);

- simultaneous use of non-selective and selective inhibitors of MAO type B, Sumatriptan;

- hypersensitivity to the drug.

Relative

- obstruction of the urinary tract (mainly with prostatic hyperplasia);

- pregnancy;

- lactation (breastfeeding);

- simultaneous reception with adrenaline, norepinephrine, clonidine and its derivatives;

- simultaneous administration of selective inhibitors of MAO type A, Digoxin.

WITH caution should use the drug for angle-closure glaucoma, epilepsy.

Use during pregnancy and lactation

It is not recommended to prescribe Ixel during pregnancy and lactation.

Application for violations of the liver

In some cases, there is a moderate increase in transaminase activity without clinical manifestations.

Application for violations of kidney function

Have patients with renal insufficiency (CC 50-10 ml / min) recommended to reduce the daily dose depending on the values ​​of QC.

To use the drug with caution in the obstruction of the urinary tract (especially with benign prostatic hyperplasia).

Use in children

Contraindications: children and adolescents up to 15 years (due to the lack of clinical data).

Special notes

With extreme caution should use the drug in patients with adenoma (benign hyperplasia) of the prostate gland, with convulsive seizures in history, with arterial hypertension, cardiomyopathy (due to a slight increase in heart rate).

Ixel can be administered no earlier than 14 days after discontinuation of MAO inhibitors. In addition, from the moment of withdrawal of the drug Ixel before the start of therapy with MAO inhibitors should take at least 7 days.

During the period of treatment Ixel not to allow alcohol.

Influence on ability to drive motor transport and control mechanisms

During the period of use of the drug should refrain from engaging in potentially hazardous activities that require increased attention and quick psychomotor reactions.

Overdosage

Symptoms: with an accidental increase in dose, nausea, vomiting, sweating, and constipation were noted. When taking the drug in a dose exceeding 800-1000 mg, vomiting, difficulty breathing, tachycardia are possible. After taking in an excessively high dose (1900-2800 mg of milnacipran) in combination with other psychotropic drugs (most often benzodiazepines), drowsiness, hypercapnia, and impaired consciousness are added to the above symptoms. Manifestations of cardiotoxicity and death in overdose of Ixel is not observed.

Treatment: gastric lavage followed by symptomatic therapy. Recommended medical monitoring of the patient for at least a day. The specific antidote is unknown.

Drug interaction

Concurrent use is contraindicated. Ixel with non-selective MAO inhibitors (iproniazid), with selective MAO type B inhibitors (selegilin), with sumatriptan due to the risk of developing serotonin syndrome, arterial hypertension, coronary artery spasm (the minimum interval after the end of treatment with these drugs and the appointment of Ixel is 2 weeks).

Not recommended simultaneous use Ixel with adrenaline and norepinephrine due to the risk of hypertension and arrhythmia; with clonidine and related compounds due to the reduction of their hypotensive effect; with digoxin (especially when administered parenterally) because of the risk of developing tachycardia and hypertension; with selective MAO type A inhibitors (moccobemide, toloxaton) due to the risk of developing serotonin syndrome.

Carefully Ixel should be prescribed in combination with epinephrine (adrenaline) and norepinephrine (norepinephrine) (in case of local anesthesia, the doses should not exceed 100 μg for 10 minutes or 300 μg for 1 h) with lithium preparations because of the risk of developing serotonin syndrome.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not higher than 30 ° C.