Expiration date: 01/2026

Structure and Composition:

The capsules. 1 capsule contains milnacipran hydrochloride 25 mg

Other ingredients: calcium hydrogen phosphate dihydrate - 50.925 mg calcium carmellose - 22,150 mg povidone K30 (polyvidone K30) - 2,100 mg colloidal anhydrous silica - magnesium stearate 0.625 mg - 2,100 mg talc - 2,100 mg

Capsule shell: Titanium dioxide (E171) Iron oxide red (E172) iron oxide yellow (E172) Gelatin

in blister 14 pcs. in box 4 blisters.

The capsules. 1 capsule contains milnacipran hydrochloride 50 mg

excipients: calcium hydrogen phosphate dihydrate - carmellose calcium 101.85 mg - 44.30 mg Povidone K30 (polyvidone K30) - 4,200 mg colloidal silicon dioxide anhydrous - magnesium stearate 1.25 mg - Talc 4.200 mg - 4,200 mg

Capsule shell: Titanium dioxide (E171) Iron oxide red (E172) iron oxide yellow (E172) Gelatin

in blister 14 pcs. in box 4 blisters.

Description pharmaceutical form:

25 mg capsules: Gelatin capsules size ?4. Lid orange-pink color with black imprint «IXEL». Housing orange-pink color with black imprint "25".

50 mg capsules: Gelatin capsules size ?3. Lid orange-pink color with black imprint «IXEL». Housing yellow-orange (rust) color with black axial imprint "50".

The contents of capsules for both doses: powder white to almost white color.

Pharmacokinetics:

After taking the drug inside Ixel well absorbed. Bioavailability is about 85% and does not depend on the nature and diet. Cmax plasma levels achieved after approximately 2 hours after dosing. After the re-admission of the drug equilibrium state is achieved after 2-3 days. Plasma protein binding is about 13% and is not accompanied by saturation.

Metabolism Ixel limited mainly by conjugation with glucuronic acid. Active metabolite exists.

T1 / 2 of the drug is 8 h. Write mainly kidneys (about 90% of the administered dose).

Fully drug excreted from the body within 2-3 days.

Description of the pharmacological actions:

Antidepressant broad-spectrum, is a selective inhibitor of the reuptake of monoamines (norepinephrine and serotonin).

Ixel not associated with m-cholinergic receptors, & alpha1- adrenoreceptors and histamine H1-receptor, and D1- and the D2-dopaminergic, benzodiazepine and opioid receptors. Do not have a sedative effect, it improves physiological sleep at night and does not negatively affect the cognitive functions. Ixel no effect on the cardiac conduction system and blood pressure, which is especially important for elderly patients continuously receiving cardiotropic drugs.

Testimony:

Depressive disorders of varying severity.

Contraindications:

• Absolute contraindications include:
  
• hypersensitivity to milnacipran
  
• up to age 15 years (due to the lack of clinical data)
  
• co-administration of non-selective and selective MAO type B inhibitors and sumatriptan.
  

The drug is not recommended:

• along with adrenaline, noradrenaline, clonidine and its derivatives
  
• with selective MAO inhibitors type A, digoxin
  
• in the presence of urinary tract obstruction (mainly prostatic hyperplasia)
  
• during pregnancy and lactation.
  

Carefully:

• angle-closure glaucoma
  
• epilepsy.
  

Side effect:

Ixel Side effects are rare, especially during the first two weeks of treatment, and expressed slightly. Usually, the side effects of their own cropped as regression of depressive symptoms and do not require discontinuation of treatment. The most common side effects include - anxiety, dizziness, increased sweating, flushing, difficulty in urination. Less commonly observed nausea, vomiting, dry mouth, constipation, tremor, palpitations, headache, rash. In rare cases can develop serotonergic syndrome, as well as a moderate increase in transaminases without clinical manifestations. Reduce the severity and number of side effects can be with a gradual build-up doses of the drug in the treatment process.

Drug Interactions:

Contraindicated combinations:

• A non-selective (iproniazid) and selective MAO-B inhibitors (selegiline)
  
• With sumatriptan because of the risk of serotonin syndrome, hypertension and coronary spasm.
  

The minimum amount of time after the end of treatment listed drugs and purpose Ixelles - 2 weeks.

Not recommended combinations:

• Adrenaline and noradrenaline due to the risk of hypertension and arrhythmias
  
• Clonidine and related compounds due to reduction of the hypotensive effect
  
• With digoxin (especially when administered parenterally) because of the risk of development of hypertension and tachycardia
  
• With selective inhibitors of MAO-A (moclobemide toloksaton) because of the risk of serotonin syndrome.
  

Combinations requiring caution when using:

• Noradrenaline and adrenaline in the case of local anesthesia (dose should not exceed 0.1 mg per 10 min or 0.3 mg in 1 hour)
  
• With lithium therapy due to the risk of serotonin syndrome.
  

Dosage and administration:

Inside, in the morning, preferably with food. The average daily dose for adults is 100 mg. The daily dose should be administered in 2 divided doses. Depending on the severity of symptoms the dose can be increased to 250 mg / day. Patients with kidney disease (glomerular filtration rate of 10-50 ml / min) a decrease the daily dose recommended depending on Cl creatinine. The duration of the drug is determined individually.

Overdose:

Symptoms: Accidental increasing doses Ixelles one of the first symptoms appear: nausea, vomiting, sweating and constipation. In case of overdose, exceeding 800-1000 mg, - vomiting, shortness of breath, tachycardia. Upon receiving excessively high doses (1900-2800 mg milnacipran) in combination with other psychotropic drugs (mostly benzodiazepines) the symptoms described above are added drowsiness, hypercapnia, disturbances of consciousness.

Manifestations of cardiac toxicity, as well as deaths, were observed with overdoses Ixelles. Milnacipran specific antidote does not exist.

Treatment: the first stage - gastric lavage, followed by symptomatic treatment. It is also recommended for monitoring the state of the patient for at least a day.

Precautionary measures:

Ixel should be used with extreme caution in patients with BPH, in epileptic seizures in history and in patients with hypertension or cardiomyopathy (due to a slight increase in heart rate).

Special instructions:

Ixel can be administered no earlier than 14 days after discontinuation of MAO inhibitors. In addition, the period of time from the date of cessation of Ixelles before the MAO inhibitor therapy should be at least 7 days.

During treatment, it is recommended to avoid alcohol consumption.

In the period of treatment should refrain from potentially hazardous activities requiring increased attention and rapid psychomotor reactions.