Revival kaps. gastrorez. firm 30 mg No. 30

Revival capsules are shown at:

• Treatment of big depressive disorder.
• Treatment of diabetic peripheral neuropatichesky pain.
• Treatment of a generalized anxiety disorder.

Structure

Active ingredient: duloksetina hydrochloride;

1 capsule of a gastrorezistentn firm supports a duloksetin a hydrochloride of 33.68 mg that is equivalent a duloksetina of 30 mg, or a duloksetina a hydrochloride of 67.35 mg that is equivalent a duloksetina of 60 mg;

Excipients: sugar spherical (sucrose, starch corn), gipromelloza 2910/5mPa.s, krospovidon type A, sucrose, gipromelloza of acetate succinate, triethyl citrate (E 1505), talc, macrogoal 8000, titan dioxide (E 171);

a capsule Cover (for capsules of 30 mg):

Structure of a cover of the capsule: the titan dioxide (E 171), gelatin, patent blue V (E 131), sodium lauryl sulfate, karmoizin (E 122), water cleaned;

a capsule Cover (for capsules of 60 mg):

Structure of a cover of the capsule: the titan dioxide (E 171), gelatin, sodium lauryl sulfate, erythrosine (E 127), ferrous oxide red (E 172), ferrous oxide black (E 172), water cleaned.

Contraindication

• Hypersensitivity to a duloksetin or to any excipients of drug.
• Simultaneous use with the MAO (MAO) non-selective irreversible inhibitors or during at least 14 days after the treatment termination by MAO inhibitors. Considering a half-life period of a duloksetin, it is impossible to appoint MAO inhibitors at least within 5 days after the treatment termination duloksetiny.
• Simultaneous use with fluvoksaminy, ciprofloxacin or enoksatsiny (strong CYP1A2 inhibitors) because of increase in concentration of a duloksetin in blood plasma.
• Unstable arterial hypertension which can provoke hypertensive crisis.
• End-stage of a renal failure (clearance of creatinine <30 ml/min.).
• Disease of a liver that can give a liver failure.

Route of administration

Big depressive disorder. Initial the maintenance dose is also recommended makes 60 mg of 1 times a day irrespective of meal. A dosage more than 60 mg of 1 times a day, to the maximum 120 mg a day, were estimated in terms of safety. However there are no clinical data that patients who do not react to the initial recommended dose can benefit from increase in a dose.

in 2-4 weeks of treatment.

. At patients who react on duloksetin and at the anamnesis of repeated episodes of a great depression it is necessary to consider further long-term treatment in a dose of 60-120 mg a day.

Use of medicament during pregnancy is recommended to

Feature of use

only under a condition if the expected advantage for the pregnant woman exceeds potential risk for a fruit.

Children

to children did not study Safety and efficiency of use of a duloksetin therefore medicament is contraindicated to this age category of patients.

Drivers

during treatment to patients should abstain from potentially dangerous types of activity requiring special attention and speed of psychomotor reactions.

Data on overdose of a duloksetin are limited to

. There are messages about reception of high doses (up to 1400 mg) a duloksetina separately or in a combination with other medicines that had no lethal outcomes. Overdose symptoms (mainly at a combination with other medicines) included drowsiness, a coma, a serotoninovy syndrome, epileptic seizures, vomiting and tachycardia.

Treatment. Specific antidotes are unknown. At emergence of a serotoninovy syndrome the specific treatment (use of cyproheptadine and/or control of temperature) is necessary. The passability of airways needs to be checked. It is recommended to carry out monitoring of warm activity and control of key indicators of activity together with the appropriate symptomatic and supporting measures. Gastric lavage can be appropriate if it is carried out right after administration of drug. Activated carbon reduces medicament absorption. Duloksetin has the large volume of distribution in an organism in this connection an artificial diuresis, hemoperfusion and exchange perfusion will be hardly useful.

to

Side effects

It was reported about dizziness, nausea and a headache as adverse symptoms at the termination of reception of a duloksetin. At the termination of reception of a duloksetin it was also reported about disturbance of sensitivity, a sleep disorder, excitement or uneasiness, a tremor, irritability, diarrhea and a hyperhidrosis.

• from an endocrine system: hypothyroidism.
• from the immune system: anaphylactic reactions, hypersensitivity.
• from metabolism: loss of appetite, hyperglycemia, dehydration, hyponatremia, syndrome of inadequate secretion of antidiuretic hormone.
• from mentality: insomnia, agitation, decrease in a libido, uneasiness, abnormal visions and abnormal orgasm, sleep disorders, bruxism, disorientation, apathy, suicide thinking, mania, hallucinations, aggression and malignancy, suicide behavior.
• from nervous system: headache, drowsiness, dizziness, tremor, paresthesias, myoclonia, akathisia, nervousness, attention disorders, lethargy, dyskinesia, disturbances of taste, restless legs syndrome, bad dream, serotoninovy syndrome, spasms, extrapyramidal disorders.
• From dock of organs of sight: indistinct image, mydriasis, disorders of vision, xerophthalmus, glaucoma.
• from organs of hearing: a ring in ears, vertigo, ear pain.
• from a cardiovascular system: heartbeat; tachycardia inflows; supraventricular arrhythmia; fibrillation, atrial is more often; arterial hypertension; increase in arterial blood pressure; orthostatic hypotension; loss of consciousness; cryesthesia in extremities; hypertensive crisis.
• from a respiratory system: yawning, oropharyngeal pain, feeling of compression in a throat, nasal bleeding.
• from a digestive tract: nausea, vomiting, dyspepsia, a meteorism, an abdominal pain, a constipation, diarrhea, gastrointestinal bleedings, a gastroenteritis, an eructation, gastritis, stomatitis, an unpleasant smell from a mouth, presence of blood in Calais, dryness in a mouth.

Interaction

Drugs operating on the central nervous system. At reception of a duloksetin in a combination with other medicaments operating on the central nervous system, especially with the similar mechanism of action, including alcohol and sedative medicines it is necessary to observe certain precautionary measures.

MAO Inhibitors. Duloksetin it is not necessary to appoint together with the MAO non-selective irreversible inhibitors because of risk of emergence of a serotoninovy syndrome. At intake of reverse selection monoamine oxidase inhibitors (MAO), for example a moklobemida, the risk of emergence of a serotoninovy syndrome is less, however use of such combination is not recommended.

Medicines containing duloksetin. It is necessary to avoid combined use with other medicines containing duloksetin.

Drugs containing a St. John's wort grass. At combined use often there are side reactions.

to Store

at a temperature not above 25 °C in original packing.

to Store

out of children's reach.

Expiration date - 3 years.