The instruction for medical use
of Erius® medicine
the Trade name
the International unlicensed
name Dezloratadin Lekarstvennaya
the Tablet form, coated, 5 mg
One tablet contains
active agent – dezloratadin 5 mg,
excipients: calcium phosphate disubstituted, cellulose microcrystalline, starch corn, talc,
cover: opadray II blue 32B10817 (lactoses monohydrate, hydroksipropilmetiltsellyuloz, titan dioxide (E 171), polyethyleneglycol, varnish aluminum blue FD&C No. 2 (indigotin (E 132)), opadray colourless YS-1-19025-A (hydroksipropilmetiltsellyuloza, polyethyleneglycol), wax karnaubsky, white wax.
Round biconvex tablets, coated light blue color, with the SP logo on one party.
Antihistaminic drugs of systemic action. Antihistaminic drugs of systemic action others. Dezloratadin
the ATX R06AX27 Code
Pharmacokinetics Dezloratadin properties begins to be defined in blood plasma within 30 min. after reception. The maximum concentration of a dezloratadin in plasma is reached on average in 3 h, elimination half-life averages 27 h. Extent of cumulation of a dezloratadin corresponds to its elimination half-life (about 27 h) and frequency rate of use (once a day). The bioavailability of a dezloratadin was proportional to a dose in the range from 5 to 20 mg. Is exposed to intensive metabolism. The main way of metabolism of a dezloratadin – hydroxylation in provision 3 with education 3-OH dezloratadin, connected to a glucuronide. Does not get through a blood-brain barrier. Dezloratadin moderately (83 – 87%) contacts proteins of plasma. At use of a dezloratadin in a dose from 5 to 20 mg once a day within 14 days of signs of clinically significant cumulation of drug it is not revealed. The bioequivalence of drug in the form of tablets and syrup is revealed. It is established that food (fat high-calorific breakfast) or grapefruit juice do not influence distribution of a dezloratadin.
Dezloratadin is brought from an organism in the form of glyukuronidny connection. A small part of a dose is removed in not changed view with a stake and urine.
Dezloratadin is a selection blocker peripheral histamine H1 receptors which do not render sedation. Dezloratadin is primary active metabolite of a loratadin. Qualitative or quantitative divergences of toxicity of a dezloratadin and a loratadin in comparable doses (taking into account concentration of a dezloratadin) are not revealed. After oral administration of Erius® selectively blocks peripheral H1-histamine receptors and does not get through a blood-brain barrier. Except antihistaminic activity of Erius® has antiallergic and anti-inflammatory effect. It is established that Erius® oppresses a cascade of various reactions which are the cornerstone of development of allergic inflammation namely:
· discharge of pro-inflammatory cytokines,
· discharge of pro-inflammatory chemokines,
· products of superoxidic anion the activated polymorphonuclear neutrophils,
· adhesion and chemotaxis of eosinophils,
· expression of molecules of adhesion,
· dependent discharge of a histamine, prostaglandin and leukotriene,
· sharp allergic bronchospasm.
Эриус® does not get through a blood-brain barrier, does not cause drowsiness and does not influence psychomotor function.
– a pollinosis, allergic rhinitis (sneezing, discharges from a nose, an itching, hypostasis and congestion of a nose and also an itching of eyes, dacryagogue and reddening of eyes, naggers in the field of the sky and cough)
– a small tortoiseshell (elimination of symptoms of a skin itching, rash)
the Route of administration and doses
Inside. The adult – on 1 tablet (5 mg) of 1 times a day. The tablet should be swallowed entirely, without chewing and to wash down with water. Time of day, regardless of meal is desirable to take the drug regularly in one and too. The course of treatment is appointed by the doctor individually.
– increased fatigue
– dryness in a mouth
– a headache, hallucinations, dizziness, drowsiness, insomnia
– psychomotor hyperactivity, spasms
– tachycardia, heartbeat
– abdominal pains
– nausea, vomiting, dyspepsia, diarrhea
– increase in activity of enzymes of a liver, increase in concentration of bilirubin, hepatitis
– hyper sensitive reactions (such as anaphylaxis, huge small tortoiseshell, small tortoiseshell, asthma, rash)
of the Contraindication
– hypersensitivity to components of drug or to a loratadin
– the period of pregnancy and a lactation
– children’s age up to 18 years
Interaction with other medicines is not revealed. Meal does not influence efficiency of drug. Эриус® does not strengthen the oppressing effect of ethanol on psychomotor function.
With care of Erius® to apply in a heavy renal failure.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
of Influence Eriusa® on driving or work with difficult technical devices was not noted. However it is necessary to consider that in rare instances after administration of drug the drowsiness which can influence ability to drive the car is observed and to work with other mechanisms.
Symptoms: reception of the dose exceeding 25 mg did not lead to emergence of any symptoms.
Treatment: gastric lavage with the subsequent intake of activated carbon as adsorbent and purpose of symptomatic treatment. Эриус® it is not removed by means of a hemodialysis.
A form of release and packing
On 10 tablets in blister strip packaging from aluminum foil with a vinyl covering.
1 planimetric packing together with the instruction for medical use in the state and Russian languages is put in a pack cardboard.
To Store storage conditions at a temperature from 2 °C to 30 °C.
To store out of children’s reach.
not to apply a period of storage after an expiration date.
According to the prescription
Shering-Plau Labo Producer H. B., Belgium
the Owner of the registration certificate
Shering-Plau Sentral East AG, Switzerland