Instruction for use: Histafen

Dosage form: Tablets

Active substance: Sequifenadine*

ATX

R06AX Antihistamines, systemic, other

Pharmacological groups:

Antiallergic agent - H1-histamine receptor blocker [H1-antihistamines]

The nosological classification (ICD-10)

H10.1 Acute atopic conjunctivitis: Allergic conjunctivitis; Allergic eye diseases; Allergic conjunctivitis; Allergic conjunctivitis caused by chemical and physical factors; Allergic rhinoconjunctivitis; Allergic inflammation of the eyes; Spring Qatar; Spring keratitis; Spring conjunctivitis; Conjunctivitis allergic; Year-round allergic conjunctivitis; Exacerbation of pollinosis in the form of rhinoconjunctival syndrome; Acute allergic keratoconjunctivitis; Acute allergic conjunctivitis; Superficial bacterial infection of the eyes; Rhinoconjunctivitis; Seasonal allergic conjunctivitis; Seasonal conjunctivitis; SENSORY; Chronic allergic keratoconjunctivitis; Chronic allergic conjunctivitis

J30 Vasomotor and allergic rhinitis: Allergic rhinopathy; Allergic rhinosinusopathy; Allergic diseases of the upper respiratory tract; Allergic rhinitis; Allergic rhinitis seasonal; Vasomotor runny nose; Prolonged allergic rhinitis; All-year-round allergic rhinitis; All-year allergic rhinitis; Year-round or seasonal allergic rhinitis; All-the-year-round rhinitis of an allergic nature; Rhinitis vasomotor allergic; Exacerbation of pollinosis in the form of rhinoconjunctival syndrome; Acute allergic rhinitis; Edema of the nasal mucosa; Edema of the nasal mucosa; Edema of the mucous membrane of the nasal cavity; Swelling of the nasal mucosa; Swelling of the nasal mucosa; Pollinosis; Permanent allergic rhinitis; Rhinoconjunctivitis; Rhinosinusitis; Rhinosinusopathy; Seasonal allergic rhinitis; Seasonal allergic rhinitis; Hay rhinitis; Chronic allergic rhinitis; Allergic diseases of the respiratory tract

L20 Atopic dermatitis: Allergic diseases of the skin; Allergic skin disease noninfectious etiology; Allergic skin disease etiology nemikrobnoy; Allergic skin diseases; Allergic skin lesions; Allergic reactions on the skin; atopic dermatitis; Allergic dermatosis; Allergic diathesis; Allergic itching dermatosis; Allergic skin disease; Allergic skin irritation; allergic Dermatitis; atopic Dermatitis; allergic dermatoses; exudative diathesis; Itchy atopic eczema Itchy allergic dermatosis; Allergic skin disease; Cutaneous allergic reaction to drugs and chemicals; Cutaneous reactions to medications; Skin and allergic disease; Acute eczema; common neurodermatitis; Chronic atopic dermatitis; Exudative diathesis

L50 Urticaria: Idiopathic chronic urticarial; Injury Urticaria; Chronic urticarial; Hives of the newborn

T78.3 Angioedema: Edema Quincke; Laryngeal exacerbation with angioneurotic edema; Recurrent angioedema; Allergic edema; Recurrent swelling of Quincy

Composition

Tablets - 1 table.

active substance: Sepsifenadine hydrochloride dihydrate 50 mg

(In terms of sehifenadina hydrochloride)

Auxiliary substances: lactose monohydrate - 302 mg; MCC - 20 mg; Corn starch - 20 mg; Silicon dioxide - 2 mg; Magnesium stearate - 6 mg

Description of dosage form

Round flat-cylindrical with a bevel and a risk of a tablet of white or almost white color.

Pharmachologic effect

Mode of action - antiallergic.

Pharmacodynamics

Seyfenadine is a blocker of H1-histamine receptors, it also moderately blocks serotonin 5-HT1 receptors, thus, Weakening the action of mediators of histamine and serotonin allergy. Histamine causes clinical manifestations of allergic inflammation: edema (increases the permeability of capillaries), skin flushing (vasodilation), skin itching and pain. The peculiarity of sehifenadine is that it has antihistamine action, not only blocking histamine H1 receptors, but also reducing histamine content in tissues by accelerating its destruction by diaminoxidase.

In allergic diseases, serotonin levels in the blood also increase. Serotonin raises blood pressure, causes bronchospasm, increases the permeability of capillaries, enhances the action of inflammatory mediators - histamine, bradykinin, PG. Seifenadine prevents or weakens the spasmogenic effect of histamine and serotonin on the smooth muscles of the bronchi, intestines, vessels; Violation of permeability of capillaries and development of edema.

Sephifenadine has a pronounced antipruritic and antiexcadative effect of a prolonged nature.

Affects the immunological reactivity of the body, reducing the number of B-lymphocytes in the spleen, bone marrow, lymph nodes, and also reduces the elevated Ig concentration of classes A and G.

Slightly penetrates the BBB, which explains the absence of a pronounced inhibitory effect on the central nervous system, but in some cases with an individual hypersensitivity there is a slight sedative effect.

When receiving sehifenadina not observed changes in biochemical parameters of blood and urine, the drug does not affect blood pressure, ECG, the concentration of glucose and cholesterol in the blood, does not affect the EEG.

Pharmacokinetics

Quickly absorbed from the digestive tract. Cmax of the active substance in the blood plasma is achieved in 1-2 hours Accumulated mainly in the lungs, the liver, the lowest concentration - in the brain. Metabolized by oxidation, forming a pharmacologically inactive metabolite.

After taking a single dose of 50 mg of T1 / 2 active substance from the blood plasma is 12 hours, and after repeated doses is shortened to 5-8 hours, i.e. Sephifenadine does not accumulate in the body. 50% of the dose is excreted through the intestine, more than 20% by the kidneys. About 30% of the dose is excreted unchanged, 40-50% - in the form of metabolites.

Indication for the Histafen

Allergic rhinitis;

Allergic conjunctivitis;

Pollinosis;

hives;

Angioedema;

Allergic itching dermatoses, incl. atopic dermatitis;

Prevention of allergic diseases before the season of their seasonal exacerbation and maintenance therapy.

Contraindications

Hypersensitivity to the active substance or excipients of the drug;

bronchial asthma;

pregnancy;

Lactation period;

Children's age till 18 years;

Simultaneous administration of MAO inhibitors.

The tablet contains lactose. The drug should not be used with a deficiency of lactase, a rare hereditary lactose intolerance or glucose / galactose malabsorption.

With caution: for violations of the kidneys, severe diseases CCC, GIT, liver.

Side effects

Dry mouth, epigastric pain, indigestion, increased appetite, leukopenia, menstrual irregularities, increased urination, headache, drowsiness. Excitation, insomnia, which are more common when taking high doses.

Interaction

Sephifenadine does not exacerbate the depressing effect of hypnotics and alcohol on the central nervous system, however, during the treatment period one should refrain from drinking alcohol.

Dosing and Administration

Inside, after eating, washed down with water. Adults with acute and chronic allergic diseases - 50-100 mg 2-3 times a day. Usually, the therapeutic effect occurs 3 days after the start of treatment. The duration of the course of treatment is 5-15 days.

Prevention of allergic diseases before the season of their seasonal exacerbation and for maintenance therapy - 50 mg 2 times a day. It is recommended to start taking the drug 2 weeks before the expected effect of the seasonal allergen.

Overdose

Symptoms: dry mucous membranes, headache, vomiting, abdominal pain.

Treatment: symptomatic therapy. The antidote is unknown.

Special instructions

There are no clinical studies on the use of the drug in children and patients aged (after 70 years) age.

Tablets sehifenadina can be combined with topical preparations (ointment, eye drops, drops in the nose).

In most cases, drowsiness decreases or disappears after 2-5 days after the start of treatment.

Influence on the ability to drive a car or perform work that requires an increased speed of physical and mental reactions. Persons whose work requires a quick physical or mental reaction (transport drivers, etc.), during the treatment period, it is necessary to refrain from driving and practicing potentially dangerous activities.

Release form

Tablets, 50 mg. For 10 tab. In a contoured cell pack of a PVC film of white color and aluminum foil. 2 contour squares in a pack of cardboard.

Manufacturer

JSC "Olainfarm"

Conditions of leave from pharmacies

On prescription.

Storage conditions of the drug Histafen

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Histafen

4 years.

Do not use after the expiry date printed on the package.