Expiration date: 06/2025

Structure and Composition: 

Tablets. Active substance (oer 1 tablet):

Sequifenadine hydrochloride dihydrate 50 mg (Based on Sequifenadine hydrochloride)

Excipients: lactose monohydrate - MCC 302 mg - corn starch 20 mg - 20 mg of silicon dioxide - Magnesium stearate 2 mg - 6 mg

in blisters of PVC film 10 pcs. 2 In the paper cartons packaging.

Description pharmaceutical form:

Round Valium with a facet and Valium tablets white or nearly white.

Pharmacokinetics:

Rapidly absorbed from the gastrointestinal tract. Cmax active substance in plasma is achieved in 1-2 hours is accumulated mainly in the lungs, the liver, the lowest concentration of -. The brain. It is metabolized by oxidation to form a pharmacologically inactive metabolite.

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

Description of the pharmacological actions:

Sequifenadine is a blocker of H1-histamine receptors, and moderate blocks serotonin 5-HT1 receptors, thus weakening the action of mediators of allergy histamine and serotonin. Histamine causes the clinical manifestations of allergic inflammation: swelling (increased capillary permeability), flushing of the skin (vasodilation), itching and pain. Sequifenadine feature consists in the fact that it has an antihistaminic effect, not only blocking the histamine H1-receptors but also reducing the content of histamine in tissues by accelerating its destruction diamine.

In allergic diseases also increases blood serotonin. Serotonin increases blood pressure, causes bronchoconstriction, increased capillary permeability, enhances the action of inflammatory mediators - histamine, bradykinin, PG. Sequifenadine prevents or reduces spazmogennoe influence of histamine and serotonin in the smooth muscles of the bronchi, intestines, blood vessels violation of capillary permeability and edema development.

Sequifenadine has a significant antipruritic effect and antiekssudativnoe extended character.

Affects the immunologic reactivity, reducing the number of B lymphocytes in the spleen, bone marrow, lymph nodes, and reduces the increased concentration of Ig classes A and G.

Slightly penetrates the BBB, which explains the lack of pronounced inhibitory effect on the central nervous system, but in some cases, individual sensitivity observed light sedation.

When receiving Sequifenadine not observed changes in biochemical parameters of blood and urine, the drug has no effect on blood pressure, ECG, the concentration of glucose and cholesterol in the blood, does not affect the EEG.

Testimony:

• nasal allergy
  
• allergic conjunctivitis
  
• pollen disease
  
• hives
  
• angioedema
  
• allergic pruritic dermatoses, including atopic dermatitis
  
• prevention of allergic diseases to their period of seasonal acute and maintenance therapy.
  

Contraindications:

• Hypersensitivity to the active substance or excipients of the drug
  
• bronchial asthma
  
• pregnancy
  
• lactation
  
• Children up to age 18 years
  
• simultaneous reception of MAO inhibitors.
  

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

Precautions: renal impairment, severe illness cardiovascular system, gastrointestinal tract and liver.

Side effect:

Dry mouth, epigastric pain, dyspepsia, increased appetite, leukopenia, menstrual disorders, frequent urination, headache, somnolence. Agitation, insomnia, are more likely to occur at high doses.

Drug Interactions:

Sequifenadine no dampening effect on the central nervous system of hypnotic drugs and alcohol, but in the period of treatment should refrain from drinking alcohol.

Dosage and administration:

Inside, after eating, squeezed water. Adults with acute and chronic allergic diseases - 50-100 mg 2-3 times a day. Typically, the therapeutic effect occurs within 3 days after starting treatment. Duration of treatment - 5-15 days.

Prevention of allergic diseases to their period of seasonal acute and maintenance therapy - 50 mg 2 times a day. The drug is recommended to start 2 weeks before the expected impact of seasonal allergies.

Overdose:

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

Treatment: symptomatic therapy. Antidote is unknown.

Special instructions:

There are no clinical studies of drug use among children and senile patients (after 70 years) age.

Sequifenadine tablets can be combined with topical therapy (ointment, eye drops, nose drops).

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

Effects on ability to drive or to perform work requiring higher rate of physical and mental reactions. Persons whose work requires quick mental or physical reaction (transport drivers, and others.), In the period of treatment should refrain from driving and transport activities potentially hazardous activities.