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Eslotin 5 mg No. 10 tablet p.p.o.

Instructions for medical use of the drug ESLOTIN Trade name Eslotin International nonproprietary name Desloratadine Dosage form Film-coated tablets Composition 1 tablet contains the active substance - desloratadine 5 mg, excipients: calcium hydrogen phosphate dihydrate, corn starch, microcrystalline cellulose, talc, magnesium stearate, shell composition: opadry blue 85F20400 (polyvinyl alcohol, titanium dioxide E171, macrogol, talc, indigo carmine aluminum varnish E132). Description Tablets are round in shape, with a biconvex surface, blue film-coated, with a score line on one side. Pharmacotherapeutic group Systemic antihistamines. Other systemic antihistamines. Desloratadine ATX code R06AX27 Pharmacological properties Pharmacokinetics The drug is well absorbed from the gastrointestinal tract, maximum plasma concentration is achieved after approximately 3 hours. The half-life is approximately 27 hours. Bioavailability is proportional to the dose taken (in the dose range from 5 mg to 20 mg). Does not pass through the blood-brain barrier, penetrates the placental barrier and into breast milk. Pharmacodynamics Eslotin has antihistamine, antiallergic and anti-inflammatory effects and does not cause drowsiness. When taken orally, desloratadine (the primary active metabolite of loratadine) selectively blocks peripheral histamine H1 receptors. Suppresses the cascade of cytostatic reactions: the release of pro-inflammatory cytokines, incl. interleukin-4 (IL-4), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-13 (IL-13), pro-inflammatory chemokines like RANTES, production of superoxide anions by activated polymorphonuclear neutrophils, adhesion and chemotaxis of eosinophils, expression of adhesion molecules, incl. P-selectin, IgE-mediated release of histamine, prostaglandin D2 and leukotriene C4. Indications for use - hay fever, allergic rhinitis - urticaria. Method of administration and dosage Eslotin is taken orally, regardless of food intake, at a dosage of 5 mg 1 time per day. The tablet should be swallowed whole, without chewing, and washed down with water. Side effects - increased fatigue - dry mouth - photosensitivity, myalgia, fatigue, asthenia - headache, hallucinations, dizziness, drowsiness, insomnia - psychomotor hyperactivity, convulsions, hallucinations - tachycardia, palpitations, QT prolongation - abdominal pain - nausea, vomiting, dyspepsia, diarrhea, abdominal pain - increased activity of liver enzymes, increased concentration of bilirubin, hepatitis, jaundice - hypersensitive reactions (such as anaphylaxis, giant urticaria, urticaria, shortness of breath, angioedema, rash) Contraindications - hypersensitivity to the components of the drug - pregnancy and lactation - children under 18 years of age. Drug interactions When studying drug interactions with repeated combined use of desloratadine with ketoconazole, erythromycin, azithromycin, fluoxetine, cimetidine, no clinically significant changes in the concentration of desloratadine in plasma were detected. Desloratadine does not enhance the effects of alcohol on the central nervous system. Special instructions Use the drug with caution in patients with severe renal failure. Use in pediatrics The use of the drug is possible only as prescribed by a doctor. Pregnancy and lactation The drug is contraindicated for use during pregnancy due to the lack of clinical data on the safety of use during pregnancy. Desloratadine is excreted in breast milk, so use during breastfeeding is contraindicated. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms The drug may have a slight effect on the ability to drive a car and operate other mechanisms; patients should be informed that in rare cases, drowsiness may occur. Overdose Symptoms: increased severity of adverse reactions. Treatment: gastric lavage followed by taking activated charcoal; if necessary, symptomatic therapy. Hemodialysis is ineffective. The effectiveness of peritoneal dialysis has not been established. Release form and packaging 10 tablets are placed in a blister pack made of polyvinyl chloride film and aluminum foil. 1 or 2 contour packages together with instructions for medical use in the state and Russian languages are placed in a cardboard pack. Storage conditions Store in a place protected from moisture at a temperature not exceeding 25ºС. Keep out of the reach of children! Shelf life: 3 years Do not use after expiration date. Conditions for dispensing from pharmacies By prescription, TURKEY (Bagcilar Ilchesi, Gunashli, Evren Mahallesi, Jami Yolu Jad. No. 50 K. 1B Zemin 4-5-6, Istanbul) “WORLD MEDICINE İLAÇ SAN. VE TIC. A.Ş.”, TURKEY (Bağcılar İlçesi, Güneşli, Evren Mahallesi, Cami Yolu Cad. No:50 K. 1B Zemin 4-5-6, İstanbul). Owner of the registration certificate “WORLD MEDICAL ILACH SAN. WE TIJ. A.Sh.”, TURKEY Address of the organization in the territory of the Republic of Kazakhstan accepting claims (suggestions) from consumers regarding the quality of the medicine of the Republic of Kazakhstan, Almaty, RIN Pharm LLP Turksib district, Suyunbay Ave., 222b Tel/fax: 8 (7272) 529090 Address of the organization responsible for post-registration monitoring of the safety of the drug, TROKA-S PHARMA LLP, Almaty, Suyunbay Avenue 222-b Cell phone, (24-hour access). e-mail: [email protected]

Eslotin tablets 5 mg, 10 pcs.

In clinical studies for indications including allergic rhinitis and chronic idiopathic urticaria, adverse effects were reported 3% more often in patients receiving a dose of 5 mg per day than in patients receiving placebo.

The most commonly reported side effects compared to placebo were fatigue (1.2%), dry mouth (0.8%) and headache (0.6%).

Children.

In clinical studies of 578 adolescents aged 12 to 17 years, the most common side effect was headache; it was observed in 5.9% of patients receiving desloratadine and in 6.9% of patients receiving placebo.

Adverse reactions that were reported more frequently than with placebo, as well as other adverse reactions that were reported during the post-marketing period. The frequency of occurrence of adverse reactions is classified as follows: very often (≥1/10), often (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rarely (≥1/10000, <1/1000), very rare (<1/10000) and frequency unknown (cannot be determined from available data).

From the side of metabolism and nutrition:

frequency unknown - increased appetite.

From the mental side:

very rarely - hallucinations, frequency unknown - aggression, abnormal behavior.

From the nervous system:

often - headache; very rarely - dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions.

From the heart:

very rarely - tachycardia, rapid heartbeat; frequency unknown - prolongation of the QT interval.

From the digestive tract:

often - dry mouth; very rarely - abdominal pain, nausea, vomiting, dyspepsia, diarrhea.

From the digestive system:

very rarely - increased levels of liver enzymes, increased bilirubin levels, hepatitis; frequency unknown - jaundice.

From the musculoskeletal system and connective tissue:

very rarely - myalgia.

For the skin and subcutaneous tissues:

frequency unknown - photosensitivity.

From the body as a whole:

often - increased fatigue; very rarely - hypersensitivity reactions (for example, anaphylaxis, angioedema, shortness of breath, itching, rash and urticaria); frequency unknown - asthenia.

Research:

frequency unknown - weight gain.

Children.

In the post-marketing period, the following adverse reactions with an unknown frequency were also observed in children: prolongation of the QT interval, arrhythmia, bradycardia, abnormal behavior and aggression.

Report suspected adverse reactions.

Reporting suspected adverse reactions occurring after drug registration is very important. This allows you to constantly monitor the benefit/risk balance of the drug. Health care professionals are asked to report any suspected adverse reactions through the national reporting system.

Eslotin tablet. 5 mg No. 10 (desloratadine)

Full description

[RU]

Tradename

Eslotin

International nonproprietary name

Desloratadine

Dosage form

Syrup for oral administration

Compound

5 ml syrup contains

active substance - desloratadine 2.50 mg,

excipients: glycerin, sodium benzoate, propylene glycol, citric acid monohydrate, sucrose, orange flavor, orange G, purified water.

Description

Orange syrup with a sweet taste

Pharmacotherapeutic group

Systemic antihistamines. Other systemic antihistamines. Desloratadine.

ATX code R06AX27

Pharmacological properties

Pharmacokinetics

The drug is well absorbed from the gastrointestinal tract, maximum plasma concentration is reached after approximately 3 hours. The half-life is approximately 27 hours. Does not penetrate the blood-brain barrier, penetrates the placental barrier and into breast milk.

Pharmacodynamics

Eslotin has antihistamine, antiallergic and anti-inflammatory effects and does not cause drowsiness. When taken orally, desloratadine (the primary active metabolite of loratadine) selectively blocks peripheral histamine H1 receptors. Suppresses the cascade of cytostatic reactions: the release of pro-inflammatory cytokines, incl. interleukin-4 (IL-4), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-13 (IL-13), pro-inflammatory chemokines like RANTES, production of superoxide anions by activated polymorphonuclear neutrophils, adhesion and chemotaxis of eosinophils, expression of adhesion molecules, incl. P-selectin, IgE-mediated release of histamine, prostaglandin D2 and leukotriene C4.

Indications for use

— seasonal hay fever and year-round allergic rhinitis (elimination or relief of sneezing, mucus from the nose, itching and nasal congestion, itching and redness of the eyes, watery eyes, itching of the palate)

- chronic idiopathic urticaria (reduction or elimination of skin itching and rash).

Directions for use and doses

Eslotin is taken orally, regardless of meals, with a small amount of water.

Children aged 1 to 5 years are prescribed 1.25 mg (2.5 ml of syrup) 1 time per day.

Children aged 6 to 11 years - 2.5 mg (5 ml of syrup) 1 time per day.

Adults and adolescents over 12 years old - 5 mg (10 ml syrup) 1 time per day.

To dose the syrup, use a measuring cup graduated to 15 ml, 10 ml and 5 ml.

The course of treatment and duration of treatment is determined by the nature of the disease. When treating seasonal hay fever, the drug should be discontinued after the symptoms disappear. In the treatment of year-round allergic rhinitis, the drug is used continuously throughout the entire period of patient contact with the allergen.

Side effects

- increased fatigue, dry mouth, headache

Very rarely

- dizziness, drowsiness

- tachycardia, palpitations

- abdominal pain, nausea, vomiting, dyspepsia, diarrhea, increased levels of bilirubin, liver enzymes in the blood serum

- anaphylaxis, angioedema, itching, rash, urticaria.

In children under 2 years of age:

- diarrhea, fever, insomnia.

Contraindications

- known hypersensitivity to the components of the drug.

Drug interactions

When studying drug interactions with repeated combined use of desloratadine with ketoconazole, erythromycin, azithromycin, fluoxetine, cimetidine, no clinically significant changes in the concentration of desloratadine in plasma were detected.

Desloratadine does not enhance the effects of alcohol on the central nervous system.

special instructions

The drug should be used with caution in patients with severe renal failure.

Eslotin in the form of syrup is prescribed with caution to patients with diabetes mellitus, as dose adjustment of hypoglycemic agents may be required.

It is not prescribed to patients with rare hereditary diseases, such as galactose intolerance, Lapp-lactase deficiency, glucose-galactose malabsorption.

Use in pediatrics

The effectiveness and safety of Eslotin in children under 6 months of age has not been proven.

Pregnancy and lactation

There are no clinical data on the safety of using Eslotin during pregnancy, so use of the drug during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.

Desloratadine passes into breast milk, so breastfeeding should be discontinued while taking Eslotin.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Eslotin does not affect the ability to drive a car or perform work that requires a high speed of psychomotor reactions.

Overdose

Symptoms: increased severity of adverse reactions.

Treatment: gastric lavage followed by taking activated charcoal; if necessary, symptomatic therapy. Hemodialysis is ineffective. The effectiveness of peritoneal dialysis has not been established.

Release form and packaging

60 ml of the drug is placed in a glass bottle with a screw-on plastic cap with control of the first opening. A self-adhesive label is placed on the bottle.

1 bottle, along with a measuring cup and instructions for medical use in the state and Russian languages, is placed in a cardboard pack.

Storage conditions

Store at a temperature not exceeding 25°C.

Keep out of the reach of children!

Shelf life

3 years

Do not use after the expiration date.

Conditions for dispensing from pharmacies

On prescription

, Türkiye

(Küçükkaryshtyran Mevkii, 39780 Lüleburgaz, Kirklareli)

“Zentiva Sağlık Ürünleri Sanayi ve Ticaret A.Ş.”, Turkey

(Küçükkarıştıran Mevkii, 39780 Lüleburgaz, Kırklareli).

Registration Certificate Holder

WORLD MEDICAL ILACH SAN. WE TIJ. A.Ş., Türkiye

(“WORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş.”, TURKEY).

Address of the organization that accepts claims from consumers regarding product quality on the territory of the Republic of Kazakhstan

LLP "RIN Farm", RK, Almaty, Turksibsky district, Suyunbay Ave., 222b

Tel/fax: 8 (7272) 529090

Address of the organization responsible for post-registration monitoring of the safety of the medicinal product

"TROKA-S PHARMA" LLP, Almaty, Suyunbay Avenue 222-b

Cell phone, (24-hour access).

e-mail