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Dezlorem Neo – film-coated tablets

INSTRUCTIONS FOR MEDICAL USE

DEZLOREM NEO

Trade name of the drug: Dezlorem Neo

Active substance (INN): Desloratadine

Dosage form: film-coated tablets

Composition:

1 tablet contains:

Active ingredient: desloratadine 5 mg

Excipients: microcrystalline cellulose, corn starch, povidone, crosspovidone, colloidal silica, magnesium stearate

Excipients of the shell: hydroxypropylmethylcellulose, polyethylene glycol 4000, titanium dioxide, iron oxide red

Description: Round, biconvex pink film-coated tablets.

Pharmacotherapeutic group: Anti-allergic agent.

ATX code: R06AX27

Pharmacological properties

Pharmacodynamics

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

Pharmacokinetics

Desloratadine begins to be determined in blood plasma of adults and adolescents within 30 min after oral administration. Desloratadine is well absorbed from the gastrointestinal tract, Cmax in plasma is reached after approximately 3 hours. T1/2 averages 27 h (20-30 h). It is 83-87% bound to plasma proteins. There is no clinically significant cumulation when administered in adults and adolescents in doses from 5 to 20 mg once daily for 14 days. Simultaneous intake of food or grapefruit juice does not affect the distribution of desloratadine administered at a dose of 7.5 mg once daily. Desloratadine is not a CYP3A4 or CYP2D6 inhibitor and is not a P-glycoprotein substrate or inhibitor. Desloratadine is biotransformed in the body by hydroxylation to form 3- OH-desloratadine coupled to glucuronide. A small portion of the unchanged drug is excreted by the kidneys and intestines.

Indications for use

  • Seasonal pollen allergy and year-round allergic rhinitis (elimination or relief of sneezing, nasal mucus secretion, itching and stuffy nose, itching and red eyes, lacrimation, itching palate)
  • chronic idiopathic urticaria (reduction or elimination of skin itching and rash).

Dosage and administration

The drug is taken orally, with a small amount of water, regardless of meals. Children 6 to 11 years of age: 1/2 tablet (2.5 mg) once a day.

Adults: 1 tablet (5 mg) 1 time per day.

The course of treatment and duration of administration are determined by the nature of the disease. In the treatment of seasonal pollinosis the drug is discontinued after the disappearance of symptoms. When treating year-round allergic rhinitis, the drug is used continuously, for the entire period of patient’s contact with the allergen.

Side effect

Increased fatigue, dry mouth, headache. The following side effects have been reported very rarely: CNS disorders: dizziness, somnolence;

Cardiovascular system: tachycardia, palpitations;

Digestive system: abdominal pain, nausea, vomiting, dyspepsia, diarrhea, increased bilirubin, liver enzymes in blood serum;

allergic reactions: anaphylaxis, angioneurotic edema, itching, rash, urticaria.

Contraindications

Hypersensitivity to the drug components, children under 6 years of age.

Drug interactions

In the study of drug interactions during multiple co-administration of desloratadine with ketoconazole, erythromycin, azithromycin, fluoxetine, cimetidine no clinically significant changes in the plasma concentration of desloratadine were found. Desloratadine does not increase the effect of alcohol on the central nervous system.

Special indications

Use with caution in patients with severe renal insufficiency. Efficacy and safety of using the drug in children under 6 months has not been proved.

There are no clinical data about safety of this medicine use during pregnancy, therefore during pregnancy the medicine can be used only in case when the expected benefits for a mother exceed the potential risk for a fetus. Desloratadine penetrates into breast milk, therefore breast-feeding should be discontinued while using the drug.

The drug does not affect the ability to drive a vehicle and perform work requiring high speed psychomotor reactions.

Overdose

Symptoms: increased severity of adverse reactions.

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

Form of production

film-coated tablets, 5 mg in carton packs.

Storage conditions

Store in a dry, dark place at temperatures not exceeding 25ºC. Keep out of the reach of children!

Shelf life

2 years. Do not use after the expiration date.

Conditions of dispensing from pharmacies.

Released without a prescription.

Dezlorem Neo – syrup

INSTRUCTIONS FOR MEDICAL USE

DEZLOREM NEO

Trade name of the drug: Dezlorem Neo

Active substance (INN): Desloratadine

Dosage form: Syrup

Contents:

5 ml of syrup contains:

Active substance: Desloratadine-2.5 mg;

Excipients: sodium benzoate, glycerin, sorbitol 70% solution, citric acid (anhydrous), sodium citrate dihydrate, mannitol, propylene glycol, aspartame, potassium acesulfame, essence of mint, FDC red dye 40, purified water.

Description: clear liquid, pink in color, with a minty odor and sweet taste.

Pharmacotherapeutic group: Anti-allergic agent.

ATX code: R06AX27

Pharmacological properties

Pharmacodynamics

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

Pharmacokinetics

Desloratadine begins to be determined in blood plasma of adults and adolescents within 30 min after oral administration. Desloratadine is well absorbed from the gastrointestinal tract, Cmax in plasma is reached after approximately 3 hours. T1/2 averages 27 h (20-30 h). It is 83-87% bound to plasma proteins. There is no clinically significant cumulation when administered in adults and adolescents in doses from 5 to 20 mg once daily for 14 days. Simultaneous intake of food or grapefruit juice does not affect the distribution of desloratadine administered at a dose of 7.5 mg once daily. Desloratadine is not a CYP3A4 or CYP2D6 inhibitor and is not a P-glycoprotein substrate or inhibitor. Desloratadine is biotransformed in the body by hydroxylation to form 3- OH-desloratadine coupled to glucuronide. A small portion of the unchanged drug is excreted by the kidneys and intestines.

Indications for use

  • Seasonal pollen allergy and year-round allergic rhinitis (elimination or relief of sneezing, nasal mucus secretion, itching and stuffy nose, itching and red eyes, lacrimation, itching palate)
  • chronic idiopathic urticaria (reduction or elimination of skin itching and rash).

Dosage and administration

Children from 6 to 11 months: 2 ml syrup (1.0 mg) once a day.

Children 1 to 5 years of age are prescribed 2.5 ml (1.25 mg) syrup 1 time per day. Children 6 to 11 years of age are prescribed 5 ml of syrup (2.5 mg) once a day.

Adults and adolescents over 12 years of age take 10 ml of syrup (5 mg) once a day.

The course of treatment and duration of administration is determined by the nature of the disease. In the treatment of seasonal pollen allergy the drug is discontinued after the disappearance of symptoms. In the treatment of allergic rhinitis year-round the drug is used continuously, during the entire period of patient’s contact with the allergen.

Side effects

Increased fatigue, dry mouth, headache. The following side effects have been noted very rarely:

CNS disorders: dizziness, somnolence;

Cardiovascular system: tachycardia, palpitations;

Digestive system: abdominal pain, nausea, vomiting, dyspepsia, diarrhea, increased bilirubin, liver enzymes in blood serum;

Allergic reactions: anaphylaxis, angioneurotic edema, itching, rash, urticaria. In children under 2 years of age: diarrhea, fever, insomnia.

Contraindications

  • Hypersensitivity to any of the components that are part of the drug.

Drug interactions

In studies of drug interactions during multiple co-administration of desloratadine with ketoconazole, erythromycin, azithromycin, fluoxetine, cimetidine no clinically significant changes in plasma concentration of desloratadine were found.

Desloratadine does not increase the effect of alcohol on the central nervous system.

Special indications

Use with caution in patients with severe renal failure. The drug in syrup form is used with caution in patients with diabetes mellitus, because correction of the dose of hypoglycemic agents may be required. Efficacy and safety of using the drug in children under 6 months is not proved.

There are no clinical data on safety of the drug administration during pregnancy; therefore, the drug administration during pregnancy is possible only when the expected benefits to the mother exceed the potential risk to the fetus. Desloratadine penetrates into breast milk, therefore breast-feeding should be discontinued while using the drug. The drug does not affect the ability to drive a vehicle and perform work requiring high speed psychomotor reactions.

Overdose

Symptoms: increased severity of adverse reactions.

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

Form of production

Syrup, 2.5 mg/5 ml – 50 ml or 60 ml in vials, complete with measuring spoon or cup.

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25ºC. Keep out of the reach of children!

Shelf life

2 years. Do not use after the expiration date.

Conditions of dispensing from pharmacies.

Released without a prescription.

Allegra – coated tablets

MEDICAL INSTRUCTIONS FOR USE

ALLEGRA

Trade name of the drug: Allegra

Active substance (INN): Cetirizine hydrochloride

Contents:

1 tablet contains:

active substance: Cetirizine dihydrochloride 10 mg;

Excipients: corn starch, nipagin, nipazole, lactose, talc, magnesium stearate.

Shell: hydroxypropyl methylcellulose, titanium dioxide, talc, propylene glycol 4000.

Description: Round, biconvex, white or almost white coated tablets.

Pharmacotherapeutic group: Anti-allergic agents.

ATX code: R06AE07

Pharmacological properties

Cetirizine dihydrochloride is a metabolite of hydroxyzine, belongs to the group of competitive histamine antagonists and blocks H1-histamine receptors.

The drug prevents the development and facilitates the course of allergic reactions, has antipruritic and antiexudative actions. It affects the “early” histamine-dependent stage of allergic reactions, limits the release of inflammatory mediators at the “late” stage of the allergic reaction, and also reduces the migration of eosinophils, neutrophils and basophils, stabilizes mast cell membranes. It reduces capillary permeability, prevents the development of tissue edema, relieves smooth muscle spasm. Eliminates the skin reaction to the introduction of histamine, specific allergens, as well as to cooling (in cold urticaria). Reduces histamine-induced bronchoconstriction in mild bronchial asthma.

It has no anticholinergic and antiserotonin action. In therapeutic doses the drug has no sedative effect. An effect after a single dose of 10 mg of cetirizine develops in 20 minutes in 50% of patients and in 60 minutes in 95% of patients and lasts for more than 24 hours. During a course of treatment, tolerance to the antihistamine effect of cetirizine does not develop. After discontinuation of therapy the effect lasts up to 3 days.

Pharmacokinetics

Pharmacokinetic parameters of the drug change linearly.

Absorption: after oral administration the drug is quickly and completely absorbed from the gastrointestinal tract. Food intake does not affect the completeness of absorption, although its speed decreases. In adults after a single use of the drug in a therapeutic dose, the maximum concentration (Cmax) in blood plasma is reached after 10.5 hours and is 300 ng/ml.

Distribution: cetirizine is 930.3% bound to plasma proteins. The volume of distribution (Vd) is 0.5 l/kg. No cetirizine cumulation is observed when taking the drug in a dose of 10 mg for 10 days.

Metabolism: it is metabolized in small amounts in the body by O-dealkylation (unlike other H1-histamine receptor antagonists, which are metabolized in the liver via the cytochrome system) to form a pharmacologically inactive metabolite.

Excretion: in adults the half-life (T1/2) is approximately 10 hours; T1/2 in children from 6 to 12 years is 6 hours, from 2 to 6 years is 5 hours, from 6 months to 2 years is 3.1 hours. Approximately 2/3 of the administered dose is excreted unchanged by the kidneys.

In elderly patients and patients with chronic liver diseases in single use of 10 mg dose T1/2 is increased approximately by 50%, and systemic clearance is decreased by 40%.

In patients with mild renal insufficiency (creatinine clearance (CK) 40 ml/min) pharmacokinetic parameters are similar to those in patients with normal renal function.

In patients with moderate renal insufficiency and in patients on hemodialysis (CKR 7 ml/min), in per oral administration with 10 mg dose T1/2 is prolonged by 3 times and total clearance is decreased by 70% relative to patients with normal renal function, which requires appropriate change of dosage regimen.

Cetirizine dihydrochloride is practically not eliminated from the body during hemodialysis.

Indications

For adults and children over 6 years of age:

  • Treatment of symptoms of allergic year-round (persistent) and seasonal (intermittent) allergic rhinitis (hay fever, pollinosis; maximum duration of treatment of seasonal rhinitis in children is 4 weeks);
  • Allergic conjunctivitis;
  • Chronic idiopathic urticaria.

Dosage and administration

Treatment of allergic rhinitis.

Adults and adolescents above 12 years of age: Recommended dose is 10 mg (1 tablet) once a day.

Children 6 to 12 years of age: 10 mg (1 tablet) once a day. Maximum duration of treatment is 4 weeks.

The dose may be divided into 2 doses of 5 mg (1/2 tablet) in the morning and evening respectively.

Treatment of allergic conjunctivitis

Adults and adolescents over 12 years of age: recommended dose is 10 mg (1 tablet) once a day.

Children 6 to 12 years of age: 10 mg (1 tablet) once a day. Maximum duration of treatment is 4 weeks. The dose may be divided into 2 doses of 5 mg (1/2 tablet) in the morning and evening respectively.

Treatment of year-round rhinitis and chronic idiopathic urticaria

Adults and adolescents over 12 years of age: recommended dose is 10 mg (1 tablet) once daily.

Children 6 to 12 years of age: 10 mg (1 tablet) once daily. The dose may be divided into 2 doses of 5 mg (1/2 tablet) in the morning and evening, respectively.

Children 6 to 12 years of age: 10 mg (1 tablet) once a day. The dose may be divided into two doses of 5 mg (1/2 tablet) in the morning and evening, respectively.

Patients who require a special dosing regimen

Elderly patients

In case of age-related reduction of glomerular filtration the drug administration for elderly patients is prescribed in the same dosage as for patients with renal insufficiency.

Patients with renal failure

Intervals between doses of the drug are individually adjusted according to the degree of renal insufficiency.

Patients with hepatic impairment.

Patients with liver dysfunction only do not need to make dosage adjustment.

Administration of the drug

It should be taken in the evening, because the symptoms are more intense at this time of day. The tablet is swallowed whole, without chewing and with water.

The drug is taken regardless of food intake.

In case of mild side effects in adults and adolescents over 12 years old, it is recommended to take 5 mg (1/2 tablet) of the drug in the morning and in the evening respectively.

Side effects

Possible side effects are listed below by body system and frequency of occurrence: very common (≥1/10), common (≥1/100, <1/10), infrequent (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), frequency unknown (due to insufficient data).

Immune system disorders: rare: hypersensitivity reactions; very rare: anaphylactic shock.

Metabolic and nutritional disorders: frequency unknown: increase in appetite.

Nervous system disorders: infrequent: paresthesias; rare: seizures; very rare: perversion of taste, dyskinesia, dystonia, syncope, tremor; frequency unknown: deafness, memory impairment, amnesia.

Mental disorders: infrequent: agitation; rare: aggression, confusion, depression, hallucinations, sleep disturbance; very rare: tics; frequency unknown: suicidal ideation.

Eye: very rare: accommodation disorder, blurred vision, nystagmus; frequency unknown: vasculitis.

Hearing and balance: frequency unknown: vertigo.

Digestive system: infrequent: diarrhea.

Cardiovascular system: rare: tachycardia.

Urinary system: very rare: dysuria, enuresis; frequency unknown: urinary retention.

Blood and lymphatic system: very rare: thrombocytopenia.

Skin: infrequent: rash, itching; rare: urticaria; very rare: angioedema, persistent erythema.

Laboratory tests: rare: changes of liver function tests (increase of transaminases, alkaline phosphatase, gamma-glutamintransferase and bilirubin activity); very rare: thrombocytopenia.

General disorders: infrequent: asthenia, malaise; rarely: peripheral edema.

Metabolism: rarely: weight gain.

In case of adverse reactions, as well as reactions not mentioned in the instructions, it is necessary to consult a physician.

Contraindications

  • Hypersensitivity to cetirizine, hydroxyzine or piperazine derivatives, as well as other components of the drug;
  • terminal stage of renal failure (creatinine clearance 10 ml/min);
  • congenital galactose intolerance, lactose deficiency and glucose-galactose malabsorption syndrome.

With caution

  • Chronic renal insufficiency (in creatinine clearance >10 ml/min, dosage regimen adjustment is required);
  • elderly patients (with age-related decrease in glomerular filtration);
  • epilepsy and patients with increased seizure readiness;
  • patients with predisposing factors to urinary retention.

Drug interactions

When concomitant use with pseudoephedrine, cimetidine, ketoconazole, erythromycin or azithromycin, no effect on the pharmacokinetics of cetirizine was found.

No pharmacokinetic interactions were observed. In vitro tests have shown that the drug does not affect the properties of warfarin to bind to proteins.

When concomitant use with azithromycin, erythromycin, ketoconazole, theophylline and pseudoephedrine no clinically significant adverse interactions were found, no changes on electrocardiogram were noted.

Simultaneous use of the drug (20 mg/day) with theophylline (400 mg/day) showed a small but stable increase of the area under the curve of concentration-time-dependence of the drug by 19%, theophylline – 11%. Moreover, maximum plasma levels reached 7.7% and 6.4% for cetirizine and theophylline, respectively. At the same time, total cetirizine clearance decreased by 16% and theophylline clearance decreased by 10% if theophylline treatment was given before cetirizine administration.

However, when initially treated with cetirizine, no significant effect on the pharmacokinetics of theophylline was detected.

After a single dose of 10 mg of cetirizine, the effects of alcohol (0.8%) were not significantly enhanced; a marked interaction was noted with diazepam 5 mg in 1 of 16 psychometric tests.

When cetirizine (10 mg) is used concomitantly daily with glipizide, the glucose index is slightly decreased. However, this has not been clinically proven. Nevertheless, it is recommended to take these drugs separately – glipizide in the morning and cetirizine in the evening.

Food intake does not affect the completeness of absorption, although its rate is reduced by 1 hour.

When ritonavir (600 mg twice daily) and cetirizine (10 mg/day) were taken repeatedly, the duration of action was increased by 40%, while the effect of ritonavir changed slightly (-11%) with subsequent administration of cetirizine.

A three-day “washout” period is recommended before allergy testing is administered.

Special indications

Use during pregnancy and lactation

At the moment there are no available clinical trials on use of the drug in pregnant women. Experimental studies on animals did not reveal any direct or indirect toxic effects of the drug on pregnancy, germinal development, embryonal development, including the postnatal period.

The potential risk to women is unknown.

Use is possible in cases when the expected benefit to the mother exceeds the potential risk to the fetus.

Cetirizine dihydrochloride is excreted with breast milk, therefore, the drug should not be taken during the period of lactation.

Effect on the ability to drive motor transport and operate machinery.

The drug may cause increased somnolence. Consequently, it affects the ability to drive vehicles and operate machinery.

Overdose

The following symptoms have been observed after a single dose of 50 mg: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, weakness, restlessness, sedation, somnolence, stupor, tachycardia, tremor, urinary retention.

Treatment: immediately after taking the drug – gastric lavage or stimulation of vomiting. Administration of activated charcoal, symptomatic and supportive therapy are recommended. There is no specific antidote. Hemodialysis is ineffective.

Form of production

10 mg coated tablets.

Storage conditions

Store in a dry, dark place 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 of dispensing from pharmacies

Released without a prescription.

Allegra-syrup

MEDICAL INSTRUCTIONS FOR USE

ALLEGRA

Trade name of the drug: Allegra

Active substance (INN): Cetirizine hydrochloride

Contents per 5 ml of syrup:

Active ingredient: cetirizine hydrochloride – 5 mg

Excipients: sucrose, propylene glycol, sodium benzoate, sodium edetate (trilon B), “Sunset Yellow” dye E110, essence of orange, citric acid, purified water.

Description: syrup-like liquid of orange color, sweet taste and characteristic odor.

Pharmacotherapeutic group: Anti-allergic agents.

ATX code: R06AE07

Pharmacological properties

Antiallergic drug, blocker of histamine H1-receptors. Cetirizine belongs to competitive histamine antagonists. It has a pronounced antiallergic effect, prevents the development and facilitates the course of allergic reactions. It has an antipruritic and antiexudative effect. It affects the early stage of allergic reactions and also reduces the migration of inflammatory cells; it inhibits the release of mediators involved in late allergic reactions. Reduces capillary permeability, prevents the development of tissue edema, relieves smooth muscle spasm. It eliminates the skin reaction to the introduction of histamine, specific allergens, as well as to cooling (with cold urticaria).

It practically has no anticholinergic and antiserotonin action.

In therapeutic doses does not cause a sedative effect. Tolerance does not develop during a course of treatment.

The action of the drug starts within 20 minutes (50% of patients) or within 1 hour (95% of patients) and lasts for 24 hours.

Pharmacokinetics

After oral administration, cetirizine is quickly and well absorbed from the gastro-intestinal tract. The maximum level of concentration (Cmax) in plasma is determined after about 30-60 minutes. Food intake has no significant effect on the absorption value, but in this case the absorption rate is slightly reduced.

Distribution: Cetirizine binds to plasma proteins by approximately 93%. Volume of distribution (Vd low 0.5 l/kg) The drug does not penetrate the cell. It does not penetrate through the blood-brain barrier.

The drug is weakly metabolized in the liver to form inactive metabolite. There is no accumulation of the drug in 10-day use at a dose of 10 mg.

About 70% is excreted by the kidneys mainly unchanged. Systemic clearance is about 54 ml/min.

After a single dose, the half-life (T ½ ) is about 10 hours. In children aged 2 to 12 years, T ½ is reduced to 5-6 hours. In patients with impaired renal function, creatinine clearance (CK below 11-31 ml/min) and in patients on hemodialysis (CK less than 7 ml/min) T ½ increases 3-fold, clearance decreases by 70%. Against the background of chronic diseases and in elderly patients there is an increase in T ½ by 50% and a decrease in clearance by 40%. Hemodialysis is ineffective.

Indications for use

  • Seasonal and year-round allergic rhinitis, and conjunctivitis;
  • pruritic allergic dermatoses;
  • Pollinosis (hay fever);
  • Urticaria (including chronic idiopathic);
  • Quincke’s edema.

Methods of administration and dosage.

The drug is prescribed orally, regardless of food intake.

It is recommended to adults and children above 12 years old to take 10 ml of syrup 1-2 times per day, preferably in the evening.

Children aged 6 to 12 years old should take 10 ml of the syrup once a day or 5 ml twice a day, morning and evening.

Children from 2 to 6 years of age should take 5 ml of syrup once a day or 2.5 ml twice a day, morning and evening.

For patients with moderate or severe renal failure, the drug dosage should be reduced by half.

For patients with liver dysfunction the dose should be adjusted individually, reducing it to 5 ml/day or less, with special caution in concomitant renal failure.

Dose adjustment is not required for elderly patients with normal renal function.

Side effects

Digestive system: dry mouth, dyspepsia.

CNS disorders: headache, drowsiness, fatigue, dizziness, agitation, migraine.

Allergic reactions: skin rash, angioedema, urticaria, itching.

 The drug is usually well tolerated. Side effects are rare and transient.

Contraindications

Hypersensitivity to the components of the drug, severe kidney disease, the elderly, children under 2 years of age, pregnancy and lactation.

Drug interactions

No clinically significant interactions of cetirizine with other drugs have been established. Concomitant use with theophylline (400 mg/day) leads to decreased total clearance of the drug (theophylline kinetics does not change).

Special indications

Simultaneous use of agents depressing the central nervous system and alcohol consumption is not recommended.

It must be taken into account that if patients with diabetes mellitus take the drug, 10 ml of syrup contains 3 g sorbitol, which corresponds to 0.25 units.

During the treatment, it is necessary to refrain from potentially hazardous activities that require high concentration and quick psychomotor reactions.

Keep the drug out of reach of children and do not use it after expiration date.

Overdose

Symptoms: drowsiness, restlessness, lethargy, weakness, fatigue (more often when taking cetirizine at a dose of 50 mg/day), headache, irritability, urinary retention, tremor, tachycardia, itching, rash are possible.

Treatment: gastric lavage, administration of activated charcoal; symptomatic therapy. No specific antidote was found. Hemodialysis is ineffective.

Form of production

Syrup in 50, 60 and 100 ml bottles.

Storage conditions

Store in a dry, dark place 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 of dispensing from pharmacies

 Released without a prescription.

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