Nemozole chewable tablets 400mg, No. 1

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Expiration Date: 05/2027

Russian Pharmacy name:

Немозол таблетки жевательные 400мг, №1

Nemozole chewable tablets 400mg, No. 1

- nematodes:
ascariasis, causative agent - round helminth Ascaris lumbricoidesl;
trichocephalosis (whipworm), causative agent - round helminth Trichocephalus trichiurus;
enterobiasis (pinworms), causative agent - round helminth Enterobius vermicularis;
ankylostomiasis (crooked heads), pathogens - Ancylostoma duodenale and Necator americanus;
trichinosis, causative agent - Trichinella spiralis;
toxocariasis, causative agent - Toxocara canis;
giardiasis, causative agent - Giardia intestinalis;
strichoidosis (intestinal acne), the causative agent is the round helminth Strongiloides strcoralis, as well as mixed invasions.

- tissue cestodoses:
neurocysticercosis, causative agent - Cysticercus cellulosus (larval stage of pork tapeworm);
hydatid echinococcosis of the liver, lungs, peritoneum, causative agent - Echinococcus granulosus (larval stage of canine tapeworm);
as an adjuvant in the surgical treatment of alveolar echinococcosis, the causative agent is Echinococcus multilocularis.

Inside, during or after meals. No special training or diet is required. The dosage form is chosen individually, depending on the convenience of taking the drug and the tolerance of the substances included in it.

The dose of the drug is set individually, depending on the type of invasion and the patient's body weight.

The maximum daily dose is 800 mg.

In children, the use of high doses of albendazole for a long time should be avoided, if possible.

With nematodes (including ascariasis, trichocephalosis, necatorosis)
The standard dose for the treatment of roundworm infestation for adults and children weighing 60 kg or more is 400 mg once a day;
for adults and children weighing less than 60 kg -15 mg / kg body weight once or in 2 divided doses.

With enterobiasis, adults and children over 3 years old take the drug in a dose of 400 mg once. If necessary, after 14 days, repeat the course of treatment in the same dose and in the same regimen.

With strongyloidosis, ankylostomiasis, adults and children over 3 years old take the drug at a dose of 400 mg once for 3 days. If necessary, after 7 days, repeat the course of treatment in the same doses.

With trichinosis, the drug is taken at 400 mg 2 times a day for 10-14 days. With severe invasion and organ lesions (myocarditis, pneumonitis, meningoencephalitis), glucocorticosteroid and symptomatic agents are also taken.

With toxocariasis, adults and children over 14 years old and weighing more than 60 kg take the drug 400 mg 2 times a day for 10 days, with a body weight of less than 60 kg 200 mg. Requires repeated courses of treatment at intervals of 2 weeks / month. In the course of treatment, it is necessary to control peripheral blood (once every 5-7 days) and aminotransferases at the same time.

With giardiasis: 400 mg once a day for 3 days. For children weighing less than 10 kg -200 mg once a day, once for 5 days.

For mixed invasions, the drug is taken at 400 mg 2 times a day, for 3 days. If necessary, the course of treatment can be repeated after 1 month.

For neurocysticercosis and hydatid echinoccosis, patients weighing 60 kg or more take 400 mg 2 times a day, with a body weight less than 60 kg - at the rate of 15 mg / kg body weight per day in 2 divided doses; the maximum daily dose is 800 mg. The course of treatment for neurocysticercosis is 28-30 days (2 days before taking the drug and in the first week of taking glucocorticosteroid drugs), with echinococcosis - 3 cycles of 28 days with a 14-day break between cycles.

Before using the drug, a clinical blood test and a biochemical blood test are required. Treatment is carried out at normal laboratory values. In the course of treatment, blood and aminotransferases are tested every 5-7 days.

With a decrease in leukocytes below 3.0x109 and a 2-fold increase in the activity of aminotransferases, it is necessary to suspend treatment until the parameters return to normal.

Drug therapy can be resumed after laboratory values ??return to the level that was before the start of therapy, however, laboratory tests should be performed regularly during therapy.

The appointment of hepatoprotectors during treatment and in cases of toxic manifestations is ineffective, it is necessary to cancel the drug.

Treatment with albendazole for alveolar echinococcosis is an adjunct.

Doses and regimen of administration of the drug are the same as for hydatid echinococcosis. The duration and course of treatment is determined by the patient's condition and the tolerability of the drug.

Each film-coated tablet contains:

Active substance: albendazole - 400.00 mg

Excipients: corn starch - 83.00 mg, dried corn starch - 10.00 mg, sodium lauryl sulfate -5.00 mg, povidone (polyvinylpyrrolidone K 30) -5.00 mg, methyl parahydroxybenzoate - 0.360 mg, propyl parahydroxybenzoate -0.040 mg, gel 5.50 mg, purified talc - 10.00 mg, sodium carboxymethyl starch - 5.20 mg, colloidal silicon dioxide - 3.00 mg, magnesium stearate - 3.00 mg.

Sheath: hypromellose - 5.32 mg, titanium dioxide - 3.20 mg, purified talc - 1.60 mg, propylene glycol - 1.60 mg.

- hypersensitivity to albendazole, other components of the drug and other benzimidazole derivatives;
- pathology of the retina;
- children's age up to 3 years (for this dosage form);
- pregnancy and the period of breastfeeding

With caution
The drug albendazole is used with caution in case of liver dysfunction (it is necessary to regularly monitor liver function before and during treatment), inhibition of bone marrow hematopoiesis, liver cirrhosis.

Trade name: NemozolЃ

International non-proprietary name: albendazole

Dosage form: film-coated tablets

Composition:
Each film-coated tablet contains:

Active substance: albendazole -200.00 / 400.00 mg

Excipients: corn starch - 129.70 / 83.00 mg, dried corn starch - 0 / 10.00 mg, sodium lauryl sulfate - 4.00 / 5.00 mg, povidone (polyvinylpyrrolidone K 30) -3.350 / 5.00 mg, methyl parahydroxybenzoate -0.270 / 0.360 mg, propyl parahydroxybenzoate - 0.030 / 0.040 mg, gelatin - 3.70 / 5.50 mg, purified talc - 6.70 / 10.00 mg, sodium carboxymethyl starch - 3.350 / 5.20 mg, colloidal silicon dioxide - 2.00 / 3.00 mg, magnesium stearate - 2.00 / 3.00 mg.

Sheath: hypromellose - 2.40 / 5.32 mg, titanium dioxide - 1.80 / 3.20 mg, purified talc - 1.20 / 1.60 mg, sodium lauryl sulfate - 0.10 / 0 mg, macrogol 400-0.500 / 0 mg, propylene glycol - 0 / 1.60 mg.

Description:
Tablets of white or almost white color, round, biconvex, film-coated.

Pharmacotherapeutic group: anthelmintic and antiprotozoal agent.

ATX code: P02SA03

Pharmacological properties
Pharmacodynamics
Albendazole is an anthelmintic drug, the pharmacological properties of which are due to the action of the active substance - albendazole. Albendazole belongs to the group of benzimidazole carbamate. The mechanism of action of albendazole is its ability to disrupt the activity of the microtubular system of cells in the intestinal canal of helminths, causing damage to the tubulin protein. The consequence of this is biochemical disturbances in the cell - inhibition of the transport of glucose and fumarate reductose, which underlies the suppression of cell division at the metaphase stage and which is associated with the inhibition of oviposition and the development of helminth larvae. Albendazole blocks the movement of secretory granules and other organelles in the muscle cells of roundworms, causing their death.

Albendazole is effective against most intestinal nematodes, as well as larval (larval stages) cestodes, as well as lamblia. Albendazole as an antiparasitic drug has a fairly wide spectrum of action.

Pharmacokinetics
Absorption. After oral administration, the drug is poorly absorbed in the gastrointestinal tract, unchanged is not detected in blood plasma. Oral bioavailability is low. Eating fatty foods increases absorption and maximum concentration by 5 times.

Metabolism. Albendazole is rapidly converted in the liver to the primary metabolite, albendazole sulfoxide, which also has anthelmintic activity.

Distribution. The maximum plasma concentration of albendazole sulfoxide is reached 2-5 hours after administration. The metabolite is 70% bound to plasma proteins and is completely distributed throughout the body: it is found in urine, bile, liver, in the wall and fluid of helminth cysts, cerebrospinal fluid.

Excretion. Albendazole sulfoxide is converted in the liver to albendazole sulfone (a secondary metabolite) and other oxidized products. The half-life of albendazole sulfoxide is 8-12 hours. It is excreted through the kidneys in the form of various metabolites. Excretion through the kidneys of albendazole and albendazole sulfoxide is negligible. In patients with impaired renal function, clearance does not change.

In patients with liver damage, bioavailability increases, the maximum concentration of albendazole sulfoxide in the blood plasma doubles, and the half-life is lengthened.

Albendazole induces cytochrome CYP1A2 in human liver cells, accelerates the metabolism of many drugs.

Indications for use

- nematodes:
ascariasis, causative agent - round helminth Ascaris lumbricoidesl;
trichocephalosis (whipworm), causative agent - round helminth Trichocephalus trichiurus;
enterobiasis (pinworms), causative agent - round helminth Enterobius vermicularis;
ankylostomiasis (crooked heads), pathogens - Ancylostoma duodenale and Necator americanus;
trichinosis, causative agent - Trichinella spiralis;
toxocariasis, causative agent - Toxocara canis;
giardiasis, causative agent - Giardia intestinalis;
strichoidosis (intestinal acne), the causative agent is the round helminth Strongiloides strcoralis, as well as mixed invasions.

- tissue cestodoses:
neurocysticercosis, causative agent - Cysticercus cellulosus (larval stage of pork tapeworm);
hydatid echinococcosis of the liver, lungs, peritoneum, causative agent - Echinococcus granulosus (larval stage of canine tapeworm);
as an adjuvant in the surgical treatment of alveolar echinococcosis, the causative agent is Echinococcus multilocularis.

Contraindications
- hypersensitivity to albendazole, other components of the drug and other benzimidazole derivatives;
- pathology of the retina;
- children's age up to 3 years (for this dosage form);
- pregnancy and the period of breastfeeding

With caution
The drug albendazole is used with caution in case of liver dysfunction (it is necessary to regularly monitor liver function before and during treatment), inhibition of bone marrow hematopoiesis, liver cirrhosis.

Application during pregnancy and during breastfeeding
The drug albendazole is contraindicated during pregnancy and during breastfeeding.

Method of administration and dosage
Inside, during or after meals. No special training or diet is required. The dosage form is chosen individually, depending on the convenience of taking the drug and the tolerance of the substances included in it.

The dose of the drug is set individually, depending on the type of invasion and the patient's body weight.

The maximum daily dose is 800 mg.

In children, the use of high doses of albendazole for a long time should be avoided, if possible.

With nematodes (including ascariasis, trichocephalosis, necatorosis)
The standard dose for the treatment of roundworm infestation for adults and children weighing 60 kg or more is 400 mg once a day;
for adults and children weighing less than 60 kg -15 mg / kg body weight once or in 2 divided doses.

With enterobiasis, adults and children over 3 years old take the drug in a dose of 400 mg once. If necessary, after 14 days, repeat the course of treatment in the same dose and in the same regimen.

With strongyloidosis, ankylostomiasis, adults and children over 3 years old take the drug at a dose of 400 mg once for 3 days. If necessary, after 7 days, repeat the course of treatment in the same doses.

With trichinosis, the drug is taken at 400 mg 2 times a day for 10-14 days. With severe invasion and organ lesions (myocarditis, pneumonitis, meningoencephalitis), glucocorticosteroid and symptomatic agents are also taken.

With toxocariasis, adults and children over 14 years old and weighing more than 60 kg take the drug 400 mg 2 times a day for 10 days, with a body weight of less than 60 kg 200 mg. Requires repeated courses of treatment at intervals of 2 weeks / month. In the course of treatment, it is necessary to control peripheral blood (once every 5-7 days) and aminotransferases at the same time.

With giardiasis: 400 mg once a day for 3 days. For children weighing less than 10 kg -200 mg once a day, once for 5 days.

For mixed invasions, the drug is taken at 400 mg 2 times a day, for 3 days. If necessary, the course of treatment can be repeated after 1 month.

For neurocysticercosis and hydatid echinoccosis, patients weighing 60 kg or more take 400 mg 2 times a day, with a body weight less than 60 kg - at the rate of 15 mg / kg body weight per day in 2 divided doses; the maximum daily dose is 800 mg. The course of treatment for neurocysticercosis is 28-30 days (2 days before taking the drug and in the first week of taking glucocorticosteroid drugs), with echinococcosis - 3 cycles of 28 days with a 14-day break between cycles.

Before using the drug, a clinical blood test and a biochemical blood test are required. Treatment is carried out at normal laboratory values. In the course of treatment, blood and aminotransferases are tested every 5-7 days.

With a decrease in leukocytes below 3.0x109 and a 2-fold increase in the activity of aminotransferases, it is necessary to suspend treatment until the parameters return to normal.

Drug therapy can be resumed after laboratory values ??return to the level that was before the start of therapy, however, laboratory tests should be performed regularly during therapy.

The appointment of hepatoprotectors during treatment and in cases of toxic manifestations is ineffective, it is necessary to cancel the drug.

Treatment with albendazole for alveolar echinococcosis is an adjunct.

Doses and regimen of administration of the drug are the same as for hydatid echinococcosis. The duration and course of treatment is determined by the patient's condition and the tolerability of the drug.

Side effect
From the digestive system: liver dysfunction with changes in liver function tests (mild or moderate increase in the activity of 'liver' transaminases), hepatitis, acute liver failure, epigastric pain, anorexia, constipation, diarrhea and dry mouth. nausea, vomiting.

From the hematopoietic system: inhibition of bone marrow hematopoiesis (leukopenia, granulocytopenia, agranulocytosis, thrombocytopenia, pancytopenia, aplastic anemia, suppression of bone marrow activity, neutropenia).

On the part of the cardiovascular system: increased blood pressure.

From the side of the central nervous system: headache and dizziness, meningeal symptoms, increased intracranial pressure.

From the urinary system: changes in renal function indicators (acute renal failure).

On the part of the skin: itching, skin rash, erythema multiforme, Stevens-Johnson syndrome.

Allergic reactions: angioedema, immediate hypersensitivity reactions.

Others: hyperthermia, alopecia.

If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.

Overdose
Symptoms: increased dose-dependent side effects.
Treatment: gastric lavage, the use of activated carbon, symptomatic therapy.

Interaction with other drugs The
simultaneous use of albendazole with iraziquantel, dexamethasone and cimetidine may increase the concentration of albendazole sulfoxide in the blood. Simultaneous use with carbamazepine, phenytoin, phenobarbital and common ginseng can lead to a decrease in the concentration of the drug albendazole in the intestine.

Special instructions
It is recommended to carry out the simultaneous treatment of all family members.

Monitoring of the cellular composition of the blood is recommended; if leukopenia occurs, drug therapy is stopped.

In neurocysticercosis with eye damage, a retinal examination is necessary before starting treatment due to the risk of aggravating its pathology.

In women of childbearing age, a pregnancy test is performed before starting treatment. During therapy and within 1 month after its completion, reliable contraception is required.

It should be remembered that before using Nemozole, like any other anthelmintic drug, you should thoroughly clean the room, wash children's toys, carry out hygiene procedures daily (morning and evening), and change your underwear. During treatment and several days after taking the drug, it is advisable to change bed linen more often or iron it with a hot iron.

The simultaneous use of albendazole and theophylline may increase the risk of theophylline toxicity (nausea, vomiting, heart palpitations, seizures). Although single doses of albendazole do not inhibit theophylline metabolism, albendazole still induces cytochrome P4501A in hepatocytes. In this regard, it is recommended to monitor the plasma concentrations of theophylline during treatment with albendazole.

Patients should avoid eating foods with grapefruit while taking albendazole, as plasma concentrations of albendazole may increase, which increases the risk of adverse side effects.

¬ли¤ние на способность управл¤ть транспортными средствами, механизмами
Ќеобходимо избегать управлени¤ транспортными средствами и зан¤ти¤ другими потенциально опасными видами де¤тельности, требующими повышенной концентрации внимани¤ и быстроты психомоторных реакций, так как препарат может вызывать головокружение и другие побочные эффекты, которые могут вли¤ть на указанные способности.

‘орма выпуска
“аблетки покрытые пленочной оболочкой 200 мг, 400 мг.
ѕо 2 таблетки 200 мг в блистер из ѕ¬’/јл.фольги.
ѕо 1 или 5 таблеток 400 мг в блистер из ѕ¬’/јл.фольги.
ѕо 1 блистеру с инструкцией по применению в картонную пачку.

—рок годности
3 года.
Ќе использовать после истечени¤ срока годности.

Storage
conditions Store in a dry, dark place at temperatures below 25 ? C.
Keep out of reach of children.

Pharmacy
Dispensing Conditions Prescription.

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