Altdazol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ALDAZOLE (ALDAZOLE)

Composition:

Active substance: albendazole;

1 tablet contains 400 mg of albendazole;

Excipients: maize starch, sodium lauryl sulfate, povidone, gelatin, talc, colloidal anhydrous silicon dioxide, sodium starch glycolate (type A), magnesium stearate;

Coating: film-coating mixture Opadry II White (hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide (E 171), triacetin).

Pharmaceutical form. Film-coated tablets.

Main physicochemical characteristics: white or almost white, round, biconvex film-coated tablets.

Pharmacotherapeutic group. Antihelminthic agents. Agents used in nematode infections. Benzimidazole derivatives. ATC code P02CA03.

Pharmacological properties.

Pharmacodynamics.

Albendazole is an antiprotozoal and anthelmintic agent belonging to the benzimidazole carbamate group. The drug is active against both intestinal and tissue parasites in the form of eggs, larvae, and adult helminths. The anthelmintic effect of albendazole is due to inhibition of tubulin polymerization, leading to disruption of parasite metabolism and subsequent death.

Albendazole is active against the following intestinal parasites:
Nematodes – Ascaris lumbricoides, Trichuris trichiura, Enterobius vermicularis, Ancylostoma duodenale, Necator americanus, Strongyloides stercoralis, Cutaneous Larva Migrans;
Cestodes – Hymenolepis nana, Taenia solium, Taenia saginata;
Trematodes – Opisthorchis viverrini, Clonorchis sinensis;
Protozoa – Giardia lamblia (intestinalis or duodenalis).

Albendazole is also active against tissue parasites, including cystic and alveolar echinococcosis caused by Echinococcus granulosus and Echinococcus multilocularis, respectively. Albendazole is an effective treatment for neurocysticercosis caused by larval invasion of Taenia solium, capillariasis caused by Capillaria philippinensis, and gnathostomiasis caused by Gnathostoma spinigerum.

Albendazole destroys cysts or significantly reduces their size (by up to 80%) in patients with granular echinococcosis. After treatment with albendazole, the proportion of non-viable cysts increases to 90%, compared to 10% in untreated patients. In the treatment of cysts caused by Echinococcus multilocularis, complete recovery was observed in a minority of patients, while most experienced improvement or stabilization of their condition.

Pharmacokinetics.

After oral administration, albendazole is poorly absorbed (less than 5%). Systemic availability increases when the drug is taken with fatty food, which enhances absorption by fivefold. It is rapidly metabolized in the liver during first-pass metabolism. The primary metabolite, albendazole sulfoxide, is the main active compound responsible for efficacy in tissue infections. The elimination half-life is 8.5 hours. Albendazole sulfoxide and its metabolites are primarily excreted via bile, with only a small fraction eliminated in urine. It has been established that with prolonged high-dose treatment, elimination of the drug from cysts continues for several weeks.

Clinical characteristics.

Indications.

Intestinal forms of helminthiases and cutaneous syndrome Larva Migrans (short-term treatment with low doses): enterobiasis, ancylostomiasis and necatoriasis, hymenolepiasis, teniasis, strongyloidiasis, ascariasis, trichocephalosis, clonorchiasis, opisthorchiasis, cutaneous syndrome Larva Migrans, giardiasis in children.

Systemic helminthic infections (long-term treatment with high doses):

cystic echinococcosis (caused by Echinococcus granulosus):

• when surgical intervention is impossible;
• prior to surgery;
• after surgery, if preoperative treatment was short, when widespread helminthic infection is observed or live forms were found during surgery;
• after percutaneous drainage of cysts for diagnostic or therapeutic purposes;

alveolar echinococcosis (caused by Echinococcus multilocularis):

• in inoperable disease, particularly in cases of local or distant metastases;
• after palliative surgical intervention;
• after radical surgical intervention or liver transplantation;

neurocysticercosis (caused by larvae of Taenia solium):

• in presence of single or multiple cysts or granulomatous brain lesions;
• in arachnoid or intraventricular cysts;
• in racemose cysts;

capillariasis (caused by Capillaria philippinensis), gnathostomiasis (caused by Gnathostoma spinigerum and related species), trichinellosis (caused by Trichinella spiralis and T. pseudospiralis), toxocariasis (caused by Toxocara canis and related species).

Contraindications.

Hypersensitivity to albendazole or to any component of the medicinal product.

Pregnancy and breastfeeding period.

Contraindicated in women planning pregnancy. Women of reproductive age should use effective non-hormonal contraceptive methods during treatment and for 1 month after completion of therapy with the drug.

Interaction with other medicinal products and other types of interactions.

Albendazole induces enzymes of the cytochrome P450 system.

Medicinal products that may slightly reduce albendazole efficacy: anticonvulsants (e.g., phenytoin, fosphenytoin, carbamazepine, phenobarbital, primidone), levamisole, ritonavir. Efficacy of treatment in patients should be monitored—alternative dosing regimens or therapies may be required.

Cimetidine, praziquantel, and dexamethasone increase plasma levels of the albendazole metabolite responsible for systemic activity, which in turn may lead to increased incidence of adverse reactions.

Grapefruit juice also increases plasma levels of albendazole sulfoxide.

Due to possible effects on cytochrome P450 activity, there is a theoretical risk of interaction with the following drugs: oral contraceptives, anticoagulants, oral hypoglycemic agents, theophylline.

Special precautions for use.

Treatment of intestinal helminth infections and cutaneous Larva Migrans syndrome.

To prevent inadvertent administration of Albendazole during early pregnancy, women of childbearing potential should be treated during the first week of the menstrual cycle or only after a negative pregnancy test. Reliable contraception is required during treatment.

Albendazole treatment may unmask pre-existing neurocysticercosis, particularly in areas with a high prevalence of Tenia solium infection. Neurological symptoms such as seizures, increased intracranial pressure, and focal neurological signs may occur due to inflammatory reactions caused by the death of parasites in the brain. These symptoms may appear rapidly after initiation of treatment; therefore, prompt therapy with corticosteroids and anticonvulsant medications should be started immediately.

Treatment of systemic helminthic infections.

Albendazole treatment may be associated with mild to moderate elevations in liver enzymes, which usually normalize after discontinuation of therapy. Cases of hepatitis have been reported. Therefore, liver enzyme levels should be assessed before starting each treatment course and at least every 2 weeks during treatment. If liver enzyme levels increase significantly (more than twice the upper limit of normal), treatment with albendazole should be discontinued. Treatment may be resumed after normalization of enzyme levels, but the patient must be closely monitored.

Albendazole may cause bone marrow suppression; therefore, blood counts should be performed at the beginning of treatment and every 2 weeks during a 28-day treatment cycle. Patients with hepatic disease, including hepatic echinococcosis, are more susceptible to bone marrow suppression, which may result in pancytopenia, aplastic anemia, agranulocytosis, and leukemia, necessitating careful monitoring of hematological parameters. If significant hematological abnormalities occur, treatment should be discontinued (see sections "Dosage and administration" and "Side effects").

To prevent inadvertent use of albendazole during early pregnancy, women of childbearing potential should:

• begin treatment only after a negative pregnancy test;
• use effective contraceptive measures during treatment and for at least one month after discontinuation of the drug.

In patients with neurocysticercosis treated with albendazole, symptoms such as seizures, increased intracranial pressure, and focal neurological signs may occur due to inflammatory reactions following parasite death. These adverse reactions should be managed with corticosteroids and anticonvulsant medications. To prevent increased cerebral pressure during the first week of treatment, oral or intravenous corticosteroids are recommended.

Albendazole treatment may also reveal pre-existing neurocysticercosis, especially in regions with high prevalence of Tenia solium infection. Neurological symptoms such as seizures, increased intracranial pressure, and focal neurological signs may develop rapidly after treatment due to inflammatory reactions caused by the death of brain parasites. Therefore, prompt therapy with corticosteroids and anticonvulsants should be initiated immediately.

This medicinal product contains lactose and should not be administered to patients with rare hereditary forms of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding.

This medicinal product is contraindicated during pregnancy and breastfeeding, and in women planning to become pregnant (see section "Contraindications").

Ability to affect reaction rate while driving or operating machinery.

Given the potential for adverse reactions such as dizziness, it is recommended to avoid driving or operating machinery during treatment with albendazole.

Dosage and Administration.

Intestinal infections and cutaneous syndrome Larva Migrans.

The medication should be taken with food. It is advisable to take it at the same time each day. If recovery does not occur within three weeks, the physician should prescribe a second course of treatment.

In some patients, especially children, difficulty swallowing the whole tablet may occur – in such cases, the tablet may be chewed with a small amount of water or crushed.

For use in adults and children aged 3 years and older.

* For children aged 2 to 3 years, other dosage forms of albendazole should be used.

Elderly patients. Experience with the use of the drug in elderly patients is limited. Dose adjustment is not required; however, albendazole should be used with caution in elderly patients with impaired liver function.

Renal impairment. Since albendazole is excreted by the kidneys in very small amounts, dose adjustment is not required in this patient group. However, patients with signs of renal impairment should be closely monitored.

Hepatic impairment. Since albendazole is extensively metabolized in the liver to its pharmacologically active metabolite, impaired liver function may significantly affect its pharmacokinetics. Therefore, patients with altered liver function tests (elevated transaminase levels) should be closely monitored when starting albendazole treatment.

Systemic helminthic infections (prolonged treatment with high doses).

The drug should be taken with food.

To be used in adults and children aged 6 years and older.

Administration of high doses of the drug is not recommended in children under 6 years of age. The dosage regimen should be determined individually by a physician, depending on age, body weight, and severity of infection.

The dose for patients with body weight over 60 kg is 400 mg (1 tablet) twice daily. For patients with body weight less than 60 kg, the dose should be 15 mg/kg/day, divided into two doses. Maximum daily dose – 800 mg.

** For the treatment of patients with neurocysticercosis, appropriate corticosteroid and anticonvulsant therapy should be prescribed. Oral and intravenous corticosteroids are recommended to prevent the development of cerebral hypertension during the first week of treatment.

*** Usually, a single course of treatment is required, but further courses may be needed if parasitological examination results remain positive.

Elderly patients. Experience with the use of the drug in elderly patients is limited. Dose adjustment is not required; however, albendazole should be used with caution in elderly patients with impaired liver function.

Renal impairment. Since albendazole is excreted in very small amounts by the kidneys, dose adjustment is not required in this patient group. However, patients with signs of renal impairment should be closely monitored.

Hepatic impairment. Since albendazole is actively metabolized in the liver to a pharmacologically active metabolite, impaired liver function may significantly affect its pharmacokinetics. Therefore, patients with abnormal liver function tests (elevated transaminase levels) at the start of albendazole treatment should be carefully evaluated. Treatment should be discontinued in cases of marked elevation in transaminase levels or clinically significant blood count abnormalities (see sections "Special precautions" and "Adverse reactions").

Children.

The medicinal product is intended for use in children aged 3 years and older.

For treatment of children aged 2 to 3 years, other medicinal forms of albendazole should be used.

Administer to children according to the recommendations in the section "Dosage and administration".

Overdose.

Symptoms. Depending on the dose ingested, overdose may cause diarrhea, nausea, vomiting, tachycardia, and elevated transaminase levels.

Treatment: symptomatic, based on the clinical condition.

Adverse reactions.

Adverse effects occurring during short-term treatment of intestinal infections and cutaneous Larva Migrans syndrome.

Immune system disorders: hypersensitivity reactions, including rash, pruritus, and urticaria.

Nervous system disorders: headache and dizziness.

Gastrointestinal disorders: symptoms related to the upper gastrointestinal tract (e.g., epigastric pain, nausea, vomiting) and diarrhea.

Hepatobiliary disorders: elevated liver enzyme levels.

Skin and subcutaneous tissue disorders: polymorphic erythema, Stevens-Johnson syndrome.

Adverse effects occurring during long-term treatment of systemic helminthic infections.

Blood and lymphatic system disorders: leukopenia, pancytopenia, aplastic anemia, agranulocytosis.

Patients with liver disease, including hepatic echinococcosis, are more prone to bone marrow suppression (see sections "Dosage and administration" and "Special precautions").

Immune system disorders: hypersensitivity reactions, including rash, pruritus, and urticaria.

Nervous system disorders: headache, dizziness.

Gastrointestinal disorders: gastrointestinal disturbances (abdominal pain, nausea, vomiting). These events are associated with albendazole treatment in patients with echinococcosis.

Hepatobiliary disorders: mild to moderate elevation of liver enzyme levels, hepatitis.

Skin and subcutaneous tissue disorders: reversible alopecia (thinning and moderate hair loss), polymorphic erythema, Stevens-Johnson syndrome.

General disorders: fever.

Shelf life. 4 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 3 tablets in a blister; 1 blister per carton.

Prescription status. Prescription only.

Manufacturer: JSC "KYIV VITAMIN PLANT".

Manufacturer's address and place of business:

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Website: www.vitamin.com.ua.

INSTRUCTION

for medical use of medicinal product

ALDAZOLE

(ALDAZOLE)

Composition:

Active substance: albendazole;

1 tablet contains 400 mg of albendazole;

Excipients: maize starch, sodium lauryl sulfate, povidone, gelatin, talc, colloidal anhydrous silicon dioxide, sodium starch glycolate (type A), magnesium stearate;

Coating: film-coating mixture Opadry II White (hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide (E 171), triacetin).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: round, biconvex tablets coated with a white or almost white film-coating.

Pharmacotherapeutic group. Anthelmintics, drugs used in nematode infections. Benzimidazole derivatives. ATC code P02CA03.

Pharmacological properties.

Pharmacodynamics.

Albendazole is an antiprotozoal and anthelmintic agent belonging to the benzimidazole carbamate group. The drug acts on both intestinal and tissue parasites in egg, larval, and adult forms. The anthelmintic effect of albendazole is due to inhibition of tubulin polymerization, leading to disruption of parasite metabolism and subsequent death.

Albendazole is active against the following intestinal parasites:
Nematodes – Ascaris lumbricoides, Trichuris trichiura, Enterobius vermicularis, Ancylostoma duodenale, Necator americanus, Strongyloides stercoralis, Cutaneous Larva Migrans;
Cestodes – Hymenolepis nana, Taenia solium, Taenia saginata;
Trematodes – Opisthorchis viverrini, Clonorchis sinensis;
Protozoa – Giardia lamblia (intestinalis or duodenalis).

Albendazole is also effective against tissue parasites, including cystic and alveolar echinococcosis caused by Echinococcus granulosus and Echinococcus multilocularis, respectively. Albendazole is an effective treatment for neurocysticercosis caused by larval Taenia solium, capillariasis caused by Capillaria philippinensis, and gnathostomiasis caused by Gnathostoma spinigerum.

Albendazole destroys cysts or significantly reduces their size (by up to 80%) in patients with granular echinococcosis. After albendazole treatment, the proportion of non-viable cysts increases to 90% compared to 10% in untreated patients. In patients with Echinococcus multilocularis-induced cysts, complete recovery occurs in only a minority; most experience improvement or stabilization of disease.

Pharmacokinetics.

After oral administration, albendazole is poorly absorbed (less than 5%). Systemic exposure increases when the drug is taken with fatty food, which enhances absorption by 5-fold. It undergoes extensive first-pass metabolism in the liver. The main metabolite is albendazole sulfoxide, which is the primary active compound responsible for efficacy in tissue infections. The elimination half-life is 8.5 hours. Albendazole sulfoxide and its metabolites are primarily excreted via bile, with only a small fraction eliminated in urine. With prolonged high-dose therapy, elimination from cysts may continue for several weeks.

Clinical characteristics.

Indications.

Intestinal helminth infections and cutaneous Larva Migrans syndrome (short-term treatment with low doses): enterobiasis, ancylostomiasis and necatoriasis, hymenolepiasis, taeniasis, strongyloidiasis, ascariasis, trichuriasis, clonorchiasis, opisthorchiasis, cutaneous Larva Migrans syndrome, giardiasis in children.

Systemic helminthic infections (long-term treatment with high doses):

Cystic echinococcosis (caused by Echinococcus granulosus):

• when surgery is not feasible;
• preoperatively;
• postoperatively, if preoperative treatment was short, widespread infestation is present, or live parasites were found during surgery;
• after percutaneous drainage of cysts for diagnostic or therapeutic purposes;

Alveolar echinococcosis (caused by Echinococcus multilocularis):

• in inoperable disease, particularly with local or distant metastases;
• after palliative surgery;
• after radical surgery or liver transplantation;

Neurocysticercosis (caused by Taenia solium larvae):

• with single or multiple cysts or granulomatous brain lesions;
• with arachnoid or intraventricular cysts;
• with racemose cysts;

Capillariasis (caused by Capillaria philippinensis), gnathostomiasis (caused by Gnathostoma spinigerum and related species), trichinellosis (caused by Trichinella spiralis and T. pseudospiralis), toxocariasis (caused by Toxocara canis and related species).

Contraindications.

Hypersensitivity to albendazole or any component of the medicinal product.
Pregnancy and breastfeeding.

Albendazole is contraindicated in women planning pregnancy. Women of childbearing potential must use effective non-hormonal contraception during and for one month after treatment.

Interaction with other medicinal products and other forms of interaction.

Albendazole induces enzymes of the cytochrome P450 system.

Medicinal products that may slightly reduce albendazole efficacy: anticonvulsants (e.g., phenytoin, fosphenytoin, carbamazepine, phenobarbital, primidone), levamisole, ritonavir. Efficacy should be monitored; alternative dosing regimens or therapies may be required.

Cimetidine, praziquantel, and dexamethasone increase plasma levels of the active albendazole metabolite, which may increase the risk of adverse reactions.

Grapefruit juice also increases plasma levels of albendazole sulfoxide.
Due to potential interference with cytochrome P450 activity, there is a theoretical risk of interaction with oral contraceptives, anticoagulants, oral hypoglycemics, and theophylline.

Special precautions.

Treatment of intestinal helminth infections and cutaneous Larva Migrans syndrome.

To prevent inadvertent use during early pregnancy, women of childbearing potential should be treated only during the first week after menstruation or after a negative pregnancy test. Reliable contraception is required during treatment.

Albendazole treatment may unmask pre-existing neurocysticercosis, especially in areas with high prevalence of Taenia solium infection. Patients may develop neurological symptoms such as seizures, increased intracranial pressure, and focal neurological deficits due to inflammatory reactions following parasite death in the brain. These symptoms may appear shortly after treatment; prompt therapy with corticosteroids and anticonvulsants is recommended.

Treatment of systemic helminthic infections.

Albendazole treatment may cause mild to moderate elevation of liver enzymes, which usually normalizes after discontinuation. Cases of hepatitis have been reported. Liver enzyme levels should be checked before each treatment cycle and at least every 2 weeks during therapy. If liver enzymes increase significantly (more than twice the upper limit of normal), albendazole treatment should be discontinued. Treatment may be resumed after normalization of enzyme levels, but close monitoring is required.

Albendazole may cause bone marrow suppression; therefore, complete blood counts should be performed at the start of treatment and every 2 weeks during each 28-day treatment cycle. Patients with liver disease, including hepatic echinococcosis, are more susceptible to bone marrow suppression, which may lead to pancytopenia, aplastic anemia, agranulocytosis, or leukemia. Close hematological monitoring is essential. Treatment should be discontinued if significant blood count reductions occur (see sections "Dosage and administration" and "Adverse reactions").

To prevent inadvertent use during early pregnancy, women of childbearing potential must:

• initiate treatment only after a negative pregnancy test;
• use effective contraception during and for one month after treatment.

Patients with neurocysticercosis treated with albendazole may develop symptoms (e.g., seizures, increased intracranial pressure, focal deficits) due to inflammatory reactions following parasite death. These adverse effects should be managed with corticosteroids and anticonvulsants. Oral or intravenous corticosteroids are recommended during the first week of treatment to prevent increased intracranial pressure.

Albendazole treatment may also reveal pre-existing neurocysticercosis, particularly in areas with high Taenia solium prevalence. Neurological symptoms such as seizures, increased intracranial pressure, and focal deficits may occur due to inflammatory reactions following parasite death in the brain. Symptoms may appear shortly after treatment; prompt therapy with corticosteroids and anticonvulsants is required.

This medicinal product contains lactose and should not be used in patients with rare hereditary conditions of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated during pregnancy and breastfeeding and in women planning to become pregnant (see section "Contraindications").

Effect on ability to drive and use machines.

Given the potential for dizziness as an adverse reaction, patients should avoid driving or operating machinery during treatment with albendazole.

Dosage and administration.

Intestinal infections and cutaneous Larva Migrans syndrome.

The medicinal product should be taken with food. It is preferable to take it at the same time each day. If no improvement occurs within three weeks, a second course of treatment should be prescribed by a physician.

Some patients, especially children, may have difficulty swallowing the whole tablet; in such cases, the tablet may be chewed with a small amount of water or crushed.

For use in adults and children over 3 years of age.

* For children aged 2 to 3 years, other pharmaceutical forms of albendazole should be used.

Elderly patients. Experience with the use of the drug in elderly patients is limited. Dose adjustment is not required; however, albendazole should be used with caution in elderly patients with impaired liver function.

Renal insufficiency. Since albendazole is excreted by the kidneys in very small amounts, dose adjustment is not required for this patient group. However, patients with signs of renal insufficiency should be closely monitored.

Hepatic insufficiency. Since albendazole is extensively metabolized in the liver to its pharmacologically active metabolite, impaired liver function may significantly affect its pharmacokinetics. Therefore, patients with abnormal liver function tests (elevated transaminase levels) should be closely monitored at the beginning of albendazole treatment.

Systemic helminthic infections (long-term treatment with high doses).

The drug should be taken with food.

For use in adults and children aged 6 years and older.

The administration of high doses of the drug is not recommended in children under 6 years of age. The dosing regimen should be determined individually by a physician based on age, body weight, and severity of infection.

The dose for patients weighing more than 60 kg is 400 mg (1 tablet) twice daily. For patients weighing less than 60 kg, the drug should be administered at a dose of 15 mg/kg/day, divided into two doses. The maximum daily dose is 800 mg.

For the treatment of patients with neurocysticercosis, appropriate corticosteroid and anticonvulsant therapy should be administered. Oral and intravenous corticosteroids are recommended to prevent the development of cerebral hypertension during the first week of treatment.

***One course of treatment is usually sufficient, but further courses may be required if parasitological examination results remain positive.

Elderly patients. Experience with the use of the drug in elderly patients is limited. Dose adjustment is not required; however, albendazole should be used with caution in elderly patients with impaired liver function.

Renal impairment. Since albendazole is excreted in very small amounts by the kidneys, dose adjustment is not required in this patient group. However, patients with signs of renal impairment should be closely monitored.

Hepatic impairment. Since albendazole is extensively metabolized in the liver to its pharmacologically active metabolite, impaired liver function may significantly affect its pharmacokinetics. Therefore, patients with abnormal liver function tests (elevated transaminase levels) should be carefully evaluated before starting albendazole. If a significant increase in transaminase levels or clinically significant drop in blood counts occurs, treatment should be discontinued (see sections "Special precautions" and "Adverse reactions").

Children.

The medicinal product is intended for use in children aged 3 years and older.

For treatment of children aged 2 to 3 years, other albendazole formulations should be used.

Administer to children according to the recommendations in the section "Dosage and administration".

Overdose.

Symptoms. Depending on the dose ingested, overdose may cause diarrhea, nausea, vomiting, tachycardia, and elevated transaminase levels.

Treatment: symptomatic treatment according to clinical presentation.

Adverse reactions.

Adverse effects occurring during short-term treatment of intestinal infections and cutaneous larva migrans.

Immune system disorders: hypersensitivity reactions, including skin rash, pruritus, and urticaria.

Nervous system disorders: headache and dizziness.

Gastrointestinal disorders: upper gastrointestinal symptoms (e.g., epigastric pain, nausea, vomiting) and diarrhea.

Hepatobiliary disorders: increased liver transaminase levels.

Skin and subcutaneous tissue disorders: polymorphic erythema, Stevens–Johnson syndrome.

Adverse effects occurring during long-term treatment of systemic helminthic infections.

Blood and lymphatic system disorders: leukopenia, pancytopenia, aplastic anemia, agranulocytosis.

Patients with liver disease, including hepatic echinococcosis, are more prone to bone marrow suppression (see sections "Dosage and administration" and "Special precautions").

Immune system disorders: hypersensitivity reactions, including skin rash, pruritus, and urticaria.

Nervous system disorders: headache and dizziness.

Gastrointestinal disorders: gastrointestinal disturbances (abdominal pain, nausea, vomiting). These events are associated with albendazole treatment in patients with echinococcosis.

Hepatobiliary disorders: mild to moderate elevation of liver enzymes, hepatitis.

Skin and subcutaneous tissue disorders: reversible alopecia (hair thinning and moderate hair loss), polymorphic erythema, Stevens–Johnson syndrome.

General disorders: fever.

Shelf life. 4 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 3 tablets in a blister; 1 blister per carton.

Prescription status. Prescription only.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's address and place of business.

38, Kopylivska St., Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua.