Albela®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ALBELA® (ALBELA®)

Composition:

Active substance: albendazole;

1 tablet contains 400 mg of albendazole;

Excipients: lactose monohydrate, corn starch, sodium lauryl sulfate, sodium croscarmellose, povidone, microcrystalline cellulose, sodium saccharin, magnesium stearate, colloidal anhydrous silicon dioxide, orange flavoring agent.

Pharmaceutical form. Tablets.

Main physicochemical characteristics: white or almost white, capsule-shaped, biconvex tablets with a characteristic odor, smooth on both sides.

Pharmacotherapeutic group.

Anthelmintic agents. Agents used in nematodosis. Benzimidazole derivatives.

ATC code P02C A03.

Pharmacological Properties.

Pharmacodynamics.

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

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

Albendazole is 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 granulomatous echinococcosis. After treatment with albendazole, the proportion of non-viable cysts increases to 90%, compared to 10% in untreated patients. Following albendazole treatment for cysts caused by Echinococcus multilocularis, complete recovery was observed in a minority of patients, while in most cases, improvement or stabilization of the condition was achieved.

Pharmacokinetics.

After oral administration, albendazole is poorly absorbed (less than 5%). Systemic exposure increases when the drug is administered with fatty food, which enhances absorption by fivefold. It is rapidly metabolized in the liver during first-pass metabolism. The primary metabolite is albendazole sulfoxide, which is the main active compound responsible for the treatment of 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 administration, elimination of the drug from cysts continues for several weeks.

Elderly Patients.

Some clinical data suggest that the pharmacokinetics in elderly patients are similar to those in young healthy volunteers.

Renal Impairment.

The pharmacokinetics of albendazole in this patient group have not been studied.

Hepatic Impairment.

The pharmacokinetics of albendazole in this patient group have not been studied.

Clinical characteristics.

Indications.

Intestinal forms of helminthiasis and cutaneous Larva Migrans syndrome (short-term treatment with low doses): enterobiasis, ancylostomiasis and necatoriasis, hymenolepiasis, teniasis, strongyloidiasis, ascariasis, trichocephalosis, 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 surgical intervention is not possible;
• prior to surgical intervention;
• after surgery, if preoperative treatment was short, if widespread helminth infection is observed, or if 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 Taenia solium larvae):

• in the 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 or breastfeeding.

Women who plan to become pregnant. Women of childbearing potential should use effective non-hormonal contraceptive methods during treatment and for 1 month after treatment with the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Albendazole induces enzymes of the cytochrome P450 system.

Medicinal products that may slightly reduce the efficacy of albendazole: anticonvulsants (e.g., phenytoin, fosphenytoin, carbamazepine, phenobarbital, primidone), levamisole, ritonavir. The effectiveness of treatment in patients should be monitored, and alternative dosing regimens or therapies should be considered if necessary.

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

Grapefruit juice also increases plasma levels of albendazole sulfoxide.

Due to the potential for cytochrome P450 activity disruption, there is a theoretical risk of interaction between albendazole and 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 Albel® during early pregnancy, women of childbearing potential should only be treated during the first week of the menstrual cycle or after a negative pregnancy test. Reliable contraception is required during treatment with albendazole and for one month after discontinuation of the drug.

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

Treatment of systemic helminthic infections.

Albendazole treatment may be associated with mild to moderate elevations in liver enzymes, which typically normalize after treatment discontinuation. 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 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 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 the 28-day treatment cycle. Patients with liver 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 deterioration in blood counts occurs, treatment should be discontinued (see sections "Dosage and administration" and "Side effects").

To prevent inadvertent administration of Albel® during early pregnancy, women of childbearing potential should:

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

In patients with neurocysticercosis treated with albendazole, symptoms related to inflammatory reactions caused by parasite death (e.g., seizures, increased intracranial pressure, focal neurological signs) may occur. Such adverse reactions should be managed with corticosteroids and anticonvulsant therapy. To prevent episodes of increased intracranial pressure during the first week of treatment, oral or intravenous corticosteroids are recommended.

Albendazole treatment may also reveal pre-existing neurocysticercosis, especially in areas with high prevalence of Taenia solium infection. Neurological symptoms such as seizures, increased intracranial pressure, and focal neurological signs may develop due to inflammatory reactions following parasite death in the brain. Symptoms may appear rapidly after treatment, so prompt initiation of appropriate therapy with corticosteroids and anticonvulsants is essential.

Excipients. The product contains lactose. If the patient has known intolerance to certain sugars, consultation with a physician is necessary before taking this medicinal product.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy and breastfeeding, and in women who are planning to become pregnant (see section "Contraindications").

Effect on ability to drive and operate machinery.

Given the potential for dizziness as an adverse reaction, it is recommended that patients refrain from driving or operating machinery during treatment with albendazole.

Dosage and Administration.

Intestinal infections and cutaneous larva migrans syndrome.

The medication should be taken with food. It is advisable to take it at the same time each day. If no improvement occurs within 3 weeks, the physician should prescribe a second course of treatment.

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 aged 3 years and older.

* For children aged 2 to 3 years, another formulation of the drug should be used – oral suspension.

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 for 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 closely monitored at the beginning of albendazole therapy.

Systemic helminthic infections (prolonged high-dose treatment).

Take the drug with food.

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

The use 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 based 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. The maximum daily dose is 800 mg.

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

***Typically, a single course of treatment is required, but additional courses may be necessary if parasitological test 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 for treating 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 therapy should be carefully evaluated. If significant increases in transaminase levels or clinically relevant deterioration in blood parameters occur, treatment should be discontinued (see sections "Special precautions" and "Adverse reactions").

Children.

The drug is intended for use in children aged 3 years and older. For treatment of children aged 2 to 3 years, another dosage form is recommended – oral suspension.

Administer to children according to the information specified 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.

Side effects.

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

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

Nervous system disorders: headache, dizziness.

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

Hepatobiliary disorders: increased levels of liver enzymes.

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

Side 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: symptoms related to the upper gastrointestinal tract (e.g., epigastric pain, nausea, vomiting), diarrhea. 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: polymorphic erythema, Stevens–Johnson syndrome, reversible alopecia (hair thinning and moderate hair loss).

General disorders: fever.

Shelf life.

3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

1 tablet in a blister; 1 or 3 blisters in a cardboard pack.

3 tablets in a blister; 1 blister in a cardboard pack.

Prescription status.

Prescription only.

Manufacturer.

LLC "KUSUM PHARM".

Manufacturer's address and location of business activity.

54 Skryabina Street, Sumy, Sumy Region, 40020, Ukraine.

or

Manufacturer.

LLC "GLEDPHARM LTD".

Manufacturer's address and location of business activity.

54 Davydovskoho Hryhoriia Street, Sumy, Sumy Region, 40020, Ukraine.