Helmadol
(Albendazole)




COMPOSITION

One film-coated tablet contains

Active substance: albendazole 200 mg or 400 mg.

Excipients: lactose monohydrate, maize starch pregelatinised, sodium starch glycolate, talc, crospovidone, povidone K25, magnesium stearate, sodium lauryl sulfate.

Coat composition: Opadry® white 03F180011 (hypromellose, macrogol, titanium dioxide), Opadry® II pink 85F240091 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, talc, red iron oxide).

THERAPEUTIC INDICATIONS

- nematodosis (ascaridosis, enterobiasis, ancylostomiasis, necatoriasis, trichocephaliasis);

- mixed helminth infections;

- strongyloidosis;

- neurocysticercosis caused by the larval form of Taenia solium;

- hepatic, renal, peritoneal echinococcosis caused by the larval form of Echinococcus granulosus;

- lambliasis;

- toxocariasis;

- as an auxiliary aid in surgical treatment of echinococcal cysts.

CONTRAINDICATIONS

- hypersensitivity to the medicinal product ingredients and other benzimidazole derivatives;

- eye retina pathology;

- pregnancy;

- lactation.

ADVERSE EFFECTS

The parameters below that show undesirable effect frequency are determined as follows: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rarely (≥ 1/10000, < 1/1000); very rarely (< 1/10000).

Undesirable effects, observed in short-term treatment:

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

Central nervous system disorders: uncommon - headache, dizziness.

Digestive system disorders: uncommon - abdominal pain, nausea, vomiting, diarrhea.

Hepatobiliary disorders: rarely – increased liver enzyme levels.

Skin and subcutaneous tissue disorders: very rarely - erythema multiforme, Stevens-Johnson syndrome.

Undesirable effects, observed in long-term treatment of systemic helminth infections:

Blood and lymphatic system disorders: uncommon - leukopenia; very rarely - pancytopenia, aplastic anemia, agranulocytosis.

Patients with hepatic disorders, including hepatic echinococciasis, are more prone to bone marrow suppression.

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

Central nervous system disorders: very common – headache; common - dizziness.

Digestive system disorders: common – abdominal pain, nausea, vomiting, diarrhea.

Hepatobiliary disorders: very common – mild to moderate elevations of liver enzyme levels; uncommon - hepatitis.

Skin and subcutaneous tissue disorders: common – reversible alopecia; very rarely - erythema multiforme, Stevens-Johnson syndrome.

General disorders and administration site conditions: common - fever.

DOSAGE AND ADMINISTRATION

The medicinal product is administered orally, with or after meals, without chewing, with water. Special preparation and diet is not required.

The dose of the medicinal product is established individually. Maximum daily dose - 800 mg.

The medicinal product is prescribed at the following doses:

In ascaridosis , enterobiasis, ancylostomiasis in adults and children above 2 years old, the dosage is 400 mg. In enterobiasis, the treatment course should be repeated in 14 days at the same dosage and with the same regimen.

In trichocephaliasis, the dose is 400 mg a day as a single dose for 3 days in adults and children.

In strongyloidosis, the dose is 400 mg 2 times a day for 7 days in adults and children above 2 years old.

In trichinellosis, the dose is 400 mg 2 times a day for 14 days in adults and children above 2 years old.

In lambliasis, the dose is 10-15 mg/kg once a day for 5-7 days in children.

In toxocariasis, the dose is 400 mg 2 times a day for 7-14 days in adults and children weighing more than 60 kg; weighing less than 60 kg - 200 mg 2 times a day for 7-14 days, children - 10 mg/kg 2 in 2 divided doses a day for 7-14 days.

In echinococcosis, the dose is 400 mg 2 times a day in adults and children above 12 years old (weighing more than 60 kg), 10 mg/kg a day in 2-3 divided doses daily after meals for 4 weeks – in children at the age of 6-12 years old.

In cysticercosis, the dose is 400 mg 3 times a day in adults and children above 12 years old (weighing more than 60 kg), and the dose of 15 mg/kg body weight in 3 divided doses after meals in children at the age of 6-12 years old. The treatment course duration is 28-30 days.

SPECIAL INDICATIONS

Caution should be exercised when using Helmadol in patients with hepatic disorders.

A pregnancy test that should be negative is performed in women of childbearing potential before treatment. Reliable contraception is required during therapy.

PREGNANCY AND LACTATION

Helmadol is contraindicated in pregnancy and lactation.

MANUFACTURED FORM AND PACKAGE

Helmadol 200 mg

Film-coated tablets.

2 or 6 tablets in a blister.

1 blister with the enclosed leaflet in a carton box.

10 tablets in a blister.

1 or 4 blisters with the enclosed leaflet in a carton box.

Helmadol 400 mg

Film-coated tablets.

1, 2 or 3 tablets in a blister.

1 blister with the enclosed leaflet in a carton box.

10 tablets in a blister.

1 or 6 blisters with the enclosed leaflet in a carton box.

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