Helminthox

APPROVED by Order of the Ministry of Health of Ukraine

1. 08.2019, No. 1820

Registration Certificate No. UA/10137/01/02 – AMENDMENTS MADE by Order of the Ministry of Health of Ukraine __________ No. __________ INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HELMINTOX (HELMINTOX)

Composition:

Active substance: pyrantel;

One tablet contains pyrantel embonate equivalent to pyrantel 125 mg;

Excipients: pregelatinized starch, povidone, sodium croscarmellose, magnesium stearate, Sepifilm™ 002*, Sepispers™ AP3065 yellow**.

*Sepifilm™ 002: hypromellose, microcrystalline cellulose, polyglycol stearate type I;

**Sepispers™ AP3065 yellow: purified water, propylene glycol, hypromellose, titanium dioxide (E 171), yellow FCF (E 110) aluminum lake.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: film-coated tablets of yellow-orange color with a score line.

The score line is intended only to facilitate tablet splitting for ease of swallowing, not for dividing into equal doses.

Pharmacotherapeutic group. Antiparasitic agents, insecticides and repellents. Anthelmintics. Agents used in nematode infections. Tetrahydropyrimidine derivatives. Pyrantel. ATC code P02CC01.

Pharmacological properties.

Pharmacodynamics.

Pyrantel is an anthelmintic agent. It is active against Enterobius vermicularis, Ascaris lumbricoides, Ancylostoma duodenale, and Necator americanus. Pyrantel induces neuromuscular blockade, paralyzing helminths, thus enabling their elimination from the gastrointestinal tract via peristalsis along with fecal matter. Pyrantel is effective against both mature and immature susceptible stages of helminths. It has no effect on migrating tissue-phase larvae.

Pharmacokinetics.

Gastrointestinal absorption of pyrantel is very low. After administration, plasma concentrations are very low (0.05–0.13 mcg/mL) and reach maximum levels within 1–3 hours. Up to 93% of the administered dose is excreted unchanged in feces. Less than 7% is recovered in urine as unchanged drug and metabolites.

Clinical characteristics.

Indications.

Enterobiasis, ascariasis, ancylostomiasis.

The medicinal product is intended for use in adults and children aged 6 years and older.

Contraindications.

Hypersensitivity to any component of the drug.

Interaction with other medicinal products and other forms of interaction.

Do not use concomitantly with piperazine, which is an antagonist of the anthelmintic effect of pyrantel.

Special precautions for use

In case of hepatic insufficiency, dose reduction is recommended.

Enterobiasis. To prevent reinfection, strict hygiene measures must be observed: daily perianal hygiene, cleaning of nails several times a day. Children should have their nails kept short. Change underwear and nightwear regularly. Avoid scratching. Simultaneous treatment of all family members is recommended, as infection often occurs asymptomatically.

This medicinal product contains the colouring agent sunset yellow FCF (E 110), which may cause allergic reactions.

This medicinal product contains 1.53 mg of sodium per tablet, equivalent to 0.075% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Use during pregnancy or breastfeeding.

Pregnancy

Due to the absence of teratogenic effects in animals, congenital malformations in humans are not expected. To date, congenital malformations or fetotoxic effects have not been clinically confirmed. However, monitoring of pyrantel use during pregnancy is insufficient to exclude all possible risks. Therefore, this medicinal product may be used during pregnancy only if absolutely necessary, after careful evaluation of the benefit-risk ratio for the mother and fetus, as determined by a physician.

Breastfeeding

Due to the lack of published studies on the adverse effects of pyrantel in infants on breastfeeding, the use of Helmintox may be considered if necessary, following consultation with a physician.

Fertility

In animal studies, no effects on fertility in males or females were observed.

Ability to influence reaction speed when driving vehicles or operating machinery.

Adverse reactions affecting the nervous system, which may occasionally occur during treatment with Helmintox, may affect reaction speed when driving vehicles or operating other machinery.

Method of Administration and Dosage.

Dosage

FOR ADULTS AND CHILDREN AGED 6 YEARS AND OLDER ONLY.

For children under 6 years of age, it is preferable to use the suspension.

Enterobiasis and Ascariasis.

For the treatment of enterobiasis and ascariasis, the usual dosage is a single dose of 10 mg/kg to 12 mg/kg body weight.

Children aged 6 years and older: 1 tablet per 10 kg body weight as a single dose.

Adults with body weight less than 75 kg: 6 tablets as a single dose.

Adults with body weight greater than 75 kg: 8 tablets as a single dose.

In the treatment of enterobiasis, strict hygiene measures should be followed and close contacts and family members should be treated simultaneously to ensure complete eradication of parasites. To prevent autoinfection (self-reinfection), a second dose of the drug is recommended 3 weeks after the initial dose.

Hookworm Infection (Ankylostomiasis)

In endemic areas, for infection with Necator americanus or heavy infestation with Ancylostoma duodenale, the dosage is 20 mg/kg per day (in 1 or 2 divided doses) for 2–3 days.

Children aged 6 years and older: 2 tablets per 10 kg body weight per day.

Adults with body weight less than 75 kg: 12 tablets per day.

Adults with body weight greater than 75 kg: 16 tablets per day.

In cases of moderate infection with Ancylostoma duodenale (commonly seen in non-endemic areas), a single dose of 10 mg/kg may be sufficient.

Method of Administration

For oral use.

The drug can be taken at any time; it is not necessary to take it on an empty stomach or to use laxatives prior to administration.

Children.

Should be administered to children aged 6 years and older. For children under 6 years of age, it is preferable to use the drug in the form of a suspension.

Overdose.

Due to low systemic absorption, plasma concentrations of the drug remain low. Overdose may cause mild gastrointestinal disturbances (e.g., nausea, vomiting, diarrhea) and minor transient central nervous system effects (e.g., asthenia, dizziness, headache). Occasionally, elevated levels of liver transaminases (AcAT) may occur. Specific antidotes are not known. Immediate gastric lavage is recommended, along with monitoring of respiratory and cardiovascular functions. Symptomatic treatment is advised.

Adverse reactions.

Rare: gastrointestinal disorders (anorexia, nausea, vomiting, abdominal pain, diarrhea), decreased or transient increased levels of transaminases.

In individual cases: headache, dizziness, somnolence, insomnia, asthenia, weakness, increased fatigue, skin rashes, urticaria.

Hypersensitivity reactions are possible.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients are encouraged to report any suspected adverse reactions and lack of efficacy of the medicinal product via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

6 tablets in a blister, 1 blister per cardboard box.

Availability. Over-the-counter.

Manufacturer.

Innothera Chouzy, France/Innothera Chouzy, France.

Manufacturer’s name and address.

Rue René Chantereau, Chouzy-sur-Cisse, Valloire-sur-Cisse, 41150, France/Rue René Chantereau, Chouzy-sur-Cisse, Valloire-sur-Cisse, 41150, France.

Marketing authorization holder.

Laboratoire Innotech International, France/Laboratoire Innotech International, France.

Address of the marketing authorization holder.

22 avenue Aristide Briand, 94110 Arcueil, France/22 avenue Aristide Briand, 94110 Arcueil, France.