Helminthox

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

Composition:

Active substance: pyrantel;

1 tablet contains pyrantel embonate equivalent to pyrantel 250 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, yellow-orange in color, with a score line.

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

Pharmacotherapeutic group. Antiparasitic agents, insecticides and repellents. Anthelmintics. Agents used in nematodosis. Tetrahydropyrimidine derivatives. Pyrantel. ATC code P02C C01.

Pharmacological properties.

Pharmacodynamics.

Pyrantel is an anthelmintic agent. It is active against Enterobius vermicularis, Ascaris lumbricoides, Ancylostoma duodenale, and Necator americanus. Pyrantel causes neuromuscular blockade, paralyzing the helminths, resulting in their elimination via intestinal peristalsis along with fecal matter. Pyrantel is effective against both mature and immature susceptible forms of helminths. It has no effect on migrating tissue-dwelling helminth larvae.

Pharmacokinetics.

Gastrointestinal absorption of pyrantel is very low. After administration, plasma concentration is very low (0.05–0.13 mcg/mL) and reaches its maximum within 1–3 hours. Up to 93 % of the drug is excreted unchanged in feces. Less than 7 % is found in urine, both unchanged and as 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 with piperazine, which is an antagonist of pyrantel's anthelmintic effect.

Special precautions for use

In case of hepatic insufficiency, dose reduction is recommended.

Enterobiasis. To prevent reinfection, strict hygiene measures must be followed: daily perianal hygiene, cleaning of nails several times a day. Children should have their nails kept short. Underwear and nightwear should be changed regularly. Scratching should be avoided. Simultaneous treatment of all family members is recommended, as infection often occurs without symptoms.

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

This medicinal product contains 3.06 mg of sodium per tablet, equivalent to 0.15% of the WHO recommended maximum daily intake of sodium for an adult, which is 2 g.

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 developmental abnormalities 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 should be used during pregnancy only if absolutely necessary, after careful assessment of the benefit to the woman versus the risk to the fetus, as determined by the physician.

Breastfeeding

Due to the lack of published studies on the adverse effects of pyrantel in infants receiving breast milk, Helminthox may be used if necessary, following consultation with a physician.

Fertility

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

Ability to affect reaction speed when driving or operating machinery.

Adverse reactions affecting the nervous system, which may occasionally occur during treatment with Helminthox, may influence the speed of reaction when driving vehicles or operating 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 medication in the form of a 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.

Children aged 6 years and older: 1 tablet per 20 kg body weight as a single dose.

Adults with body weight less than 75 kg: 3 tablets as a single dose.

Adults with body weight over 75 kg: 4 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 achieve complete eradication of parasites. To prevent autoinfection (self-reinfection), a second dose of the medication 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: 1 tablet per 10 kg body weight per day.

Adults with body weight less than 75 kg: 6 tablets per day.

Adults with body weight over 75 kg: 8 tablets per day.

For mild 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 medication can be taken at any time; there is no need 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 medication in the form of a suspension.

Overdose.

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

Adverse Reactions

Rare: gastrointestinal disorders (anorexia, nausea, vomiting, abdominal pain, diarrhea), decreased or transient increase in transaminase levels.

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

Hypersensitivity reactions are possible.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after medicinal product authorization is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy 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

3 tablets in a blister pack, 1 blister pack in a cardboard box.

Supply category: Over-the-counter (without prescription)

Manufacturer

Innothera Chouzy, France / Innothera Chouzy, France

Manufacturer's 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