Helminthox

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

Composition:

Active substance: pyrantel;

1 measuring spoon (2.5 mL) of suspension contains pyrantelemboate equivalent to pyrantel 125 mg;

Excipients: sorbitol crystallizing solution; glycerol; polysorbate 80; lecithin; povidone; anhydrous citric acid; sodium benzoate (E 211); silicone emulsion; caramel/black currant flavor; aluminum-magnesium silicate; purified water.

Pharmaceutical form. Oral suspension.

Main physicochemical properties: homogeneous light yellow liquid. In case sedimentation occurs, particles readily resuspend.

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 helminths, thus enabling their elimination via intestinal peristalsis along with fecal matter. Pyrantel is effective against both mature and immature sensitive forms of helminths. It does not affect tissue-migrating helminth larvae.

Pharmacokinetics.

Intestinal absorption of pyrantel is very low. After administration, plasma concentration is very low (0.05–0.13 µg/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 as unchanged drug and metabolites.

Clinical characteristics.

Indications.

Enterobiasis, ascariasis, ancylostomiasis.

Contraindications.

Hypersensitivity to any component of the drug.

Hypersensitivity to peanuts or soy.

Interaction with other medicinal products and other forms of interaction.

Do not use with piperazine, which is an antagonist of pyrantel's anthelmintic action.

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 fingernails several times a day. Children should have their nails kept short. Change underwear and pajamas regularly. Avoid scratching. Simultaneous treatment of all family members is recommended, as infection often occurs asymptomatically.

This medicinal product contains 5.9 mg of sodium benzoate in each measuring spoon.

This medicinal product contains 1.3 g of sorbitol in each measuring spoon. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect. It should not be used in patients with fructose intolerance (a rare hereditary disorder).

This product contains lecithin (from soy). This medicinal product should not be taken by patients with hypersensitivity to peanuts or soy.

Use during pregnancy or breastfeeding.

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 drug may be used during pregnancy only if absolutely necessary, after careful assessment of the benefit-risk ratio for the mother and fetus, as determined by the physician.

Due to the lack of published studies on the adverse effects of pyrantel on breastfed infants, Helminthox may be used during breastfeeding if necessary, following consultation with a physician.

Ability to affect reaction speed while driving or operating machinery.

If dizziness or drowsiness occurs during treatment with this drug, patients should refrain from driving or operating machinery.

Method of Administration and Dosage

Dosage

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: 1 measuring spoon (5 mL) per 10 kg body weight as a single dose.

Adults with body weight less than 75 kg: 6 measuring spoons (15 mL of suspension) as a single dose.

Adults with body weight over 75 kg: 8 measuring spoons (20 mL of suspension) as a single dose.

In cases of enterobiasis, to achieve complete elimination of parasites, strict hygiene measures must be followed and all family members should be treated simultaneously. To prevent re-infection, a repeat dose should be taken 3 weeks after the initial administration.

Hookworm infection (Ankylostomiasis)

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

Children: 2 measuring spoons per 10 kg body weight daily.

Adults with body weight less than 75 kg: 12 measuring spoons (30 mL of suspension) daily.

Adults with body weight over 75 kg: 16 measuring spoons (40 mL of suspension) daily.

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

Adult patients are advised to use Helminthox in tablet form; however, if tablets cannot be taken, the suspension form is recommended.

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.

Shake well before use.

Children

Should be administered to children with body weight of at least 10 kg.

Overdose

Due to the low systemic absorption of the drug, plasma concentrations remain low. Even in cases of overdose, only mild gastrointestinal disturbances (nausea, vomiting, diarrhea) and minor transient central nervous system effects (asthenia, dizziness, headache) may occur. Occasionally, elevated liver transaminase levels (AST) may be observed. 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.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging. Keep out of reach of children.

Packaging.

15 ml of suspension in a bottle, 1 bottle with a measuring spoon in a cardboard box.

Prescription status.

Over-the-counter.

Manufacturer.

Innothera Chouzy, France/Innothera Chouzy, France.

Manufacturer's location and address of its place of business.

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