Para Plus (Aerosol) Instructions for Use

Marketing Authorization Holder

Omega Pharma France Laboratories (France)

Manufactured By

Aerofarm (France)

ATC Code

P03AC54 (Permethrin in combination with other drugs)

Active Substances

Permethrin (Rec.INN registered by WHO)

Malathion (BAN adopted for use in the United Kingdom)

Piperonyl butoxide (BAN adopted for use in the United Kingdom)

Dosage Form

Para Plus

Aerosol for external use 290 mg+580 mg+2.32 g/116 g: canister 1 pc.

Dosage Form, Packaging, and Composition

Aerosol for external use in the form of a transparent oily solution with a yellowish tint, with a slight characteristic odor; sprayed as fine particles.

Excipients: isododecane – 54.81 g, propellant HFA 134a – 58 g.

116 g – aluminum aerosol canisters with a continuous action valve and a spray device (1) – cardboard packs.

Clinical-Pharmacological Group

Drug for the treatment of head lice

Pharmacotherapeutic Group

Ectoparasiticide

Pharmacological Action

Combined drug for the treatment of head lice.

The pharmacological action of the drug is due to the presence of active substances with insecticidal action. Permethrin is a neurotoxic poison for insects.Piperonyl butoxide enhances the effect of permethrin.Malathion is an organophosphorus insecticide.

Pharmacokinetics

Pharmacokinetic data for Para Plus are not available.

Indications

• Treatment of head lice (effect on lice and nits).

ICD codes

Dosage Regimen

Apply the aerosol to dry hair and scalp in a well-ventilated area.

Hold the canister upright and spray from a distance of approximately 20-30 cm, ensuring complete coverage of the scalp and the entire length of the hair.

Use short, firm presses to dispense the product; one canister is sufficient for one application for medium-length hair.

The exposure time is 10 minutes; do not cover the head during this period and keep away from open flames or heat sources.

After 10 minutes, thoroughly wash hair with regular shampoo or a pediculicide shampoo and rinse with warm water.

While the hair is still damp, systematically comb through with a fine-toothed comb to remove dead lice and nits.

In cases of severe infestation or if live lice are observed after 7 days, a single repeat application is recommended.

Do not exceed two applications within a one-week period.

To prevent reinfestation, concurrently wash or dry-clean all recently used bedding, clothing, and hats in hot cycles.

Inspect all household members for lice and treat simultaneously if infested.

Adverse Reactions

Local reactions very rarely – a sensation of slight tingling or burning of the scalp.

Contraindications

• Bronchial asthma;
• Children under 2.5 years of age;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Adequate and strictly controlled studies on the safety of Para Plus use during pregnancy and lactation (breastfeeding) have not been conducted.

Use of the drug during pregnancy and lactation (breastfeeding) is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or child.

Pediatric Use

Contraindicated for use in children under 2.5 years of age.

Use in children over 2.5 years of age is possible according to the dosage regimen.

Special Precautions

The drug should be sprayed in a well-ventilated area. During spraying and exposure of the drug, one should stay away from fire.

Avoid getting the drug in the eyes and on mucous membranes. If accidentally gets into the eyes, rinse them thoroughly with warm water.

To avoid re-infestation, all textiles that the patient has been in contact with (including pillows, hats, clothing collars) should be treated.

Effect on the ability to drive vehicles and operate machinery

There are no data on the negative effect of the drug use on the ability to drive a car and other vehicles.

Overdose

No cases of overdose with Para Plus have been reported to date.

Drug Interactions

No drug interactions for Para Plus have been identified.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 4 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.