HOMEOPLASMINE ointment tube (aluminium/plastic)/18 g

Marigold tincture ........................................................................................................................0,1 g

Phytolacca tincture ..................................................................................................................................0,3 g

Bryony tincture .........................................................................................................................................0,1 g

Laos benzoin tincture..........................................................................................................................0,1 g

Boric acid....................................................................................................................................................4,0 g

For 100 g of ointment

Adjunctive treatment of irritative dermatitis.

Dosage

Skin irritations: 1 to 3 applications per day in a thin layer.

Method of administration

Cutaneous route

• Children under 30 months.
• History of hypersensitivity to any of the components (or group sensitisation).
• Superinfected or weeping lesions.

Linked to the presence of boric acid: application to a mucous membrane or to damaged skin increases the systemic absorption of boric acid and, in children, may expose them to toxic systemic effects. These effects are all the more to be feared when the topical product is used for a prolonged or repeated period, over a large surface, under occlusion, on damaged skin (in particular burnt skin), on a mucous membrane, and in young children.

Pregnancy

Studies carried out in animals have shown reproductive toxicity. There are no or few data on the use of HOMEOPLASMINE in pregnant women.
HOMEOPLASMINE is not recommended during pregnancy and in women of childbearing potential not using effective contraception.

Breast-feeding

There are insufficient data on the excretion of HOMEOPLASMINE in human milk. A risk to newborns/infants cannot be excluded. A decision must be made either to discontinue breastfeeding or to discontinue treatment with HOMEOPLASMINE, taking into account the benefit of breastfeeding for the child and the benefit of the treatment for the woman. For women who decide to breastfeed, in case of application to the breasts, clean the skin before each feed.

Fertility

In studies carried out in animals, boron caused testicular damage and a decrease in fertility.

The following adverse effects have been reported:

Burning sensation at the application site, redness at the application site, eczema, hypersensitivity reactions including angioedema.

Risk of systemic effects (see section Warnings and precautions)

Paediatric population

In infants and children, boric acid has been responsible for serious poisonings. Skin signs (intense, diffuse erythroderma, followed by desquamation with an initial erythema often predominating in the diaper area and the mouth) should raise the alarm.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: www.signalement-sante.gouv.fr.

Pharmacotherapeutic class: skin protectant (D: Dermatology)

Homeoplasmine, ointment is a locally acting topical medicinal product.

In view of the experimental data, the systemic passage of the boric acid contained in Homeoplasmine, ointment is low.

Data relating to boric acid :

Genotoxicity and carcinogenicity studies have not shown any particular risk for humans at therapeutic doses.

Repeated-dose oral toxicity studies conducted in rats and dogs revealed kidney lesions and changes in the glial cells of the cerebral cortex and spinal cord at doses of 400-700 mg Boron/kg, which corresponds, for an adult weighing 50 kg, to more than 2600 times the therapeutic dose, and for a child weighing 12 kg, to more than 630 times the therapeutic dose provided by HOMEOPLASMINE, ointment.

A teratogenic effect has been reported in rats and mice (skeletal abnormalities of the ribs) and in rabbits (cardiovascular malformations, agenesis of the gallbladder). The no-effect oral dose was 9,6 mg Boron/kg/day (equivalent to a human dose of 1,5 mg Boron/kg/day), i.e. 10 times the therapeutic dose provided by HOMEOPLASMINE, ointment.

In mice and rats treated orally, testicular effects (atrophy, degeneration of Leydig and Sertoli cells), impaired semen quality and decreased fertility have been reported. The no-effect oral dose was 17 mg Boron/kg/day (equivalent to a human dose of 2,8 mg Boron/kg/day), i.e. 18 times the therapeutic dose provided by HOMEOPLASMINE, ointment. The reversibility of these effects is not known.

Tube (lacquered aluminium): 3 years

Tube (aluminium-plastic): 3 years

After opening the tube : 1 year

Store below 25°C.

No special requirements.