ARNICAN 4 % Cream Tube/50g

IN THIS ANNEX, THE TERMS "MARKETING AUTHORISATION" ARE UNDERSTOOD AS "REGISTRATION OF TRADITIONAL HERBAL MEDICINAL PRODUCT" AND THE TERM "AUTHORISATION" AS "REGISTRATION"

Arnica (Arnica chamissonis Less subsp. foliosa (Nutt.) Maguire) (fluid extract of flower)............... 4,0 g

Solvent: ethanol at 60 % V/V

Drug/extract ratio: 1 : 1

For 100 g of cream.

Excipient with known effect: ethanol.

Herbal traditional medicinal product used for the symptomatic treatment of bruises, sprains and localised muscle pain.

Its use is restricted to the specified indications on the exclusive basis of long-standing use.

ARNICAN 4 PERCENT, cream is indicated in adults and children from 30 months of age.

Dosage

2 to 3 times a day.

Paediatric population

ARNICAN 4 PERCENT, cream is contraindicated in children under 30 months of age (see section Contraindications).

Method of administration

Cutaneous use.

Apply a thin layer to the affected areas with light massage until fully absorbed.

Wash hands after application.

Duration of treatment

If symptoms persist beyond 3 or 4 days of use, a doctor or pharmacist should be consulted.

Hypersensitivity to the active substance or to other plants of the family of the Asteraceae (Compositae) or to any of the excipients listed in section Composition.

Due to the presence, as excipients, of terpene derivatives, this medicine is contraindicated in:

• Children under 30 months of age.
• Children with a history of epilepsy or febrile convulsions.

Do not use on mucous membranes, the eyes, weeping dermatosis, an infected lesion or a wound.

This product contains terpene derivatives, as excipients, which may lower the epileptogenic threshold and cause, at excessive doses, neurological events such as convulsions in infants and children.

In case of a history of epilepsy, take into account the presence, as excipients, of terpene derivatives.

This medicine contains alcohol (ethanol). This may cause a burning sensation on damaged skin.

Observe the dosages and instructions for use, in particular do not apply to a large area of the body.

If symptoms worsen during use of this medicine, a doctor or pharmacist must be consulted.

No interaction studies have been performed.

Pregnancy

Safety in pregnant women has not been established. In the absence of sufficient data, use of this medicine is not recommended during pregnancy.

Breast-feeding

Safety in breastfeeding women has not been established. In the absence of sufficient data, use of this medicine is not recommended during breastfeeding.

Fertility

No fertility data are available.

The effects on the ability to drive vehicles and use machines have not been studied.

Allergic reactions such as pruritus, skin redness and eczema may occur. The frequency is not known.

Given the presence of terpene derivatives as excipients and in case of failure to observe the recommended doses, there is a risk of convulsions in children and infants.

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.

No cases of overdose have been reported.

The genotoxicity study in vitro conducted with the arnica flower extract contained in ARNICAN 4 PERCENT, cream concludes to the absence of a mutagenic effect in the Ames test.

No data on carcinogenicity or on reproductive and developmental toxicity are available.

3 years.

Store at a temperature less than or equal to 25°C.

No special requirements.

Detailed information on this medicinal product is available on the ANSM website.