HEMOCLAR 0,5 % cream, tube/30 g

Pentosan polysulfate .............................................................................................. 0,500 g

For 100 g of cream.

Excipients with known effect: propylene glycol, methyl parahydroxybenzoate

Adjunctive local treatment of minor trauma (ecchymoses, contusions) in adults and children from one year of age.

Dosage

Apply 2 to 4 times a day on the area to be treated, massaging very lightly to facilitate penetration.

Method of administration

Cutaneous route. Local application.

• History of allergy or thrombocytopenia to heparins or heparinoids.

• Hypersensitivity to the other constituents (methyl parahydroxybenzoate and propylene glycol).

For external use only. Do not swallow.

This medicine contains propylene glycol and may cause skin irritation.

This medicine contains "Parahydroxybenzoate" and may cause allergic reactions (possibly delayed).

Stop treatment in case of allergic manifestations.

Do not apply in the immediate vicinity of the eyes, on mucous membranes, wounds, burns, infected lesions or on weeping dermatoses.

Wash hands thoroughly after each use (to avoid any contact with the eyes or mucous membranes).

Animal experimentation is insufficient to establish safety with regard to reproduction, the course of pregnancy, embryo or foetal development and peri- and postnatal development.

In pregnant or breastfeeding women, the safety of HÉMOCLAR 0,5 percent, cream has not been evaluated in controlled clinical trials and post-marketing data are insufficient.

Therefore the use of HÉMOCLAR 0,5 percent, cream is not recommended during pregnancy or breastfeeding.

Possibility of localised allergic reactions at the site of application.

Due to the presence of propylene glycol, this medicine may cause skin irritation.

Due to the presence of methyl parahydroxybenzoate, this medicine may cause allergic reactions (possibly delayed).

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: https://signalement.social-sante.gouv.fr/.

No cases of overdose have been reported; however, excessive use may lead to an exacerbation of undesirable effects, in particular skin irritation.

Pharmacotherapeutic class: LOCAL PRODUCT FOR MUSCLE AND JOINT PAIN. (M: musculoskeletal system)

2 years.

Store at a temperature not exceeding 25°C.