Cortidro 0.5% cream

NAME

Cortidro 0.5% cream

Active ingredients

100 g of cream contain 0.5 g of acetate hydrochortisone excipients with known effects: cetosterylic alcohol, methyl p-hydroxybenzoate and propyle p-hydroxybenzoate for the complete list of excipients, see section 6.1

Excipients

Cetosterylic alcohol, sodium laurilsolfate, vaseline oil, stringy vaseline, methyl p-hydroxybenzoate, propyle p-hydroxybenzoate, distilled water.

Therapeutic indications

The product is used in case of insect stings, itching, erythema or circumscribed burns, eczema.

Contraindications/side effects

Hypersensitivity to the active ingredient or to any of the excipients listed in paragraph 6.1. The use of hydrocortisone is contraindicated in the case of viral, bacterial or fungal affections.

Dosage

For adults and children over two years of age: to apply a minimum amount of cream on the part and launch slightly in order to facilitate its penetration. The application can be repeated two or three times a few days. In case of non -response to therapy, you should contact the doctor. Do not exceed the recommended dose.

CONSERVATION

Do not keep at temperature above 30 ° C.

Warnings

The cream finds no ophthalmological use or must be applied in the periocular areas. Avoid employment in the treatment of vulvar itching if associated with vaginal losses. Avoid prolonged applications, in particular on large surfaces. The use, especially if prolonged, of topical products can give rise to phenomena of irritation or awareness. In this case it is necessary to stop the treatment and consult the doctor in order to establish suitable therapy. Visual disorders With the use of systemic and topical corticosteroids, visual disorders can be reported. If a patient presents itself with symptoms such as blurred vision or other visual disorders, it is necessary to consider referral to an ophthalmologist for the evaluation of the possible causes that may include cataracts, glaucoma or rare diseases such as central serous corooretinopathy (CSCR), which have been reported after the use of systemic and topical corticosteroids. Pediatric population In children under the age of two, the product must be administered in cases of effective need under the direct control of the doctor.

Interactions

It is necessary to observe caution in the association of corticosteroids with Amsfotericin B because they can add their hypokalemizing actions. Corticosteroids corner the effects of anticoagulants, therefore contemporary use is not recommended with the same especially if cumarin derivatives. The barbiturates accelerate the metabolism of corticosteroids for enzymatic induction and reduce their effect, therefore, their association is not recommended.

Side effects

The systemic side effects of the corticosteroid preparations for topical use are extremely unlikely for the low dosages used: in case of onset, stop the therapy. Pathologies of the eye, uncommon (≥1/1,000, <1/100): vision, blurred (see also paragraph 4.4). Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk ratio of the medicine. Healthcare professionals are required to report any suspicious adverse reaction through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnolare-a-ospetta-reation-avversa

Overdose

Clinically unfavorable symptomatologies were noted at the doses indicated; In the event of an emergency, the doctor intervenes according to the symptoms detected.

Pregnancy and breastfeeding

The product should be administered in cases of effective necessity and under the direct control of the doctor.