Ruscoroid 1% + 1% Cream 40gr

INDICATIONS

Treatment of symptoms associated with hemorrhoids, anal fissures and proctitis, such as: itching, pain and feeling of weight.

ACTIVE INGREDIENTS

100 g of cream contains: Ruscogenin 1 g Tetracaine hydrochloride 1 g Excipients with known effects: cetyl alcohol, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, Rosemary 7144 perfume. For the complete list of excipients, see paragraph 6.1.

EXCIPIENTS

Cetyl alcohol, polysorbate 80, macrogol 400, macrogol 4000, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, Rosemary 7144* perfume, purified water. *Rosemary 7144 perfume contains the following allergens: amyl cinnamale, amylcinnamal alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, geraniol, hexylcinnamale, hydroxycitronellal, d-limonene, linalool (see section 4.4).

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active ingredient or to any of the excipients listed in paragraph 6.1 or to other closely related substances from a chemical point of view.

DOSAGE

Dosage 1 - 2 applications per day Do not exceed the recommended doses. Method of administration Apply directly or using the appropriate applicator.

CONSERVATION

Store below 25°C.

WARNINGS

Do not use for prolonged treatments. After a short period of treatment without appreciable results and in case of prolonged use, consult your doctor. The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena; if this happens, treatment should be stopped and the doctor should be consulted to adopt suitable therapeutic measures. Clinical use has not highlighted the need for particular precautions for the use of Ruscoroid. Use under 12 years of age is not recommended, unless under direct medical supervision. Ruscoroid 10 mg/g + 10 mg/g cream contains cetyl alcohol May cause localized skin reactions (e.g. contact dermatitis). Ruscoroid 10 mg/g + 10 mg/g cream contains methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate They can cause allergic reactions (even delayed). Ruscoroid 10 mg/g + 10 mg/g cream contains Rosemary 7144 perfume This medicine contains a flavoring (Rosemary 7144 perfume) which itself contains allergens which may cause allergic reactions. For the complete composition of allergens see paragraph 6.1.

INTERACTIONS

Phenomena referable to interaction with other substances have never been reported.

SIDE EFFECTS

Rare cases of sensitization, such as local and generalized erythema associated with itching. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

There are no known cases of overdose.

PREGNANCY AND BREASTFEEDING

The product should be used in cases of actual necessity under direct medical supervision.

EFFECTS ON DRIVING ABILITY

Ruscoroid does not alter the ability to drive and use machines.