Hirudoid 40 000 IU 50 g gel

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Thrombophlebitis and superficial phlebitis. Venous stasis edema. Pain, inflammation, edema, trophic disorders in post-phlebitic and varicose states. Hematomas.

ACTIVE INGREDIENTS

100 g of cream contains: Active ingredient: glycosaminoglycanopolysulphate (M.V. 5700-13700) 445 mg equal to 40000 I.U.; 100 g of gel contain: Active ingredient: glycosaminoglycanopolysulphate (M.V. 5700-13700) 445 mg equal to 40000 I.U. Excipient with known effect: 0.50 g of propylene glycol (E1520). For the full list of excipients, see section 6.1.

EXCIPIENTS

Cream: LE cutin, medium chain triglycerides, myristic alcohol, isopropyl myristate, bentonite, perfume essence, isopropyl alcohol, imidurea, phenoxyethanol, rosemary oil. Gel: isopropanol, propylene glycol (E1520), polyacrylic acid, sodium hydroxide, purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substance, to a heparinoid or to any of the excipients listed in paragraph 6.1.

DOSAGE

Pierce the tube membrane with the capsule pin. Cream: unless otherwise prescribed, place 3-5 cm of cream on the affected part 2-3 times a day (even more if necessary and in the initial applications) and massage lightly until the cream is absorbed. In the case of particularly painful inflammations and in the presence of thrombosis, carefully spread Hirudoid 40000 U.I. cream over the entire affected skin area and also around it, and cover with cotton gauze or similar. In these cases the therapeutic effect of Hirudoid 40000 I.U. cream can be amplified by rubbing even areas further away from the part. Gel: unless otherwise prescribed, 3-5 cm of gel 2-3 times a day. Hirudoid 40000 I.U. gel is suitable for use in physiotherapeutic techniques such as iontophoresis and phonophoresis. If it is used with an iontophoretic technique, it must be applied to the cathode.

CONSERVATION

Hirudoid 40000 I.U. gel: this medicine does not require any particular storage conditions Hirudoid 40000 I.U. cream: store below 25°C.

WARNINGS

External use; if sensitization phenomena appear, which may arise with prolonged use of products for cutaneous application, treatment must be interrupted. Hirudoid 40000 I.U. gel and cream contain an alcohol among the excipients and therefore must not be applied to open wounds or mucous membranes. Important information about some excipients: Hirudoid 40000 I.U. gel. This medicinal product contains 5 mg of propylene glycol per g of gel.

INTERACTIONS

No particular interactions with other medicines have been reported.

SIDE EFFECTS

No particular side effects have been reported. Reporting of suspected adverse reactions : Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. 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

No particular effects due to overdose have been reported.

PREGNANCY AND BREASTFEEDING

There are no particular precautions or warnings for the product in case of pregnancy and breastfeeding.

EFFECTS ON DRIVING ABILITY

No particular effects on the ability to drive and use machinery have been reported.