Active ingredients: Glycosaminoglycanopolysulphate
HIRUDOID 25,000 I.U. Cream
Hirudoid package inserts are available for pack sizes:- HIRUDOID 25,000 I.U. Cream
- HIRUDOID 40.000 I.U. Cream
- HIRUDOID 25,000 I.U. Gel
- HIRUDOID 40.000 I.U. Gel
Indications Why is Hirudoid used? What is it for?
HIRUDOID contains the active ingredient glycosaminoglycanopolysulfate, which has anti-inflammatory and antithrombotic activity, that is, it prevents the formation of blood clots (thrombus).
HIRUDOID is used to treat:
- inflammation of a vein that is below the surface of the skin (superficial phlebitis) or a blood clot that causes inflammation of a vein (thrombophlebitis);
- inflammation caused by the dilation of a vein (varicosis);
- hematomas.
Contraindications When Hirudoid should not be used
Do not use HIRUDOID
- if you are allergic to the active substance, to a heparinoid (medicine with anticoagulant action similar to that of heparin) or to any of the other ingredients of this medicine (listed in section 6).
Precautions for use What you need to know before taking Hirudoid
Talk to your doctor or pharmacist before using HIRUDOID.
Stop the treatment and contact your doctor immediately if you experience allergic reactions after applying the cream.
Interactions Which drugs or foods can change the effect of Hirudoid
There are no known interactions of HIRUDOID with other medicines. However, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
HIRUDOID does not affect the ability to drive or use machines.
HIRUDOID contains para-hydroxybenzoates, lanolin and cetylstearyl alcohol
Parahydroxybenzoates can cause allergic reactions (including delayed).
Lanolin and cetylstearyl alcohol can cause local skin reactions (eg contact dermatitis).
Dose, Method and Time of Administration How to use Hirudoid: Posology
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
If the inflammation is not particularly extensive, the recommended dose is 3-5 cm of cream 1-2 times a day. It is possible to spread the dose of cream on a gauze, then applying it on the area to be treated.
If the inflammation is extensive the recommended dose is 25 cm of cream per day for 3-4 days, after which the dose should be halved and the treatment continued until the symptoms disappear.
How to use:
- Massage lightly near the inflamed area, avoiding the diseased area.
- Do not apply the cream to open wounds or mucous membranes.
- Do not swallow.
Overdose What to do if you have taken too much Hirudoid
If you accidentally use an overdose of HIRUDOID, talk to your doctor or pharmacist.
Side Effects What are the side effects of Hirudoid
No undesirable effects have been reported following the use of HIRUDOID.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other_information "> Other information
What HIRUDOID contains
- The active ingredient is glycosaminoglycanopolysulfate. 100 g of cream contain 0.3 g (equal to 25,000 I.U.) of active ingredient.
- The other ingredients are glycerin, potassium hydroxide, stearic acid, lanolin, cetylstearyl alcohol, myristic alcohol, thymol, methyl para-hydroxybenzoate, propyl para-hydroxybenzoate, isopropyl alcohol, purified water.
Description of the appearance of HIRUDOID and contents of the pack
Cream for skin use, white in color and with a characteristic odor. HIRUDOID is available in packs of 40 g of cream in an aluminum tube.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
HIRUDOID 25,000 I.U.
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Active ingredient per 100 g of cream: glycosaminoglycanopolysulphate (M.V. 5700-13700) 0.3 g equal to 25000 U.I.
Active ingredient per 100 g of gel: glycosaminoglycanopolysulphate (PM 5700-13700) 0.3 g, equal to 25000 I.U.
Excipients with known effect: the cream contains lanolin, methyl parahydroxybenzoate, propyl parahydroxybenzoate and cetylstearyl alcohol; the gel contains propylene glycol.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
Cream and gel.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Superficial thrombophlebitis and phlebitis, variceal inflammation states, hematomas.
04.2 Posology and method of administration -
Cream:
In small inflammatory processes, apply a 3-5 cm long stream of cream 1-2 times a day (about 0.5-1 g) or cover with a gauze tablet coated with Hirudoid 25000 I.U. cream. The cream can be lightly rubbed in the vicinity of the diseased area; never rub on the inflamed part.
In more extensive processes, larger quantities of the drug are required: about 25 cm (about 4 to 6 g) of cream per day. Practice the treatment for 3-4 days, after this period halve the dose until the symptoms disappear;
Gel:
Apply a 5-10 cm long drop of gel several times a day. In case of inflamed surfaces it is advisable not to rub on the diseased part but in the immediate vicinity. Hirudoid 25000 U.I. gel is particularly suitable for percutaneous therapy of large surfaces. Larger quantities of the drug are then required. Apply the treatment for 3-4 days; after this period, halve the dose until the symptoms disappear.
04.3 Contraindications -
Hypersensitivity to the active substance, to a heparinoid or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use -
The use, especially if prolonged, of products for cutaneous use can give rise to sensitization phenomena, in which case the treatment must be interrupted.
Hirudoid 25000 I.U. gel and cream contain an alcohol among the excipients and therefore should not be applied to open wounds or mucous membranes.
Hirudoid 25000 I.U. cream contains para-hydroxybenzoates which can cause allergic reactions (including delayed).
Hirudoid 25000 I.U. cream contains lanolin and cetylstearyl alcohol which can cause local skin reactions (e.g. contact dermatitis).
Hirudoid 25000 I.U. gel contains propylene glycol which can cause skin irritation.
04.5 Interactions with other medicinal products and other forms of interaction -
There are no known interactions with other medicines.
04.6 Pregnancy and breastfeeding -
There are no special precautions or warnings for the product in case of pregnancy and lactation.
04.7 Effects on ability to drive and use machines -
No particular effects on the ability to drive and use machines have been reported.
04.8 Undesirable effects -
There are no known side effects.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring 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. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose -
No particular effects due to overdose are reported.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Medicinal product category: antivaricose therapy, organic heparinoids. ATC code: C05BA01.
Hirudoid 25000 I.U. it is used in the cutaneous treatment of superficial thrombophlebitic and inflammatory processes and of hematomas and swellings. The active substance polyester sulfuric mucopolysaccharide (MPS) possesses an anticoagulant activity. The formation of thrombi is prevented and the regression of existing thrombi is favored. MPS has an anti-inflammatory, anti-edematous effect and accelerates the absorption of infiltrates and hematomas.
Through its regulatory properties on the water retention capacity of the intercellular substance and through the increase in mesenchymal metabolism, MPS promotes the regeneration of connective tissue.
05.2 "Pharmacokinetic properties -
Percutaneous absorption was assessed with the help of a labeled active substance.
05.3 Preclinical safety data -
The alcoholic gel does not irritate the skin and is well tolerated even under prolonged bandages. The product has no acute and chronic toxicity, does not interfere with the gestational process and is devoid of teratogenic activity even though it has been administered to laboratory animals in doses considerably higher than the therapeutic ones, and, in any case, the maximum possible taking into account the pharmaceutical form and route of administration.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Excipients per 100 g of cream:
Glycerine; potassium hydroxide; stearic acid; lanolin; cetylstearyl alcohol; myristic alcohol; thymol; methyl parahydroxybenzoate; propyl parahydroxybenzoate; isopropyl alcohol; purified water.
Excipients per 100 g of gel:
Isopropanol; polyacrylic acid; propylene glycol; sodium hydroxide; purified water.
06.2 Incompatibility "-
No particular types of incompatibility are reported.
06.3 Period of validity "-
5 years.
06.4 Special precautions for storage -
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package -
Aluminum tubes
cream: 40 g tube;
gel: tube of 40 g.
06.6 Instructions for use and handling -
None in particular.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Crinos S.p.A. - Via Pavia, 6 - 20136 Milan
08.0 MARKETING AUTHORIZATION NUMBER -
40 g cream tube - AIC: 010386011
40 g gel tube - AIC: 010386023
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
40 g cream tube: 1955;
40 g gel tube: 1980.
Renewal: June 2005
10.0 DATE OF REVISION OF THE TEXT -
July 2014
