Active ingredients: Aqueous extract of Triticum vulgare
FITOSTIMOLINE 15% CREAM
The package inserts of Fitostimoline are available for the packs:- FITOSTIMOLINE 15% CREAM
- FITOSTIMOLINE 15% IMPREGNATED GAUZE
- FITOSTIMOLINE 20% VAGINAL CREAM
- FITOSTIMOLINE 600 mg Eggs
- FITOSTIMOLINE 4% Vaginal solution
Why is Fitostimoline used? What is it for?
Pharmacotherapeutic group
Cicatrizing
Therapeutic indications
Fitostimoline® 15% Cream is indicated for the treatment of ulcers and pressure sores
Contraindications When Fitostimoline should not be used
Hypersensitivity to the active substance or to any of the excipients
Precautions for use What you need to know before taking Fitostimoline
The use, especially if prolonged, of all products for topical use can give rise to sensitization phenomena. If this occurs, treatment must be interrupted and appropriate therapy instituted, if necessary. The same applies to the development of germs. insensitive.
Interactions Which drugs or foods can modify the effect of Fitostimoline
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription. There are no known interactions or incompatibilities.
Warnings It is important to know that:
Fitostimoline® 15% Cream contains cetyl and stearyl alcohol: May cause localized skin reactions (eg contact dermatitis).
Pregnancy and Breastfeeding
FITOSTIMOLINE® 15% Cream can be used without problems during pregnancy and breastfeeding
Effects on ability to drive or use machines
Fitostimoline ® 15% Cream does not interfere with the ability to drive and use of machines.
Dose, Method and Time of Administration How to use Fitostimoline: Posology
The treatment involves at least two applications of cream per day. These applications, according to the extent, extent and location of the manifestations, can be reduced to simple absorption massages, as well as it may be necessary to cover the part according to the suggested application methods.
Application procedure:
Spread the necessary amount of cream on the part and cover with sterile gauze, possibly soaked with the same cream in order to maintain the softness and plasticity of the application.
In subsequent dressings, except for specific contraindications, it is possible to proceed with a preventive washing of the part with simple sterile water, as the cream is completely water-dispersible and leaves no residue.
Overdose What to do if you have taken too much Phytostimoline
There have been no reported cases of overdose.
If you have any questions about the use of Fitostimoline, ask your doctor or pharmacist.
Side Effects What are the side effects of Fitostimoline
Like all medicines, Fitostimoline can cause side effects, although not everybody gets them
No undesirable effects were reported.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date indicated on the package.
Store the product at a temperature not exceeding 30 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep this medicine out of the reach and sight of children
Composition
100 g of cream contain:
Active ingredient: aqueous extract of Triticum vulgare (dry residue equal to 200 mg / 100 ml) 15 g.
Excipients: 2-phenoxyethanol; macrogol 400; macrogol 1500; macrogol 3000; macrogol 4000; liquid paraffin; cetyl alcohol; stearyl alcohol; glycerine; purified water
Pharmaceutical form and content
Cream. 32 g 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
FITOSTIMOLINE CREAM - IMPREGNATED GAUZE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
FITOSTIMOLINE 15% Cream
100 g of cream contain the following active ingredient:
aqueous extract of Triticum vulgare (dry residue equal to 200 mg / 100 ml) 15 g. Excipients: cetyl alcohol; stearyl alcohol.
FITOSTIMOLINE 15% Impregnated gauze
Each gauze is saturated with 4 g of cream containing, in 100 g, the following active ingredient:
aqueous extract of Triticum vulgare (dry residue equal to 200 mg / 100 ml) 15 g. For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Cream - Impregnated gauzes.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
FITOSTIMOLINE 15% Cream and FITOSTIMOLINE 15% Impregnated gauze: treatment of ulcers and pressure sores
04.2 Posology and method of administration
FITOSTIMOLINE 15% Cream: The treatment involves at least two applications of cream per day. These applications, according to the extent, extent and location of the manifestations, can be reduced to simple absorption massages, as well as it may be necessary to cover the part according to the suggested application methods.
• Application procedure:
To open the tube for the first time, pierce the protective membrane of the tube using the perforator contained in the top of the locking cap.
Spread as much cream as necessary on the part and cover with sterile gauze, possibly soaked with the same cream in order to maintain the softness and plasticity of the application. simple sterile water, as the cream is completely water dispersible and leaves no residue.
FITOSTIMOLINE 15% Impregnated gauzes: The treatment ranges from one to two applications per day, taking care that the dressing is always moist, soft and plastic.
• Application procedure:
Take the gauze with a sterile forceps and apply it directly on the previously cleaned and disinfected part. Cover with sterile gauze and then with cotton wool (in the case of very secreting sores).
In subsequent dressings, except for specific contraindications, it is possible to proceed with a preventive washing of the part with sterile water only, as the cream is completely water-dispersible and leaves no residue.
04.3 Contraindications
Hypersensitivity to the active substance to any of the excipients.
04.4 Special warnings and appropriate precautions for use
The use, especially if prolonged, of all products for topical use, can give rise to sensitization phenomena. If this occurs, treatment must be suspended and appropriate therapy instituted, if necessary. The same applies to the development of insensitive germs.
Important information about some of the ingredients
Fitostimoline 15% Cream contains cetyl and stearyl alcohol: they can cause localized reactions on the skin (eg contact dermatitis).
04.5 Interactions with other medicinal products and other forms of interaction
There are no known interactions or incompatibilities.
04.6 Pregnancy and lactation
FITOSTIMOLINE 15% Cream and FITOSTIMOLINE 15% Impregnated gauze can be used without problems during pregnancy and breastfeeding.
04.7 Effects on ability to drive and use machines
FITOSTIMOLINE 15% Cream and FITOSTIMOLINE 15% Impregnated gauzes do not affect the ability to drive or use machines.
04.8 Undesirable effects
There are no clinical side manifestations or undesirable secondary effects.
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: healing
ATC code: D03AX49
The aqueous extract of Triticum vulgare (ETV) determines an intense acceleration of tissue reparative processes, stimulates chemotaxis and fibroblastic maturation and significantly increases the fibroblastic index, crucial points of the reparative processes. This activity finds experimental confirmation both in the accelerated protein synthesis (ODCase activity), and in the increased capacity of uptake and incorporation of marked proline by the tissues.
05.2 Pharmacokinetic properties
After topical application, no clinically relevant systemic absorption of the aqueous extract of Triticum vulgare was detected.
05.3 Preclinical safety data
Non-clinical data reveal no risk for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
FITOSTIMOLINE 15% Cream
2-phenoxyethanol; macrogol 400; macrogol 1500; macrogol 3000; macrogol 4000; liquid paraffin; cetyl alcohol; stearyl alcohol; glycerine; purified water.
FITOSTIMOLINE 15% Impregnated gauze
2-phenoxyethanol; macrogol 400; macrogol 600; macrogol 1500; macrogol 4000; glycerine; purified water.
06.2 Incompatibility
Incompatibilities with other medicines are unknown.
06.3 Period of validity
FITOSTIMOLINE 15% Cream and FITOSTIMOLINE 15% Impregnated gauze: 5 years.
06.4 Special precautions for storage
FITOSTIMOLINE 15% Cream: keep the product at a temperature not exceeding 30 ° C.
FITOSTIMOLINE 15% Impregnated gauzes: keep the product at a temperature not exceeding 30 ° C.
06.5 Nature of the immediate packaging and contents of the package
FITOSTIMOLINE 15% Cream: 32 g tube of lithographed aluminum coated inside with protective plastic film. FITOSTIMOLINE 15% Impregnated gauzes: 10 impregnated gauze 10x10 cm, in single bags; each bag is in paper / aluminum / polyethylene and contains a gauze impregnated 10x10 enclosed in a polypropylene / polyethylene plastic film.
06.6 Instructions for use and handling
Before use, it is advisable to consult what is indicated in the "Clinical information" paragraph.
Unused product and waste derived from this medicine must be disposed of in accordance with local legal requirements.
07.0 MARKETING AUTHORIZATION HOLDER
FARMACEUTICI DAMOR S.p.A.
Via E. Scaglione, 27 - 80145 Naples
08.0 MARKETING AUTHORIZATION NUMBER
FITOSTIMOLINE 15% Cream: AIC n ° 009115027.
FITOSTIMOLINE 15% Impregnated gauzes: AIC n ° 009115039.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
FITOSTIMOLINE 15% Cream: December 2009.
FITOSTIMOLINE 15% Impregnated gauzes: December 2009.
10.0 DATE OF REVISION OF THE TEXT
Determination of 12-10-2010
