Active ingredients: Troxerutin, Carbazochrome
FLEBOSIDE 300 mg + 3 mg coated tablets
Fleboside package inserts are available for pack sizes:- FLEBOSIDE 300 mg + 3 mg coated tablets
- FLEBOSIDE 150 mg / 3 ml + 1.5 mg / 3 ml solution for injection
Indications Why is Fleboside used? What is it for?
Fleboside contains two active ingredients, troxerutin and carbazochrome. Troxerutin is a substance of natural origin (bioflavonoid) which has a protective effect on blood vessels (capillary protective action). Carbazochrome, by narrowing the small blood vessels (local vasoconstrictive action), reduces the bleeding time (haemorrhage). The combination of these two active ingredients determines the arrest of bleeding (haemostasis) and protection of the blood vessels (vasoprotection).
This medicine is indicated in the treatment of:
- symptoms due to blood circulation problems (venous insufficiency);
- fragility of small blood vessels (capillaries).
Contraindications When Fleboside should not be used
Do not use Fleboside if you are allergic to troxerutin, carbazochrome or any of the other ingredients of this medicine.
Precautions for use What you need to know before taking Fleboside
Talk to your doctor or pharmacist before using Fleboside. This medicine is not authorized for administration through injections under the skin (mesotherapy).
Interactions Which drugs or foods can modify the effect of Fleboside
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
There are no known interactions between Fleboside and 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.
The use of Fleboside during pregnancy and lactation is not recommended, as the risk of harmful effects on the fetus and infant cannot be excluded.
Driving and using machines
This medicine does not affect the ability to drive and use machines.
Phleboside contains sucrose and the dye sunset yellow orange (E110)
This medicine contains sucrose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains orange sunset yellow dye which may cause allergic reactions.
Dosage and method of use How to use Phleboside: Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended dose is 2-4 tablets per day to be taken by mouth (orally). Your doctor will work out the right dose for you, based on your needs.
If you forget to use Fleboside
Do not use a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken an overdose of Fleboside
There are no known cases of overdose.
In case of accidental ingestion / intake of an overdose of Fleboside, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Fleboside
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):
skin irritation (local and generalized erythema), in case of inadequate administration under the skin (mesotherapy: intradermal or subcutaneous route).
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.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 package after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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
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
FLEBOSIDE 300
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:
Active ingredients: troxerutin 300 mg, carbazochrome 3 mg.
03.0 PHARMACEUTICAL FORM
Coated tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptoms attributable to venous insufficiency; states of capillary fragility.
04.2 Posology and method of administration
2 to 4 tablets per day orally, according to medical prescription.
04.3 Contraindications
Hypersensitivity to the components of the product.
04.4 Special warnings and appropriate precautions for use
The experience acquired up to now with FLEBOSIDE 300 has never highlighted evidence that limited its use.
04.5 Interactions with other medicinal products and other forms of interaction
None known.
04.6 Pregnancy and breastfeeding
The risk of harmful effects on the fetus and infant following the intake of FLEBOSIDE 300 is not excluded. The safety of the drug in pregnancy has not been established, therefore it is advisable not to administer the product during pregnancy.
04.7 Effects on ability to drive and use machines
It has no effect on the ability to drive and use machines.
04.8 Undesirable effects
Following oral administration, the product is generally well tolerated. Rare cases of gastric intolerance, with nausea, have been reported.
04.9 Overdose
There are no known cases of overdose with FLEBOSIDE 300.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
FLEBOSIDE 300 contains a "combination of two active ingredients: troxerutin and carbazochrome.
There troxerutin (trihydroxyethylrutoside), also known as vitamin P4, is a bioflavonoid that acts by increasing the resistance of the vessels (capillaroprotective action) and decreasing their permeability, thus preventing the excess passage of the liquid component of the blood to the tissues (anti-waterproofing and anti-edema action) .
The mechanism of action of bioflavonoids is based on multifactorial hypotheses:
- vasoconstrictive action on the precapillary sphincter;
- enhancement of the action of adrenaline;
- indirect action of increasing ascorbic acid;
- enhancement of the action of adrenaline and vitamin C due to an indirect antioxidant effect;
- antagonizing action of histamine;
- inhibition of hyaluronidase.
The currently most accredited hypothesis is that troxerutin favors the permanence and concentration of adrenaline in the circulation, through an inhibition of the catabolism of the neuromediator by COMTs. Adrenaline therefore exerts a peripheral vasoconstrictive action, mainly arteriolar and meta-arteriolar, with blockage of the precapillary sphincter. The result is an important decrease in blood flow with a state of capillary vacuum which eliminates permeability due to the impossibility of blood tissue exchanges.
In addition to the action on the catabolism of noradrenaline, the enhancement of the action of vitamin C which has a protective effect on membrane permeability and the inhibition of hyaluronidase which, once activated, metabolizes hyaluronic acid, responsible mucopolysaccharide, would contribute to the pharmacological effect. the compactness of the vascular walls. Furthermore, the inhibition of the release of histamine, a vasodilating and proedemigenic substance, would improve the resistance and permeability of the capillaries.
The carbazochrome (adenochromosemicarbazone), orthquinone derived from adrenaline by oxidation and cyclization of the side chain, is totally devoid of sympathomimetic action, due to the absence of the secondary amino function and of the ortho-diphenolic grouping, and exerts an "action that shortens the bleeding time by means of a "local vasoconstrictor action on the small vessels of the bleeding area. This phenomenon occurs without causing an increase in blood pressure. For carbazochrome, a clear action on capillary resistance and permeability and on the tone and contractile force of the vessels has also been demonstrated.
The troxerutin-carbazochrome association finds its rationale in the reciprocal interaction for the purposes of haemostasis and vasoprotection for the complementarity of the pharmacological and therapeutic effects achieved.
Chronic toxicity studies conducted with FLEBOSIDE 300 in rats (at a dose of 1.2 tablets / kg / day) and in dogs (at a dose of 1/4 and 1/2 tablet / kg / day) have shown the good tolerance of the preparation. for the entire duration of the experiment, during which no signs of general or gastrointestinal distress, behavioral disturbances or changes in body weight were detected. Reproduction studies (embryo-fetal toxicity and teratogenesis in rats and rabbits) did not reveal any difference in all the parameters taken into consideration, between the animals treated with FLEBOSIDE 300 and the controls.
05.2 Pharmacokinetic properties
05.3 Preclinical safety data
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Gum arabic, corn starch, talc, titanium dioxide (E171), polyvinylpyrrolidone, colloidal silica, magnesium stearate, calcium carbonate, kaolin, orange yellow S (E110), indigo carmine (E 132), sucrose.
06.2 Incompatibility
FLEBOSIDE 300 is not compatible with ascorbic acid.
06.3 Period of validity
5 years from the date of preparation.
06.4 Special precautions for storage
No special storage precautions.
06.5 Nature of the immediate packaging and contents of the package
3 PVC / aluminum blisters of 10 coated tablets
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
ACARPIA Farmaceutici srl
via Vivaio, 17
20122 MILAN (ITALY)
08.0 MARKETING AUTHORIZATION NUMBER
020561027
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal: 06/2010
10.0 DATE OF REVISION OF THE TEXT
06/2010
