Active ingredients: Flavonoids
ARVENUM 500 mg film-coated tablets
Why is Arvenum used? What is it for?
Pharmacotherapeutic group
Vasoprotectors
Therapeutic indications
Symptoms attributable to venous insufficiency; states of capillary fragility.
Contraindications When Arvenum 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 Arvenum
None.
Interactions Which drugs or foods may change the effect of Arvenum
No interaction studies have been performed.
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Warnings It is important to know that:
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
The safety of the drug in pregnancy has not been determined, therefore it is advisable not to administer the product during pregnancy.
Feeding time
In the absence of data on milk excretion, treatment should be avoided during lactation,
Effects on ability to drive and use machines
No studies have been conducted to evaluate the effect of the flavonoic fraction on the ability to drive or use machines.
Dose, Method and Time of Administration How to use Arvenum: Posology
2 film-coated tablets per day (1 at noon and 1 in the evening) at mealtimes, even in venous insufficiency of the haemorrhoidal plexus.
Overdose What to do if you have taken too much Arvenum
There are no reported cases of overdose.
If you accidentally take an overdose of Arvenum, notify your doctor immediately or go to the nearest hospital.
IF YOU ARE IN ANY DOUBT ABOUT THE USE OF THIS MEDICINAL PRODUCT, CONTACT YOUR DOCTOR OR PHARMACIST.
Side Effects What are the side effects of Arvenum
Like all medicines, Arvenum can cause side effects, although not everybody gets them.
The frequency of possible adverse reactions listed below is described using the following convention:
- very common (affects more than 1 in 10 patients)
- common (affects 1 to 10 users in 100)
- uncommon (affects 1 to 10 users in 1,000)
- rare (affects 1 to 10 users in 10,000)
- very rare (affects less than 1 user in 10,000)
- not known (frequency cannot be estimated from the available data).
Side effects include:
Nervous system disorders
Rare: dizziness, headache, malaise
Gastrointestinal disorders
Common: diarrhea, dyspepsia, nausea, vomiting.
Uncommon: colitis
Not known: abdominal pain.
Skin and subcutaneous tissue disorders
Rare: rash, itching, urticaria.
Not known: edema of the face, lips, eyelid (swelling); Quincke's edema (rapid swelling of the face, lips, mouth, tongue or throat which can lead to difficulty in breathing).
Disorders of the blood and lymphatic system
Not known: thrombocytopenia.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https: // www. aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Expiry: see the expiry date indicated on the package.
Warning: do not use the medicine after the expiry date indicated on the package.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
Composition
Each tablet contains: active ingredient: purified micronized flavonoic fraction 500 mg - consisting of diosmin 450 mg, flavonoids expressed in hesperidin 50 mg - excipients: sodium starch glycolate; microcrystalline cellulose; jelly; glycerine; hypromellose; sodium lauryl sulfate; yellow iron oxide E 172; red iron oxide E 172; titanium dioxide; macrogol 6000; magnesium stearate; talc.
Pharmaceutical form and content
15 film-coated tablets
30 film-coated tablets
60 film-coated tablets
Oral way.
Not all pack sizes may be marketed.
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
ARVENUM 500 MG TABLETS COATED WITH FILM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
active principle
Purified flavonoic fraction, micronized 500 mg
consisting of:
diosmin 450 mg;
flavonoids expressed in hesperidin 50 mg.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Film-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 film-coated tablets per day (1 at noon and 1 in the evening) at mealtimes, even in venous insufficiency of the haemorrhoidal plexus.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
None.
04.5 Interactions with other medicinal products and other forms of interaction
No interaction studies have been performed.
04.6 Pregnancy and lactation
Pregnancy
The safety of the drug in pregnancy has not been determined, therefore it is advisable not to administer the product during pregnancy.
Feeding time
In the absence of data on milk excretion, treatment should be avoided during lactation.
04.7 Effects on ability to drive and use machines
No studies have been conducted to evaluate the effect of the flavonoic fraction on the ability to drive or use machines.
04.8 Undesirable effects
The following adverse effects or reactions have been reported and ranked under the following frequency: very common (≥1 / 10); common (≥1 / 100,
Nervous system disorders
Rare: dizziness, headache, malaise
Gastrointestinal disorders
Common: diarrhea, dyspepsia, nausea, vomiting
Uncommon: colitis
Not known: abdominal pain
Skin and subcutaneous tissue disorders
Rare: rash, itching, urticaria
Not known: edema of the face, lips, eyelid; Quincke's edema
Disorders of the blood and lymphatic system
Not known: thrombocytopenia
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows for 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: vasoprotective and venotonic.
ATC code: C05CA53.
- Pharmacology
The product carries out its activity:
- at the level of the veins, decreasing their distensibility and reducing stasis;
- at the level of microcirculation, normalizing permeability and increasing capillary resistance.
- Clinical Pharmacology
The pharmacological properties of the product have been confirmed in humans by double-blind studies conducted with methods that have made it possible to object and quantify its activity on venous hemodynamics.
Dose / effect relationship:
The existence of statistically significant dose / effect relationships was established on the basis of venous plethysmographic parameters: capacity, distensibility and voiding time.
The best dose / effect ratio was obtained with 2 tablets.
Venotonic activity:
Increase in venous tone: strain gauge plethysmography shows a decrease in venous emptying times.
Microcirculatory activity:
The activity evaluated from double-blind controlled clinical trials is statistically significant compared to placebo.
In patients with capillary fragility, capillary resistance controlled by angiosterrometry increases.
- Clinic
The therapeutic activity of the drug in the treatment of chronic functional and organic venous insufficiency of the lower limbs is demonstrated by double-blind controlled studies.
05.2 Pharmacokinetic properties
In man, after oral administration of carbon 14-labeled diosmin, it is observed that:
- excretion is essentially fecal while urinary excretion represents, on average, 14% of the quantity administered;
- the elimination half-life is 11 hours;
- the product is extensively metabolised, as demonstrated by the presence of different acid phenols in the urine.
05.3 Preclinical safety data
The preclinical data have little clinical relevance in the light of the vast experience acquired with the use in humans of the active ingredient contained in the medicinal product.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Sodium carboxymethyl starch, microcrystalline cellulose, gelatin, glycerin, hypromellose, sodium lauryl sulfate, yellow iron oxide E 172, red iron oxide E 172, titanium dioxide, macrogol 6000, magnesium stearate, talc.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
The film-coated tablets are packaged in thermoformed blisters consisting of a PVC / aluminum coupling and each containing 15 tablets.
The blisters are enclosed in a cardboard box which also contains the package leaflet.
Packs containing 15, 30 or 60 film-coated tablets.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
I.F.B. STRODER S.r.l. - Via di Ripoli, 207 / v - 50126 FLORENCE
08.0 MARKETING AUTHORIZATION NUMBER
AIC n ° 024552059 - "500 mg film-coated tablets" 15 tablets
AIC n ° 024552022 - "500 mg film-coated tablets" 30 tablets
AIC n ° 024552046 - "500 mg film-coated tablets" 60 tablets
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal date: 03/2011
10.0 DATE OF REVISION OF THE TEXT
03/2015
