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Endocrine - Metabolic

VENOKERN 500mg

  1. NAME OF THE MEDICINAL PRODUCT

VenoKern 500 mg film-coated tablets.

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains:

Micronised purified flavonoid fraction …………. 500 mg, containing:

– Diosmin (90%)………………………………………… 450 mg

– Flavonoids expressed as hesperidin (10%) ….. 50 mg

3.    PHARMACEUTICAL FORM

Film-coated tablet.

Orange-coloured oblong film-coated tablet, scored on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4.    CLINICAL PARTICULARS

4.1 Therapeutic indications

Short-term relief of the oedema and symptoms relating to chronic venous insufficiency in adults.

4.2 Posology and method of administration

Adults

The usual therapeutic dose is 2 tablets per day taken separately, one tablet with lunch and the other with the evening meal.

Maximum duration of treatment is 2 to 3 months.

Paediatric population

The safety and efficacy of diosmin in paediatric population have not yet been established.

4.3 Contraindications

Documented hypersensitivity to diosmin, other flavonoids or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

See section 4.6

4.5 Interaction with other medicinal products and other forms of interaction

No specific studies have been performed on the possible pharmaceutical and/or pharmacodynamic interaction of diosmin-hesperidin with other medicinal products or food. Nevertheless, and particularly considering the extensive post-marketing experience with the product, no interactions have been reported with any other drugs to date.

4.6 Fertility, pregnancy and lactation

Pregnancy

There is no evidence of harmful effects in humans.

The documented clinical data on a limited number of exposed pregnancies indicate no adverse effects of diosmin-hesperidin on pregnancy or on foetal/postnatal development. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).

Breast-feeding

It is not known whether or not the medicinal product is excreted in breast milk. Therefore, in the absence of such data, its use during breast-feeding is not advised.

Fertility

No toxicity for fertility or reproduction function has been reported.

4.7 Effects on ability to drive and use machines

Diosmin has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Adverse reactions are below listed according to its frequency:

Very common (³1/10)

Common (³1/100 to <1/10)

Uncommon (³1/1,000 to <1/100)

Rare (³1/10.000 to <1/1,000)

Very rare (<1/10,000)

Not known (frequency cannot be estimated from the available data)

Gastrointestinal disorders:

Common: nausea, vomiting, diarrhoea, dyspepsia.

General disorders and administration site disturbances

Rare: headache, malaise, vertigo.

Skin and subcutaneous tissue disorders

Rare: rash, pruritus, urticaria.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.

4.9 Overdose

No cases of overdose have been reported.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Capillary stabilising agents: Bioflavonoids, ATC code: C05CA53

Diosmin is a venotonic drug and a vascular protecting agent (causing venoconstriction, an increase in venous resistance and a decrease in permeability).

In experimental models, diosmin exercises a double action on the venous return system:

  • in the veins and venules: it increases parietal tone and exercises an antistasis action;

  • at the microcirculation level: it normalises capillary permeability and strengthens capillary resistance.

In humans, the existence of statistically significant dose/effect relationships have been established in the venous plethysmography parameters: capacitance, distensibility and emptying time. The best dose/effect relationship has been seen with 2 tablets.

  • Venotonic activity: diosmin-hesperidin increases venous tone. Mercury strain-gauge venous occlusion plethysmography has shown a decrease in venous emptying time.

  • Microcirculatory activity: In patients presenting signs of capillary fragility, it increases capillary resistance measured by angiostereometry.

5.2. Pharmacokinetic properties

Absorption

Following oral administration, diosmin is rapidly transformed into the intestine by the intestinal flora and is absorbed in its aglicone form, diosmetin. The oral bioavailability is approximately 57.9%.

Distribution

Diosmetin is widely distributed in tissues; the volume of distribution is 62.1 l.

Biotransformation
Diosmetin rapidly and extensively degrades to phlebotonics acids or its glycine conjugated derivatives, which are eliminated in the urine. The predominant metabolite in man is hydroxyphenylpropionic acid, which is primarily eliminated as its conjugated form. Metabolites found in lesser amounts include other phenolic acids corresponding to the 1-hydroxy-4-methoxybenzoic acid, 3-methoxy-4-hydroxyphenylacetic acid and 3,4-dihydroxybenzoic acid.

Elimination
Elimination is relatively fast in humans. In studies with radiolabeled diosmin, 34% of the dose was recovered in urine and feces after the first 24 h, and approximately 86% was recovered in urine and feces after the first 48 h.

Linearity/non-linearity

Pharmacokinetics of diosmin is linear.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.

6  PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Microcrystalline cellulose (E-460i)

Gelatin

Sodium starch glycolate

Magnesium stearate

Talc (E-553b)

Sodium laurilsulfate

Coating film containing:

          Hidroxypropylmethylcellulose (E-464)

          Glycerol

          Titanium dioxide (E-171)

          Red iron oxide (E-172)

          Yellow iron oxide (E-172)

          Macrogol 6000

          Magnesium stearate

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store below 30ºC.

6.5 Nature and contents of the container

Tablets are packaged in aluminium/PVC film blister and in a cardboard box with 60 tablets.

6.6 Special precautions for disposal and other handling

No special requirements.

7.   MARKETING AUTHORISATION HOLDER

KERN PHARMA, S.L.

Polígono Ind. Colón II. Venus, 72

08228 Terrassa (Barcelona)

Spain

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