ACTION AND MECHANISM

Venotonic and vasoprotective. It produces venoconstriction, increasing vascular resistance and decreasing their permeability.

In animals, it exerts a double action on the venous return system:

- at the level of the veins and venules: increases parietal tonicity and exerts an antistatic action;

- at the microcirculation level: normalizes capillary permeability and strengthens capillary resistance.

In humans, double-blind controlled studies have confirmed venotonic activity: it increases venous tone: venous occlusion plethysmography with a mercury ring has shown a decrease in venous emptying times.

It has also demonstrated activity on microcirculation: in patients with signs of capillary fragility, it increases capillary resistance measured by angiosterometry.

PATIENT ADVICE

- It is recommended to take the tablets after lunch and dinner.

- This medicine is intended for the short-term treatment of venous insufficiency, for periods of less than 2-3 months.

CONTRAINDICATIONS

- Hypersensitivity to diosmin or other flavonoids.

ADVANCED AGE

In one study, no significant differences in adverse effects were found between geriatric and younger patients. Accepted use.

EFFECTS ON DRIVING

- No studies have been conducted to evaluate the effect on driving ability. Based on the overall safety profile, there are no effects on driving ability.

PREGNANCY

Animal safety: No embryotoxic or teratogenic effects have been observed in rats and rabbits.

Human Safety: Adequate and well-controlled human studies are lacking. As a precautionary measure, it is recommended to avoid use.

Effects on fertility: No specific studies have been conducted in humans.

PHARMACOKINETICS

The pharmacokinetics of diosmin are linear.

Oral route:

- Absorption: Diosmin is rapidly transformed by the intestinal flora and absorbed in its aglycone form (diosmetin). Bioavailability: Approx. 57.9%.

- Distribution: extensive (Vd: 62.1 L).

- Metabolism: Diosmetin is rapidly and extensively degraded to phlebotonic acids or their derivatives conjugated with glycine, which are eliminated in the urine. Predominant metabolite: hydroxyphenylpropionic acid (which is eliminated mainly conjugated). Smaller metabolites: other phenolic acids corresponding to 1-hydroxy-4-methoxybenzoic acid, 3-methoxy-4-hydroxyphenylacetic acid and 3,4-dihydroxybenzoic acid.

- Elimination: Relatively rapid. 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.

INDICATIONS

- Short-term relief (2 to 3 months) of edema and symptoms related to chronic [VENOUS INSUFFICIENCY].

LACTATION

Excretion in milk:

- Diosmin: unknown.

- Hesperidin: unknown.

Animal safety: no data available.

Human safety : It is unknown whether the product is excreted in milk. A risk to nursing infants cannot be excluded. A decision should be made whether to discontinue breastfeeding or to discontinue/discontinue treatment, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the woman.

CHILDREN

There is insufficient clinical experience in this age group. Not recommended.

RULES FOR CORRECT ADMINISTRATION

Take with meals (midday and dinner).

POSOLOGY

- Adults: Usual therapeutic dose: 2 tablets a day, divided into two doses, one tablet at midday and another at night, with meals.

- Children and adolescents < 18 years: not recommended.

- Elderly: no dosage adjustment required.

Treatment duration : 2-3 months maximum.

ADVERSE REACTIONS

Adverse effects of diosmin are generally infrequent, mild and transient.

Adverse reactions are described according to each frequency interval, considering very frequent (>10%), frequent (1-10%), unfrequent (0.1-1%), rare (0.01-0.1%), very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

-Digestive: frequent: [NAUSEA], [VOMITING], [DYSPEPSIA], [DIARRHEA].

-Neurological/psychological: rare: [HEADACHE], malaise, [VERTIGO].

-Allergic/dermatological: rare: [SKIN RASHES], [ITCHING], [URTICARIA].

OVERDOSE

No cases of overdose have been reported. The wide therapeutic range of this specialty means that the risk of poisoning is practically zero.