Variliv Diosmina 500 Mg 60 Coated Tablets

Variliv Diosmina (500 Mg 30 Coated Tablets)

ACTION AND MECHANISM

Venotonic and vasoprotective. It produces venoconstriction, increases the resistance of the vessels and decreases their permeability.

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

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

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

In man, double-blind controlled studies have confirmed venotonic activity: venous tone increases: mercury ring venous occlusion plethysmography has revealed decreased venous emptying times.

It has also shown activity on microcirculation: in patients who show signs of capillary fragility, capillary resistance measured by angiosterometry increases.

PHARMACOKINETICS

Diosmin pharmacokinetics are linear.

Orally:

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

- Distribution: extensive (Vd: 62.1 L).

- Metabolism: Diosmetine is rapidly and widely degraded to phlebotonic acids or its derivatives conjugated with glycine, which are eliminated in the urine. Predominant metabolite: hydroxyphenylpropionic acid (which is mostly eliminated conjugate). Metabolites in smaller quantities: other phenolic acids corresponding to 1-hydroxy-4-methoxybenzoic acid, 3-methoxy-4-hydroxyphenylacetic acid and 3,4-dihydroxybenzoic acid.

- Elimination: relatively fast. In studies with radiolabelled diosmin, 34% of the dose was recovered in urine and faeces after the first 24 hours, and approximately 86% were recovered in urine and faeces after the first 48 hours.

INDICATIONS

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

POSOLOGY

- Adults: Usual therapeutic dose: 500 mg / 12 h at noon and at night, with meals.

- Children and adolescents <18 years: not recommended.

- Elderly: no dosage adjustment is required.

Treatment duration : 2-3 months maximum.

RULES FOR THE CORRECT ADMINISTRATION

Take with meals (at noon and dinner).

CONTRAINDICATIONS

- Hypersensitivity to diosmin or other flavonoids.

PRECAUTIONS RELATED TO EXCIPIENTS

- This medicine contains lactose. Patients with hereditary or galactose [LACTOSE INTOLERANCE], Lapp lactase deficiency, or glucose or galactose malabsorption should not take this medicine.

- This medicine contains lactose. Intake of amounts greater than 5 g daily should be taken into account in patients with [DIABETES] and with intolerance to certain sugars.

ADVICE TO THE PATIENT

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

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

INTERACTIONS

No specific interaction studies with diosmin have been performed, although after extensive use after marketing no interaction has been described.

PREGNANCY

There is no record of any harmful effects on the human species. Experimental studies have not revealed any teratogenic effects.

Caution should be exercised in prescribing to pregnant women.

LACTATION

It is not known whether this drug is excreted in human milk, however, a minimal human milk excretion (1%) has been observed in an animal model study. In the absence of conclusive data on the passage to breast milk, its use during lactation is not recommended.

CHILDREN

Not enough clinical experience is available in this age group. Not recommended use.

ELDERLY

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

ADVERSE REACTIONS

Diosmin side effects are generally infrequent, mild and transient.

Adverse reactions are described according to each frequency interval, being considered very frequent (> 10%), frequent (1-10%), infrequent (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: [NAUSEAS], [VOMITS], [DYSPEPSIA], [DIARRHEA].

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

-Allergic / dermatological: rare: [EXANTEMATIC ERUPTIONS], [PRURITO], [URTICARIA].

ADVERSE REACTIONS RELATED TO EXCIPIENTS

- This medicine contains lactose, which may contain milk proteins. It could cause [HYPERSENSITIVITY REACTIONS] in people with allergy to cow's milk proteins.

OVERDOSE

No cases of overdose have been described. The wide therapeutic margin of this specialty determines that the risk of poisoning is practically nil.

Variliv Diosmina Package Leaflet (500 Mg 60 Coated Tablets)