ACTION AND MECHANISM

Diosmin produces vasoconstriction, while simultaneously increasing capillary resistance and decreasing capillary permeability. These effects reduce venous emptying time and peripheral edema, improving the symptoms associated with venous insufficiency.

PATIENT ADVICE

- Do not use this medication for prolonged periods of time without your doctor's recommendation.

If you miss a dose, take it as soon as possible, unless it is almost time for your next dose. Then continue your treatment at the usual times. Do not double the next dose to make up for a missed one.

- Consult your doctor and/or pharmacist if symptoms continue or worsen during treatment.

CONTRAINDICATIONS

- Hypersensitivity to diosmin or any other component of the medication.

ADVANCED AGE

No specific problems have been described in the elderly.

EFFECTS ON DRIVING

No studies have been conducted to assess the effect on driving ability. However, the influence on driving ability is negligible or nonexistent.

PREGNANCY

Animal safety: Studies conducted on animals have not shown any reported embryonal or fetal side effects, nor any adverse effects during pregnancy, childbirth or postnatal development.

Safety in humans: There are no adequate and well-controlled studies in humans. The use of diosmin in pregnant women did not cause harm to the fetus or its postnatal development. As a precautionary measure, it is preferable to avoid its use during pregnancy.

Effects on fertility: No specific studies have been conducted in humans. Reproductive toxicity studies showed no effect on fertility in male and female rats.

PHARMACOKINETICS

Linear pharmacokinetics.

- Absorption: After administration, diosmin is rapidly transformed in the intestine by the intestinal flora and absorbed in its aglycone form, diosmetin. Oral bioavailability is approximately 57.9%.

- Distribution: extensive in tissues. Vd 62.1 l.

- Metabolism: Diosmetin is rapidly and extensively degraded to phlebotonic acids or their glycine-conjugated derivatives, which are eliminated in the urine. The predominant metabolite in humans is hydroxyphenylpropionic acid, which is mainly eliminated in its conjugated form. Metabolites found in smaller amounts include other phenolic acids corresponding to 1-hydroxy-4-methoxybenzoic acid, 3-methoxy-4-hydroxyphenylacetic acid, and 3,4-dihydroxybenzoic acid.

- Elimination: in urine (86%) and feces (14%), with 34% recovered in 24 h.

INDICATIONS

- Short-term relief of symptoms related to mild [VENOUS INSUFFICIENCY] in adults.

INTERACTIONS

No specific interaction studies have been conducted with diosmin, although after its extensive post-marketing use no interactions have been described.

LACTATION

Animal safety: no data available.

Safety in humans: It is unknown whether this product is excreted in breast milk. A risk to infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/stop treatment, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.

CHILDREN

Safety and efficacy have not been evaluated in children and adolescents under 18 years of age. No data are available.

GUIDELINES FOR PROPER ADMINISTRATION

Swallow the tablets with water.

Administration with food: can be taken with or without food.

POSOLOGY

- Adults: 1000 mg per day, preferably in the morning.

- Children and adolescents < 18 years: safety and efficacy have not been established.

Duration of treatment: If the patient does not improve or worsens within the first 2 weeks of treatment, the clinical situation should be reassessed. If necessary, treatment can be continued, at the same daily dose, for up to 2-3 months.

Missed dose: Take the missed dose as soon as possible. Take the next dose at the usual time. Do not double the next dose.

PRECAUTIONS RELATING TO EXCIPIENTS

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

This medicine contains fructose. Patients with fructose intolerance should not take this medicine.

ADVERSE REACTIONS

The adverse effects of diosmin are generally infrequent, mild, and transient.

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

- Nervous system disorders: rare: [DIZZINESS], [HEADACHE], [GENERAL MALAISE].

- Gastrointestinal disorders: common: [DIARRHEA], [DYSPEPSIA], [NAUSEA], [VOMITING]; uncommon [COLITIS]; frequency unknown [ABDOMINAL PAIN].

- Skin and subcutaneous tissue disorders: rare [PRURITUS], [SKIN ERUPTIONS], [URTICARIA]; frequency unknown [SKIN EDEMA] in face, lips or [EYELID EDEMA], [ANGIOEDEMA].

OVERDOSE

Symptoms: There is little experience with diosmin overdose. The most frequent adverse reactions are usually gastrointestinal (diarrhea, nausea, and abdominal pain) and dermatological (itching and rash).

Measures to be taken:

- Antidote: there is no specific antidote.

- General elimination measures: none have been established.

- Monitoring: no special measures have been described

- Treatment: symptomatic.