Viatris 600 mg tablet 30 tablets Heavy legs, Hemorrhoids - Adults

Diosmine Viatris 600 mg has venotonic and vasculoprotective  properties that stimulate blood circulation and combat the degradation of capillary vessels. It is indicated in the symptomatic treatment of venous circulation disorders (heavy legs, pain, unpleasant sensations called impatience when going to bed) and hemorrhoidal crisis . In one tablet: Diosmine ............................................................................... 600 mg The other ingredients are:  Corn starch, microcrystalline cellulose, magnesium stearate, povidone.

Dosage of Viatris Diosmine 600 mg veinotonic

The dosage for circulatory disorders is 1 tablet per day in the morning before breakfast.
To treat hemorrhoidal crisis , the dosage is 2 to 3 tablets per day at mealtimes.

The duration of treatment should follow your doctor's recommendations.
 

Contraindications of Diosmin 600 mg Viatris against heavy legs

In case of allergy to the active substance or to one of the excipients.

If the symptoms persist after 15 days in the case of circulation disorders, consult your doctor, likewise after a few days in the case of a hemorrhoidal crisis.

This treatment is associated with hygiene and dietary rules such as avoiding exposure to the sun, heat, prolonged standing, excess weight. Walking and possibly wearing suitable stockings promotes blood circulation.

Diosmine can be used during pregnancy on medical advice from your doctor but is rather not recommended during breastfeeding because diosmin passes into breast milk.
You should always seek advice from your doctor or pharmacist.

Packaging: box of 30 tablets

Please read the following full disclosure before taking or using this product.

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM - Updated on: 18/03/2022

1. NAME OF THE MEDICINE

DIOSMINE VIATRIS CONSEIL 600 mg, tablet

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Diosmine............................................................................................................................. 600 mg

Per tablet.

For the complete list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablet.

4. CLINICAL DATA

4.1. Therapeutic indications

• Improvement of symptoms related to venolymphatic insufficiency: heavy legs, pain, restlessness during the first stages of lying down.
• Adjunctive treatment of functional symptoms of capillary fragility.
• Treatment of functional symptoms associated with hemorrhoidal crisis.

4.2. Posology and method of administration

Posology

• Venous insufficiency: 1 tablet per day with a meal.
• Hemorrhoidal crisis: 2 to 3 tablets per day with meals.

Pediatric population

The safety and efficacy of DIOSMINE VIATRIS CONSEIL in children and adolescents under 18 years have not been established.

Method of administration

Oral route.

Take the tablet with half a glass of water.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Hemorrhoidal crisis

The administration of this product does not replace specific treatment for other anal diseases. The treatment should be short-term. If symptoms do not quickly subside, a proctological examination should be conducted, and the treatment should be reviewed.

4.5. Interactions with other medicines and other forms of interaction

No clinically relevant drug interactions have been reported to date with diosmine.

4.6. Fertility, pregnancy, and breastfeeding

Pregnancy

There are no or limited data on the use of diosmine in pregnant women. Animal studies have not shown direct or indirect harmful effects on reproduction (see section 5.3). As a precaution, it is preferable to avoid using DIOSMINE VIATRIS CONSEIL during pregnancy.

Breastfeeding

It is unknown whether diosmine or its metabolites are excreted in human milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from DIOSMINE VIATRIS CONSEIL therapy, considering the benefit of breastfeeding for the child and the benefit of treatment for the woman.

Fertility

Reproductive toxicity studies have not shown any effect on the fertility of male and female rats (see section 5.3).

4.7. Effects on the ability to drive and use machines

No specific studies on the effects of diosmine on the ability to drive and use machines have been performed. However, given the overall safety profile of diosmine, DIOSMINE VIATRIS CONSEIL has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

The undesirable effects listed below are presented by MedDRA system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000), and frequency not known (cannot be estimated from available data).

System organ class

Common

Uncommon

Rare

Gastrointestinal disorders*

Gastralgia

Bloating, diarrhea, dyspepsia, nausea

Vomiting

Skin and subcutaneous tissue disorders

Allergic reactions such as rash, pruritus, urticaria, angioedema

*Gastrointestinal disorders rarely lead to discontinuation of treatment.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.

4.9. Overdose

No cases of overdose associated with adverse effects have been reported with DIOSMINE VIATRIS CONSEIL when administered alone.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: vasoprotective / capillary stabilizing agent, ATC code: C05CA03 (cardiovascular system).

Veinotonic and vasoprotective resulting in vasoconstriction, increased vessel resistance, and decreased permeability.

Various pharmacodynamic studies have been conducted to demonstrate these properties.

In Humans

Veinotonic properties

• Increased vasoconstrictor action of adrenaline, noradrenaline, and serotonin on superficial hand veins or an isolated saphenous vein.
• Increased venous tone, evidenced by measuring venous capacitance using strain gauge plethysmography; decreased volume of venous stasis.
• The veinoconstrictive effect is dose-related.
• Lowering of average venous pressure in both superficial and deep systems, demonstrated by a double-blind, placebo-controlled study using Doppler.
• Increased systolic and diastolic blood pressure in postoperative orthostatic hypotension.
• Activity in the aftermath of saphenectomy.

Vasoprotective properties

• Increased capillary resistance, effect related to the oral dose administered.

5.2. Pharmacokinetic properties

Absorption

After oral administration of 600 mg diosmine, diosmine is metabolized into diosmetin by intestinal bacteria. Diosmetin is then absorbed and found in the blood compartment as glucuronide and sulfate conjugates. Diosmetin-3-glucuronide is one of the main metabolites of diosmine.

The peak plasma concentration is reached between 12 and 15 hours after taking 600 mg diosmine.

Distribution

In animals, pharmacokinetic studies with carbon-14 labeled diosmine showed preferential distribution of radioactivity in the vena cava and saphenous veins.

Elimination

In animals, elimination is urinary (79%), fecal (11%), and biliary (2.4%), with enterohepatic cycling.

In humans, diosmetin-3-glucuronide is found in the urine.

5.3. Preclinical safety data

Non-clinical data from repeated toxicity, genotoxicity, and reproductive toxicity studies revealed no special hazard for humans.

6. PHARMACEUTICAL DATA

6.1. List of excipients

Corn starch, microcrystalline cellulose, magnesium stearate, povidone.

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years

6.4. Special precautions for storage

This medicine does not require any special storage conditions.

6.5. Nature and contents of the outer packaging

30 tablets in blister packs (PVC/Aluminum).

30 tablets in blister packs (PVC/PVDC/Aluminum).

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and handling

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. MARKETING AUTHORIZATION HOLDER

VIATRIS SANTE

1 RUE DE TURIN

69007 LYON

8. MARKETING AUTHORIZATION NUMBER(S)

• 34009 349 115 1 4: 30 tablets in blister packs (PVC/Aluminum).
• 34009 360 480 4 1: 30 tablets in blister packs (PVC/PVDC/Aluminum).

9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION

[To be completed later by the holder]

10. DATE OF REVISION OF THE TEXT

[To be completed later by the holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

CONDITIONS OF PRESCRIPTION AND DISPENSING

Medicinal product not subject to medical prescription.