Disomin HesperinFlavonoid Micromized Tablets (Venostor)-500 mg Taj Pharma

1.NAME OF THE MEDICINAL PRODUCT

Micronized Purofird Flavonoid Fraction (Venostor) 500 mg film-coated tablets

2.QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 500 mg diosmin.

Excipients with known effect:

Each tablet contains 4.626 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

3.PHARMACEUTICAL FORM

Film-coated tablet.

Pink (salmon) coloured, oblong, biconvex coated tablets with the inscription D500 on one side. The dimensions of diosmin tablets are 19.1 mm x 7.4 mm x 5.8 mm.

4. CLINICAL PARTICULARS 4.1 Therapeutic indications

Micronized Purofird Flavonoid Fraction (Venostor) is indicated in adults as a short-term treatment of symptoms of established chronic venous insufficiency (CVI) adjuvant to conventional treatment of CVI.

4.2 Posology and method of administration

Posology

Adults (≥ 18 years)

The recommended daily dose is two tablets: one tablet at noon and one tablet in the evening, with food.

The maximum duration of treatment is 2 to 3 months.

Paediatric population

No data are available.

Method of administration

For oral use.

The tablets should be taken with food.

4.3 Contraindications

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

4.4 Special warnings and precautions for use

This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

The efficacy and safety of the preparation have not been studied in the following groups/conditions, which has to be taken into account when the preparation is used:

  • children and adolescents (under 18 years).

 

  • hepatic and/or renal impairment.

4.5 Interaction with other medicinal products and other forms of interaction

No pharmacokinetic and pharmacodynamic interaction studies have been performed with diosmin and other medicinal products or with diosmin and food.

In the post-marketing experience, no interactions of diosmin and other medicinal products have been reported.

4.6 Fertility, pregnancy and lactation

Pregnancy

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic or foetal development (see section 5.3).

The available clinical experience in pregnant women is too limited to exclude a risk, and administration of diosmin is therefore not recommended during pregnancy.

Breastfeeding

It is not known whether diosmin is excreted into human milk. Therefore, in the absence of further information, this medicinal product should not be administered during breastfeeding.

Fertility

Reproductive toxicity studies in rats show no effect on fertility. No clinical data are available about the use of diosmin and fertility.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

However, based on the overall safety profile, diosmin has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Gastrointestinal adverse reactions were the most common reported adverse drug reactions. They include nausea, dyspepsia, vomiting and diarrhoea.

The most serious ADR associated with the use of diosmin was angioedema.

The following headings are used to rank the ADRs by frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, ADRs are presented in order of decreasing seriousness.

MedDRA SOC Frequency Undesirable effect
Nervous system disorders Common Insomnia, dizziness, tiredness,
anxiety, cramps, drowsiness
Rare Headache, malaise, vertigo
Cardiac disorders Common Palpitations, hypotension
Gastrointestinal disorders Common Nausea, vomiting, diarrhoea,
dyspepsia
Uncommon Colitis
Skin and subcutaneous tissue Rare Urticaria, rash, pruritus
disorders Not known Angioedema.
Oedema of the face, lips and
eyelids.

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.

4.9 Overdose

No cases of overdose have been reported.

5.0 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Vasoprotectives, bioflavonoids

Mechanism of action

Activity on veins

This medicinal product reduces the predisposition of veins to vasodilate and reduces venous stasis.

Activity on microcirculation

This product reduces capillary permeability and increases capillary resistance.

Pharmacodynamic effects

Pharmacological activity of this medicinal product in humans has been substantiated by controlled, double-blind clinical studies and also by objective and quantitative methods in investigating the influence of the active substance on venous haemodynamics.

Effects on venous tone

This medicinal product enhances venous tone and therefore, reduces the capacitance, distensibility and stasis of blood: venous occlusal mercurial plethysmography indicates reduction of emptying time of veins.

The final effect is a reduction in venous hypertension in patients with venous insufficiency.

Effects on lymphatic system

Diosmin stimulates the lymphatic activity, improving drainage of the interstitial space and increasing lymphatic flow. The administration of 1 g a day for 28 days is capable of reducing lymphatic capillary diameter and intralymphatic pressure, improving the number of functioning lymphatic capillaries, in patients with severe chronic venous insufficiency, without ulcers.

Anti-inflammatory effects

Diosmin reduces various inflammation indexes in peripheral microvascularisation. In vitro and in animal studies, diosmin reduces the release of different inflammation prostaglandin mediators E2 and F2α (PGE2 and PGF2α) and thromboxane A2 (TxA2). Consequently, it inhibits the adhesion of leukocytes to the vascular wall and reduces capillary permeability and resistance, thus favouring venous return.

Effects on microcirculation

Controlled, double-blind clinical studies demonstrate statistically significant difference between diosmin and placebo. In patients with capillary fragility, diosmin treatment increases capillary resistance and reduced the clinical manifestations.

A decrease in capillary permeability was also observed after administration of 1 g of daily diosmin for 6 weeks, with respect to placebo, using technetium-labelled albumin, or plethysmography.

Clinical efficacy and safety

Controlled, double-blind clinical studies demonstrate therapeutic activity of the product in adults as a short-term treatment of symptoms of established chronic venous insufficiency (CVI) adjuvant to conventional treatment of CVI.

5.2Pharmacokinetic properties

Absorption

Following oral administration, diosmin is rapidly hydrolyzed in the intestine by intestinal flora and absorbed as its aglycone derivative, diosmetin. Oral bioavailability is approximately 57.9%.

Distribution

Diosmetin has a volume of distribution of 62.1 L indicating a broad distribution into tissues.

Biotransformation

Diosmetin is extensively metabolized to phenolic acids or to its glucuronide derivatives of aglycone that are eliminated in urine.

The major metabolite found in urine is m-hydroxyphenylpropionic acid which is mainly eliminated in its conjugated form. Metabolites found in small quantities include phenolic acids corresponding to 3-hydroxy-4 methoxybenzoic acid, 3-metoxy-4-hydroxyphenylacetic acid and 3,4-dihydroxybenzoic acid.

Elimination

The elimination half-life of diosmetin showed a mean value of 31.5 hours, ranging between 26 and 43 hours. In studies with 14C radiolabelled diosmin, 34% of the dose is found in urine and faeces after 24 hours and approximately 86% of the dose were found in urine and faeces after 48 hours.

5.3 Preclinical safety data

Oral administration in mice, rats and monkeys of doses 180 times higher than the therapeutic dose in humans reveals no toxic or lethal effect.

There was no evidence of embryotoxicity or teratogenic effects in studies in rats. Reproductive toxicity studies in rats show no effect on fertility. No impairment of the reproductive function was found in rats after administration of an oral dose representing 37 times the daily therapeutic dose or concerning fertility of animals, embryotoxicity, and perinatal and postnatal development of the generation born to treated parents.

In-vitro and in-vivo tests reveal no mutagenic potential.

6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients

Tablet core

Cellulose, microcrystalline, Gelatin, Sodium starch glycolate type A, Talc, Magnesium stearate

Film-coating

Lactose monohydrate, Hypromellose, Macrogo, Titanium dioxide ,Iron oxide, yellow Iron oxide, red Iron oxide.

6.2Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

This medicinal product does not require any special temperature storage conditions.

Store in the original package in order to protect from light.

6.5  Nature and contents of container

PVC-PVDC/aluminium blister packs.

Pack sizes:

30 or 60 film-coated tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7. Manufactured BY:

Taj Pharmaceuticals Limited.

at: Plot No. 220, Mahagujarat Industrial Estate, At &

Post: Moraiya, Tal- Sanand, Dist. Ahmedabad,

Gujarat (India)

Micronized Purofird Flavonoid Fraction (Venostor) 500 mg film-coated tablets

 Package leaflet: Information for the patient

 Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Micronized Purofird Flavonoid Fraction(Venostor) is and what it is used for

2. What you need to know before you take Micronized Purofird Flavonoid Fraction(Venostor)

3. How to take Micronized Purofird Flavonoid Fraction(Venostor)

4. Possible side effects

5. How to store Micronized Purofird Flavonoid Fraction(Venostor)

6. Contents of the pack and other information

  1. What Micronized Purofird Flavonoid Fraction(Venostor) is and what it is used for

Diosmin is a venotonic medicine. It increases the tone of veins and the resistance of the capillaries (small blood vessels).

Diosmin is used together with conventional treatment in adults for short-term (2-3 months) relief of symptoms associated with chronic venous insufficiency (poor flow of venous blood).

2. What you need to know before you take Micronized Purofird Flavonoid Fraction(Venostor)

Do not take Micronized Purofird Flavonoid Fraction(Venostor)

  • If you are allergic to diosmin, other flavonoids or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Micronized Purofird Flavonoid Fraction(Venostor)

  • if you suffer from liver problems
  • if you suffer from kidney problems

Children and adolescents:

The use of Micronized Purofird Flavonoid Fraction(Venostor) is not recommended in children and adolescents under the age of 18 years owing to the lack of data.

Other medicines and Micronized Purofird Flavonoid Fraction(Venostor)

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

No interactions with food or with other medicines are known, but in any case you should never take other medicines without consulting your doctor.

Micronized Purofird Flavonoid Fraction(Venostor) with food and drink

Take Micronized Purofird Flavonoid Fraction(Venostor) with food during meals.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not use Micronized Purofird Flavonoid Fraction(Venostor) if you are pregnant, unless advised by your doctor.

Breast-feeding

It is not known whether this medicine passes into breast milk. Micronized Purofird Flavonoid Fraction(Venostor) is not recommended during breast-feeding.

Driving and using machines

No effects on the ability to drive and use machines have been described with diosmin.

Micronized Purofird Flavonoid Fraction(Venostor) might cause dizziness and drowsiness. Do not drive or operate machines if you experience such side effects.

Micronized Purofird Flavonoid Fraction(Venostor) contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Micronized Purofird Flavonoid Fraction(Venostor)

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended daily dose is two tablets: one tablet at noon and one tablet in the evening, with food.

If you take more Micronized Purofird Flavonoid Fraction(Venostor) than you should

If you take more Micronized Purofird Flavonoid Fraction(Venostor) than recommended or if a child accidentally takes this medicine, talk to your doctor or pharmacist.

No cases of overdose with diosmin have been reported.

If you forget to take Micronized Purofird Flavonoid Fraction(Venostor)

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Micronized Purofird Flavonoid Fraction(Venostor) and contact your doctor immediately if you get any of the following symptoms that might indicate a serious side effect:

  • swelling of the face or mouth (angioedema) causing difficulty in breathing. The frequency of the symptoms is not known (cannot be estimated from the available data).

Other side effects are:

Common (may affect up to 1 in 10 people)

Nausea (feeling sick), vomiting (being sick), diarrhoea, heartburn (indigestion).

  • Difficulty sleeping, dizziness, tiredness, anxiety, drowsiness.
  • Muscle spasms, a forceful heartbeat that may be rapid or irregular palpitations, low blood pressure.

Uncommon (may affect up to 1 in 100 people)

  • Diarrhoea, mucus and bleeding from the rectum caused by bowel inflammation.

Rare (may affect up to 1 in 1,000 people)

  • Headache, malaise (feeling unwell), a spinning sensation (vertigo).
  • Itchy rash (urticarial), rash, itching.

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

  • swelling of the face, lips and eyelids (oedema).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Micronized Purofird Flavonoid Fraction(Venostor)

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after “EXP:”. The expiry date refers to the last day of that month.

This medicinal product does not require any special temperature storage conditions.

Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Micronized Purofird Flavonoid Fraction (Venostor) contains

  • The active substance is diosmin.
  • Each film-coated tablet contains 500 mg diosmin.

 

  • The other ingredients are:

Tablet core: Cellulose, microcrystalline , gelatin, sodium starch glycolate type A, talc, magnesium stearate

Film-coating: Lactose monohydrate, hypromellose, macrogol, titanium dioxide ,iron oxide, yellow , iron oxide red.

What Micronized Purofird Flavonoid Fraction(Venostor) looks like and contents of the pack

Micronized Purofird Flavonoid Fraction(Venostor) film-coated tablets are pink (salmon) coloured, oblong, biconvex coated tablets with the inscription D500 on one side. The dimensions of diosmin tablets are 19.1 mm x 7.4 mm x 5.8 mm.

Micronized Purofird Flavonoid Fraction(Venostor) film-coated tablets are supplied in blister packs (PVC-PVDC/aluminium) of 30 or 60 film-coated tablets.Not all pack sizes may be marketed.

 7. Manufactured BY:

Taj Pharmaceuticals Limited.

at: Plot No. 220, Mahagujarat Industrial Estate, At &

Post: Moraiya, Tal- Sanand, Dist. Ahmedabad,

Gujarat (India)

 

 

 

 

Related Products

Taj Generics (Taj Pharma) provides a wide range of products to the Indian market, including an extensive range of generics and specialty products; Our products cover a vast array of therapeutic categories, and we offer an extensive range of dosage forms and delivery systems including oral solids, controlled-release, steriles, injectables, topicals, liquids, transdermals, semi-solids and high-potency products. Our Generics portfolio offers over 1500 products in the major therapeutic areas of gastro-intestinal, cardiovascular, pain management, oncology, anti-infectives, paediatrics and dermatology.