NOTICE
ANSM - Updated on : 14/06/2022
Product name
FLAVONOIDS VIATRIS CONSEIL 500 mg, film-coated tablet
Micronized flavonoids, containing 90% diosmin and 10% hesperidin flavonoids
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor or pharmacist if you do not feel any improvement or if you feel worse after 6 weeks of treatment for a chronic venous condition or after 7 days of treatment for an acute hemorrhoidal attack.
What does this leaflet contain?
1. What is FLAVONOÏDES VIATRIS CONSEIL 500 mg, film-coated tablet and what is it used for?
2. What do I need to know before taking FLAVONOÏDES VIATRIS CONSEIL 500 mg, film-coated tablet?
3. How should FLAVONOÏDES VIATRIS CONSEIL 500 mg, film-coated tablet be taken?
4. What are the possible side effects?
5. How do I keep FLAVONOÏDES VIATRIS CONSEIL 500 mg, film-coated tablet?
6. Package contents and other information.
1. WHAT IS FLAVONOÏDES VIATRIS CONSEIL 500 mg, film-coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: vasoprotectors, capillary stabilizers, bioflavonoids, ATC code: C05CA53.
FLAVONOÏDES VIATRIS CONSEIL 500 mg, film-coated tablet contains active substances that affect venous activity and protect the veins; it increases venous tone and capillary resistance. FLAVONOIDS VIATRIS CONSEIL 500 mg, film-coated tablet reduces the frequency of edema and has an anti-inflammatory effect.
FLAVONOÏDES VIATRIS CONSEIL is indicated in adults for :
- treatment of signs and symptoms of chronic venous disease, such as pain, heaviness, night cramps, edema and trophic changes in the lower limbs;
- treatment of symptoms associated with acute hemorrhoidal disease, such as pain, bleeding and swelling in the anal region.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING FLAVONOIDS VIATRIS CONSEIL 500 mg, film-coated tablet?
Never take FLAVONOÏDES VIATRIS CONSEIL 500 mg, film-coated tablet:
- if you are allergic to diosmin and other hesperidin flavonoids or to any of the other ingredients listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:
Chronic venous disease
If your condition worsens during treatment, e.g. inflammation of the skin or veins, hardening of the tissue under the skin, severe pain, skin ulcers or atypical symptoms such as sudden swelling of one or both legs, you should consult your doctor immediately.
Treatment with FLAVONOIDS VIATRIS CONSEIL is particularly beneficial if accompanied by a balanced lifestyle:
- sun exposure and prolonged standing should be avoided,
- maintain an appropriate weight,
- wearing special stockings can improve circulation in some patients.
FLAVONOIDS VIATRIS CONSEIL will not reduce swelling of the lower limbs caused by heart, kidney or liver disease.
Acute hemorrhoidal disease
If you suffer from an acute hemorrhoidal attack, you should limit your intake of FLAVONOÏDES VIATRIS CONSEIL to 15 days only. If symptoms do not subside within this time, consult your doctor.
If the condition worsens during treatment, i.e. if you notice increased bleeding from the rectum, blood in the stools or if you think you may have bleeding hemorrhoids, consult your doctor.
Treatment with FLAVONOIDS VIATRIS CONSEIL does not replace specific treatment for other anal disorders.
Children and adolescents
Use in children and adolescents under 18 years of age is not recommended.
Special populations
No dosage studies have been conducted in patients with impaired renal or hepatic function, or in the elderly.
Other drugs and FLAVONOIDS VIATRIS CONSEIL 500 mg, film-coated tablet
To date, no interactions between this drug and other medical products have been reported. However, you should still inform your doctor or pharmacist if you are taking, have recently taken or may take any other medication.
FLAVONOIDS VIATRIS CONSEIL 500 mg, film-coated tablet with food and drink
FLAVONOÏDES VIATRIS CONSEIL should be taken with meals.
Pregnancy and breast-feeding
The safety of FLAVONOÏDES VIATRIS CONSEIL during pregnancy and lactation has not been established. Its use is therefore not recommended during these periods.
If you are pregnant or breastfeeding, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and use of machinery
FLAVONOIDS VIATRIS CONSEIL has no or negligible effect on the ability to drive and use machines.
Warning regarding excipients
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is "essentially sodium-free".
3. HOW DO I TAKE FLAVONOIDS VIATRIS CONSEIL 500 mg, film-coated tablet?
Always take this medicine exactly as instructed in this leaflet, or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The recommended adult dose is :
Chronic venous disease
The recommended daily dose is 2 tablets, which can be taken as a single dose or as 2 separate doses.
You must take this medication for at least 4 or 5 weeks before you can expect any improvement. If your symptoms worsen or do not improve after 6 weeks of treatment, you should consult your doctor.
Self-medication without consulting a doctor can last up to 3 months. However, you may continue to take FLAVONOIDS VIATRIS CONSEIL for a longer period if your doctor determines that you do not need any other specific treatment.
Acute hemorrhoidal disease
The recommended daily dose for the first 4 days of treatment is 6 tablets.
For the next 3 days, the dose is 2 tablets twice a day (4 tablets a day). Thereafter , as a maintenance treatment, the dose is 1 tablet twice a day.
If symptoms do not improve or worsen after 7 days of treatment, you should consult your doctor. Treatment with FLAVONOIDS VIATRIS CONSEIL may last 15 days; if symptoms have not disappeared within this period, you should consult your doctor.
Method of administration
FLAVONOÏDES VIATRIS CONSEIL should be taken with meals.
Swallow the tablet with a liquid.
If you have taken more FLAVONOÏDES VIATRIS CONSEIL 500 mg, film-coated tablet than you should have
If you have taken more tablets than you should have, consult your doctor or pharmacist.
To date, no cases of overdosage have been reported.
If you forget to take FLAVONOÏDES VIATRIS CONSEIL 500 mg, film-coated tablet
Do not take a double dose to make up for the one you forgot to take.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone. The following adverse reactions have been reported:
Common (affecting up to 1 in 10 people):
- Diarrhea, indigestion, nausea (vomiting), vomiting .
Uncommon (affecting up to 1 in 100 people):
- Colitis (inflammation of the colon) .
Rare (may affect up to 1 in 1,000 people):
- Headache, malaise (not feeling well), vertigo (a feeling of dizziness) .
- Rash, itching, urticaria .
Undetermined frequency (frequency cannot be estimated on the basis of available data):
- Abdominal pain .
- edema (swelling of the face, lips and eyelids), angioedema in exceptional cases (rapid swelling of tissues, such as those of the face, lips, tongue or throat, which may cause difficulty in breathing).
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: www.signalement-sante.gouv.fr
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE FLAVONOIDS VIATRIS CONSEIL 500 mg, film-coated tablet?
Keep out of sight and reach of children.
No special storage precautions are required.
Do not use this medicine after the expiration date indicated on the box and blister after "EXP". The expiration date refers to the last day of that month.
Do not dispose of any medicine in the garbage. Ask your pharmacist to delimit any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What FLAVONOÏDES VIATRIS CONSEIL 500 mg, film-coated tablet contains
- The active ingredients are micronized flavonoids, containing 90% diosmin and 10% other flavonoids expressed as hesperidin .
Each film-coated tablet contains 500 mg micronized flavonoids, made up of 450 mg diosmin and 50 mg other flavonoids expressed as hesperidin.
- Other components include
Tablet core: gelatin, sodium starch glycolate (type A), microcrystalline cellulose, talc, magnesium stearate.
Film coating: sodium lauryl sulfate, hypromellose (E464), glycerol (E442), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 6000, magnesium stearate (E470b).
What FLAVONOÏDES VIATRIS CONSEIL 500 mg, film-coated tablet is and what it contains
Pink-orange, oblong, film-coated tablets with a breakline on one side. The breakline is intended only to make the tablet easier to take, not to divide it into equal doses.
The tablets are packaged in aluminum/PVC blister packs, and the blister packs are packed in a cardboard box.
FLAVONOIDS VIATRIS CONSEIL is available in boxes of 15, 20, 30, 36, 50, 60, 100 and 120 film-coated tablets.
Not all presentations may be marketed.
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Manufacturer
KERN PHARMA, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain
or
MYLAN HUNGARY LTD
MYLAN UTCA 1
2900 KOMAROM
HUNGARY
Product names in member states of the European Economic Area
This product is authorized in the member states of the European Economic Area under the following names: In accordance with current regulations.
[To be completed subsequently by the holder].
The last date on which this leaflet was revised was :
[to be completed later by the holder]
{month YYYY}.
Other
Detailed information on this drug is available on the ANSM (France) website.
ADVICE / HEALTH EDUCATION
If you suffer from veno-lymphatic circulation disorders of the legs:
- Avoid sitting or standing for long periods.
- Elevate your bed slightly.
- Engage in regular physical activity, such as walking, swimming or cycling.
- Avoid strong sources of heat (sun exposure, hot baths, saunas, etc.).
- Shower your legs with cold water to stimulate blood circulation.
- Eat a healthy, balanced diet.
- Wear loose-fitting clothing.
- Wear compression socks, stockings or tights.
You are prone to hemorrhoids:
- Stay sufficiently hydrated.
- Eat high-fiber foods to avoid the risk of constipation (fruit, green vegetables, wholegrain cereals).
- Avoid fats, coffee, alcohol and spicy foods.
- Exercise regularly to stimulate blood flow.
- Avoid carrying heavy objects.