Flavonoids 500mg (ex-fraction) Mylan Viatris 60cp

MYLAN PHARMA FLAVONOIC FRACTION 500 mg, film-coated tablet generic to Daflon

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Leaflet summary

In this leaflet :

1. WHAT IS MYLAN PHARMA PURIFIED FLAVONOIC FRACTION 500 mg, film-coated tablet AND WHAT IS IT USED FOR?

2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE MYLAN PHARMA PURIFIED FLAVONOIC FRACTION 500 mg, film-coated tablet

3. HOW DO I TAKE MYLAN PHARMA PURIFIED FLAVONOIC FRACTION 500 mg, film-coated tablet?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW TO USE MYLAN PHARMA PURIFIED FLAVONOIC ACID 500 mg, film-coated tablet?

6. ADDITIONAL INFORMATION

1. WHAT IS PURIFIED FLAVONOIC FRACTION MYLAN PHARMA 500 mg, film-coated tablet AND WHAT IS IT USED FOR?

Pharmacotherapeutic class

This drug is a venotonic (it increases the tone of the veins) and a vasculoprotector (it increases the resistance of small blood vessels).

Therapeutic indications

It is recommended in the treatment of venous circulation disorders and in the treatment of functional signs related to hemorrhoidal crisis.

2. WHAT YOU SHOULD KNOW BEFORE TAKING MYLAN PHARMA PURIFIED FLAVONOIC FRACTION 500 mg, film-coated tablet

List of information needed before taking the medicine

Not applicable.

Contraindications

Do not take MYLAN PHARMA PURIFIED FLAVONOIC ACTION 500 mg film-coated tablet:

If you are allergic (hypersensitive) to flavonoids or any of the other ingredients in FRACTION FLAVONOIC PURIFIED MYLAN PHARMA 500mg, film-coated tablet.

Precautions for use; special warnings

Take care with PURIFIED FLAVONOIC FRACTION MYLAN PHARMA 500 mg, film-coated tablet :

Hemorrhoidal crisis:

If hemorrhoidal disorders do not subside within 15 days, it is essential to consult your doctor.

Disorders of the venous circulation:

This treatment has all its effectiveness when it is associated with a good hygiene of life.

-Avoid exposure to the sun, heat, prolonged standing and excess weight.

-Walking and possibly wearing adapted support stockings help blood circulation.

IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Interactions with other drugs

Please tell your doctor or pharmacist if you are taking or have recently taken any other medication, even if it is obtained without a prescription.

Interactions with food and beverages

Food and Beverage

Not applicable.

Interactions with herbal products or alternative therapies

Not applicable.

Use during pregnancy and lactation

This medication should only be used during pregnancy on the advice of your doctor.

If you discover that you are pregnant during treatment, consult your doctor, as only he/she can judge the necessity of continuing the treatment.

Breastfeeding: in the absence of data on the passage in the breast milk, breastfeeding is not recommended during the treatment.

Ask your doctor or pharmacist for advice before taking any medication.

Sportsmen

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with a known effect

Not applicable.

3. HOW TO TAKE MYLAN PHARMA PURIFIED FLAVONOIC ACID 500 mg, film-coated tablet

Instructions for proper use

Not applicable.

Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment

Dosage: Venous insufficiency 2 tablets per day, i.e. 1 tablet at noon and 1 tablet in the evening.

In hemorrhoidal crisis: the dosage is 6 tablets per day the first 4 days, then 4 tablets per day the following 3 days.

Mode of administration

Oral way.

Swallow the tablets without chewing them with water, at mealtime.

In all cases, follow your doctor's prescription or your pharmacist's recommendations.

Symptoms and instructions in case of overdose

If you have taken more PURIFIED FLAVONOIC FRACTION MYLAN PHARMA 500 mg film-coated tablet than you should have

Tell your doctor or pharmacist.

Instructions in case of missed dose(s)

If you forget to take MYLAN PHARMA PURIFIED FLAVONOIC FRACTION 500 mg film-coated tablets:

Do not take a double dose to make up for the dose you forgot to take.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of side effects

Like all medicines, MYLAN PHARMA PURIFIED FLAVONOIC FRACTION 500 mg, film-coated tablet may have side effects, although not everyone is likely to experience them:

A few cases of trivial digestive disorders and neurovegetative disorders (sensations of discomfort) have been described, which do not require discontinuation of treatment.

5. HOW TO USE MYLAN PHARMA PURIFIED FLAVONOIC ACID 500 mg, film-coated tablet

Keep out of the reach and sight of children.

Expiration date

Do not use MYLAN PHARMA PURIFIED FLAVONOIC ACID 500 mg, film-coated tablet after the expiration date stated on the box or blister. The expiration date refers to the last day of that month.

Conditions of storage

No particular precautions of conservation.

If necessary, warnings against certain visible signs of deterioration

Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medication. This will help protect the environment.

6. ADDITIONAL INFORMATION

Complete list of active ingredients and excipients

What does PURIFIED FLAVONOIC FRACTION MYLAN PHARMA 500 mg, film-coated tablet contain?

The active substance is :

Micronized purified flavonoid fraction ......................................................................................... 500.00 mg

Corresponding to :

Diosmin (90%)............................................................................................................................ 450.00 mg

Flavonoids expressed as hesperidin (10%) ..................................................................................... 50.00 mg

For a film-coated tablet.

The other components are :

Core core : microcrystalline cellulose, gelatin, sodium carboxymethyl starch (type A), talc, magnesium stearate.

Film coating: sodium lauryl sulfate, Opadry orange 03G34105 (hypromellose, glycerol, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), polyethylene glycol 6000, magnesium stearate).

Pharmaceutical form and content

What is PURIFIED FLAVONOIC FRACTION MYLAN PHARMA 500 mg, film-coated tablet and what does it contain?

This medicine takes the form of a pink-orange, oblong, film-coated tablet with a break-off bar on one side.

The break bar is there only to facilitate the taking of the tablet, it does not divide it into equal doses.

30 or 60 film-coated tablets in blister packs (PVC/ Aluminium).

All presentations may not be marketed.

Name and address of the marketing authorization holder and of the manufacturing authorization holder responsible for batch release, if different

Holder

MYLAN SAS

117 ALLEE DES PARCS

69800 SAINT-PRIEST