MYLAN PHARMA FLAVONOIC FRACTION 500 mg, film-coated tablet generic to Daflon
Boxed
Please read this leaflet carefully before taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist for more information.
Keep this leaflet as you may need to read it again.
If you need more information and advice, ask your pharmacist.
If symptoms worsen or persist, consult your doctor.
If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
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 do I 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 medicine is a venotonic (increases the tone of the veins) and a vasculoprotector (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 PURIFIED FLAVONOIC FRACTION MYLAN PHARMA 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 suitable support stockings will improve blood circulation.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
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 drink
Food and beverages
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
This medicine 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 or she can decide whether to continue the treatment.
Breast-feeding: in the absence of data on the passage into breast milk, breast-feeding is not recommended during 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 haemorrhoidal crisis: the dosage is 6 tablets per day for the first 4 days, then 4 tablets per day for the following 3 days.
Mode of administration
Oral route.
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 MYLAN PHARMA PURIFIED FLAVONOIC FRACTION 500 mg film-coated tablets than you should have, tell your doctor or pharmacist:
Tell your doctor or pharmacist.
Instructions in case of missed doses
If you forget to take MYLAN PHARMA PURIFIED FLAVONOIC FRACTION 500 mg, film-coated tablet:
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 STORE MYLAN PHARMA PURIFIED FLAVONOIC FRACTION 500 mg, film-coated tablet
Keep out of the reach and sight of children.
Expiry date
Do not use MYLAN PHARMA PURIFIED FLAVONOIC ACID 500 mg film-coated tablets after the expiry date stated on the box or blister. The expiry date refers to the last day of that month.
Storage conditions
No special storage precautions.
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 medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does PURIFIED FLAVONOIC FRACTION MYLAN PHARMA 500 mg, film-coated tablet contain?
The active substance is :
Micronised purified flavonoid fraction ......................................................................................... 500.00 mg
Corresponding to :
Diosmin (90%)............................................................................................................................ 450.00 mg
Flavonoids expressed as hesperidin (10%) ..................................................................................... 50.00 mg
For one 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 is a pink-orange, oblong, film-coated tablet with a score line on one side.
The breakline is there only to make it easier to take 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 authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
MYLAN SAS
117 ALLEE DES PARCS
69800 SAINT-PRIEST
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