Micronized purified flavonoid fraction Mylan

Patient Information Leaflet

Purified Micronized Flavonoid Fraction Mylan 1 000 mg tablets

Micronized flavonoids, consisting of 90% diosmin and 10% flavonoids (expressed as
hesperidin)
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms after 6 weeks of treatment for chronic venous disease or after 7 days of treatment for acute haemorrhoidal attack.

Contents of this leaflet

1. What Frazione Flavonoica Purificata Micronizzata Mylan is and what it is used for
2. What you need to know before taking Frazione Flavonoica Purificata Micronizzata Mylan
3. How to take Frazione Flavonoica Purificata Micronizzata Mylan
4. Possible side effects
5. How to store Frazione Flavonoica Purificata Micronizzata Mylan
6. Contents of the pack and other information

1. What Frazione Flavonoica Purificata Micronizzata Mylan is and what it is used for

Frazione Flavonoica Purificata Micronizzata Mylan contains active substances that affect venous function and protect the veins; they increase venous tone and capillary resistance.
Frazione Flavonoica Purificata Micronizzata Mylan is indicated in adults for:

• the treatment of signs and symptoms of chronic venous disease of the lower limbs, such as pain, heaviness, nocturnal cramps, and swelling.
• the treatment of symptoms associated with acute hemorrhoidal attack, such as pain, bleeding, and swelling in the anal region. If you are taking this medicine to treat symptoms of chronic venous disease and also have a leg ulcer, other skin changes, or hemorrhoids, always consult your doctor for appropriate treatment.

2. What you need to know before taking Purified Micronized Flavonoid Fraction Mylan

Do not take Purified Micronized Flavonoid Fraction Mylan

• if you are allergic to diosmin and other flavonoids expressed as hesperidin or to any of the other components of this medicine (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, with symptoms such as inflammation of the skin or veins, hardening of the subcutaneous tissue, severe pain, skin ulcers, or atypical symptoms such as sudden swelling of one or both legs, speak to your doctor immediately.
Purified Micronized Flavonoid Fraction Mylan does not help reduce swelling of the lower limbs if this is caused by heart, kidney, or liver diseases.
If you are using compression therapy for chronic venous disease, you must continue compression therapy during treatment with Purified Micronized Flavonoid Fraction Mylan.
Treatment with Purified Micronized Flavonoid Fraction Mylan is more effective when combined with a healthy lifestyle. It is recommended to avoid sun exposure, follow a healthy diet, engage in regular physical activity, and avoid prolonged sitting or standing.
Acute haemorrhoidal attack
If you have an acute haemorrhoid attack, you may take Purified Micronized Flavonoid Fraction Mylan only for a limited period of time. If symptoms worsen or persist after 7 days, consult your doctor.
If your condition worsens during treatment, for example if you notice increased rectal bleeding, blood in the stool, or have doubts about bleeding from haemorrhoids, consult your doctor.
Treatment with Purified Micronized Flavonoid Fraction Mylan does not replace specific treatment for other anal disorders.
Other medicines and Purified Micronized Flavonoid Fraction Mylan
No interactions between this medicine and other medicines have been reported so far. However, you must inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Children and adolescents
Use in children and adolescents under 18 years of age is not recommended.
Special populations
No studies on dosage have been conducted in patients with renal and/or hepatic impairment or in elderly patients.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking any medicine.
The safety of Purified Micronized Flavonoid Fraction Mylan during pregnancy has not been established. Therefore, its use is not recommended during this period.
It is not known whether Purified Micronized Flavonoid Fraction Mylan passes into human breast milk. Your doctor must decide whether to discontinue breastfeeding or discontinue/abstain from treatment with Purified Micronized Flavonoid Fraction Mylan.
Driving and using machines
Purified Micronized Flavonoid Fraction Mylan has no effect or has a negligible effect on the ability to drive vehicles and use machines.

3. How to take Purified Micronized Flavonoid Fraction Mylan

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose in adults is:

• Chronic venous disease: The recommended daily dose is 1 tablet (taken as a single dose in the morning or evening).

You should take the medicine for at least 4–5 weeks before an improvement can be expected. If symptoms of the disease worsen or do not improve after 6 weeks of treatment, you must consult your doctor.
If symptoms improve, treatment may be continued for up to 2 months. Upon advice from your doctor, treatment may be further prolonged.

• Acute hemorrhoidal attack: During the first 4 days of treatment, the recommended daily dose for acute hemorrhoidal attack is 3 tablets (1 tablet in the morning, 1 tablet at midday, and 1 tablet in the evening). For the following 3 days, the dose is 2 tablets per day (1 tablet in the morning and 1 tablet in the evening). If symptoms worsen or persist after 7 days of treatment, you must consult your doctor.

Method of administration
Purified Micronized Flavonoid Fraction Mylan should be taken during meals.
Swallow the tablet with liquid.

If you take more Purified Micronized Flavonoid Fraction Mylan than you should
If you have taken more tablets than prescribed, speak to your doctor or pharmacist.

If you forget to take Purified Micronized Flavonoid Fraction Mylan
Do not take a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Reported side effects include:
Common (may affect up to 1 in 10 people):
Diarrhoea, indigestion, nausea (feeling unwell), vomiting.
Uncommon (may affect up to 1 in 100 people):
Colitis (inflammation of the colon).
Rare (may affect up to 1 in 1,000 people):
Dizziness, feeling restless, headache, malaise (feeling unwell), vertigo (spinning sensation).
Skin rash, itching, urticaria.
Not known (frequency cannot be estimated from the available data):
Abdominal pain.
Oedema (swelling of the face, lips and eyelids), angioedema (rapid swelling of tissues, such as face, lips, tongue or throat, which may cause breathing difficulties).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Purified Micronized Flavonoid Fraction Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Frazione Flavonoica Purificata Micronizzata Mylan tablets contain

• The active substance is 1,000 mg of micronized flavonoids, consisting of diosmin at 90% (900 mg) and flavonoids at 10% (expressed as hesperidin) (100 mg).
• The other components are
• Tablet core: crospovidone (type A), microcrystalline cellulose, orange flavour Tetrarome P0551, maize maltodextrin, alpha tocopherol (E 307), orange pigment mixture PB-230018, pregelatinized maize starch, yellow iron oxide (E 172), red iron oxide (E 172), sucralose, talc, magnesium stearate

Description of the appearance of Frazione Flavonoica Purificata Micronizzata Mylan and contents of the
pack
Reddish-brown, capsule-shaped tablets, with a double score line, 22 mm in length and 8.5 mm in width.
The tablets are packaged in PVC/PVDC/aluminum blisters, and the blisters are contained in a cardboard carton.
Pack sizes: 18, 30 and 60 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer
Kern Pharma S.L.
Poligono Industrial Colon II, Calle Venus 72
Terrassa, Barcelona 08228
Spain

Mylan Hungary Kft.
Mylan Utca 1
2900 Komarom
Hungary