Auroflavon

Package leaflet: Information for the user

AUROFLAVON 500 mg film-coated tablets, 1000 mg film-coated tablets

Micronized purified flavonoid fraction
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 your symptoms worsen after 7 days.

Contents of this leaflet

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

1. What AUROFLAVON is and what it is used for

AUROFLAVON is a vasoprotective agent that acts on the small blood vessels. By stabilizing the walls of blood vessels, it reduces both excessive dilation and increased permeability of blood vessels, which may be caused by your condition.
AUROFLAVON is used in adults for the treatment of:

• signs and symptoms of chronic venous insufficiency of the legs (such as pain, sensation of heaviness, leg fatigue and edema);
• symptoms related to active haemorrhoidal disease, such as pain, bleeding and swelling in the anal region.
  Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking AUROFLAVON

Do not take AUROFLAVON
If you are hypersensitive (allergic) to micronized purified flavonoid fraction or to any of the other
components of this medicinal product.

Warnings and precautions
Consult your doctor or pharmacist before taking AUROFLAVON.

Chronic venous insufficiency
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, consult your doctor immediately.
The most effective way to take this treatment is in combination with a healthy lifestyle.

• Avoid sun exposure and prolonged standing.
• Maintain a healthy weight.
• Wearing special compression stockings may improve circulation in some patients.

AUROFLAVON does not help reduce swelling of the lower limbs if this is caused by heart, kidney, or liver diseases.

Acute haemorrhoidal attack
If you have an acute haemorrhoid attack, you may take AUROFLAVON only for a limited period of 7 days. If symptoms do not resolve within this time, consult your doctor.
If your condition worsens during treatment, or if you notice increased rectal bleeding, blood in the stools, or have any doubts about bleeding from haemorrhoids, consult your doctor immediately.
Treatment with AUROFLAVON does not replace specific treatment for other anorectal disorders.

Children and adolescents
Use in children and adolescents under 18 years of age is not recommended.

Other medicines and AUROFLAVON
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
AUROFLAVON may increase blood concentrations and reduce the elimination of metronidazole (an antibacterial and antiprotozoal medicine), diclofenac (an analgesic and anti-inflammatory medicine), fexofenadine (an antihistamine medicine), warfarin (an anticoagulant medicine), and carbamazepine (an antiepileptic medicine).
Therefore, caution is recommended when AUROFLAVON is administered concomitantly with these medicines and with others that share the same metabolic pathways.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
As a precautionary measure, it is preferable to avoid using AUROFLAVON during pregnancy.
Due to the lack of data on excretion in breast milk, AUROFLAVON is not recommended during breastfeeding.

Driving and using machines
AUROFLAVON does not affect or affects negligibly the ability to drive vehicles or use machinery.

AUROFLAVON contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take AUROFLAVON

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose for adults is:
For 500 mg
Chronic venous insufficiency: The recommended daily dose is 2 tablets, taken either as a single dose or in two separate doses (one in the morning and one in the evening). You should take this medicine for 4–5 weeks.
Consult your doctor if you do not feel better or if you feel worse, or if the medicine is needed for longer than 4–5 weeks.
Acute haemorrhoidal disease: The recommended daily dose for the first 4 days is 6 tablets (3 tablets twice daily or 2 tablets three times daily), followed by 4 tablets daily (2 tablets twice daily) for the following 3 days.
Consult your doctor if you do not feel better or if you feel worse, or if the medicine is needed for longer than 7 days.
For 1000 mg
Chronic venous insufficiency: The recommended daily dose is 1 tablet. You should take this medicine for 4–5 weeks.
Consult your doctor if you do not feel better or if you feel worse, or if the medicine is needed for longer than 4–5 weeks.
Acute haemorrhoidal disease: The recommended daily dose for the first 4 days is 3 tablets (1 tablet three times daily), followed by 2 tablets daily (1 tablet twice daily) for the following 3 days.
Consult your doctor if you do not feel better or if you feel worse, or if the medicine is needed for longer than 7 days.
Method of administration
Oral use.
AUROFLAVON should be taken with food.
If you take more AUROFLAVON than you should
If you have taken more AUROFLAVON than you should, contact your doctor or pharmacist immediately.
Experience with overdosage of AUROFLAVON is limited, but reported symptoms include diarrhoea, nausea, abdominal pain, pruritus, and skin rash.
If you forget to take AUROFLAVON
If you forget to take a dose, take the next dose at your usual time. Do not take a double dose to make up for a forgotten 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 everybody will experience them.
In decreasing order of frequency, possible side effects may include:

Common (may affect up to 1 in 10 people)

• Diarrhoea.
• Indigestion.
• Feeling unwell (nausea).
• Vomiting.

Uncommon (may affect up to 1 in 100 people)

• Inflammation of the colon (colitis).

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

• Dizziness.
• Headache.
• Malaise.
• Rash.
• Itching.
• Hives (urticaria).

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

• Abdominal pain.
• Swelling of the face, lips and eyelids (oedema).
• Rapid swelling of tissues such as face, lips, tongue and throat, which may cause breathing difficulties (angioedema).

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 AUROFLAVON

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 blister and carton 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. Return unused medicines to your pharmacist. This will help protect the environment.

6. Package contents and other information

What AUROFLAVON contains

• The active substance is 500 mg of micronized purified flavonoid fraction corresponding to 450 mg of diosmin (90%) and flavonoids expressed as 50 mg of hesperidin (10%) per film-coated tablet. – The active substance is 1000 mg of micronized purified flavonoid fraction corresponding to 900 mg of diosmin (90%) and flavonoids expressed as 100 mg of hesperidin (10%) per film-coated tablet.
• The other components are:
  Tablet core: Microcrystalline cellulose, anhydrous colloidal silica, talc and stearic acid 50.
  Tablet coating: Hypromellose, macrogol, glycerol, magnesium stearate, sodium lauryl sulfate, titanium dioxide, yellow iron hydroxide, red iron hydroxide.

Description of the appearance of AUROFLAVON and contents of the pack

AUROFLAVON 500 mg film-coated tablets
Orange to light orange film-coated tablets, oval-shaped, biconvex, approximately 16.5 x 8.2 mm in size, imprinted with "D500" on one side and smooth on the other.

AUROFLAVON 1000 mg film-coated tablets
Orange film-coated tablets, capsule-shaped, biconvex, approximately 23.7 x 9 mm in size, with "1000" printed on one side and a break line on the other.
The tablet can be divided into equal doses.
AUROFLAVON film-coated tablets are available in blister packs.
Pack sizes: 10, 18, 30, 60, 90, 120 and 180 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102 - 21047 Saronno (VA), Italy

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG3000, Malta
Generis Farmacêutica SA
Rua João de Deus, n. 19, Venda Nova, 2700-487 Amadora, Portugal
Arrow Génériques
26 avenue Tony Garnier, Lyon, 69007, France

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium: Diosmine + Hesperidine AB 450 mg + 50 mg / 900 mg + 100 mg filmomhulde tabletten/comprimés pelliculés / Filmtabletten
France: Flavonoides Arrow Conseil 500 mg, comprimé pelliculé
Flavonoides Arrow Conseil 1000 mg, comprimé pelliculé sécable
Italy: AUROFLAVON
Portugal: Diosmina + Hesperidina Vasoflon