Package leaflet: Information for the patient

ARVENUM 500 mg film-coated tablets

micronized purified flavonoid fraction
Please read all of 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 to do.

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.

Contents of this leaflet:

What Arvenum is and what it is used for
What you need to know before taking Arvenum
How to take Arvenum
Possible side effects
How to store Arvenum
Contents of the pack and other information

1. What ARVENUM is and what it is used for

Arvenum is a medicine containing a micronized purified flavonoid fraction, used to protect the veins.

Arvenum is indicated for the treatment of:

symptoms and signs due to venous insufficiency (such as, for example, swelling of the ankles and legs; localized sensations in the legs of pain, heaviness, tingling, itching, diffuse burning; restless legs; evening or nocturnal cramps; varicose veins; skin changes such as hardening, color changes, eczema or ulcerations)
capillary fragility (such as, for example, broken capillaries in the leg, frequent haematomas or spontaneous bruising).

2. What you need to know before taking ARVENUM

Do not take Arvenum
if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in
section 6);

Children and adolescents
There are no data available to support the use of this medicine in children and adolescents.

Other medicines and Arvenum
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
As a precautionary measure, it is advisable to avoid using Arvenum during pregnancy.

Breastfeeding
Breastfeeding is not recommended during treatment due to the lack of data on the excretion of the medicine in breast milk.

Driving and using machines
There are no data available to assess the effect of this medicine on the ability to drive vehicles or operate machinery.

3. How to take Arvenum

Take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2 film-coated tablets daily (1 at noon and 1 in the evening), taken with meals, even in case of haemorrhoids.
If you take more Arvenum than you should
If you have taken more Arvenum than you should, contact your doctor or pharmacist immediately.
Experience with overdose of Arvenum is limited, but reported symptoms include diarrhoea, nausea, abdominal pain, pruritus, and rash.
If you forget to take Arvenum
Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects that may occur with the frequency described below include:
Common (occurs in 1 to 10 patients out of 100):
diarrhoea, indigestion (dyspepsia), nausea, vomiting.
Uncommon (occurs in 1 to 10 patients out of 1,000):
colitis.
Rare (occurs in 1 to 10 patients out of 10,000):
skin redness (rash), itching, urticaria, dizziness, headache, malaise.
Not known (frequency cannot be estimated from the available data):
abdominal pain, swelling of the face, lips, or eyelids (edema), rapid swelling of the face, lips, mouth, tongue, or throat which may lead to breathing difficulties (angioedema), abnormally low platelet count (thrombocytopenia).
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You may also report side effects directly via the website
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 Arvenum

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 Arvenum contains
The active substance is micronized purified flavonoid fraction 500 mg, consisting of 450 mg diosmin,
flavonoids expressed as hesperidin 50 mg.
The other components are: sodium carboxymethyl starch; microcrystalline cellulose; gelatin; glycerin;
hypromellose; sodium lauryl sulfate; yellow iron oxide E 172; red iron oxide E 172; titanium dioxide;
macrogol 6000; magnesium stearate; talc.

Description of the appearance of Arvenum and contents of the pack
Arvenum is presented in a cardboard box containing 15, 30 or 60 film-coated tablets,
packaged in blisters of 15 tablets each.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Istituto Farmaco Biologico Stroder S.r.l.
Via Luca Passi, 85
00166 Rome, Italy

Manufacturer
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy - France