Fladios

Fladios, 1000 mg, tablets
Micronized Diosmin
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if your condition worsens after 6 weeks of treatment for chronic venous disease or 7 days after the onset of symptoms related to hemorrhoidal flare-ups, consult your doctor.

Table of Contents

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

1. What Fladios is and what it is used for

Diosmin belongs to a group of substances called bioflavonoids and is used to stabilize blood vessels. Fladios contains an active ingredient that affects venous function and protects veins. It increases venous tone and capillary resistance. Fladios reduces swelling and has anti-inflammatory properties.
Fladios is indicated for use in adults for the treatment of symptoms of chronic venous disease, such as leg pain, sensation of heaviness, leg fatigue, restless legs syndrome, nocturnal cramps, edema, and skin changes. It is also indicated in the treatment of symptoms associated with acute hemorrhoidal disease, such as pain, bleeding, and swelling around the anus.
If there is no improvement or if your condition worsens after 6 weeks of taking Fladios for chronic venous disease symptoms, consult your doctor.
If there is no improvement or if your condition worsens after 7 days of taking Fladios for hemorrhoidal flare-up symptoms, consult your doctor.
If you are taking Fladios for venous disease symptoms and also experience problems related to leg ulcers, other skin changes, or hemorrhoids, consult your doctor.

2. Important information before using Fladios

When not to take Fladios

• if the patient is allergic to diosmin or to any of the excipients (listed in section 6).

Warnings and precautions
Before starting treatment with Fladios, discuss this with your doctor or pharmacist:
Chronic venous disease
Contact your doctor immediately if your condition worsens during treatment, which may manifest as skin inflammation, phlebitis, subcutaneous induration, severe pain, subcutaneous ulcers, or unusual symptoms such as sudden swelling of one or both legs.
Treatment with Fladios is most beneficial when accompanied by a balanced lifestyle:

• avoid exposure to sunlight and prolonged standing,
• maintain a healthy body weight,
• wearing special compression stockings may improve circulation in some patients.

Fladios is not effective in reducing lower limb edema caused by heart, liver, or kidney disease.
Acute hemorrhoidal disease
In case of an acute flare-up of hemorrhoidal symptoms, the duration of Fladios treatment is limited to 15 days. If symptoms do not improve within this time, contact your doctor.
If your condition worsens during treatment—for example, if you notice increased rectal bleeding, blood in stool, or have any doubts about hemorrhoidal bleeding—you should contact your doctor.
Treatment with Fladios does not replace treatment for other anorectal disorders.
Children and adolescents
Fladios is not recommended for use in children and adolescents.
Fladios with other medicines
No interactions between diosmin and other medicinal products have been reported so far. However, you should inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Pregnancy and breastfeeding
The safety of Fladios during pregnancy and breastfeeding has not been established. Therefore, its use during these periods is not recommended.
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
Fladios has no effect or negligible effect on the ability to drive and operate machinery.
Fladios contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to take Fladios

This medicine should always be taken exactly as described in this patient leaflet or as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Dosage

• Chronic venous disease: The recommended daily dose is 1 tablet. The medicine should be taken for at least 4 to 5 weeks before improvement can be expected. If symptoms worsen or do not improve after 6 weeks of treatment, consult your doctor. Self-treatment without medical consultation may last up to 3 months. However, patients may continue using Fladios for a longer period if the doctor decides that no other specialist treatment is required.
• Acute hemorrhoidal disease: The recommended daily dose during the first 4 days of treatment is 3 tablets. For the next 3 days, the recommended daily dose is 2 tablets. Afterwards, the recommended daily maintenance dose is 1 tablet. If symptoms worsen or do not improve after 7 days of treatment, consult your doctor. Self-treatment with Fladios may last up to 15 days. If symptoms do not improve within this time, consult your doctor.

Method of administration
Fladios should be taken with food.
Tablets should be swallowed with liquid.
If you take more Fladios than you should
If you take more than the recommended dose, contact your doctor or pharmacist immediately.
No cases of diosmin overdose have been reported so far.
If you forget to take Fladios
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody gets them.

Common (may affect up to 1 in 10 people):

• Diarrhoea, indigestion, nausea, vomiting

Uncommon (may affect up to 1 in 100 people):

• Inflammation of the large intestine (colitis)

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

• Headache, malaise, dizziness (feeling of spinning)
• Rash, itching, urticaria

Frequency not known (frequency cannot be estimated from the available data):

• Abdominal pain
• Swelling (oedema of the face, lips and eyelids), very rarely angioedema (sudden swelling of tissues, e.g. face, lips, tongue or throat, which may cause difficulty in breathing)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Fladios

Keep the 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 the stated month.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Fladios contains

• The active substance is diosmin. Each tablet contains 1000 mg of micronized diosmin.
• The other ingredients are polyvinyl alcohol, sodium croscarmellose and magnesium stearate. See section 2 "Fladios contains sodium".

What Fladios looks like and contents of the pack
Pale greenish or greyish-yellow to pale greenish or greyish-brown, slightly oval, mottled tablets on both sides.
The tablet dimensions are defined by perforated formers with a size of 18.0 mm × 9.0 mm.
Fladios is available in packages containing: 20, 30, 60, 90 or 120 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw, Poland
Tel. 22 57 37 500

This medicinal product is authorised in the European Economic Area countries under the following names: