Fladios

Patient Leaflet: Patient Information

Fladios, 500 mg, coated tablets

Micronized diosmin

Read the leaflet carefully before taking the 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 a doctor, pharmacist, or nurse.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If, after 6 weeks of treatment for chronic venous disease or 7 days from the onset of hemorrhoid symptoms, there is no improvement or the patient feels worse, they should consult a doctor.

Table of Contents of the Leaflet

• 1. What is Fladios and what is it used for
• 2. Important information before taking Fladios
• 3. How to take Fladios
• 4. Possible side effects
• 5. How to store Fladios
• 6. Package contents and other information

1. What is Fladios and what is it used for

Diosmin belongs to a group of substances called bioflavonoids and is used to stabilize blood vessels. Fladios contains an active substance that affects vein function and protects veins. It increases vein tension and capillary resistance. Fladios reduces swelling and has anti-inflammatory effects.
Fladios is indicated for the treatment of symptoms of chronic venous disease in adults, such as leg pain, feeling of heaviness, leg fatigue, restless legs syndrome, nocturnal cramps, leg swelling, and skin changes. It is also indicated for the treatment of symptoms associated with acute hemorrhoidal disease, such as pain, bleeding, and swelling in the anal area.
If there is no improvement or the patient feels worse after 6 weeks of taking Fladios for chronic venous disease symptoms, they should consult a doctor.
If there is no improvement or the patient feels worse after 7 days of taking Fladios for hemorrhoid symptoms, they should consult a doctor.
If the patient is taking the medicine for venous disease symptoms and also experiences symptoms of leg ulcers, other skin changes, or hemorrhoids, they should consult a doctor.

2. Important information before taking Fladios

When not to take Fladios

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

Warnings and precautions

Before starting treatment with Fladios, the patient should discuss it with their doctor or pharmacist.
Chronic venous disease
The patient should immediately contact their doctor if their condition worsens during treatment, which may manifest as skin inflammation, phlebitis, subcutaneous induration, severe pain, subcutaneous ulcers, or atypical symptoms, such as sudden swelling of one or both legs.
Treatment with Fladios is most beneficial when combined with a balanced lifestyle:

• the patient should avoid sun exposure and standing for long periods,
• the patient should maintain a healthy weight,
• wearing special compression stockings may improve circulation in some patients.

Fladios is not effective in reducing swelling of the lower limbs caused by heart, liver, or kidney disease.
Acute hemorrhoidal disease
In case of worsening hemorrhoid symptoms, the treatment duration with Fladios is limited to 15 days. If symptoms do not improve within this time, the patient should consult a doctor.
If the patient's condition worsens during treatment, i.e., if they experience increased rectal bleeding, blood in the stool, or have doubts about hemorrhoidal bleeding, they should consult a doctor.
Treatment with Fladios does not replace treatment for other anal disorders.

Children and adolescents

The use of Fladios is not recommended in children and adolescents.

Fladios and other medicines

No interactions between diosmin and other medicinal products have been reported so far; however, the patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy and breastfeeding

The safety of Fladios during pregnancy and breastfeeding has not been established. Therefore, its use is not recommended during this period.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Fladios has no or negligible influence on the ability to drive and use machines.

Fladios contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means 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 directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Dosage

• Chronic venous disease:The recommended daily dose is 2 tablets, which can be taken in one dose or in 2 separate doses. The medicine should be taken for at least 4 to 5 weeks before improvement can be expected. If, after 6 weeks of treatment, the symptoms of the disease worsen or do not improve, the patient should consult a doctor. Self-treatment without consulting a doctor can last for 3 months. However, the patient may continue taking Fladios for a longer period if the doctor decides that no other specialized treatment is required.
• Acute hemorrhoidal disease:The recommended daily dose for the first 4 days of treatment is 6 tablets (given as 3 tablets twice a day). For the next 3 days, the recommended daily dose is 4 tablets (given as 2 tablets twice a day). Then, the recommended daily maintenance dose is 2 tablets (given as 1 tablet twice a day). If symptoms worsen or do not improve after 7 days of treatment, the patient should consult a doctor. Self-treatment with Fladios can last for 15 days. If symptoms do not improve within this time, the patient should consult a doctor.

Method of administration

Fladios should be taken with food.
The tablets should be swallowed with a liquid.

Overdose

In case of overdose, the patient should immediately consult a doctor or pharmacist.
No cases of diosmin overdose have been reported so far.

Missed dose

The patient should not take a double dose to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Fladios can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):

• Diarrhea, nausea, 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):

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

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

• Abdominal pain;
• Swelling (swelling of the face, lips, and eyelids), exceptionally angioedema (sudden swelling of tissues, e.g., face, lips, tongue, or throat, which may cause breathing difficulties).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Fladios

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the packaging after: EXP.
The expiration date refers to the last day of the specified month.
The medicine should not be stored at temperatures above 25°C.
The medicine should be stored in its original packaging to protect it from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Fladios contains

• The active substance is diosmin. Each coated tablet contains 500 mg of micronized diosmin.
• The other ingredients are microcrystalline cellulose, polyvinyl alcohol, sodium carboxymethylcellulose (type A), talc, and magnesium stearate in the tablet core, and polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, talc, and yellow iron oxide (E 172) in the coating. See section 2 "Fladios contains sodium".

What Fladios looks like and contents of the pack

Brown-yellow, biconvex, capsule-shaped tablets. The tablet dimensions are defined by perforated shapes with a diameter of 16.0 mm × 8.5 mm.
Fladios is available in packs containing: 15, 30, 60, 90, 120, 150, or 180 tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For more information about this medicine, the patient should contact their local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:05.06.2025