Fladios

Fladios, 500 mg, film-coated tablets
Micronized diosmin
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If advice or additional information is needed, consult a pharmacist.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 6 weeks of treatment for chronic venous disease, or after 7 days from the onset of symptoms related to hemorrhoidal flare-ups, or if the patient feels worse, medical advice should be sought.

Leaflet contents

1. What Fladios is and what it is used for
2. What you need to know 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 edema 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, leg swelling, and skin changes. It is also indicated in the treatment of symptoms associated with acute hemorrhoidal disease, such as pain, bleeding, and swelling in the anal area.
If no improvement occurs, or if the patient feels worse after 6 weeks of taking Fladios for chronic venous disease symptoms, consult a doctor.
If no improvement occurs, or if the patient feels worse after 7 days of taking Fladios for acute hemorrhoidal symptoms, consult a doctor.
If the patient is taking the medicine for venous disease symptoms and also experiences problems related to leg ulcers, other skin changes, or hemorrhoids, medical advice should be sought.

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 it 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
During an exacerbation of hemorrhoidal symptoms, the duration of Fladios treatment is limited to 15 days. If symptoms do not improve within this period, consult your doctor.
If your condition worsens during treatment—e.g., 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 to date. 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 child, consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
Fladios has no effect or has a 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 the medicine 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 in doubt, consult your doctor or pharmacist.
Dosage

• Chronic venous disease: The recommended daily dose is 2 tablets, which can be taken as a single dose or divided into two separate doses. 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 six 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 determines that no other specialized treatment is required.
• Acute hemorrhoidal disease: The recommended daily dose during the first 4 days of treatment is 6 tablets (taken as 3 tablets twice daily). For the following 3 days, the recommended daily dose is 4 tablets (taken as 2 tablets twice daily). Then, the recommended daily maintenance dose is 2 tablets (taken as 1 tablet twice daily). 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 whole 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 to date.
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 all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.

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

• Diarrhea, 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 (sensation of spinning);
• Rash, itching, urticaria.

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

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

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 of Monitoring Adverse Drug Reactions of the Office for Registration 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fladios

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: EXP.
The expiry date refers to the last day of the specified 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 properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack 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 carboxymethyl starch (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
Brownish-yellow, biconvex, capsule-shaped tablets. The tablet dimensions are defined by shaped punches 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 Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information on 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 Member States of the European Economic Area under the following names: