Phlebodia

Package Leaflet: Information for the Patient

Phlebodia

600 mg, film-coated tablets
Diosminum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should speak to a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Phlebodia and what is it used for

Phlebodia is a medicine that increases venous tone, protects blood vessels, and reduces the fragility of small blood vessels.
Indications:
Reducing symptoms of venous insufficiency in the lower limbs (varicose veins of the lower limbs), feeling of heaviness in the legs, pain, and other discomforts caused by restless legs syndrome that force a change in body position.
Short-term symptomatic treatment of hemorrhoids during periods of exacerbation.

2. Important information before taking Phlebodia

When not to take Phlebodia

Warnings and precautions

Before starting to take Phlebodia, you should discuss it with your doctor or pharmacist.
Warnings

Precautions
Treatment will be more effective if combined with a change in lifestyle.
You should avoid excessive exposure to the sun, high temperatures, prolonged standing, and being overweight.
Wearing appropriate compression stockings supports proper blood circulation.

Children and adolescents

The medicine is intended only for adults (from 18 years of age).

Phlebodia and other medicines

Clinically significant interactions between Phlebodia and other medicines are not known.
You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
The medicine may be used during pregnancy only on the advice of a doctor. If you become pregnant during treatment, you should seek the advice of a doctor, as only they can decide whether to continue treatment.
Breastfeeding
Due to the lack of data on the penetration of the medicine into breast milk, treatment is not recommended during breastfeeding.

Driving and using machines

No or negligible influence.

Phlebodia contains Allura Red AC, Ponceau 4R (E 124)

The medicine contains Allura Red AC, Ponceau 4R (azo dye), which may cause allergic reactions.

3. How to take Phlebodia

This medicine should always be taken as directed by your doctor or pharmacist.
Dosage
Adults (from 18 years of age)
Recommended dose in:

• venous insufficiency in the lower limbs: 1 tablet per day.
• hemorrhoids: 2 to 3 tablets per day, with a meal.

Method of administration
Oral use.
You should swallow the tablet with half a glass of water.

Taking a higher dose of Phlebodia than recommended

You should immediately consult your doctor or pharmacist.

Missing a dose of Phlebodia

You should not take a double dose to make up for a missed dose.

Stopping treatment with Phlebodia

There is no data on the effects of stopping treatment.
If you have any further questions on the use of this product, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Phlebodia can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people)

• stomach pain

Uncommon (may affect up to 1 in 100 people)

• allergic reactions, such as rash, itching, hives, swelling of the face or throat
• bloating
• diarrhea
• digestive disorders
• nausea

Rare (may affect up to 1 in 1000 people)

• vomiting.

Digestive disorders rarely lead to discontinuation of treatment.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Phlebodia

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP and on the blister after EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storage.

6. Contents of the pack and other information

What Phlebodia contains

• The active substance is diosmin. Each tablet contains 600 mg of diosmin.
• The other ingredients are: stearic acid, talc, colloidal anhydrous silica (Aerosil R 972), microcrystalline cellulose. Coating:
• 1. Sepifilm 002 coating: hypromellose, microcrystalline cellulose, macrogol 400, stearyl alcohol.
• 2. Sepisperse AP 5523 coloring: propylene glycol, hypromellose, titanium dioxide (E 171), Allura Red AC, Ponceau 4R (E 124), iron oxide black (E 172), iron oxide red (E 172).
• 3. Opaglos 6000: ethanol 95%, shellac (E 904), carnauba wax (E 903), beeswax (E 901).

What Phlebodia looks like and contents of the pack

The pack contains 15, 30, or 60 film-coated tablets.

Marketing authorization holder

LABORATOIRES INNOTHERA
22 Avenue Aristide Briand
94110 Arcueil
France

Manufacturer

INNOTHERA CHOUZY
Rue Rene Chantereau - Chouzy-sur-Cisse
41150 Valloire-sur-Cisse
France
To obtain more detailed information, you should contact the local representative of the marketing authorization holder:
Mylan Healthcare Sp. z o.o.
tel. 22 546 64 00

Date of last revision of the leaflet: