Phlebodia

Patient Information Leaflet

Phlebodia
600 mg, coated tablets
Diosminum
Please read this leaflet carefully before taking 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
the physician or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Phlebodia is and what it is 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 Phlebodia is and what it is used for

Phlebodia is a medicine that increases venous tone, provides vascular protection, and reduces capillary fragility.
Indications:
Relief of symptoms associated with chronic venous insufficiency in the lower limbs (varicose veins), such as leg heaviness, pain, and other discomforts due to restless legs syndrome requiring change in body position.
Short-term symptomatic treatment of hemorrhoidal flare-ups.

2. Important information before taking Phlebodia

When not to take Phlebodia

• if the patient is allergic to diosmin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Phlebodia, consult your doctor or pharmacist.
Warnings

• if discomfort and capillary fragility do not subside within 15 days of treatment, contact your doctor
• if symptoms related to haemorrhoids persist after several days of using the medicine, contact your doctor.

Precautions
Treatment will be more effective if combined with lifestyle modifications.
Avoid excessive exposure to sunlight, high temperatures, prolonged standing, and overweight.
Wearing appropriate compression stockings helps maintain proper blood circulation.
Children and adolescents
This medicine is intended for adults only (from 18 years of age).
Phlebodia and other medicines
Clinically significant interactions between Phlebodia and other medicines are not known.
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
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
This medicine may be used during pregnancy only under medical supervision. If the patient becomes pregnant during treatment, medical advice should be sought, as only the doctor can decide whether treatment should be continued.
Breastfeeding
Due to lack of data regarding passage of the medicine into breast milk, treatment is not recommended during breastfeeding.
Driving and operating machinery
No or negligible effect.
Phlebodia contains carmine A, Ponceau 4R (E 124)
This medicine contains carmine A, Ponceau 4R (an azo dye), which may cause allergic reactions.

3. How to take Phlebodia

This medicine should always be taken according to the instructions given by your doctor or pharmacist.
Dosage
Adults (aged 18 years and over)
Recommended dose for:

• chronic venous insufficiency of the lower limbs: 1 tablet per day.
• haemorrhoidal disease: 2 to 3 tablets per day, taken with meals.

Method of administration
Oral administration.
The tablet should be swallowed with half a glass of water.
Taking more Phlebodia than recommended
Seek immediate advice from your doctor or pharmacist.
If you forget to take Phlebodia
Do not take a double dose to make up for the missed dose.
Stopping Phlebodia
There is no available data on the effects of discontinuing treatment.
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 not everyone experiences them.

Common (may affect up to 1 in 10 patients)

• stomach pain

Uncommon (may affect up to 1 in 100 patients)

• allergic reactions such as rash, itching, urticaria, facial or throat swelling
• bloating
• diarrhoea
• digestive disturbances
• nausea

Rare (may affect up to 1 in 1000 patients)

• vomiting

Digestive disturbances rarely lead to discontinuation of treatment.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 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 provide more information on the safety of this medicine.

5. How to store the Phlebodia medicine

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after: Expiry (EXP) and on the blister after: EXP. The expiry date refers to the last day of the stated month.
No special storage precautions are required for this medicine.

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, anhydrous colloidal silicon dioxide (Aerosil R 972), microcrystalline cellulose. Coating:
  1. Film-coating agent Sepifilm 002: hypromellose, microcrystalline cellulose, polyethylene glycol 400, stearate.
  2. Colouring agent Sepisperse AP 5523: propylene glycol, hypromellose, titanium dioxide (E 171), carmine red A, Ponceau 4R (E 124), black iron oxide (E 172), red iron oxide (E 172).
  3. Opaglos 6000: ethyl alcohol 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 Authorisation Holder
LABORATOIRES INNOTHERA
22 Avenue Aristide Briand
94110 Arcueil
France
Manufacturer
INNOTHERA CHOUZY
Rue Rene Chantereau - Chouzy-sur-Cisse
41150 Valloire-sur-Cisse
France
For further information, please contact the local representative of the Marketing Authorisation Holder:
Mylan Healthcare Sp. z o.o.
tel. 22 546 64 00