Doxium 500

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

DOXIUM 500, 500 mg, hard capsules
Calcii dobesilas

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is DOXIUM 500 and what is it used for
• 2. Important information before taking DOXIUM 500
• 3. How to take DOXIUM 500
• 4. Possible side effects
• 5. How to store DOXIUM 500
• 6. Contents of the packaging and other information

1. WHAT IS DOXIUM 500 AND WHAT IS IT USED FOR

Indications for use of the medicine:
Clinical symptoms of chronic venous insufficiency of the lower limbs (pain, cramps, paresthesia, swelling, skin changes due to blood stasis), mild to moderate non-proliferative diabetic retinopathy, in order to slow down the progression of the disease.

2. IMPORTANT INFORMATION BEFORE TAKING DOXIUM 500

When not to take DOXIUM 500

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

Warnings and precautions

Before starting to take DOXIUM 500, the patient should discuss it with their doctor or pharmacist.
In very rare cases, taking DOXIUM 500 may cause agranulocytosis - a disease in which a significant decrease in the number of white blood cells increases the risk of infections. In such a situation, symptoms such as high fever, infections in the mouth (tonsillitis), sore throat, inflammatory changes in the genital and anal areas, and other symptoms that usually indicate the presence of an infection may occur. If such symptoms occur, the patient should stop the treatment and inform their doctor immediately.
DOXIUM 500 may cause severe allergic reactions (anaphylactic reaction or anaphylactic shock) with symptoms such as skin reactions, fever, difficulty breathing, or dizziness. In such a case, the patient should stop the treatment and inform their doctor immediately.
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The patient should also inform their doctor:

• if they have kidney disease, especially if dialysis is required, as the dose of the medicine may need to be reduced in such cases.
• If the patient is to undergo tests during treatment with DOXIUM 500, laboratory test samples (e.g., blood samples) should be taken before taking the first dose of the medicine to minimize the potential impact of DOXIUM 500 on the test results.

Children and adolescents

The safety and efficacy of DOXIUM 500 in children and adolescents have not been evaluated.

DOXIUM 500 and other medicines

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.
So far, no confirmed cases of interaction between DOXIUM 500 and other medicines have been reported.
DOXIUM 500 may affect the results of laboratory tests for serum creatinine levels.
Therefore, the patient should inform their doctor about all laboratory tests, especially those that will assess kidney function.

Pregnancy, breastfeeding, and fertility

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.
Pregnancy
There are no data indicating that DOXIUM 500 has adverse effects on the fetus or embryo; however, this medicine should not be used during pregnancy.
Breastfeeding
After oral administration, the active substance of DOXIUM 500, calcium dobesilate, passes into breast milk in very small amounts. For safety reasons, either the treatment or breastfeeding should be discontinued. In such cases, the patient should consult their doctor.

Driving and using machines

DOXIUM 500 does not affect the ability to drive or use machines.

3. HOW TO TAKE DOXIUM 500

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
Dosage
For adults only
Recommended dose:
Diabetic retinopathy: 1000 to 1500 mg/day (500 mg 2 to 3 times a day)
Chronic venous insufficiency: 500 to 1000 mg/day (500 or 1000 mg once a day).
The dose of the medicine should be determined individually, depending on the severity of symptoms. The duration of treatment depends on the type and course of the disease and usually lasts from several weeks to several months.
Patients with renal impairment
The safety and efficacy of DOXIUM 500 in patients with renal impairment have not been evaluated. The medicine is excreted by the kidneys, so caution should be exercised, and in patients with renal impairment (especially those requiring dialysis), the dose of DOXIUM 500 may be reduced.
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Patients with liver impairment
The safety and efficacy of DOXIUM 500 in patients with liver impairment have not been evaluated, so caution should be exercised.
If the patient feels that the effect of DOXIUM 500 is too strong or too weak, they should consult their doctor or pharmacist.
Method of administration
DOXIUM 500 is taken orally. The capsules should be swallowed whole, without opening them.
To minimize potential stomach discomfort, the capsules of DOXIUM 500 should be taken during or immediately after a meal.

Taking a higher dose of DOXIUM 500 than recommended

No cases of overdose have been reported so far.

Missing a dose of DOXIUM 500

The patient should not take a double dose to make up for a missed capsule.

Stopping treatment with DOXIUM 500

Stopping treatment with DOXIUM 500 before the end of therapy may have an unfavorable effect on its success. The patient should not stop treatment without consulting their doctor.
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, DOXIUM 500 can cause side effects, although not everybody gets them.
Common side effects (may occur in up to 1 in 10 patients)
Abdominal pain, nausea, diarrhea, vomiting, headache, joint pain, muscle pain, increased alanine aminotransferase activity (change in liver function, which can be detected in blood tests)
Uncommon side effects (may occur in up to 1 in 100 patients)
Fever, chills, feeling weak, fatigue, hypersensitivity (rash, allergic dermatitis, itching, urticaria, facial edema; see section "Warnings and precautions")
Very rare side effects (may occur in up to 1 in 10,000 patients)
Significant decrease in the number of certain white blood cells, leading to an increased risk of infection (agranulocytosis; see section "Warnings and precautions"), severe allergic reaction leading to difficulty breathing or dizziness (anaphylactic reaction; see section "Warnings and precautions")
Frequency not known (frequency cannot be estimated from the available data)
Decreased number of white blood cells called neutrophils (neutropenia), decreased number of white blood cells (leukopenia)
These reactions usually resolve spontaneously after stopping treatment.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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.
Aleje Jerozolimskie 181C
02-222 Warsaw
Website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. HOW TO STORE DOXIUM 500

The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Store in a temperature below 25°C.
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. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What DOXIUM 500 contains

The active substance of the medicine is calcium dobesilate (Calcii dobesilas).
Each hard capsule contains 500 mg of calcium dobesilate.
The other ingredients are: cornstarch, magnesium stearate.
The ingredients of the capsule shell are: yellow iron oxide (E 172), titanium dioxide (E 171), gelatin, indigo carmine (E 132).

What DOXIUM 500 looks like and contents of the packaging

DOXIUM 500 capsules are opaque, with a yellow body and a dark green cap.
The packaging contains 30 or 60 hard capsules in aluminum foil or PVC/PVDC blisters (10 capsules per blister).
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

OMEDICAMED Unipessoal Lda
Avenida António Augusto de Aguiar nº 19 – 4º
1050-012 Lisboa
Portugal

Manufacturer

FLAVINE PHARMA FRANCE
3 voie d’Allemagne,
13127 Vitrolles, France
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For more detailed information, the patient should contact the local representative of the marketing authorization holder:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
phone: +48 (22) 755 96 48
[email protected]

Date of last revision of the leaflet: January 2023

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