Galvenox

Package Leaflet: Information for the Patient

GALVENOX

500 mg, hard capsules

Calcii dobesilas monohydricus

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Galvenox and what is it used for

The active substance of Galvenox is calcium dobesilate. The site of action of calcium dobesilate is:
the endothelium of capillaries, the walls of veins, and lymphatic vessels. The maximum concentration of the medicine in the blood is reached about 6 hours after administration.
Galvenox reduces the permeability of capillary walls, resulting in reduced exudation; increases the elasticity and tone of venous walls; reduces blood viscosity by changing the protein composition and reducing platelet aggregation; improves microcirculation, prevents blood stasis in venous vessels, and prevents thrombosis formation.
The medicine also reduces the permeability of lymphatic vessels and increases lymphatic drainage, resulting in reduced swelling.

Indications for Use

• Diabetic retinopathy,
• Clinical symptoms of chronic venous insufficiency of the lower limbs (pain, muscle cramps, paresthesia, edema, skin changes associated with venous stasis),
• Supportive treatment for superficial thrombophlebitis of the lower limbs,
• Hemorrhoids.

2. Important Information Before Taking Galvenox

When Not to Take Galvenox

• in children.

Warnings and Precautions

Before starting treatment with Galvenox, discuss it with your doctor.
Contact your doctor if you have active gastric or duodenal ulcer or chronic gastritis. Periodic monitoring of gastric and duodenal function is recommended. If symptoms worsen, the medicine should be discontinued and a doctor consulted.
Consult your doctor, even if the above warnings refer to past situations.

Use of Galvenox in Patients with Renal Impairment

In patients with severe renal impairment, especially those undergoing dialysis, reduced doses of the medicine should be used.

Children

The effect of the medicine has not been studied in children under 12 years of age. The medicine should not be used in children.

Galvenox and Other Medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
There are no data on the interaction of the medicine with other medicines.

Galvenox with Food

The medicine is taken orally during main meals.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine.
Pregnancy
Galvenox may be used in pregnant women only if the potential benefit of the medicine outweighs the possible risk to the fetus.
Breastfeeding
The medicine passes into breast milk in small amounts. There are no data on the effect of the medicine on breastfed infants.
Before starting treatment with the medicine, breastfeeding should be stopped.

Driving and Using Machines

Galvenox does not affect the ability to drive and use machines.

Galvenox Contains Azorubine (E122) and Quinoline Yellow (E104)

The medicine contains azorubine (E122) and quinoline yellow (E104) and may cause allergic reactions.

3. How to Take Galvenox

This medicine should always be taken exactly as advised by your doctor. If you are unsure, ask your doctor.

Recommended Dose

Usually, 1 hard capsule is taken once or twice a day (i.e., 500 mg to 1000 mg per day).
The treatment period usually lasts from several weeks to several months.

Method of Administration

The medicine is taken orally, during main meals.

Overdose of Galvenox

If you have taken more than the recommended dose of the medicine, contact your doctor or pharmacist.

Missed Dose of Galvenox

Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rarely (in less than 1 in 1000 people, but more than 1 in 10,000 people), the following may occur:

• abdominal pain,
• nausea,
• diarrhea,
• vomiting,
• skin reactions,
• joint pain,
• headache and dizziness,
• fever.

Very rarely (in less than 1 in 10,000 people), bone marrow depression with agranulocytosis (an acute condition that may manifest as high fever, infections in the mouth or inflammatory conditions in the anus and genital organs) has been observed. In such cases, the medicine should be discontinued and a doctor consulted.
Local (rash) and generalized (urticaria) allergic reactions have been reported.
Most side effects disappear after discontinuation of Galvenox or dose reduction.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring of 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
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 Galvenox

Store below 30°C. Store in the original package to protect from moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package after EXP. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Galvenox Contains

• The active substance of the medicine is calcium dobesilate monohydrate. One hard capsule contains 500 mg of calcium dobesilate monohydrate.
• The other ingredients are: microcrystalline cellulose, magnesium stearate, titanium dioxide (E171), azorubine (E122), quinoline yellow (E104), gelatin.

What Galvenox Looks Like and Contents of the Pack

Galvenox is available in the form of hard capsules. The capsule is oval, two-part. The inner part (body) is white, the outer part (cap) is red.
The contents of the capsule are white or almost white powder.
Available packs:
30 hard capsules,
60 hard capsules,
90 hard capsules.
The pack consists of blisters made of PVC/PVDC/Aluminum in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pharmaceutical Cooperative "GALENA"
ul. Dożynkowa 10
52-311 Wrocław
Poland
Phone: +48 71 710 62 01
Date of Last Revision of the Leaflet:27.04.2023