Galvenox Veno

Package Leaflet: Information for the Patient

Galvenox Veno

500 mg, Hard Capsules

Calcii dobesilas monohydricus

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

This medication should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

• 1. What is Galvenox Veno and What is it Used For
• 2. Important Information Before Using Galvenox Veno
• 3. How to Use Galvenox Veno
• 4. Possible Side Effects
• 5. How to Store Galvenox Veno
• 6. Contents of the Pack and Other Information

1. What is Galvenox Veno and What is it Used For

Galvenox Veno is a medication in the form of hard capsules. It contains the active substance calcium dobesilate monohydrate, which acts on the walls of blood vessels. It reduces their excessive permeability and fragility, increases their strength, thereby preventing fluid leakage through the vessel walls.

Additionally, it accelerates collagen synthesis, which is an important structural component of arterial walls.

Galvenox Veno reduces blood viscosity, increases erythrocyte elasticity, and also exhibits anti-aggregatory activity. This results in improved peripheral venous circulation, reduced venous stasis, and inhibition of thrombotic changes associated with varicose vein formation.

Galvenox Veno also reduces the permeability and fragility of lymphatic vessels and improves lymphatic drainage, resulting in reduced swelling.

Indications for Use

Symptoms of chronic venous insufficiency of the lower limbs: pain, cramps, feeling of heaviness in the legs, tingling, numbness of the lower limbs, skin changes associated with venous stasis, varicose veins of the lower limbs, swelling associated with chronic venous insufficiency.

Symptomatic treatment of hemorrhoids (anal varices).

2. Important Information Before Using Galvenox Veno

When Not to Use Galvenox Veno

• if the patient is allergic to the active substance or any of the other ingredients of this medication (listed in section 6),
• in children.

Warnings and Precautions

The medication should be used with caution if there is active gastric or duodenal ulcer disease or chronic gastritis. Periodic monitoring of gastric and duodenal function is recommended. If symptoms worsen, the medication should be discontinued and the doctor consulted.

The medication should be stopped immediately and the doctor consulted if symptoms such as fever, sore throat or pharynx, difficulty swallowing, nasal mucositis, oral mucositis, genital or anal inflammation occur, as these may be symptoms of a severe disease - agranulocytosis.

The doctor should be consulted, even if the above warnings refer to past situations.

Using Galvenox Veno in Patients with Renal Impairment

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

Children

The effect of the medication has not been studied in children. The medication should not be used in children.

Galvenox Veno and Other Medications

The doctor or pharmacist should be informed about all medications currently or recently used by the patient, as well as any planned medications.

There is no data on the interaction of Galvenox Veno with other medications.

Galvenox Veno with Food and Drink

The medication is taken orally, during main meals.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medication.

Pregnancy

Galvenox Veno may be used in pregnant women only if the potential benefit of using the medication outweighs the possible risk to the fetus.

Galvenox Veno is contraindicated in the first trimester of pregnancy.

Breastfeeding

The medication passes into breast milk in small amounts. There is no data on the effect of the medication on breastfed infants.

Before starting the medication, breastfeeding should be stopped.

Driving and Operating Machinery

Galvenox Veno does not affect the ability to drive or operate machinery.

Galvenox Veno Contains Azorubine (E 122)

The medication may cause allergic reactions.

3. How to Use Galvenox Veno

This medication should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Recommended Dose

Unless otherwise directed by the doctor, the usual dose for adults is 1 to 2 capsules per day (corresponding to a daily dose of 500 mg to 1000 mg of calcium dobesilate monohydrate).

The treatment period usually lasts from several weeks to several months.

Method of Administration

The medication is taken orally, during main meals.

Using a Higher Than Recommended Dose of Galvenox Veno

In case of taking a higher dose than recommended, consult your doctor or pharmacist.

Missing a Dose of Galvenox Veno

Do not take a double dose to make up for a missed dose.

If you have any further doubts about using this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Galvenox Veno can cause side effects, although not everybody gets them.

Rare (in less than 1 in 1000 patients, but more than 1 in 10,000 patients):

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

Very Rare (in less than 1 in 10,000 patients):

• 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 area). In such cases, the medication should be discontinued and the doctor consulted.

Local and generalized allergic reactions (rash, urticaria) have been reported.

Most side effects disappear after discontinuation of Galvenox Veno or dose reduction.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, inform 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.

Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Galvenox Veno

Store in a temperature below 25°C. Store in the original packaging to protect from moisture.

The medication should be stored out of sight and reach of children.

Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Galvenox Veno Contains

• The active substance of the medication is calcium dobesilate monohydrate. One hard capsule contains 500 mg of calcium dobesilate monohydrate.
• Other ingredients are: microcrystalline cellulose, magnesium stearate, titanium dioxide (E 171), azorubine (E 122), quinoline yellow (E 104), gelatin.

What Galvenox Veno Looks Like and What the Pack Contains

Galvenox Veno is available in the form of hard capsules.

The capsule is oval-cylindrical, two-part. The inner part (body) - white, the outer part (cap) - red. The capsule contents - white or almost white powder.

Available packs:

30 hard capsules,

60 hard capsules.

The packaging is PVC/PVDC/Aluminum blisters 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

Tel.: +48 71 710 62 01

Date of Last Revision of the Leaflet:14.04.2023