GALVENOX VENO

Package leaflet: Information for the patient

Galvenox Veno
500 mg, hard capsules
Calcii dobesilas monohydricus
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, contact your doctor.

Table of contents

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

1. What Galvenox Veno is and what it is used for

Galvenox Veno is a medicine in the form of hard capsules. It contains the active substance calcium dobesilate monohydrate, which acts on the walls of capillaries. It reduces their excessive permeability and fragility, increases their resistance, 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 flexibility, and also exhibits anti-aggregatory properties. This improves peripheral venous circulation, reduces venous stasis, and inhibits the development of thrombotic changes associated with varicose veins.
Galvenox Veno also reduces permeability and fragility of lymphatic vessels and improves lymphatic drainage, resulting in reduced edema.

Indications
Symptoms of chronic venous insufficiency of the lower limbs: pain, cramps, sensation of heaviness in the legs, tingling, numbness of the lower limbs, skin changes related to venous stasis, varicose veins of the lower limbs, edema associated with chronic venous insufficiency.
Symptomatic treatment of anal varices (hemorrhoids).

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 medicine (listed in section 6),
• in children.

Warnings and precautions
Use this medicine with caution if there is active gastric and/or duodenal ulcer disease or chronic gastritis.
Periodic monitoring of gastric and duodenal function is recommended. If symptoms worsen, discontinue the medicine and consult a doctor.
Immediately stop using the medicine and contact a doctor if symptoms such as fever, sore throat or larynx, pain during swallowing, nasal mucosal inflammation, oral mucosal inflammation, or inflammation around the genital and anal areas occur, as these may be signs of a serious condition – agranulocytosis.
Consult a doctor, even if the above warnings refer to conditions that occurred in the past.

Use of Galvenox Veno in patients with kidney function disorders
In patients with severe renal insufficiency, especially those undergoing dialysis, reduced doses should be used.

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

Galvenox Veno with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
There are no data available regarding interactions between Galvenox Veno and other medicines.

Galvenox Veno with food and drink
The medicine should be taken orally during main meals.

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 a doctor or pharmacist before using this medicine.

Pregnancy
Galvenox Veno may be used during pregnancy only if the potential benefit outweighs the possible risk to the fetus.
Galvenox Veno is contraindicated during the first trimester of pregnancy.

Breastfeeding
The medicine passes into breast milk in small amounts. There are no data on the effects of the medicine on breastfed infants.
Women should discontinue breastfeeding before starting treatment with this medicine.

Driving and operating machinery
Galvenox Veno has no influence on the ability to drive or operate machinery.

Galvenox Veno contains azorubine (E 122)
This medicine may cause allergic reactions.

3. How to use Galvenox Veno

This medicine should always be used exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
Unless otherwise directed by a 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 medicine is taken orally, during main meals.
Taking more Galvenox Veno than recommended
If you have taken more than the recommended dose of this medicine, consult your doctor or pharmacist immediately.
Missed dose of Galvenox Veno
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning 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 will experience them.
Rare (in less than 1 in 1,000 people, but more than 1 in 10,000 people):

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

Very rare (in less than 1 in 10,000 people):

• bone marrow suppression with agranulocytosis (an acute condition which may present with high fever, oral infections, or inflammatory conditions affecting the anorectal area and genital organs). In such cases, the medicine should be discontinued and medical advice sought immediately.

Cases of local (rash) and generalized allergic reactions (urticaria) have been reported.
Most adverse reactions resolve after discontinuation of Galvenox Veno or after dose reduction.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Galvenox Veno

Store below 25°C. Keep in the original packaging to protect from moisture.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Galvenox Veno contains

• The active substance is calcium dobesilate monohydrate. Each hard capsule contains 500 mg of calcium dobesilate monohydrate.
• The 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 contents of the pack
Galvenox Veno is available as hard capsules.
The capsule is cylindrical-oval, two-piece. The inner part (body) – white, the outer part (cap) – red. The capsule contents – white or almost white powder.
Available pack sizes:
30 hard capsules,
60 hard capsules.
The packaging consists of PVC/PVDC/Aluminium blisters in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Farmaceutyczna Spółdzielnia Pracy „GALENA”
ul. Dożynkowa 10
52-311 Wrocław
Poland
Tel.: + 48 71 710 62 01