Calcium dobesilate Galena

Package Leaflet: Information for the Patient

CALCIUM DOBESILATE GALENA

250 mg, tablets

Calcii dobesilas

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

1. What is Calcium dobesilate Galena and what is it used for

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

Indications for Use

• Microangiopathies, especially diabetic retinopathy,
• Clinical symptoms of chronic venous insufficiency of the lower limbs (pain, muscle cramps, paresthesia, swelling, skin changes associated with venous stasis),
• As an adjunct in superficial thrombophlebitis of the lower limbs,
• As an adjunct in hemorrhoids,
• As an adjunct in microcirculation disorders of arteriovenous origin.

2. Important Information Before Taking Calcium dobesilate Galena

When Not to Take Calcium dobesilate Galena

• in children.

Warnings and Precautions

Before starting treatment with Calcium dobesilate Galena, discuss it with your doctor. You should 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 your doctor consulted. You should consult your doctor even if the above warnings refer to past situations.

Use of Calcium dobesilate Galena in Patients with Renal and/or Hepatic Impairment

In patients with severe renal impairment, especially those on 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.

Calcium dobesilate Galena 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.

Calcium dobesilate Galena 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 Calcium dobesilate Galena may be used in pregnant women only if the potential benefit of the medicine outweighs the potential 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 the breastfed child. Before starting treatment with the medicine, breastfeeding should be stopped.

Driving and Using Machines

Calcium dobesilate Galena does not affect the ability to drive and use machines.

Calcium dobesilate Galena Contains Lactose Monohydrate

If you have been told that you have an intolerance to some sugars, contact your doctor before taking the medicine.

3. How to Take Calcium dobesilate Galena

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.

Recommended Dose

Usually, 2 tablets are 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.

Taking a Higher Dose of Calcium dobesilate Galena Than Recommended

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

Missing a Dose of Calcium dobesilate Galena

Do not take a double dose to make up for a forgotten 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), agranulocytosis (a serious condition that may manifest as high fever, infections in the mouth or inflammatory conditions in the anus and genital area) has been observed. In such cases, the medicine should be discontinued and your doctor consulted. Localized (rash) and generalized (urticaria) allergic reactions have been reported. Most side effects disappear after discontinuation of the medicine or reduction of the dose.

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 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Calcium dobesilate Galena

Store in a temperature below 30°C. Store in the original package. The medicine should be stored out of 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 Calcium dobesilate Galena Contains

• The active substance of the medicine is calcium dobesilate (in the form of calcium dobesilate monohydrate). One tablet contains 250 mg of calcium dobesilate in the form of calcium dobesilate monohydrate.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, talc, magnesium stearate, anhydrous colloidal silica.

What Calcium dobesilate Galena Looks Like and Contents of the Pack

Calcium dobesilate Galena is available in the form of tablets. The tablet is white, round, and slightly convex on both sides. Available packs: 30 tablets, 60 tablets. The pack is a blister pack 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 Tel.: +48 71 710 62 01

Date of Last Revision of the Leaflet:14.04.2023