Calcium dobesilate galena

Package leaflet: Information for the patient

CALCIUM DOBESILATE GALENA
250 mg, tablets
Calcii dobesilas
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

The active substance in Calcium dobesilate Galena is calcium dobesilate. The sites of action of calcium dobesilate are the capillary endothelium, venous walls, and lymphatic vessels. Maximum blood concentration of the drug is reached approximately 6 hours after administration.
Calcium dobesilate Galena reduces capillary wall permeability, thereby decreasing exudation; increases venous wall elasticity and tone; reduces blood viscosity by altering protein composition and decreases platelet aggregation; improves microcirculation and prevents blood stasis in venous vessels and thrombus formation.
The drug also reduces lymphatic vessel permeability and enhances lymphatic drainage, leading to a reduction in edema.

Therapeutic indications

• Microangiopathies, especially diabetic retinopathy;
• Clinical symptoms of chronic venous insufficiency of the lower limbs (pain, muscle cramps, paresthesia, edema, skin changes associated with venous stasis);
• Adjunctive treatment in superficial thrombophlebitis of the lower limbs;
• Adjunctive treatment in hemorrhoids;
• Adjunctive treatment in microcirculatory disorders of arteriovenous origin.

2. Important information before using Calcium dobesilate Galena

When not to use Calcium dobesilate Galena

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

Warnings and precautions
Before starting treatment with Calcium dobesilate Galena, discuss this with your doctor.
Contact your doctor if you have active peptic ulcer disease of the stomach and/or duodenum, or chronic gastritis. Periodic monitoring of gastric and duodenal function is recommended. If symptoms worsen, discontinue the medicine and contact your doctor.
Consult your doctor, even if the above warnings refer to conditions that occurred in the past.

Use of Calcium dobesilate Galena in patients with renal and/or hepatic impairment
In patients with severe renal impairment, especially those undergoing dialysis, reduced doses should be used.

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

Calcium dobesilate Galena with other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
There are no data available on interactions with other medicines.

Calcium dobesilate Galena and food
The medicine should be taken orally during main meals.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.

Pregnancy
Calcium dobesilate Galena may be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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

Driving and operating machinery
Calcium dobesilate Galena has no influence on the ability to drive or operate machinery.

Calcium dobesilate Galena contains monohydrate lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Calcium dobesilate Galena

This medicine should always be taken as directed by a physician. In case of doubts, consult your doctor.
Recommended dose
The usual dose is 2 tablets once or twice daily (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 should be taken orally, during main meals.
Taking more Calcium dobesilate Galena than prescribed
If you have taken more than the recommended dose of this medicine, consult your doctor or pharmacist immediately.
Missed dose of Calcium dobesilate Galena
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Rarely (in less than 1 in 1,000 people, but more than 1 in 10,000 people) the following occur:

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

Very rarely (in less than 1 in 10,000 people), bone marrow suppression with agranulocytosis has been observed (an acute condition which may present as high fever, oral infections, or inflammatory conditions affecting the anal region and genital organs). In such cases, the medicine must be discontinued and a doctor should be consulted immediately.
Cases of local (rash) and generalized (urticaria) allergic reactions have been reported.
Most adverse reactions resolve after discontinuation of the medicine or after dose reduction.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
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 Calcium dobesilate Galena

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

6. Contents of the packaging and other information

What Calcium dobesilate Galena contains

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

What Calcium dobesilate Galena looks like and contents of the packaging
Calcium dobesilate Galena is available in the form of tablets. The tablet is white, round,
slightly convex on both sides.
Available pack sizes:
30 tablets,
60 tablets.
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