Calcium dobesilate hasco

Package leaflet: Information for the patient

Calcium Dobesilate Hasco
500 mg, tablets
Calcii dobesilas monohydricum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What Calcium Dobesilate Hasco is and what it is used for

The active substance in Calcium Dobesilate Hasco is calcium dobesilate monohydrate, which improves venous circulation and provides protective effects on blood vessels. It reduces the permeability of vessel walls and decreases excessive blood and plasma viscosity.
Indications
Clinical symptoms of chronic venous insufficiency of the lower limbs: pain, cramps, paresthesias (numbness, tingling), edema, and skin changes due to blood stasis.
Non-proliferative diabetic retinopathy (damage to retinal blood vessels in diabetes mellitus).

2. Important information before using Calcium Dobesilate Hasco

When not to use Calcium Dobesilate Hasco:

• if the patient is allergic (hypersensitive) to the active substance (calcium dobesilate monohydrate) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Calcium Dobesilate Hasco, discuss this with your doctor,
pharmacist, or nurse.
Use this medicine with caution if the patient has gastric or duodenal ulcer disease, recurrent inflammation of the gastric mucosa, or renal insufficiency.
Calcium Dobesilate Hasco and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to take.
Calcium Dobesilate Hasco with food and drink
This medicine should be taken after meals to avoid or reduce gastrointestinal adverse effects.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Use of this medicine is not recommended during the first trimester of pregnancy. The medicine may be used during pregnancy only if, in the opinion of the physician, the benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding
This medicine should not be used during breastfeeding.
Driving and operating machinery
Calcium Dobesilate Hasco has no influence on the ability to drive or operate machinery.
Calcium Dobesilate Hasco contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Calcium Dobesilate Hasco

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Adults
The dosage should be individually adjusted depending on the severity of the disease.
Treatment may last from several weeks to several months, depending on the indication. The medicine should be
taken after meals.
Chronic venous insufficiency: 500 mg to 1000 mg (1 to 2 tablets) daily.
Non-proliferative diabetic retinopathy: 1000 mg to 1500 mg (2 to 3 tablets) daily.
The medicine is taken orally.
Taking more Calcium Dobesilate Hasco than recommended
If you take more than the recommended dose, consult your doctor or pharmacist immediately.
Symptoms of overdose are unknown.
Missing a dose of Calcium Dobesilate Hasco
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 experiences them.
The listed adverse reactions usually resolve spontaneously after discontinuation of treatment.
Rare (in 1 to 10 out of 10,000 patients): nausea, diarrhoea, skin reactions, joint pain.
Very rare (less than 1 in 10,000 patients): agranulocytosis – an acute condition which may present with high fever, oral infections, sore throat, inflammatory changes in the anal and genital areas.
If any of these symptoms or other signs of infection occur,
the medicine should be discontinued immediately and medical advice should be sought.
Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 4921301, fax: +48 22 4921309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables better assessment of the safety profile of the medicine.

5. How to store Calcium Dobesilate Hasco

Store in the original packaging, at a temperature below 25 °C.
Keep the medicine in a place inaccessible and out of sight 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Calcium Dobesilate Hasco contains

• The active substance is calcium dobesilate monohydrate (Calcii dobesilas monohydricum). One tablet contains 500 mg of calcium dobesilate monohydrate.
• Other ingredients are: microcrystalline cellulose, potato starch, lactose monohydrate, talc, magnesium stearate, anhydrous colloidal silicon dioxide.

What Calcium Dobesilate Hasco looks like and contents of the pack
Uncoated tablets, double-sided oval, convex, smooth, uniform, white and odourless.
One pack contains 2 blisters with 15 tablets each, placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal product information
tel.: (22) 742 00 22
e-mail: [email protected]