Package leaflet: Information for the patient

DOBENOX, 250 mg, film-coated tablets
DOBENOX Forte, 500 mg, film-coated tablets
Calcii dobesilas monohydricus
Please read all of this leaflet carefully before taking this medicine, because 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 doctor or pharmacist.

Keep this leaflet so that it can be read again if necessary.
If advice or further information is needed, please consult the pharmacist.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
If there is no improvement or if the patient feels worse, they should contact their doctor.

Table of contents

What Dobenox or Dobenox Forte is and what it is used for
Important information before taking Dobenox or Dobenox Forte
How to take Dobenox or Dobenox Forte
Possible side effects
How to store Dobenox or Dobenox Forte
Contents of the pack and other information

1. What Dobenox or Dobenox Forte is and what it is used for

The active substance in this medicine is calcium dobesilate monohydrate, which improves venous circulation and provides protective action on blood vessels. It reduces the permeability of their walls and excessive viscosity of blood and plasma, thereby preventing the development of stasis and thrombosis in the venous vessels.
Indications
Symptomatic treatment of chronic venous insufficiency of the lower limbs (leg pain and nocturnal cramps, sensation of heaviness in the legs, paresthesia, edema, skin changes due to blood stasis), varicose veins of the lower limbs.
Symptomatic treatment of hemorrhoidal varices.

2. Important information before using Dobenox or Dobenox Forte

When not to use Dobenox or Dobenox Forte
if the patient is allergic to calcium dobesilate monohydrate or any of the other
components of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Dobenox or Dobenox Forte, consult your doctor or
pharmacist.
Use this medicine with caution if the patient has gastric or duodenal ulcer disease, recurrent gastritis, or renal insufficiency.
Discontinue the medicine immediately and contact a doctor if symptoms such as fever, sore throat or larynx, pain during swallowing, oral inflammation, rhinitis, stomatitis, or inflammation around the genital organs and anus occur, as these may be symptoms of a serious condition—agranulocytosis.
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Dobenox or Dobenox Forte with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take.

Dobenox or Dobenox Forte 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 child, she should consult a doctor or pharmacist before using this medicine.
Use of this medicine is not recommended during the first trimester of pregnancy.
This medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.
This medicine should not be used during breastfeeding.

Driving and operating machinery
Dobenox or Dobenox Forte has no influence on the ability to drive or operate machinery.

Dobenox or Dobenox Forte contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
1 tablet of Dobenox contains 25 mg of lactose.
1 tablet of Dobenox Forte contains 50 mg of lactose.

3. How to take Dobenox or Dobenox Forte

This medicine should always be taken exactly as described in this patient information leaflet or as
advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use.
Take this medicine after meals.

Dobenox, 250 mg, coated tablets
Unless otherwise directed by a physician, the usual dose for adults is 2 to 4 tablets per day (corresponding
to a daily dose of 500 mg to 1000 mg of active substance - calcium dobesilate monohydrate):
venous insufficiency - usually 2 tablets 1-2 times daily;
haemorrhoids - usually 2 tablets 1-2 times daily.

Dobenox Forte, 500 mg, coated tablets
Unless otherwise directed by a physician, the usual dose for adults is 1 to 2 tablets per day (corresponding
to a daily dose of 500 mg to 1000 mg of active substance - calcium dobesilate monohydrate):
venous insufficiency - usually 1 to 2 tablets daily;
haemorrhoids - usually 1 to 2 tablets daily.

If in doubt, consult your doctor or pharmacist.
Treatment may last from several weeks to several months, depending on the indication.

Taking more Dobenox or Dobenox Forte than recommended
Symptoms of overdose are unknown.
If you take more than the recommended dose, contact your doctor or pharmacist immediately.

Missing a dose of Dobenox or Dobenox Forte
Do not take a double dose to make up for a missed dose.

Stopping Dobenox or Dobenox Forte
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
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4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The listed adverse reactions usually resolve spontaneously after discontinuation of treatment.

Adverse reactions occurring rarely (in 1 to 10 patients per 10,000):
nausea, diarrhoea,
skin reactions,
joint pain.

Adverse reactions occurring very rarely (less frequently than in 1 patient per 10,000):
agranulocytosis – an acute condition which may present with high fever, oral infections, sore throat, inflammatory lesions in the anorectal and genital areas.
If any of these symptoms or other signs of infection occur,
the medicine must be discontinued immediately and medical advice must be sought.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Aleje Jerozolimskie 181C, 02-222 Warsaw
Tel.: 22 49 21 301, Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.

Adverse reactions may 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 Dobenox or Dobenox Forte

Store in the original packaging, at a temperature below 25 °C.
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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
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6. Contents of the pack and other information

What Dobenox or Dobenox Forte contains
The active substance is calcium dobesilate monohydrate.
Each tablet contains either 250 mg or 500 mg of calcium dobesilate monohydrate.
The other ingredients (excipients) are: microcrystalline cellulose, potato starch, monohydrate lactose, talc, magnesium stearate, colloidal anhydrous silica, coating Opadry II 57U18539 White containing: hypromellose, polydextrose, titanium dioxide (E 171), talc, maltodextrin, medium-chain triglycerides.

What Dobenox or Dobenox Forte looks like and contents of the pack
Dobenox
Film-coated tablets – round, biconvex, white, with uniform and smooth surface.
One pack of Dobenox contains 30 film-coated tablets.

Dobenox Forte
Film-coated tablets – oval, biconvex, white, with uniform and smooth surface.
One pack of Dobenox Forte contains either 30 or 60 film-coated tablets.

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]
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