Dobenox

Package Leaflet: Information for the Patient

DOBENOX, 250 mg, coated tablets

DOBENOX Forte, 500 mg, coated tablets

Calcii dobesilas monohydricus

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, a doctor should be consulted.

Table of Contents of the Package Leaflet

• 1. What is Dobenox or Dobenox Forte and what is it used for
• 2. Important information before taking Dobenox or Dobenox Forte
• 3. How to take Dobenox or Dobenox Forte
• 4. Possible side effects
• 5. How to store Dobenox or Dobenox Forte
• 6. Package contents and other information

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

The active substance of the medicine is calcium dobesilate monohydrate, which improves venous circulation and has a protective effect on blood vessels. It reduces the permeability of their walls and excessive blood and serum viscosity, preventing the formation of stasis and thrombosis in venous vessels.

Indications for Use

Symptomatic treatment of chronic venous insufficiency of the lower limbs (pain and nocturnal cramps in the legs, feeling of heaviness in the legs, paresthesia, swelling, skin changes due to blood stasis), varicose veins of the lower limbs.
Symptomatic treatment of hemorrhoids.

2. Important Information Before Taking Dobenox or Dobenox Forte

When Not to Take Dobenox or Dobenox Forte

If the patient is allergic to calcium dobesilate monohydrate or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Before starting treatment with Dobenox or Dobenox Forte, the doctor or pharmacist should be consulted.
The medicine should be used with caution if the patient has gastric or duodenal ulcer disease, or renal insufficiency.
Treatment with the medicine should be stopped immediately and a doctor consulted if symptoms such as fever, sore throat, difficulty swallowing, oral inflammation, nasal mucosa inflammation, inflammation of the genital and anal areas occur, as these may be symptoms of a serious disease - agranulocytosis.

Dobenox or Dobenox Forte and Other Medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Dobenox or Dobenox Forte with Food and Drink

The medicine should be taken after meals to avoid or minimize gastrointestinal side effects.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
The medicine is not recommended during the first trimester of pregnancy.
The medicine may be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
The medicine should not be used during breastfeeding.

Driving and Operating Machines

The medicine does not affect the ability to drive or operate machines.

Dobenox or Dobenox Forte Contains Lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.
One tablet of Dobenox contains 25 mg of lactose.
One 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 package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the doctor or pharmacist should be consulted.
The medicine is taken orally.
The medicine should be taken after meals.

Dobenox, 250 mg, Coated Tablets

Unless the doctor has prescribed otherwise, the usual dose for adults is 2 to 4 tablets per day (corresponding to a daily dose of 500 mg to 1000 mg of the active substance - calcium dobesilate monohydrate):
venous insufficiency - usually 2 tablets 1-2 times a day;
hemorrhoids - usually 2 tablets 1-2 times a day.

Dobenox Forte, 500 mg, Coated Tablets

Unless the doctor has prescribed otherwise, the usual dose for adults is 1 to 2 tablets per day (corresponding to a daily dose of 500 mg to 1000 mg of the active substance - calcium dobesilate monohydrate):
venous insufficiency - usually 1 to 2 tablets per day;
hemorrhoids - usually 1 to 2 tablets per day.
If in doubt, the doctor or pharmacist should be consulted.
Treatment may last from several weeks to several months, depending on the indications.

Taking a Higher Dose of Dobenox or Dobenox Forte Than Recommended

There are no known symptoms of overdose.
If a higher dose of the medicine than recommended is taken, a doctor or pharmacist should be consulted immediately.

Missing a Dose of Dobenox or Dobenox Forte

A double dose should not be taken to make up for a missed dose.

Stopping Treatment with Dobenox or Dobenox Forte

If there are any further doubts about taking this medicine, a doctor or pharmacist should be consulted.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The listed side effects usually resolve on their own after stopping treatment.
Uncommon side effects (occurring in 1 to 10 patients out of 10,000):
nausea, diarrhea,
skin reactions,
joint pain.
Rare side effects (occurring in less than 1 patient out of 10,000):
agranulocytosis - an acute condition that may manifest as high fever, infections in the mouth, sore throat, changes in the anal and genital areas.

If Any of These Symptoms or Other Infection Symptoms Occur, the Medicine Should Be Stopped Immediately and a Doctor Consulted.

Reporting Side Effects

If any side effects occur, including any side effects not listed in this package leaflet, the doctor or pharmacist should be informed. 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
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: 22 49 21 301, fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather 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.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package Contents and Other Information

What Dobenox or Dobenox Forte Contains

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

What Dobenox or Dobenox Forte Looks Like and Contents of the Package

Dobenox
Coated tablets - round, biconvex, white, with a uniform and smooth surface.
One package of Dobenox contains 30 coated tablets.
Dobenox Forte
Coated tablets - oval, biconvex, white, with a uniform and smooth surface.
One package of Dobenox Forte contains 30 or 60 coated tablets.

Marketing Authorization Holder and Manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine Information
tel. 22 742 00 22
e-mail: [email protected]
Date of Last Update of the Package Leaflet:03/2024