Doxi-Hem^® (Capsules) Instructions for Use

Marketing Authorization Holder

Hemofarm, A.D. (Serbia)

Contact Information

NIZHFARM group of companies (Russia)

ATC Code

C05BX01 (Calcium dobesilate)

Active Substance

Calcium dobesilate (Rec.INN registered by WHO)

Dosage Form

Doxi-Hem®

Capsules 500 mg: 30 or 90 pcs.

Dosage Form, Packaging, and Composition

Capsules are hard gelatin, size No. 0, with an opaque light yellow body and a dark green cap; the capsule contents are a powder from white to yellowish-white in color; the presence of conglomerates is allowed, which turn into a free-flowing powder when lightly pressed with a glass rod.

Excipients : corn starch – 25.164 mg, magnesium stearate – 8.326 mg.

Capsule shell composition body – titanium dioxide (E171) – 0.864 mg, iron oxide yellow dye (E172) – 0.144 mg; cap – iron oxide black dye (E172) – 0.192 mg, indigotine dye (E132) – 0.1728 mg, titanium dioxide (E171) – 0.48 mg, iron oxide yellow dye (E172) – 0.576 mg, gelatin – up to 96 mg.

10 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Drug improving microcirculation. Angioprotector

Pharmacotherapeutic Group

Angioprotective agent

Pharmacological Action

An angioprotector, it reduces increased vascular permeability, increases the resistance of capillary walls, improves microcirculation and the drainage function of lymphatic vessels, moderately reduces platelet aggregation and blood viscosity, and increases the elasticity of the erythrocyte membrane.

The action is associated to a certain extent with an increase in plasma kinin activity.

Pharmacokinetics

It is rapidly absorbed from the gastrointestinal tract. The maximum plasma concentration is reached 6 hours after oral administration. Plasma protein binding is 20-25%.

It practically does not penetrate the blood-brain barrier.

It is excreted by the kidneys (about 50%) and through the intestines (about 50%) mainly unchanged within 24 hours, 10% as metabolites. The half-life is 5 hours.

In very small amounts (0.4 µg/ml after taking 1.5 g of the drug), it is excreted in breast milk.

Indications

• Vascular lesions with increased capillary fragility and permeability (diabetic retinopathy and nephropathy) and other microangiopathies associated with various cardiovascular and metabolic diseases;
• Venous insufficiency of varying severity and its consequences (pre-varicose condition with symptoms of tissue swelling, pain, paresthesia, stasis dermatitis; superficial phlebitis, varicose veins, trophic ulcers).

ICD codes

Dosage Regimen

Orally, without chewing, during meals.

It is prescribed at 500 mg 3 times a day for 2-3 weeks, then the dose is reduced to 500 mg once a day. For the treatment of retinopathy and microangiopathy, 500 mg is prescribed 3 times a day for 4-6 months, then the daily dose is reduced to 500 mg once a day. The course of treatment is from 3-4 weeks to several months depending on the therapeutic effect.

Adverse Reactions

Classification of adverse reactions by frequency of occurrence: common – 1-10%, uncommon – 0.1-1%, rare – 0.01-0.1%, very rare, including isolated cases – < 0.01%.

Gastrointestinal disorders

Rare: nausea, diarrhea, vomiting.

Skin and subcutaneous tissue disorders

Rare: allergic reactions (itching, rash).

General disorders

Rare: fever, chills.

Musculoskeletal and connective tissue disorders

Rare: arthralgia.

Blood and lymphatic system disorders

In isolated cases: agranulocytosis. The reaction is reversible and disappears after discontinuation of therapy.

Contraindications

• Hypersensitivity to calcium dobesilate or any component of the drug;
• Gastric and duodenal ulcer (in the acute stage);
• Gastrointestinal bleeding;
• Kidney and liver diseases;
• Hemorrhages caused by anticoagulants;
• Pregnancy (first trimester);
• Children’s age (under 13 years).

Use in Pregnancy and Lactation

Adequate and strictly controlled studies on the safety of use in pregnant and breastfeeding women have not been conducted.

The use of the drug is contraindicated in the first trimester of pregnancy.

In the second and third trimesters of pregnancy, the drug is prescribed only for vital indications if the expected benefit of use outweighs the possible risk to the fetus.

When prescribed during lactation, the issue of discontinuing breastfeeding should be considered.

Use in Hepatic Impairment

Contraindicated in liver diseases.

Use in Renal Impairment

Contraindicated in kidney diseases.

Pediatric Use

Contraindicated in children under 13 years of age.

Special Precautions

The drug can be prescribed prophylactically.

If symptoms of agranulocytosis occur (fever, headache, chills, weakness, pain when swallowing, inflammation of the oral mucosa), you should immediately consult a doctor and perform a clinical blood test.

Calcium dobesilate may affect the results of laboratory tests to determine creatinine levels.

Effect on the ability to drive vehicles and operate machinery

The drug does not adversely affect the ability to drive vehicles and operate machinery.

Overdose

No cases of overdose have been reported.

Drug Interactions

Cases of drug interaction of calcium dobesilate have not been identified to date.

Storage Conditions

At a temperature from 15 to 25°C (77°F) in a dry place. Keep out of reach of children.

Shelf Life

Shelf life – 5 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.