Instruction for use: Doxi-Hem

Dosage form: capsules

Active substance: Calcii dobesilas

ATX

C05BX01 Calcium dobezilate

Pharmacological group

Angioprotective agent [Angioprotectors and microcirculation correctors]

The nosological classification (ICD-10)

H36.0 Diabetic retinopathy (E10-E14 + with common fourth character .3): Haemorrhagic diabetic retinopathy; Diabetic retinopathy; Macular degeneration in patients with diabetes

I73.8 Other specified peripheral vascular disease: Syndrome of intermittent claudication; endarteritis obliterans; acrocyanosis; vasoconstriction; occlusive disease; Intermittent claudication; Disorders of vascular innervation; Spasm of peripheral arteries; Arterial angiopathy; Venous insufficiency and its complications; Spasm of peripheral vessels; The spasm of coronary vessels; endarteritis; cooling stop; Occlusal disorders of peripheral circulation; Peripheral vascular occlusion

I78.8 Other capillary diseases: Capillary bleeding; Capillary bleeding in dentistry; Capillary bleeding from superficial wounds; Capillary bleeding in general surgery; Bleeding capillary; Increased brittleness of blood vessels; Teleangiectasia

I78.9 Unspecified Disease of capillaries: Increased permeability of capillaries; Teleangiectasia; Violation of the permeability of capillaries; Violation of capillary blood flow; Microcirculatory trophic disorder; Disturbances of microcirculation

I79 lesions of arteries, arterioles and capillaries in diseases classified elsewhere: Lack of capillary circulation

I80 Phlebitis and thrombophlebitis: Diseases of peripheral vessels; Inflammation of superficial veins; Inflammatory diseases of veins; Deep venous thrombophlebitis; The disease of veins; Disease of the veins of the lower extremities; Diseases of peripheral vessels; Migrating phlebitis; Insufficiency of veins of lower extremities; Exacerbation of chronic thrombophlebitis; Acute thrombophlebitis; Acute thrombophlebitis of superficial veins; Periphlebitis; Periflebit surface; Superficial inflammation of veins; Surface thrombophlebitis; Surface phlebitis; Thrombophlebitis; Deep vein thrombophlebitis; Thrombophlebitis superficial; Phlebitis; Phlebitis of deep veins; Phlebitis of superficial veins; Phlebopathy; Chronic thrombophlebitis; Endophlebitis

I83 Varicose veins of lower extremities: The feeling of heaviness and fatigue in the lower limbs; Varicose disseminated type; varicose veins; Varicose veins of the lower extremities; Varicose disease of lower limbs; Varicose superficial veins; Varicose veins; Varicose vein disease; varicose syndrome; varicose syndrome; Venous claudication; venous varices; venous disease; The disease of the lower extremities; Prevarikozny syndrome; Predvarikozny syndrome; Chronic varicose veins; Sclerotherapy varices

I83.1 Varicose veins of lower extremities with inflammation: Dermatitis stagnant; Varicose veins of lower limbs complicated by phlebitis; Varicose dermatitis; Varicose veins with inflammation; Eczema varicose; Varicose Eczema; Venous dermatitis

I87.2 Venous insufficiency (chronic) (peripheral): Painful foot fatigue; The pain and feeling of heaviness in the legs; The pain of chronic venous insufficiency; Venous insufficiency; Venous insufficiency of the lower limbs; Venous-lymphatic insufficiency; Venous edema; phlebostasis; Ischemic lesions stop; Lipedema; Microcirculatory-trophic disorders; Violation of venous circulation; Violation of venous circulation of the lower limbs; Disorders of venous circulation; Disorders of the peripheral circulation in the extremities; Lack of chronic venous; Insufficiency of venous circulation; Organic venous insufficiency of the lower limbs; Acute venous insufficiency of the lower limbs; Swelling in the legs; limb edema; Swelling in the legs; Swelling of lower limbs due to chronic venous insufficiency; Swelling of the legs; Edematous pain in venous insufficiency; Swelling and pain in the legs; The feeling of heaviness in the legs; Prevarikozny syndrome; The static heaviness in the legs; Trophic tissue changes; Trophic tissue disorders; Trophic disorders; Heaviness in the legs; Fatigue in the legs; Chronic venous insufficiency; Chronic venous insufficiency of the lower limbs; Chronic ischemic disease of the lower extremities; Chronic insufficiency of venous circulation; The feeling of heaviness in the legs; The feeling of heaviness in the legs during pregnancy; The feeling of heaviness in the legs after prolonged standing

L30.9 Unspecified Dermatitis: Allergic dermatoses complicated by a secondary bacterial infection; Anal eczema; Bacterial maturation; Varicose Eczema; Venous dermatitis; Inflammation of the skin; Inflammation of the skin upon contact with plants; Inflammatory Skin Disease; Inflammatory Skin Diseases; Inflammatory Skin Diseases; Inflammatory skin reactions; Inflammatory processes of the skin; Hypostatic dermatitis; Fungal Eczema; Fungal dermatosis; Dermatitis; Dermatitis is stagnant; Dermatitis and eczema in the anal area; Dermatitis acute contact; Perianal dermatitis; Dermatosis; Dermatosis of the scalp; Dermatosis of psoriasis; Dermatosis with persistent itching; Dermatoses; Dermatoses itchy; Other itching dermatoses; Significant eczematous manifestations; Itching with dermatoses; Itching eczema; Itching dermatoses; Itching dermatitis; Itching dermatosis; True eczema; Skin reaction to insect bites; Skin itching with dermatosis; Constitutional eczema; Weeping eczema; Drowsing inflammatory skin disease; Dying Infectious-Inflammatory Skin Disease; Non-allergic dermatitis; Nummular eczema; Acute contact eczema; Acute inflammatory skin disease; Acute dermatosis; Acute severe dermatosis; Perianal dermatitis; Superficial dermatosis; Subacute Contact Eczema; Simple dermatitis; Occupational dermatitis; Psychogenic dermatosis; Bubble dermatitis of newborns; Pustular eruptions; Irritation and redness of the skin; Low-flammable eczema; Dry atrophic eczema; Dry eczema; Toxic dermatitis; Ear eczema like dermatitis; Chronic eczema; Chronic dermatosis; Chronic dermatosis; Chronic common dermatosis; Scaly papular dermatosis; Eczema; Eczema anal region; Eczema of the hands; Eczema Contact; Eczema lichenized; Eczema Nummular; Eczema acute; Eczema acute contact; Eczema subacute; Eczematous dermatitis; Eczema-like rashes; Ecome exogenous; Endogenous eczema; Gluteal dermatitis; Limited itching dermatitis

M31.1 Thrombotic microangiopathy: Thrombotic thrombocytopenic purpura; Thrombocytopenic acroangiothrombosis; Moshkovich disease; Moshkovich-Singer-Simmers syndrome; Thrombotic microangiopathy; Purpura thrombotic; Purpura thrombocytopenic thrombohemolytic

N08.3 Glomerular lesions in diabetes mellitus (E10-14 + with common fourth sign .2): Nephropathy diabetic; Diabetic Nephropathy; Diabetic nephropathy in the background of type 1 diabetes mellitus; Diabetic nephropathy in patients with type I diabetes; Proteinuria in patients with type 2 diabetes mellitus

R20.2 Paresthesia of the skin: Paroxysmal paresthesia; Paresthesia

Composition

Capsules 1 caps.

active substance: Calcium dobezilate - 500 mg

(In the form of calcium dobezilate monohydrate 521.51 mg)

Auxiliary substances: corn starch - 25.164 mg; Magnesium stearate - 8.326 mg

Shell capsule: body - titanium dioxide (E171) - 0.864 mg, iron dye oxide yellow (E172) - 0.144 mg; (E172) - 0.192 mg, indigo carmine dye (E132) 0.1728 mg, titanium dioxide (E171) 0.48 mg, iron oxide yellow oxide (E172) 0.576 mg, gelatin up to 96 Mg

Description of dosage form

Capsules: hard gelatinous ¹0, body - opaque light yellow color, lid - opaque dark green color. The contents of the capsules are white to yellowish white powder. Conglomerates are allowed, which turn into free-flowing powder when the glass rod is lightly pressed.

Pharmacology

Mode of action - Antiaggregational, angioprotective.

Pharmacodynamics

Angioprotector, reduces the increased vascular permeability, increases the resistance of the capillary walls, improves microcirculation and drainage function of lymphatic vessels, moderately reduces platelet aggregation and blood viscosity, increases the elasticity of the erythrocyte membrane. The effect is related to a certain extent with an increase in the activity of plasma kinins.

Pharmacokinetics

Quickly absorbed in the digestive tract. Tmax in the blood plasma - 6 hours after ingestion. Binding to plasma proteins is 20-25%. Virtually does not penetrate the BBB.

It is excreted by the kidneys (about 50%) and through the intestine (about 50%), basically unchanged for 24 hours, 10% - in the form of metabolites. T1 / 2 - 5 hours. In very small amounts (0.4 μg / ml after taking 1.5 g of the drug) is excreted in breast milk.

Indications for Doxi-Hem

Vascular lesions with increased fragility and permeability of capillaries (diabetic retinopathy and nephropathy) and other microangiopathies associated with various cardiovascular and metabolic diseases;

Venous insufficiency of various severity and its consequences (pre-existing condition with puffiness symptoms of the tissues, pains, paresthesias, congestive dermatitis, superficial phlebitis, varicose veins, trophic ulcers).

Contraindications for Doxi-Hem

Hypersensitivity to calcium dobesilate or any component of the drug;

Peptic ulcer of the stomach and duodenum (in the stage of exacerbation);

Bleeding from the gastrointestinal tract;

Kidney and liver diseases;

Hemorrhages caused by anticoagulants;

Pregnancy (I trimester);

Children's age (up to 13 years).

Pregnancy and breast-feeding

Adequate and strictly controlled studies of safety of use in pregnant and lactating women are not conducted. The use of the drug is contraindicated in the first trimester of pregnancy. In the II and III trimesters of pregnancy, the drug is prescribed only for life indications if the expected effect of the application exceeds the possible risk to the fetus.

When appointing during lactation, it is necessary to resolve the issue of stopping breastfeeding.

Side effects

Classification of adverse reactions according to the frequency of development: often - 1-10%; Infrequently, 0.1-1%; Rarely - 0,01-0,1%; Very rarely, including individual cases - <0.01%.

From the digestive tract: rarely - nausea, diarrhea, vomiting.

From the skin and subcutaneous tissues: rarely - allergic reactions (pruritus, rash).

Common disorders: rarely - fever, chills.

From the musculoskeletal and connective tissue: rarely - arthralgia.

On the part of the blood and lymphatic system: in some cases - agranulocytosis. The reaction is reversible and disappears after discontinuation of therapy.

Interaction

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

Dosage and Administration

Inside, not chewing, with food.

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

Overdose

Cases of overdose were not observed.

Special instructions

The drug can be prescribed prophylactically.

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

Calcium dobesilate can affect the results of laboratory tests to determine the level of creatinine.

Influence on the ability to drive vehicles and work with machinery. The drug does not adversely affect the ability to drive vehicles and work with mechanisms.

Release form

Capsules, 500 mg. In a blister of PVC / aluminum, 10 pcs. 3 bl. In a pack of cardboard.

Manufacturer

Manufacturer / packer / bundler: Hemofarm AD Vršac, branch Production site Šabac, Serbia.

15000, Shabac, ul. Hajduk Velkova bb.

The owner of the registration certificate / issuing quality control: Hemofarm AD, Serbia, 26300, Vršac, Beograd road bb.

The organization accepting the claims: JSC "Nizhpharm", Russia, 603950, Nizhny Novgorod, GSP-459, ul. Salgan, 7.

Conditions of supply of pharmacies

On prescription.

Storage conditions of Doxi-Hem

In a dry place, at a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf life

5 years

Do not use beyond the expiration date printed on the package.