Fitobene®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PHYTOBENE® (PHYTOBENE)

Composition:

Active substances: dexpanthenol, sodium heparin, dimethyl sulfoxide;

1 g of gel contains:
dexpanthenol, recalculated to 100 % substance – 0.025 g;
sodium heparin, recalculated to 100 % substance – 500 IU;
dimethyl sulfoxide, recalculated to 100 % substance – 0.15 g;

Excipients: ethanol 96 %, carbomer 980, polyoxethylated hydrogenated castor oil, tromethamine, rosemary oil, pine oil, lemon oil, purified water.

Pharmaceutical form. Topical gel.

Main physicochemical characteristics: colorless transparent or almost transparent gel with a specific odor. It should be homogeneous in appearance.

Pharmacotherapeutic group.

Topical preparations for joint and muscular pain.

ATC code M02AX.

Pharmacological properties.

Pharmacodynamics.

Phytobene® gel is a combined topical medication. The effect of the drug is due to the components contained in its formulation.

Dimethyl sulfoxide exerts anti-inflammatory, anti-exudative, and local anesthetic effects by inactivating hydroxyl radicals and improving metabolic processes at the site of inflammation, as well as by reducing the conduction velocity of nociceptive impulses in peripheral neurons. Dimethyl sulfoxide penetrates through biological membranes and facilitates the absorption of other drug components.

Sodium heparin, a direct-acting anticoagulant and a natural anti-aggregatory factor of the body, exerts a moderate anti-inflammatory effect by inactivating biogenic amines in tissues. It improves microcirculation, prevents thrombosis, activates fibrinolytic activity of blood, and promotes regeneration of connective tissue by inhibiting hyaluronidase activity.

Dexpanthenol, a derivative of vitamin B5, is converted into pantothenic acid in the skin. Pantothenic acid is a component of coenzyme A, which plays an essential role in acetylation and oxidation processes. By enhancing metabolic processes, dexpanthenol stimulates regeneration of damaged tissues.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Traumas (including sports injuries), hematomas, muscle injuries, periarticular structures or joints (without skin involvement); tendinitis and tenosynovitis, bursitis, periarthritis of the shoulder and elbow (pathological basis of the clinical syndrome "tennis elbow"); acute neuralgias.

Contraindications.

Hypersensitivity to the components of the medicinal product; severe impairment of liver and/or kidney function; bronchial asthma; unstable hemodynamics; severe cardiovascular disorders (severe angina pectoris, myocardial infarction, stroke, severe generalized atherosclerosis); bleeding trophic ulcers of the legs, open and/or infected wounds, hemorrhagic diathesis, purpura, thrombocytopenia, hemophilia, tendency to bleeding; comatose states, glaucoma, cataract.

Interaction with other medicinal products and other types of interactions.

The use of heparin may prolong prothrombin time in patients taking oral anticoagulants. The product should not be used concomitantly with topical medicinal products, e.g., those containing tetracycline, hydrocortisone, salicylic acid, or anticoagulants.

Due to the ability of dimethyl sulfoxide to enhance both the specific activity and toxicity of certain medicinal products, simultaneous application of other topical medicinal products should be avoided.

Fitobene® containing dimethyl sulfoxide must not be used with sulindac (a nonsteroidal anti-inflammatory drug) due to the possibility of severe toxic reactions (peripheral neuropathy).

Dimethyl sulfoxide enhances the effects of ethanol (alcohol inhibits the elimination of the drug) and insulin, acetylsalicylic acid, butadione; digitalis preparations, quinidine, nitroglycerin, antibiotics (streptomycin, monomycin); it also sensitizes the body to anesthetic agents.

Special safety precautions.

The product should not be applied to mucous membranes, open wound surfaces, or damaged skin (e.g., after irradiation, in dermatitis, dermatoses, postoperative scars, burns).

Other medicinal products should not be applied to treated skin areas for several hours before and after gel application.

To prevent unwanted effects, the product must be applied to skin cleaned of other medicinal products, cosmetics, and contaminants.

Contact with eyes should be avoided.

The product does not leave a greasy shine on the skin or stains on clothing.

Polyoxylethylated castor oil may cause severe allergic reactions.

Application of dimethyl sulfoxide may lead to the development of photosensitization. Therefore, during the use of Fitobene® gel, sunbathing and visiting solariums should be avoided. If hypersensitivity reactions occur, the use of the product should be discontinued.

Special precautions for use.

Use during pregnancy or breastfeeding.

Potential teratogenic effects of dimethyl sulfoxide have been reported in animals.

Experience with the use of dimethyl sulfoxide in pregnant women is insufficient; therefore, the use of Fitobene® during pregnancy or breastfeeding is contraindicated.

Dimethyl sulfoxide passes into breast milk; therefore, the use of Fitobene® during breastfeeding is contraindicated.

Ability to influence reaction speed when driving vehicles or operating machinery.

The drug does not affect reaction speed when driving vehicles or operating machinery.

Method of Administration and Dosage

Apply the gel as a thin layer (e.g., a 3 cm strip of gel should be applied to an area corresponding to the projection of the knee joint) to affected areas and/or around them (in case of abrasions), spreading it evenly over the skin surface and gently rubbing in with light movements. Repeat the procedure 2–4 times daily.

When applying dressings with Fitobene® gel, use an air-permeable dressing material. Apply the dressing after most of the gel has penetrated into the skin and the alcohol contained in the medicinal product has evaporated (i.e., after several minutes).

During iontophoresis, due to its good contact properties and content of active substances, the preparation enhances the physiotherapeutic effect of ultrasound waves.

The duration of treatment with Fitobene® gel is determined individually by the physician and depends on the severity of the disease and the therapeutic response.

Children. The product is not recommended for use in children due to limited experience of application.

Overdose.

Cases of overdose have not been observed with the use of Fitobene® medicinal product.

Overdose may intensify the manifestations of adverse effects, requiring discontinuation of the product and initiation of symptomatic therapy.

Increased bruising and elevated risk of bleeding have been reported following topical application of heparin in doses exceeding 180,000 IU. Gastrointestinal absorption of heparin is negligible; therefore, overdose following accidental ingestion is unlikely.

Side effects.

Immune system disorders: allergic skin reactions; in individual cases, immediate-type allergic reactions such as urticaria and Quincke's edema are possible.

Cardiovascular system disorders: in individual cases, when applied to large areas of skin, cardiac disturbances are possible (causal relationship not established).

Respiratory system disorders: in individual cases, when applied to large areas of skin, respiratory system disturbances are possible (causal relationship not established).

Gastrointestinal disorders: temporary garlic-like breath odor (due to dimethyl sulfide – a metabolite of dimethyl sulfoxide); altered taste sensations which resolve within several minutes; in individual cases, when applied to large skin areas, gastric disturbances, nausea, diarrhea (causal relationship not established).

Skin disorders: photosensitivity reactions.

General disorders: erythema, itching, burning, blisters, urticaria at the application site. These reactions usually resolve during treatment. If they do not, the use of the product should be discontinued. In individual cases, when applied to large skin areas, increased fatigue, headache, chills may occur (causal relationship not established).

Due to the effect of dimethyl sulfoxide: dizziness, insomnia, adynamia, dermatitis, bronchospasm, vomiting.

Due to the effect of dexpanthenol: contact dermatitis, allergic dermatitis, eczema, rash, skin irritation.

Due to the effect of heparin: skin swelling, skin rash, hemorrhages; occasionally, small pustules, vesicles or bullae may develop, which rapidly resolve after discontinuation of the product.

If any adverse effects or other unusual reactions occur, use of the product should be discontinued and medical advice must be sought regarding further therapy.

Shelf life. 3 years.

Storage conditions. Store in original packaging at a temperature not exceeding 25 °C. Do not freeze. Keep out of reach of children.

Packaging. 20 g, 40 g, or 100 g in tubes; 1 tube in a carton.

Prescription status. Over-the-counter.

Manufacturer. JSC "FITOFARM".

Manufacturer's address and location of business activity.

2 Sybitskova St., Bakhmut, Donetsk region, 84500, Ukraine.

Marketing authorization holder. JSC "FITOFARM".

Address of the marketing authorization holder.

7, Verkhovnoyi Rady Ave., Kyiv, 02100, Ukraine, premises 18, floor 3.