Espol

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ESPOL (ESPOL)

Composition:

Active substances: capsicum oleoresin, dimethyl sulfoxide;

1 g of ointment contains: capsicum oleoresin (Extractum Capsici annuis pissum) – 100 mg, (5.55:1) (extractant – 80% ethanol), expressed as total capsaicinoids – 1 mg; dimethyl sulfoxide – 30 mg;

Excipients: coriander oil, lavender oil, chloroform, lanolin, white soft paraffin, yellow soft paraffin.

Pharmaceutical form. Ointment.

Main physicochemical properties: ointment of light brown to reddish-brown color, of uniform consistency, with a faint specific odor.

Pharmacotherapeutic group.

Topical preparations used for joint and muscular pain. Capsicum preparations and similar agents.

ATC code M02AB.

Pharmacological Properties

Pharmacodynamics

Espol exerts analgesic, distracting, warming, resorptive, anti-inflammatory, and local irritant effects. The therapeutic effect is due to the combined action of the components contained in the medicinal product. Capsaicins from capsicum pepper extract produce a strong local irritant effect on skin sensory receptors; dimethyl sulfoxide exerts analgesic and anti-inflammatory actions and exhibits moderate fibrinolytic activity. The preparation enhances penetration of drugs through intact skin and mucous membranes, promoting deeper penetration of concurrently applied medicinal substances. Coriander oil exerts general strengthening and tonic effects; lavender oil exhibits mild sedative and spasmolytic properties. The ointment components induce reflexive dilation of small blood vessels and improve blood supply to the painful area, thereby enhancing drainage of the affected site and facilitating removal of inflammatory mediators.

Pharmacokinetics

The effect begins within 10–15 minutes after application and reaches its maximum within 30 minutes. The duration of analgesia ranges from 30 minutes to 2 hours.

Clinical characteristics.

Indications.

Myositis, injuries without skin integrity disruption, muscle strains and ruptures, neuralgia, lumbago, lumboischialgia, fractures.

Contraindications.

Hypersensitivity to the components of the medicinal product, bronchial asthma, renal failure, hepatic failure, cardiac insufficiency, circulatory insufficiency, glaucoma, cataract, pronounced atherosclerosis, angina pectoris, stroke, myocardial infarction, comatose states, pregnancy, breastfeeding period, children under 12 years of age, injuries, skin integrity impairment, open wounds, eczema, active stage of any inflammatory process, purulent skin diseases.

Interaction with other medicinal products and other types of interactions.

Dimethyl sulfoxide, which is part of the preparation, enhances the effects of ethanol (alcohol inhibits the elimination of the preparation) and insulin, acetylsalicylic acid, butadione; digitalis preparations, quinidine, nitroglycerin, antibiotics (streptomycin, monomycin, etc.), chloramphenicol, rifampicin, griseofulvin, and sensitizes the organism to anesthetic agents. One should take into account the enhancement by the preparation of both the specific activity and the toxicity of medicinal products. The preparation may be used in combination with nonsteroidal anti-inflammatory agents in complex therapy of osteoarthritis and rheumatoid arthritis; in combination with locally acting antimicrobial agents (synthomycin liniment) — for the treatment of streptodermia.

Do not apply the ointment simultaneously with other locally irritating medicinal products, agents that increase blood supply and cause skin reddening.

Increases the likelihood of neuropathy when used with preparations containing sulindac.

Concomitant use with analgesic gels is not recommended.

Interaction with other medicinal products applied to the same site is possible even within 12 hours after removal of the ointment.

When using any other medicinal products simultaneously, inform your physician.

Special precautions for use.

Do not allow the ointment to come into contact with damaged skin, eyes, or mucous membranes.

Bandaging is permissible only after most of the ointment has been absorbed.

Avoid using additional heat sources during treatment (e.g., sunlight or infrared radiation, heating pads, or warm water). The warming effect may also be intensified by physical activity (increased sweating).

If excessive warming occurs, treatment should be discontinued. In such a case, any excess ointment should be removed.

If symptoms worsen during application of Espol ointment, consult a physician.

Use during pregnancy or breastfeeding.

Do not use during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

Use with caution, taking into account the effect on the central nervous system, particularly the possibility of dizziness.

Method of Administration and Dosage.

For external use in adults and children aged 12 years and older.

Apply a strip of ointment 4–7 cm long (2–3 g of ointment) in a thin layer to an area of skin approximately the size of the palm, using gentle rubbing motions with the hand, avoiding contact with damaged skin or open wounds. Apply 2–3 times daily.

The duration of treatment, determined individually by a physician, is usually from 1 to 10 days. Hands must be thoroughly washed after each application. After the procedure, any remaining ointment on the skin should be removed with a cloth moistened with soapy water.

Children.

For use in children aged 12 years and older.

Overdose.

Symptoms of overdose may include allergic reactions such as skin rash, urticaria, and skin desquamation.

Treatment: upon signs of overdose, remove any remaining ointment from the skin using a cloth moistened with soapy water and consult a physician. Symptomatic therapy is recommended.

Adverse Effects.

Skin reactions: dermatitis, skin rash, pruritus, skin desquamation at the application site, hyperemia, erythema, sensation of warmth and burning at the site of application, tingling, contact eczema.

Hypersensitivity reactions: angioneurotic edema, bronchospasm, hypersensitivity, allergic reactions including urticaria and blister formation.

Central nervous system: dizziness, headache, insomnia, adynamia.

Gastrointestinal tract: nausea, vomiting.

These symptoms usually resolve quickly after discontinuation of the drug. If any adverse reactions occur, discontinue use immediately and consult a physician without delay.

Shelf Life.

3 years.

Do not use after the expiry date stated on the packaging.

Storage Conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

30 g in tubes.

1 tube per cardboard box.

Prescription Status.

Over-the-counter (non-prescription).

Manufacturer.

PJSC "CHIMFARMZAVOD "CHERVONA ZIRKA".

Manufacturer's Address.

Ukraine, 61010, Kharkiv Oblast, Kharkiv, Gordeyenkivska Street, 1.