Eurofast plus

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT EUROFAST PLUS (EUROFAST PLUS)

Composition:

Active substances: ibuprofen; levomenthol;

1 g of gel contains ibuprofen 50 mg, levomenthol 30 mg;

Excipients: carbomer, ethanol 96%, propylene glycol, diethylamine, purified water.

Pharmaceutical form. Gel.

Main physicochemical properties: colorless gel, transparent or nearly transparent, with a characteristic odor. Opalescence and presence of a yellowish tint are permissible.

Pharmacotherapeutic group.

Topical preparations used for joint and muscle pain.

ATC code M02AX10.

Pharmacological Properties.

Pharmacodynamics.

Eurofast Plus is a combined topical medication containing ibuprofen and naturally derived menthol. Ibuprofen, a derivative of phenylpropionic acid, belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs) and exerts analgesic and anti-inflammatory effects by inhibiting prostaglandin synthetase. The action of levomenthol, the optical isomer of menthol, is mediated by reflex responses associated with stimulation of cutaneous sensory nerve endings. Menthol stimulates skin nociceptors, resulting in the release of peptides that produce vasodilatory effects. The drug exerts a counterirritant and stimulating effect and helps relieve pain.

Pharmacokinetics.

After topical application, ibuprofen is well and rapidly absorbed through the skin. Only a very small amount reaches the systemic circulation. Maximum plasma concentration of ibuprofen is achieved 2 hours after application and amounts to 0.6 mcg/mL. The extent of ibuprofen absorption following topical administration is approximately 5% of that observed after oral administration.

Levomenthol, absorbed through the skin, is transported to the liver. Some Phase I metabolism may occur in the skin, but the majority takes place in the liver. Menthol is hydroxylated and then conjugated with glucuronide prior to circulation to the kidneys for urinary excretion.

Clinical characteristics.

Indications.

Eurofast Plus is recommended for relief of pain and reduction of inflammation in rheumatic, muscular and joint pain, back pain, as well as pain and swelling due to injury, ligament sprains, and sports injuries.

Contraindications.

The medicinal product is contraindicated:

in case of hypersensitivity to ibuprofen, levomenthol, acetylsalicylic acid, or to any component of the preparation or other nonsteroidal anti-inflammatory drugs (including oral use);

in asthma, or history of bronchial asthma attacks, urticaria, angioedema (Quincke's edema), or acute rhinitis induced by acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs;

for application on damaged or denuded (epithelium-free) skin;

for application on open wounds, inflammatory or infectious skin diseases such as weeping eczema, as well as for application on mucous membranes;

in dermatoses;

in presence of local infection;

for simultaneous use on the same area with other topical medicinal products;

in peptic ulceration of the gastrointestinal tract;

third trimester of pregnancy.

Interaction with other medicinal products and other forms of interaction.

When used concomitantly with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, the risk of adverse effects increases. Nonsteroidal anti-inflammatory drugs may interact with antihypertensive agents, may reduce the diuretic effect of furosemide, and may potentiate the effect of anticoagulants, although the likelihood of such interactions with topically acting preparations is very low.

Special precautions for use.

The product contains propylene glycol, which may cause skin irritation; therefore, prior to first use, the patient's sensitivity to Eurofast Plus should be tested on a small area of skin.

It is known that oral ibuprofen may exacerbate renal insufficiency or aggravate active peptic ulcer disease. Patients with impaired renal function, asthma, active peptic ulcer disease of the stomach or duodenum in their medical history, and patients undergoing treatment with oral nonsteroidal anti-inflammatory drugs should consult a physician before using the product.

The gel must not be applied to mucous membranes, areas adjacent to mucous membranes, lips, nostrils, around the eyes, genital or anal areas, or on damaged, inflamed, or irritated skin. If the gel comes into contact with the aforementioned areas, it should be immediately washed off thoroughly with plenty of clean water.

After applying Eurofast Plus gel, hands must always be washed unless they are the area being treated.

If the product is accidentally swallowed, the patient must seek immediate medical attention at a doctor's office or the nearest emergency facility.

An occlusive dressing must not be applied over the area where the gel has been applied.

Treatment should be discontinued if a rash or irritation occurs, and the patient should consult a physician.

Adverse reactions may be minimized by using the lowest effective dose for the shortest possible duration.

If any adverse effects occur, or if there is no improvement or worsening of the condition, the patient should consult a physician.

Use of Eurofast Plus, like other drugs that inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility, although this likelihood is lower with topically applied nonsteroidal anti-inflammatory drugs compared to oral formulations. Women who have difficulty conceiving or who are undergoing fertility investigations may consider discontinuing use of Eurofast Plus.

Patients with bronchial asthma, hay fever, chronic lung disease, or hypersensitivity to analgesics and anti-rheumatic drugs are at higher risk of developing asthma attacks, mucosal edema (angioedema), or urticaria compared to other patients. Systemic absorption of ibuprofen following topical application is lower than with oral administration; therefore, the aforementioned complications may occur only rarely. Use of this product in such patients should be under medical supervision.

Care must be taken to ensure that children do not come into contact with skin areas treated with the product.

Skin areas treated with the product should not be exposed to prolonged sunlight to avoid photosensitivity.

During use of the medicinal product, safety precautions must be observed: do not smoke or approach open flames, as there is a risk of severe burns. Fabric (clothing, bed linen, dressings, etc.) that has been in contact with the medicinal product Eurofast Plus is more flammable and poses a serious fire hazard. Washing clothes and bed linen may reduce accumulation of the medicinal product but will not completely remove it.

Use during pregnancy or breastfeeding.

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development. Epidemiological data indicate an increased risk of miscarriage, cardiac malformations, and gastroschisis after use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiovascular malformation increased from less than 1% to approximately 1.5%. The risk is considered to increase with higher doses and longer duration of therapy. Animal studies have shown that administration of prostaglandin synthesis inhibitors leads to increased pre- and post-implantation loss and embryonic-fetal mortality. In addition, increased incidence of various developmental abnormalities, including cardiovascular defects, has been reported in animals treated with prostaglandin synthesis inhibitors during the organogenetic period.

Clinical data on the use of the topical medicinal product Eurofast Plus during pregnancy are lacking. Although systemic exposure to ibuprofen following topical application is lower than with oral administration, it is unknown whether systemic exposure to the medicinal product Eurofast Plus achieved after topical application could be harmful to the embryo/fetus. During the first and second trimesters of pregnancy, Eurofast Plus should not be used unless clearly necessary. If used, the dose should be as low as possible and the duration of treatment as short as possible.

During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors, including Eurofast Plus, may cause cardiovascular and renal toxicity in the fetus. Use of ibuprofen towards the end of pregnancy may delay labor and lead to prolonged bleeding in both mother and child; maternal edema and delayed labor may occur; the risk of premature closure of the ductus arteriosus is increased. Therefore, Eurofast Plus is contraindicated during the last trimester of pregnancy (see section "Contraindications").

Breastfeeding

Ibuprofen is excreted in breast milk in minimal amounts, and its effect on the breastfed infant is not expected to be significant. Topically applied ibuprofen as a single ingredient may be used during breastfeeding. However, there is insufficient information regarding the excretion of levomenthol and its metabolites into breast milk. In the absence of adequate data, use during breastfeeding is not recommended.

Ability to affect reaction speed when driving or operating machinery.

Not established.

Method of Administration and Dosage

For external use only.

The sealed opening of the tube must be pierced using the spike located on the upper outer part of the cap.

Apply a 1–4 cm strip of gel from the tube at each application.

Apply the gel to the affected area and gently rub in until completely absorbed. If necessary, apply up to 3 times daily, but no more frequently than every 4 hours. If there is no improvement after 2 weeks, consult a physician.

A dressing must not be applied over the area where the gel has been applied.

Children

Eurofast Plus is contraindicated for use in children under 12 years of age.

Overdose

The likelihood of overdose when using ibuprofen in the form of a topical gel is low. However, in case of overdose, adverse effects associated with systemic use of ibuprofen may occur (dyspeptic symptoms: nausea, heartburn, vomiting, flatulence; skin allergic reactions; headache, drowsiness, dizziness; arterial hypotension). If symptoms of overdose occur, discontinue use of the medicinal product and consult a physician.

In case of exceeding the recommended dose, wash off the gel with water. There is no specific antidote. Correction of the electrolyte balance is indicated.

Side effects.

Skin and subcutaneous tissue disorders: Hypersensitivity reactions may manifest as purpura, Quincke's edema (angioedema), bullous dermatoses (including epidermal necrolysis and Stevens-Johnson syndrome, erythema multiforme); skin redness, skin irritation. Most commonly observed skin-related disorders include: rash, urticaria, pruritus, dry skin, burning sensation, contact dermatitis. Photosensitivity reaction – frequency unknown.

Respiratory system, thoracic organs and mediastinum disorders: Hypersensitivity reactions such as bronchial asthma attacks or worsening of asthma symptoms, dyspnea, shortness of breath, and bronchospasm may occur in patients with a history of bronchial asthma or allergic diseases.

Gastrointestinal tract disorders: Depending on the amount of gel applied, the application area, integrity of the skin, duration of treatment, and use of occlusive dressing, the following adverse effects are possible, although unlikely: abdominal pain, dyspepsia.

Renal and urinary system disorders: Renal function impairment in patients with a history of kidney disease.

Immune system disorders: Hypersensitivity reactions, including anaphylactic shock, angioneurotic edema, and nonspecific allergic reactions.

Other systemic adverse reactions to nonsteroidal anti-inflammatory drugs depend on the amount of gel applied, the size of the application area, integrity of the skin, duration of treatment, and use of an occlusive dressing.

Shelf life. 3 years.

Do not use after the expiry date.

Storage conditions.

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

Keep out of reach of children.

Incompatibility.

Do not use with other topical medicinal products.

Packaging.

50 g of gel in an aluminum tube; 1 tube per cardboard box.

Availability.

Over-the-counter (without prescription).

Manufacturer.

JSC "CHEMICAL PHARMACEUTICAL PLANT "CHERVONA ZIRKA".

Manufacturer's address and location of business activity.

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