Instructions Eurofast Plus gel tube 50 g
Composition
active ingredients: ibuprofen; levomenthol;
1 g of gel contains ibuprofen 50 mg, levomenthol 30 mg;
Excipients: carbomer, ethanol 96%, propylene glycol, diethylamine, purified water.
Dosage form
Gel.
Main physicochemical properties: colorless, transparent or almost transparent gel with a specific odor. Opalescence and the presence of a yellowish tint are allowed.
Pharmacotherapeutic group
Topical agents used for joint and muscle pain.
ATX code M02A X10.
Pharmacological properties
Pharmacodynamics.
Eurofast Plus is a combined preparation for external use containing ibuprofen with menthol of natural origin. Ibuprofen, a derivative of phenylpropionic acid, is a representative of the group of nonsteroidal anti-inflammatory drugs, has an analgesic, anti-inflammatory effect due to the inhibition of prostaglandin synthetase. The action of levomenthol, an optical isomer of menthol, is due to reflex reactions associated with irritation of sensitive nerve endings of the skin. Menthol stimulates skin nociceptors. As a result, peptides are released that have a vasodilating effect. The drug has a distracting, irritating effect and relieves pain.
Pharmacokinetics.
Ibuprofen is well and rapidly absorbed through the skin when applied topically. It enters the systemic circulation in very small amounts. The maximum concentration of ibuprofen in the blood plasma is reached 2 hours after application of the drug and is 0.6 μg/ml. The absorption of ibuprofen when applied topically is approximately 5% of the absorption when taken orally.
Levomenthol absorbed through the skin is transported to the liver. Some phase I metabolism may occur in the skin, but the majority occurs in the liver. Menthol is hydroxylated and then conjugated with a glucuronide before circulating to the kidneys for excretion in the urine.
Indication
Eurofast Plus is recommended for pain relief and inflammation reduction in rheumatic, muscle and joint pain, back pain, as well as pain and swelling due to injuries, sprains and sports injuries.
Contraindication
The drug is contraindicated:
with hypersensitivity to ibuprofen, levomenthol, acetylsalicylic acid or to any component of the drug or other non-steroidal anti-inflammatory drugs (including oral administration);
with asthma and a history of attacks of bronchial asthma, urticaria, angioedema or acute rhinitis caused by taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
for use on damaged or bare (without epithelium) skin;
for use on open wounds, for inflammatory and infectious skin diseases such as wet eczema, as well as for use on mucous membranes;
for dermatoses;
in the presence of local infection;
for simultaneous use on the same area with other topical preparations;
with ulcerative lesions of the gastrointestinal tract.
Interaction with other medicinal products and other types of interactions
When used together with acetylsalicylic acid or other drugs from the group of non-steroidal anti-inflammatory drugs, the risk of side effects increases. Non-steroidal anti-inflammatory drugs may interact with drugs intended to lower blood pressure, may reduce the diuretic effect of furosemide and may enhance the effect of anticoagulants, although this probability is very low for topical drugs.
Application features
The drug contains propylene glycol, which may cause skin irritation, so before first use, it is necessary to check the patient's sensitivity to Eurofast Plus on a small area of skin.
Oral ibuprofen is known to worsen renal failure or exacerbate active peptic ulcer disease. Patients with impaired renal function, asthma, a history of active gastric or duodenal ulcer disease, and patients receiving oral nonsteroidal anti-inflammatory drugs should consult a doctor before using the drug.
The gel should not be applied to or near mucous membranes, lips, nostrils, areas near the eyes, genitals, or anus, or to damaged, inflamed, or irritated skin. If the gel gets on the above areas, rinse immediately with plenty of clean water.
After applying Eurofast Plus gel, you should always wash your hands unless they are the object of treatment.
If the drug is swallowed, the patient should immediately consult a doctor or the nearest emergency room.
Do not apply an airtight bandage to the area where the gel was applied.
Discontinue use if rash or irritation occurs and consult a doctor.
If any undesirable effects occur, as well as if there is no improvement or if the condition worsens, the patient should consult a doctor.
The use of Eurofast Plus, as with other drugs that inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility, although this is less likely for topical NSAIDs than for oral agents. In women who have difficulty conceiving or who are undergoing fertility studies, it may be appropriate to discontinue Eurofast Plus.
Patients with bronchial asthma, hay fever, chronic lung disease, and patients with hypersensitivity to analgesics and antirheumatic drugs are at greater risk of developing asthma attacks, swelling of the mucous membrane (Quincke's edema) or urticaria than other patients. Systemic absorption of ibuprofen with topical application is less than with oral administration, so the listed complications may occur in rare cases. The use of the drug in these patients should be carried out under the supervision of a physician.
It is necessary to ensure that children do not touch the areas of skin on which the drug has been applied.
Areas of skin to which the drug is applied should not be exposed to prolonged sunlight to avoid photosensitivity of the skin.
Use during pregnancy or breastfeeding
The safety of ibuprofen during pregnancy in humans has not been adequately documented. Animal studies using the oral formulation have not shown teratogenic effects.
Ibuprofen and its metabolites pass into breast milk, so the use of this drug during breastfeeding is not recommended.
The drug is not recommended for use during the first and second trimesters of pregnancy or during breastfeeding. The drug is contraindicated in the third trimester, since in the case of sufficient systemic concentration, the risk of delayed labor, premature closure of the ductus arteriosus, bleeding in the mother and newborn, and edema in the mother increases.
Ability to influence reaction speed when driving vehicles or other mechanisms
Not installed.
Method of administration and doses
For external use only.
The sealed hole in the tube must be pierced with a spike located in the upper outer part of the cap.
With each application, use a strip of gel 1-4 cm from the tube.
Apply the gel to the painful area, rub in gently until completely absorbed. If necessary, apply up to 3 times a day, but not more often than every 4 hours. If there is no improvement in the condition after 2 weeks, consult a doctor.
A bandage should not be applied to the area where the gel was applied.
Children.
Eurofast Plus is contraindicated for use in children under 12 years of age.
Overdose
The probability of overdose when using ibuprofen in the form of a gel for external use is insignificant. However, in case of overdose, side effects are possible that are observed with systemic use of ibuprofen (dyspepsia: nausea, heartburn, vomiting, flatulence; allergic skin reactions; headache, drowsiness, dizziness; arterial hypotension). If symptoms of overdose appear, you should stop using the drug and consult a doctor.
If the recommended dose is exceeded, the gel should be washed off with water. Specific antidote is unknown. Correction of electrolyte balance is indicated.
Side effects
Skin and subcutaneous tissue disorders: hypersensitivity reactions, which may manifest as cutaneous purpura, angioedema, bullous dermatoses (including epidermal necrolysis and erythema multiforme); skin redness, skin irritation. The most common skin disorders are: rash, urticaria, itching, dry skin, burning sensation, contact dermatitis.
Respiratory, thoracic and mediastinal disorders: Hypersensitivity reactions in the form of asthma attacks or worsening of asthma, shortness of breath, dyspnoea and bronchospasm may occur in patients with a history of asthma attacks or allergic diseases.
From the gastrointestinal tract, depending on the amount of gel applied, the area of application, the integrity of the skin, the duration of treatment, and the presence of an occlusive dressing, the following are possible, although unlikely: abdominal pain, dyspepsia.
Renal and urinary disorders: renal dysfunction in patients with a history of renal disease.
Immune system disorders: Hypersensitivity reactions, including anaphylactic shock, angioedema and non-specific allergic reactions.
Other systemic adverse reactions to nonsteroidal anti-inflammatory drugs depend on the amount of gel applied, the area of application, the integrity of the skin, the duration of treatment, and the use of an occlusive dressing.
Expiration date
3 years.
Do not use after the expiration 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 medications.
Packaging
50 g of gel in an aluminum tube; 1 tube in a cardboard pack.
Vacation category
Without a prescription.
Producer
Public Joint Stock Company "Chempharmaceutical Plant "Red Star".
Address.
Ukraine, 61010, Kharkiv region, Kharkiv city, Hordienkivska street, building 1.
