Inforin Active Gel 40g

Product Trade Name: Inforin Active Active Ingredient: Ibuprofen, Levomenthol Dosage Form: External Use Gel Composition: Active Ingredients: Ibuprofen - 50mg, Levomenthol - 30mg. Excipients: 96% Ethanol, Propylene Glycol, Carbomer Interpolymer (Carbopol Ultrez), Diisopropanolamine, Purified Water. Description: Transparent gel-like mass Pharmacotherapeutic Group: Other agents for topical use in joint and muscle pain, other preparations. Pharmacological Action: Pharmacodynamics: The pharmacological action is due to the two components of the gel: ibuprofen and menthol. Ibuprofen, a derivative of phenylpropionic acid, is a prostaglandin synthetase inhibitor, which has analgesic and anti-inflammatory effects when used topically. Menthol reflexively stimulates skin pain receptors, exhibits vasodilating and transdermal effects, which manifest as pain relief and increased temperature of the skin and subcutaneous tissues, and skin hyperemia. Thus, menthol helps reduce pain in muscles, tendons, and joints. Pharmacokinetics: When used topically, ibuprofen is absorbed through the skin. The degree of absorption with topical use is approximately 5% compared to oral administration. The maximum concentration of ibuprofen in plasma is reached after 2 hours and is 0.6 mcg/ml. Ibuprofen is rapidly and extensively distributed throughout the body, binding to proteins by 99%. Ibuprofen undergoes metabolism in the liver through hydroxylation and carboxylation. Two inactive metabolites are formed as a result. The plasma half-life of ibuprofen is 2.5 hours. Pharmacologically inactive metabolites are excreted mainly by the kidneys (90%), and also by bile. Levomenthol is excreted by the kidneys in the form of polar metabolites and in small amounts in exhaled air as CO2. Indications for Use: • For local symptomatic treatment of mild traumatic injuries of muscles and joints, swelling (sprains, bruises, sports injuries); • For pain syndrome in the complex treatment of rheumatism; Method of Administration and Dosage: For external use only in adults and children over 12 years of age, as well as in the elderly. Apply 1-4 cm of gel (a 1 cm column contains 0.55g of gel) to the painful area and rub gently until absorbed. Reapply as needed, up to a maximum of 3 times a day, strictly observing a 4-hour interval between applications. If the condition does not improve after 2 weeks of treatment, consult a doctor. Children under 12 years of age: Due to lack of safety and efficacy data, the use of the drug in children under 12 years of age is not recommended. Elderly: Elderly patients should use all NSAIDs with caution due to an increased risk of side effects. Patients with impaired liver and kidney function: In patients with mild to moderate impairment of liver and kidney function, NSAID-containing drugs should be used at the minimum effective dose to control clinical symptoms for the shortest possible duration. Side Effects: The following criteria are used to assess the frequency of adverse reactions: very common (≥1/10), common (≥1/100 - <1/10), uncommon (≥1/1000 - <1/100), rare (≥1/10000 - <1/1000), very rare (<1/10000), unknown (frequency cannot be determined from available data). Common: • Rash, itching, urticaria, dry skin, redness, burning sensation, contact dermatitis; Rare (hypersensitivity reactions associated with ibuprofen): • Non-specific allergic and anaphylactic reactions; • Hypersensitivity reactions of the respiratory system (asthma, exacerbation of asthma, bronchospasm, and shortness of breath); • Rash, itching, urticaria, purpura, angioneurotic edema, rarely bullous dermatitis (toxic epidermal necrolysis, erythema multiforme). Very Rare: • With topical use of NSAIDs (depending on the amount of gel used, the area of the treated surface, the integrity of the skin, the duration of treatment, and the use of occlusive dressings), systemic effects such as abdominal pain, dyspepsia, and renal failure may develop. Unknown: • Impaired kidney function (in patients with a history of kidney disease). Contraindications: • Hypersensitivity to ibuprofen, levomenthol, acetylsalicylic acid, components of the drug, or other NSAIDs; • Bronchial asthma, bronchospasm, rhinitis, urticaria associated with the intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs; • Damaged skin or skin inflammation; • Presence of local infection; • Concurrent use with other topical preparations on the same area of skin; • Last trimester of pregnancy; • Children under 12 years of age. Interactions with Other Drugs: Concomitant use with acetylsalicylic acid or other NSAIDs may increase the risk of adverse reactions. Given the low systemic absorption, interactions described for oral forms of NSAIDs are not usually expected under normal conditions. Special Instructions: Do not apply the gel to inflamed or damaged skin areas. Before use, perform a sensitivity test on a small area of skin. Avoid contact with eyes and mucous membranes. If redness, swelling, rash, or other signs of possible allergy develop, discontinue use of the drug and consult a doctor regarding continuation of treatment. Do not apply an occlusive (airtight) dressing to the area where the gel is applied. Always wash your hands after using Inforin Active, unless they are the treatment site. Patients with bronchial asthma or allergic diseases in their medical history or at the time of use may develop hypersensitivity reactions of the respiratory system in the form of asthma, its complications, bronchospasm, or shortness of breath. Side effects can be minimized by using the minimum effective doses for the shortest possible duration. If the gel accidentally gets into the eyes during treatment, or if there is no improvement or worsening of the condition, consult a doctor. Given the effect of ibuprofen on kidney function, in patients with impaired kidney function, the drug can only be used after consulting a doctor. Fertility, Pregnancy, and Lactation: Inforin Active gel contains ibuprofen as an active substance, which is a cyclooxygenase synthesis inhibitor and may affect fertility when used systemically (although the probability of this is extremely low). Therefore, Inforin Active is not recommended for women who have problems with conception or who are undergoing investigations for infertility. Experimental studies in animals have shown no teratogenic effects. There is data on the effect of ibuprofen on delaying or prolonging labor. The use of ibuprofen in topical preparations is not recommended during the first 6 months of pregnancy. Ibuprofen and its metabolites are excreted in breast milk, therefore, the use of the drug during lactation is not recommended. Effect on Ability to Drive and Operate Machinery: Topical preparations of ibuprofen do not affect the ability to drive vehicles and operate machinery. The product should be stored out of reach of children and should not be used after the expiry date. Overdose: The probability of overdose with topical use of the drug is minimal. Symptoms of ibuprofen overdose (if taken orally): headache, vomiting, drowsiness, hypotension. Treatment: If taken orally, gastric lavage, induction of vomiting, administration of activated charcoal, symptomatic treatment, correction of electrolyte balance if necessary. No specific antidote is known. Dosage Form: The preparation is available in a 40g aluminum tube with an internal lacquered surface, sealed with a plastic screw cap, with a latex ring at the bottom. 1 tube with instructions for use in state and Russian languages is placed in a cardboard box. Storage Conditions: Store at a temperature not exceeding 25°C, do not freeze. Shelf Life: Indicated on the packaging. Do not use after the expiry date. Dispensing Category: Pharmaceutical product group III, available without a prescription. Manufacturer: Balkanpharma-Razgrad AD, 68, Aprilsko Vastanie Blvd, 7200 Razgrad, Bulgaria Holder of Commercial License and Registration Certificate: Spey Medical Ltd London, Great Britain