Ibufen gel for 10% 50g №1

Name:
Ibufen gel. Release formGel. INNIBuprofen. FTGNpvp. Composition 1 g of gel contains: active ingredient: ibuprofen lysine salt 100 mg excipients: polyethylene glycol 200, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), carbomer 980, bitter orange oil, triethanolamine, purified water.
Description:
Light yellow or yellow, slightly opalescent gel with a characteristic odor. Pharmacotherapeutic group Non-steroidal anti-inflammatory drugs for external use ATC code: M02AA13 Pharmacological properties Ibufen® gel has a pronounced analgesic and anti-inflammatory effect due to the suppression of prostaglandin synthesis. Suppresses the production of inflammatory mediators. Inhibits cyclooxygenase and blocks the biosynthesis of prostaglandins. The anti-inflammatory effect is due to the normalization of increased vascular permeability, improvement of microcirculation, a decrease in the liberation of histamine, bradykinin and other inflammatory mediators, inhibition of ATP formation, which leads to a decrease in the energy supply of the inflammatory process. The analgesic effect of ibuprofen is associated with a decrease in the intensity of inflammation, a decrease in the production and weakening of the algogenicity of bradykinin. Ibufen® gel contains ibuprofen in the form of a hydrotropic compound with lysine – ibuprofen lysinate. The hydrotropic properties of ibuprofen lysinate result in a faster release of ibuprofen in larger amounts than when using free acid ibuprofen. Lysine, which is part of this active substance, accelerates the penetration of ibuprofen into the deep layers of the skin without increasing the degree of overall absorption, by increasing its solubility in the hydrophilic gel. The effect occurs after 30 minutes and lasts for several hours. In the articular tissues, therapeutically significant concentrations of the drug are retained for several hours, while the active substance is contained in the blood serum only in a small amount. Biological transformation of ibuprofen occurs in the liver, its excretion – in the kidneys. Indications for use Ibufen® gel is used for local primary and secondary treatment for: – muscle pain; – degenerative joint diseases (osteoarthritis); – inflammatory rheumatic diseases of the joints and spine; – swelling and inflammation of the periarticular soft tissues (joint bag, tendon, ligaments, joint capsule, tendon sheath); – humeroscapular periarthritis (frozen shoulder syndrome), lower back pain, lumbago; – injuries (including sports ones) without breaking the integrity of soft tissues (contusion, sprain, tendons). Contraindications Ibufen® should not be used in case of: – individual hypersensitivity to ibuprofen or any of the excipients, acetylsalicylic acid and other non-steroidal anti-inflammatory drugs, – allergic skin diseases, – infectious diseases with changes in the skin, – burns, – violations of the integrity skin, – bronchospasm, rhinitis and urticaria in history associated with taking acetylsalicylic acid or other NSAIDs. There are no sufficient indications for the use of the drug Ibufen® gel in children under 12 years of age, therefore, it is not recommended to use the drug in children under 12 years of age without a doctor’s prescription. Interaction with other medicinal products Drug interactions of ibuprofen with external use are not described, however, interactions, such as when taken orally, cannot be completely excluded. However, it should be borne in mind that even when applied topically, ibuprofen has a systemic effect, and, theoretically, side effects may increase with the simultaneous use of the gel with other NSAIDs. Cautions When using ibuprofen, care should be taken in patients with impaired liver or kidney function, as well as with peptic ulcer of the stomach and (or) duodenum. Patients with bronchial asthma who have not previously taken acetylsalicylic acid or other NSAIDs are advised to consult a doctor before using the medicinal product Ibufen® gel. Topical ibuprofen can cause gastrointestinal side effects. Although the risk of these side effects is much less than with oral ibuprofen, patients with gastrointestinal disorders should seek medical advice before using Ibufen® Gel. Avoid getting the gel in the eyes and mucous membranes. In case of skin changes in the area of application, the use of the drug should be discontinued. If long-term application to the skin is required, it is recommended to use protective gloves. The interval between applications of the drug should be at least 4 hours. After using the gel, wash your hands thoroughly, except when it is the hands that are the painful place. If after 2 weeks after taking the drug, the symptoms do not stop or increase, you should consult a doctor. The concentration of ibuprofen in the circulatory system when applied externally is less than when taken orally. However, due to the fact that ibuprofen taken by mouth can exacerbate existing renal failure, patients with a history of kidney disease should seek medical advice before using the drug Ibufen® gel. Pregnancy and lactation Do not use during pregnancy or lactation. Pregnancy: Although no teratogenic effect has been found, the use of ibuprofen during pregnancy should be avoided. It is possible to delay the onset of labor and lengthen the period of delivery. Lactation: Ibuprofen is able to pass into breast milk in very low concentrations, but its effect on a child who is breastfed is unlikely. Influence on the ability to drive motor vehicles and maintain mechanical equipment There is no information on contraindications to the management of transport and maintenance of mechanisms after the drug Ibufen® gel. Method of application and doses For external use. Adults and children over 12 years of age: A strip of gel about 3 cm long is applied to the affected area and carefully rubbed with light movements until completely absorbed 3 times a day. Do not exceed the recommended dose. Overdose Overdose after external application is unlikely. If the drug enters the oral cavity, overdose symptoms are possible. The half-life of the drug after an overdose is from 1.5 to 3 hours. Symptoms of an overdose when taking the drug orally The majority of patients taking NSAIDs observed: nausea, vomiting, pain in the epigastric region, less often diarrhea. Tinnitus, headache, and bleeding from the gastrointestinal tract were also noted. In more severe cases, disturbances from the peripheral nervous system were noted in the form of drowsiness, temporary arousal, disorientation, or coma. Seizures were also periodically observed, and in severe poisoning, metabolic acidosis and prolongation of the prothrombin time (PT/INR). Acute renal failure and liver disorders have also been noted. The possibility of worsening asthma symptoms in asthmatics was also stated. Measures in case of overdose If the drug was accidentally taken orally, it is necessary to stimulate vomiting, gastric lavage (within an hour after ingestion), take activated charcoal, alkaline drink. Symptomatic and supportive therapy is used. Side effects Violations of a general nature at the site of application: – skin disorders (for example, redness) and a feeling of crawling at the site of application of the drug, – non-specific allergic and anaphylactic reactions. Respiratory, thoracic and mediastinal disorders: – Asthma, exacerbation of asthma, bronchospasm or shortness of breath. Disorders of the skin and subcutaneous tissues: – a rash of a different nature, – itching, – urticaria, – Quincke’s edema, – toxic epidermal necrolysis and polymorphic erythema (rarely). Gastrointestinal disorders: – abdominal pain, – dyspepsia. With prolonged use on a large surface of the body, additional side effects may develop, such as: headache, dizziness, changes in the blood picture (granulocytopenia, agranulocytosis), hyperuricemia, and on the part of the gastrointestinal tract – nausea, vomiting, loss of appetite, relapse of gastric ulcer and duodenum. In the course of treatment with ibuprofen, kidney disorders are also possible, in particular in patients with kidney disease. The appearance of all side (unusual) effects, including those not listed in the package insert, must be reported to the attending physician. Shelf life 2 years. An opened tube must be used within 6 months. Holiday conditions Without a prescription. Storage conditionsKeep in a place protected from light at a temperature of 15°C to 25°C. The drug should be kept out of the reach of children. Packing 50 g in aluminum tubes. 1 tube, together with the leaflet, is placed in individual cardboard packs. Buy Ibufen gel for 10% 50g No. 1