1 g gel contains naproxen 100 mg
other ingredients:chloral hydrate, levomenthol, ethanol 96%, metilparagidroksibenzoat (E 214), sodium hydroxide, carbomer, purified water.The
basic physico-chemical properties: homogeneous mass of gel-like consistency, white, with a characteristic smell of menthol, without mechanical inclusions.The
Nonsteroidal anti-inflammatory drugs for topical use.
ATX Code M02A A12.The
Pharmacodynamics.the Gel has a local anti-inflammatory, analgesic and anti-edema effect. The mechanism of action of the active substance, i.e. naproxen, is associated with inhibition of enzyme - prostaglandinsynthase. Cyclooxygenase catalyzes the oxidation of arachidonic acid into endoperoxide. This reaction is the first step in the synthesis of prostaglandins, which stop the development of the late phase of the inflammatory process - hyperemia and edema. Naproxen's anti-inflammatory properties are also associated with suppression of lysosomal activity, inhibition of leukocyte migration, neutralization of free radicals, and suppression of interleukin-2.
Gel due to the presence of menthol and ethanol in its composition also shows a surface cooling and soothing effect.
Menthol contained in the preparation, causes a feeling of coolness, reduces the sensitivity of the skin nerve endings and locally dilates blood vessels. Menthol also enhances the absorption of naproxen through the skin.
Pharmacokinetics. With local use of drugs, contains naproxen, absorption is slower than when administered orally or rectally. The maximum concentration of the drug in the blood appears after 4: 00 after topical application on the skin. With local application, there is a significant cumulation of naproxen in the epidermis, derma and muscle tissue. After topical application of naproxen in the form of 10% gel, there was a slight concentration of this compound in plasma, about 1.1%, in urine the concentration was 1%. The concentration of the drug in the synovial fluid - after topical application - is small (about 50% concentration in serum).
99.9% naproxen binds to plasma proteins, mainly albumin. Naproxen is rapidly eliminated from the blood; approximately 98% of naproxen is excreted in urine 10% of the dose is excreted unchanged, 60% is in the form of the linked naproxen (40% in form of glucuronides and 20% in the form of unknown related compounds), 5% - in the form of a 6 - desmethylnaproxen, 12% - in the form of guluronate 6-desmethylnaproxen, 11% - in the form of unknown related compounds 6-methylenedioxy. From 0.5 to 2.5% is excreted in the feces. Naproxen crosses the placental barrier and in breast milk. In women's milk naproxen manifests itself in a concentration of approximately 1% of the drug concentration in serum.
age up to 3 years. Hypersensitivity to the drug, salicylates and other nonsteroidal anti-inflammatory drugs; pregnancy (III trimester), lactation, inflammatory conditions and skin lesions, open wounds.
direct sunlight exposure (also sun exposure) should be avoided during treatment as well as during 2 weeks after treatment.
the drugShould be used with caution The
you should Not use the drug under the bandage (bandages, plasters). To avoid getting the drug on mucous membranes and eyes. In case of contact with the gel in the eyes or mucous membranes should be removed by washing with plenty of water.The
is Not installed. However, in the case of prolonged use of the drug in large areas of the skin can not be completely excluded the appearance of such interaction.
Do not apply to damaged skin, skin with signs of inflammation. In case of adverse reactions, discontinue use of the drug.
since there is a possibility of absorption into the systemic bloodstream, the drug should be used with caution in patients with hepatic and renal insufficiency, ulcers in the gastrointestinal tract or hemorrhagic diathesis.
the product contains metilparagidroksibenzoat that may lead to the development of allergic reactions.
use during pregnancy or lactation.
Naproxen causes delayed delivery in animals and damages the fetal cardiovascular system (may trigger closure of the arterial duct) in humans. For this reason, the drug should not be used during pregnancy, except in cases prescribed by the doctor and only under his supervision. The possibility of naproxen in pregnancy requires careful consideration of the potential benefits for the mother and fetus, especially in the I and III trimester of pregnancy.
Naproxen penetrates breast milk, so the doctor should decide whether to stop breastfeeding or discontinue the drug, taking into account the benefits of the use.
Ability to influence the reaction rate when driving motor transport or operating intima mechanisms.
the Drug does not affect the reaction rate when driving motor transport or operating other mechanisms.
Apply externally. It is recommended to apply a strip of gel with a length of about 4 cm, applying it to clean and dry skin 4-5 times a day at intervals of several hours.
After application of the drug to spread and gently RUB in until completely absorbed. After applying the drug should wash your hands to reduce the concentration of gel absorbed through the skin. The application of the drug should not be cover with a bandage or plaster.
The duration of treatment depends on the course of the disease as well as the effectiveness of the treatment and is generally not more than 4 weeks. If the pain and/or swelling does not decrease or increase after 1 week of use, or, conversely, should consult your doctor.
the Drug should not be used in children under 3 years.
Symptoms of drug overdose are not described. Given the slight absorption of naproxen through the skin into the systemic bloodstream, there is no risk of overdose or intoxication with a drug intended for topical use. However, due to improper use or accidental consumption, systemic side effects may occur. In this case, therapeutic tactics should be applied, as in the intoxication of NSAIDs with drugs.
Irritation, rash, rash vesicular, photosensitivity, burning sensation. With prolonged use on large areas of the skin, side effects may occur due to the General action of naproxen (including nausea, diarrhea, drowsiness, headache, allergic reactions, including skin rashes, erythema, urticaria, itching).The
do Not use after the expiry date.
Store in a tightly closed tube at a temperature not exceeding 25 ° C, out of reach of children. Do not cool or freeze.The
the Aluminum tube of 50 g with internal lacquer coating, with a protective membrane, with cover-Busoni screw, cardboard box.The
over the counter.The
EMO-FARM limited liability company/EMO-FARM Sp. z o.Oh.
Ul. Ludzki 52, 95-054 Ksawerow, Poland/52 Lodzka Str., 95-054 Ksawerow, Poland
Naproxen gel 100 mg tube 50 g of the drug for local application pertaining to NSAIDs. The main pharmacological properties include:
Menthol included in the composition of the medication produces a calming, cooling effect. The component reduces the sensitivity of nerve endings on the skin, dilates blood vessels, increases the adsorption of Naproxen. Pharmaceutical preparation is indicated to reduce pain in muscle injuries, degenerative diseases of the joints.
Naproxen gel is intended for external use only. The drug is applied to the skin with a thin layer up to five times a day. Rubbed until completely absorbed. The total duration of use depends on the type and course of the disease. Before starting local therapy is recommended to consult a doctor. In the period treatment should be avoided direct sunlight.
the Product is contraindicated in children under three years old, pregnant women, inflammatory diseases of the skin, injuries, open wounds, ulcers. It is not recommended to use the medicine in case of intolerance of any components included in the composition.