Aulin 3% W/w Nimesulidegel Anti-inflammatory 50g

NAME
AULIN 3% P / P GEL

PHARMACOTHERAPEUTIC CATEGORY
Non-steroidal anti-inflammatory preparations for topical use.

ACTIVE PRINCIPLES
Nimesulide.

EXCIPIENTS
Purified water; diethylene glycol monoethyl ether; caprilcaproil macrogolglycerides; carbomers; edetate disodium; triethanolamine; methyl parahydroxybenzoate (E218); propyl parahydroxybenzoate (E216).

INDICATIONS
Symptomatic relief of pain associated with acute traumatic sprains and tendinitis.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the listed excipients; use in patients in whom aspirin or other pharmaceutical products that inhibit prostaglandin synthesis have induced allergic reactions such as rhinitis, urticaria or bronchospasm; use on torn or de-epithelialized skin or in the presence of local infections; use together with other topical creams; use in children under 12 years.

DOSAGE
Adults: apply a thin layer of gel (usually 3 g, corresponding to a strip 6-7 cm long) on the affected area 2 or 3 times a day, massaging until completely absorbed. Duration of treatment: 7 - 15 days. Children under the age of 12: the gel has not been studied in children. Therefore, its safety and efficacy have not been established and the product should not be used in children.

STORAGE
Store at a temperature not exceeding 30 degrees C.

WARNINGS
The medicine should not be applied to skin lesions or open wounds. The drug must not come into contact with the eyes or mucous membranes; in case of accidental contact, wash immediately with water. The product should absolutely not be ingested. Wash hands after application. Do not cover the skin treated with the product with an occlusive bandage or tight or waterproof clothing. Undesirable effects can be reduced by using the lowest effective dose for the shortest possible time. Treat patients with active gastrointestinal bleeding or suspected peptic ulcer, severe renal or hepatic insufficiency, severe coagulation disorders, or severe / uncontrolled heart failure with caution. Since the drug has not been studied in hypersensitive subjects, particular caution should be exercised in treating patients with known hypersensitivity to other NSAIDs. The possibility of onset of hypersensitivity during therapy cannot be excluded. Since 'with other topical NSAIDs can occur burning sensation and, in exceptional cases, photodermatitis, special attention should also be paid during treatment with the drug. To reduce the risk of photosensitization, patients should not be exposed to direct sunlight or tanning lamps. If symptoms persist or symptoms worsen, see your doctor. The product contains parahydroxybenzoates: these substances can cause the onset of allergic reactions, even of the delayed type. The medicine can cause a temporary yellow coloring of the treated area, as well as of the clothing that comes into contact with it.

INTERACTIONS
Topically, there are no known or expected interactions between the drug and other pharmaceutical products.

SIDE EFFECTS
The following list of side effects is based on clinical studies, in a limited number of patients, in which mild local reactions have been reported. The reported cases are classified as very common (> 1/10), common (> 1/100, <1/10), uncommon (> 1 / 1,000, <1/100), rare (> 1 / 10,000, < 1 / 1,000), very rare (<1 / 10,000), including isolated cases. Skin and subcutaneous tissue disorders. Common: itching, erythema. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
There are no data on the topical use of the medicinal product in pregnant or lactating women. Therefore do not use the drug during pregnancy or breastfeeding unless it is absolutely necessary. For systemically administered nimesulide, animal studies have shown reproductive toxicity.