AULIN GEL 50G 3%

AULIN 3% P/P GEL

active ingredients

Aulin 3% p/p gel contains 3% p/p of nimesulide (1 g gel contains 30 mg nimesulide) Excipients with known effects: Metil-parahydroxybenzoate 0.08% p/p Propil-parahydroxybenzoate 0.02% p/p For full list of excipients, see paragraph 6.1

Excellent

Perpil parahydroxybenzoate (E216).

Therapeutic indications

Syntomatic relief of pain associated with acute traumatic strains and tendonitis.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. Usage in patients where aspirin or other pharmaceutical products that inhibit the synthesis of prostaglandins have induced allergic reactions such as rhinitis, hives or bronchospasm. Use on lacerated or disepitelized skin or in the presence of local infections. I use it with other topical creams. Use in children under 12.

Population

Adults : Apply 2 or 3 times a day a thin layer of Aulin 3% p/p gel (usually 3 g, corresponding to a 6-7 cm long strip) on the affected area by massaging until completely absorbed. Duration of treatment: 7 - 15 days. Children under 12 years: Aulin 3% p/p gel has not been studied in children. Safety and effectiveness were not determined and the product should not be used in children (see 4.3).

Conservation

Store at temperature not exceeding 30°C.

Warnings

Aulin 3% p/p gel should not be applied on skin lesions or open wounds. Aulin 3% p/p gel should not come into contact with eyes or mucosa; in case of accidental contact, wash immediately with water. The product should not be ingested. Wash your hands after application. Do not cover the treated skin with Aulin 3% p/p gel with an occlusive bandage or adhering or waterproof clothes. Undesirable effects can be reduced using the minimum effective dose for as little time as possible. Carefully treat patients with active gastrointestinal hemorrhages or suspected peptic ulcer, severe kidney or liver failure, severe coagulation disorders or severe/uncontrolled heart failure. As Aulin 3% p/p gel has not been studied in hypersensitive subjects, special caution should be given in treating patients with hypersensitivity known to other NSAIDs. One cannot exclude the possibility of hypersensitivity onset during therapy. Since with other topical NSAIDs you can experience burning sensation and, in exceptional cases, photodermatitis, special attention should also be paid during treatment with Aulin 3% p/p gel. To reduce the risk of photo-awareness, patients should not be exposed to direct sunlight or tanned lamps. If symptoms persist or disorders become worse, consult your doctor. The product contains parahydroxybenzoates: these substances can cause allergic reactions, even delayed. Aulin 3% p/p gel can cause temporary yellow coloring of the treated area, as well as clothing that came into contact with it.

Interactions

Typically, there are no known or planned interactions between Aulin 3% p/p gel and other pharmaceutical products.

Effects

The following list of side effects is based on clinical studies, in a limited number of patients, where mild local reactions were reported. The cases listed are classified as very common (>1/10), common (>1/100, 1/1.000, 1/10.000, Pathologies of skin and subcutaneous tissue (see also 4.4) Municipalities Prurito, Eritema Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Nimesulid intoxication is not expected due to the topical application of Aulin 3% p/p gel, especially since the maximum plasma levels of nimesulide after the application of Aulin 3% p/p gel are much lower than those after systemic administration.

Pregnancy and nursing Data on topical use of Aulin 3% p/p gel in pregnant or breastfeeding women are not available. Therefore do not use Aulin 3% p/p pregnant or breastfeeding gel if it is absolutely not necessary. Fertility For systemically administered nimesulide, animal studies showed reproductive toxicity (see paragraph 5.3).

Source: Farmadati