NAPROSYN GEL 50G 10%

NAPROSYN 10% GEL

active ingredients

100 g gel contains 10 g naprossene. For the full list of excipients, see paragraph 6.1.

Excellent

Carbomer, ethanol, triethanolamine, metabisulphite sodium, rose scent, purified water.

Therapeutic indications

Myalgies, lombalgies, torcicollo, fibromyosites, borsites, tendonitis, tenosinovitis, periartriti, bruises, muscle tears, sprains, hematomas, edemi and traumatic infiltrates, phlebites. Coadjuvant of orthopedic and rehabilitative therapies.

Contraindications

Hypersensitivity to the active ingredient or substances strictly related to the chemical and/or any of the excipients listed in the paragraph 6.1. The risk of harmful effects on the fetus and/or child is not excluded. Therefore the use of Naprosyn pregnant and/or breastfeeding is to be reserved, according to the doctor, to cases of absolute necessity.

Population

Spread the gel in the seat of the pain, 2 times a day, massaging slightly until completely absorbed.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Avoid the use of gel on wounds. The product contains metabisulphite sodium, this substance can result in sensitive subjects and particularly in asthmatic allergic reactions and severe asthmatic attacks. The amount of active ingredient absorbed through the skin does not reach concentrations in circulation such as to expose to the risks of side effects and to make valid warnings regarding the administration of the drug by systemic way. However, we do not recommend the use of Naprosyn to patients in which acetylsalicylic acid and/or other NSAIDs induce allergic reactions and we also do not recommend the use of patients with active allergic manifestations or anamnesi. In addition, if the product is applied on a large area and for a prolonged period of time, the appearance of systemic side effects cannot be excluded. To avoid any phenomena of hypersensitivity or photosensitization avoid exposure to direct sunlight, including solarium, during treatment and in the next two weeks.

Interactions

Possible synergism with systemic anti-flogistic therapies.

Effects

With some nonsteroidal anti-inflammatory drugs for topical skin or transdermal use, propyonic acid derivatives, skin adverse reactions with erythema, itching, irritation, feeling of heat or burning and contact dermatitis have been reported. Some cases of boiling eruptions of varying severity have also been reported. Photosensitivity reactions are possible. The use, especially if prolonged use of topical products, can give rise to awareness-raising phenomena. In this case, suspend treatment and take appropriate therapeutic measures. 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

No overdose cases have been reported.

The risk of harmful effects on the fetus and/or child is not excluded. Therefore the use of Naprosyn pregnant and/or breastfeeding is to be reserved, according to the doctor, to cases of absolute necessity.

Source: Farmadati