MOMENDOL 10% naproxen gel - 50gr

Local treatment of pain in muscular and joint conditions such as myalgia, lumbago, stiff neck, bursitis, tendonitis, tenosynovitis, periarthritis, muscle strains, contusions, hematomas. Adjuvant to orthopedic and rehabilitative therapies.

Active Ingredients

1 g contains: Active ingredient: 100 mg naproxen (10% w/w). Excipients with known effect: D-Limonene flavour. For the full list of excipients, see section 6.1.

Excipients

Isopropyl alcohol, Trolamine, Glycerol, Hydroxyethylcellulose, Sodium hydroxide, Perfume containing menthol and eucalyptol, Purified water.

Dosage

Dosage : Spread Momendol 10% gel on the site of pain 2 times a day. The duration of treatment should not exceed 7 days. Paediatric population : Momendol 10% gel is contraindicated in children under 12 years of age. The safety and efficacy of Momendol 10% gel in children under 12 years of age have not yet been established. No data are available. Method of administration : Spread Momendol 10% gel on the site of pain and massage lightly until completely absorbed.

Warnings

Avoid using the gel on eyes, mucous membranes, wounds and/or skin lesions. The amount of active ingredient absorbed through the skin does not reach blood concentrations that expose to the risk of side effects or that make the warnings relating to systemic administration of the drug applicable. However, the use of Momendol 10% gel is not recommended for patients in whom acetylsalicylic acid and/or other NSAIDs induce allergic reactions and furthermore it is not recommended for use in patients with current allergic manifestations or a positive history. To prevent any hypersensitivity or photosensitivity phenomena, avoid exposure to direct sunlight, including solarium, during treatment and in the two weeks following. Discontinue treatment if skin rashes or irritation occur. This medicine contains a fragrance with D-Limonene. D-Limonene may cause allergic reactions.

Conservation

This medicine does not require any special temperature storage. Store in the original package with the cap closed in order to protect the medicine from light and evaporation.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Third trimester of pregnancy.

Side effects

The following adverse reactions are listed below, organised according to MedDRA System Organ Class. The frequency is defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (frequency cannot be estimated from the available data).

¹⁾ Adverse skin reactions have been reported with some non-steroidal anti-inflammatory drugs for cutaneous or transdermal use, derivatives of propionic acid. ²⁾ The use, especially if prolonged, of products for topical use may give rise to sensitization phenomena. In this case, suspend treatment and adopt appropriate therapeutic measures. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdose

No case of overdose has been reported.

Pregnancy

The risk of harmful effects on the fetus and/or child is not excluded. Therefore, during pregnancy and/or breastfeeding Momendol gel should be used at the discretion of the doctor and when strictly necessary. Momendol gel should not be used in the third trimester of pregnancy.