MOMENDOL GEL 50G 10%

MOMENDOL 10% GEL

active ingredients

1 g contains: Active ingredient: 100 mg of naprossene (10% p/p). Excipients with known effects: D-Limonene aroma. For the full list of excipients, see paragraph 6.1.

Excellent

Hisopropyl alcohol, Trolamina, Glicerol, Hydroxyethylcellulose, Sodium hydroxide, Perfume containing menthol and eucalyptol, Purified water.

Therapeutic indications

Momendol 10% gel is indicated in adults and children over 12 years old for the local treatment of pains in muscle and joint affections such as myalgies, lombalgies, torcicollo, borsiti, tenosinovitis, periartriti, muscle tears, bruises, hematomas. Coadjuvant of orthopedic and rehabilitative therapies.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Third quarter of pregnancy.

Population

Population: Spread Momendol 10% gel in the site of pain 2 times a day. The duration of treatment shall not exceed 7 days. Pediatric population: Momendol 10% gel is contraindicated in children under 12 years. The safety and effectiveness of Momendol 10% gel in children under 12 years have not yet been established. There are no available data. Method of administration: Spread Momendol 10% gel in the site of pain and massage slightly until completely absorbed.

Conservation

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

Warnings

Avoid the use of gel on eyes, mucosa, wounds and/or skin lesions. The amount of active ingredient absorbed through the skin does not reach blood concentrations such as to expose to the risks of undesirable effects or such as to enforce warnings relating to the administration of the drug by systemic means. However, we do not recommend the use of Momendol 10% gel to patients in which acetylsalicylic acid and/or other NSAIDs induce allergic reactions and we also do not recommend use in patients with active allergic manifestations or with positive anamnesi. To prevent any phenomena of hypersensitivity or photosensitization avoid exposure to direct sunlight, including solarium, during treatment and in the next two weeks. Stop the treatment if skin rash or skin irritations arise. This medicine contains a fragrance with D-Limonene. D-Limonene can cause allergic reactions.

Interactions

Nono studies were carried out’ interaction. The product is poorly absorbed on a systemic level therefore interactions with other drugs are unlikely, even if they cannot be excluded.

Effects

Below are the side effects organized according to the classification for MedDRA Systems and Organs. The frequency is so defined: very common (≥1/10), common (from ≥1/100 to Classification for systems and organs according to MedDRA/Frequenza INDESIDER Pathologies of skin and subcutaneous tissue ⁽¹⁾ Notable Eritema, Prurito, Skin irritation, Skin burning sensation, Contact Dermatitis, Bollous rash, Photosensitivity reaction Immune system disorders Notable Awareness ⁽²⁾ Systemic pathologies and conditions for administration Notable Feeling of heat ⁽¹⁾ With some non-steroidal anti-inflammatory drugs for skin or transdermal use, propionic acid derivatives, skin adverse reactions have been reported. ⁽²⁾ The use, especially if prolonged, of products for topical use can give rise to phenomena of sensitization. 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 addresshttps://www.aifa.gov.it/content/indications-reaction-adverse.

Overdosing

No case of overdose has been reported.

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 in medical opinion and when strictly necessary. Momendol gel should not be used in the third trimester of pregnancy.

Source: Farmadati