LASONIL ANTI-PAIN * GEL 50G 10%

LASONIL ANTI-PAIN * GEL 50G 10%

Therapeutic indications

Local treatment of bruises, sprains, myalgia, muscle tears, stiff neck.

Dosage and method of use

2-4 applications per day on the painful area. Elderly patients should adhere to the minimum dosages indicated above. Apply a thin layer of gel on the area to be treated with a light massage. Use the medicine for the shortest possible time. Wash your hands thoroughly and for a long time after application.

Contraindications

- Hypersensitivity to the active substance or to any of the excipients. Due to the possibility of cross-sensitization, the medicinal product should not be administered to patients in whom acetylsalicylic acid or other non-steroidal anti-inflammatory drugs have caused asthma, rhinitis, urticaria or other allergic manifestations. - Pregnancy. - Breastfeeding - Children and adolescents under 14 years of age.

Side effects

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms.Skin and subcutaneous tissue disordersSkin reactions with erythema, itching, irritation, sensation of heat or burning and contact dermatitis have been reported with some non-steroidal anti-inflammatory drugs derived from propionic acid for local or transdermal use. A few cases of bullous eruptions of varying severity have also been reported, including Stevens Johnson syndrome, and toxic epidermal necrolysis (very rarely). Frequency not known: - Acute generalized exanthematous pustulosis (PEAG) (see section 4.4) - Photosensitivity reactions (see section 4.4) Reporting of suspected adverse reactions Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. 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.

Special warnings

It is advisable to avoid the application of LASONIL ANTIDOLORE in correspondence of open wounds or skin lesions. The use of LASONIL ANTIDOLORE, as with any drug that inhibits the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to become pregnant. The administration of LASONIL ANTIDOLORE should be discontinued in women who have fertility problems or who are undergoing fertility investigations. The use of LASONIL ANTIDOLORE, especially if prolonged, can give rise to local sensitization phenomena: at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity, interrupt the treatment and adopt adequate therapeutic measures. To avoid more serious phenomena of hypersensitivity or photosensitization, the patient must not expose himself to direct sunlight, including the solarium, during the treatment and for the following two weeks (see section 4.8). Do not use LASONIL ANTIDOLORE together with another NSAID or, in any case, do not use more than one NSAID at a time. Severe skin reactions Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with medicinal products containing ibuprofen. Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other signs of hypersensitivity.Important information about some of the ingredients of LASONIL ANTIDOLORE: The medicine contains methyl sodium para-hydroxybenzoate and ethyl sodium para-hydroxybenzoate which may cause allergic reactions (including delayed).

Pregnancy and breastfeeding

The use of LASONIL ANTIDOLORE is contraindicated in pregnancy and breastfeeding. Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo / fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals given prostaglandin synthesis inhibitors during the organ genetic period. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose • the fetus to: - cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligo-hydroamnios; • the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and antiplatelet effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor.

Expiration and retention

No special instructions

Interactions with other drugs

The paucity of the data and the uncertainties relating to their application to the clinical situation do not allow definitive conclusions to be drawn on possible interactions with other drugs for the continuous use of ibuprofen; no clinically relevant interactions were found with the occasional use of ibuprofen. However, it should be borne in mind that Ibuprofen can increase the effects of anticoagulants such as warfarin.

Overdose

No cases of overdose have been reported.

Active principles

100 g of gel contain:Active principle: Ibuprofen lysine salt 10 gExcipients: Methyl sodium para-oxybenzoate, ethyl para-oxybenzoate sodium. For the full list of excipients, see section 6.1.

Excipients

Isopropanol, hydroxyethylcellulose, methyl sodium para-oxybenzoate, ethyl para-hydroxybenzoate sodium, glycerol, lavender essence, purified water.