LASONIL GEL 50G 10%

LASONIL ANTIDOLO 10% GEL

active ingredients

100 g gel contains: Active ingredient: Ibuprofen salt of lisina 10 g Excipient: Sodium para-oxybenzoate of ethyl, para-oxidized sodium of ethyl. For the full list of excipients, see paragraph 6.1.

Excellent

Isopropanol, hydroxyethylcellulose, methyl para-oxidated sodium, ethyl para-oxidised sodium, glycerol, lavender essence, purified water.

Therapeutic indications

Local treatment of contusions, sprains, myalgies, muscle tears, torquel.

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients. For the possibility of cross-sensitization, the drug should not be administered to patients in which acetylsalicylic acid or other non-steroidal anti-inflammatory drugs have caused asthma, rhinitis, hives or other allergic manifestations. - Pregnancy. - Nursing - Children and adolescents under the age of 14.

Population

2-4 applications per day on the sore part. Senior patients should stick to the minimum doses mentioned above. Apply a thin layer of gel on the part to be treated with a light massage. Use the medicine for the shortest period possible. Wash carefully and prolonged hands after application.

Conservation

No special education

Warnings

It is appropriate to avoid application of LASONIL ANTIDOLOR in correspondence of open wounds or skin injuries. The use of LASONIL ANTIDOLORE, as with any drug inhibitor of the synthesis of prostaglandins and cycloxygenase, is not recommended in women who intend to begin a pregnancy. The administration of LASONIL ANTIDOLOR should be suspended in women who have fertility problems or who are subject to fertility surveys. The use of LASONIL ANTIDOLORE, especially if prolonged, can give rise to local phenomena of sensitization: to the first appearance of skin rash, lesions of the mucosa or any other sign of hypersensitivity interrupt treatment and take appropriate therapeutic measures. To avoid more serious hypersensitivity or photosensitization, the patient should not expose himself to direct sunlight, including the solarium, during treatment and in the next two weeks (see paragraph 4.8). Do not use LASONIL ANTIDOLORE together with another NSAID or, however, do not use more than one NSAID at a time. Severe skin reactions Serious skin reactions have been reported, some of which fatal, including exfoliatory dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis in association with the use of NSAIDs (see paragraph 4.8). Patients seem 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. Generalized acute urstolosis (PEAG) was reported in relation to medicines containing ibuprofen. Ibuprofen should be suspended at the first appearance of severe skin signs and symptoms such as rash, mucosa lesions or any other sign of hypersensitivity. Important information about some excipients LASONIL ANTIDOLO: the drug contains para-oxidised methyl sodium and para-oxidised ethyl sodium that can cause allergic reactions (also delayed).

Interactions

The exigity of data and uncertainties related to their application to the clinical situation do not allow to draw definitive conclusions on possible interactions with other drugs for the continuous use of ibuprofen; no clinically relevant interactions were found with the occasional use of ibuprofen. Take into account, however, that Ibuprofen may increase the effects of anticoagulants such as warfarin.

Effects

Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Pathologies of skin and subcutaneous tissue With some non-steroidal anti-inflammatory drugs derived from propyonic acid for local or transdermal use, skin reactions with erythema, itching, irritation, feeling of heat or burning and contact dermatitis were reported. Some cases of boiling eruptions of varying severity, including Stevens Johnson syndrome, and epidermal toxic necrolysis (very rarely). Frequency not noted: - Generalized acute exantelosis (PEAG) (see paragraph 4.4) - Photosensitivity reactions (see paragraph 4.4) 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No overdose cases have been reported.

The use of LASONIL ANTIDOLORE is contraindicated in pregnancy and nursing. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has shown to cause an increase in the loss of pre and post plant and embryo/fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disease, was reported in animals that had been given prostaglandin synthesis inhibitors during the genetic organ period. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose • fetus to: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligo-idroamnios; • the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the time of bleeding, and anti-aggregating effect that can also be necessary at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor.

Source: Farmadati