Composition

100 g of gel contain: Active ingredient: Ibuprofen Lysine 10 g. Excipients: Methyl sodium para-oxybenzoate, ethyl para-oxybenzoate sodium.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Due to the possibility of cross-sensitization, the 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. The use of the product is not recommended in pregnancy, breastfeeding and in subjects under 14 years of age.

Dosage

The following average dosage is recommended: 2–4 applications per day on the painful area. Warning: do not exceed the indicated doses. Elderly patients should adhere to the minimum dosages indicated above.

Warnings and Precautions

It is advisable to avoid the application of JOINTRAL Gel in correspondence of open wounds or continuous lesions of the skin. The use of JOINTRAL, as with any prostaglandin synthesis and cyclooxygenase inhibitor drug, is not recommended in women intending to become pregnant. The administration of JOINTRAL Gel should be discontinued in women who have fertility problems or who are undergoing fertility investigations. The use of JOINTRAL Gel, especially if prolonged, can give rise to local sensitization phenomena, which require the interruption of the treatment and the adoption of adequate therapeutic measures. In topical use, to avoid any hypersensitivity or photosensitization phenomena, avoid exposure to direct sunlight, including the solarium, during the treatment and in the following two weeks. In the event of allergic reactions or adverse reactions of greater importance, it is necessary to discontinue therapy and consult a doctor. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens – Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. JOINTRAL Gel should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. After a short period of treatment without appreciable results, consult your doctor. JOINTRAL Gel contains sodium methyl para-oxybenzoate and sodium ethyl para-oxybenzoate which can cause allergic reactions (even delayed).

Interactions

The accuracy of the data and the uncertainties relating to their application to the clinical situation do not allow definitive conclusions to be drawn for the continued use of ibuprofen; there appears to be no clinically relevant effect from the occasional use of ibuprofen. Ibuprofen can increase the effects of blood thinners, such as warfarin. It is therefore advisable to consult your doctor in case of concomitant treatment with anticoagulants.

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 reactions with erythema, itching, irritation, sensation of heat or burning and contact dermatitis have been reported with some non-steroidal anti-inflammatory drugs for topical or transdermal use, derivatives of propionic acid. Some cases of bullous eruptions of varying severity have also been reported. Bullous reactions including Stevens Johnson syndrome and toxic epidermal necrolysis (very rarely). Photosensitivity reactions are possible.

Pregnancy and breastfeeding

The use of JOINTRAL Gel is not recommended during 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 month 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 can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor.

storage

No special instructions

Format

50g tube.