Vegetalumina Pain Relief 10% Ibuprofen Gel Salt Of Lysine 50g

NAME
VEGETALLUMINA ANTI-PAIN 1 '% GEL

PHARMACOTHERAPEUTIC CATEGORY
Topical drugs for joint and muscle pain - Non-steroidal anti-inflammatory drugs for topical use.

ACTIVE PRINCIPLES
100 g of gel contain: ibuprofen lysine salt 10 g.

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

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

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients. Due to the possibility of cross sensitization, the drug 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. Feeding time. Children and adolescents under the age of 14.

DOSAGE
2-4 applications per day on the painful area. Elderly patients should adhere to the minimum dosages indicated above. Pediatric population: no data are available. Method of administration: apply a thin layer of gel on the area to be treated with a light massage. Use the medicine for the shortest period possible. Wash your hands thoroughly and for a long time after application.

STORAGE
No special instructions.

WARNINGS
It is advisable to avoid application in correspondence with open wounds or skin lesions. The use is not recommended in women who intend to become pregnant. Administration should be discontinued in women who have fertility problems 'or who are undergoing investigation of fertility'. The use, 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 in the following two weeks. In case of allergic reactions or adverse reactions of major importance (skin reactions, some of which fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis) it is necessary to immediately discontinue therapy at the first appearance of skin rash, lesions of the mucosa or any other sign of hypersensitivity '. Patients appear to be at higher risk in the early stages of therapy: the onset of skin reactions occur in most cases within the first month of treatment. Do not use together with another NSAID or, in any case, do not use more than one NSAID at a time. Contains sodium methyl para-oxybenzoate. It can cause allergic reactions (even delayed). This medicinal product contains ethyl sodium para-hydroxybenzoate. It can cause allergic reactions (even delayed).

INTERACTIONS
The lack of 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 continued use of ibuprofen; no clinically relevant interactions were found with the occasional use of ibuprofen. However, it should be noted that Ibuprofen can increase the effects of anticoagulants such as warfarin. Pediatric population: no data are available.

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 derived from propionic acid for local or transdermal use. There have also been some reports of bullous eruptions of variability, including Stevens Johnson syndrome, and toxic epidermal necrolysis (very rarely). Photosensitivity reactions are possible. Pediatric population: no data are available. Report any suspected adverse reactions via the national reporting system of the Italian Medicines Agency.

PREGNANCY AND BREASTFEEDING
The use is contraindicated in pregnancy and lactation. Inhibition of prostaglandin synthesis can negatively 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 has been believed 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 organogenetic 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 can occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor.