VEGETALLUMINA ANTID * GEL 50G10%
Local treatment of bruises, sprains, myalgia, muscle tears, stiff neck.
Dosage and method of use
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.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 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. • Feeding time. • Children and adolescents under the age of 14.
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. A few cases of bullous eruptions of varying severity have also been reported, including Stevens Johnson syndrome, and toxic epidermal necrolysis (very rarely). Photosensitivity reactions are possible. Pediatric population No data are available. Reporting of suspected adverse reactions The reporting of suspected adverse reactions occurring after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system of the Italian Medicines Agency at: http://www.agenziafarmaco.gov.it/it/responsabili
It is advisable to avoid the application of VEGETALLUMINA Antidolore in correspondence of open wounds or skin lesions. The use of VEGETALLUMINA 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 VEGETALLUMINA Antidolore should be discontinued in women who have fertility problems or who are undergoing fertility investigations. The use of VEGETALLUMINA 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 in the following two weeks. In case of allergic reactions or adverse reactions of major importance (skin reactions, some of them fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis) it is necessary to discontinue therapy immediately at the first appearance of skin rash, lesions of the mucosa or any other signs of hypersensitivity (see section 4.8). 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 VEGETALLUMINA Antidolore together with another NSAID or, in any case, do not use more than one NSAID at a time. Important information about some of the ingredients of VEGETALLUMINA Pain relief This medicinal product contains methyl sodium para-oxybenzoate. It can cause allergic reactions (even delayed). This medicinal product contains sodium ethyl para-oxybenzoate. It can cause allergic reactions (even delayed).
Pregnancy and breastfeeding
The use of VEGETALLUMINA Antidolore is contraindicated in pregnancy and breastfeeding. Pregnancy Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased by less than 1% up to about 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 can 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 noted that Ibuprofen can increase the effects of anticoagulants such as warfarin. Pediatric population No data are available.
Toxicity Signs and symptoms of toxicity were generally not observed at doses below 100 mg / kg in children or adults. However, in some cases supportive treatment may be required. Children have been observed to exhibit signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg / kg or greater. Symptoms Most patients who have ingested significant amounts of ibuprofen will experience symptoms within 4 to 6 hours. The most commonly reported symptoms of overdose include: nausea, vomiting, abdominal pain, lethargy and somnolence. Effects on the central nervous system (CNS) include headache, tinnitus, dizziness, seizures, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea, and CNS and respiratory depression have also been reported rarely. Disorientation, arousal state, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. Treatment There is no specific antidote for ibuprofen overdose. In the event of an overdose, symptomatic and supportive treatment is therefore indicated. Particular attention is paid to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Within one hour of ingesting a potentially toxic amount, administration of activated charcoal should be considered. Alternatively, gastric lavage should be considered in adults within one hour of ingesting a potentially life-threatening overdose. Adequate diuresis must be ensured and renal and hepatic functions closely monitored. The patient should remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged convulsions should be treated with intravenous diazepam. Depending on the patient's clinical condition, other supportive measures may be necessary. For more information, contact your local poison control center.
100 g of gel contain: Active ingredient: Ibuprofen lysine salt 10 g Excipients with known effect: sodium methyl para-oxybenzoate and sodium para-ethyl para-oxybenzoate For a full list of excipients, see section 6.1.
Isopropanol, hydroxyethylcellulose, sodium methyl para-oxybenzoate, sodium ethyl para-oxybenzoate, glycerol, lavender essence, purified water.