VEGETALLUMINA ANTID GEL120G

VEGETALLUMINA ANTIDOLO 10% GEL

active ingredients

100 g gel contains: Active ingredient: Ibuprofen salt of lysine 10 g Excipients with known effects: para-oxybenzoate sodium of ethyl and para-oxidised sodium, lavender essence (containing allergens). 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 listed in the paragraph 6.1. 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. - Nurse. - Children and teenagers under the age of 14.

Population

Population 2-4 applications per day on the sore part. Senior patients should stick to the minimum doses mentioned above. Pediatric population There are no available data. Method of administration 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 VEGETALLUMINA Pain in correspondence of open wounds or skin injuries. The use of VEGETALLUMINA Pain, as with any drug inhibitor of the synthesis of prostaglandins and cycloxygenase, is not recommended in women who intend to start a pregnancy. The administration of VEGETALLUMINA Pain should be suspended in women who have fertility problems or who are subject to fertility surveys. The use of VEGETALLUMINA Pain, especially if prolonged, may give rise to local phenomena of sensitization: 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 phenomena of hypersensitivity or photosensitization, the patient should not expose himself to direct sunlight, including the solarium, during treatment and in the next two weeks. In the case of allergic reactions or adverse reactions of greater importance (cutaneous reactions, some of which fatal, such as exfoliatory dermatitis, Stevens-Johnson syndrome and epidermal toxic necrolysis) it is necessary to immediately suspend therapy to the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity (see paragraph 4.8). Patients seem 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 Pain pain along with another NSAID or, however, do not use more than one NSAID at a time. Important information about some excipients VEGETALLUMINA Sweetener Vegetallumina antidolore contains the lavender essence in turn containing cytral, citronellol, cumarin, eugenol, evernia furfuracea extract, evernia prunastri extract, geraaniol, lemonne, linalol. Citral, citronellol, cumarin, eugenol, geranium, lemon, linalol can cause allergic reactions. This medicine contains para-hydroxybenzoate sodium of methyl and para-hydroxybenzoate sodium of ethyl. Sodium benzoate methyldrosis and benzoate ethylhydroxy sodium 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. Pediatric population There are no available data.

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. 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 bollose eruptions of varying severity, including Stevens Johnson syndrome, epidermal toxic necrolysis (very rarely) and photosensitivity reactions (unknown frequency). Pediatric population There are no available data. 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 professionals are required to report any adverse reaction suspected through the national reporting system of the Italian Pharmaco Agency at: http://www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Toxicity Signs and symptoms of toxicity were generally not observed at doses less than 100 mg/kg in children or adults. However, in some cases you may need a support treatment. It has been observed that children manifest signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or greater. Synonyms Most patients who have ingested significant quantities of ibuprofen will manifest symptoms within 4 to 6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy and drowsiness. The effects on the central nervous system (SNC) include headaches, tinnitus, dizziness, seizures and loss of consciousness. Rarely, nistagm, metabolic acidosis, hypothermia, kidney effects, gastrointestinal bleeding, coma, apnea, diarrhea and depression of the SNC and respiratory system were also reported. Disorientation, state of excitement, fainting and cardiovascular toxicity include hypotension, bradycardia and tachycardia. In cases of significant overdose are possible kidney failure and liver damage. Treatment There is no specific antidote for overdosing ibuprofen. In case of overdose, a symptomatic and support treatment is therefore indicated. Particular attention is given to the control of blood pressure, acid-base balance and gastrointestinal bleeding. Within an hour of the ingestion of a potentially toxic quantity must be considered the administration of activated carbon. Alternatively, in the adult, within an hour of the ingestion of a potentially dangerous overdose for life, the gastric lavender must be taken into account. An adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours after ingestion of a potentially toxic drug. Any occurrence of frequent or prolonged seizures must be treated with intravenous diazepam. Other support measures may be required in relation to the patient's clinical conditions. For more information, contact the local anti-veleni center.

The use of VEGETALLUMINA Pain is contraindicated in pregnancy and nursing.

Pregnancy

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