Vegetallumina paintolor 10% gel 120g - OTC

NAME
Vegetallumina painulore 10 '% gel

Pharmacotherapeutic category
Drugs for topical use for joint and muscle pain - non -steroidal anti -inflammatory for topical use.

Active ingredients
100 g of gel contain: ibuprofen lysine rooms 10 g.

Excipients
Isopropanol, hydroxietilcellulosa, sodium para-oxibenzoate of methyl, sodium para-oxibenzoate of ethile, glycerol, lavender essence, purified water.

Indications
Local treatment of bruises, distortions, myalgies, muscle tears, torchol.

Contraindications/Eff.Secondar
Hypersensitivity to the active ingredient or to any of the excipients.
For the possibility of crushed sensitization, the medicine 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.
Breastfeeding.
Children and adolescents of age of less than 14 years.

Dosage
2-4 Applications per day on the sore part.
Elderly patients should comply with the minimum dosages indicated above.
ATRIC POPE POPULATION: There are no available data.
Way of administration: Apply a thin layer of gel on the part to be treated with a light massage.
Use the medicine for the shortest possible period.
Wash your hands carefully and prolongedly after application.

CONSERVATION
No particular instruction.

Warnings
It is appropriate to avoid the application in correspondence with open wounds or skin injuries.
Use is not recommended in women who intendan or start pregnancy.
Administration must be suspended in women who have fertility problems or who are subject to investigations on fertility.
The use, especially if prolonged, can give rise to local awareness phenomena: the first appearance of skin rash, mucosa injuries or any other sign of hypersensitivity to stop treatment and adopt adequate therapeutic measures.
To avoid more serious hypersensitivity phenomena or photosensitization, the patient must not expose himself to direct sunlight, including or solarium, during treatment and in the following two weeks.
In the case of allergic reactions or adverse reactions of greater implementation (skin reactions, some of which are fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermic toxic necrolysis) it is necessary to immediately suspend the therapy at the first appearance of skin rash , lesions of the mucous membrane or any other sign of hypersensitivity.
Patients seem to be 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 with another fans or, in any case, don't use more than one fans at a time.
Contains sodium para-oxibenzoate of methyl.
Can cause allergic reactions (also delayed).
This medicine contains ETIL para-oxibenzoate hatred.
It can cause allergic reactions (even and delayed).

Interactions
The small of the data and the uncertainties relating to their application to the clinical situation do not allow to derive define conclusions on possible interactions with other drugs for continuous use of ibuprofen; No clinically relevant interactions have been found with the occasional use of hybuprofen.
It is taken into account, in the case, that Ibuprofen can increase the effects of anticoagulants i as Warfarin.
Pediatric population: there are no available data there.

Side effects
The side effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment that is needed to control the symptoms.
With some non -steroidal anti -steroid anti -senifia drugs derivatives of propionic acid for local or transdermal use, skin reactions have been reported with erythema, itching, irritation, feeling of heat or burning and contact dermatitis.
Some cases of stamping eruptions of various gravity have also been reported, including Stevens Johnson syndrome, and epidermal toxic necrolysis (very rarely).
Photossensability reactions are possible.
Pediatric population: there are no data available.
Report any suspect adverse reaction through the national reporting system of the Italian drug agency.

Pregnancy and breastfeeding
Use is contraindicated in pregnancy and breastfeeding.
The inhibition and synthesis of prostaglandins may negatively affect gr and/or embry/fetal development.
Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisi after the use of an inhibitor of the synthesis of prostaglandins in the early stages of pregnancy.
The absolute risk of cardiac malformations increased from less than 1% to about 1, 5%.
It was believed that the risk increases with the dose and duration of the therapy.
In animals, the administration of prostaglandin s inhibitors has shown to cause an increase in the loss of pre and post system and embryo/fetal mortality.
In addition, an increase in the incidence of various malformations, including the vascular cardio one, was reported in animals to which prostaglandin synthesis inhibitors had been administered during the genetic organ period.
During the third trimester of pregnancy, all the inhibitors of prostaglandin synthesis can expose the fetus to: cardiopulmonary toxicity (with premature closure of the arterial duct and hyperteus pulmonary nose), renal dysfunction, which can progress in renal insufficiency with the oligo- Idroamnios; The mother and the newborn, in the end of pregnancy, to: possible extension of the bleeding time, and anti -aggregating effect that can also be needed at very low doses; inhibition of uterine contractions resulting late or extension of labor.