what is turn Medicated patches;
pharmacotheutic category:
drugs for topical use for joint and muscle pain.
active ingredients:
diclofenac sodium.
excipients:
< p> Butil Metacriolato Basic Copolimero; ACRIATE-VINIL ACETATO COPOLIMER; Polyetilenglicle 12 stearato; oleate flee; Non-woven fabric ; Siliconed paper.
indications:
Local treatment of painful and inflammatory states of rheumatic or traumatic nature of the joints, muscles, of tendons and ligaments.
contraindications/Eff.Secondar:
hypersensitivity to the active ingredient, to acid acetylsalicylic or other non-steroidal anti-inflammatory preparations (NSAIDs) or one of the excipients listed; Patients in which asthmatic accesses have occurred, urticaria or acute rhinitis after taking acetylsalicylic acid or other non -steroidal anti -inflammatory drugs (fan s); damaged skin, regardless of the type of injury: exudative dermatitis, eczema, infected injury, burns or wounds; Third Trime Stret of pregnancy; Patients with active peptic ulcer.
children and teenagers: use in children and adolescents of age of less than 16 is contraindicated.
< Stren> Dosage:
only for skin use. shower.
The medicated patch of diclofenac must be used for the shortest possible time in relation to the indication of use.
adults and adolescents from 16 years up: unless otherwise prescribed medic prescription to apply a patch 2 times a day, in the morning and in the evening, on the skin of the area to be treated, for a period not exceeding 7-10 gi orni.
in adolescents of age equal to or over 16 years of age, if this product is necessary for a period of treatment of more than 7 g ilins for pain relief or if the symptoms worsen, consigl the patient or ai relatives of the teenager to consult A doctor.
children and adolescents under the age of 16: the use of this eight medicated is not recommended in children and adolescents of and ta 'less than 16 years because Sufficient data are not available to evaluate the security and effectiveness of the medicine.
elderly: this medicine must be used with caution in elderly patients as it is more predisposed to undesirable effects.
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way of administration: cut the envelope along the outlined line and take the patch.
for the application of the patch: remove one of the two for protective; apply on the part to be treated and remove the remaining protective sheet; exercise slight pressure with the palm of the hand until complete adhesion to the skin.
the patch must be used entire the patch with water and then lift a flap then pulling gently; For Elimi nare any residues of the product wash the affected area with water by performing circular movements with your fingers. Do not keep at temperature above 30 degrees C.
Warnings:
If the medicated patches of diclofenac are used on Cu surfaces extended tango and for a prolonged period of time, it is not possible to ascertain the possibility of adverse events. Being Appli cato on the harmful skin or on open wounds.
the patches must not get in touch with the eyes or the mucous membranes and must not be ing eriti.
< p> The side effects can be minimized with the use of the lower dose effective dose for the shortest possible duration of the TR Act that is needed to control the symptoms.
the treatment must e ssere interrupted immediately if yes It develops a skin rash after the storage of the medicated patch.
asthmatic patients, with cro cro cro oyster niche of the bronchi, allergic rhinitis or inflammation of nasal mosa (nasal polyp) react with asthmatic attacks, Local Action of the skin or mucosa (Edema di Quincke) or urticaries to the treatment carried out with fans more often than other patients. or that are subjected to investigations on fertility. this case it is necessary to stop the treatment and consult the doctor for the purpose of establishing suitable therapy. Any drug of the synthesis of the prostaglandins and cyclossigenasis is not cons ille in women who intend to start a pregnancy.
do not simultaneously administer another medicine based on diclofenac or other fans at the same time.
although the Systemic effects should be low, the medicated patch should be used or with caution in patients with renal, cardiac or liver compromise, history of peptic ulcer or inflammatory intestinal disease or hemorrhagic diathesis.
anti -inflammatory drugs Non steroidi must be used with particular attention to elderly patients who are updated to the side effects. occlusive that it does not let air pass.
patients should be warned not to expose themselves to direct sunlight or to the light of sunscreen for about a day after the removal of the medicated patch in order to reduce the risk of photosensitivity.
interactions:
The systemic absorption of Diclofenac following the use of medicated patches e 'Very low, the risk of developing clinically significant interactive ions with other medicines is negligible.
It is not however to be excluded the possibility of competition between the absorbed clofenac and other high drugs link with the SMATIC PLA proteins.
The topical or systemic concomitant use of other drugs containing diclofenac or other fans is not recommended.
effects Undesirable: The adverse reactions are listed by frequency, first the most Freente, using the following agreement: Municipality (& GT; = 1/100, & LT; 1/ 10); uncommon (& gt; = 1/1000, & lt; 1/100); rare (& gt; = 1/10,000, & lt; 1/1, 000); very rare (& lt; 1/10,000); It does not notice.
Infections and infestations.
very rare: rash with pustules.
disorders of the immune system. BR>
Very rare: IPERSENSIB ILITA '(including urticaria), angioneurotic edema, anaphylacto reaction de.
respiratory, chest and mediastinic pathologies.
very rare: asthma.
pathologies of the skin and subcutaneous tissue. with touch), itching; Rare: Bollosa dermatitis (p.es. Bolloso), dryness of the skin, burning; Very rare: reaction of photosensitivity. Systemicpares and conditions relating to the administration headquarters.
Common: reactions in the administration headquarters.
The use of the product in association with other drugs containing diclofenac can give rise to reactions Rooms with severe evolution (Stevens- Jo Hnson, Lyell syndrome).
The reporting of the adverse reactions SOSP ETTE that occur after the authorization of the medicine is imported nte, as it allows continuous monitoring of the benefit relationship o/risk of the medicine.
pregnancy and breastfeeding:
the systemic concentration of diclofenac compared with oral formulations, is lower after topical administration.
by referring to the experience with treatment with fans for administration CA systems, the following is recommended: the inhibition of the synthesis of Prostagl Andine can negatively affect pregnancy and/or the EM BRIO development /fetal
results of epidemiological studies suggest an increase in risk of abortion and cardiac malformation and DOP gastroschisi or the use of an inhibitor of the synthesis of prostaglandins in the early stages of pregnancy.
has been considered that the risk increases with the dose and the duration of the therapy.
in animals, the administration of prostaglandin synthesis inhibitors has shown to cause u n Increase in the loss of pre and post-plant and embryo-fetal mortality.
also, an increase in the incidence of various malformations, includes knowing the cardiovascular one, was reported in animals to which they were s tati administered prostaglandin synthesis, during the organogenetic period.
during the first and second quarter of pregnancy, the diclofenac must not be administered except in strictly necessary cases.
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If the diclofenac is used by a woman in attic of conception, or during the First and second quarter of pregnant nza, the dose must be maintained as low as possible and the duration of the shortest possible treatment.
during the third quarter of grav Idanza, all the inhibitors of the synthesis of prostaglandins can exist the fetus to: or heart -pounded toxicity (with premature closure of the arterial duct and pulmonary hypertension); o renal dysfunction, that can progress in renal failure with oligo-hydroamnios; The but Dre and the newborn, at the end of pregnancy, to: O possible prolongam in the bleeding time, and anti -aggregating effect that can also run at very low doses; o Inhibition of the uterine contractions resulting late or extension of labor.
consequently, the diclofenac is contraindicated during the third trimester of pregnancy.
the diclofenac passes In breast milk in small quantities.
However, the therapeutic doses of medicinal product are not expected effects on the infant.
due to the lack of controlled studies in Women ch and breastfeed, the product must be used during breastfeeding only under the advice of a healthcare professional.
in this circumstance, the drug must not be applied on the breast of the mothers who anno ano, nor elsewhere on extended areas of skin or for a prolonged period of time.