Description
PATIENT ADVICE- Do not cut the dressings into pieces.- Do not use for more than 7 days.PREGNANCYSafety in animals: Prenatal, perinatal and postnatal development of the offspring was not affected.Safety in humans: Approximately 10% of a topical dose is absorbed systemically with considerably lower bioavailability by the topical route than by the oral route. Adequate and well-controlled studies in humans with topical diclofenac are not available, but systemic diclofenac has resulted in fetal toxic effects in late pregnancy. Although cutaneous absorption is minimal, systemic effects cannot be ruled out. Topical use of diclofenac during the first two trimesters of pregnancy is only accepted if, in the absence of other safer therapeutic alternatives, the benefits outweigh the potential risks. The use of diclofenac during the third trimester of pregnancy is contraindicated, as diclofenac has been associated with delayed delivery and adverse cardiopulmonary effects in the fetus, such as premature closure of the ductus arteriosus and pulmonary hypertension, and renal effects, such as acute renal failure and oligohydramnios. It may also increase bleeding time in the mother. Effects on fertility: There is no evidence that diclofenac has a teratogenic potential in mice, rats, or rabbits. In humans, preclinical data obtained in acute and repeated dose toxicity studies, as well as in genotoxicity, mutagenesis and carcinogenesis studies with diclofenac have revealed no specific risk at the intended therapeutic doses. PHARMACOKINETICS* Dressings: Diclofenac is slowly absorbed through the skin. It is released continuously and sustained, obtaining a Cp of 3 ng/ml. The binding affinity of diclofenac to plasma proteins is high (99%). Metabolism and elimination are similar after cutaneous and oral use. INDICATIONS - Symptomatic treatment of conditions that present with [INFLAMMATION] and/or [ACUTE PAIN], such as:* [CONTUSION] or [SPRAIN] caused by twists. BREASTFEEDING Safety in animals: no data available. Safety in humans: Diclofenac is excreted in milk, although it is not believed to produce adverse effects on the infant. Due to insufficient data, a decision must be made whether to discontinue breast-feeding or to discontinue/discontinue therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. DOSAGE "Voltadol apositios"One medicated plaster should be applied to the sore area once a day. The maximum daily dose is 1 medicated plaster per day, even if more than one injured area is to be treated. Therefore, only one sore area can be treated at a time. PRECAUTIONS - [PHOTOSENSITIVITY REACTIONS]. Diclofenac has caused photosensitivity reactions. It is recommended not to expose the treated areas to the sun or UV light for at least one day. - Systemic reactions. The risk of systemic reactions to topical diclofenac is minimal, although it cannot be ruled out if significant systemic absorption occurs, as may occur if applied to damaged skin (dermatitis, burns, wounds) or with an occlusive dressing. It is recommended to adhere to the dosage recommendations in patients with asthma, history of peptic ulcer, kidney or heart failure, as well as hypertension. OVERDOSE Symptoms: Due to its route of administration, symptoms are not very likely to appear in the event of an overdose, although accidental ingestion or improper application could produce typical systemic adverse effects. Treatment: In case of accidental ingestion, stomach lavage and symptomatic treatment should be performed.
Features
Product code | 503360 |
Category | Cold and Flu Medicines |
Delivery from | Spain |
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