PATIENT ADVICE

- Do not cut the dressings into pieces.

- Do not use for more than 7 days.

PREGNANCY

Animal safety: prenatal, perinatal and postnatal development of the offspring was not affected.

Human Safety: Approximately 10% of the topical dose is absorbed systemically, with considerably lower bioavailability by the topical route than by the oral route. Adequate and well-controlled human studies with topical diclofenac are lacking, but systemic diclofenac has caused fetal toxicity in the final stages of 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 acceptable 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 from acute and repeated-dose toxicity studies, as well as genotoxicity, mutagenesis, and carcinogenicity 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 sustainably, with a Cp of 3 ng/ml. Diclofenac has a high binding affinity for plasma proteins (99%). Metabolism and elimination are similar after cutaneous and oral administration.

INDICATIONS

- Symptomatic treatment of processes that present with [INFLAMMATION] and/or [ACUTE PAIN], such as:

* [CONTUSION] or [SPRAIN] caused by twists.

LACTATION

Animal safety: no data available.

Human safety: Diclofenac is excreted in milk, although it is not believed to produce adverse effects on the nursing infant. Due to insufficient data, a decision must be made whether to discontinue breastfeeding or to discontinue/discontinue treatment, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the woman.

POSOLOGY

"Voltadol dressings"

A medicated adhesive bandage should be applied to the affected area once a day. The maximum daily dose is one medicated adhesive bandage per day, even if more than one injured area is to be treated. Therefore, only one affected 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 that patients with asthma, a history of peptic ulcer, kidney or heart failure, or hypertension adhere to the dosage recommendations.

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 will be performed.