ACTION AND MECHANISM

- Topical anti-inflammatory and analgesic. Diclofenac is a non-steroidal anti-inflammatory drug derived from phenylacetic acid. It works by preventing the synthesis of prostaglandins and other prostanoids by inhibiting cyclooxygenase, which is involved in inflammatory processes.

SENIORS

The elderly may be especially susceptible to adverse reactions from diclofenac, so caution is advised when using it.

PATIENT ADVICE

- Consult your doctor and/or pharmacist if you have previously reported allergic reactions to other anti-inflammatory drugs, including aspirin.

- Do not cover the area with occlusive dressings.

- It should not be applied to areas of skin with burns, open wounds, dermatitis or infections.

- Do not expose treated areas to the sun or UVA light sources until at least one day after the last application.

- Consult your doctor and/or pharmacist if symptoms persist or worsen after the days indicated in the package leaflet for the corresponding presentation.

CONTRAINDICATIONS

- Hypersensitivity to diclofenac or any other component of the medication. There have been reports of cross-allergic reactions between different NSAIDs, as well as with salicylates, so diclofenac is not recommended in cases of [NSAID ALLERGY] or [SALICYLATE ALLERGY].

- In patients who have previously suffered attacks of [ASTHMA], [URTICARIA] or [RHINITIS] caused by acetylsalicylic acid or another non-steroidal anti-inflammatory drug (NSAID).

- Do not apply to wounds, eczematous lesions, mucous membranes, or burns.

- In children and adolescents under 14 years of age.

- In the third trimester of pregnancy.

- Do not administer concomitantly with other products containing diclofenac

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

Topical route:

INDICATIONS

- [PAIN]. Symptomatic treatment of acute inflammatory and/or painful processes, such as:

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

INTERACTIONS

No interactions have been reported at the recommended doses. However, in the case of significant systemic absorption, the same interactions as with systemic diclofenac may occur.

Additionally, as with any topical treatment, it is not advisable to administer two topical medications at the same time on the same area.

LACTATION

It is unknown whether topical diclofenac is excreted in breast milk, and what consequences this may have for the nursing infant. Approximately 10% of the topically applied dose is absorbed systemically. Systemic diclofenac is excreted in small amounts in breast milk. The manufacturers advise discontinuing breastfeeding or avoiding its administration.

CHILDREN

See the dosage section for details of the age at which it can be used in children.

RULES FOR CORRECT ADMINISTRATION

- It should be applied on healthy, intact skin, without lesions or open wounds.

- It is not recommended to cover the area with occlusive dressings.

- Application near the eyes and mucous membranes should be avoided.

- After application, hands should be washed unless they are the treatment site.

POSOLOGY

"Voltadol Forte"

- Adults and adolescents over 14 years: apply a thin layer (2-4 g of gel, equivalent to the size of a cherry or walnut, respectively) every 12 hours (preferably morning and night).

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.

ADVERSE REACTIONS RELATED TO EXCIPIENTS

- Because it contains butyl hydroxytoluene as an excipient, it may produce local skin reactions, such as [CONTACT DERMATITIS], [EYE IRRITATION] or [SKIN IRRITATION] on mucous membranes.

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.