Voltadol 11.6 Mg/G Topical Gel 75 G With Applicator Cap

Voltadol (11.6 Mg/G Topical Gel 75 G with Applicator Cap)
Active ingredient: Diclofenac

Voltadol is a topical diclofenac gel indicated for the relief of pain and local inflammation in acute musculoskeletal processes. Its presentation with an applicator cap facilitates the precise application of the gel on the affected area, acting directly on the area to reduce pain and inflammation.

ACTION AND MECHANISM
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) derived from phenylacetic acid that inhibits the synthesis of prostaglandins and other mediators of inflammation by inhibiting the enzyme cyclooxygenase. This helps to reduce inflammation and pain in a localized manner.

PHARMACOKINETICS
Topical route

• Absorption : Bioavailability is 6%, reaching maximum concentrations (Cmax) of between 15 and 53.8 ng/ml 10-14 hours after application.
• Distribution : High binding to plasma proteins (99%), mainly to albumin. Volume of distribution (Vd) of 1.3 l/kg.
• Metabolism : It is almost completely metabolized in the liver by hydroxylation and conjugation with glucuronic acid.
• Elimination : It is eliminated mainly in urine (65%) and to a lesser extent in bile (35%), mainly as conjugated metabolites. Elimination half-life (t1/2) of 2 hours.

INDICATIONS
Symptomatic treatment of acute inflammatory and/or painful processes, such as:

• Contusion or sprain caused by twisting.
• Torticollis or other muscle contractures.
• Low back pain.

POSOLOGY

• Adults and adolescents over 14 years : Apply a thin layer of gel (2-4 g, equivalent to the size of a cherry or walnut) 3-4 times a day to the affected area.

RULES FOR CORRECT ADMINISTRATION

• Apply only to healthy, intact skin, avoiding use on areas with open wounds, lesions, burns or infections.
• Do not cover the treated area with occlusive dressings.
• Avoid contact with eyes and mucous membranes.
• Wash hands after application, unless they are the treatment area.
• Gently massage the treated area until the gel is completely absorbed.
• If symptoms persist or worsen after 7 days of use, it is recommended to consult a doctor or pharmacist.

CONTRAINDICATIONS

• Hypersensitivity to diclofenac or any of the components of the medication.
• Known allergy to NSAIDs or salicylates due to possible cross-reactions.
• Patients with a history of asthma attacks, urticaria or rhinitis caused by acetylsalicylic acid or other NSAIDs.
• Do not apply to open wounds, eczematous lesions, mucous membranes or burns.
• Contraindicated in children and adolescents under 14 years of age.
• Contraindicated during the third trimester of pregnancy.
• Do not administer together with other products containing diclofenac.

PRECAUTIONS

• Photosensitivity reactions : Diclofenac may cause photosensitivity reactions; it is recommended not to expose the treated areas to sunlight or UV light for at least one day after application.
• Systemic reactions : Although the risk is low, it may be increased if the gel is applied to areas of damaged skin or if an occlusive dressing is used. Dosage recommendations should be followed in patients with asthma, history of peptic ulcer, renal or cardiac insufficiency, and hypertension.

ADVICE TO THE PATIENT

• Consult your doctor if you have had allergic reactions to other NSAIDs, including aspirin.
• Do not cover the treated area with occlusive dressings.
• Do not apply on burned skin, open wounds, dermatitis or infections.
• Do not expose the treated area to the sun or UVA light sources for at least one day after the last application.
• Consult your doctor or pharmacist if symptoms persist or worsen after several days of use.
• Apply the gel with a gentle massage until completely absorbed.

INTERACTIONS
No significant interactions have been described at the doses recommended for topical use. However, in case of significant systemic absorption, the same interactions as with systemic diclofenac could occur. Simultaneous application of other topical treatments to the same area is not recommended.

PREGNANCY

• Safety in animals : No adverse effects were observed on prenatal, perinatal and postnatal development.
• Safety in humans : Approximately 10% of the topical dose is absorbed systemically, with bioavailability being considerably lower than that obtained by oral administration. Although there are no adequate studies in humans, systemic diclofenac has shown adverse fetal effects during the final stages of pregnancy.
  • First two trimesters : Acceptable use if there are no safer alternatives and the benefits outweigh the risks.
  • Third trimester : Contraindicated, as it has been associated with delayed delivery and adverse cardiovascular and renal effects in the fetus, such as premature closure of the ductus arteriosus and acute renal failure.

BREASTFEEDING
It is not known whether topical diclofenac is excreted in breast milk. Systemic diclofenac is excreted in small amounts in breast milk, so manufacturers advise stopping breastfeeding or avoiding administration, evaluating the benefits for the mother and the risks for the infant.

CHILDREN
Not recommended for children under 14 years of age.

ELDERLY
The elderly are more susceptible to adverse reactions from diclofenac, so it should be used with caution.

ADVERSE REACTIONS

• Dermatological : Common (1-10%) such as pruritus, skin irritation, erythema, exanthematous eruptions, and occasional appearance of pustules or papules.
• Allergic : Uncommon (0.1-1.0%) such as hypersensitivity reactions, contact dermatitis, anaphylaxis, angioedema and photosensitivity reactions.
  In case of significant absorption, systemic adverse effects similar to those of oral diclofenac may occur.

ADVERSE REACTIONS RELATED TO EXCIPIENTS

• This medicine contains propylene glycol, which may cause skin irritation.

OVERDOSE

• Symptoms : Unlikely given the route of administration, although accidental ingestion or excessive application could cause systemic adverse effects typical of diclofenac.
• Treatment : In case of accidental ingestion, gastric lavage is recommended and symptomatic treatment administered according to medical criteria.

See leaflet Voltadol 11.6 Mg/G Topical Gel 75 G With Applicator Cap

See Technical Data Sheet Voltadol 11.6 Mg/G Topical Gel 75 G With Applicator Cap