Voltadol/Voltaren/Voltarol 11,6 Mg/G Gel 60g

Voltadol/Voltaren/Voltarol 11,6 Mg/G Gel 60g

Active substance: Diclofenac

Voltadol, Voltaren or Voltarol is the same product with different names depending on the country in wich it is sold, we sell the Spanish version called Voltadol.

You can buy Voltadol/Voltaren 60 grams online from UK, Austria, Belgium, Cyprus, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Slovakia and Slovenia. 

ACTION AND MECHANISM

- Voltadol Gel is an anti-inflammatory and topical analgesic. Diclofenac is a non-steroidal anti-inflammatory drug derived from phenylacetic acid, which acts by preventing the synthesis of prostaglandins and other prostanoids, by inhibiting cyclooxygenase that is involved in inflammatory processes.

PHARMACOKINETICS

Topical route:
- Absorption:
* Gel: Bioavailability of 6%. The Cmax is 15-53.8 ng / ml, reached after 10-14 h of application.
- Distribution: High plasma protein binding (99%), mainly albumin. Vd of 1.3 l / kg.
- Metabolism: It is almost completely metabolized in the liver, by hydroxylation reactions and conjugation with glucuronic.
- Elimination: It is eliminated in urine (65%) and bile (35%), mainly as conjugated metabolites. Small amounts of unchanged diclofenac in urine and bile are detected. The t1 / 2 is 2 h.

VOLTADOL/VOLTAREN GEL INDICATIONS

- [PAIN]. Symptomatic treatment of acute inflammatory and / or painful processes, such as:
* [CONTUSION] or [ESGUINCE] produced by kinks.
* [TORTICOLIS] or other [CONTRACTOR].
* [LUMBALGIA].
* Acute or posttraumatic osteomuscular processes, such as [TENDINITIS], [TENOSINOVITIS], [ARTHRITIS].
- [ARTHRISIS].

POSOLOGY

- Diclofenac Kern Pharma, Diclokern, Voltadol and Voltadol Forte (adults and adolescents over 14 years): apply a thin layer (2-4 g gel, equivalent to the size of a cherry or walnut, respectively), 3-4 times Day or 1 application every 12 hours (preferably morning and evening) in the case of Voltadol Forte.

RULES FOR CORRECT ADMINISTRATION

It should be avoided in areas of skin that present dermatitis, open wounds, burns or infections, as well as covering the area with occlusive dressings, as it could favor a greater systemic absorption of diclofenac.
Avoid application near the eyes as well as mucous membranes.
After the application, hands should be washed unless they are the treatment site.
If symptoms continue or worsen after 5 days of use, consult your doctor and / or pharmacist.

- Emulsion, gel: It will be applied over the area to be treated, performing a massage until the gel is absorbed. Wash your hands then.

CONTRAINDICATIONS

- Hypersensitivity to diclofenac or to any of the other ingredients. There are reports of cross-allergic reactions between different NSAIDs as well as salicylates, so diclofenac is not recommended for [NSAID ALLERGY] or [SALICILATE ALLERGY].
- [PEPTICAL ULCER] active. Although topical application limits the absorption of diclofenac, its use is not recommended in patients with peptic ulcer due to the potential worsening of the ulcer.

PRECAUTIONS

- [PHOTOSENSIBILITY REACTIONS]. Diclofenac has led to photosensitivity reactions. It is recommended not to expose treated areas to the sun or UV light for at least one day.
- Systemic reactions. The risk of systemic reactions to diclofenac topical is minimal, but can not be ruled out if there is significant systemic absorption, such as may occur in areas of damaged skin (dermatitis, burns, wounds) or occlusive dressing . Adherence to dosing recommendations in patients with asthma, history of peptic ulcer, renal or cardiac failure, as well as hypertension is recommended.

WARNINGS ABOUT EXCIPIENTS:

- This medicinal product contains propylene glycol, therefore may cause skin irritation.

PATIENT TIPS

- Consult with your doctor and / or pharmacist if allergic reactions to other anti-inflammatory agents, including acetylsalicylic acid, have been reported.
- Do not cover the area with occlusive bandages.
- It should not be applied on areas of skin with burns, open wounds, dermatitis or infections.
- Do not expose treated areas to the sun or to UVA light sources until at least one day after the last application.
- If symptoms continue or worsen after 3 days of use, consult your doctor and / or pharmacist.
- Apply to the skin by performing a massage until the gel is absorbed.

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 appear.
In addition, and as with any topical treatment, it is not advisable to administer two topical medications at a time over the same area.

PREGNANCY

- Category C (D) of the FDA. Category C during the first 30 weeks of pregnancy and category D as of the 30th week of pregnancy. Approximately 10% of the topical dose is absorbed systemically with a considerably lower bioavailability by topical route than by oral route. There are no adequate and well-controlled studies in humans with topical diclofenac, but systemic diclofenac has resulted in fetal toxic effects in the late stages of pregnancy. Although the skin absorption is minimal, it can not be ruled out that no systemic effects appear.
The topical use of diclofenac during the first two trimesters of pregnancy is only accepted if there are no safer alternative therapies, and the benefits outweigh the possible risks.
The use of diclofenac during the third trimester of pregnancy is contraindicated, since diclofenac has been associated with delayed delivery, and cardiovascular adverse effects on the fetus, such as premature closure of the ductus arteriosus and pulmonary hypertension, and renal, such as acute renal failure And oligohydramnios. It can also increase bleeding time in the mother.

LACTATION

It is not known whether topical diclofenac is excreted in milk, and the consequences it may have for the infant. Approximately 10% of the topically applied dose is absorbed systemically. Systemic diclofenac is excreted in small amounts with breast milk. Some experts accept the use of diclofenac topical during breastfeeding. Manufacturers advise discontinuing breastfeeding or avoiding breastfeeding.

CHILDREN

See Dosage.

ELDERLY

Elderly people may be especially susceptible to the adverse reactions of diclofenac, so it is recommended to use with caution.

ADVERSE REACTIONS

- Dermatologic: Common (1-10%) local reactions in the area of ​​application, such as [PRURITO], [CUTANEOUS IRRITATION], [ERYTHEMA], [EXANEMATIC ERUPTIONS], with occasional pustules or papules.
- Allergic: Uncommon (0.1-1.0%) [HYPERSENSITIVITY REACTIONS], [CONTACT DERMATITIS]; Specific cases of [ANAFILAXIA], [ANGIOEDEMA] and [PHOTOSENSIBILITY REACTIONS].
In case of significant absorption, systemic adverse reactions of diclofenac may occur.

OVERDOSE

Symptoms: Due to the route of administration, symptoms are not very likely to occur in the event of an overdose, although accidental ingestion or inappropriate application may produce typical systemic adverse effects.
Treatment: In case of accidental ingestion, stomach washing and symptomatic treatment will be performed.