Voltex Kool Gel

Voltex Kool Gel

diclofenac

Manufacturer:

Favorex

Distributor:

DKSH
Full Prescribing Info
Contents
Diclofenac diethylammonium.
Description
Each 100 g contains diclofenac diethylammonium equivalent to diclofenac sodium 1 g.
Action
Voltex Kool is an anti-inflammatory and analgesic preparation for topical application. The white, creamy, non-greasy preparation is easy to rub into the skin, and its aqueous-alcohol base gives it a soothing and cooling effect. In inflammation of traumatic or rheumatic origin, it relieves pain, reduces oedema, and also affords effective relief from tenderness and pain on movement.
Indications/Uses
Local treatment of: Traumatic inflammation of the tendons, ligaments, muscles, and joints eg, due to sprains, strains or bruises.
Localized forms of soft tissue rheumatism eg, tendovaginitis, shoulder-hand syndrome, and bursitis.
Localized rheumatic diseases eg, osteoarthrosis of peripheral joints and of the vertebral column, periarthropathy.
Dosage/Direction for Use
Apply 2-4 g of Voltex Kool, 3-4 times daily to the affected sites and rub in gently.
Overdosage
In the event of significant systemic side effects occurring as a result of improper use or accidental overdosage (eg, in children), it should be treated with the general therapeutic measures employed to manage poisoning with nonsteroidal anti-inflammatory drugs.
Contraindications
Hypersensitivity to diclofenac, acetylsalicylic acid and other nonsteroidal anti-inflammatory agents, as well as to isopropanol or propylene glycol.
Special Precautions
Voltex Kool should be applied only to intact skin, and not to skin wounds or open injuries. It should not be allowed to come in contact with the eye or mucous membranes.
Use in pregnancy & lactation: 1st & 2nd Trimesters: Pregnancy Category B: Animal studies have shown no risk to the fetus, but no controlled studies are available in pregnant women.
3rd Trimester: Pregnancy Category D: It should not be used owing to risk of premature closure of the ductus arteriosus and suppression of uterine contractility.
Measurable quantities of the active substance should not be seen in the breast milk, but no experience is available in breastfeeding women.
Use in children: No dosage recommendations and indications have been established to date for the use in children.
Use In Pregnancy & Lactation
1st & 2nd Trimesters: Pregnancy Category B: Animal studies have shown no risk to the fetus, but no controlled studies are available in pregnant women.
3rd Trimester: Pregnancy Category D: It should not be used owing to risk of premature closure of the ductus arteriosus and suppression of uterine contractility.
Measurable quantities of the active substance should not be seen in the breast milk, but no experience is available in breastfeeding women.
Side Effects
Itching, reddening, or smarting of the skin or outbreak of a skin rash may occasionally occur. Photosensitivity reactions have been observed in isolated cases.
Where Voltex Kool is applied to large areas of the skin and over prolonged periods, the possibility of systemic side effects cannot be completely excluded.
Drug Interactions
No drug interactions have been reported.
Storage
Store <25°C. Protect from light.
ATC Classification
M02AA15 - diclofenac ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
Presentation/Packing
Topical gel 1 g/100 g x 25 g, 50 g.
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