VOLINI Gel

For the local symptomatic relief of pain and inflammation in:

- trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and bruises

- localised forms of soft issue rheumatism

- muscle and joint diseases (rheumatoid arthritis and osteoarthritis, radiculitis, low back pain, ischias)

It is recommended that treatment be reviewed after 14 days in these indications except osteoarthritis. In the treatment of osteoarthritis, therapy should be reviewed after 4 weeks.

DOSE AND ADMINISTRATION

Adults

The gel should be rubbed gently into the skin. Depending of the size of the affected site to be treated 2-4g (a circular shaped mass approximately 2-2.5cm in diameter) should be applied 3-4 times a daily. After application, the hands should be washed unless they are the site being treated.

Use in elderly: The usual adult dosage may be used.

Children: There are insufficient data on efficacy and safely available for the children and adolescents below 14 years of age. In children aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor.

This gel is suitable for the transmission of ultrasound and may be used as a couplant in combination with ultrasound therapy. If large areas of the body are covered with gel, systemic absorption will be greater and the risk of side-effects increased, especially if the therapy is used frequently.

- Patients with or without chronic asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid (aspirin) or other NSAIDs. Severe, rarely fatal anaphylactic-like reactions to NSAIDs have been reported in such patients.

- Setting of coronary artery bypass graft surgery.

- Patients with a known hypersensitivity to diclofenac, linseed oil, racementhol and methyl salicylate or any of the excipients.

- Third trimester of pregnancy.

- Children and adolescents aged less than 14 years.

See the package insert about details below:

Aspirin, Anticoagulants, ACE-inhibitors, Diuretics, Lithium, Methotrexate, Cyclosporine, Oral NSAIDs, Topical Treatments

(See the package insert about details.)

Pregnancy

During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

Diclofenac is contraindicated during the third trimester of pregnancy.

Lactation

Because of a lack of controlled studies in lactating women, the product should only be used during lactation under advice from a healthcare professional. Under this circumstance, gel should not be applied on the breasts of nursing mothers, nor do elsewhere on large areas of skin or for a prolonged period of time.

The possibility of systemic adverse events from application of gel cannot be excluded if the preparation is used on large areas of skin and over a prolonged period.

Concomitant use of oral NSAID’s should be cautioned as the incidence of untoward effects, particularly systemic side effects, may increase.

Diclofenac diethylamine, linseed oil, methyl salicylate and racementhol get should not be co-administered with other products containing diclofenac.

Diclofenac diethylamine, linseed oil, methyl salicylate and racementhol get should be applied only in intact, non-diseased skin and not to skin wounds or open injuries. It should not be allowed to come into contact with the eyes or mucous membranes, and should not be infested.

Diclofenac diethylamine, linseed oil, methyl salicylate and racementhol gel can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.

Menthol may give rise to hypersensitivity reactions including contact dermatitis. Ingestion of significant quantities of menthol is reported to cause symptoms similar to those seen after ingestion of camphor including severe abdominal pain, nausea, vomiting, vertigo, ataxia, drowsiness, and coma.

This gel contains propylene glycol, which may cause mild, localized skin irritation in some people.

See the package insert about details below:

Cardiovascular Thrombotic Events

Gastrointestinal Effects: Risk of GI Ulceration, Bleeding, and Perforation

Hepatic Effects

Hypertension

Congestive Heart Failure and Edema

Renal Effects

Anaphylactoid Reactions

Skin Reactions

Pregnancy

Corticosteroid treatment

Inflammation

Hematological Effects

Pre-existing Asthma

Sun Exposure

Eye Exposure

Laboratory Tests

Effects on ability to drive and use machines

Information for Patients

Diclofenac

Diclofenac inhibits the enzyme, cyclooxygenase (COX), an early component of the arachidonic acid cascade, resulting in the reduced formation of prostaglandins, thromboxanes and prostacyclin. It is not completely understood how reduced synthesis of these compounds results in therapeutic efficacy.

Diclofenac linseed oil, methyl salicylate and racementhol gel has anti-inflammatory, anti-nociception, and antipyretic effects.

Linseed oil

Alpha-Linolenic acid is the main constituent of linseed oil. Alpha-linolenic acid gets converted to eicosapentaenoic acid (EPA). EPA is acted upon by cyclo-oxygenase enzyme to produce Prostaglandin E2, which decreases inflammation. Presence of EPA prevents the action of cyclo-oxygenase on arachidonic acid, which reduces its conversion to PGE2 (a highly inflammatory agent).

Methyl salicylate

Methyl salicylate is an irritant to the skin and is used topically in rubefacient preparations for the relief of pain in musculoskeletal, joint, and soft tissue disorders.

Racementhol

Racementhol is a racemic mixture of menthol. When menthol applied to the skin it dilates the blood vessels causing a sensation of coldness followed by an analgesic effect. In addition it also helps to relieve itching and is used in pruritus and urticaria. It has also been applied to the forehead, presumably as a counter-irritant.

This analgesic preparation is designed for external application. Due to an aqueous-alcoholic base the gel exerts a soothing and cooling effect.